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1007433

Infomed Fluids SRL — FEI 3010600744

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
March 3, 2017
Fiscal Year
2017
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Bucharest (Romania)

Facility

Other inspections at this facility

  • 1237913 (VAI Fri Apr 07 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1128810 (VAI Fri Sep 28 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 914166 (VAI Tue Jan 20 2015 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
110521 CFR 211.22(d)Procedures not in writing, fully followed
117721 CFR 211.63Equipment Design, Size and Location
121521 CFR 211.67(b)Written procedures not established/followed
360321 CFR 211.160(b)Scientifically sound laboratory controls
361321 CFR 211.160(b)(4)Establishment of calibration procedures