FDA 483 - Michigan Medicine - December 14, 2018

Michigan Medicine, a producer of sterile and non-sterile drug products in Ann Arbor, MI, was inspected by the FDA and cited for multiple deficiencies in aseptic processing. Observations included inadequate disinfection of materials, poor personnel practices, facility design issues affecting material flow, and insufficient use and documentation of sporicidal agents. These issues indicate a risk of contamination in their sterile drug production.