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1026364

Ipsen BioPharm Ltd — FEI 1000346340

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
September 12, 2017
Fiscal Year
2017
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Wrexham (United Kingdom)

Facility

Other inspections at this facility

  • 1283174 (VAI Thu May 22 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1117834 (VAI Fri Apr 26 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1059005 (VAI Fri Jul 06 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 965116 (VAI Wed Jan 20 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 892573 (VAI Tue Jul 08 2014 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
126321 CFR 211.68(b)Computer control of master formula records
145121 CFR 211.113(b)Procedures for sterile drug products
202821 CFR 211.192Extent of discrepancy, failure investigations
357021 CFR 211.100(a)Approval and review of procedures
360321 CFR 211.160(b)Scientifically sound laboratory controls