723394

Sumitomo Pharma America, Inc. — FEI 1222021

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
April 20, 2011
Fiscal Year
2011
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Marlborough, MA (United States)

Citations

IDCFRDescription
107921 CFR 211.22(a)Contract drug products--lack of responsibility
891121 CFR 314.81(b)(1)(ii)Failure to meet specifications