[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-warning-letter-s-j-international-enterprises-public-company-limited-668482-01262024":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},1647,"s-j-international-enterprises-public-company-limited-668482-01262024","Warning Letter","S & J International Enterprises Public Company Limited",null,"Center for Drug Evaluation and Research | CDER","CGMP\u002FFinished Pharmaceuticals\u002FAdulterated","2024-01-30","2024-01-26","Issued","https:\u002F\u002Fwww.fda.gov\u002Finspections-compliance-enforcement-and-criminal-investigations\u002Fwarning-letters\u002Fs-j-international-enterprises-public-company-limited-668482-01262024","668482","Drugs","VIA UPS","Mr. Praj Srichandra","\n\n                            \n                            \n                            \n                            \n                                              \n  \n \n\n                 \n\n  \u003Chr>\n \n\n\u003Cdiv class=\"inset-column\">\n  \u003Cdl class=\"lcds-description-list--grid\">\n\n              \u003Cdt class=\"cell-1_1\">Delivery Method:\u003C\u002Fdt> \n        \u003Cdd class=\"cell-2_1\">VIA UPS\n                                                                                                                                                                                                                                                                                                                                                                                                                              \u003C\u002Fdd>\n      \n      \n              \u003Cdt class=\"cell-1_3\">Product:\u003C\u002Fdt> \n        \u003Cdd class=\"cell-2_3\">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 class=\"row inset-column\">\n  \u003Cdiv class=\"col-xs-12 col-md-6\">\n    \u003Cdl class=\"\">\n\n        \u003Cdt>Recipient:\u003C\u002Fdt>\n\n                      \u003Cdd>\n  \u003Cdiv class=\"field field--name-field-recipient-name field--type-string field--label-above\">\n    \u003Cdiv class=\"field--label\">Recipient Name\u003C\u002Fdiv>\n              \u003Cdiv class=\"field--item\">Mr. Praj Srichandra\u003C\u002Fdiv>\n          \u003C\u002Fdiv>\n\u003C\u002Fdd>\n                                \u003Cdd>\n  \u003Cdiv class=\"field field--name-field-recipient-title field--type-string field--label-above\">\n    \u003Cdiv class=\"field--label\">Recipient Title\u003C\u002Fdiv>\n              \u003Cdiv class=\"field--item\">Factory Division Manager, Board Member of Saha Group\u003C\u002Fdiv>\n          \u003C\u002Fdiv>\n\u003C\u002Fdd>\n          \n            \u003Cdd>S & J International Enterprises Public Company Limited\u003C\u002Fdd>\n\n          \n                      \u003Cdd>\u003Cp class=\"address\" translate=\"no\">\u003Cspan class=\"address-line1\">600\u002F4 Moo.11 Sukaphiban 8 Road\u003C\u002Fspan>\u003Cbr>\n\u003Cspan class=\"dependent-locality\">Nongkharm\u003C\u002Fspan>, \u003Cspan class=\"locality\">Si Racha\u003C\u002Fspan>\u003Cbr>\n\u003Cspan class=\"administrative-area\">Chon Buri\u003C\u002Fspan> \u003Cspan class=\"postal-code\">20230\u003C\u002Fspan>\u003Cbr>\n\u003Cspan class=\"country\">Thailand\u003C\u002Fspan>\u003C\u002Fp>\u003C\u002Fdd>\n          \n          \n          \n    \u003C\u002Fdl>\n  \u003C\u002Fdiv>            \n\n       \u003Cdiv class=\"col-xs-12 col-md-6\">\n    \u003Cdl class=\"\">\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 class=\"address\" translate=\"no\">\u003Cspan class=\"country\">United States\u003C\u002Fspan>\u003C\u002Fp>\u003C\u002Fdd>\n        \n        \n        \n        \n        \n    \u003C\u002Fdl>\n    \u003Cdl class=\"\"> \n      \n  \u003Cdiv class=\"field field--name-field-issuing-office-paragraph field--type-entity-reference-revisions field--label-above\">\n    \u003Cdiv class=\"field--label\">Secondary Issuing Offices\u003C\u002Fdiv>\n          \u003Cdiv class=\"field--items\">\n              \u003Cdiv class=\"field--item\">    \u003Cbr>\n    \n     \n        \u003Cdd>\u003Cp class=\"address\" translate=\"no\">\u003Cspan class=\"country\">United States\u003C\u002Fspan>\u003C\u002Fp>\u003C\u002Fdd>\n    \n    \n    \n    \n\u003C\u002Fdiv>\n              \u003C\u002Fdiv>\n      \u003C\u002Fdiv>\n\n    \u003C\u002Fdl>\n  \u003C\u002Fdiv>  \n      \n\u003C\u002Fdiv>\n\n \n\n \n\n\u003Chr>\n\n\u003Cp class=\"text-align-center\">\u003Cstrong>Warning Letter\u003C\u002Fstrong> 320-24-17\u003C\u002Fp>\n\n\u003Cp>January 26, 2024\u003Cbr>\n\u003Cbr>\nDear Mr. Srichandra:\u003C\u002Fp>\n\n\u003Cp>The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, S & J International Enterprises Public Company Limited, FEI 3005979923, at 600\u002F4 Moo.11 Sukaphiban 8 Road, Nongkharm, Si Racha, from July 17 to July 21, 2023.