FDA 483 - Rovi Pharma Industrial Services S.A. - September 22, 2023

Rovi Pharma Industrial Services S.a. in San Sebastian De Los Reyes, Madrid, a sterile manufacturer, received a Form 483 with two observations. The inspection revealed significant issues with quality control, specifically regarding the thorough review of unexplained discrepancies and out-of-specification results. Additionally, the firm's procedures for cleaning and maintaining equipment were found to be deficient, leading to potential contamination risks.