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1190765

Haupt Pharma Wolfratshausen GmbH — FEI 3000310230

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
November 15, 2022
Fiscal Year
2023
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Wolfratshausen (Germany)

Facility

Other inspections at this facility

  • 1133484 (VAI Wed Aug 05 2020 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1031639 (VAI Fri Oct 20 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 964643 (VAI Sat Apr 09 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 876712 (VAI Tue Mar 18 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 790703 (VAI Fri May 11 2012 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
360321 CFR 211.160(b)Scientifically sound laboratory controls