FDA 483 - Rovi Pharma Industrial Services S.A. - June 20, 2022

Rovi Pharma Industrial Services S.A., a sterile drug manufacturer in San Sebastian De Los Reyes, Spain, was inspected by the FDA from June 6-20, 2022. The inspection revealed significant deficiencies in quality control, including a failure to investigate numerous out-of-specification and out-of-trend results, inadequate aseptic processing controls, and poorly designed equipment. The firm's Quality Unit was found to not be fully following its responsibilities and procedures, indicating a systemic breakdown in quality assurance for sterile drug products.