CUPRON PERFORMANCE ADDITIVES, INC. – FDA 483, Sep 19, 2019

Cupron Inc. in Richmond, VA, was inspected by the FDA, revealing a significant deficiency in its complaint handling system. The firm failed to establish proper procedures for receiving, reviewing, and evaluating complaints related to its patient gowns, bed sheets, and blankets. This indicates a lack of a formally designated unit and established processes for managing product complaints.