914112

Central Admixture Pharmacy Services, Inc. — FEI 3009590582

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
February 11, 2015
Fiscal Year
2015
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Allentown, PA (United States)

Citations

IDCFRDescription
115921 CFR 211.28(a)Clothing appropriate for duties performed
145121 CFR 211.113(b)Procedures for sterile drug products
145221 CFR 211.113(b)Validation lacking for sterile drug products
193221 CFR 211.167(a)Sterility/pyrogen-free testing
202721 CFR 211.192Investigations of discrepancies, failures
436621 CFR 211.188(a)Accurate reproduction included