877947

SCA Pharmaceuticals, Inc. — FEI 3010683157

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
April 2, 2014
Fiscal Year
2014
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Little Rock, AR (United States)

Citations

IDCFRDescription
115921 CFR 211.28(a)Clothing appropriate for duties performed
143521 CFR 211.42(c)(10)(v)Cleaning System
143621 CFR 211.42(c)(10)(vi)Equipment to control conditions
145221 CFR 211.113(b)Validation lacking for sterile drug products
188321 CFR 211.165(a)Testing and release for distribution
202721 CFR 211.192Investigations of discrepancies, failures
355921 CFR 211.56(a)Sanitation--buildings not clean, free of infestation