FDA 483 - Eurofarma Laboratorios S/A - September 20, 2022

Eurofarma Laboratorios S.A. in Itapevi, Brazil, a pharmaceutical drug manufacturer, was inspected and cited for significant deficiencies in aseptic processing, data integrity, and environmental controls. Observations included inadequate physical separation in critical aseptic areas, failure to follow procedures for preventing microbiological contamination, and lack of proper validation and audit trail review for electronic data systems. The firm also failed to provide adequate airflow pattern studies and maintain stability chambers in qualified configurations.