enforcement database
FDA General Warning Letters
73 documented actions on record. FDA warning letters not otherwise categorized by a more specific violation type.
- Total actions
- 73
- Earliest on record
- March 18, 2026
- Most recent
- October 6, 2026
- Source
- openFDA (warning_letter)
Severity breakdown
- Critical15
- High10
- Medium2
- Low46
Most recent general warning letters (30 of 73 shown)
- Lovelace Biomedical Research Institute — Good Laboratory Practice (GLP) for Nonclinical Laboratory Studies (2026-10-06)
October 6, 2026·Low
- John & Nicole Santos Dairy — New Animal Drug/Adulterated (2026-10-02)
October 2, 2026·High
- Moda Food LLC — Foreign Supplier Verification Program (FSVP) (2026-09-09)
September 9, 2026·Low
- Stephen J. Fallon, Ph.D. — Bioresearch Monitoring Program/Institutional Review Board (IRB) (2026-08-27)
August 27, 2026·High
- Union Trade Inc. — Foreign Supplier Verification Program (FSVP) (2026-08-27)
August 27, 2026·High
- Advance-Esthetic LLC — Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated Device (2026-08-25)
August 25, 2026·Critical
- B&P Mutual Corp — Foreign Supplier Verification Program (FSVP) (2026-08-18)
August 18, 2026·Low
- Bo Wah Enterprises Inc — Foreign Supplier Verification Program (FSVP) (2026-08-13)
August 13, 2026·Low
- Quantum Star LLC — Foreign Supplier Verification Program (FSVP) (2026-08-05)
August 5, 2026·Medium
- Mesquite Gourmet LLC — Foreign Supplier Verification Program (FSVP) (2026-08-04)
August 4, 2026·Low
- Stokes Healthcare Inc. dba Epicur Pharma — Animal Drugs/Adulterated (2026-08-04)
August 4, 2026·Critical
- 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
- Ohom Padmaavathii, LLC — Foreign Supplier Verification Program (FSVP) (2026-07-22)
July 22, 2026·Low
- Ruukoo International Food Market Inc. — Foreign Supplier Verification Program (FSVP) (2026-07-22)
July 22, 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
- LDNN Produce 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
- Beauty Store LLC — Foreign Supplier Verification Program (FSVP) (2026-07-08)
July 8, 2026·Low
- IJAJ Group Inc DBA Sanz Wholesale Foods — 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
- Shouly Import Corp. — Foreign Supplier Verification Program (FSVP) (2026-06-26)
June 26, 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
Other enforcement types
Sourced from openFDA public enforcement data. Not legal or regulatory advice. Report an error via /contact.