FDA 483 - Qualgen LLC - September 13, 2018

Qualgen LLC, an outsourcing facility in Edmond, OK, was inspected from August 8 to September 13, 2018, and received nine observations. The inspection revealed significant deficiencies in quality control, aseptic processing, facility maintenance, and laboratory controls, including repeat observations related to investigation failures and facility conditions. These issues indicate a lack of adherence to good manufacturing practices and a potential risk to drug product quality and sterility.