[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-warning-letter-conroe-welding-supply-inc-731507-10292026":3,"fda-latest-sync-dates":30},{"id":4,"letter_id":5,"action_type":6,"firm_name":7,"fei_number":8,"issuing_office":9,"subject":10,"posted_date":11,"action_taken_date":12,"response_letter_date":8,"closeout_date":8,"case_status":13,"letter_url":14,"reference_number":15,"marcs_cms_no":16,"product_type":17,"delivery_method":18,"recipient_name":19,"recipient_title":8,"body_html":20,"body_text":21,"body_fetched_at":22,"medical_device_id":8,"raw":23,"created_at":28,"updated_at":29},22111,"conroe-welding-supply-inc-731507-10292026","Warning Letter","Conroe Welding Supply, Inc.",null,"Center for Drug Evaluation and Research (CDER)","CGMP\u002FMedical Gases\u002FAdulterated","2026-11-03","2026-10-29","Issued","https:\u002F\u002Fwww.fda.gov\u002Finspections-compliance-enforcement-and-criminal-investigations\u002Fwarning-letters\u002Fconroe-welding-supply-inc-731507-10292026","320-27-16","731507","Drugs","VIA ELECTRONIC MAIL READ\u002FDELIVERY RECEIPT REQUESTED","Mr. Ricky Morton","\n\n                            \n                            \n                            \n                            \n                                              \n  \n \n\n                 \n\n  \u003Chr>\n \n\n\u003Cdiv>\n  \u003Cdl>\n\n              \u003Cdt>Delivery Method:\u003C\u002Fdt> \n        \u003Cdd>VIA ELECTRONIC MAIL READ\u002FDELIVERY RECEIPT REQUESTED\n                                                                                                                                                                                                                                                                                                                                                                                                                              \u003C\u002Fdd>\n      \n              \u003Cdt>Reference #:\u003C\u002Fdt> \n        \u003Cdd>320-27-16\u003C\u002Fdd>\n      \n              \u003Cdt>Product:\u003C\u002Fdt> \n        \u003Cdd>Drugs                          \n            \n            \n            \n            \n            \n            \n            \n             \n            \n            \n            \n              \n            \n            \n            \u003C\u002Fdd>\n      \n          \u003C\u002Fdl>\n  \u003C\u002Fdiv>            \n\n\n\u003Chr>\n\n\u003Cdiv>\n  \u003Cdiv>\n    \u003Cdl>\n\n        \u003Cdt>Recipient:\u003C\u002Fdt>\n\n                      \u003Cdd>\n  \u003Cdiv>\n    \u003Cdiv>Recipient Name\u003C\u002Fdiv>\n              \u003Cdiv>Mr. Ricky Morton\u003C\u002Fdiv>\n          \u003C\u002Fdiv>\n\u003C\u002Fdd>\n                                \u003Cdd>\n  \u003Cdiv>\n    \u003Cdiv>Recipient Title\u003C\u002Fdiv>\n              \u003Cdiv>Acting President\u003C\u002Fdiv>\n          \u003C\u002Fdiv>\n\u003C\u002Fdd>\n          \n            \u003Cdd>Conroe Welding Supply, Inc.\u003C\u002Fdd>\n\n          \n                      \u003Cdd>\u003Cp>\u003Cspan>4425 North Frazier Street\u003C\u002Fspan>\u003Cbr>\n\u003Cspan>Conroe\u003C\u002Fspan>, \u003Cspan>TX\u003C\u002Fspan> \u003Cspan>77303\u003C\u002Fspan>\u003Cbr>\n\u003Cspan>United States\u003C\u002Fspan>\u003C\u002Fp>\u003C\u002Fdd>\n          \n          \n            \n            \u003Cdd>\n\n    \u003C\u002Fdd>\u003Cdd>\u003Cspan>\u003C\u002Fspan>\u003Ca href=\"mailto:(b)(4)\"> (b)(4)\u003C\u002Fa>\u003C\u002Fdd>\n\n          \n    \u003C\u002Fdl>\n  \u003C\u002Fdiv>            \n\n       \u003Cdiv>\n    \u003Cdl>\n          \n          \u003Cdt>Issuing Office:\u003C\u002Fdt>\n        \n         \n          \u003Cdd>Center for Drug Evaluation and Research (CDER)\u003C\u002Fdd>\n        \n         \n          \u003Cdd>\u003Cp>\u003Cspan>United States\u003C\u002Fspan>\u003C\u002Fp>\u003C\u002Fdd>\n        \n        \n        \n        \n        \n    \u003C\u002Fdl>\n    \u003Cdl> \n      \n    \u003C\u002Fdl>\n  \u003C\u002Fdiv>  \n      \n\u003C\u002Fdiv>\n\n \n\n \n\n\u003Chr>\n\n\u003Cp>October 29, 2026\u003C\u002Fp>\u003Cp>\u003Cstrong>WARNING LETTER\u003C\u002Fstrong>\u003Cbr>Reference number: 320-27-16\u003C\u002Fp>\u003Cp>To Mr. Ricky Morton:\u003C\u002Fp>\u003Cp>This warning letter advises you of significant violations identified during a U.S. Food and Drug Administration (FDA) inspection of your facility and provides you an opportunity to address them. Promptly address any violations described herein without delay, including ensuring that appropriate resources are allocated to fully address them and prevent their recurrence. This is not intended to be an all-inclusive list of the violations that exist at your facility. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations. Failure to adequately address any violations may result in regulatory or legal action without further notice.\u003C\u002Fp>\u003Cp>\u003Cstrong>FDA Inspection\u003C\u002Fstrong>\u003C\u002Fp>\u003Cp>Violations were identified and documented during an inspection of your drug manufacturing facility, Conroe Welding Supply, Inc., FDA Establishment Identifier (FEI) 1625647, at 4425 North Frazier Street, Conroe, from March 30 to April 3, 2026. This inspection was conducted under FDA’s statutory authority and public health responsibilities to protect the public from unsafe, ineffective, and poor quality drugs, including medical gases.\u003C\u002Fp>\u003Cp>This warning letter summarizes significant violations of Current Good Manufacturing Practice (CGMP) regulations for medical gases. See Title 21 Code of Federal Regulations (CFR), part 213 (21 CFR part 213).\u003C\u002Fp>\u003Cp>Because your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your drug products are adulterated within the meaning of section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), (21 U.S.C. 351(a)(2)(B)).\u003C\u002Fp>\u003Cp>\u003Cstrong>Requirements for Medical Gases\u003C\u002Fstrong>\u003C\u002Fp>\u003Cp>Under section 501(a)(2)(B) of the FD&C Act (21 U.S.C. 351(a)(2)(B)), a drug, including a medical gas, is deemed to be adulterated if “the methods used in, or the facilities or controls used for, its manufacture, processing, packing, or holding do not conform to or are not operated or administered in conformity with current good manufacturing practice.” Section 501 of the FD&C Act states that “the term \u003Cem>current good manufacturing practice\u003C\u002Fem> includes the implementation of oversight and controls over the manufacture of drugs to ensure quality, including managing the risk of and establishing the safety of raw materials, materials used in the manufacturing of drugs, and finished drug products.”\u003C\u002Fp>\u003Cp>On June 18, 2024, FDA issued a final rule to take effect on December 18, 2025, revising the requirements concerning CGMP, postmarketing safety reporting, certification, and labeling that apply to certain medical gases. This rule implemented new and revised regulations tailored to medical gases, including CGMP requirements codified in part 213 (21 CFR part 213) and postmarketing quality and safety reporting requirements codified in part 230 (21 CFR part 230). Prior to implementation of these requirements, medical gas manufacturers were subject to the statutory CGMP requirements in section 501(a)(2)(B) of the FD&C Act as well as the regulations for finished pharmaceuticals in parts 210 and 211 (21 CFR parts 210 and 211) and postmarketing quality and safety reporting requirements in part 314 (21 CFR part 314). The requirements codified in parts 213 and 230 are consistent with the prior regulations, including robust quality systems, proper documentation, and timely adverse event reporting, such that the deficiencies observed during the inspection would constitute violations under either regulatory framework.