Home / Inspections / 1226163

1226163

B. Braun US Pharmaceutical Manufacturing, LLC — FEI 2021236

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
December 15, 2023
Fiscal Year
2024
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))
  • 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))
  • 1057639 (OAI Fri Jun 29 2018 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
195621 CFR 211.180(e)(1)Representative Number of Batches for Annual Review
202721 CFR 211.192Investigations of discrepancies, failures
435521 CFR 211.165(c)Sampling and testing plans not followed