# Drug manufacturing (CGMP) warning letters: 235

Updated October 29, 2026.

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 full list

FDA warning letters: drug manufacturing (cgmp): 235 rows for $11.75, FDA warning letters issued November 12, 2024 to October 30, 2026. Columns: Company, Issue date, Posted, Issuing office, Subject, Subject group, Response letter posted, Closeout letter posted, Read on, Source. The new rows each week by email, about 12 rows a month: $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 rows on this page are a sample.

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- Letters: 235
- With closeout: 2
- Latest issued: October 29, 2026

## Newest letters

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

| Issued | Company | Issuing office | Subject | Posted | Source |
| --- | --- | --- | --- | --- | --- |
| October 29, 2026 | Conroe Welding Supply, Inc. | Center for Drug Evaluation and Research | CGMP/Medical Gases/Adulterated | November 3, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/conroe-welding-supply-inc-731507-10292026) |
| October 27, 2026 | Pritam International Private Limited | Center for Drug Evaluation and Research | CGMP/Finished Pharmaceuticals/Adulterated | November 3, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/pritam-international-private-limited-738079-10272026) |
| October 27, 2026 | Guangzhou Jiugong Research And Development Biotechnology Co., Ltd. | Center for Drug Evaluation and Research | CGMP/Finished Pharmaceuticals/Adulterated | November 3, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/guangzhou-jiugong-research-and-development-biotechnology-co-ltd-737769-10272026) |
| October 26, 2026 | Guangdong Bangze Medicine Co., Ltd. | Center for Drug Evaluation and Research | CGMP/Finished Pharmaceuticals/Adulterated | November 3, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/guangdong-bangze-medicine-co-ltd-734509-10262026) |
| October 22, 2026 | TSP Solutions Pte. Ltd. | Center for Drug Evaluation and Research | Request for Records/CGMP/Finished Pharmaceuticals/Adulterated | October 27, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/tsp-solutions-pte-ltd-735071-10222026) |
| October 22, 2026 | Sanrace Biotechnology Co., Ltd. | Center for Drug Evaluation and Research | CGMP/Finished Pharmaceuticals/Adulterated | October 27, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/sanrace-biotechnology-co-ltd-737549-10222026) |
| October 22, 2026 | Northland Nuclear Medicine, LLC | Center for Drug Evaluation and Research | CGMP/Finished Pharmaceuticals/Adulterated | October 27, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/northland-nuclear-medicine-llc-736893-10222026) |
| October 14, 2026 | Rohto Pharmaceutical Co., Ltd. | Center for Drug Evaluation and Research | CGMP/Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated | October 20, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/rohto-pharmaceutical-co-ltd-733215-10142026) |
| October 6, 2026 | Eurofins SF Analytical Laboratories, Inc. | Center for Drug Evaluation and Research | CGMP/Finished Pharmaceuticals/Adulterated | October 13, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/eurofins-sf-analytical-laboratories-inc-736056-10062026) |
| October 5, 2026 | Silgan Dispensing Systems | Center for Drug Evaluation and Research | CGMP/Finished Pharmaceuticals/Adulterated/Unapproved New Drug | October 13, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/silgan-dispensing-systems-734538-10052026) |
| October 2, 2026 | Hanlim Pharm Co., Ltd. | Center for Drug Evaluation and Research | CGMP/Finished Pharmaceuticals/Adulterated | October 13, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/hanlim-pharm-co-ltd-734782-10022026) |
| October 1, 2026 | Zhejiang Gaorong Cosmetic Co., Ltd. | Center for Drug Evaluation and Research | CGMP/Finished Pharmaceuticals/Adulterated | October 20, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/zhejiang-gaorong-cosmetic-co-ltd-732511-10012026) |
| October 1, 2026 | Signature Formulations LLC | Center for Drug Evaluation and Research | CGMP/Finished Pharmaceuticals/Adulterated | October 20, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/signature-formulations-llc-737964-10012026) |
