994655

Otsuka Pharmaceutical Co., Ltd. — FEI 3004810250

Inspection Details

Classification
No Action Indicated (NAI) (NAI)
End Date
September 22, 2016
Fiscal Year
2016
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Naka-Gun (Japan)

Citations

IDCFRDescription
672821 CFR 314.80(b)Failure to review ADE information