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Compliance actions
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Warning Letter
Case 657085 — FEI 2627511
Facility
Facility 2627511
Recent inspections
1250072
(VAI Wed Sep 18 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
1180297
(OAI Sat Sep 24 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
1152927
(OAI Fri Sep 24 2021 00:00:00 GMT+0000 (Coordinated Universal Time))
1102938
(OAI Thu Sep 26 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
1022483
(VAI Tue Aug 22 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
Other compliance actions
Warning Letter (603610)
(Fri May 15 2020 00:00:00 GMT+0000 (Coordinated Universal Time))
Warning Letter (405903)
(Fri Aug 16 2013 00:00:00 GMT+0000 (Coordinated Universal Time))
Warning Letter (306980)
(Fri Jun 01 2012 00:00:00 GMT+0000 (Coordinated Universal Time))
Action Details
Facility
Fenwal International, Inc.
Date
September 14, 2023
Fiscal Year
2023
Product Type
Biologics
Center
CBER
Location
Maricao, PR (United States)