FDA 483 - Siegfried El Masnou, S.A. - July 11, 2025

Siegfried El Masnou, S.A., a sterile drug product manufacturer in El Masnou, Spain, was cited for significant deficiencies in its aseptic processing, quality control, and record-keeping practices. The inspection revealed inadequate validation of aseptic processes, insufficient cleaning and disinfection protocols, and a deficient environmental monitoring system. Additionally, batch production records were incomplete, and the quality control unit failed to consistently follow its own procedures, including operator re-certification.