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1056286

Klosterfrau Berlin GmbH — FEI 3004187716

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
June 7, 2018
Fiscal Year
2018
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Berlin (Germany)

Facility

Other inspections at this facility

  • 1204454 (VAI Fri Sep 02 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 917840 (VAI Fri Feb 13 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 818016 (VAI Wed Feb 13 2013 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
110521 CFR 211.22(d)Procedures not in writing, fully followed
113621 CFR 211.25(c)Inadequate number of personnel
145221 CFR 211.113(b)Validation lacking for sterile drug products