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917536

B. Braun US Pharmaceutical Manufacturing, LLC — FEI 2021236

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
March 3, 2015
Fiscal Year
2015
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))
  • 1152417 (VAI Tue Aug 17 2021 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
110521 CFR 211.22(d)Procedures not in writing, fully followed
194221 CFR 211.180(e)Records reviewed annually
202721 CFR 211.192Investigations of discrepancies, failures
241921 CFR 211.198(a)Complaint Handling Procedure
890721 CFR 314.81(b)(1)(ii)Contamination, chemical or physical change, deterioration