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

The FDA inspected Manchester VA Medical Center, a producer of sterile and non-sterile drug products, and identified significant deficiencies. Observations included non-sterile cleaning agents and practices in aseptic processing areas, inadequate facility design leading to poor air quality, and insufficient environmental monitoring. These issues collectively indicate a lack of control over the manufacturing environment, posing risks to product quality and patient safety.