FDA 483 - CoreRX Inc. - March 20, 2025

CoreRX Inc. in Clearwater, FL, a biologic drug manufacturer, was cited with six observations during an FDA inspection from March 12-20, 2025. The inspection revealed significant deficiencies in production and process controls, quality control unit procedures, equipment cleaning, discrepancy investigations, facility maintenance, and material storage. These issues indicate a lack of adherence to established written procedures and proper control over manufacturing operations.