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Compliance actions
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Warning Letter
Case 709859 — FEI 3008563008
Facility
Facility 3008563008
Recent inspections
1096634
(VAI Thu Jul 18 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
1081405
(NAI Wed Dec 19 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
1067755
(NAI Tue Sep 11 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
1026858
(VAI Thu Sep 28 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
988490
(NAI Wed Jun 08 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
Other compliance actions
Warning Letter (611316)
(Fri Apr 09 2021 00:00:00 GMT+0000 (Coordinated Universal Time))
Action Details
Facility
Exela Pharma Sciences LLC
Date
July 2, 2025
Fiscal Year
2025
Product Type
Drugs
Center
CDER
Location
Lenoir, NC (United States)