FDA 483 - Rovi Pharma Industrial Services S.A. - June 02, 2023

An FDA inspection of Rovi Pharma Industrial Services S.A. in Alcala de Henares, Spain, revealed deficiencies in equipment cleaning, facility segregation, and reserve sample examination. The firm failed to adequately clean equipment between batches and ensure proper separation of manufacturing operations. Additionally, procedures for visually examining reserve samples for deterioration were found to be insufficient.