\u003C\u002Fp>\n\n\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>\n\n\u003Cp>Because your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your drug product is 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>\n\n\u003Cp>Furthermore, during the inspection you delayed or limited access to or copying of records requested. Due to your delay and limiting access to or copying of records during the inspection, the drug products you manufacture are also deemed adulterated within the meaning of section 501(j) of the FD&C Act, 21 U.S.C. 351(j).\u003C\u002Fp>\n\n\u003Cp>We reviewed your response\u003Csup>\u003Cem>\u003Cstrong>1\u003C\u002Fstrong>\u003C\u002Fem>\u003C\u002Fsup> to our Form FDA 483. Your response is inadequate because it did not provide sufficient detail or evidence of corrective actions to bring your operations into compliance with CGMP.\u003C\u002Fp>\n\n\u003Cp>During our inspection, our investigator observed specific violations including, but not limited to, the following.\u003C\u002Fp>\n\n\u003Cp>\u003Cstrong>1. 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>\n\n\u003Cp>Your quality unit (QU) did not provide adequate oversight and control over your drug manufacturing operations. Specifically, your QU did not implement adequate controls to prevent the alteration of production records, to ensure the complete documentation of laboratory preparation, and to ensure the review of raw analytical data. For example, production staff are able to alter master batch records, including modifying batch formulations and other parameters or formulations before printing. Laboratory sample preparation is not documented, and weight print-outs are not retained. Lastly, your QU only reviews analytical results entered into your enterprise system and does not review raw analytical data before releasing quarantined materials or finished drug products.\u003C\u002Fp>\n\n\u003Cp>An adequate QU overseeing all manufacturing operations is necessary to consistently ensure drug quality. See FDA’s guidance document \u003Cem>Quality Systems Approach to Pharmaceutical CGMP Regulations\u003C\u002Fem> for help implementing quality systems and risk management approaches to meet the requirements of CGMP regulations 21 CFR, parts 210 and 211 at https:\u002F\u002Fwww.fda.gov\u002Fmedia\u002F71023\u002Fdownload.\u003C\u002Fp>\n\n\u003Cp>In response to this letter, provide 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:\u003C\u002Fp>\n\n\u003Cul>\n\t\u003Cli>A determination of whether procedures used by your firm are robust and appropriate.\u003C\u002Fli>\n\t\u003Cli>Provisions for QU oversight throughout your operations to evaluate adherence to appropriate practices.\u003C\u002Fli>\n\t\u003Cli>A complete and final review of each batch and its related information before the QU disposition decision.\u003C\u002Fli>\n\t\u003Cli>Oversight and approval of investigations and discharging of all other QU duties to ensure identity, strength, quality, and purity of all products. 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>\n\u003C\u002Ful>\n\n\u003Cp>\u003Cstrong>2. Your firm failed to prepare batch production and control records with complete information relating to the production and control of each batch of drug product produced (21 CFR 211.188).\u003C\u002Fstrong>\u003C\u002Fp>\n\n\u003Cp>You recorded production data on laminated sheets using erasable markers that could be easily altered or lost. These logs were used to record \u003Cstrong>(b)(4)\u003C\u002Fstrong> weight verification checks for balances and scales, room cleaning checklists, employee health and hygiene checks, operator shoe cleaning, pest control checks, facility and equipment checks, and \u003Cstrong>(b)(4)\u003C\u002Fstrong> temperature and humidity monitoring in manufacturing areas. You stated that these temporary records are scanned and retained. However, you could not provide the permanent version of these records and stated that only production staff and production supervisors, and not the QU, have access to the scanned sheets and logs. Without adequate and complete batch records, you cannot assure the uniformity of your drug products from batch to batch and may impact your ability to adequately investigate any product deviations.