TAKA USA, INC. – FDA 483, Feb 7, 2023

TAKA USA, INC. dba Cosmetic Innovations, a contract manufacturer in Coppell, TX, was cited with nine observations during an FDA inspection, indicating significant deficiencies across its manufacturing and quality control systems for OTC drug products. The firm failed to ensure proper product release testing, lacked process validation, maintained incomplete batch records, and had inadequate laboratory controls and employee training. These findings highlight a broad non-compliance with current good manufacturing practices.