1099150

Medoz Pharmacy of Polk Inc — FEI 3015316526

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
August 9, 2019
Fiscal Year
2019
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Davenport, FL (United States)

Citations

IDCFRDescription
18933FDCA 501(a)(2)(A)Vermin, production area
18934FDCA 501(a)(2)(A)Vermin, adjacent area
18938FDCA 501(a)(2)(A)Hazardous drugs, prevention of cross-contamination
18941FDCA 501(a)(2)(A)Improper gowning, contamination
18942FDCA 501(a)(2)(A)Personnel habits, contamination
18950FDCA 501(a)(2)(A)Personnel contact on container or closure
18956FDCA 501(a)(2)(A)Cleanliness, ISO-classified areas
18964FDCA 501(a)(2)(A)Unsealed HEPA filter, perimeter
18971FDCA 501(a)(2)(A)No sporicidal agents, cleanroom and ISO 5 area