\u003C\u002Fp>\n\n\u003Cp>In response to this letter, provide a complete 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 records throughout your operation.\u003C\u002Fp>\n\n\u003Cp>\u003Cstrong>Data Integrity Remediation\u003C\u002Fstrong>\u003C\u002Fp>\n\n\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\u003C\u002Fem> for guidance on establishing and following CGMP compliant data integrity practices at https:\u002F\u002Fwww.fda.gov\u002Fmedia\u002F119267\u002Fdownload.\u003C\u002Fp>\n\n\u003Cp>We strongly recommend that you retain a qualified consultant to assist in your remediation. In response to this letter, provide:\u003C\u002Fp>\n\n\u003Cul>\n\t\u003Cli>A comprehensive investigation into the extent of the inaccuracies in data records and reporting, including results of the data review for drugs distributed to the United States. Include a detailed description of the scope and root causes of your data integrity lapses.\u003C\u002Fli>\n\t\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 lapse of data integrity and analyses of the risks posed by ongoing operations.\u003C\u002Fli>\n\t\u003Cli>A management strategy for your firm that includes the details of your global CAPA plan. The detailed corrective action plan should describe how you intend to ensure the reliability and completeness of all data generated by your firm including microbiological and analytical data, manufacturing records, and all data submitted to FDA.\u003C\u002Fli>\n\u003C\u002Ful>\n\n\u003Cp>\u003Cstrong>Delaying, Denying, Limiting, or Refusing a Drug Inspection\u003C\u002Fstrong>\u003C\u002Fp>\n\n\u003Cp>You delayed and limited access to or copying of records requested during the inspection. During the inspection, our investigator provided a list of requested documents and made numerous repeat requests during the inspection for these documents. Yet, your firm only provided or allowed access to a limited number of documents.\u003C\u002Fp>\n\n\u003Cp>For example, upon request for the current labeling for your United States (U.S.) drug product, you provided a single photograph of the primary and secondary drug product packaging on the last day of the inspection, which was of poor quality and not legible.\u003C\u002Fp>\n\n\u003Cp>Additionally, upon request for a list of all laboratory non-conformances and investigations during the inspection, your staff initially stated that there were no out-of-trend, out-of-specification (OOS), incidents, non-conformances, or investigations, and provided blank logs for years 2021-2023. However, later during the inspection, our investigator observed logs for these years on an electronic drive that contained non-conformance report numbers, dates, descriptions, and close-out dates, and appeared to include a raw material OOS entry for \u003Cstrong>(b)(4)\u003C\u002Fstrong>, the active ingredient in your U.S. drug product. Only after discovery by our investigator were these logs provided to our investigator.\u003C\u002Fp>\n\n\u003Cp>When an owner, operator, or agent delays, denies, limits, or refuses an inspection, the drugs may be deemed adulterated under section 501(j) of the FD&C Act. See FDA’s guidance document \u003Cem>Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug Inspection\u003C\u002Fem> at https:\u002F\u002Fwww.fda.gov\u002Fmedia\u002F86328\u002Fdownload.\u003C\u002Fp>\n\n\u003Cp>\u003Cstrong>CGMP Consultant Recommended\u003C\u002Fstrong>\u003C\u002Fp>\n\n\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\u003Csup>\u003Cem>\u003Cstrong>2\u003C\u002Fstrong>\u003C\u002Fem>\u003C\u002Fsup> of your entire operation for CGMP compliance and evaluate the completion and efficacy of your corrective actions and preventive actions before you pursue resolution of your firm’s compliance status with FDA.