FDA 483 - Laboratorios Farmaceuticos Rovi S. A. - May 19, 2023

Laboratorios Farmaceuticos Rovi S. A. in Madrid, Spain, a sterile drug manufacturer, was cited for significant deficiencies in its aseptic processing, quality control, and laboratory operations. The inspection revealed inadequate procedures for preventing microbiological contamination, insufficient validation of aseptic and sterilization processes, and a lack of robust controls for visual inspection and investigations. These issues indicate a systemic failure to ensure the sterility, quality, and purity of drug products.