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Data / FDA warning letters / Drug manufacturing (CGMP)

Drug manufacturing (CGMP) warning letters: 235

The full list. FDA warning letters: drug manufacturing (cgmp): 235 rows for $11.75, FDA warning letters issued November 12, 2024 to October 30, 2026. The list gains about 12 rows a month. The new rows come each week by email, $19 a month.

Pay by card with no account. Prices exclude VAT. CSV and Excel files with the columns this page does not show (issue date, subject group, response letter posted, closeout letter posted and read on), which open on your screen as soon as the payment clears and come by email. The weekly rows run until you cancel, from the link in each delivery. The rows on this page are a sample.

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Updated October 29, 2026. Source: FDA warning letters (U.S. Food and Drug Administration).

FDA issued 235 warning letters on drug manufacturing (cgmp) from November 12, 2024 to October 29, 2026, to 235 companies; 2 have a closeout letter. The newest, issued October 29, 2026 by the Center for Drug Evaluation and Research, went to Conroe Welding Supply, Inc. (CGMP/Medical Gases/Adulterated).

The request: Every new FDA warning letter on drug manufacturing (cgmp), with the company, the office and the letter. $10 of credit on sign-up, no card.

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  • 235Letters
  • 2With closeout
  • October 29, 2026Latest issued

Newest letters

The newest 100 of 235 by issue date, each linked to the letter on fda.gov.

