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936026

AstraZeneca Nijmegen B.V. — FEI 3003000472

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
June 5, 2015
Fiscal Year
2015
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Nijmegen (Netherlands)

Facility

Other inspections at this facility

  • 1276715 (VAI Wed Apr 10 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1112441 (NAI Tue Sep 10 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 850854 (VAI Fri Jun 21 2013 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 757334 (VAI Tue Sep 27 2011 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 548265 (VAI Thu Oct 23 2008 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
121321 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
145121 CFR 211.113(b)Procedures for sterile drug products
360321 CFR 211.160(b)Scientifically sound laboratory controls
434421 CFR 211.160(b)(1)Sampling and testing procedures described