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1019455

Kymos S.L. — FEI 3008661256

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
July 18, 2017
Fiscal Year
2017
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Cerdanyola Del Valles (Spain)

Facility

Other inspections at this facility

  • 1297704 (VAI Thu Mar 14 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1207132 (VAI Wed Mar 17 2021 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1123784 (VAI Fri Mar 23 2018 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
125621 CFR 211.68(b)Backup file not maintained
126321 CFR 211.68(b)Computer control of master formula records
145021 CFR 211.113(a)Procedures for non-sterile drug products
188321 CFR 211.165(a)Testing and release for distribution
202721 CFR 211.192Investigations of discrepancies, failures
203121 CFR 211.194(a)Complete test data included in records
360221 CFR 211.160(a)Deviations from laboratory control requirements
360321 CFR 211.160(b)Scientifically sound laboratory controls