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754803

Otsuka Pharmaceutical Co., Ltd. — FEI 3003656524

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
October 21, 2011
Fiscal Year
2012
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))
  • 873409 (VAI Thu Mar 20 2014 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
136121 CFR 211.100(a)Absence of Written Procedures
192021 CFR 211.166(a)(3)Valid stability test methods
203121 CFR 211.194(a)Complete test data included in records
363221 CFR 211.170(b)Annual visual exams of drug products
432521 CFR 211.110(a)Control procedures fail to include the following
435221 CFR 211.160(b)(4)Calibration - at intervals, written program, remedial action