FDA 483 - Maguire Enterprises, Inc. - June 28, 2023

Maguire Enterprises, Inc., a medical device manufacturer in Sunrise, FL, was inspected by the FDA from June 26-28, 2023. The inspection revealed a significant issue regarding the labeling of their medical devices. Specifically, the firm's interconnect cables lacked the required unique device identifiers (UDI) on labels and packages.