Davion Inc – FDA 483, May 15, 2019

Davion Inc. in Newark, NJ, a contract manufacturer, was inspected and cited for significant quality system deficiencies. Observations included failures to follow quality control unit procedures, such as inadequate documentation for annual drug product reviews and change control, and not adhering to written cleaning and maintenance procedures for manufacturing equipment. Additionally, the firm lacked proper temperature and humidity monitoring in its warehouse for drug product storage.