[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-warning-letter-pritam-international-private-limited-738079-10272026":3,"fda-latest-sync-dates":29},{"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":8,"marcs_cms_no":15,"product_type":16,"delivery_method":17,"recipient_name":18,"recipient_title":8,"body_html":19,"body_text":20,"body_fetched_at":21,"medical_device_id":8,"raw":22,"created_at":27,"updated_at":28},22099,"pritam-international-private-limited-738079-10272026","Warning Letter","Pritam International Private Limited",null,"Center for Drug Evaluation and Research (CDER)","CGMP\u002FFinished Pharmaceuticals\u002FAdulterated","2026-11-03","2026-10-27","Issued","https:\u002F\u002Fwww.fda.gov\u002Finspections-compliance-enforcement-and-criminal-investigations\u002Fwarning-letters\u002Fpritam-international-private-limited-738079-10272026","738079","Drugs Over-the-Counter Drugs","VIA ELECTRONIC MAIL READ\u002FDELIVERY RECEIPT REQUESTED","Dr. Rahul Mahajan Sr","\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      \n              \u003Cdt>Product:\u003C\u002Fdt> \n        \u003Cdd>Drugs                          \n            \n            \n            \n            \n                          \u003Cbr>Over-the-Counter Drugs\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>Dr. Rahul Mahajan Sr \u003C\u002Fdiv>\n          \u003C\u002Fdiv>\n\u003C\u002Fdd>\n                                \u003Cdd>\n  \u003Cdiv>\n    \u003Cdiv>Recipient Title\u003C\u002Fdiv>\n              \u003Cdiv>General Manager Quality\u003C\u002Fdiv>\n          \u003C\u002Fdiv>\n\u003C\u002Fdd>\n          \n            \u003Cdd>Pritam International Private Limited\u003C\u002Fdd>\n\n          \n                      \u003Cdd>\u003Cp>\u003Cspan>Khasra No. 138, Raipur Industrial Area\u003C\u002Fspan>\u003Cbr>\n\u003Cspan>Bhagwanpur\u003C\u002Fspan>\u003Cbr>\n\u003Cspan>Haridwar\u003C\u002Fspan> \u003Cspan>247667\u003C\u002Fspan>\u003Cbr>\n\u003Cspan>Uttarakhand\u003C\u002Fspan>\u003Cbr>\n\u003Cspan>India\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 27, 2026\u003C\u002Fp>\u003Cp>\u003Cstrong>WARNING LETTER\u003C\u002Fstrong>\u003Cbr>Reference number: 320-27-12\u003C\u002Fp>\u003Cp>To Dr. Rahul Mahajan:\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 during a review of records submitted from 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 the violations 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 action without further notice.\u003C\u002Fp>\u003Cp>\u003Cstrong>FDA Review\u003C\u002Fstrong>\u003C\u002Fp>\u003Cp>Violations were identified and documented during review of your drug manufacturing facility, Pritam International Private Limited, FDA Establishment Identifier (FEI) 3020826443. This review was conducted under FDA’s statutory authority and public health responsibilities to protect the public from unsafe, ineffective, and poor quality drugs.\u003C\u002Fp>\u003Cp>Your facility is registered with the FDA as a manufacturer of over-the-counter (OTC) drug products. FDA has reviewed the records you submitted in response to our April 24, 2026, request for records and other information pursuant to section 704(a)(4) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) for your facility.\u003C\u002Fp>\u003Cp>\u003Cstrong>FDA Inspection\u003C\u002Fstrong>\u003C\u002Fp>\u003Cp>Violations were also identified and documented during an inspection of your drug manufacturing facility, Pritam International Private Limited, FEI 3020826443 from June 2 to 6, 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.\u003C\u002Fp>\u003Cp>This warning letter summarizes significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals. See Title 21 Code of Federal Regulations (CFR), parts 210 and 211 (21 CFR parts 210 and 211).\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 FD&C Act, 21 U.S.C. 351(a)(2)(B).\u003C\u002Fp>\u003Cp>In addition, your “Brush Buddies Cookies ‘n Cream Ice Cream Flavored Toothpaste” is adulterated under section 501(a)(4)(A) as this drug product bears or contains a color additive that is unsafe within the meaning of section 721 of the FD&C Act, 21 U.S.C. 379e. Accordingly, the introduction or delivery for introduction of “Brush Buddies Cookies ‘n Cream Ice Cream Flavored Toothpaste” into interstate commerce is a prohibited act under section 301(a) of the FD&C Act, 21 U.S.C. 331(a).\u003C\u002Fp>\u003Cp>We reviewed your May 11, 2026, response to our request for records in detail, and your June 25, 2026, response to our Form FDA 483 in detail and acknowledge receipt of your subsequent correspondence.\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 our records review. As a reminder, this is not an all-inclusive list of violations at your facility.\u003C\u002Fp>\u003Cp>\u003Cstrong>Adulterated within the meaning of section 501(a)(4)(A) of the FD&C Act\u003C\u002Fstrong>\u003C\u002Fp>\u003Cp>Your firm contract manufactures OTC toothpaste and \u003Cstrong>(b)(4)\u003C\u002Fstrong> drug products for distribution to the U.S. market. Your toothpaste drug products are indicated for use in both children and adults.\u003C\u002Fp>\u003Cp>Based on our review of batch records and product labels, your “Brush Buddies Cookies ‘n Cream Ice Cream Flavored Toothpaste” contains the color additive “CI 14720” (also known as Ext. D&C Red No. 10 or Acid Red No. 14 or Food Red 3 or Carmoisine or Azorubine (E122)). In 1966, FDA cancelled the certification and delisted Ext. D&C Red No. 10 due to lack of safety data from any manufacturer. Under 21 CFR 81.30(d), using Ext. D&C Red No.10 after October 4, 1966, results in the drug being adulterated.