FDA 483 - Nomax Inc - February 01, 2018

Nomax, Inc. in Saint Louis, Missouri, was inspected by the FDA from January 23 to February 1, 2018, as a human drug manufacturer. The inspection revealed significant issues related to equipment cleaning and maintenance, as well as inadequate procedures for the annual visual examination of reserve drug product samples for deterioration. These findings indicate a moderate level of non-compliance with good manufacturing practices.