TAKA USA, INC. – FDA 483, Jun 6, 2019

TANO USA, INC. dba Cosmetic Innovations in Carrollton, TX, a contract manufacturer of OTC human topical drug products, was cited with seven observations during an FDA inspection. The firm lacked written procedures for its Quality Control Unit, failed to conduct finished product testing for identity and strength of active ingredients, and did not have a written stability testing program or adequate process validation studies. Additionally, deficiencies were noted in batch production records, cleaning validation, and the testing of active pharmaceutical ingredient components.