1069714

Promise Pharmacy, LLC — FEI 3013207472

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
October 25, 2018
Fiscal Year
2019
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Palm Harbor, FL (United States)

Citations

IDCFRDescription
109821 CFR 211.22(c)Approve or reject procedures or specs
117421 CFR 211.42(b)Product flow through building is inadequate
121321 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
145121 CFR 211.113(b)Procedures for sterile drug products
188321 CFR 211.165(a)Testing and release for distribution
188521 CFR 211.165(b)Microbiological testing
191421 CFR 211.166(a)Lack of written stability program