warning letter database

FDA Warning Letters

An FDA Warning Letter is a formal notice the FDA sends a company after finding significant regulatory violations, typically following an inspection. Argus HQ tracks 285 published FDA Warning Letters from 2026 to 2026, each with an AI-generated summary and the specific violations cited, sourced from and linked back to fda.gov.

• Bioactive Services USA, LLC / Herstat Inc. — Unapproved New Drugs (2026-10-01)

  Bioactive Services USA, LLC / Herstat Inc.·Center for Drug Evaluation and Research (CDER)·October 1, 2026·Other

• OrganiCare, LLC / OrganiCare Nature’s Science, LLC — Unapproved New Drugs (2026-10-01)

  OrganiCare, LLC / OrganiCare Nature’s Science, LLC·Center for Drug Evaluation and Research (CDER)·October 1, 2026·Other

• Amazon.com, Inc. — Unapproved New Drugs (2026-10-01)

  Amazon.com, Inc.·Center for Drug Evaluation and Research (CDER)·October 1, 2026·Other

• Graceful Touch, LLC — Unapproved New Drugs (2026-10-01)

  Graceful Touch, LLC·Center for Drug Evaluation and Research (CDER)·October 1, 2026·Other

• Walmart, Inc. — Unapproved New Drugs (2026-10-01)

  Walmart, Inc.·Center for Drug Evaluation and Research (CDER)·October 1, 2026·Other

• DesBio/Deseret Biologicals, Inc. — Unapproved New Drugs (2026-10-01)

  DesBio/Deseret Biologicals, Inc.·Center for Drug Evaluation and Research (CDER)·October 1, 2026·Other

• The Platinum Healthcare LLC — Unapproved New Drugs (2026-10-01)

  The Platinum Healthcare LLC·Center for Drug Evaluation and Research (CDER)·October 1, 2026·Other

• RoyceDerm LLC — Unapproved New Drugs (2026-10-01)

  RoyceDerm LLC·Center for Drug Evaluation and Research (CDER)·October 1, 2026·Other

• Terramed — Unapproved New Drugs (2026-10-01)

  Terramed·Center for Drug Evaluation and Research (CDER)·October 1, 2026·Other

• Aidance Scientific, Inc. — Unapproved New Drugs (2026-10-01)

  Aidance Scientific, Inc.·Center for Drug Evaluation and Research (CDER)·October 1, 2026·Other

• Sciarra Aeromed, Inc. — CGMP/Drugs for Animals/Prepared, Packed or Held Under Insanitary Conditions/Adulterated (2026-09-23)

  Sciarra Aeromed, Inc.·Center for Veterinary Medicine·September 23, 2026·Other

• Neogen Corporation — CGMP/Drugs for Animals/Prepared, Packed or Held Under Insanitary Conditions/Adulterated (2026-09-23)

  Neogen Corporation·Center for Veterinary Medicine·September 23, 2026·Other

• Online Generic Medicine/www.onlinegenericmedicine.com — Unapproved New Drug/Misbranded (Internet Pharmacy) (2026-09-23)

  Online Generic Medicine/www.onlinegenericmedicine.com·Center for Drug Evaluation and Research (CDER)·September 23, 2026·Other

• Fresenius Kabi AG — CGMP/Finished Pharmaceuticals/Adulterated (2026-09-22)

  Fresenius Kabi AG·Center for Drug Evaluation and Research (CDER)·September 22, 2026·Other

• Unilam Co., LTD — CGMP/QSR/Medical Devices/Adulterated (2026-09-22)

  Unilam Co., LTD·Center for Devices and Radiological Health·September 22, 2026·Other

• Babikian Healthcare Products CJSC — CGMP/Finished Pharmaceuticals/Adulterated (2026-09-21)

  Babikian Healthcare Products CJSC·Center for Drug Evaluation and Research (CDER)·September 21, 2026·Other

• Empower Clinic Services, LLC dba Empower Pharmacy — CGMP/Finished Pharmaceuticals/Adulterated/Unapproved New Drug (2026-09-18)

  Empower Clinic Services, LLC dba Empower Pharmacy·Center for Drug Evaluation and Research (CDER)·September 18, 2026·Other

• Curia New York, Inc. — CGMP/Active Pharmaceutical Ingredient (API)/Adulterated (2026-09-18)

  Curia New York, Inc.·Center for Drug Evaluation and Research (CDER)·September 18, 2026·Other

• Bentley Laboratories LLC — CGMP/Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated (2026-09-17)

  Bentley Laboratories LLC·Center for Drug Evaluation and Research (CDER)·September 17, 2026·Other

• Celmade — Review of Website/Unapproved New Drug/Misbranded (2026-09-14)

  Celmade·Center for Drug Evaluation and Research (CDER)·September 14, 2026·Other

• NexCell Scientific Inc — Unapproved New Drugs/Unlicensed Biological Product Violations (2026-09-11)

  NexCell Scientific Inc·Center for Biologics Evaluation and Research·September 11, 2026·Other

• kdc/one Chatsworth, Inc. — CGMP/Finished Pharmaceuticals/Adulterated (2026-09-08)

  kdc/one Chatsworth, Inc.·Center for Drug Evaluation and Research (CDER)·September 8, 2026·Other

• Bausch & Lomb Inc. — CGMP/Finished Pharmaceuticals/Adulterated (2026-09-04)

  Bausch & Lomb Inc.·Center for Drug Evaluation and Research (CDER)·September 4, 2026·Other

• TCI Co., Ltd BioCosme PABP BRANCH — CGMP/Finished Pharmaceuticals/Adulterated (2026-09-02)

  TCI Co., Ltd BioCosme PABP BRANCH·Center for Drug Evaluation and Research (CDER)·September 2, 2026·Other

• Happy Farm Botanicals, Inc. — CGMP/Finished Pharmaceuticals/Adulterated (2026-09-01)

  Happy Farm Botanicals, Inc.·Center for Drug Evaluation and Research (CDER)·September 1, 2026·Other