\u003C\u002Fp>\u003Cp>We reviewed your April 15, 2026, response to our Form FDA 483 in detail.\u003C\u002Fp>\u003Cp>\u003Cstrong>Violations of the Federal Food, Drug, and Cosmetic Act\u003C\u002Fstrong>\u003C\u002Fp>\u003Cp>The following are violations identified during our inspection and review. As a reminder, this is not an all-inclusive list of violations at your facility.\u003C\u002Fp>\u003Cp>\u003Cstrong>1. Your firm failed to have, for each batch of medical gas, appropriate laboratory determination of satisfactory conformance to final specifications for the medical gas, including the identity and strength of each active ingredient, prior to release (21 CFR 213.165(a)).\u003C\u002Fstrong>\u003Cem>\u003Cstrong>\u003Csup>1\u003C\u002Fsup>\u003C\u002Fstrong>\u003C\u002Fem>\u003C\u002Fp>\u003Cp>Your firm is a manufacturer of Oxygen, USP for administration by inhalation, including for use in hospital settings. Your firm failed to adequately test finished batches of your medical gases for the identity and strength of your active ingredients (Oxygen, USP) before release and distribution, which includes using properly calibrated instruments. For example, while reviewing an investigation into a customer complaint for a medical gas mix-up, our investigator identified that your filling technician reported passing testing results for batches of Oxygen, USP prior to their release without actually performing the required tests. The customer complaint revealed that third-party testing of the Oxygen, USP batches showed the presence of \u003Cstrong>(b)(4)\u003C\u002Fstrong> as high as 99% within the containers. A container labeled as medical oxygen administered to a patient despite having a level of 99% \u003Cstrong>(b)(4)\u003C\u002Fstrong> (and less than 1% oxygen) represents a catastrophic, immediately life-threatening event from complete oxygen deprivation.\u003C\u002Fp>\u003Cp>Appropriate release testing, which includes strength and identity testing of the active ingredient, must be performed before drug product batch release and distribution. Without adequate testing, you do not have adequate scientific evidence to assure that your medical gases conform to appropriate specifications before release. Further, a second person verification (witness) of all critical testing and adequate review of the testing results by the quality unit prior to release of the drug products should be documented to ensure accuracy and accountability.\u003C\u002Fp>\u003Cp>In your response, you state that you are in the process of developing and implementing comprehensive standard operating procedures (SOPs) with the relocation to your new facility, including procedures for testing and release for distribution. Additionally, you state that you are updating your fill logs to include a second-person verification and plan to record all testing results to enhance the accountability of the testing.\u003C\u002Fp>\u003Cp>Your response is inadequate because you failed to provide your finished product specifications for Oxygen, USP, procedures for medical gas testing and release, evidence of proper calibration of your testing instruments, or testing results to demonstrate that your firm can manufacture medical gases that meet all quality attributes.\u003C\u002Fp>\u003Cp>In response to this letter, provide:\u003C\u002Fp>\u003Cul>\u003Cli>A list of all test methods and specifications used to analyze each batch of your drug product before making a batch disposition decision, and the associated written procedures.\u003C\u002Fli>\u003Cli>A comprehensive, independent assessment of your laboratory practices, procedures, methods, equipment, documentation, and analyst competencies. Based on this review, provide a detailed plan to remediate and evaluate the effectiveness of your laboratory system.\u003C\u002Fli>\u003C\u002Ful>\u003Cp>\u003Cstrong>2. Your firm failed to test samples of each incoming designated medical gas for identity and conformity with all appropriate written specifications for purity, strength, and quality. Your firm also failed to validate and establish the reliability of your incoming designated medical gas supplier’s test analyses at appropriate intervals (21 CFR 213.82(a) and 213.82(b)).\u003C\u002Fstrong>\u003Cem>\u003Cstrong>\u003Csup>2\u003C\u002Fsup>\u003C\u002Fstrong>\u003C\u002Fem>\u003C\u002Fp>\u003Cp>Your firm failed to conduct identity testing for each incoming designated medical gas (DMG) lot used in medical gas manufacturing, including Oxygen, USP. Additionally, you relied on your supplier’s certificates of analysis (COA) of your incoming DMG without establishing the reliability of your supplier’s test analyses at appropriate intervals.\u003C\u002Fp>\u003Cp>CGMP requires identity testing for each DMG lot used in medical gas manufacturing, and you can only rely on the COA for other DMG attributes if you also appropriately validate the supplier’s testing results at appropriate intervals.\u003C\u002Fp>\u003Cp>In your response, you state that you are in the process of developing and implementing comprehensive SOPs as part of the relocation to your new facility, including procedures for control of incoming medical gases as well as supplier qualification and vendor audits. Additionally, you state that you will initiate \u003Cstrong>(b)(4)\u003C\u002Fstrong> vendor audits to ensure supplier compliance with applicable quality and regulatory requirements.\u003C\u002Fp>\u003Cp>Your response is inadequate because you have not provided your specifications for your incoming DMG, procedures for testing and release of incoming DMG, evidence of proper calibration of testing instruments, or testing results to demonstrate that your firm can test your incoming DMG to ensure that they meet all quality attributes prior to use in medical gas manufacturing.\u003C\u002Fp>\u003Cp>In your response to this letter, provide:\u003C\u002Fp>\u003Cul>\u003Cli>A comprehensive, independent review of your material system, including but not limited to:\u003Cbr>o Evaluating all suppliers of materials (DMGs, containers, and closures) to determine if they are reliable and appropriately qualified\u003Cbr>o An assessment of all materials to determine whether they are consistently of acceptable quality\u003Cbr>o A review to ensure assigned expiration or retest dates are appropriate (supported by data)\u003Cbr>o Adequacy of the supplier qualification program, and its selection, qualification, and disqualification provisions\u003C\u002Fli>\u003Cli>Based on a thorough review, provide a summary of your system’s corrective action and preventive action (CAPA) to remediate the vendor qualification program and prevent use of unsuitable DMGs, containers and closures.\u003C\u002Fli>\u003Cli>All quality control specifications you use to test and release each incoming lot of DMGs for use in manufacturing.\u003C\u002Fli>\u003Cli>A description of how you will test each DMG lot for conformity with all appropriate specifications for identity, strength, quality, and purity. If you intend to accept any results from your supplier’s COA instead of testing each DMG lot for strength, quality, and purity, specify how you will robustly establish the reliability of your supplier’s results through initial validation as well as periodic revalidation. In addition, include a commitment to always conduct at least one specific identity test for each incoming DMG lot.\u003C\u002Fli>\u003Cli>A summary of results obtained from testing all DMG to evaluate the reliability of the COA from each DMG manufacturer. Include your SOP that describes this COA validation program.