FDA 483 - PN Medical, Inc. - October 17, 2019

FX Medical, Inc., a medical device specification developer located in Cocoa Beach, FL, was cited by the FDA for inadequate procedures related to purchasing controls. The inspection revealed deficiencies in the firm's supplier evaluation reports and a failure to conduct required on-site audits of contract manufacturers. These issues indicate a lack of established processes to ensure that purchased products and services meet specified quality requirements.