FDA 483 - Chattem Inc - March 13, 2020

Chattem Plant 1 in Chattanooga, TN, was inspected from March 9-13, 2020, and received one observation related to inadequate maintenance of equipment and utensils. The inspection found multiple instances of leaking equipment and dirty apparatus used in the manufacturing of OTC creams, ointments, lotions, and liquid products. This indicates a failure to prevent malfunctions that could impact drug product safety, identity, strength, quality, or purity.