FDA 483 - Ercros S.A. - November 22, 2024

Ercros Industrial S.A., a sterile drug substance manufacturer in Aranjuez, Spain, was cited for significant deficiencies in its aseptic processing, environmental monitoring, and quality control systems. The inspection revealed issues including inadequate continuous air monitoring, flawed aseptic process simulations, insufficient investigation of particle alarms and visible particles, and poor airflow studies. Additionally, the firm failed to prevent a deviated batch from release testing and lacked proper stability studies for intermediates and disinfection system validation.