890723

Central Admixture Pharmacy Services Inc — FEI 3004378804

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
August 8, 2014
Fiscal Year
2014
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
San Diego, CA (United States)

Citations

IDCFRDescription
115921 CFR 211.28(a)Clothing appropriate for duties performed
121321 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
121521 CFR 211.67(b)Written procedures not established/followed
143421 CFR 211.42(c)(10)(iv)Environmental Monitoring System
145121 CFR 211.113(b)Procedures for sterile drug products
154021 CFR 211.125(a)Strict control not exercised over labeling issued
188321 CFR 211.165(a)Testing and release for distribution
193221 CFR 211.167(a)Sterility/pyrogen-free testing
360321 CFR 211.160(b)Scientifically sound laboratory controls