\u003C\u002Fli>\u003Cli>A summary of your program for qualifying and overseeing contract facilities that test the DMGs and medical gases you manufacture.\u003C\u002Fli>\u003Cli>An independent, comprehensive review of your material system to determine whether all suppliers of DMGs, containers, and closures, are appropriately qualified; materials are of consistently acceptable quality; and appropriate expiration or retest dates are assigned. Based on this systemic review, provide a summary of a systemic CAPA that remediates your vendor qualification program and prevents use of unsuitable DMGs, containers, and closures.\u003C\u002Fli>\u003C\u002Ful>\u003Cp>\u003Cstrong>3. Your firm failed to establish and follow adequate written procedures describing the handling of all written and oral complaints regarding a medical gas, including provisions for review by the quality control unit of any complaint involving the possible failure of a medical gas to meet any of its specifications and, for such medical gas, a determination as to the need for an investigation in accordance with 21 CFR 213.192 (21 CFR 213.198(a)).\u003C\u002Fstrong>\u003Cem>\u003Cstrong>\u003Csup>3\u003C\u002Fsup>\u003C\u002Fstrong>\u003C\u002Fem>\u003C\u002Fp>\u003Cp>A hospital contacted your firm in October 2025 to report the presence of \u003Cstrong>(b)(4)\u003C\u002Fstrong> in containers of Oxygen, USP that you filled and distributed to them. You stated to our investigator that you told the complainant it was impossible to have \u003Cstrong>(b)(4)\u003C\u002Fstrong> in the oxygen tank and subsequently failed to document and investigate the incident in a timely manner per your complaint handling procedure. It was not until after the complainant conducted third-party testing on the contents of the containers and sent you a termination of services letter on November 20, 2025, that you initiated an investigation into the complaint.\u003C\u002Fp>\u003Cp>Your firm’s investigations into the errant Oxygen, USP containers were deficient. Your firm’s investigations revealed that the errant Oxygen, USP containers were filled with \u003Cstrong>(b)(4)\u003C\u002Fstrong> during repair by a third party, but upon receipt by your firm, your filling technician failed to test the lot as required. However, your investigations did not consider other containers repaired by the third party; other Oxygen, USP batches that may be affected by the incident; or remediations beyond employee termination and additional employee training.\u003C\u002Fp>\u003Cp>Additionally, you received a complaint from a different hospital about batches of high-pressure Oxygen, USP that contained liquid (e.g., water). Your firm’s investigation into the incident was inconclusive regarding the source of the water and hypothesized that the new equipment with your relocation would be sufficient to \u003Cstrong>(b)(4)\u003C\u002Fstrong> any residual water. Your investigation failed to consider incoming DMGs or process-related water sources; other finished Oxygen, USP batches that may be affected by the incident; or corrections that would be appropriate to remediate the cause of the incident. The presence of condensation or water in medical grade oxygen (high-pressure cylinders\u002Ftanks) can pose multiple potential risks to patients, including microbial growth, aspiration of aerosolized water droplets, particulate exposure due to internal corrosion, and\u002For obstruction of oxygen flow.\u003C\u002Fp>\u003Cp>In your response, you state that you are in the process of developing and implementing comprehensive SOPs as part of the relocation to your new facility, including procedures for complaint files, as well as CAPA. Additionally, you state that you have scheduled an interview with the third party that repairs your medical gas containers to finish the complaint investigation into the mix-up incident.\u003C\u002Fp>\u003Cp>Your response is inadequate because you failed to provide sufficient details for how you intend to handle complaints and implement appropriate CAPA. You also did not provide adequate details of your expanded investigations into the complaint incidents related to other batches of medical gases that may be affected, consideration of other sources of the manufacturing defects, and identification of adequate CAPA plans.\u003C\u002Fp>\u003Cp>In your response to this letter, provide:\u003C\u002Fp>\u003Cul>\u003Cli>A comprehensive, independent assessment of your overall system for investigating deviations, discrepancies, complaints, out-of-specification results, and failures. Provide a detailed action plan to remediate this system. Your action plan should include, but not be limited to, significant improvements in investigation competencies, scope determination, root cause evaluation, CAPA effectiveness, quality unit oversight, and written procedures. Address how your firm will ensure all phases of investigations are appropriately conducted.\u003C\u002Fli>\u003Cli>An independent, retrospective review of all critical investigations (including each in-process, release, and stability test specification failure) for the last three years as of the date of this letter. Evaluate the adequacy of each investigation, including but not limited to:\u003Cbr>o Determine whether a thorough review of production (e.g., batch manufacturing records, adequacy of the manufacturing steps, suitability of equipment\u002Ffacilities, variability of raw materials, process capability, deviation history, complaint history, batch failure history) was conducted.\u003Cbr>o Assess sufficiency of review of related data and investigations to identify if there are potential systemic linkages.\u003Cbr>o Evaluate adequacy of scope, rigor, staff competencies, scientific\u002Fanalytical foundation, root cause determinations, and CAPA.\u003Cbr>o Summary of findings of the assessment for each of the above elements.\u003C\u002Fli>\u003Cli>An independent assessment and remediation plan for your CAPA program. Provide a report that evaluates whether the program includes effective root cause analysis, ensures CAPA effectiveness, analyzes investigations trends, improves the CAPA program whenever needed, ensures final quality unit decision authority, and is fully supported by executive management.\u003C\u002Fli>\u003C\u002Ful>\u003Cp>\u003Cstrong>4. Your firm’s quality unit failed to exercise its responsibility to ensure medical gases are manufactured in compliance with CGMP, and meet established specifications for identity, strength, quality, and purity (21 CFR 213.22).\u003C\u002Fstrong>\u003Cem>\u003Cstrong>\u003Csup>4\u003C\u002Fsup>\u003C\u002Fstrong>\u003C\u002Fem>\u003C\u002Fp>\u003Cp>Your firm failed to establish an adequate quality unit (QU) with the responsibilities and authority to oversee the manufacture of medical gases. For example, you failed to ensure:\u003C\u002Fp>\u003Cul>\u003Cli>Assignment of an adequate QU with sufficient responsibilities and authorities (213.22(a)).\u003C\u002Fli>\u003Cli>Establishment of appropriate written procedures for medical gas manufacturing (213.22(c)).\u003C\u002Fli>\u003Cli>Personnel training in CGMP requirements with sufficient frequency (213.25(a)).\u003C\u002Fli>\u003C\u002Ful>\u003Cp>Your QU fundamentally failed to oversee manufacturing procedures, practices, and manufacturing operations. In addition, even when a QU consists of one or only a few persons, those persons are still accountable for ensuring the ongoing effectiveness of all systems and procedures, and for reviewing manufacturing results to ensure a state of control and adherence to all quality standards.