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Warning Letter

Case 630316 — FEI 1000512361

Facility

Recent inspections

  • 1236852 (NAI Thu Jul 25 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1215798 (VAI Thu Aug 10 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1162959 (OAI Fri Feb 18 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1140286 (VAI Fri Apr 16 2021 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1091850 (NAI Fri May 10 2019 00:00:00 GMT+0000 (Coordinated Universal Time))

Action Details

Facility
Bora Pharmaceuticals Injectables Inc
Date
August 10, 2022
Fiscal Year
2022
Product Type
Drugs
Center
CDER
Location
Baltimore, MD (United States)