\u003C\u002Fp>\n\n\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>\n\n\u003Cp>\u003Cstrong>Conclusion\u003C\u002Fstrong>\u003C\u002Fp>\n\n\u003Cp>The violations cited in this letter are not intended to be an all-inclusive list of violations that exist at your facility. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations.\u003C\u002Fp>\n\n\u003Cp>FDA placed your firm on Import Alert 66-40 on January 23, 2024.\u003C\u002Fp>\n\n\u003Cp>Correct any violations promptly. 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>\n\n\u003Cp>Failure to address any violations may also result in the FDA continuing to refuse admission of articles manufactured at S & J International Enterprises Public Company Limited, 600\u002F4 Moo.11 Sukaphiban 8 Road, 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>\n\n\u003Cp>This letter notifies you of our findings and provides you an opportunity to address the above deficiencies. After you receive this letter, respond to this office in writing within 15 working days. Specify what you have done to address any violations and to prevent their recurrence. In response to this letter, you may provide additional information for our consideration as we continue to assess your activities and practices. If you cannot complete corrective actions within 15 working days, state your reasons for delay and your schedule for completion.\u003C\u002Fp>\n\n\u003Cp>Send your electronic reply to CDER-OC-OMQ-Communications@fda.hhs.gov. Identify your response with FEI 3005979923 and ATTN: Christina Capacci-Daniel.\u003C\u002Fp>\n\n\u003Cp>Sincerely,\u003Cbr>\n\u002FS\u002F\u003C\u002Fp>\n\n\u003Cp>Francis Godwin\u003Cbr>\nDirector\u003Cbr>\nOffice of Manufacturing Quality\u003Cbr>\nOffice of Compliance\u003Cbr>\nCenter for Drug Evaluation and Research\u003C\u002Fp>\n\n\u003Cp>_________________\u003C\u002Fp>\n\n\u003Cp>\u003Cem>\u003Cstrong>1\u003C\u002Fstrong>\u003C\u002Fem> Response provided by email on December 19, 2023 following the July 17 to July 21, 2023 inspection.\u003C\u002Fp>\n\n\u003Cp>\u003Cem>\u003Cstrong>2\u003C\u002Fstrong>\u003C\u002Fem> i.e., Quality System, Facilities & Equipment System, Materials System, Production System, Packaging & Labeling System, and Laboratory Control System per FDA’s guidance document Quality Systems Approach to Pharmaceutical CGMP Regulations.\u003C\u002Fp>\n\n\n\u003C!--BEGIN QUALTRICS WEBSITE FEEDBACK SNIPPET-->\n\u003C!--BEGIN QUALTRICS WEBSITE FEEDBACK SNIPPET-->\n\n\n\n              \n                                            \n              \n            ","Delivery Method:\n\nVIA UPS\n\nProduct:\n\nDrugs\n\nRecipient:\n\nRecipient Name\n\nMr. Praj Srichandra\n\nRecipient Title\n\nFactory Division Manager, Board Member of Saha Group\n\nS & J International Enterprises Public Company Limited\n\n600\u002F4 Moo.11 Sukaphiban 8 Road\n\nNongkharm, Si Racha\n\nChon Buri 20230\n\nThailand\n\nIssuing Office:\n\nCenter for Drug Evaluation and Research | CDER\n\nUnited States\n\nSecondary Issuing Offices\n\nUnited States\n\nWarning Letter 320-24-17\n\nJanuary 26, 2024\n\nDear Mr. Srichandra:\n\nThe U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, S & J International Enterprises Public Company Limited, FEI 3005979923, at 600\u002F4 Moo.11 Sukaphiban 8 Road, Nongkharm, Si Racha, from July 17 to July 21, 2023.\n\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).\n\nBecause your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your drug product is 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).\n\nFurthermore, during the inspection you delayed or limited access to or copying of records requested. Due to your delay and limiting access to or copying of records during the inspection, the drug products you manufacture are also deemed adulterated within the meaning of section 501(j) of the FD&C Act, 21 U.S.C. 351(j).\n\nWe reviewed your response1 to our Form FDA 483. Your response is inadequate because it did not provide sufficient detail or evidence of corrective actions to bring your operations into compliance with CGMP.\n\nDuring our inspection, our investigator observed specific violations including, but not limited to, the following.\n\n1. 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).