\u003C\u002Fp>\u003Cp>Any color additive not explicitly listed as safe for its intended use is deemed unsafe within the meaning of section 721(a) of the FD&C Act. The inclusion of a delisted color additive in your drug product formulation indicates that your quality unit’s review (as required under 21 CFR 211.22) of your raw material qualification process and formulation review procedures are inadequate to ensure that only acceptable ingredients are used in the manufacture of drug products, especially those marketed to children.\u003C\u002Fp>\u003Cp>In response to this letter, provide:\u003C\u002Fp>\u003Cul>\u003Cli>A risk assessment to review all your drug formulations to ensure the use of appropriate color additives, including any that may use alternate names. For more information, see the webpage for Regulatory Status of Color Additives at https:\u002F\u002Fwww.hfpappexternal.fda.gov\u002Fscripts\u002Ffdcc\u002Findex.cfm?set=ColorAdditives.\u003C\u002Fli>\u003C\u002Ful>\u003Cp>\u003Cstrong>Adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act\u003C\u002Fstrong>\u003C\u002Fp>\u003Cp>\u003Cstrong>1. Your firm failed to ensure that laboratory records included complete data derived from all tests necessary to ensure compliance with established specifications and standards (21 CFR 211.194(a)).\u003C\u002Fstrong>\u003C\u002Fp>\u003Cp>You lacked complete and original laboratory data demonstrating that the required testing was performed.\u003C\u002Fp>\u003Cp>You use \u003Cstrong>(b)(4)\u003C\u002Fstrong> as a major component of your drug products. During the inspection, we observed multiple media plates with \u003Cstrong>(b)(4)\u003C\u002Fstrong> for \u003Cstrong>(b)(4)\u003C\u002Fstrong> samples in your incubator with visible microbiological growth. However, on the next day, during plate reading and result recording, there was no visible microbiological growth on plates labeled as the same samples observed the day before. Additionally, we identified multiple discrepancies between the labeling of the sample identification information handwritten on the exterior of the plates from one day to the subsequent day.\u003C\u002Fp>\u003Cp>Microbiological monitoring and testing are essential quality control steps that are integral to ensure raw materials are adequate for use. Such programs provide critical information on the state of control of the manufacturing operation. Substitution of unreliable or false results fundamentally compromises a facility’s ability to identify risks to the drug product.\u003C\u002Fp>\u003Cp>In your response, you indicate that an investigation into the falsified results concluded that the “… transposition of plates …” was a deliberate but isolated act by the microbiologist to circumvent your procedure. You state that you retrained the microbiologists to recognize when a plate should be considered Too Numerous To Count (TNTC), introduced a tamper evident seal for the plate, implemented color coding to differentiate the negative control plate from the product or component sample, and mandated that all microbiological plate reading must be performed by two analysts concurrently prior to data entry.\u003C\u002Fp>\u003Cp>Your response is inadequate since you fail to address the severity of the observed data integrity violation for the falsification and alteration of the microbiological test results. Your proposed corrective actions address the data integrity breaches as isolated procedural gaps rather than as evidence of a systemic breakdown in quality unit (QU) oversight and a deficient quality culture.\u003C\u002Fp>\u003Cp>Your response does not address the fundamental failure of your QU to ensure the integrity and completeness of all data related to your drug manufacturing operations, nor does it include an adequate assessment of the potential impact on the quality of drug products already distributed to the U.S. market. Furthermore, your response lacks a sufficient comprehensive evaluation of your QU’s capabilities to fulfill all required quality-related functions.\u003C\u002Fp>\u003Cp>Microbiological testing, an essential quality control step, is integral in preventing distribution of unsafe products. Integrity of data is fundamentally compromised when there is a failure to record or maintain complete and accurate records of test results or conditions associated with drug testing. Furthermore, the lack of reliable data compromises the QU’s ability to exercise its function of ensuring compliance with applicable standards.\u003C\u002Fp>\u003Cp>In response to this letter, provide:\u003C\u002Fp>\u003Cul>\u003Cli>A comprehensive, independent assessment of your laboratory practices, procedures, methods, equipment, documentation, supervisory oversight, and analyst competencies. Based on this review, provide a detailed plan to remediate and evaluate the effectiveness of your laboratory system.\u003C\u002Fli>\u003Cli>A comprehensive, independent assessment of documentation systems used throughout your manufacturing and laboratory operations to determine where documentation practices are insufficient. Include a detailed Corrective Action and Preventive Action (CAPA) plan that comprehensively remediates your firm’s documentation practices to ensure you retain attributable, legible, complete, original, accurate, contemporaneous (ALCOA) records throughout your operation.