Intelligence · Warning Letters
Warning Letter Intelligence
AI-clustered analysis of recurring FDA warning letter themes — root issues, CAPA failures, data integrity, sterility, and inspection trends.
Recent warning letters
30 indexed1w ago
Other/Warning Letter
· 1w agoWarning Letter — Bausch & Lomb Inc.
Bausch & Lomb Inc.
Bausch & Lomb Inc.
Medium
1w agoFood/Warning Letter
· 1w agoWarning Letter — H2 BEV, LLC and H2 RENU, INC
H2 BEV, LLC, H2 RENU, INC.
H2 BEV, LLC, H2 RENU, INC.
Medium
2w agoBiologics/Warning Letter
· 2w agoWarning Letter — Stephen J. Fallon, Ph.D.
Stephen J. Fallon, Ph.D.
Stephen J. Fallon, Ph.D.
Medium
2w agoDrugs/Warning Letter
· 2w agoWarning Letter — Happy Farm Botanicals, Inc.
Happy Farm Botanicals, Inc.
Happy Farm Botanicals, Inc.
Medium
3w agoDrugs/Warning Letter
· 3w agoWarning Letter — Peak Performance Peptides
Peak Performance Peptides
Peak Performance Peptides
Medium
3w agoDrugs/Warning Letter
· 3w agoWarning Letter — Reliance Life Sciences Private Limited
Reliance Life Sciences Private Limited
Reliance Life Sciences Private Limited
Medium
3w agoDrugs/Warning Letter
· 3w agoWarning Letter — Jabil Inc.
Jabil Inc.
Jabil Inc.
Medium
3w agoDrugs/Warning Letter
· 3w agoWarning Letter — Shoolin Pharma Chem LLP
Shoolin Pharma Chem LLP
Shoolin Pharma Chem LLP
Medium
3w agoDrugs/Warning Letter
· 3w agoWarning Letter — Royal Peptides LLC
Royal Peptides LLC
Royal Peptides LLC
Medium
3w agoDrugs/Warning Letter
· 3w agoWarning Letter — NuScience Peptides LLC
NuScience Peptides LLC
NuScience Peptides LLC
Medium
3w agoDrugs/Warning Letter
· 3w agoWarning Letter — TXP Innovations LLC dba Tex Peptides
TXP Innovations LLC, Tex Peptides
TXP Innovations LLC, Tex Peptides
Medium
3w agoOther/Warning Letter
· 3w agoWarning Letter — Mesquite Gourmet LLC
Mesquite Gourmet LLC
Mesquite Gourmet LLC
Medium
4w agoOther/Warning Letter
· 4w agoWarning Letter — Vargas Produce LLC
Vargas Produce LLC
Vargas Produce LLC
Medium
4w agoBiologics/Warning Letter
· 4w agoWarning Letter — R3 Medical Companies
R3 Medical Companies
R3 Medical Companies
High
Aug 18, 2026Tobacco/Warning Letter
· Aug 18, 2026Warning Letter — giantnic.com
giantnic.com
giantnic.com
Medium
Aug 18, 2026Veterinary/Warning Letter
· Aug 18, 2026Warning Letter — Waves and Wine, Inc.
Waves and Wine, Inc.
Waves and Wine, Inc.
Medium
Aug 18, 2026Tobacco/Warning Letter
· Aug 18, 2026Warning Letter — mikuvape.com
mikuvape.com
mikuvape.com
Medium
Aug 18, 2026Devices/Warning Letter
· Aug 18, 2026Warning Letter — Nipro Renal Solutions USA, Corporation
Nipro Renal Solutions USA, Corporation
Nipro Renal Solutions USA, Corporation
Medium
Aug 18, 2026Drugs/Warning Letter
· Aug 18, 2026Warning Letter — Tianjin Kilo Pharmaceutical Sci-tech Co., Ltd.
Tianjin Kilo Pharmaceutical Sci-tech Co., Ltd.
Tianjin Kilo Pharmaceutical Sci-tech Co., Ltd.
Medium
Aug 18, 2026Drugs/Warning Letter
· Aug 18, 2026Warning Letter — Safrel Pharmaceuticals LLC
Safrel Pharmaceuticals LLC
Safrel Pharmaceuticals LLC
Medium
Aug 18, 2026Drugs/Warning Letter
· Aug 18, 2026Warning Letter — Suretec Innovations, LLC
Suretec Innovations, LLC
Suretec Innovations, LLC
Medium
Aug 18, 2026Other/Warning Letter
· Aug 18, 2026Warning Letter — Auriga Research Pvt. Ltd.
Auriga Research Pvt. Ltd.
Auriga Research Pvt. Ltd.
Medium
Aug 18, 2026Veterinary/Warning Letter
· Aug 18, 2026Warning Letter — DeJong Family Dairy, LLC
DeJong Family Dairy, LLC
DeJong Family Dairy, LLC
Medium
Aug 18, 2026Drugs/Warning Letter
· Aug 18, 2026Warning Letter — K.C. Pharmaceuticals, Inc.
K.C. Pharmaceuticals, Inc.
K.C. Pharmaceuticals, Inc.
Medium
Aug 18, 2026Drugs/Warning Letter
· Aug 18, 2026Warning Letter — Eugia Pharma Specialities Limited
Eugia Pharma Specialities Limited
Eugia Pharma Specialities Limited
Medium
Aug 11, 2026Food/Warning Letter
· Aug 11, 2026Warning Letter — California Dairies, Inc.
California Dairies, Inc.
California Dairies, Inc.
Medium
Aug 11, 2026Drugs/Warning Letter
· Aug 11, 2026Warning Letter — FairyGene, Inc.
FairyGene, Inc.
FairyGene, Inc.
Medium
Aug 11, 2026Veterinary/Warning Letter
· Aug 11, 2026Warning Letter — Tex-Stein Dairy
Tex-Stein Dairy
Tex-Stein Dairy
Medium
Aug 11, 2026Drugs/Warning Letter
· Aug 11, 2026Warning Letter — Lico Industries, LLC., d.b.a. American Towelette Company
Lico Industries, LLC., American Towelette Company
Lico Industries, LLC., American Towelette Company
Medium
Aug 4, 2026Drugs/Warning Letter
· Aug 4, 2026Warning Letter — Thomas Brunner Hygiene GmbH
Thomas Brunner Hygiene GmbH
Thomas Brunner Hygiene GmbH
Medium