FDA 483 - Drug Depot, LLC., dba APS Pharmacy - June 17, 2022

An FDA inspection of Drug Depot, LLC., dba APS Pharmacy in Palm Harbor, FL, a producer of sterile and non-sterile drug products, revealed significant deficiencies in aseptic processing and environmental controls. Observations included dirty equipment in ISO 5 areas, improper aseptic techniques, disrupted airflow due to personnel movements, inadequate smoke studies, and insufficient personnel monitoring. These conditions raise serious concerns regarding the sterility and quality of drug products manufactured at the facility.