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1103317

Chugai Pharma Manufacturing Co. Ltd. — FEI 3006942691

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
September 26, 2019
Fiscal Year
2019
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))
  • 1031133 (VAI Fri Nov 10 2017 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
103321 CFR 211.22(a)Authority lacking to review records, investigate errors
126321 CFR 211.68(b)Computer control of master formula records
203121 CFR 211.194(a)Complete test data included in records
358521 CFR 211.110(a)Control procedures to monitor and validate performance