Conopco, Inc – FDA 483, Apr 6, 2022

An FDA inspection of Conopco, Inc. in Jefferson City, MO, revealed significant deficiencies in quality control practices for OTC drug manufacturing. Observations included failures to properly sample, test, and release components and drug product containers, inadequate laboratory controls for raw material identification, and a lack of annual visual examination of reserve samples for deterioration. These issues indicate a lack of adherence to good manufacturing practices.