Maguire Enterprises, Inc.June 28, 2023

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

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Record Details

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.

Company: Maguire Enterprises, Inc.
Inspection Date: June 28, 2023
Product Type: Device
Office: Office of Medical Device and Radiological Health Division II
Person: Dianiris C. Ayala

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