\u003C\u002Fli>\u003Cli>A comprehensive CAPA, overseen by a qualified consultant, for handling microbiological sampling media to ensure robust and reliable data. Establish a system that ensures uninterrupted and uncompromised custody, with full reconciliation of all microbiological samples, including but not limited to:\u003Cbr>o unique labeling of each sample\u003Cbr>o signatures of all staff who handle the sample\u003Cbr>o complete tracking of sample integrity and custody\u003Cbr>o date and time of each activity (e.g., sample collection, transport, delivery, incubation, removal from incubator)\u003Cbr>o digital time-stamped photos of all plates at the time of plate reading\u003Cbr>o laboratory tools (e.g., magnification, appropriate light) and methods that optimize visibility and detectability of colonies on plates\u003Cbr>o signatures of personnel performing reading of microbial counts\u003Cbr>o provisions for verifications and routine quality assurance oversight\u003C\u002Fli>\u003C\u002Ful>\u003Cp>\u003Cstrong>2. Your firm failed to conduct at least one test to verify the identity of each component of a drug product. Your firm also failed to validate and establish the reliability of your component supplier’s test analyses at appropriate intervals (21 CFR 211.84(d)(1) and 211.84(d)(2)).\u003C\u002Fstrong>\u003C\u002Fp>\u003Cp>You failed to perform adequate identity testing for each component lot used in the production of your OTC drug products. You relied on the certificates of analysis (COAs) from your suppliers and failed to establish the reliability of each of your suppliers’ COA for component specifications and characteristics.\u003C\u002Fp>\u003Cp>\u003Cem>\u003Cstrong>Products Contain Ingredients at Risk for Diethylene Glycol or Ethylene Glycol (DEG or EG) Contamination\u003C\u002Fstrong>\u003C\u002Fem>\u003C\u002Fp>\u003Cp>You manufacture multiple toothpaste drug products (intended for adults and children) that contain sorbitol solution. You failed to adequately test your incoming components at high risk of DEG and EG contamination for identity before using them to manufacture your drug products. For example, during the inspection, you provided our investigators with one COA with independent identity testing results, including DEG and EG, out of approximately \u003Cstrong>(b)(4)\u003C\u002Fstrong> shipments of sorbitol solution. Identity testing, including DEG and EG, is required for each lot that you receive.\u003C\u002Fp>\u003Cp>The use of ingredients contaminated with DEG or EG has resulted in various lethal poisoning incidents in humans worldwide. See FDA’s guidance document, \u003Cem>Testing of Glycerin, Propylene Glycol, Maltitol Solution, Hydrogenated Starch Hydrolysate, Sorbitol Solution, and Other High-Risk Drug Components for Diethylene Glycol and Ethylene Glycol\u003C\u002Fem>, to help you meet the CGMP requirements when manufacturing drugs containing ingredients at high-risk for DEG or EG contamination at https:\u002F\u002Fwww.fda.gov\u002Fmedia\u002F167974\u002Fdownload.\u003C\u002Fp>\u003Cp>In your response, you proposed modifying the receipt of drums and tanker trucks of the sorbitol solution component to perform identity testing prior to use in manufacturing. You also indicated that you would perform destructive testing of all finished drug product reserve (control) samples.\u003C\u002Fp>\u003Cp>Your response is inadequate. You did not provide any additional evidence that sorbitol solution had been properly tested to confirm identity prior to use. Furthermore, you did not address whether identity testing is performed for other potential high-risk components (such as glycerin and polyethylene glycol).\u003C\u002Fp>\u003Cp>Without appropriate testing of components and ingredients, you cannot ensure the quality and safety of your drug products. Without adequate testing and confirmation of reliability of supplier and external laboratory testing results, you lack scientific evidence that the components or drug products conform to appropriate specifications.\u003C\u002Fp>\u003Cp>In response to this letter, provide:\u003C\u002Fp>\u003Cul>\u003Cli>A commitment to provide DEG and EG test results, no later than 30 calendar days from the date of this letter, from testing retains for all lots of high-risk drug components used in the manufacture of drug products. Alternatively, if a retain of a component lot is unavailable, perform retain sample testing of all implicated finished drug product batches for the presence of DEG and EG.\u003C\u002Fli>\u003Cli>A full risk assessment for drug products that are within expiry which contain any ingredient at risk for DEG or EG contamination (including, but not limited to, glycerin). Take prompt and appropriate actions to determine the safety of all lots of the component(s) and any related drug product that could contain DEG or EG, including customer notifications and product recalls for any contaminated lots. Identify additional appropriate CAPA that secure supply chains in the future, including, but not limited to, ensuring that all incoming raw material lots are from fully qualified manufacturers and free from unsafe impurities. Detail these actions in your response to this letter.\u003C\u002Fli>\u003Cli>A description of how you will test each component 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 component 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 component lot. In the case of glycerin, propylene glycol, and certain additional high-risk components we note that this includes the performance of parts A, B, and C of the United States Pharmacopeia (USP) monograph.\u003C\u002Fli>\u003Cli>The chemical quality control specifications you use to test each incoming lot of high-risk drug components to determine acceptability for use in manufacturing.\u003C\u002Fli>\u003Cli>A comprehensive, independent review of your material system to determine whether all suppliers of components, containers, and closures, are each qualified and the materials are assigned appropriate expiration or retest dates. The review should also determine whether incoming material controls are adequate to prevent use of unsuitable components, containers, and closures.