FDA 483 - VHA Office of Advanced Manufacturing - Ft Lawton - January 23, 2025

VHA Office of Advanced Manufacturing - Ft. Lawton, a manufacturer of medical devices including the Class II VHA Radiotherapy Bolus, was inspected and cited for significant quality system deficiencies. Observations included inadequate documentation of corrective and preventive actions, failures in complaint handling procedures, and insufficient supplier and internal quality audit processes. These issues indicate a lack of adherence to established quality system requirements and internal procedures.