FDA 483 - Dougherty's Pharmacy - July 01, 2019

An FDA inspection of Dougherty's Pharmacy, a producer of sterile and non-sterile drugs, was conducted from June 19 to July 1, 2019. The inspection resulted in several significant observations highlighting concerns with the facility's manufacturing controls and aseptic processing.Key findings included the production of drugs while construction was ongoing in an adjacent area, lacking adequate contamination prevention measures. Inspectors noted exposed wires, missing ceiling tiles, and construction materials openly visible to critical processing environments, posing a risk of airborne contaminants to the unclassified lab and ISO7 cleanrooms.Furthermore, poor aseptic technique was observed, specifically a sterile technician placing non-sterile covered forearms and wrists into an ISO5 biological safety cabinet during the processing of sterile drugs. This practice directly jeopardizes the sterility of manufactured products.Lastly, the firm failed to conduct media fill studies that accurately simulate worst-case or challenging conditions for aseptic production. Current procedures did not adequately qualify technicians for larger batch sizes, exceeding the maximum vials per batch for which they were assessed. This raises concerns about the robustness of their sterile manufacturing processes.These observations indicate a need for Dougherty's Pharmacy to implement comprehensive corrective actions to address identified deficiencies in environmental control, personnel aseptic practices, and process validation to ensure compliance with quality standards for drug production.