FDA 483 - União QuÍmica Farmacêutica Nacional SA - December 11, 2012

An FDA inspection of Laboratorios Pfizer Ltda in Guarulhos, Brazil, revealed that procedures to prevent microbiological contamination of sterile drug products are not adequately established. Specifically, the firm's air flow pattern testing (smoke studies) for the filling room was found to be insufficient, failing to accurately represent conditions during equipment assembly with multiple operators. This inadequacy may lead to an incomplete understanding of contamination risks and improper identification of environmental monitoring locations.