| September 29, 2026 | Baxter International Inc. | Center for Drug Evaluation and Research | CGMP/Finished Pharmaceuticals/Adulterated | October 20, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/baxter-international-inc-733231-09292026) |
| September 28, 2026 | SnugZ USA, Inc. | Center for Drug Evaluation and Research | CGMP/Finished Pharmaceuticals/Adulterated | October 20, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/snugz-usa-inc-735284-09282026) |
| September 23, 2026 | Jiangmen Shuizirun Sanitary Articles Co., Ltd. | Center for Drug Evaluation and Research | CGMP/Finished Pharmaceuticals/Adulterated | October 13, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/jiangmen-shuizirun-sanitary-articles-co-ltd-722974-09232026) |
| September 22, 2026 | Fresenius Kabi USA LLC | Center for Drug Evaluation and Research | CGMP/Finished Pharmaceuticals/Adulterated | September 29, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/fresenius-kabi-usa-llc-733107-09222026) |
| September 21, 2026 | Babikian Healthcare Products CJSC | Center for Drug Evaluation and Research | CGMP/Finished Pharmaceuticals/Adulterated | September 29, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/babikian-healthcare-products-cjsc-730513-09212026) |
| September 18, 2026 | Curia New York, Inc. | Center for Drug Evaluation and Research | CGMP/Active Pharmaceutical Ingredient (API)/Adulterated | September 29, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/curia-new-york-inc-728790-09182026) |
| September 18, 2026 | Empower Clinic Services, LLC dba Empower Pharmacy | Center for Drug Evaluation and Research | CGMP/Finished Pharmaceuticals/Adulterated/Unapproved New Drug | September 22, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/empower-clinic-services-llc-dba-empower-pharmacy-738238-09182026) |
| September 17, 2026 | Bentley Laboratories LLC | Center for Drug Evaluation and Research | CGMP/Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated | September 29, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/bentley-laboratories-llc-732028-09172026) |
| September 14, 2026 | SCA Pharmaceuticals, LLC | Center for Drug Evaluation and Research | CGMP/Finished Pharmaceuticals/Adulterated | October 13, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/sca-pharmaceuticals-llc-724202-09142026) |
| September 8, 2026 | kdc/one Chatsworth, Inc. | Center for Drug Evaluation and Research | CGMP/Finished Pharmaceuticals/Adulterated | September 22, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/kdcone-chatsworth-inc-733205-09082026) |
| September 4, 2026 | Bausch & Lomb Inc. | Center for Drug Evaluation and Research | CGMP/Finished Pharmaceuticals/Adulterated | September 15, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/bausch-lomb-inc-732398-09042026) |
| September 2, 2026 | TCI Co., Ltd BioCosme PABP BRANCH | Center for Drug Evaluation and Research | CGMP/Finished Pharmaceuticals/Adulterated | October 6, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/tci-co-ltd-biocosme-pabp-branch-736888-09022026) |
| September 1, 2026 | Happy Farm Botanicals, Inc. | Center for Drug Evaluation and Research | CGMP/Finished Pharmaceuticals/Adulterated | September 8, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/happy-farm-botanicals-inc-731926-09012026) |
| August 27, 2026 | Jabil Inc. | Center for Drug Evaluation and Research | CGMP/Finished Pharmaceuticals/Adulterated | September 1, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/jabil-inc-731037-08272026) |
| August 25, 2026 | Fresenius Medical Care AG & Co. KGaA | Center for Drug Evaluation and Research | CGMP/Finished Pharmaceuticals/Adulterated | September 1, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/fresenius-medical-care-ag-co-kgaa-730319-08252026) |
| August 18, 2026 | Shoolin Pharma Chem LLP | Center for Drug Evaluation and Research | CGMP/Active Pharmaceutical Ingredient (API)/Adulterated | September 1, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/shoolin-pharma-chem-llp-734100-08182026) |
| August 18, 2026 | Reliance Life Sciences Private Limited | Center for Drug Evaluation and Research | CGMP/Finished Pharmaceuticals/Adulterated | September 1, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/reliance-life-sciences-private-limited-730801-08182026) |