IssuedCompanyIssuing officeSubjectPostedSource
October 29, 2026Conroe Welding Supply, Inc.Center for Drug Evaluation and ResearchCGMP/Medical Gases/AdulteratedNovember 3, 2026fda.gov
October 27, 2026Pritam International Private LimitedCenter for Drug Evaluation and ResearchCGMP/Finished Pharmaceuticals/AdulteratedNovember 3, 2026fda.gov
October 27, 2026Guangzhou Jiugong Research And Development Biotechnology Co., Ltd.Center for Drug Evaluation and ResearchCGMP/Finished Pharmaceuticals/AdulteratedNovember 3, 2026fda.gov
October 26, 2026Guangdong Bangze Medicine Co., Ltd.Center for Drug Evaluation and ResearchCGMP/Finished Pharmaceuticals/AdulteratedNovember 3, 2026fda.gov
October 22, 2026TSP Solutions Pte. Ltd.Center for Drug Evaluation and ResearchRequest for Records/CGMP/Finished Pharmaceuticals/AdulteratedOctober 27, 2026fda.gov
October 22, 2026Sanrace Biotechnology Co., Ltd.Center for Drug Evaluation and ResearchCGMP/Finished Pharmaceuticals/AdulteratedOctober 27, 2026fda.gov
October 22, 2026Northland Nuclear Medicine, LLCCenter for Drug Evaluation and ResearchCGMP/Finished Pharmaceuticals/AdulteratedOctober 27, 2026fda.gov
October 14, 2026Rohto Pharmaceutical Co., Ltd.Center for Drug Evaluation and ResearchCGMP/Finished Pharmaceuticals/Unapproved New Drug/Misbranded/AdulteratedOctober 20, 2026fda.gov
October 6, 2026Eurofins SF Analytical Laboratories, Inc.Center for Drug Evaluation and ResearchCGMP/Finished Pharmaceuticals/AdulteratedOctober 13, 2026fda.gov
October 5, 2026Silgan Dispensing SystemsCenter for Drug Evaluation and ResearchCGMP/Finished Pharmaceuticals/Adulterated/Unapproved New DrugOctober 13, 2026fda.gov
October 2, 2026Hanlim Pharm Co., Ltd.Center for Drug Evaluation and ResearchCGMP/Finished Pharmaceuticals/AdulteratedOctober 13, 2026fda.gov
October 1, 2026Zhejiang Gaorong Cosmetic Co., Ltd.Center for Drug Evaluation and ResearchCGMP/Finished Pharmaceuticals/AdulteratedOctober 20, 2026fda.gov
October 1, 2026Signature Formulations LLCCenter for Drug Evaluation and ResearchCGMP/Finished Pharmaceuticals/AdulteratedOctober 20, 2026fda.gov
September 29, 2026Baxter International Inc.Center for Drug Evaluation and ResearchCGMP/Finished Pharmaceuticals/AdulteratedOctober 20, 2026fda.gov
September 28, 2026SnugZ USA, Inc.Center for Drug Evaluation and ResearchCGMP/Finished Pharmaceuticals/AdulteratedOctober 20, 2026fda.gov
September 23, 2026Jiangmen Shuizirun Sanitary Articles Co., Ltd.Center for Drug Evaluation and ResearchCGMP/Finished Pharmaceuticals/AdulteratedOctober 13, 2026fda.gov
September 22, 2026Fresenius Kabi USA LLCCenter for Drug Evaluation and ResearchCGMP/Finished Pharmaceuticals/AdulteratedSeptember 29, 2026fda.gov
September 21, 2026Babikian Healthcare Products CJSCCenter for Drug Evaluation and ResearchCGMP/Finished Pharmaceuticals/AdulteratedSeptember 29, 2026fda.gov
September 18, 2026Curia New York, Inc.Center for Drug Evaluation and ResearchCGMP/Active Pharmaceutical Ingredient (API)/AdulteratedSeptember 29, 2026fda.gov
September 18, 2026Empower Clinic Services, LLC dba Empower PharmacyCenter for Drug Evaluation and ResearchCGMP/Finished Pharmaceuticals/Adulterated/Unapproved New DrugSeptember 22, 2026fda.gov
September 17, 2026Bentley Laboratories LLCCenter for Drug Evaluation and ResearchCGMP/Finished Pharmaceuticals/Unapproved New Drug/Misbranded/AdulteratedSeptember 29, 2026fda.gov
September 14, 2026SCA Pharmaceuticals, LLCCenter for Drug Evaluation and ResearchCGMP/Finished Pharmaceuticals/AdulteratedOctober 13, 2026fda.gov
September 8, 2026kdc/one Chatsworth, Inc.Center for Drug Evaluation and ResearchCGMP/Finished Pharmaceuticals/AdulteratedSeptember 22, 2026fda.gov
