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1031133

Chugai Pharma Manufacturing Co. Ltd. — FEI 3006942691

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
November 10, 2017
Fiscal Year
2018
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Utsunomiya (Japan)

Facility

Other inspections at this facility

  • 1236880 (VAI Tue Apr 02 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1103317 (VAI Thu Sep 26 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 918526 (NAI Tue Mar 24 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 827757 (NAI Fri Mar 15 2013 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 709260 (VAI Tue Feb 01 2011 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
121921 CFR 211.67(b)(2)Cleaning SOPs/schedules
127021 CFR 211.68(b)input/output verification
127421 CFR 211.68(a)Calibration/Inspection/Checking not done
360321 CFR 211.160(b)Scientifically sound laboratory controls
440221 CFR 211.192Written record of investigation incomplete