| August 18, 2026 | PReye, LLC | Center for Drug Evaluation and Research | CGMP/Finished Pharmaceuticals/Adulterated/Unapproved New Drug | September 1, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/preye-llc-732141-08182026) |
| August 13, 2026 | Suretec Innovations, LLC | Center for Drug Evaluation and Research | CGMP/Finished Pharmaceuticals/Adulterated and Misbranded | August 18, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/suretec-innovations-llc-730122-08132026) |
| August 13, 2026 | Eugia Pharma Specialities Limited | Center for Drug Evaluation and Research | CGMP/Finished Pharmaceuticals/Adulterated | August 18, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/eugia-pharma-specialities-limited-730469-08132026) |
| August 12, 2026 | K.C. Pharmaceuticals, Inc. | Center for Drug Evaluation and Research | CGMP/Finished Pharmaceuticals/Adulterated | August 18, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/kc-pharmaceuticals-inc-729870-08122026) |
| August 12, 2026 | Auriga Research Pvt. Ltd. | Center for Drug Evaluation and Research | CGMP/Finished Pharmaceuticals/Adulterated | August 18, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/auriga-research-pvt-ltd-730694-08122026) |
| August 7, 2026 | Safrel Pharmaceuticals LLC | Center for Drug Evaluation and Research | CGMP/Finished Pharmaceuticals/Adulterated | August 18, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/safrel-pharmaceuticals-llc-730520-08072026) |
| August 6, 2026 | Tianjin Kilo Pharmaceutical Sci-tech Co., Ltd. | Center for Drug Evaluation and Research | CGMP/Active Pharmaceutical Ingredient (API)/Adulterated/Misbranded | August 18, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/tianjin-kilo-pharmaceutical-sci-tech-co-ltd-731761-08062026) |
| July 31, 2026 | FairyGene, Inc. | Center for Drug Evaluation and Research | CGMP/Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated | August 11, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/fairygene-inc-726976-07312026) |
| July 30, 2026 | Lico Industries, LLC., d.b.a. American Towelette Company | Center for Drug Evaluation and Research | CGMP/Finished Pharmaceuticals/Adulterated | August 11, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/lico-industries-llc-dba-american-towelette-company-729921-07302026) |
| July 27, 2026 | Woodbine Products Company Inc. | Center for Drug Evaluation and Research | CGMP/Finished Pharmaceuticals/Adulterated | August 4, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/woodbine-products-company-inc-729345-07272026) |
| July 24, 2026 | Thomas Brunner Hygiene GmbH | Center for Drug Evaluation and Research | CGMP/Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated | August 4, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/thomas-brunner-hygiene-gmbh-729018-07242026) |
| July 24, 2026 | Dabur India Limited | Center for Drug Evaluation and Research | CGMP/Finished Pharmaceuticals/Adulterated | August 4, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/dabur-india-limited-728828-07242026) |
| July 23, 2026 | ABS Corporation | Center for Veterinary Medicine | CGMP/Finished Pharmaceuticals/Adulterated | August 4, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/abs-corporation-732115-07232026) |
| July 16, 2026 | Island Kinetics, Inc. d.b.a. CoValence Laboratories | Center for Drug Evaluation and Research | CGMP/Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated | July 21, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/island-kinetics-inc-dba-covalence-laboratories-726379-07162026) |
| July 13, 2026 | Shimoga Chemicals | Center for Drug Evaluation and Research | CGMP/Active Pharmaceutical Ingredient (API)/Adulterated | July 21, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/shimoga-chemicals-727904-07132026) |
| July 13, 2026 | BioMylz Pvt. Ltd. | Center for Drug Evaluation and Research | CGMP/Finished Pharmaceuticals/Adulterated/Misbranded | July 21, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/biomylz-pvt-ltd-729483-07132026) |
| July 13, 2026 | Almon Healthcare Private Limited | Center for Drug Evaluation and Research | CGMP/Active Pharmaceutical Ingredient (API)/Adulterated | July 21, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/almon-healthcare-private-limited-729291-07132026) |
