Site Achieves “No Action Indicated” Status
CLEARWATER, FL, November 22, 2021, CoreRx is pleased to announce that the U.S. Food and Drug Administration (FDA) has issued their Establishment Inspection Report (EIR) for FEI registration number 3007209985, with the inspection status of NAI (No Action Indicated) following its most recent audit at its Clearwater facility in Florida.
The inspection took place between the 9th and 13th August 2021 and focused on a General GMP and two Pre-Approval Inspections (PAIs).
Christy Tobias, Head of Quality at CoreRx, commented ‘this inspection status by the FDA highlights CoreRx’s commitment to Quality. Our systems enable robust drug development and manufacturing for our clients and their patients globally. Our entire team is very proud of this outcome’.
CoreRx is a Contract Development Manufacturing Organization (CDMO) with capabilities to support clinical and commercial manufacturing needs, offering state of the art facilities to support customers’ supply chain needs. Our integrated offerings provide comprehensive services for the development, manufacturing, and testing of solid, liquid and semi-solid dosage forms.