FDA 483 - BSP Pharmaceuticals SpA - February 29, 2024

During an inspection conducted from February 19-23 and 26-29, 2024, the U.S. Food and Drug Administration (FDA) issued a Form 483 to BSP Pharmaceuticals S.p.A. in Latina Scalo, Italy. The inspection revealed two significant observations concerning the firm's manufacturing practices related to aseptic processing.

Firstly, the FDA noted inadequate personnel monitoring during critical operations in Grade A Restricted Access Barrier Systems (RABS). Specifically, air operators involved in introducing packaged and bagged sterile components into the filling line were not being monitored via finger dab plates for these high-risk activities, raising concerns about maintaining aseptic conditions.

Secondly, the inspection found that indirect product contact surfaces used in aseptic drug product filling operations were not consistently sterile. An example cited was the use of a merely sanitized, rather than sterile, transfer chute for loading sterile stoppers into sterile bags, which compromises the sterility assurance of drug product components.

These observations highlight deviations from regulatory expectations for aseptic processing, which are crucial for ensuring drug product quality and patient safety. BSP Pharmaceuticals S.p.A. is required to thoroughly investigate these issues, implement effective corrective and preventive actions, and respond to the FDA to address the noted deficiencies and demonstrate compliance with current Good Manufacturing Practices.