| July 8, 2026 | Spa De Soleil, Inc. | Center for Drug Evaluation and Research | CGMP/Finished Pharmaceuticals/Adulterated | July 14, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/spa-de-soleil-inc-728508-07082026) |
| July 2, 2026 | International Medication Systems Limited | Center for Drug Evaluation and Research | CGMP/Finished Pharmaceuticals/Adulterated | July 14, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/international-medication-systems-limited-727560-07022026) |
| June 25, 2026 | Excelvision - Fareva | Center for Drug Evaluation and Research | CGMP/Finished Pharmaceuticals/Adulterated | June 30, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/excelvision-726714-fareva) |
| June 24, 2026 | Wizcure Pharmaa Private Limited | Center for Drug Evaluation and Research | CGMP/Finished Pharmaceuticals/Adulterated | June 30, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/wizcure-pharmaa-private-limited-726378-06242026) |
| June 15, 2026 | Huons Co., Ltd. | Center for Drug Evaluation and Research | CGMP/Finished Pharmaceuticals/Adulterated | June 23, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/huons-co-ltd-724650-06152026) |
| June 12, 2026 | AHC Products, Inc. | Center for Veterinary Medicine | CGMP/Finished Pharmaceuticals/Adulterated | July 28, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/ahc-products-inc-728604-06122026) |
| June 5, 2026 | Sante Manufacturing Inc. | Center for Drug Evaluation and Research | CGMP/Finished Pharmaceuticals/Adulterated | June 16, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/sante-manufacturing-inc-724931-06052026) |
| June 3, 2026 | Hubei Gedian Humanwell Pharmaceutical Co., Ltd. | Center for Drug Evaluation and Research | CGMP/Active Pharmaceutical Ingredient (API)/Adulterated | June 9, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/hubei-gedian-humanwell-pharmaceutical-co-ltd-725591-06032026) |
| June 2, 2026 | Zydus Lifesciences Limited | Center for Drug Evaluation and Research | Request for Records/CGMP/Finished Pharmaceuticals/Adulterated | June 9, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/zydus-lifesciences-limited-722576-06022026) |
| June 2, 2026 | Umendra Life Sciences Private Limited | Center for Drug Evaluation and Research | CGMP/OTC Finished Pharmaceuticals/Adulterated | June 9, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/umendra-life-sciences-private-limited-721752-06022026) |
| June 2, 2026 | Shantou Qiwei Industry Co., LTD | Center for Drug Evaluation and Research | CGMP/OTC Finished Pharmaceuticals/Adulterated | June 9, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/shantou-qiwei-industry-co-ltd-721753-06022026) |
| June 2, 2026 | Revlon Group Holdings, LLC | Center for Drug Evaluation and Research | CGMP/OTC Finished Pharmaceuticals/Adulterated | June 9, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/revlon-group-holdings-llc-722596-06022026) |
| June 2, 2026 | PLZ Corp | Center for Drug Evaluation and Research | CGMP/OTC Finished Pharmaceuticals/Adulterated | June 9, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/plz-corp-721140-06022026) |
| June 2, 2026 | Laboratorios Dr. Collado S.A. | Center for Drug Evaluation and Research | CGMP/OTC Finished Pharmaceuticals/Adulterated | June 9, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/laboratorios-dr-collado-sa-723285-06022026) |
| June 2, 2026 | Gopaldas Visram & Co., Ltd. | Center for Drug Evaluation and Research | CGMP/OTC Finished Pharmaceuticals/Adulterated | June 9, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/gopaldas-visram-co-ltd-721755-06022026) |
| June 2, 2026 | Erkul Kozmetik Sanayi ve Ticaret A.S. | Center for Drug Evaluation and Research | CGMP/OTC Finished Pharmaceuticals/Adulterated | June 9, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/erkul-kozmetik-sanayi-ve-ticaret-721964-06022026) |
| June 2, 2026 | Asanuma Corporation - Sagamihara Factory | Center for Drug Evaluation and Research | CGMP/OTC Finished Pharmaceuticals/Adulterated | June 9, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/asanuma-corporation-721136-sagamihara-factory) |
| May 28, 2026 | Jubilant HollisterStier General Partnership | Center for Drug Evaluation and Research | CGMP/Finished Pharmaceuticals/Adulterated | June 23, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/jubilant-hollisterstier-general-partnership-723537-05282026) |