\u003C\u002Fp>\u003Cp>In your response, you state that you are in the process of developing and implementing comprehensive SOPs as part of the relocation to your new facility, including quality control procedures, training programs and requirements. Additionally, you state that you are establishing a structured process for conducting internal audits and implementing \u003Cstrong>(b)(4)\u003C\u002Fstrong> reviews of production activities and associated documentation to ensure ongoing compliance, identify gaps proactively, and drive continuous improvement.\u003C\u002Fp>\u003Cp>Your response is inadequate because you failed to provide sufficient detail or evidence of corrective actions taken that will ensure your QU maintains proper oversight of your firm’s operations. Additionally, you failed to include details of how your personnel are adequately trained to perform their assigned functions, including CGMP requirements.\u003C\u002Fp>\u003Cp>Significant findings in this letter demonstrate that your firm does not operate an effective quality system in accordance with CGMP. In addition to the lack of effective management oversight of your production and laboratory operations, we found your QU is not enabled to exercise proper authority and\u002For has insufficiently implemented its responsibilities. Executive management should immediately and comprehensively assess your company’s global manufacturing operations to ensure that your systems, processes, and products conform to FDA requirements.\u003C\u002Fp>\u003Cp>Your firm’s quality systems are inadequate. See FDA’s guidance document \u003Cem>Medical Gases—Current Good Manufacturing Practice\u003C\u002Fem> at https:\u002F\u002Fwww.fda.gov\u002Fmedia\u002F70973\u002Fdownload.\u003C\u002Fp>\u003Cp>In your response to this letter, provide:\u003C\u002Fp>\u003Cul>\u003Cli>A comprehensive assessment and remediation plan to ensure your QU is given the authority and resources to effectively function. The assessment should also include, but not be limited to:\u003Cbr>o A determination of whether procedures used by your firm are robust and appropriate\u003Cbr>o Provisions for QU oversight throughout your operations to evaluate adherence to appropriate practices\u003Cbr>o A complete and final review of each batch and its related information before the QU disposition decision\u003Cbr>o Oversight and approval of investigations and discharging of all other QU duties to ensure identity, strength, quality, and purity of all products\u003Cbr>o Also describe how top management supports quality assurance and reliable operations, including but not limited to timely provision of resources to proactively address emerging manufacturing\u002Fquality issues and to assure a continuing state of control\u003C\u002Fli>\u003Cli>A comprehensive assessment of documentation systems used throughout your manufacturing and laboratory operations to determine where documentation practices are insufficient. Include a detailed CAPA plan that comprehensively remediates your firm’s documentation practices to ensure you retain attributable, legible, complete, original, accurate, contemporaneous records throughout your operation.\u003C\u002Fli>\u003C\u002Ful>\u003Cp>\u003Cstrong>Data Integrity Remediation\u003C\u002Fstrong>\u003C\u002Fp>\u003Cp>Your quality system does not adequately ensure the accuracy and integrity of data to support the safety, effectiveness, and quality of the drugs you manufacture. It may be helpful to refer to FDA’s guidance document \u003Cem>\u003Cu>Data Integrity and Compliance With Drug CGMP: Questions and Answers\u003C\u002Fu>\u003C\u002Fem> for guidance on establishing and following CGMP compliant data integrity practices at https:\u002F\u002Fwww.fda.gov\u002Fmedia\u002F119267\u002Fdownload.\u003C\u002Fp>\u003Cp>We strongly recommend that you retain an independent, qualified third-party consultant to assist in your remediation. In response to this letter, provide:\u003C\u002Fp>\u003Cul>\u003Cli>A comprehensive investigation into the extent of the inaccuracies and inconsistencies in data, records, and reporting. Your investigation should include:\u003Cbr>o A detailed investigation protocol and methodology; a summary of all laboratories, manufacturing operations, and systems to be covered by the assessment; and a justification for any part of your operation that you propose to exclude.\u003Cbr>o Interviews of current and former employees to identify the nature, scope, and root cause of data inaccuracies. We recommend that these interviews be conducted by a qualified third party.\u003Cbr>o An assessment of the extent of data integrity deficiencies at your facility. Identify omissions, alterations, deletions, record destruction, non-contemporaneous record completion, and other deficiencies. Describe all parts of your facility’s operations in which you discovered data integrity deficiencies.\u003Cbr>o A comprehensive retrospective evaluation of the nature of the data integrity deficiencies. We recommend that a qualified third party with specific expertise in the area where potential breaches were identified should evaluate all occurrences.\u003C\u002Fli>\u003Cli>A current risk assessment of the potential effects of the observed failures on the quality of your drugs. Your assessment should include analyses of the risks to patients caused by the release of drugs affected by a data integrity event and analyses of the risks posed by ongoing operations.\u003C\u002Fli>\u003Cli>A management strategy for your firm that includes the details of your global CAPA plan. Your strategy should include:\u003Cbr>o A detailed corrective action plan that describes how you intend to ensure the reliability and completeness of all data, including analytical data, manufacturing records, and all data submitted to FDA.\u003Cbr>o A comprehensive description of the root causes of each data integrity deviation, including evidence that the scope and depth of the current action plan is commensurate with the findings of the investigation and risk assessment. Indicate whether individuals responsible for the data integrity breaches remain able to influence CGMP-related data at your firm.\u003Cbr>o Interim measures describing the actions you have taken or will take to ensure the quality of your drugs and protect patients, such as notifying your customers, recalling product(s), conducting additional testing, adding lots to your stability programs to assure stability, and enhanced complaint monitoring.\u003Cbr>o Long-term measures describing any remediation efforts and enhancements to procedures, processes, methods, controls, systems, management oversight, and human resources (e.g., training, staffing improvements) designed to ensure the integrity of your company’s data.\u003Cbr>o A commitment to have a qualified consultant conduct extensive annual audits, for at least two years, to assist in evaluating CAPA effectiveness after you have executed your data integrity remediation protocol.\u003Cbr>o Inform FDA if you will be hiring a Chief Integrity Officer who is fully empowered to receive anonymous complaints from employees reporting data integrity concerns and with the authority to ensure any potential breach is promptly investigated (by an independent quality assurance function, along with expertise from outside entities whenever needed).\u003Cbr>o A status report for any of the above activities already underway or completed.\u003C\u002Fli>\u003C\u002Ful>\u003Cp>\u003Cstrong>Drug Production Status\u003C\u002Fstrong>\u003C\u002Fp>\u003Cp>Given the concerning state of your manufacturing and testing controls for medical grade gases, the unacceptable patient risks posed by your product defects, and the fact that the majority of your operations are unrelated to medical grade gases, in response to this letter, clarify whether you intend to continue to manufacture drugs (e.g., medical gases) for the U.S. market at this facility.