BSP Pharmaceuticals SpA – FDA 483, Sep 8, 2026

BSP Pharmaceuticals SpA in Latina, Italy, was cited for significant deficiencies in aseptic processing and contamination control during the manufacture of sterile drug products. The inspection revealed inadequate procedures to prevent microbiological contamination, poor aseptic practices by operators, and insufficient environmental monitoring. These issues pose a high risk to the sterility and quality of the firm's sterile drug products.