| May 28, 2026 | Medline Inc | Center for Drug Evaluation and Research | CGMP/Finished Pharmaceuticals/Adulterated | June 2, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/medline-inc-724347-05282026) |
| May 27, 2026 | Pharmathen International S.A. | Center for Drug Evaluation and Research | CGMP/Active Pharmaceutical Ingredient (API)/Adulterated | June 16, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/pharmathen-international-sa-723680-05272026) |
| May 22, 2026 | Laboratorios Jaloma S.A. de C.V. | Center for Drug Evaluation and Research | CGMP/OTC/Finished Pharmaceuticals/Adulterated | June 2, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/laboratorios-jaloma-sa-de-cv-725939-05222026) |
| May 21, 2026 | Alchymars ICM SM Private Limited | Center for Drug Evaluation and Research | CGMP/Active Pharmaceutical Ingredient (API)/Adulterated | May 26, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/alchymars-icm-sm-private-limited-724429-05212026) |
| May 18, 2026 | Sato Pharmaceutical Co., Ltd. | Center for Drug Evaluation and Research | CGMP/Drugs/Adulterated/OTC | May 26, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/sato-pharmaceutical-co-ltd-723059-05182026) |
| May 14, 2026 | GC America, Inc. | Center for Drug Evaluation and Research | CGMP/Finished Pharmaceuticals/Adulterated | May 26, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/gc-america-inc-727602-05142026) |
| May 4, 2026 | Naveh Pharma LTD/Bigdam Inc. | Center for Drug Evaluation and Research | CGMP/Finished Pharmaceuticals/Adulterated/Unapproved New Drug | May 12, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/naveh-pharma-ltdbigdam-inc-724669-05042026) |
| May 4, 2026 | IDO Pharm Co., Ltd. | Center for Drug Evaluation and Research | CGMP/OTC Finished Pharmaceuticals/Adulterated | May 12, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/ido-pharm-co-ltd-723449-05042026) |
| May 1, 2026 | Harbin Jixianglong Biotech Co., Ltd. | Center for Drug Evaluation and Research | CGMP/API/Adulterated and Misbranded Drugs | May 19, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/harbin-jixianglong-biotech-co-ltd-723330-05012026) |
| April 30, 2026 | CareFusion 213, LLC | Center for Drug Evaluation and Research | CGMP/Finished Pharmaceuticals/Adulterated | May 5, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/carefusion-213-llc-722729-04302026) |
| April 22, 2026 | Active Cosmetics Manufacturing Inc. | Center for Drug Evaluation and Research | CGMP/Finished Pharmaceuticals/Adulterated | May 5, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/active-cosmetics-manufacturing-inc-722408-04222026) |
| April 20, 2026 | Respilon Production S.R.O. | Center for Drug Evaluation and Research | CGMP/OTC/Finished Pharmaceuticals/Adulterated | May 5, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/respilon-production-sro-719705-04202026) |
| April 15, 2026 | JW Nutritional LLC | Center for Drug Evaluation and Research | CGMP/OTC Finished Pharmaceuticals/Adulterated | May 19, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/jw-nutritional-llc-722096-04152026) |
| April 15, 2026 | Hangzhou Yiqi Biotechnology Co., Ltd | Center for Drug Evaluation and Research | CGMP/Active Pharmaceutical Ingredient (API)/Adulterated | May 19, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/hangzhou-yiqi-biotechnology-co-ltd-720707-04152026) |
| April 15, 2026 | Par Health USA, LLC & Endo USA, Inc. | Center for Drug Evaluation and Research | CGMP/Finished Pharmaceuticals/Adulterated | April 21, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/par-health-usa-llc-endo-usa-inc-722121-04152026) |
| April 14, 2026 | Ava Inc. | Center for Drug Evaluation and Research | CGMP/Finished Pharmaceuticals/Adulterated | May 5, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/ava-inc-721180-04142026) |
| April 14, 2026 | New Life Pharma LLC | Center for Drug Evaluation and Research | CGMP/Adulterated and Unapproved New Drug/Misbranded | April 21, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/new-life-pharma-llc-725661-04142026) |