\n\nYour quality unit (QU) did not provide adequate oversight and control over your drug manufacturing operations. Specifically, your QU did not implement adequate controls to prevent the alteration of production records, to ensure the complete documentation of laboratory preparation, and to ensure the review of raw analytical data. For example, production staff are able to alter master batch records, including modifying batch formulations and other parameters or formulations before printing. Laboratory sample preparation is not documented, and weight print-outs are not retained. Lastly, your QU only reviews analytical results entered into your enterprise system and does not review raw analytical data before releasing quarantined materials or finished drug products.\n\nAn adequate QU overseeing all manufacturing operations is necessary to consistently ensure drug quality. See FDA’s guidance document Quality Systems Approach to Pharmaceutical CGMP Regulations for help implementing quality systems and risk management approaches to meet the requirements of CGMP regulations 21 CFR, parts 210 and 211 at https:\u002F\u002Fwww.fda.gov\u002Fmedia\u002F71023\u002Fdownload.\n\nIn response to this letter, provide 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:\n\nA determination of whether procedures used by your firm are robust and appropriate.\n\nProvisions for QU oversight throughout your operations to evaluate adherence to appropriate practices.\n\nA complete and final review of each batch and its related information before the QU disposition decision.\n\nOversight and approval of investigations and discharging of all other QU duties to ensure identity, strength, quality, and purity of all products. 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.\n\n2. Your firm failed to prepare batch production and control records with complete information relating to the production and control of each batch of drug product produced (21 CFR 211.188).\n\nYou recorded production data on laminated sheets using erasable markers that could be easily altered or lost. These logs were used to record (b)(4) weight verification checks for balances and scales, room cleaning checklists, employee health and hygiene checks, operator shoe cleaning, pest control checks, facility and equipment checks, and (b)(4) temperature and humidity monitoring in manufacturing areas. You stated that these temporary records are scanned and retained. However, you could not provide the permanent version of these records and stated that only production staff and production supervisors, and not the QU, have access to the scanned sheets and logs. Without adequate and complete batch records, you cannot assure the uniformity of your drug products from batch to batch and may impact your ability to adequately investigate any product deviations.\n\nIn response to this letter, provide a complete 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 records throughout your operation.\n\nData Integrity Remediation\n\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 for guidance on establishing and following CGMP compliant data integrity practices at https:\u002F\u002Fwww.fda.gov\u002Fmedia\u002F119267\u002Fdownload.\n\nWe strongly recommend that you retain a qualified consultant to assist in your remediation. In response to this letter, provide:\n\nA comprehensive investigation into the extent of the inaccuracies in data records and reporting, including results of the data review for drugs distributed to the United States. Include a detailed description of the scope and root causes of your data integrity lapses.\n\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 lapse of data integrity and analyses of the risks posed by ongoing operations.\n\nA management strategy for your firm that includes the details of your global CAPA plan. The detailed corrective action plan should describe how you intend to ensure the reliability and completeness of all data generated by your firm including microbiological and analytical data, manufacturing records, and all data submitted to FDA.\n\nDelaying, Denying, Limiting, or Refusing a Drug Inspection\n\nYou delayed and limited access to or copying of records requested during the inspection. During the inspection, our investigator provided a list of requested documents and made numerous repeat requests during the inspection for these documents. Yet, your firm only provided or allowed access to a limited number of documents.