FDA 483 - Unknown Company - March 24, 2017

An FDA inspection conducted from March 20-24, 2017, at Hartley Medical Center Pharmacy, Incorporated, a producer of sterile drug products, identified two significant observations detailed in a Form FDA 483. The first observation noted that equipment was not adequately disinfected before entering aseptic processing areas. Specifically, a repeater pump used for dispensing drug stocks was moved between the ISO-7 Anteroom and the ISO-6 IV Clean Room as needed, without prior disinfection, raising concerns about potential contamination risks in critical sterile environments. Secondly, the inspection found issues with the cleanliness and integrity of surfaces within ISO-classified areas. It was observed that gaps in the emergency exit double doors of the ISO-6 IV room were sealed with tape that was either worn or not fully maintaining its seal. This condition could compromise the crucial environmental control and integrity of the ISO-6 room, which is vital for sterile product manufacturing. These observations indicate potential deviations from established sterile compounding practices designed to ensure product quality and patient safety. While the FDA 483 itself is not a final determination of non-compliance, it necessitates that Hartley Medical Center Pharmacy address these identified issues by implementing appropriate corrective and preventive actions to ensure compliance with regulatory standards for sterile drug production.