\u003C\u002Fp>\u003Cp>If you plan to continue CGMP activities, you are responsible for resolving all deficiencies and systemic flaws to ensure your firm is capable of ongoing CGMP compliance. In addition, based upon the nature of the violations we identified at your firm, you should engage a consultant qualified as set forth in 21 CFR 213.34 to assist your firm in meeting CGMP requirements. The qualified consultant should also perform a comprehensive six-system audit of your entire operation for CGMP compliance and evaluate the completion and efficacy of all CAPA, before you pursue resolution of your firm’s compliance status with FDA.\u003C\u002Fp>\u003Cp>In your response to this letter, provide a summary of your remediations to demonstrate that you have appropriately completed all CAPA.\u003C\u002Fp>\u003Cp>\u003Cstrong>Conclusion\u003C\u002Fstrong>\u003C\u002Fp>\u003Cp>As previously stated, you are responsible for investigating and determining the root causes of any violations and implementing corrective and preventative measures to ensure future and sustained compliance so that these violations and any others do not occur.\u003C\u002Fp>\u003Cp>Unresolved violations may prevent other Federal agencies from awarding contracts. Failure to address violations may also cause FDA to withhold issuance of Export Certificates. FDA may withhold approval of new applications or supplements listing your firm as a drug manufacturer until any violations are completely addressed and we confirm your compliance with CGMP. We may re-inspect to verify that you have completed corrective actions to address any violations.\u003C\u002Fp>\u003Cp>Send your written response to CDER-OC-OMQ-Communications@fda.hhs.gov within fifteen (15) business days of receipt of this letter. Identify your written response with FEI 1625647 and ATTN: Philip Kreiter in the letter.\u003C\u002Fp>\u003Cp>If you have information that you believe demonstrates that your products are not in violation of the FD&C Act and FDA regulations, include that information for our consideration.\u003C\u002Fp>\u003Cp>Please note FDA posts warning letters on www.FDA.gov.\u003C\u002Fp>\u003Cp>Sincerely,\u003Cbr>\u002FS\u002F\u003C\u002Fp>\u003Cp>Francis Godwin\u003Cbr>Director\u003Cbr>Office of Manufacturing Quality\u003Cbr>Office of Compliance\u003Cbr>Center for Drug Evaluation and Research\u003Cbr>U.S. Food and Drug Administration\u003C\u002Fp>\u003Cp>______________________\u003C\u002Fp>\u003Cp>\u003Cem>\u003Cstrong>1\u003C\u002Fstrong>\u003C\u002Fem> See also 21 CFR 211.165(a)\u003C\u002Fp>\u003Cp>\u003Cem>\u003Cstrong>2\u003C\u002Fstrong>\u003C\u002Fem> See also 21 CFR 211.84(d).\u003C\u002Fp>\u003Cp>\u003Cem>\u003Cstrong>3\u003C\u002Fstrong>\u003C\u002Fem> See also 21 CFR 211.198(a).\u003C\u002Fp>\u003Cp>\u003Cem>\u003Cstrong>4\u003C\u002Fstrong>\u003C\u002Fem> See also 21 CFR 211.22.\u003C\u002Fp>\n\n\n\n\n\n\n              \n                                            \n              \n            ","Delivery Method:\n\nVIA ELECTRONIC MAIL READ\u002FDELIVERY RECEIPT REQUESTED\n\nReference #:\n\n320-27-16\n\nProduct:\n\nDrugs\n\nRecipient:\n\nRecipient Name\n\nMr. Ricky Morton\n\nRecipient Title\n\nActing President\n\nConroe Welding Supply, Inc.\n\n4425 North Frazier Street\n\nConroe, TX 77303\n\nUnited States\n\n(b)(4)\n\nIssuing Office:\n\nCenter for Drug Evaluation and Research (CDER)\n\nUnited States\n\nOctober 29, 2026\nWARNING LETTER\nReference number: 320-27-16\nTo Mr. Ricky Morton:\nThis warning letter advises you of significant violations identified during a U.S. Food and Drug Administration (FDA) inspection of your facility and provides you an opportunity to address them. Promptly address any violations described herein without delay, including ensuring that appropriate resources are allocated to fully address them and prevent their recurrence. This is not intended to be an all-inclusive list of the violations that exist at your facility. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations. Failure to adequately address any violations may result in regulatory or legal action without further notice.\nFDA Inspection\nViolations were identified and documented during an inspection of your drug manufacturing facility, Conroe Welding Supply, Inc., FDA Establishment Identifier (FEI) 1625647, at 4425 North Frazier Street, Conroe, from March 30 to April 3, 2026. This inspection was conducted under FDA’s statutory authority and public health responsibilities to protect the public from unsafe, ineffective, and poor quality drugs, including medical gases.\nThis warning letter summarizes significant violations of Current Good Manufacturing Practice (CGMP) regulations for medical gases. See Title 21 Code of Federal Regulations (CFR), part 213 (21 CFR part 213).\nBecause your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your drug products are adulterated within the meaning of section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), (21 U.S.C. 351(a)(2)(B)).\nRequirements for Medical Gases\nUnder section 501(a)(2)(B) of the FD&C Act (21 U.S.C. 351(a)(2)(B)), a drug, including a medical gas, is deemed to be adulterated if “the methods used in, or the facilities or controls used for, its manufacture, processing, packing, or holding do not conform to or are not operated or administered in conformity with current good manufacturing practice.” Section 501 of the FD&C Act states that “the term current good manufacturing practice includes the implementation of oversight and controls over the manufacture of drugs to ensure quality, including managing the risk of and establishing the safety of raw materials, materials used in the manufacturing of drugs, and finished drug products.”\nOn June 18, 2024, FDA issued a final rule to take effect on December 18, 2025, revising the requirements concerning CGMP, postmarketing safety reporting, certification, and labeling that apply to certain medical gases. This rule implemented new and revised regulations tailored to medical gases, including CGMP requirements codified in part 213 (21 CFR part 213) and postmarketing quality and safety reporting requirements codified in part 230 (21 CFR part 230). Prior to implementation of these requirements, medical gas manufacturers were subject to the statutory CGMP requirements in section 501(a)(2)(B) of the FD&C Act as well as the regulations for finished pharmaceuticals in parts 210 and 211 (21 CFR parts 210 and 211) and postmarketing quality and safety reporting requirements in part 314 (21 CFR part 314). The requirements codified in parts 213 and 230 are consistent with the prior regulations, including robust quality systems, proper documentation, and timely adverse event reporting, such that the deficiencies observed during the inspection would constitute violations under either regulatory framework.\nWe reviewed your April 15, 2026, response to our Form FDA 483 in detail.\nViolations of the Federal Food, Drug, and Cosmetic Act\nThe following are violations identified during our inspection and review. As a reminder, this is not an all-inclusive list of violations at your facility.