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1101303

HP Halden Pharma AS — FEI 3002608066

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
September 3, 2019
Fiscal Year
2019
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Halden (Norway)

Facility

Other inspections at this facility

  • 1205610 (VAI Wed May 10 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1014636 (VAI Fri May 26 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 931958 (VAI Fri Jun 26 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 863615 (VAI Fri Dec 20 2013 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 797565 (VAI Thu Aug 23 2012 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
110521 CFR 211.22(d)Procedures not in writing, fully followed
202721 CFR 211.192Investigations of discrepancies, failures
890721 CFR 314.81(b)(1)(ii)Contamination, chemical or physical change, deterioration