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892490

Eurofins BioPharma Product Testing Czech Republic s.r.o. — FEI 3008920466

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
July 29, 2014
Fiscal Year
2014
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Brno-Jih (Czech Republic)

Facility

Other inspections at this facility

  • 1270980 (VAI Wed Jul 24 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1134811 (VAI Thu Jul 16 2020 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 988104 (NAI Tue Aug 09 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 727383 (VAI Fri May 20 2011 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
110521 CFR 211.22(d)Procedures not in writing, fully followed
111221 CFR 211.25(a)Training--operations, GMPs, written procedures
126321 CFR 211.68(b)Computer control of master formula records
203121 CFR 211.194(a)Complete test data included in records