\n1. Your firm failed to have, for each batch of medical gas, appropriate laboratory determination of satisfactory conformance to final specifications for the medical gas, including the identity and strength of each active ingredient, prior to release (21 CFR 213.165(a)).1\nYour firm is a manufacturer of Oxygen, USP for administration by inhalation, including for use in hospital settings. Your firm failed to adequately test finished batches of your medical gases for the identity and strength of your active ingredients (Oxygen, USP) before release and distribution, which includes using properly calibrated instruments. For example, while reviewing an investigation into a customer complaint for a medical gas mix-up, our investigator identified that your filling technician reported passing testing results for batches of Oxygen, USP prior to their release without actually performing the required tests. The customer complaint revealed that third-party testing of the Oxygen, USP batches showed the presence of (b)(4) as high as 99% within the containers. A container labeled as medical oxygen administered to a patient despite having a level of 99% (b)(4) (and less than 1% oxygen) represents a catastrophic, immediately life-threatening event from complete oxygen deprivation.\nAppropriate release testing, which includes strength and identity testing of the active ingredient, must be performed before drug product batch release and distribution. Without adequate testing, you do not have adequate scientific evidence to assure that your medical gases conform to appropriate specifications before release. Further, a second person verification (witness) of all critical testing and adequate review of the testing results by the quality unit prior to release of the drug products should be documented to ensure accuracy and accountability.\nIn your response, you state that you are in the process of developing and implementing comprehensive standard operating procedures (SOPs) with the relocation to your new facility, including procedures for testing and release for distribution. Additionally, you state that you are updating your fill logs to include a second-person verification and plan to record all testing results to enhance the accountability of the testing.\nYour response is inadequate because you failed to provide your finished product specifications for Oxygen, USP, procedures for medical gas testing and release, evidence of proper calibration of your testing instruments, or testing results to demonstrate that your firm can manufacture medical gases that meet all quality attributes.\nIn response to this letter, provide:\nA list of all test methods and specifications used to analyze each batch of your drug product before making a batch disposition decision, and the associated written procedures.\nA comprehensive, independent assessment of your laboratory practices, procedures, methods, equipment, documentation, and analyst competencies. Based on this review, provide a detailed plan to remediate and evaluate the effectiveness of your laboratory system.\n2. Your firm failed to test samples of each incoming designated medical gas for identity and conformity with all appropriate written specifications for purity, strength, and quality. Your firm also failed to validate and establish the reliability of your incoming designated medical gas supplier’s test analyses at appropriate intervals (21 CFR 213.82(a) and 213.82(b)).2\nYour firm failed to conduct identity testing for each incoming designated medical gas (DMG) lot used in medical gas manufacturing, including Oxygen, USP. Additionally, you relied on your supplier’s certificates of analysis (COA) of your incoming DMG without establishing the reliability of your supplier’s test analyses at appropriate intervals.\nCGMP requires identity testing for each DMG lot used in medical gas manufacturing, and you can only rely on the COA for other DMG attributes if you also appropriately validate the supplier’s testing results at appropriate intervals.\nIn your response, you state that you are in the process of developing and implementing comprehensive SOPs as part of the relocation to your new facility, including procedures for control of incoming medical gases as well as supplier qualification and vendor audits. Additionally, you state that you will initiate (b)(4) vendor audits to ensure supplier compliance with applicable quality and regulatory requirements.\nYour response is inadequate because you have not provided your specifications for your incoming DMG, procedures for testing and release of incoming DMG, evidence of proper calibration of testing instruments, or testing results to demonstrate that your firm can test your incoming DMG to ensure that they meet all quality attributes prior to use in medical gas manufacturing.\nIn your response to this letter, provide:\nA comprehensive, independent review of your material system, including but not limited to:\no Evaluating all suppliers of materials (DMGs, containers, and closures) to determine if they are reliable and appropriately qualified\no An assessment of all materials to determine whether they are consistently of acceptable quality\no A review to ensure assigned expiration or retest dates are appropriate (supported by data)\no Adequacy of the supplier qualification program, and its selection, qualification, and disqualification provisions\nBased on a thorough review, provide a summary of your system’s corrective action and preventive action (CAPA) to remediate the vendor qualification program and prevent use of unsuitable DMGs, containers and closures.\nAll quality control specifications you use to test and release each incoming lot of DMGs for use in manufacturing.\nA description of how you will test each DMG lot for conformity with all appropriate specifications for identity, strength, quality, and purity. If you intend to accept any results from your supplier’s COA instead of testing each DMG lot for strength, quality, and purity, specify how you will robustly establish the reliability of your supplier’s results through initial validation as well as periodic revalidation. In addition, include a commitment to always conduct at least one specific identity test for each incoming DMG lot.\nA summary of results obtained from testing all DMG to evaluate the reliability of the COA from each DMG manufacturer. Include your SOP that describes this COA validation program.\nA summary of your program for qualifying and overseeing contract facilities that test the DMGs and medical gases you manufacture.\nAn independent, comprehensive review of your material system to determine whether all suppliers of DMGs, containers, and closures, are appropriately qualified; materials are of consistently acceptable quality; and appropriate expiration or retest dates are assigned. Based on this systemic review, provide a summary of a systemic CAPA that remediates your vendor qualification program and prevents use of unsuitable DMGs, containers, and closures.\n3. Your firm failed to establish and follow adequate written procedures describing the handling of all written and oral complaints regarding a medical gas, including provisions for review by the quality control unit of any complaint involving the possible failure of a medical gas to meet any of its specifications and, for such medical gas, a determination as to the need for an investigation in accordance with 21 CFR 213.192 (21 CFR 213.198(a)).3\nA hospital contacted your firm in October 2025 to report the presence of (b)(4) in containers of Oxygen, USP that you filled and distributed to them. You stated to our investigator that you told the complainant it was impossible to have (b)(4) in the oxygen tank and subsequently failed to document and investigate the incident in a timely manner per your complaint handling procedure. It was not until after the complainant conducted third-party testing on the contents of the containers and sent you a termination of services letter on November 20, 2025, that you initiated an investigation into the complaint.