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873409

Otsuka Pharmaceutical Co., Ltd. — FEI 3003656524

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
March 20, 2014
Fiscal Year
2014
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Itano-Gun (Japan)

Facility

Other inspections at this facility

  • 1291346 (NAI Fri Oct 10 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1079491 (VAI Fri Feb 15 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 980250 (VAI Fri Jul 22 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 754803 (VAI Fri Oct 21 2011 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
121521 CFR 211.67(b)Written procedures not established/followed
172621 CFR 211.86Rotation of components/containers/closures
361321 CFR 211.160(b)(4)Establishment of calibration procedures
440221 CFR 211.192Written record of investigation incomplete