FDA 483 - MassBiologics - December 18, 2025

An FDA inspection of MassBiologics, a Gene Therapy Testing Lab in Boston, revealed a significant deficiency regarding written procedures. The firm failed to establish and follow written procedures for annual evaluations, including reviews of complaints, recalls, and investigations for each drug product. Specifically, quality indicator reports for Kebilidi manufacturing lacked proper documentation and visual representation of drug product batch release data trends.