\u003C\u002Fli>\u003Cli>A summary of results obtained from testing all components to evaluate the reliability of the COA from each component manufacturer. Include your SOP that describes this COA validation program.\u003C\u002Fli>\u003C\u002Ful>\u003Cp>\u003Cstrong>3. Your firm’s quality control unit failed to exercise its responsibility to ensure drug products manufactured are in compliance with CGMP, and meet established specifications for identity, strength, quality, and purity (21 CFR 211.22).\u003C\u002Fstrong>\u003C\u002Fp>\u003Cp>Your QU failed to exercise its authority and responsibilities over your drug manufacturing operations, including ensuring the data integrity of your records. For example, the QU failed to ensure:\u003C\u002Fp>\u003Cul>\u003Cli>\u003Cstrong>(b)(4)\u003C\u002Fstrong> was suitable for its intended use (21 CFR 211.100).\u003C\u002Fli>\u003Cli>An adequate training program for your microbiology laboratory employees that objectively evaluated competency and proficiency results to assess training effectiveness (21 CFR 211.25(c)).\u003C\u002Fli>\u003Cli>Adequate laboratory controls that include scientifically sound and appropriate specifications, standards, sampling plans, and test procedures (21 CFR 211.160(b)).\u003C\u002Fli>\u003C\u002Ful>\u003Cp>For help implementing quality system and risk management approaches to meet the requirements of CGMP regulations 21 CFR, parts 210 and 211, see FDA’s guidance documents \u003Cem>Quality Systems Approach to Pharmaceutical CGMP Regulations\u003C\u002Fem> at https:\u002F\u002Fwww.fda.gov\u002Fmedia\u002F71023\u002Fdownload, as well as ICH Q10 \u003Cem>Pharmaceutical Quality System\u003C\u002Fem> at https:\u002F\u002Fwww.fda.gov\u002Fmedia\u002F71553\u002Fdownload.\u003C\u002Fp>\u003Cp>In 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 quality issues and to assure a continuing state of control.\u003C\u002Fli>\u003Cli>A comprehensive remediation plan for the design, control, and maintenance of the \u003Cstrong>(b)(4)\u003C\u002Fstrong> system, including:\u003Cbr>o A comprehensive evaluation of vulnerabilities of \u003Cstrong>(b)(4)\u003C\u002Fstrong> system design and control and summarize all deficiencies found in the system. The summary should, at minimum, describe various system characteristics that were assessed for adequacy (system temperature, materials of construction, slope, any identified dead-legs, any stagnant locations, any unsanitary fittings, flow velocity, etc.)\u003C\u002Fli>\u003Cli>Your total microbiological count limits to monitor whether this system produces \u003Cstrong>(b)(4)\u003C\u002Fstrong> suitable for the intended uses for each of your products.\u003C\u002Fli>\u003Cli>A detailed risk assessment addressing the potential effects of the observed \u003Cstrong>(b)(4)\u003C\u002Fstrong> system failures on the quality of all drug product lots currently in U.S. distribution. Specify actions that you will take in response to the risk assessment, such as customer notifications and product recalls.\u003C\u002Fli>\u003C\u002Ful>\u003Cp>\u003Cstrong>CGMP Consultant Recommended\u003C\u002Fstrong>\u003C\u002Fp>\u003Cp>Based upon the nature of the violations we identified at your firm, you should engage a consultant qualified as set forth in 21 CFR 211.34 to evaluate your operations and to assist your firm in meeting CGMP requirements if your firm intends to resume manufacturing drugs for the U.S. market. 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 your CAPA before you pursue resolution of your firm’s compliance status with FDA.\u003C\u002Fp>\u003Cp>Your use of a consultant does not relieve your firm’s obligation to comply with CGMP. Your firm’s executive management remains responsible for resolving all deficiencies and systemic flaws to ensure ongoing CGMP compliance.\u003C\u002Fp>\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. See FDA’s guidance document \u003Cem>Data Integrity and Compliance With Drug CGMP: Questions and Answers\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 data integrity 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.\u003Cbr>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 testing 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 or drug application 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, drug application actions, 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 Recall\u003C\u002Fstrong>\u003C\u002Fp>\u003Cp>On September 1, 2026, FDA held a teleconference with you recommending you remove your toothpaste drug products within expiry from the U.S. market.\u003C\u002Fp>\u003Cp>On September 10, 2026, you issued a voluntary recall of all toothpaste drug products within expiry that were shipped between September 2024 and August 2026 currently in distribution in the United States. This recall included the “Brush Buddies Cookies ‘n Cream Ice Cream Flavored Toothpaste” that contained a cancelled color additive.\u003C\u002Fp>\u003Cp>The recall was posted to the FDA’s Enforcement Report website at: https:\u002F\u002Fwww.accessdata.fda.gov\u002Fscripts\u002Fires\u002F?Event=99849.\u003C\u002Fp>\u003Cp>\u003Cstrong>Revocation of FD&C Red No. 3\u003C\u002Fstrong>\u003C\u002Fp>\u003Cp>FDA revoked the authorization for the use of FD&C Red No. 3. We recommend manufacturers review their drug product formulations. Manufacturers who use FD&C Red No. 3 in ingested drugs will have until January 18, 2028, to reformulate their products. For more information see https:\u002F\u002Fwww.fda.gov\u002Ffood\u002Fhfp-constituent-updates\u002Ffda-revoke-authorization-use-red-no-3-food-and-ingested-drugs.