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887144

Otsuka Pharmaceutical Co., Ltd. — FEI 3004810250

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
June 17, 2014
Fiscal Year
2014
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Naka-Gun (Japan)

Facility

Other inspections at this facility

  • 1265342 (VAI Tue Jun 17 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1107691 (VAI Tue Oct 22 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 994655 (NAI Thu Sep 22 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 793343 (VAI Thu Jul 19 2012 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
145121 CFR 211.113(b)Procedures for sterile drug products
202721 CFR 211.192Investigations of discrepancies, failures
363221 CFR 211.170(b)Annual visual exams of drug products