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 223 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.

• R3 Medical Companies — Unapproved New Drugs/Unlicensed Biological Product Violations (2026-08-14)

  R3 Medical Companies·Center for Biologics Evaluation and Research (CBER)·August 14, 2026·Other

• Suretec Innovations, LLC — CGMP/Finished Pharmaceuticals/Adulterated and Misbranded (2026-08-13)

  Suretec Innovations, LLC·Center for Drug Evaluation and Research (CDER)·August 13, 2026·Other

• Eugia Pharma Specialities Limited — CGMP/Finished Pharmaceuticals/Adulterated (2026-08-13)

  Eugia Pharma Specialities Limited·Center for Drug Evaluation and Research (CDER)·August 13, 2026·Other

• Auriga Research Pvt. Ltd. — CGMP/Finished Pharmaceuticals/Adulterated (2026-08-12)

  Auriga Research Pvt. Ltd.·Center for Drug Evaluation and Research (CDER)·August 12, 2026·Other

• K.C. Pharmaceuticals, Inc. — CGMP/Finished Pharmaceuticals/Adulterated (2026-08-12)

  K.C. Pharmaceuticals, Inc.·Center for Drug Evaluation and Research (CDER)·August 12, 2026·Other

• mikuvape.com — Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded (2026-08-07)

  mikuvape.com·Center for Tobacco Products·August 7, 2026·Other

• giantnic.com — Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded (2026-08-07)

  giantnic.com·Center for Tobacco Products·August 7, 2026·Other

• Safrel Pharmaceuticals LLC — CGMP/Finished Pharmaceuticals/Adulterated (2026-08-07)

  Safrel Pharmaceuticals LLC·Center for Drug Evaluation and Research (CDER)·August 7, 2026·Other

• Tianjin Kilo Pharmaceutical Sci-tech Co., Ltd. — CGMP/Active Pharmaceutical Ingredient (API)/Adulterated/Misbranded (2026-08-06)

  Tianjin Kilo Pharmaceutical Sci-tech Co., Ltd.·Center for Drug Evaluation and Research (CDER)·August 6, 2026·Other

• DeJong Family Dairy, LLC — New Animal Drug/Adulterated (2026-07-30)

  DeJong Family Dairy, LLC·Center for Veterinary Medicine·July 30, 2026·Other

• Vargas Produce LLC — Foreign Supplier Verification Program (FSVP) (2026-07-27)

  Vargas Produce LLC·Office of Inspections and Investigations·July 27, 2026·Other

• Woodbine Products Company Inc. — CGMP/Finished Pharmaceuticals/Adulterated (2026-07-27)

  Woodbine Products Company Inc.·Center for Drug Evaluation and Research (CDER)·July 27, 2026·Other

• Maria E. De La Torre Silva, M.D. — Clinical Investigator (2026-07-27)

  Maria E. De La Torre Silva, M.D.·Center for Drug Evaluation and Research (CDER)·July 27, 2026·Other

• Thomas Brunner Hygiene GmbH — CGMP/Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated (2026-07-24)

  Thomas Brunner Hygiene GmbH·Center for Drug Evaluation and Research (CDER)·July 24, 2026·Other

• Nipro Renal Solutions USA, Corporation — CGMP/QSR/Medical Devices/Adulterated (2026-07-24)

  Nipro Renal Solutions USA, Corporation·Center for Devices and Radiological Health·July 24, 2026·Other

• Dabur India Limited — CGMP/Finished Pharmaceuticals/Adulterated (2026-07-24)

  Dabur India Limited·Center for Drug Evaluation and Research (CDER)·July 24, 2026·Other

• Eherbs Imports, Inc — Foreign Supplier Verification Program (FSVP) (2026-07-23)

  Eherbs Imports, Inc·Office of Inspections and Investigations·July 23, 2026·Other

• ABS Corporation — CGMP/Finished Pharmaceuticals/Adulterated (2026-07-23)

  ABS Corporation·Center for Veterinary Medicine·July 23, 2026·Other

• Koven Technologies, Inc. — CGMP/QSR/Medical Devices/Adulterated (2026-07-21)

  Koven Technologies, Inc.·Center for Devices and Radiological Health·July 21, 2026·Other

• mkpodplug.co.uk — Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded (2026-07-17)

  mkpodplug.co.uk·Center for Tobacco Products·July 17, 2026·Other

• Island Kinetics, Inc. d.b.a. CoValence Laboratories — CGMP/Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated (2026-07-16)

  Island Kinetics, Inc. d.b.a. CoValence Laboratories·Center for Drug Evaluation and Research (CDER)·July 16, 2026·Other

• San Jorge Produce LLC — Foreign Supplier Verification Program (FSVP) (2026-07-16)

  San Jorge Produce LLC·Human Foods Program·July 16, 2026·Other

• AAL Trading Inc. — Foreign Supplier Verification Program (FSVP) (2026-07-15)

  AAL Trading Inc.·Office of Inspections and Investigations·July 15, 2026·Other

• Friend’s Stable and Orchard, Inc. — Food/Prepared Packed or Held Under Insanitary Conditions/Adulterated (2026-07-14)

  Friend’s Stable and Orchard, Inc.·Human Foods Program·July 14, 2026·Other

• Almon Healthcare Private Limited — CGMP/Active Pharmaceutical Ingredient (API)/Adulterated (2026-07-13)

  Almon Healthcare Private Limited·Center for Drug Evaluation and Research (CDER)·July 13, 2026·Other