\n\nFor example, upon request for the current labeling for your United States (U.S.) drug product, you provided a single photograph of the primary and secondary drug product packaging on the last day of the inspection, which was of poor quality and not legible.\n\nAdditionally, upon request for a list of all laboratory non-conformances and investigations during the inspection, your staff initially stated that there were no out-of-trend, out-of-specification (OOS), incidents, non-conformances, or investigations, and provided blank logs for years 2021-2023. However, later during the inspection, our investigator observed logs for these years on an electronic drive that contained non-conformance report numbers, dates, descriptions, and close-out dates, and appeared to include a raw material OOS entry for (b)(4), the active ingredient in your U.S. drug product. Only after discovery by our investigator were these logs provided to our investigator.\n\nWhen an owner, operator, or agent delays, denies, limits, or refuses an inspection, the drugs may be deemed adulterated under section 501(j) of the FD&C Act. See FDA’s guidance document Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug Inspection at https:\u002F\u002Fwww.fda.gov\u002Fmedia\u002F86328\u002Fdownload.\n\nCGMP Consultant Recommended\n\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 audit2 of your entire operation for CGMP compliance and evaluate the completion and efficacy of your corrective actions and preventive actions before you pursue resolution of your firm’s compliance status with FDA.\n\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.\n\nConclusion\n\nThe violations cited in this letter are not intended to be an all-inclusive list of violations that exist at your facility. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations.\n\nFDA placed your firm on Import Alert 66-40 on January 23, 2024.\n\nCorrect any violations promptly. 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.\n\nFailure to address any violations may also result in the FDA continuing to refuse admission of articles manufactured at S & J International Enterprises Public Company Limited, 600\u002F4 Moo.11 Sukaphiban 8 Road, 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).\n\nThis letter notifies you of our findings and provides you an opportunity to address the above deficiencies. After you receive this letter, respond to this office in writing within 15 working days. Specify what you have done to address any violations and to prevent their recurrence. In response to this letter, you may provide additional information for our consideration as we continue to assess your activities and practices. If you cannot complete corrective actions within 15 working days, state your reasons for delay and your schedule for completion.\n\nSend your electronic reply to CDER-OC-OMQ-Communications@fda.hhs.gov. Identify your response with FEI 3005979923 and ATTN: Christina Capacci-Daniel.\n\nSincerely,\n\n\u002FS\u002F\n\nFrancis Godwin\n\nDirector\n\nOffice of Manufacturing Quality\n\nOffice of Compliance\n\nCenter for Drug Evaluation and Research\n\n_________________\n\n1 Response provided by email on December 19, 2023 following the July 17 to July 21, 2023 inspection.\n\n2 i.e., Quality System, Facilities & Equipment System, Materials System, Production System, Packaging & Labeling System, and Laboratory Control System per FDA’s guidance document Quality Systems Approach to Pharmaceutical CGMP Regulations.","2026-08-20T00:21:40.309+00:00",[23,24,25,9,10,26,26,26],"\u003Ctime datetime=\"2024-01-30T14:20:00Z\">01\u002F30\u002F2024\u003C\u002Ftime>\n","\u003Ctime datetime=\"2024-01-26T05:00:00Z\">01\u002F26\u002F2024\u003C\u002Ftime>\n","\u003Ca href=\"\u002Finspections-compliance-enforcement-and-criminal-investigations\u002Fwarning-letters\u002Fs-j-international-enterprises-public-company-limited-668482-01262024\">S & J International Enterprises Public Company Limited\u003C\u002Fa>","","2026-08-18T06:42:28.994808+00:00","2026-08-20T02:24:56.185295+00:00",{"510k":30,"classification":31,"enforcement":32,"event":33,"pma":34,"warning_letter":35},"2026-08-18T06:35:18.347+00:00","2026-08-18T05:52:53.75+00:00","2026-08-18T08:01:54.918+00:00","2026-08-19T02:58:35.995+00:00","2026-08-18T06:36:30.549+00:00","2026-08-20T03:28:02.95+00:00"]