FDA 483 - União QuÍmica Farmacêutica Nacional SA - August 09, 2023

An FDA inspection of Inovat Industria Farmaceutica Ltda., a sterile drug manufacturer in Guarulhos, Sao Paulo, Brazil, revealed significant deficiencies. The firm's complaint handling procedures were found to be inadequate, failing to ensure proper quality unit review and investigation of product failures. Additionally, the company lacked established control procedures to monitor manufacturing output and validate process performance, specifically regarding unchallenged yield specifications and uninvestigated out-of-specification results for US-market products.