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1265342

Otsuka Pharmaceutical Co., Ltd. — FEI 3004810250

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
June 17, 2025
Fiscal Year
2025
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Naka-Gun (Japan)

Facility

Other inspections at this facility

  • 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))
  • 887144 (VAI Tue Jun 17 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 793343 (VAI Thu Jul 19 2012 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
136121 CFR 211.100(a)Absence of Written Procedures
143421 CFR 211.42(c)(10)(iv)Environmental Monitoring System
145221 CFR 211.113(b)Validation lacking for sterile drug products
360321 CFR 211.160(b)Scientifically sound laboratory controls