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Warning Letter

Case 501232 — FEI 2021236

Facility

Recent inspections

  • 1292536 (OAI Fri Nov 21 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1231010 (NAI Tue Aug 06 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1226163 (VAI Fri Dec 15 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1222593 (NAI Fri Oct 13 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1152417 (VAI Tue Aug 17 2021 00:00:00 GMT+0000 (Coordinated Universal Time))

Action Details

Facility
B. Braun US Pharmaceutical Manufacturing, LLC
Date
May 12, 2017
Fiscal Year
2017
Product Type
Drugs
Center
CDER
Location
Irvine, CA (United States)