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999137

GC Hanford Manufacturing Company — FEI 1310197

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
December 16, 2016
Fiscal Year
2017
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Syracuse, NY (United States)

Facility

Other inspections at this facility

  • 1264589 (OAI Thu Mar 20 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1172077 (VAI Fri Jun 17 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1102962 (VAI Fri Sep 27 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1102963 (VAI Fri Sep 27 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 997479 (NAI Wed Dec 14 2016 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
126321 CFR 211.68(b)Computer control of master formula records
141821 CFR 211.42(c)(7)Quarantined Drug Products Area
180921 CFR 211.160(a)Following/documenting laboratory controls
435221 CFR 211.160(b)(4)Calibration - at intervals, written program, remedial action
440121 CFR 211.186(b)(9)Complete instructions, procedures, specifications et. al.
440221 CFR 211.192Written record of investigation incomplete