922792

Innovative Compounding Pharmacy — FEI 3011396023

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
April 17, 2015
Fiscal Year
2015
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Folsom, CA (United States)

Citations

IDCFRDescription
116221 CFR 211.28(a)Protective Apparel Not Worn
119421 CFR 211.42(c)Defined areas of adequate size for operations
143421 CFR 211.42(c)(10)(iv)Environmental Monitoring System
143521 CFR 211.42(c)(10)(v)Cleaning System
143621 CFR 211.42(c)(10)(vi)Equipment to control conditions
145121 CFR 211.113(b)Procedures for sterile drug products
188321 CFR 211.165(a)Testing and release for distribution
193221 CFR 211.167(a)Sterility/pyrogen-free testing
355921 CFR 211.56(a)Sanitation--buildings not clean, free of infestation
435721 CFR 211.166(a)Results not used for expiration dates, storage cond.