FDA 483 - Michigan Medicine - December 14, 2018

An FDA inspection of Michigan Medicine, a producer of sterile and non-sterile drug products, was conducted from December 3 to December 14, 2018. The inspection resulted in an FDA Form 483, detailing significant observations related to the firm's adherence to regulatory expectations for drug manufacturing. Key issues primarily concerned aseptic processing and environmental control. Violations included the inadequate disinfection of materials, such as product labels and pens, prior to their entry into aseptic areas, with labels observed contacting the floor. Personnel practices were also cited, including rapid movements that disrupted controlled airflow, forceful handling of items within sterile hoods, and instances of exposed skin, hair, and non-sterile gown contact with aseptic work surfaces. Additionally, the facility's design allowed for poor material flow, with components entering ISO 7 buffer rooms directly from unclassified areas. Finally, the use of sporicidal agents in cleanrooms and ISO 5 aseptic processing areas was found to be inadequate, lacking proper documentation and consistent application after procedures like smoke studies. Michigan Medicine is expected to implement prompt and comprehensive corrective actions to address these observations and ensure compliance with good manufacturing practices, thereby safeguarding drug product quality and patient safety.