FDA 483 - CoreRX Inc. - March 20, 2025

CoreRX Inc. in Clearwater, FL, a biologic drug manufacturer, received a Form 483 with six observations highlighting significant deficiencies in their manufacturing operations. Issues include inadequate written procedures for production controls, insufficient investigation of discrepancies, poor equipment cleaning and facility maintenance, and failures in quality control unit procedures and material storage. These findings indicate a lack of robust controls to ensure drug product quality and integrity.