FDA 483 - Laboratorios Farmaceuticos Rovi S. A. - June 27, 2022

An FDA inspection of Laboratorios Farmaceuticos Rovi S. A. in Madrid, Spain, revealed significant deficiencies in sterile drug manufacturing. The firm failed to adequately investigate unexplained discrepancies and out-of-specification results, did not follow procedures to prevent microbiological contamination, and used equipment not of appropriate design. Additionally, the quality control unit's responsibilities were not fully followed, particularly regarding the review of contract manufacturer data, indicating serious concerns for product quality and safety.