796785

Otsuka Pharmaceutical Co., Ltd. — FEI 3002809299

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
August 2, 2012
Fiscal Year
2012
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Tokushima (Japan)

Citations

IDCFRDescription
110521 CFR 211.22(d)Procedures not in writing, fully followed
145021 CFR 211.113(a)Procedures for non-sterile drug products
430321 CFR 211.67(b)Written procedures fail to include