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961288

SWISSCAPS Romania SRL — FEI 2000030299

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
February 19, 2016
Fiscal Year
2016
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Cornu (Romania)

Facility

Other inspections at this facility

  • 1264152 (VAI Fri Oct 11 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1248518 (NAI Tue Aug 27 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1102412 (NAI Wed Aug 21 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1124208 (VAI Fri May 11 2018 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
110521 CFR 211.22(d)Procedures not in writing, fully followed
136121 CFR 211.100(a)Absence of Written Procedures
240421 CFR 211.194(a)(6)Comparison of Test Results to Specifications
357221 CFR 211.100(b)Procedure Deviations Recorded and Justified