FDA 483 - Cosmax USA, Inc. - March 17, 2020

Cosmax USA, Inc. in Solon, OH, an OTC drug manufacturer, was cited for significant deficiencies in its quality control unit, including inadequate investigations, lack of process validation, and insufficient stability testing for topical sunscreen drug products. The inspection revealed a systemic failure to adhere to cGMPs, impacting product quality, purity, and strength, and highlighting a lack of control over critical manufacturing processes and personnel training.