| April 13, 2026 | UCSF Radiopharmaceutical Facility | Center for Drug Evaluation and Research | CGMP/Finished Pharmaceuticals/Adulterated | April 21, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/ucsf-radiopharmaceutical-facility-719568-04132026) |
| April 10, 2026 | Fareva Amboise | Center for Veterinary Medicine | CGMP/Finished Pharmaceuticals/Adulterated | July 21, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/fareva-amboise-723502-04102026) |
| April 9, 2026 | Medical Products Laboratories, Inc. | Center for Drug Evaluation and Research | CGMP/Finished Pharmaceuticals/Adulterated/Unapproved New Drug | April 14, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/medical-products-laboratories-inc-721916-04092026) |
| April 7, 2026 | Lexia LLC | Center for Drug Evaluation and Research | CGMP/Finished Pharmaceuticals/Adulterated | April 28, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/lexia-llc-722251-04072026) |
| April 3, 2026 | Ridley USA Inc. | Center for Veterinary Medicine | CGMP/Medicated Feeds/Adulterated | May 12, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/ridley-usa-inc-720800-04032026) |
| April 2, 2026 | Purolea Cosmetics Lab | Center for Drug Evaluation and Research | CGMP/Finished Pharmaceuticals/Adulterated/Unapproved New Drug | April 14, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/purolea-cosmetics-lab-722591-04022026) |
| March 30, 2026 | Intas Pharmaceuticals Limited | Center for Drug Evaluation and Research | CGMP/Finished Pharmaceuticals/Adulterated | April 28, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/intas-pharmaceuticals-limited-721151-03302026) |
| March 26, 2026 | Henan Lvyuan Pharmaceutical Co. Ltd. | Center for Veterinary Medicine | CGMP/API/Adulterated | March 31, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/henan-lvyuan-pharmaceutical-co-ltd-722497-03262026) |
| March 23, 2026 | Xiamen Kang Zhongyuan Biotechnology Co., Ltd. | Center for Drug Evaluation and Research | CGMP/Finished Pharmaceuticals/Adulterated | April 21, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/xiamen-kang-zhongyuan-biotechnology-co-ltd-719320-03232026) |
| March 18, 2026 | Yangzhou H&R Plastic Daily Chemical Co., Ltd. | Center for Drug Evaluation and Research | CGMP/Finished Pharmaceuticals/Adulterated | March 24, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/yangzhou-hr-plastic-daily-chemical-co-ltd-722736-03182026) |
| March 16, 2026 | Microbiological Testing & Consulting, LLC | Center for Drug Evaluation and Research | CGMP/Finished Pharmaceuticals/Adulterated | March 31, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/microbiological-testing-consulting-llc-720374-03162026) |
| March 11, 2026 | OraLabs, Inc. | Center for Drug Evaluation and Research | CGMP/Finished Pharmaceuticals/Adulterated | March 17, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/oralabs-inc-720690-03112026) |
| March 11, 2026 | Flowchem Pharma Private Limited | Center for Drug Evaluation and Research | CGMP/Active Pharmaceutical Ingredient (API)/Adulterated | March 17, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/flowchem-pharma-private-limited-720719-03112026) |
| March 3, 2026 | Tentamus India Private Limited | Center for Drug Evaluation and Research | CGMP/Finished Pharmaceuticals/Adulterated | March 10, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/tentamus-india-private-limited-720463-03032026) |
| March 3, 2026 | Simtra BioPharma Solutions | Center for Drug Evaluation and Research | CGMP/Finished Pharmaceuticals/Adulterated | March 10, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/simtra-biopharma-solutions-720436-03032026) |
| March 3, 2026 | Fareva Morton Grove | Center for Drug Evaluation and Research | CGMP/Finished Pharmaceuticals/Adulterated | March 10, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/fareva-morton-grove-719408-03032026) |
| February 12, 2026 | A. Nelson & Co. Ltd. | Center for Drug Evaluation and Research | CGMP/Finished Pharmaceuticals/Adulterated | February 24, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/nelson-co-ltd-720283-02122026) |
| February 12, 2026 | AQ USA Inc., d.b.a Ross Healthcare Inc. | Center for Drug Evaluation and Research | CGMP/Finished Pharmaceuticals/Adulterated | February 24, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/aq-usa-inc-dba-ross-healthcare-inc-719517-02122026) |

