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1205261

Fresenius Medical Care Deutschland Gmbh — FEI 3002807005

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
May 2, 2023
Fiscal Year
2023
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
St. Wendel (Germany)

Facility

Other inspections at this facility

  • 1290514 (NAI Thu Jun 29 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1204319 (NAI Wed Jun 24 2020 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1017671 (NAI Fri Jun 09 2017 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
126321 CFR 211.68(b)Computer control of master formula records
202721 CFR 211.192Investigations of discrepancies, failures