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750629

Pfizer Manufacturing Belgium NV — FEI 1000654629

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
September 23, 2011
Fiscal Year
2011
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Puurs-Sint-Amands (Belgium)

Facility

Other inspections at this facility

  • 1208904 (VAI Thu Jun 08 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1203291 (VAI Wed Jun 22 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1036703 (NAI Thu Nov 16 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 932671 (VAI Tue Jun 30 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 876029 (NAI Tue Mar 18 2014 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
145121 CFR 211.113(b)Procedures for sterile drug products
185221 CFR 211.94(a)Reactive/Additive/Absorptive Containers/Closures
202721 CFR 211.192Investigations of discrepancies, failures
354721 CFR 211.46(b)Equipment for Environmental Control
435321 CFR 211.160(b)(4)Instruments, apparatus, et. al. not meeting specs