FDA 483 - Italfarmaco S.A. - September 15, 2023

An FDA inspection of Italfarmaco S.A. in Alcobendas, Madrid, Spain, revealed that the firm's quality control unit failed to fully follow its responsibilities and procedures. This included inadequate analytical method transfer for a drug product, where an unqualified standard was used for release testing, and an insufficient deviation investigation that failed to ensure the use of a USP-certified standard. These issues indicate significant deficiencies in quality control and analytical testing practices.