\nYour firm’s investigations into the errant Oxygen, USP containers were deficient. Your firm’s investigations revealed that the errant Oxygen, USP containers were filled with (b)(4) during repair by a third party, but upon receipt by your firm, your filling technician failed to test the lot as required. However, your investigations did not consider other containers repaired by the third party; other Oxygen, USP batches that may be affected by the incident; or remediations beyond employee termination and additional employee training.\nAdditionally, you received a complaint from a different hospital about batches of high-pressure Oxygen, USP that contained liquid (e.g., water). Your firm’s investigation into the incident was inconclusive regarding the source of the water and hypothesized that the new equipment with your relocation would be sufficient to (b)(4) any residual water. Your investigation failed to consider incoming DMGs or process-related water sources; other finished Oxygen, USP batches that may be affected by the incident; or corrections that would be appropriate to remediate the cause of the incident. The presence of condensation or water in medical grade oxygen (high-pressure cylinders\u002Ftanks) can pose multiple potential risks to patients, including microbial growth, aspiration of aerosolized water droplets, particulate exposure due to internal corrosion, and\u002For obstruction of oxygen flow.\nIn your response, you state that you are in the process of developing and implementing comprehensive SOPs as part of the relocation to your new facility, including procedures for complaint files, as well as CAPA. Additionally, you state that you have scheduled an interview with the third party that repairs your medical gas containers to finish the complaint investigation into the mix-up incident.\nYour response is inadequate because you failed to provide sufficient details for how you intend to handle complaints and implement appropriate CAPA. You also did not provide adequate details of your expanded investigations into the complaint incidents related to other batches of medical gases that may be affected, consideration of other sources of the manufacturing defects, and identification of adequate CAPA plans.\nIn your response to this letter, provide:\nA comprehensive, independent assessment of your overall system for investigating deviations, discrepancies, complaints, out-of-specification results, and failures. Provide a detailed action plan to remediate this system. Your action plan should include, but not be limited to, significant improvements in investigation competencies, scope determination, root cause evaluation, CAPA effectiveness, quality unit oversight, and written procedures. Address how your firm will ensure all phases of investigations are appropriately conducted.\nAn independent, retrospective review of all critical investigations (including each in-process, release, and stability test specification failure) for the last three years as of the date of this letter. Evaluate the adequacy of each investigation, including but not limited to:\no Determine whether a thorough review of production (e.g., batch manufacturing records, adequacy of the manufacturing steps, suitability of equipment\u002Ffacilities, variability of raw materials, process capability, deviation history, complaint history, batch failure history) was conducted.\no Assess sufficiency of review of related data and investigations to identify if there are potential systemic linkages.\no Evaluate adequacy of scope, rigor, staff competencies, scientific\u002Fanalytical foundation, root cause determinations, and CAPA.\no Summary of findings of the assessment for each of the above elements.\nAn independent assessment and remediation plan for your CAPA program. Provide a report that evaluates whether the program includes effective root cause analysis, ensures CAPA effectiveness, analyzes investigations trends, improves the CAPA program whenever needed, ensures final quality unit decision authority, and is fully supported by executive management.\n4. Your firm’s quality unit failed to exercise its responsibility to ensure medical gases are manufactured in compliance with CGMP, and meet established specifications for identity, strength, quality, and purity (21 CFR 213.22).4\nYour firm failed to establish an adequate quality unit (QU) with the responsibilities and authority to oversee the manufacture of medical gases. For example, you failed to ensure:\nAssignment of an adequate QU with sufficient responsibilities and authorities (213.22(a)).\nEstablishment of appropriate written procedures for medical gas manufacturing (213.22(c)).\nPersonnel training in CGMP requirements with sufficient frequency (213.25(a)).\nYour QU fundamentally failed to oversee manufacturing procedures, practices, and manufacturing operations. In addition, even when a QU consists of one or only a few persons, those persons are still accountable for ensuring the ongoing effectiveness of all systems and procedures, and for reviewing manufacturing results to ensure a state of control and adherence to all quality standards.\nIn your response, you state that you are in the process of developing and implementing comprehensive SOPs as part of the relocation to your new facility, including quality control procedures, training programs and requirements. Additionally, you state that you are establishing a structured process for conducting internal audits and implementing (b)(4) reviews of production activities and associated documentation to ensure ongoing compliance, identify gaps proactively, and drive continuous improvement.\nYour response is inadequate because you failed to provide sufficient detail or evidence of corrective actions taken that will ensure your QU maintains proper oversight of your firm’s operations. Additionally, you failed to include details of how your personnel are adequately trained to perform their assigned functions, including CGMP requirements.\nSignificant findings in this letter demonstrate that your firm does not operate an effective quality system in accordance with CGMP. In addition to the lack of effective management oversight of your production and laboratory operations, we found your QU is not enabled to exercise proper authority and\u002For has insufficiently implemented its responsibilities. Executive management should immediately and comprehensively assess your company’s global manufacturing operations to ensure that your systems, processes, and products conform to FDA requirements.\nYour firm’s quality systems are inadequate. See FDA’s guidance document Medical Gases—Current Good Manufacturing Practice at https:\u002F\u002Fwww.fda.gov\u002Fmedia\u002F70973\u002Fdownload.\nIn your response to this letter, provide:\nA comprehensive assessment and remediation plan to ensure your QU is given the authority and resources to effectively function. The assessment should also include, but not be limited to:\no A determination of whether procedures used by your firm are robust and appropriate\no Provisions for QU oversight throughout your operations to evaluate adherence to appropriate practices\no A complete and final review of each batch and its related information before the QU disposition decision\no Oversight and approval of investigations and discharging of all other QU duties to ensure identity, strength, quality, and purity of all products\no Also describe how top management supports quality assurance and reliable operations, including but not limited to timely provision of resources to proactively address emerging manufacturing\u002Fquality issues and to assure a continuing state of control\nA comprehensive assessment of documentation systems used throughout your manufacturing and laboratory operations to determine where documentation practices are insufficient. Include a detailed CAPA plan that comprehensively remediates your firm’s documentation practices to ensure you retain attributable, legible, complete, original, accurate, contemporaneous records throughout your operation.