FDA EIR - Rentschler Biopharma SE - February 15, 2022

An FDA inspection of Rentschler Biopharma SE in Laupheim, Germany, was conducted from February 7 to February 15, 2022. This inspection, which focused on quality, facility and equipment, production, materials, and laboratory control systems for drug substance manufacturing, revealed significant deviations from regulatory expectations. The U.S. Food and Drug Administration issued a 9-item Form FDA 483 to the company, detailing critical issues.

Main violations included a lack of controlled specifications for drug substance dispensing processes, unidentified discoloration in cleaned manufacturing equipment without formal risk assessment, and insufficient laboratory procedures to ensure compliance. The inspection also found inadequate control over a drug substance excipient, unvalidated equipment and facility systems, and poor control of rejected materials within the SAP system. Additionally, the company lacked an adequate system for monitoring environmental conditions of critical process equipment, showed inadequate maintenance of facilities and equipment, and failed to consistently follow manufacturing procedural controls.

The regulatory framework implies adherence to Good Manufacturing Practices under FDA oversight for drug manufacturing. The required action from the FDA is a "withhold" recommendation, pending the firm's adequate response to these objectionable conditions. Rentschler Biopharma SE must implement comprehensive corrective actions and provide a satisfactory response to address these regulatory deficiencies.