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

Source: https://www.keypedia.com/records/483/electro-connect-inc/a1d55a7c-a3ec-4300-b44d-d8c9b0a677d9

> FDA 483 for Electro-Connect, Inc. on May 01, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Electro-Connect, Inc.
- Inspection Date: 2025-05-01
- Product Type: device
- Office Name: Minneapolis District Office
- Summary: 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.

## Related Officers

- [Shawn Choi](https://www.keypedia.com/people/shawn-choi/77845db3-46a3-4d0f-b94c-428bc251c0dc)

Company: https://www.keypedia.com/companies/electro-connect-inc/af2d3ac7-ab68-46cf-9f2e-e606012fb841

Office: https://www.keypedia.com/offices/minneapolis-district-office/c79fc8dc-f884-48fc-ba80-2947f662511d