948676

Auro Pharmacies, Inc. — FEI 3011893599

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
November 5, 2015
Fiscal Year
2016
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
La Habra, CA (United States)

Citations

IDCFRDescription
115921 CFR 211.28(a)Clothing appropriate for duties performed
143421 CFR 211.42(c)(10)(iv)Environmental Monitoring System
143521 CFR 211.42(c)(10)(v)Cleaning System
145121 CFR 211.113(b)Procedures for sterile drug products
172821 CFR 211.87Retest of approved components/containers/closures
191421 CFR 211.166(a)Lack of written stability program
193221 CFR 211.167(a)Sterility/pyrogen-free testing
202721 CFR 211.192Investigations of discrepancies, failures
360321 CFR 211.160(b)Scientifically sound laboratory controls