FDA 483 - Ercros S.A. - December 14, 2018

Ercros S.A., an active pharmaceutical manufacturer in Aranjuez (Madrid), was inspected by the FDA from December 10-14, 2018. The inspection revealed significant deficiencies across multiple areas, including inadequate investigations into out-of-specification results, insufficient process and rework validation, and issues with equipment cleaning, control system validation, and laboratory procedures. These observations indicate a need for comprehensive improvements in quality control and manufacturing practices.