FDA 483 - Cardiocommand Inc. - December 09, 2022

Cardiocommand Inc. in Tampa, FL, a medical device manufacturer, received one FDA Form 483 observation following an inspection. The observation cited the firm for failing to adequately establish procedures to ensure purchased products and services conform to specified requirements. Specifically, the firm did not ensure its supplier of tubing for 1600 Octapolar TapCath catheters had completed adequate process validation.