FDA 483 - Electro-Connect, Inc. - May 01, 2025

An FDA inspection of Electro-Connect, Inc. in Milwaukee, WI, revealed a significant compliance issue regarding medical device labeling. The firm's (b)(4) device, identified as a Class II medical device, lacked a unique device identifier (UDI) on its labeling and was not registered in the Global Unique Device Identifier Database (GUDID). Furthermore, the firm shipped numerous prototypes of this device without a UDI since 2013 and failed to perform recalls or corrections after reclassifying the device.