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Compliance actions
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Warning Letter
Case 634647 — FEI 3010892830
Facility
Facility 3010892830
Recent inspections
1229051
(OAI Fri Feb 09 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
1167490
(OAI Wed Apr 20 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
1168119
(OAI Wed Apr 20 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
1109980
(VAI Fri Nov 15 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
1099348
(NAI Fri Jun 07 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
Other compliance actions
Warning Letter (644180)
(Fri Oct 21 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
Warning Letter (610867)
(Tue Sep 22 2020 00:00:00 GMT+0000 (Coordinated Universal Time))
Warning Letter (480214)
(Fri Sep 02 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
Warning Letter (408461)
(Tue Sep 24 2013 00:00:00 GMT+0000 (Coordinated Universal Time))
Action Details
Facility
Nephron SC, LLC
Date
October 11, 2022
Fiscal Year
2023
Product Type
Drugs
Center
CDER
Location
West Columbia, SC (United States)