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1205610

HP Halden Pharma AS — FEI 3002608066

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
May 10, 2023
Fiscal Year
2023
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Halden (Norway)

Facility

Other inspections at this facility

  • 1101303 (VAI Tue Sep 03 2019 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
136121 CFR 211.100(a)Absence of Written Procedures
179021 CFR 211.80(b)Handling and Storage to Prevent Contamination
202721 CFR 211.192Investigations of discrepancies, failures
434221 CFR 211.142(b)Storage under appropriate conditions