## Subjects as FDA words them

| Subject | Letters | Latest |
| --- | --- | --- |
| CGMP/Finished Pharmaceuticals/Adulterated | 157 | October 27, 2026 |
| CGMP/Active Pharmaceutical Ingredient (API)/Adulterated | 25 | September 18, 2026 |
| CGMP/OTC Finished Pharmaceuticals/Adulterated | 10 | June 2, 2026 |
| CGMP/Finished Pharmaceutical/Adulterated | 9 | March 14, 2025 |
| CGMP/Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated | 6 | October 14, 2026 |
| CGMP/Finished Pharmaceuticals/Adulterated/Unapproved New Drug | 6 | October 5, 2026 |
| CGMP/Finished Pharmaceutical/API/Adulterated | 3 | August 20, 2025 |
| Request for Records/CGMP/Finished Pharmaceuticals/Adulterated | 2 | October 22, 2026 |
| CGMP/Active Pharmaceutical Ingredient (API)/Adulterated/Misbranded | 2 | August 6, 2026 |
| CGMP/OTC/Finished Pharmaceuticals/Adulterated | 2 | May 22, 2026 |
| CGMP/Medical Gases/Adulterated | 1 | October 29, 2026 |
| CGMP/Finished Pharmaceuticals/Adulterated and Misbranded | 1 | August 13, 2026 |
| CGMP/Finished Pharmaceuticals/Adulterated/Misbranded | 1 | July 13, 2026 |
| CGMP/Drugs/Adulterated/OTC | 1 | May 18, 2026 |
| CGMP/API/Adulterated and Misbranded Drugs | 1 | May 1, 2026 |
| CGMP/Adulterated and Unapproved New Drug/Misbranded | 1 | April 14, 2026 |
| CGMP/Medicated Feeds/Adulterated | 1 | April 3, 2026 |
| CGMP/API/Adulterated | 1 | March 26, 2026 |
| CGMP/OTC/Adulterated/Misbranded | 1 | December 18, 2025 |
| CGMP/Positron Emission Tomography (PET) Drugs/Adulterated | 1 | December 4, 2025 |
| CGMP/Finished Pharmaceutical/Adulterated/Refusal to Allow Inspection | 1 | December 17, 2024 |
| CGMP/Finished Pharmaceuticals/Adulterated/Unapproved New Drug/Misbranded | 1 | November 21, 2024 |
| Finished Pharmaceuticals/Unapproved New Drug/Misbranded/OTC | 1 | November 15, 2024 |

## By issuing office

| Issuing office | Letters | Latest |
| --- | --- | --- |
| [Center for Drug Evaluation and Research](https://specstream.ai/data/fda-warning-letters/office/center-for-drug-evaluation-and-research) | 225 | October 29, 2026 |
| [Center for Veterinary Medicine](https://specstream.ai/data/fda-warning-letters/office/center-for-veterinary-medicine) | 6 | July 23, 2026 |
| Office of Manufacturing Quality | 3 | December 1, 2025 |
| [Center for Biologics Evaluation and Research](https://specstream.ai/data/fda-warning-letters/office/center-for-biologics-evaluation-and-research) | 1 | December 12, 2024 |

## By year issued

| Year | Letters | Latest |
| --- | --- | --- |
| [2025](https://specstream.ai/data/fda-warning-letters/year/2025) | 110 | December 30, 2025 |
| [2026](https://specstream.ai/data/fda-warning-letters/year/2026) | 109 | October 29, 2026 |
| [2024](https://specstream.ai/data/fda-warning-letters/year/2024) | 16 | December 19, 2024 |

## Where FDA publishes its warning letters

- [FDA warning letters](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/compliance-actions-and-activities/warning-letters)

Source: [FDA warning letters (U.S. Food and Drug Administration)](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/compliance-actions-and-activities/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](https://creativecommons.org/licenses/by/4.0/).