714304

Schwabe North America, Inc. — FEI 1721009

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
March 22, 2011
Fiscal Year
2011
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Lehi, UT (United States)

Citations

IDCFRDescription
121521 CFR 211.67(b)Written procedures not established/followed
434521 CFR 211.160(b)(1)Samples (various types) representative, identified properly