FDA 483 - União QuÍmica Farmacêutica Nacional SA - August 06, 2018

Inovai Industria Farmaceutica Ltda., a sterile veterinary drug product manufacturer in Villa Saint Anna Guarulhos, Sao Paulo, Brazil, was cited for two significant observations. The inspection revealed failures in establishing and following procedures to prevent microbiological contamination of sterile drug products, particularly concerning media fills and environmental monitoring. Additionally, the firm failed to consistently follow written production and process control procedures, as evidenced by undocumented interventions during media fill studies.