September 4, 2026Bausch & Lomb Inc.Center for Drug Evaluation and ResearchCGMP/Finished Pharmaceuticals/AdulteratedSeptember 15, 2026fda.gov
September 2, 2026TCI Co., Ltd BioCosme PABP BRANCHCenter for Drug Evaluation and ResearchCGMP/Finished Pharmaceuticals/AdulteratedOctober 6, 2026fda.gov
September 1, 2026Happy Farm Botanicals, Inc.Center for Drug Evaluation and ResearchCGMP/Finished Pharmaceuticals/AdulteratedSeptember 8, 2026fda.gov
August 27, 2026Jabil Inc.Center for Drug Evaluation and ResearchCGMP/Finished Pharmaceuticals/AdulteratedSeptember 1, 2026fda.gov
August 25, 2026Fresenius Medical Care AG & Co. KGaACenter for Drug Evaluation and ResearchCGMP/Finished Pharmaceuticals/AdulteratedSeptember 1, 2026fda.gov
August 18, 2026Shoolin Pharma Chem LLPCenter for Drug Evaluation and ResearchCGMP/Active Pharmaceutical Ingredient (API)/AdulteratedSeptember 1, 2026fda.gov
August 18, 2026Reliance Life Sciences Private LimitedCenter for Drug Evaluation and ResearchCGMP/Finished Pharmaceuticals/AdulteratedSeptember 1, 2026fda.gov
August 18, 2026PReye, LLCCenter for Drug Evaluation and ResearchCGMP/Finished Pharmaceuticals/Adulterated/Unapproved New DrugSeptember 1, 2026fda.gov
August 13, 2026Suretec Innovations, LLCCenter for Drug Evaluation and ResearchCGMP/Finished Pharmaceuticals/Adulterated and MisbrandedAugust 18, 2026fda.gov
August 13, 2026Eugia Pharma Specialities LimitedCenter for Drug Evaluation and ResearchCGMP/Finished Pharmaceuticals/AdulteratedAugust 18, 2026fda.gov
August 12, 2026K.C. Pharmaceuticals, Inc.Center for Drug Evaluation and ResearchCGMP/Finished Pharmaceuticals/AdulteratedAugust 18, 2026fda.gov
August 12, 2026Auriga Research Pvt. Ltd.Center for Drug Evaluation and ResearchCGMP/Finished Pharmaceuticals/AdulteratedAugust 18, 2026fda.gov
August 7, 2026Safrel Pharmaceuticals LLCCenter for Drug Evaluation and ResearchCGMP/Finished Pharmaceuticals/AdulteratedAugust 18, 2026fda.gov
August 6, 2026Tianjin Kilo Pharmaceutical Sci-tech Co., Ltd.Center for Drug Evaluation and ResearchCGMP/Active Pharmaceutical Ingredient (API)/Adulterated/MisbrandedAugust 18, 2026fda.gov
July 31, 2026FairyGene, Inc.Center for Drug Evaluation and ResearchCGMP/Finished Pharmaceuticals/Unapproved New Drug/Misbranded/AdulteratedAugust 11, 2026fda.gov
July 30, 2026Lico Industries, LLC., d.b.a. American Towelette CompanyCenter for Drug Evaluation and ResearchCGMP/Finished Pharmaceuticals/AdulteratedAugust 11, 2026fda.gov
July 27, 2026Woodbine Products Company Inc.Center for Drug Evaluation and ResearchCGMP/Finished Pharmaceuticals/AdulteratedAugust 4, 2026fda.gov
July 24, 2026Thomas Brunner Hygiene GmbHCenter for Drug Evaluation and ResearchCGMP/Finished Pharmaceuticals/Unapproved New Drug/Misbranded/AdulteratedAugust 4, 2026fda.gov
July 24, 2026Dabur India LimitedCenter for Drug Evaluation and ResearchCGMP/Finished Pharmaceuticals/AdulteratedAugust 4, 2026fda.gov
July 23, 2026ABS CorporationCenter for Veterinary MedicineCGMP/Finished Pharmaceuticals/AdulteratedAugust 4, 2026fda.gov
July 16, 2026Island Kinetics, Inc. d.b.a. CoValence LaboratoriesCenter for Drug Evaluation and ResearchCGMP/Finished Pharmaceuticals/Unapproved New Drug/Misbranded/AdulteratedJuly 21, 2026fda.gov
July 13, 2026Shimoga ChemicalsCenter for Drug Evaluation and ResearchCGMP/Active Pharmaceutical Ingredient (API)/AdulteratedJuly 21, 2026fda.gov
July 13, 2026BioMylz Pvt. Ltd.Center for Drug Evaluation and ResearchCGMP/Finished Pharmaceuticals/Adulterated/MisbrandedJuly 21, 2026fda.gov
July 13, 2026Almon Healthcare Private LimitedCenter for Drug Evaluation and ResearchCGMP/Active Pharmaceutical Ingredient (API)/AdulteratedJuly 21, 2026fda.gov
July 8, 2026Spa De Soleil, Inc.Center for Drug Evaluation and ResearchCGMP/Finished Pharmaceuticals/AdulteratedJuly 14, 2026fda.gov
