FDA 483 - CoreRX Inc. - March 20, 2025
Discuss this record with AI
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.
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.
ID · edfc4c2a-ac55-4dee-8c2f-122fff2c1404