759431

Sumitomo Pharma America, Inc. — FEI 1222021

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
December 9, 2011
Fiscal Year
2012
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Marlborough, MA (United States)

Citations

IDCFRDescription
202721 CFR 211.192Investigations of discrepancies, failures
890721 CFR 314.81(b)(1)(ii)Contamination, chemical or physical change, deterioration