\u003C\u002Fp>\u003Cp>\u003Cstrong>Conclusion\u003C\u002Fstrong>\u003C\u002Fp>\u003Cp>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>FDA placed all drugs and drug products offered for import into the United States from your firm on Import Alert 66-40 on September 3, 2026.\u003C\u002Fp>\u003Cp>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 any violations.\u003C\u002Fp>\u003Cp>Failure to address any violations may also result in the FDA continuing to refuse admission of articles manufactured at Pritam International Private Limited located at Khasra No. 138, Raipur Industrial Area, Bhagwanpur in Haridwar, India into the United States under section 801(a)(3) of the FD&C Act, 21 U.S.C. 381(a)(3). Articles under this authority that appear to be adulterated may be detained or refused admission, in that the methods and controls used in their manufacture do not appear to conform to CGMP within the meaning of section 501(a)(2)(B) of the FD&C Act, 21 U.S.C. 351(a)(2)(B).\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 3020826443 and ATTN: Frank Wackes in the subject line of the email.\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>FDA posts warning letters to 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>cc:\u003Cbr>Liberty Management Group Ltd., US agent\u003Cbr>Email: \u003Cstrong>(b)(4)\u003C\u002Fstrong>\u003C\u002Fp>\u003Cp>Mr. Pratam Singh, Plant Head, Pritam International Private Limited\u003Cbr>Email: \u003Cstrong>(b)(4)\u003C\u002Fstrong>\u003C\u002Fp>\n\n\n\n\n\n\n              \n                                            \n              \n            ","Delivery Method:\n\nVIA ELECTRONIC MAIL READ\u002FDELIVERY RECEIPT REQUESTED\n\nProduct:\n\nDrugs\n\nOver-the-Counter Drugs\n\nRecipient:\n\nRecipient Name\n\nDr. Rahul Mahajan Sr\n\nRecipient Title\n\nGeneral Manager Quality\n\nPritam International Private Limited\n\nKhasra No. 138, Raipur Industrial Area\n\nBhagwanpur\n\nHaridwar 247667\n\nUttarakhand\n\nIndia\n\n(b)(4)\n\nIssuing Office:\n\nCenter for Drug Evaluation and Research (CDER)\n\nUnited States\n\nOctober 27, 2026\nWARNING LETTER\nReference number: 320-27-12\nTo Dr. Rahul Mahajan:\nThis warning letter advises you of significant violations identified during a U.S. Food and Drug Administration (FDA) inspection of your facility and during a review of records submitted from 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 the violations 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 action without further notice.\nFDA Review\nViolations were identified and documented during review of your drug manufacturing facility, Pritam International Private Limited, FDA Establishment Identifier (FEI) 3020826443. This review was conducted under FDA’s statutory authority and public health responsibilities to protect the public from unsafe, ineffective, and poor quality drugs.\nYour facility is registered with the FDA as a manufacturer of over-the-counter (OTC) drug products. FDA has reviewed the records you submitted in response to our April 24, 2026, request for records and other information pursuant to section 704(a)(4) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) for your facility.\nFDA Inspection\nViolations were also identified and documented during an inspection of your drug manufacturing facility, Pritam International Private Limited, FEI 3020826443 from June 2 to 6, 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.\nThis warning letter summarizes significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals. See Title 21 Code of Federal Regulations (CFR), parts 210 and 211 (21 CFR parts 210 and 211).\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 FD&C Act, 21 U.S.C. 351(a)(2)(B).\nIn addition, your “Brush Buddies Cookies ‘n Cream Ice Cream Flavored Toothpaste” is adulterated under section 501(a)(4)(A) as this drug product bears or contains a color additive that is unsafe within the meaning of section 721 of the FD&C Act, 21 U.S.C. 379e. Accordingly, the introduction or delivery for introduction of “Brush Buddies Cookies ‘n Cream Ice Cream Flavored Toothpaste” into interstate commerce is a prohibited act under section 301(a) of the FD&C Act, 21 U.S.C. 331(a).\nWe reviewed your May 11, 2026, response to our request for records in detail, and your June 25, 2026, response to our Form FDA 483 in detail and acknowledge receipt of your subsequent correspondence.\nViolations of the Federal Food, Drug, and Cosmetic Act\nThe following are violations identified during our inspection and our records review. As a reminder, this is not an all-inclusive list of violations at your facility.\nAdulterated within the meaning of section 501(a)(4)(A) of the FD&C Act\nYour firm contract manufactures OTC toothpaste and (b)(4) drug products for distribution to the U.S. market. Your toothpaste drug products are indicated for use in both children and adults.\nBased on our review of batch records and product labels, your “Brush Buddies Cookies ‘n Cream Ice Cream Flavored Toothpaste” contains the color additive “CI 14720” (also known as Ext. D&C Red No. 10 or Acid Red No. 14 or Food Red 3 or Carmoisine or Azorubine (E122)). In 1966, FDA cancelled the certification and delisted Ext. D&C Red No. 10 due to lack of safety data from any manufacturer. Under 21 CFR 81.30(d), using Ext. D&C Red No.10 after October 4, 1966, results in the drug being adulterated.\nAny color additive not explicitly listed as safe for its intended use is deemed unsafe within the meaning of section 721(a) of the FD&C Act. The inclusion of a delisted color additive in your drug product formulation indicates that your quality unit’s review (as required under 21 CFR 211.22) of your raw material qualification process and formulation review procedures are inadequate to ensure that only acceptable ingredients are used in the manufacture of drug products, especially those marketed to children.