FDA 483 - BSP Pharmaceuticals SpA

An FDA inspection of BSP Pharmaceuticals S.p.A. in Latina Scalo LT, Italy, a drug substance and drug product manufacturing facility, revealed significant issues. Observations included discrepancies between facility documentation and actual operations, inadequate pressure monitoring during drug product manufacturing, and an insufficient procedure for handling out-of-specification results. These findings indicate deficiencies in quality control and manufacturing process oversight.