Hunter Holmes McGuire Veterans Affairs Medical Center Mammography – FDA 483, Oct 25, 2016

During an inspection conducted from October 17 to October 25, 2016, the Food and Drug Administration (FDA) issued a Form 483 to Hunter Holmes McGuire Veterans Affairs Medical Center, a producer of sterile drug products. The inspection revealed significant observations regarding the facility's adherence to proper manufacturing practices, which are essential for product sterility and patient safety.Key issues identified included deficiencies in the system for monitoring and maintaining environmental conditions within aseptic processing areas. Specifically, the facility failed to monitor the differential pressure between the ISO 7 clean room and its corresponding anteroom, and air returns were improperly located outside the clean rooms.Further observations highlighted an inadequate system for cleaning and disinfecting these critical aseptic processing areas. The facility was found using non-sterile disinfectants for surfaces, vials, and container/closures, and non-sterile wipes were utilized for initial disinfection of work surfaces within ISO 5 hoods and for items introduced into these areas. These practices pose a risk to the sterility of drug products.In response to these findings, Hunter Holmes McGuire Veterans Affairs Medical Center is expected to promptly address these observations by implementing comprehensive corrective and preventive actions to ensure full compliance with regulatory standards for sterile drug manufacturing.