July 2, 2026International Medication Systems LimitedCenter for Drug Evaluation and ResearchCGMP/Finished Pharmaceuticals/AdulteratedJuly 14, 2026fda.gov
June 25, 2026Excelvision - FarevaCenter for Drug Evaluation and ResearchCGMP/Finished Pharmaceuticals/AdulteratedJune 30, 2026fda.gov
June 24, 2026Wizcure Pharmaa Private LimitedCenter for Drug Evaluation and ResearchCGMP/Finished Pharmaceuticals/AdulteratedJune 30, 2026fda.gov
June 15, 2026Huons Co., Ltd.Center for Drug Evaluation and ResearchCGMP/Finished Pharmaceuticals/AdulteratedJune 23, 2026fda.gov
June 12, 2026AHC Products, Inc.Center for Veterinary MedicineCGMP/Finished Pharmaceuticals/AdulteratedJuly 28, 2026fda.gov
June 5, 2026Sante Manufacturing Inc.Center for Drug Evaluation and ResearchCGMP/Finished Pharmaceuticals/AdulteratedJune 16, 2026fda.gov
June 3, 2026Hubei Gedian Humanwell Pharmaceutical Co., Ltd.Center for Drug Evaluation and ResearchCGMP/Active Pharmaceutical Ingredient (API)/AdulteratedJune 9, 2026fda.gov
June 2, 2026Zydus Lifesciences LimitedCenter for Drug Evaluation and ResearchRequest for Records/CGMP/Finished Pharmaceuticals/AdulteratedJune 9, 2026fda.gov
June 2, 2026Umendra Life Sciences Private LimitedCenter for Drug Evaluation and ResearchCGMP/OTC Finished Pharmaceuticals/AdulteratedJune 9, 2026fda.gov
June 2, 2026Shantou Qiwei Industry Co., LTDCenter for Drug Evaluation and ResearchCGMP/OTC Finished Pharmaceuticals/AdulteratedJune 9, 2026fda.gov
June 2, 2026Revlon Group Holdings, LLCCenter for Drug Evaluation and ResearchCGMP/OTC Finished Pharmaceuticals/AdulteratedJune 9, 2026fda.gov
June 2, 2026PLZ CorpCenter for Drug Evaluation and ResearchCGMP/OTC Finished Pharmaceuticals/AdulteratedJune 9, 2026fda.gov
June 2, 2026Laboratorios Dr. Collado S.A.Center for Drug Evaluation and ResearchCGMP/OTC Finished Pharmaceuticals/AdulteratedJune 9, 2026fda.gov
June 2, 2026Gopaldas Visram & Co., Ltd.Center for Drug Evaluation and ResearchCGMP/OTC Finished Pharmaceuticals/AdulteratedJune 9, 2026fda.gov
June 2, 2026Erkul Kozmetik Sanayi ve Ticaret A.S.Center for Drug Evaluation and ResearchCGMP/OTC Finished Pharmaceuticals/AdulteratedJune 9, 2026fda.gov
June 2, 2026Asanuma Corporation - Sagamihara FactoryCenter for Drug Evaluation and ResearchCGMP/OTC Finished Pharmaceuticals/AdulteratedJune 9, 2026fda.gov
May 28, 2026Jubilant HollisterStier General PartnershipCenter for Drug Evaluation and ResearchCGMP/Finished Pharmaceuticals/AdulteratedJune 23, 2026fda.gov
May 28, 2026Medline IncCenter for Drug Evaluation and ResearchCGMP/Finished Pharmaceuticals/AdulteratedJune 2, 2026fda.gov
May 27, 2026Pharmathen International S.A.Center for Drug Evaluation and ResearchCGMP/Active Pharmaceutical Ingredient (API)/AdulteratedJune 16, 2026fda.gov
May 22, 2026Laboratorios Jaloma S.A. de C.V.Center for Drug Evaluation and ResearchCGMP/OTC/Finished Pharmaceuticals/AdulteratedJune 2, 2026fda.gov
May 21, 2026Alchymars ICM SM Private LimitedCenter for Drug Evaluation and ResearchCGMP/Active Pharmaceutical Ingredient (API)/AdulteratedMay 26, 2026fda.gov
May 18, 2026Sato Pharmaceutical Co., Ltd.Center for Drug Evaluation and ResearchCGMP/Drugs/Adulterated/OTCMay 26, 2026fda.gov
May 14, 2026GC America, Inc.Center for Drug Evaluation and ResearchCGMP/Finished Pharmaceuticals/AdulteratedMay 26, 2026fda.gov
May 4, 2026Naveh Pharma LTD/Bigdam Inc.Center for Drug Evaluation and ResearchCGMP/Finished Pharmaceuticals/Adulterated/Unapproved New DrugMay 12, 2026fda.gov
May 4, 2026IDO Pharm Co., Ltd.Center for Drug Evaluation and ResearchCGMP/OTC Finished Pharmaceuticals/AdulteratedMay 12, 2026fda.gov
May 1, 2026Harbin Jixianglong Biotech Co., Ltd.Center for Drug Evaluation and ResearchCGMP/API/Adulterated and Misbranded DrugsMay 19, 2026fda.gov
