976566

Vita Pharmacy, LLC dba Talon Compounding Pharmacy — FEI 3009192575

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
June 29, 2016
Fiscal Year
2016
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
San Antonio, TX (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
143621 CFR 211.42(c)(10)(vi)Equipment to control conditions
144821 CFR 211.111Establishment of time limitations
145121 CFR 211.113(b)Procedures for sterile drug products
145221 CFR 211.113(b)Validation lacking for sterile drug products
191221 CFR 211.166(a)Written program not followed
193221 CFR 211.167(a)Sterility/pyrogen-free testing
202721 CFR 211.192Investigations of discrepancies, failures