\nIn response to this letter, provide:\nA risk assessment to review all your drug formulations to ensure the use of appropriate color additives, including any that may use alternate names. For more information, see the webpage for Regulatory Status of Color Additives at https:\u002F\u002Fwww.hfpappexternal.fda.gov\u002Fscripts\u002Ffdcc\u002Findex.cfm?set=ColorAdditives.\nAdulterated within the meaning of section 501(a)(2)(B) of the FD&C Act\n1. Your firm failed to ensure that laboratory records included complete data derived from all tests necessary to ensure compliance with established specifications and standards (21 CFR 211.194(a)).\nYou lacked complete and original laboratory data demonstrating that the required testing was performed.\nYou use (b)(4) as a major component of your drug products. During the inspection, we observed multiple media plates with (b)(4) for (b)(4) samples in your incubator with visible microbiological growth. However, on the next day, during plate reading and result recording, there was no visible microbiological growth on plates labeled as the same samples observed the day before. Additionally, we identified multiple discrepancies between the labeling of the sample identification information handwritten on the exterior of the plates from one day to the subsequent day.\nMicrobiological monitoring and testing are essential quality control steps that are integral to ensure raw materials are adequate for use. Such programs provide critical information on the state of control of the manufacturing operation. Substitution of unreliable or false results fundamentally compromises a facility’s ability to identify risks to the drug product.\nIn your response, you indicate that an investigation into the falsified results concluded that the “… transposition of plates …” was a deliberate but isolated act by the microbiologist to circumvent your procedure. You state that you retrained the microbiologists to recognize when a plate should be considered Too Numerous To Count (TNTC), introduced a tamper evident seal for the plate, implemented color coding to differentiate the negative control plate from the product or component sample, and mandated that all microbiological plate reading must be performed by two analysts concurrently prior to data entry.\nYour response is inadequate since you fail to address the severity of the observed data integrity violation for the falsification and alteration of the microbiological test results. Your proposed corrective actions address the data integrity breaches as isolated procedural gaps rather than as evidence of a systemic breakdown in quality unit (QU) oversight and a deficient quality culture.\nYour response does not address the fundamental failure of your QU to ensure the integrity and completeness of all data related to your drug manufacturing operations, nor does it include an adequate assessment of the potential impact on the quality of drug products already distributed to the U.S. market. Furthermore, your response lacks a sufficient comprehensive evaluation of your QU’s capabilities to fulfill all required quality-related functions.\nMicrobiological testing, an essential quality control step, is integral in preventing distribution of unsafe products. Integrity of data is fundamentally compromised when there is a failure to record or maintain complete and accurate records of test results or conditions associated with drug testing. Furthermore, the lack of reliable data compromises the QU’s ability to exercise its function of ensuring compliance with applicable standards.\nIn response to this letter, provide:\nA comprehensive, independent assessment of your laboratory practices, procedures, methods, equipment, documentation, supervisory oversight, and analyst competencies. Based on this review, provide a detailed plan to remediate and evaluate the effectiveness of your laboratory system.\nA comprehensive, independent assessment of documentation systems used throughout your manufacturing and laboratory operations to determine where documentation practices are insufficient. Include a detailed Corrective Action and Preventive Action (CAPA) plan that comprehensively remediates your firm’s documentation practices to ensure you retain attributable, legible, complete, original, accurate, contemporaneous (ALCOA) records throughout your operation.\nA comprehensive CAPA, overseen by a qualified consultant, for handling microbiological sampling media to ensure robust and reliable data. Establish a system that ensures uninterrupted and uncompromised custody, with full reconciliation of all microbiological samples, including but not limited to:\no unique labeling of each sample\no signatures of all staff who handle the sample\no complete tracking of sample integrity and custody\no date and time of each activity (e.g., sample collection, transport, delivery, incubation, removal from incubator)\no digital time-stamped photos of all plates at the time of plate reading\no laboratory tools (e.g., magnification, appropriate light) and methods that optimize visibility and detectability of colonies on plates\no signatures of personnel performing reading of microbial counts\no provisions for verifications and routine quality assurance oversight\n2. Your firm failed to conduct at least one test to verify the identity of each component of a drug product. Your firm also failed to validate and establish the reliability of your component supplier’s test analyses at appropriate intervals (21 CFR 211.84(d)(1) and 211.84(d)(2)).