FDA 483 - CosMedical Technologies, LLC - March 22, 2019

Cosmedical Technologies, LLC, an OTC drug repacker and relabeler in Davie, FL, received a Form 483 with three observations. The firm failed to establish the reliability of supplier analyses for components and lacked strict control over drug product labeling operations. Additionally, employees were not provided with documented training in current good manufacturing practices for repacked and relabeled OTC drug products.