FDA 483 - Procos S.p.A. - February 22, 2016

During an inspection of Procos S.p.A., a pharmaceutical API manufacturer in Cameri, Italy, the FDA observed significant deficiencies in computerized system controls. The firm failed to maintain data integrity on its Empower-3 system, with audit trails disabled for numerous project folders and unauthorized deletion of HPLC projects. These issues raise concerns about the reliability of data used for product release and stability studies.