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964766

Janssen Pharmaceutica, N.V. — FEI 3002807336

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
March 1, 2016
Fiscal Year
2016
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Beerse (Belgium)

Facility

Other inspections at this facility

  • 1290376 (NAI Fri Nov 21 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1270321 (VAI Fri Sep 05 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1296030 (VAI Mon May 12 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1203728 (VAI Fri Jul 02 2021 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1055920 (VAI Tue Jun 12 2018 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
145121 CFR 211.113(b)Procedures for sterile drug products
202721 CFR 211.192Investigations of discrepancies, failures
202821 CFR 211.192Extent of discrepancy, failure investigations
360321 CFR 211.160(b)Scientifically sound laboratory controls
890721 CFR 314.81(b)(1)(ii)Contamination, chemical or physical change, deterioration