FDA 483 - Laboratorios Farmaceuticos Rovi S.A. - June 29, 2022

An FDA inspection of Laboratorios Farmaceuticos Rovi S.A.'s chemical and physical testing laboratory in Alcala De Henares, Madrid, Spain, revealed significant deficiencies. The firm's quality control unit failed to follow written procedures for out-of-specification investigations, maintain data integrity, and control laboratory documentation. Additionally, the inspection found inadequate performance qualification procedures and execution for critical laboratory equipment.