821896

Simtra US LLC — FEI 1000115571

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
March 12, 2013
Fiscal Year
2013
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Bloomington, IN (United States)

Citations

IDCFRDescription
145121 CFR 211.113(b)Procedures for sterile drug products
202821 CFR 211.192Extent of discrepancy, failure investigations