\nYou failed to perform adequate identity testing for each component lot used in the production of your OTC drug products. You relied on the certificates of analysis (COAs) from your suppliers and failed to establish the reliability of each of your suppliers’ COA for component specifications and characteristics.\nProducts Contain Ingredients at Risk for Diethylene Glycol or Ethylene Glycol (DEG or EG) Contamination\nYou manufacture multiple toothpaste drug products (intended for adults and children) that contain sorbitol solution. You failed to adequately test your incoming components at high risk of DEG and EG contamination for identity before using them to manufacture your drug products. For example, during the inspection, you provided our investigators with one COA with independent identity testing results, including DEG and EG, out of approximately (b)(4) shipments of sorbitol solution. Identity testing, including DEG and EG, is required for each lot that you receive.\nThe use of ingredients contaminated with DEG or EG has resulted in various lethal poisoning incidents in humans worldwide. See FDA’s guidance document, Testing of Glycerin, Propylene Glycol, Maltitol Solution, Hydrogenated Starch Hydrolysate, Sorbitol Solution, and Other High-Risk Drug Components for Diethylene Glycol and Ethylene Glycol, to help you meet the CGMP requirements when manufacturing drugs containing ingredients at high-risk for DEG or EG contamination at https:\u002F\u002Fwww.fda.gov\u002Fmedia\u002F167974\u002Fdownload.\nIn your response, you proposed modifying the receipt of drums and tanker trucks of the sorbitol solution component to perform identity testing prior to use in manufacturing. You also indicated that you would perform destructive testing of all finished drug product reserve (control) samples.\nYour response is inadequate. You did not provide any additional evidence that sorbitol solution had been properly tested to confirm identity prior to use. Furthermore, you did not address whether identity testing is performed for other potential high-risk components (such as glycerin and polyethylene glycol).\nWithout appropriate testing of components and ingredients, you cannot ensure the quality and safety of your drug products. Without adequate testing and confirmation of reliability of supplier and external laboratory testing results, you lack scientific evidence that the components or drug products conform to appropriate specifications.\nIn response to this letter, provide:\nA commitment to provide DEG and EG test results, no later than 30 calendar days from the date of this letter, from testing retains for all lots of high-risk drug components used in the manufacture of drug products. Alternatively, if a retain of a component lot is unavailable, perform retain sample testing of all implicated finished drug product batches for the presence of DEG and EG.\nA full risk assessment for drug products that are within expiry which contain any ingredient at risk for DEG or EG contamination (including, but not limited to, glycerin). Take prompt and appropriate actions to determine the safety of all lots of the component(s) and any related drug product that could contain DEG or EG, including customer notifications and product recalls for any contaminated lots. Identify additional appropriate CAPA that secure supply chains in the future, including, but not limited to, ensuring that all incoming raw material lots are from fully qualified manufacturers and free from unsafe impurities. Detail these actions in your response to this letter.\nA description of how you will test each component 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 component 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 component lot. In the case of glycerin, propylene glycol, and certain additional high-risk components we note that this includes the performance of parts A, B, and C of the United States Pharmacopeia (USP) monograph.\nThe chemical quality control specifications you use to test each incoming lot of high-risk drug components to determine acceptability for use in manufacturing.\nA comprehensive, independent review of your material system to determine whether all suppliers of components, containers, and closures, are each qualified and the materials are assigned appropriate expiration or retest dates. The review should also determine whether incoming material controls are adequate to prevent use of unsuitable components, containers, and closures.\nA summary of results obtained from testing all components to evaluate the reliability of the COA from each component manufacturer. Include your SOP that describes this COA validation program.\n3. Your firm’s quality control unit failed to exercise its responsibility to ensure drug products manufactured are in compliance with CGMP, and meet established specifications for identity, strength, quality, and purity (21 CFR 211.22).\nYour QU failed to exercise its authority and responsibilities over your drug manufacturing operations, including ensuring the data integrity of your records. For example, the QU failed to ensure:\n(b)(4) was suitable for its intended use (21 CFR 211.100).\nAn adequate training program for your microbiology laboratory employees that objectively evaluated competency and proficiency results to assess training effectiveness (21 CFR 211.25(c)).\nAdequate laboratory controls that include scientifically sound and appropriate specifications, standards, sampling plans, and test procedures (21 CFR 211.160(b)).