Home / Inspections / 1264589

1264589

GC Hanford Manufacturing Company — FEI 1310197

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
March 20, 2025
Fiscal Year
2025
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Syracuse, NY (United States)

Facility

Other inspections at this facility

  • 1172077 (VAI Fri Jun 17 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1102963 (VAI Fri Sep 27 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1102962 (VAI Fri Sep 27 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 999137 (VAI Fri Dec 16 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 997479 (NAI Wed Dec 14 2016 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
110521 CFR 211.22(d)Procedures not in writing, fully followed
121321 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
127421 CFR 211.68(a)Calibration/Inspection/Checking not done
143021 CFR 211.42(c)(10)(i)Floors, walls, ceiling surfaces
143421 CFR 211.42(c)(10)(iv)Environmental Monitoring System
355921 CFR 211.56(a)Sanitation--buildings not clean, free of infestation