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1079491

Otsuka Pharmaceutical Co., Ltd. — FEI 3003656524

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
February 15, 2019
Fiscal Year
2019
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))
  • 980250 (VAI Fri Jul 22 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 873409 (VAI Thu Mar 20 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 754803 (VAI Fri Oct 21 2011 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
121321 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
121521 CFR 211.67(b)Written procedures not established/followed
180921 CFR 211.160(a)Following/documenting laboratory controls
358521 CFR 211.110(a)Control procedures to monitor and validate performance