FDA 483 - BSP Pharmaceuticals SpA - March 23, 2022

BSP Pharmaceuticals S.p.A. in Latina Scalo, Italy, was cited for significant deficiencies across its manufacturing operations. The inspection revealed issues with media fill program controls, inadequate complaint handling, improperly qualified equipment, and deficient control over electronic data and computerized systems. These observations indicate a lack of robust quality systems necessary for drug product manufacturing.