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1292536

B. Braun US Pharmaceutical Manufacturing, LLC — FEI 2021236

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
November 21, 2025
Fiscal Year
2026
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Irvine, CA (United States)

Facility

Other inspections at this facility

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

Recent compliance actions

Citations

IDCFRDescription
110521 CFR 211.22(d)Procedures not in writing, fully followed
121321 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
189121 CFR 211.165(f)Failing drug products not rejected
202721 CFR 211.192Investigations of discrepancies, failures
361121 CFR 211.160(b)(3)Acceptance of drug products
430621 CFR 211.80(a)Written Procedures Not Followed