FDA EIR - Rentschler Biopharma Inc. - January 17, 2025

An FDA surveillance inspection of Rentschler Biopharma Inc. in Milford, MA, was conducted from January 7-17, 2025, in accordance with Compliance Program 7356.002M and ICH Q7A guidance. The inspection focused on the contract manufacturing of therapeutic bulk drug substances. The inspection concluded with a 5-item Form FDA-483 issued to company management, identifying significant deficiencies. Main violations included a failure to exercise sufficient controls over computerized systems, leading to unauthorized data access or changes, incomplete data integrity remediation protocols, and inadequate retention of original GMP data. The firm also lacked adequate written procedures for cleaning equipment and its release for use, and procedures to prevent microbial contamination were found to be insufficient, particularly concerning unvalidated changes in sporicidal disinfection practices. Other issues involved failures in recording quality-related activities at the time of performance and the quality unit's adherence to its own procedures for alarm evaluations. Rentschler Biopharma Inc. management has committed to providing a written response to the Form FDA-483 observations and proposed a corrective action plan (CAPA) to address the incomplete data integrity remediation efforts.