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Warning Letter

Case 654226 — FEI 1210580

Facility

Recent inspections

  • 1273626 (VAI Tue Aug 26 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1240591 (OAI Mon Jul 29 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1196871 (OAI Thu Feb 09 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1029761 (VAI Wed Oct 25 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 969790 (VAI Tue Apr 05 2016 00:00:00 GMT+0000 (Coordinated Universal Time))

Action Details

Facility
Denison Pharmaceuticals, LLC
Date
July 26, 2023
Fiscal Year
2023
Product Type
Drugs
Center
CDER
Location
Lincoln, RI (United States)