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1057639

B. Braun US Pharmaceutical Manufacturing, LLC — FEI 2021236

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
June 29, 2018
Fiscal Year
2018
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
103321 CFR 211.22(a)Authority lacking to review records, investigate errors
126321 CFR 211.68(b)Computer control of master formula records
135821 CFR 211.100(b)SOPs not followed / documented
189021 CFR 211.165(e)Test methods
202721 CFR 211.192Investigations of discrepancies, failures
239721 CFR 211.194(a)(1)Description and Identification of Samples
240121 CFR 211.194(a)(4)Complete Test Data
360321 CFR 211.160(b)Scientifically sound laboratory controls