TAKA USA, INC. – FDA 483, Sep 27, 2021

TAKA USA, INC. dba Cosmetic Innovations in Coppell, TX, an OTC drug manufacturer, was inspected by the FDA from September 20-27, 2021. The inspection revealed significant deficiencies across multiple systems, including a lack of personnel training, inadequate quality control unit procedures, and insufficient testing and process validation for OTC drug products. These issues indicate a broad failure to adhere to current good manufacturing practices.