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.

• O.N. Diagnostics, LLC — Medical Device Reporting/Misbranded (2026-09-01)

  O.N. Diagnostics, LLC·Center for Devices and Radiological Health·September 1, 2026·Other

• Tipical Latin Food, Corp. DBA La Pradera — CGMP/Manufacturing, Packing or Holding Human Food/Adulterated/Insanitary Conditions (2026-08-28)

  Tipical Latin Food, Corp. DBA La Pradera·Human Foods Program·August 28, 2026·Other

• Stephen J. Fallon, Ph.D. — Bioresearch Monitoring Program/Institutional Review Board (IRB) (2026-08-27)

  Stephen J. Fallon, Ph.D.·Center for Biologics Evaluation and Research (CBER)·August 27, 2026·Other

• Jabil Inc. — CGMP/Finished Pharmaceuticals/Adulterated (2026-08-27)

  Jabil Inc.·Center for Drug Evaluation and Research (CDER)·August 27, 2026·Other

• Union Trade Inc. — Foreign Supplier Verification Program (FSVP) (2026-08-27)

  Union Trade Inc.·Office of Inspections and Investigations·August 27, 2026·Other

• Fresenius Medical Care AG & Co. KGaA — CGMP/Finished Pharmaceuticals/Adulterated (2026-08-25)

  Fresenius Medical Care AG & Co. KGaA·Center for Drug Evaluation and Research (CDER)·August 25, 2026·Other

• Advance-Esthetic LLC — Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated Device (2026-08-25)

  Advance-Esthetic LLC·Center for Devices and Radiological Health·August 25, 2026·Other

• BioDrive, Inc. — Dietary Supplement/Adulterated (2026-08-24)

  BioDrive, Inc.·Human Foods Program·August 24, 2026·Other

• Peptide Partners LLC — Unapproved New Drugs/Misbranded (2026-08-24)

  Peptide Partners LLC·Center for Drug Evaluation and Research (CDER)·August 24, 2026·Other

• Peak Performance Peptides — Unapproved New Drugs/Misbranded (2026-08-24)

  Peak Performance Peptides·Center for Drug Evaluation and Research (CDER)·August 24, 2026·Other

• NuScience Peptides LLC — Unapproved New Drugs/Misbranded (2026-08-24)

  NuScience Peptides LLC·Center for Drug Evaluation and Research (CDER)·August 24, 2026·Other

• Royal Peptides LLC — Unapproved New Drugs/Misbranded (2026-08-24)

  Royal Peptides LLC·Center for Drug Evaluation and Research (CDER)·August 24, 2026·Other

• TXP Innovations LLC dba Tex Peptides — Unapproved New Drugs/Misbranded (2026-08-24)

  TXP Innovations LLC dba Tex Peptides·Center for Drug Evaluation and Research (CDER)·August 24, 2026·Other

• Raaw Energy LLC — Adulterated Animal Foods/Misbranded (2026-08-21)

  Raaw Energy LLC·Center for Veterinary Medicine·August 21, 2026·Other

• Lion Street Medical, d/b/a Pensar Medical LLC — Medical Device Reporting/Misbranded (2026-08-21)

  Lion Street Medical, d/b/a Pensar Medical LLC·Center for Devices and Radiological Health·August 21, 2026·Other

• Binh Minh Tofu — CGMP/Hazard Analysis/Risk-Based Preventive Controls for Food/Adulterated (2026-08-18)

  Binh Minh Tofu·Human Foods Program·August 18, 2026·Other

• PReye, LLC — CGMP/Finished Pharmaceuticals/Adulterated/Unapproved New Drug (2026-08-18)

  PReye, LLC·Center for Drug Evaluation and Research (CDER)·August 18, 2026·Other

• Reliance Life Sciences Private Limited — CGMP/Finished Pharmaceuticals/Adulterated (2026-08-18)

  Reliance Life Sciences Private Limited·Center for Drug Evaluation and Research (CDER)·August 18, 2026·Other

• Shoolin Pharma Chem LLP — CGMP/Active Pharmaceutical Ingredient (API)/Adulterated (2026-08-18)

  Shoolin Pharma Chem LLP·Center for Drug Evaluation and Research (CDER)·August 18, 2026·Other

• B&P Mutual Corp — Foreign Supplier Verification Program (FSVP) (2026-08-18)

  B&P Mutual Corp·Office of Inspections and Investigations·August 18, 2026·Other

• 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

• 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

• 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

• Bo Wah Enterprises Inc — Foreign Supplier Verification Program (FSVP) (2026-08-13)

  Bo Wah Enterprises Inc·Office of Inspections and Investigations·August 13, 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