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

An FDA inspection of Drug Depot, LLC., operating as APS Pharmacy, a producer of sterile and non-sterile drug products, was conducted from June 6 to June 17, 2022. The inspection revealed several significant observations regarding aseptic processing and quality control, documented in an FDA Form 483.

Key issues included the presence of difficult-to-clean, particle-generating, and visibly dirty equipment, such as stained HEPA filters, within critical ISO 5 aseptic processing areas. Inspectors also observed personnel performing aseptic manipulations in a manner that blocked first-pass air around open sterile units and reaching directly over open vials, thereby increasing the risk of contamination. Rapid movements by staff near open sterile units were also noted, which could disrupt crucial airflow.

Furthermore, the firm's smoke studies were found to be inadequate, failing to sufficiently demonstrate unidirectional airflow within the ISO 5 zones, raising concerns about the integrity of the sterile environment. Finally, the inspection identified deficiencies in personnel monitoring, specifically citing improper contact plating techniques. These observations, issued under the Federal Food, Drug, and Cosmetic Act, indicate conditions where drug products may have been prepared or held under insanitary conditions. APS Pharmacy is expected to implement prompt corrective actions to address these findings.