\nData Integrity Remediation\nYour quality system does not adequately ensure the accuracy and integrity of data to support the safety, effectiveness, and quality of the drugs you manufacture. It may be helpful to refer to FDA’s guidance document Data Integrity and Compliance With Drug CGMP: Questions and Answers for guidance on establishing and following CGMP compliant data integrity practices at https:\u002F\u002Fwww.fda.gov\u002Fmedia\u002F119267\u002Fdownload.\nWe strongly recommend that you retain an independent, qualified third-party consultant to assist in your remediation. In response to this letter, provide:\nA comprehensive investigation into the extent of the inaccuracies and inconsistencies in data, records, and reporting. Your investigation should include:\no A detailed investigation protocol and methodology; a summary of all laboratories, manufacturing operations, and systems to be covered by the assessment; and a justification for any part of your operation that you propose to exclude.\no Interviews of current and former employees to identify the nature, scope, and root cause of data inaccuracies. We recommend that these interviews be conducted by a qualified third party.\no An assessment of the extent of data integrity deficiencies at your facility. Identify omissions, alterations, deletions, record destruction, non-contemporaneous record completion, and other deficiencies. Describe all parts of your facility’s operations in which you discovered data integrity deficiencies.\no A comprehensive retrospective evaluation of the nature of the data integrity deficiencies. We recommend that a qualified third party with specific expertise in the area where potential breaches were identified should evaluate all occurrences.\nA current risk assessment of the potential effects of the observed failures on the quality of your drugs. Your assessment should include analyses of the risks to patients caused by the release of drugs affected by a data integrity event and analyses of the risks posed by ongoing operations.\nA management strategy for your firm that includes the details of your global CAPA plan. Your strategy should include:\no A detailed corrective action plan that describes how you intend to ensure the reliability and completeness of all data, including analytical data, manufacturing records, and all data submitted to FDA.\no A comprehensive description of the root causes of each data integrity deviation, including evidence that the scope and depth of the current action plan is commensurate with the findings of the investigation and risk assessment. Indicate whether individuals responsible for the data integrity breaches remain able to influence CGMP-related data at your firm.\no Interim measures describing the actions you have taken or will take to ensure the quality of your drugs and protect patients, such as notifying your customers, recalling product(s), conducting additional testing, adding lots to your stability programs to assure stability, and enhanced complaint monitoring.\no Long-term measures describing any remediation efforts and enhancements to procedures, processes, methods, controls, systems, management oversight, and human resources (e.g., training, staffing improvements) designed to ensure the integrity of your company’s data.\no A commitment to have a qualified consultant conduct extensive annual audits, for at least two years, to assist in evaluating CAPA effectiveness after you have executed your data integrity remediation protocol.\no Inform FDA if you will be hiring a Chief Integrity Officer who is fully empowered to receive anonymous complaints from employees reporting data integrity concerns and with the authority to ensure any potential breach is promptly investigated (by an independent quality assurance function, along with expertise from outside entities whenever needed).\no A status report for any of the above activities already underway or completed.\nDrug Production Status\nGiven the concerning state of your manufacturing and testing controls for medical grade gases, the unacceptable patient risks posed by your product defects, and the fact that the majority of your operations are unrelated to medical grade gases, in response to this letter, clarify whether you intend to continue to manufacture drugs (e.g., medical gases) for the U.S. market at this facility.\nIf you plan to continue CGMP activities, you are responsible for resolving all deficiencies and systemic flaws to ensure your firm is capable of ongoing CGMP compliance. In addition, based upon the nature of the violations we identified at your firm, you should engage a consultant qualified as set forth in 21 CFR 213.34 to assist your firm in meeting CGMP requirements. The qualified consultant should also perform a comprehensive six-system audit of your entire operation for CGMP compliance and evaluate the completion and efficacy of all CAPA, before you pursue resolution of your firm’s compliance status with FDA.\nIn your response to this letter, provide a summary of your remediations to demonstrate that you have appropriately completed all CAPA.\nConclusion\nAs previously stated, you are responsible for investigating and determining the root causes of any violations and implementing corrective and preventative measures to ensure future and sustained compliance so that these violations and any others do not occur.\nUnresolved violations may prevent other Federal agencies from awarding contracts. Failure to address violations may also cause FDA to withhold issuance of Export Certificates. FDA may withhold approval of new applications or supplements listing your firm as a drug manufacturer until any violations are completely addressed and we confirm your compliance with CGMP. We may re-inspect to verify that you have completed corrective actions to address any violations.\nSend your written response to CDER-OC-OMQ-Communications@fda.hhs.gov within fifteen (15) business days of receipt of this letter. Identify your written response with FEI 1625647 and ATTN: Philip Kreiter in the letter.\nIf you have information that you believe demonstrates that your products are not in violation of the FD&C Act and FDA regulations, include that information for our consideration.\nPlease note FDA posts warning letters on www.FDA.gov.\nSincerely,\n\u002FS\u002F\nFrancis Godwin\nDirector\nOffice of Manufacturing Quality\nOffice of Compliance\nCenter for Drug Evaluation and Research\nU.S. Food and Drug Administration\n______________________\n1 See also 21 CFR 211.165(a)\n2 See also 21 CFR 211.84(d).\n3 See also 21 CFR 211.198(a).\n4 See also 21 CFR 211.22.","2026-11-10T01:02:29.081+00:00",[24,25,26,9,10,27,27,27],"\u003Ctime datetime=\"2026-11-03T05:00:00Z\">11\u002F03\u002F2026\u003C\u002Ftime>\n","\u003Ctime datetime=\"2026-10-29T04:00:00Z\">10\u002F29\u002F2026\u003C\u002Ftime>\n","\u003Ca href=\"\u002Finspections-compliance-enforcement-and-criminal-investigations\u002Fwarning-letters\u002Fconroe-welding-supply-inc-731507-10292026\">Conroe Welding Supply, Inc.\u003C\u002Fa>","","2026-11-10T01:02:16.121874+00:00","2026-11-10T01:02:29.333524+00:00",{"510k":31,"classification":32,"enforcement":33,"event":34,"event_backfill":35,"pma":36,"warning_letter":37},"2026-11-09T02:00:35.105+00:00","2026-11-09T02:00:29.052+00:00","2026-11-09T02:00:32.696+00:00","2026-11-12T04:02:32.647+00:00","2026-09-07T05:17:28.839+00:00","2026-11-09T02:00:36.308+00:00","2026-11-10T01:03:48.189+00:00"]