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866672

B. Braun US Pharmaceutical Manufacturing, LLC — FEI 2021236

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
February 13, 2014
Fiscal Year
2014
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
136121 CFR 211.100(a)Absence of Written Procedures
145121 CFR 211.113(b)Procedures for sterile drug products
145221 CFR 211.113(b)Validation lacking for sterile drug products
202721 CFR 211.192Investigations of discrepancies, failures
202821 CFR 211.192Extent of discrepancy, failure investigations
354721 CFR 211.46(b)Equipment for Environmental Control