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940637

B. Braun Medical, Inc. — FEI 2523676

Inspection Details

Classification
No Action Indicated (NAI) (NAI)
End Date
September 21, 2015
Fiscal Year
2015
Product Type
Drugs
Project Area
Bioresearch Monitoring
Location
Allentown, PA (United States)

Additional Details

Postmarket Adverse Drug Experience (PADE)

Facility

Other inspections at this facility

  • 1267708 (VAI Fri May 16 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 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))

Citations

IDCFRDescription
188321 CFR 211.165(a)Testing and release for distribution
191421 CFR 211.166(a)Lack of written stability program
192621 CFR 211.166(b)Adequate number of batches on stability
202721 CFR 211.192Investigations of discrepancies, failures
436021 CFR 211.170(b)Reserve drug product sample quantity - all tests