FDA 483 - MANCHESTER VA MEDICAL CENTER - January 27, 2020

An FDA Form 483 was issued to Manchester VA Medical Center following an inspection from January 8-27, 2020. As a producer of sterile and non-sterile drug products, the facility received multiple observations indicating potential issues with maintaining drug quality and safety, under the Federal Food, Drug and Cosmetic Act. Key violations centered on environmental control and aseptic processing. The inspection revealed the use of non-sterile disinfecting agents, cleaning pads, and inadequate cleaning practices, including personnel's non-sterile gowning contacting sterile areas. Facility design issues allowed poor quality air into higher classified zones, evidenced by a lack of interlocking doors, simultaneous door openings, disabled pressure alarms, and suboptimal HVAC airflow. Furthermore, smoke studies intended to verify cleanroom airflow were insufficient. Other concerns included inadequate cleaning of dust-collecting surfaces like refrigerator tops, which were not routinely monitored. The firm also failed to adequately investigate actionable mold contamination found in an aseptic processing area and had unsealed or damaged ceiling tiles in cleanrooms. Additionally, drug production occurred concurrently with adjacent jackhammering construction without sufficient controls to prevent contamination from vibrations. Finally, non-microbial contamination, such as stained mixer parts and worn spatulas, was observed in non-sterile drug production areas. These observations highlight practices needing attention to ensure product integrity.