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Warning Letter

Case 666442 — FEI 3003092372

Facility

Recent inspections

  • 1249319 (OAI Thu Aug 29 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1210295 (OAI Tue Jul 18 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1192929 (VAI Fri Dec 16 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1031539 (VAI Fri Nov 17 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 965268 (VAI Fri Feb 12 2016 00:00:00 GMT+0000 (Coordinated Universal Time))

Action Details

Facility
Dextrum Laboratories
Date
December 7, 2023
Fiscal Year
2024
Product Type
Drugs
Center
CDER
Location
Miami, FL (United States)