April 30, 2026CareFusion 213, LLCCenter for Drug Evaluation and ResearchCGMP/Finished Pharmaceuticals/AdulteratedMay 5, 2026fda.gov
April 22, 2026Active Cosmetics Manufacturing Inc.Center for Drug Evaluation and ResearchCGMP/Finished Pharmaceuticals/AdulteratedMay 5, 2026fda.gov
April 20, 2026Respilon Production S.R.O.Center for Drug Evaluation and ResearchCGMP/OTC/Finished Pharmaceuticals/AdulteratedMay 5, 2026fda.gov
April 15, 2026JW Nutritional LLCCenter for Drug Evaluation and ResearchCGMP/OTC Finished Pharmaceuticals/AdulteratedMay 19, 2026fda.gov
April 15, 2026Hangzhou Yiqi Biotechnology Co., LtdCenter for Drug Evaluation and ResearchCGMP/Active Pharmaceutical Ingredient (API)/AdulteratedMay 19, 2026fda.gov
April 15, 2026Par Health USA, LLC & Endo USA, Inc.Center for Drug Evaluation and ResearchCGMP/Finished Pharmaceuticals/AdulteratedApril 21, 2026fda.gov
April 14, 2026Ava Inc.Center for Drug Evaluation and ResearchCGMP/Finished Pharmaceuticals/AdulteratedMay 5, 2026fda.gov
April 14, 2026New Life Pharma LLCCenter for Drug Evaluation and ResearchCGMP/Adulterated and Unapproved New Drug/MisbrandedApril 21, 2026fda.gov
April 13, 2026UCSF Radiopharmaceutical FacilityCenter for Drug Evaluation and ResearchCGMP/Finished Pharmaceuticals/AdulteratedApril 21, 2026fda.gov
April 10, 2026Fareva AmboiseCenter for Veterinary MedicineCGMP/Finished Pharmaceuticals/AdulteratedJuly 21, 2026fda.gov
April 9, 2026Medical Products Laboratories, Inc.Center for Drug Evaluation and ResearchCGMP/Finished Pharmaceuticals/Adulterated/Unapproved New DrugApril 14, 2026fda.gov
April 7, 2026Lexia LLCCenter for Drug Evaluation and ResearchCGMP/Finished Pharmaceuticals/AdulteratedApril 28, 2026fda.gov
April 3, 2026Ridley USA Inc.Center for Veterinary MedicineCGMP/Medicated Feeds/AdulteratedMay 12, 2026fda.gov
April 2, 2026Purolea Cosmetics LabCenter for Drug Evaluation and ResearchCGMP/Finished Pharmaceuticals/Adulterated/Unapproved New DrugApril 14, 2026fda.gov
March 30, 2026Intas Pharmaceuticals LimitedCenter for Drug Evaluation and ResearchCGMP/Finished Pharmaceuticals/AdulteratedApril 28, 2026fda.gov
March 26, 2026Henan Lvyuan Pharmaceutical Co. Ltd.Center for Veterinary MedicineCGMP/API/AdulteratedMarch 31, 2026fda.gov
March 23, 2026Xiamen Kang Zhongyuan Biotechnology Co., Ltd.Center for Drug Evaluation and ResearchCGMP/Finished Pharmaceuticals/AdulteratedApril 21, 2026fda.gov
March 18, 2026Yangzhou H&R Plastic Daily Chemical Co., Ltd.Center for Drug Evaluation and ResearchCGMP/Finished Pharmaceuticals/AdulteratedMarch 24, 2026fda.gov
March 16, 2026Microbiological Testing & Consulting, LLCCenter for Drug Evaluation and ResearchCGMP/Finished Pharmaceuticals/AdulteratedMarch 31, 2026fda.gov
March 11, 2026OraLabs, Inc.Center for Drug Evaluation and ResearchCGMP/Finished Pharmaceuticals/AdulteratedMarch 17, 2026fda.gov
March 11, 2026Flowchem Pharma Private LimitedCenter for Drug Evaluation and ResearchCGMP/Active Pharmaceutical Ingredient (API)/AdulteratedMarch 17, 2026fda.gov
March 3, 2026Tentamus India Private LimitedCenter for Drug Evaluation and ResearchCGMP/Finished Pharmaceuticals/AdulteratedMarch 10, 2026fda.gov
March 3, 2026Simtra BioPharma SolutionsCenter for Drug Evaluation and ResearchCGMP/Finished Pharmaceuticals/AdulteratedMarch 10, 2026fda.gov
March 3, 2026Fareva Morton GroveCenter for Drug Evaluation and ResearchCGMP/Finished Pharmaceuticals/AdulteratedMarch 10, 2026fda.gov
February 12, 2026A. Nelson & Co. Ltd.Center for Drug Evaluation and ResearchCGMP/Finished Pharmaceuticals/AdulteratedFebruary 24, 2026fda.gov
February 12, 2026AQ USA Inc., d.b.a Ross Healthcare Inc.Center for Drug Evaluation and ResearchCGMP/Finished Pharmaceuticals/AdulteratedFebruary 24, 2026fda.gov

