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1267708

B. Braun Medical, Inc. — FEI 2523676

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
May 16, 2025
Fiscal Year
2025
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Allentown, PA (United States)

Facility

Other inspections at this facility

  • 1151048 (NAI Wed Sep 01 2021 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1065649 (NAI Fri Jun 01 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1030483 (NAI Tue May 23 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 984345 (VAI Fri Aug 26 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 940637 (NAI Mon Sep 21 2015 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
126321 CFR 211.68(b)Computer control of master formula records
192021 CFR 211.166(a)(3)Valid stability test methods
202721 CFR 211.192Investigations of discrepancies, failures
361621 CFR 211.165(d)Acceptance criteria for sampling & testing
438921 CFR 211.198(a)Procedures to be written and followed
439121 CFR 211.180(e)(2)Items to cover on annual reviews