844823

Calvin Scott & Company, Inc. — FEI 1619076

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
August 1, 2013
Fiscal Year
2013
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Albuquerque, NM (United States)

Citations

IDCFRDescription
117721 CFR 211.63Equipment Design, Size and Location
136121 CFR 211.100(a)Absence of Written Procedures
154021 CFR 211.125(a)Strict control not exercised over labeling issued
430321 CFR 211.67(b)Written procedures fail to include
439121 CFR 211.180(e)(2)Items to cover on annual reviews