Subjects as FDA words them

SubjectLettersLatest
CGMP/Finished Pharmaceuticals/Adulterated157October 27, 2026
CGMP/Active Pharmaceutical Ingredient (API)/Adulterated25September 18, 2026
CGMP/OTC Finished Pharmaceuticals/Adulterated10June 2, 2026
CGMP/Finished Pharmaceutical/Adulterated9March 14, 2025
CGMP/Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated6October 14, 2026
CGMP/Finished Pharmaceuticals/Adulterated/Unapproved New Drug6October 5, 2026
CGMP/Finished Pharmaceutical/API/Adulterated3August 20, 2025
Request for Records/CGMP/Finished Pharmaceuticals/Adulterated2October 22, 2026
CGMP/Active Pharmaceutical Ingredient (API)/Adulterated/Misbranded2August 6, 2026
CGMP/OTC/Finished Pharmaceuticals/Adulterated2May 22, 2026
CGMP/Medical Gases/Adulterated1October 29, 2026
CGMP/Finished Pharmaceuticals/Adulterated and Misbranded1August 13, 2026
CGMP/Finished Pharmaceuticals/Adulterated/Misbranded1July 13, 2026
CGMP/Drugs/Adulterated/OTC1May 18, 2026
CGMP/API/Adulterated and Misbranded Drugs1May 1, 2026
CGMP/Adulterated and Unapproved New Drug/Misbranded1April 14, 2026
CGMP/Medicated Feeds/Adulterated1April 3, 2026
CGMP/API/Adulterated1March 26, 2026
CGMP/OTC/Adulterated/Misbranded1December 18, 2025
CGMP/Positron Emission Tomography (PET) Drugs/Adulterated1December 4, 2025
CGMP/Finished Pharmaceutical/Adulterated/Refusal to Allow Inspection1December 17, 2024
CGMP/Finished Pharmaceuticals/Adulterated/Unapproved New Drug/Misbranded1November 21, 2024
Finished Pharmaceuticals/Unapproved New Drug/Misbranded/OTC1November 15, 2024

By issuing office

Issuing officeLettersLatest
Center for Drug Evaluation and Research225October 29, 2026
Center for Veterinary Medicine6July 23, 2026
Office of Manufacturing Quality3December 1, 2025
Center for Biologics Evaluation and Research1December 12, 2024

By year issued

YearLettersLatest
2025110December 30, 2025
2026109October 29, 2026
202416December 19, 2024

Where FDA publishes its warning letters

Public domain (U.S. government work). Letters are as FDA lists them in its warning letters table: the company, the issue and posting dates, the issuing office and FDA's subject line. Subject groups are SpecStream's, read from the words of that subject line. FDA posts a letter some weeks after it issues it, so the newest weeks fill in later. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.