\nFor help implementing quality system and risk management approaches to meet the requirements of CGMP regulations 21 CFR, parts 210 and 211, see FDA’s guidance documents Quality Systems Approach to Pharmaceutical CGMP Regulations at https:\u002F\u002Fwww.fda.gov\u002Fmedia\u002F71023\u002Fdownload, as well as ICH Q10 Pharmaceutical Quality System at https:\u002F\u002Fwww.fda.gov\u002Fmedia\u002F71553\u002Fdownload.\nIn 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 quality issues and to assure a continuing state of control.\nA comprehensive remediation plan for the design, control, and maintenance of the (b)(4) system, including:\no A comprehensive evaluation of vulnerabilities of (b)(4) system design and control and summarize all deficiencies found in the system. The summary should, at minimum, describe various system characteristics that were assessed for adequacy (system temperature, materials of construction, slope, any identified dead-legs, any stagnant locations, any unsanitary fittings, flow velocity, etc.)\nYour total microbiological count limits to monitor whether this system produces (b)(4) suitable for the intended uses for each of your products.\nA detailed risk assessment addressing the potential effects of the observed (b)(4) system failures on the quality of all drug product lots currently in U.S. distribution. Specify actions that you will take in response to the risk assessment, such as customer notifications and product recalls.\nCGMP Consultant Recommended\nBased upon the nature of the violations we identified at your firm, you should engage a consultant qualified as set forth in 21 CFR 211.34 to evaluate your operations and to assist your firm in meeting CGMP requirements if your firm intends to resume manufacturing drugs for the U.S. market. 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 your CAPA before you pursue resolution of your firm’s compliance status with FDA.\nYour use of a consultant does not relieve your firm’s obligation to comply with CGMP. Your firm’s executive management remains responsible for resolving all deficiencies and systemic flaws to ensure ongoing CGMP compliance.\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. See 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 data integrity 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.\nDescribe all parts of your facility’s operations in which you discovered data integrity deficiencies.\no A comprehensive retrospective evaluation of the nature of the testing 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 or drug application 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, drug application actions, 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 Recall\nOn September 1, 2026, FDA held a teleconference with you recommending you remove your toothpaste drug products within expiry from the U.S. market.\nOn September 10, 2026, you issued a voluntary recall of all toothpaste drug products within expiry that were shipped between September 2024 and August 2026 currently in distribution in the United States. This recall included the “Brush Buddies Cookies ‘n Cream Ice Cream Flavored Toothpaste” that contained a cancelled color additive.\nThe recall was posted to the FDA’s Enforcement Report website at: https:\u002F\u002Fwww.accessdata.fda.gov\u002Fscripts\u002Fires\u002F?Event=99849.\nRevocation of FD&C Red No. 3\nFDA revoked the authorization for the use of FD&C Red No. 3. We recommend manufacturers review their drug product formulations. Manufacturers who use FD&C Red No. 3 in ingested drugs will have until January 18, 2028, to reformulate their products. For more information see https:\u002F\u002Fwww.fda.gov\u002Ffood\u002Fhfp-constituent-updates\u002Ffda-revoke-authorization-use-red-no-3-food-and-ingested-drugs.\nConclusion\nYou 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.\nFDA placed all drugs and drug products offered for import into the United States from your firm on Import Alert 66-40 on September 3, 2026.\nFDA 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 any violations.\nFailure to address any violations may also result in the FDA continuing to refuse admission of articles manufactured at Pritam International Private Limited located at Khasra No. 138, Raipur Industrial Area, Bhagwanpur in Haridwar, India into the United States under section 801(a)(3) of the FD&C Act, 21 U.S.C. 381(a)(3). Articles under this authority that appear to be adulterated may be detained or refused admission, in that the methods and controls used in their manufacture do not appear to conform to CGMP within the meaning of section 501(a)(2)(B) of the FD&C Act, 21 U.S.C. 351(a)(2)(B).\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 3020826443 and ATTN: Frank Wackes in the subject line of the email.\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.\nFDA posts warning letters to 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\ncc:\nLiberty Management Group Ltd., US agent\nEmail: (b)(4)\nMr. Pratam Singh, Plant Head, Pritam International Private Limited\nEmail: (b)(4)","2026-11-10T01:03:29.848+00:00",[23,24,25,9,10,26,26,26],"\u003Ctime datetime=\"2026-11-03T05:00:00Z\">11\u002F03\u002F2026\u003C\u002Ftime>\n","\u003Ctime datetime=\"2026-10-27T04:00:00Z\">10\u002F27\u002F2026\u003C\u002Ftime>\n","\u003Ca href=\"\u002Finspections-compliance-enforcement-and-criminal-investigations\u002Fwarning-letters\u002Fpritam-international-private-limited-738079-10272026\">Pritam International Private Limited\u003C\u002Fa>","","2026-11-10T01:02:16.121874+00:00","2026-11-10T01:03:30.193727+00:00",{"510k":30,"classification":31,"enforcement":32,"event":33,"event_backfill":34,"pma":35,"warning_letter":36},"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"]