enforcement database
FDA General Warning Letters
58 documented actions on record. FDA warning letters not otherwise categorized by a more specific violation type.
- Total actions
- 58
- Earliest on record
- March 18, 2026
- Most recent
- August 18, 2026
- Source
- openFDA (warning_letter)
Severity breakdown
- Critical13
- High7
- Medium1
- Low37
Most recent general warning letters (30 of 58 shown)
- B&P Mutual Corp — Foreign Supplier Verification Program (FSVP) (2026-08-18)
August 18, 2026·Low
- Mesquite Gourmet LLC — Foreign Supplier Verification Program (FSVP) (2026-08-04)
August 4, 2026·Low
- DeJong Family Dairy, LLC — New Animal Drug/Adulterated (2026-07-30)
July 30, 2026·High
- Vargas Produce LLC — Foreign Supplier Verification Program (FSVP) (2026-07-27)
July 27, 2026·Low
- Maria E. De La Torre Silva, M.D. — Clinical Investigator (2026-07-27)
July 27, 2026·Low
- Eherbs Imports, Inc — Foreign Supplier Verification Program (FSVP) (2026-07-23)
July 23, 2026·Low
- San Jorge Produce LLC — Foreign Supplier Verification Program (FSVP) (2026-07-16)
July 16, 2026·Low
- AAL Trading Inc. — Foreign Supplier Verification Program (FSVP) (2026-07-15)
July 15, 2026·Low
- Friend’s Stable and Orchard, Inc. — Food/Prepared Packed or Held Under Insanitary Conditions/Adulterated (2026-07-14)
July 14, 2026·Critical
- Pratik Doshi, M.D. / Alembic Pharmaceuticals Ltd. — In Vivo Bioavailability-Bioequivalence Studies – Clinical (2026-07-10)
July 10, 2026·Low
- Alembic Pharmaceuticals Ltd. — In Vivo Bioavailability-Bioequivalence Studies – Clinical (2026-07-10)
July 10, 2026·Low
- IJAJ Group Inc DBA Sanz Wholesale Foods — Foreign Supplier Verification Program (FSVP) (2026-07-08)
July 8, 2026·Low
- Beauty Store LLC — Foreign Supplier Verification Program (FSVP) (2026-07-08)
July 8, 2026·Low
- Piquin Y Sabores Distributors LLC — Foreign Supplier Verification Program (FSVP) (2026-07-02)
July 2, 2026·Low
- Balkanica LLC — Foreign Supplier Verification Program (FSVP) (2026-06-29)
June 29, 2026·Low
- Win Woo Trading, LLC / HF Foods Group — Foreign Supplier Verification Program (FSVP) (2026-06-24)
June 24, 2026·Low
- Allandale Dairy — New Animal Drug/Adulterated (2026-06-23)
June 23, 2026·High
- Diamond Distributions LLC — Foreign Supplier Verification Program (FSVP) (2026-06-16)
June 16, 2026·Low
- Life & Food Inc. — Foreign Supplier Verification Program (FSVP) (2026-06-15)
June 15, 2026·Low
- Happiest Baby, Inc. — Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated Device (2026-06-15)
June 15, 2026·High
- Yangzhou Hongshengding Chemical Co., Ltd. — Refusal to Provide Access to and Copying of Records (2026-06-15)
June 15, 2026·High
- YS Group Inc. — Foreign Supplier Verification Program (FSVP) (2026-06-08)
June 8, 2026·Low
- Vivot LLC — Foreign Supplier Verification Program (FSVP) (2026-06-08)
June 8, 2026·Low
- Delight Distribution Inc. — Foreign Supplier Verification Program (FSVP) (2026-06-08)
June 8, 2026·Low
- AseptiKits, LLC — Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated Device (2026-06-04)
June 4, 2026·Critical
- InvaDerm, Inc. — Electronic Drug Registration and Listing System (eDRLS)/Violations (2026-06-03)
June 3, 2026·Critical
- M G R Produce LLC — Foreign Supplier Verification Program (FSVP) (2026-06-02)
June 2, 2026·Low
- SL Follen Company — Foreign Supplier Verification Program (FSVP) (2026-06-02)
June 2, 2026·Low
- Macau-Union Pharmaceutical Limited — Nonprescription/OTC (2026-05-29)
May 29, 2026·Critical
- Jose M. Carpio, M.D. — Clinical Investigator (2026-05-28)
May 28, 2026·Low
Other enforcement types
Sourced from openFDA public enforcement data. Not legal or regulatory advice. Report an error via /contact.