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Warning Letter

Case 603610 — FEI 2627511

Facility

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

Action Details

Facility
Fenwal International, Inc.
Date
May 15, 2020
Fiscal Year
2020
Product Type
Biologics
Center
CBER
Location
Maricao, PR (United States)