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

Ercros S.A., an active pharmaceutical manufacturer in Aranjuez (Madrid), was cited for significant deficiencies in quality unit operations, process validation, and equipment control during an FDA inspection. Observations included inadequate investigations into out-of-specification results, insufficient process and control system validation, and failures in equipment cleaning and calibration. These issues collectively indicate a lack of robust quality control and adherence to established procedures.