FDA 483 - CoreRX Inc. - March 06, 2020

An FDA inspection of CoreRX Inc., a contract manufacturer of prescription drugs in Clearwater, FL, revealed significant deficiencies in their quality systems, equipment qualification, and cleaning procedures. The firm failed to adequately investigate out-of-specification results, ensure equipment was properly designed and qualified, and establish sufficient procedures to prevent objectionable microorganisms. One critical observation regarding inadequate investigations was a repeat from a previous inspection.