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1230640

Second Tokushima Factory, Otsuka Pharmaceutical Co., Ltd. — FEI 3002807834

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
March 22, 2024
Fiscal Year
2024
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Tokushima (Japan)

Facility

Other inspections at this facility

  • 1106423 (VAI Tue Sep 10 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1049653 (VAI Fri Mar 23 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 958528 (VAI Fri Feb 12 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 888415 (VAI Thu Jun 26 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 801261 (VAI Mon Jul 09 2012 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
121321 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
143421 CFR 211.42(c)(10)(iv)Environmental Monitoring System
202721 CFR 211.192Investigations of discrepancies, failures
360221 CFR 211.160(a)Deviations from laboratory control requirements
431421 CFR 211.84(d)(2)Reports of Analysis (Components)