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980250

Otsuka Pharmaceutical Co., Ltd. — FEI 3003656524

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
July 22, 2016
Fiscal Year
2016
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))
  • 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
110521 CFR 211.22(d)Procedures not in writing, fully followed
121321 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
154021 CFR 211.125(a)Strict control not exercised over labeling issued
163621 CFR 211.130(e)Packaging line inspection before use
180221 CFR 211.84(b)Representative Samples
240121 CFR 211.194(a)(4)Complete Test Data
363921 CFR 211.204Returned drug procedures in writing and followed