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Compliance actions
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Warning Letter
Case 718601 — FEI 3008694072
Facility
Facility 3008694072
Recent inspections
1251408
(OAI Tue Aug 05 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
1252691
(NAI Wed Feb 05 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
1120766
(VAI Fri Mar 13 2020 00:00:00 GMT+0000 (Coordinated Universal Time))
1059347
(OAI Wed Jul 18 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
1017551
(NAI Fri Jun 09 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
Other compliance actions
Warning Letter (567869)
(Tue Mar 26 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
Action Details
Facility
Winder Laboratories, LLC
Date
January 9, 2026
Fiscal Year
2026
Product Type
Drugs
Center
CDER
Location
Winder, GA (United States)