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1149996

New Vitalis Pharmacy LLC — FEI 3014391500

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
August 27, 2021
Fiscal Year
2021
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Louisville, KY (United States)

Facility

Other inspections at this facility

  • 1065457 (VAI Fri Sep 07 2018 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
18934FDCA 501(a)(2)(A)Vermin, adjacent area
18936FDCA 501(a)(2)(A)Non-microbial contamination, production 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
18949FDCA 501(a)(2)(A)First pass air blockage, open unit with sterile product
18964FDCA 501(a)(2)(A)Unsealed HEPA filter, perimeter