enforcement database
FDA General Warning Letters
45 documented actions on record. FDA warning letters not otherwise categorized by a more specific violation type.
- Total actions
- 45
- Earliest on record
- March 18, 2026
- Most recent
- July 10, 2026
- Source
- openFDA (warning_letter)
Severity breakdown
- Critical12
- High6
- Medium1
- Low26
Most recent general warning letters (30 of 45 shown)
- Alembic Pharmaceuticals Ltd. — In Vivo Bioavailability-Bioequivalence Studies – Clinical (2026-07-10)
July 10, 2026·Low
- Pratik Doshi, M.D. / 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
- 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
- Happiest Baby, Inc. — Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated Device (2026-06-15)
June 15, 2026·High
- Life & Food Inc. — Foreign Supplier Verification Program (FSVP) (2026-06-15)
June 15, 2026·Low
- Yangzhou Hongshengding Chemical Co., Ltd. — Refusal to Provide Access to and Copying of Records (2026-06-15)
June 15, 2026·High
- Vivot LLC — Foreign Supplier Verification Program (FSVP) (2026-06-08)
June 8, 2026·Low
- YS Group 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
- SL Follen Company — Foreign Supplier Verification Program (FSVP) (2026-06-02)
June 2, 2026·Low
- M G R Produce LLC — 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
- Pamex Foods Incorporated — Foreign Supplier Verification Program (FSVP) (2026-05-26)
May 26, 2026·Low
- Aeroflex Industria de Aerosol Ltda. — Refusal to Provide Access to and Copying of Records (2026-05-22)
May 22, 2026·High
- Golden Dakota Farms LLC — New Animal Drug/Adulterated (2026-05-20)
May 20, 2026·Critical
- HealthPartners Neuroscience Center Research and Innovation — Good Laboratory Practice (GLP) for Nonclinical Laboratory Studies (2026-05-19)
May 19, 2026·Low
- Aja Health and Wellness Inc. — Nonprescription/OTC (2026-05-18)
May 18, 2026·Critical
- GSC Products, LLC — Nonprescription/OTC (2026-05-18)
May 18, 2026·Critical
- Bushman Organic Farms, Inc. — Foreign Supplier Verification Program (FSVP) (2026-05-14)
May 14, 2026·Low
- PolleyMed, LLC — Nonprescription/OTC (2026-05-14)
May 14, 2026·Critical
- Bharat Overseas Inc. — Foreign Supplier Verification Program (FSVP) (2026-05-14)
May 14, 2026·Low
- Naseem A. Jaffrani, M.D. — Clinical Investigator (2026-05-04)
May 4, 2026·Low
- Sourav K. Mishra, M.D. / All India Institute of Medical Sciences — In Vivo Bioavailability-Bioequivalence Studies – Clinical (2026-04-29)
April 29, 2026·Medium
- Sahara Enterprise Inc. — Foreign Supplier Verification Program (FSVP) (2026-04-29)
April 29, 2026·Low
Other enforcement types
Sourced from openFDA public enforcement data. Not legal or regulatory advice. Report an error via /contact.