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1203129

Hikma Farmaceutica, (Portugal) S.A. — FEI 3002807173

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
April 21, 2023
Fiscal Year
2023
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Terrugem Snt (Portugal)

Facility

Other inspections at this facility

  • 1254066 (VAI Fri Feb 03 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1125050 (VAI Fri Mar 06 2020 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1050480 (NAI Thu Mar 22 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 970483 (VAI Tue Apr 12 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 940389 (VAI Fri Jun 19 2015 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
126121 CFR 211.68(a)Written calibration / inspection records not kept
145121 CFR 211.113(b)Procedures for sterile drug products
191221 CFR 211.166(a)Written program not followed
202721 CFR 211.192Investigations of discrepancies, failures
357221 CFR 211.100(b)Procedure Deviations Recorded and Justified
360321 CFR 211.160(b)Scientifically sound laboratory controls
434321 CFR 211.160(b)(1)Incoming lots - conformance to written specs-