FDA 483 - CoreRX Inc. - February 26, 2026

CoreRX Inc. DBA Bend Bioscience, a contract drug manufacturer in Clearwater, FL, was inspected and cited for seven observations. The inspection revealed significant deficiencies in production and process controls, component testing, environmental monitoring, facility maintenance, and computer system controls. These issues indicate a lack of adequate procedures and scientific justification to ensure drug product quality and integrity.