simplyFDA
Start free
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 indexed
Drugs/Warning Letter
· 4d ago
Warning Letter — Sante Manufacturing Inc.
Sante Manufacturing Inc.
Medium
Drugs/Warning Letter
· 4d ago
Warning Letter — Ready Med
Ready Med
Medium
Drugs/Warning Letter
· 4d ago
Warning Letter — Maximus Health, Inc. dba Maximus
Maximus Health, Inc., Maximus
Medium
Other/Warning Letter
· 4d ago
Warning Letter — Ezra Holdco LLC dba Ezra
Ezra Holdco LLC, Ezra
High
Drugs/Warning Letter
· 4d ago
Warning Letter — Trinity HealthCare Supply, LLC dba altRx
Trinity HealthCare Supply, LLC, altRx
Medium
Drugs/Warning Letter
· 4d ago
Warning Letter — Glow Medispa, LLC dba Mint Med
Glow Medispa, LLC dba Mint Med
Medium
Drugs/Warning Letter
· 4d ago
Warning Letter — Public Health Solution LLC dba DrMedHealth
Public Health Solution LLC, DrMedHealth
Medium
Food/Warning Letter
· 4d ago
Warning Letter — M G R Produce LLC
M G R Produce LLC
Medium
Drugs/Warning Letter
· 4d ago
Warning Letter — Momentum Health 360 dba Momentum Health
Momentum Health 360 dba Momentum Health
Medium
Drugs/Warning Letter
· 4d ago
Warning Letter — Medica Weight Loss
Medica Weight Loss
Medium
Devices/Warning Letter
· 5d ago
Warning Letter — Happiest Baby, Inc.
Happiest Baby, Inc.
High
Other/Warning Letter
· 1w ago
Warning Letter — Jose M. Carpio, M.D.
Jose M. Carpio, M.D.
Medium
Food/Warning Letter
· 1w ago
Warning Letter — Bharat Overseas Inc.
Bharat Overseas Inc.
Medium
Drugs/Warning Letter
· 1w ago
Warning Letter — Macau-Union Pharmaceutical Limited
Macau-Union Pharmaceutical Limited
High
Drugs/Warning Letter
· 1w ago
Warning Letter — Shantou Qiwei Industry Co., LTD
Shantou Qiwei Industry Co., LTD
Medium
Other/Warning Letter
· 1w ago
Warning Letter — Revlon Group Holdings, LLC
Revlon Group Holdings, LLC
Medium
Drugs/Warning Letter
· 1w ago
Warning Letter — PLZ Corp
PLZ Corp
Medium
Drugs/Warning Letter
· 1w ago
Warning Letter — Fagron BV
Fagron BV
Medium
Drugs/Warning Letter
· 1w ago
Warning Letter — Hubei Gedian Humanwell Pharmaceutical Co., Ltd.
Hubei Gedian Humanwell Pharmaceutical Co., Ltd.
Medium
Drugs/Warning Letter
· 1w ago
Warning Letter — Umendra Life Sciences Private Limited
Umendra Life Sciences Private Limited
Medium
Drugs/Warning Letter
· 1w ago
Warning Letter — Gopaldas Visram & Co., Ltd.
Gopaldas Visram & Co., Ltd.
Medium
Other/Warning Letter
· 1w ago
Warning Letter — Erkul Kozmetik Sanayi ve Ticaret A.S.
Erkul Kozmetik Sanayi ve Ticaret A.S.
Medium
Drugs/Warning Letter
· 1w ago
Warning Letter — Laboratorios Dr. Collado S.A.
Laboratorios Dr. Collado S.A.
Medium
Drugs/Warning Letter
· 1w ago
Warning Letter — Asanuma Corporation - Sagamihara Factory
Asanuma Corporation - Sagamihara Factory
Medium
Food/Warning Letter
· 2w ago
Warning Letter — JZ Wholesale, Inc.
JZ Wholesale, Inc.
Medium
Biologics/Warning Letter
· 2w ago
Blue Horizon International, LLC - 728085 - 05/26/2026
Blue Horizon International, LLC
High
Food/Warning Letter
· 2w ago
Warning Letter — Stavis Seafoods, LLC
Stavis Seafoods, LLC
Medium
Drugs/Warning Letter
· 2w ago
Warning Letter — Laboratorios Jaloma S.A. de C.V.
Laboratorios Jaloma S.A. de C.V.
Medium
Drugs/Warning Letter
· 2w ago
Warning Letter — HealthPartners Neuroscience Center Research and Innovation
HealthPartners Neuroscience Center Research and Innovation
Medium
Food/Warning Letter
· 2w ago
Warning Letter — Boba Factory Inc
Boba Factory Inc
Medium