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FDA Inspection 1152417 — B. Braun US Pharmaceutical Manufacturing, LLC

B. Braun US Pharmaceutical Manufacturing, LLC — FEI 2021236

The FDA completed an inspection of B. Braun US Pharmaceutical Manufacturing, LLC on August 17, 2021 in Irvine, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). Product area: Drugs.

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
August 17, 2021
Fiscal Year
2021
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Irvine, CA (United States)

Facility

Other inspections at this facility

  • 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))
  • 1057639 (OAI Fri Jun 29 2018 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

FDA data resources