# FDA 483 - QED, Inc. - April 11, 2025

Source: https://www.keypedia.com/records/483/qed-inc/59b9a4be-5909-4a24-8787-0c75fd32d7b7

> FDA 483 for QED, Inc. on April 11, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: QED, Inc.
- Inspection Date: 2025-04-11
- Product Type: device
- Office Name: Cincinnati District Office
- Summary: QED, Inc. in Lexington, KY, was inspected by the FDA from April 7-11, 2025, and received a Form 483 with two observations. The inspection revealed significant non-compliance regarding Unique Device Identification (UDI) requirements. Specifically, the firm failed to register several medical devices in the GUDID database and did not include UDIs on the labels of these devices.

## Related Documents

- [483 - 2020-02-26](https://www.keypedia.com/records/483/qed-inc/bf592b85-e7e2-4414-9d6c-fe1c1e3039ed)

## Related Officers

- [Talmane J. Fisher](https://www.keypedia.com/people/talmane-j-fisher/f69c101f-fbc7-4ca1-a6d1-1e25450c52b7)

Company: https://www.keypedia.com/companies/qed-inc/2dab8216-fd0e-4a0e-a75a-036796ec71ce

Office: https://www.keypedia.com/offices/cincinnati-district-office/b67a0c35-82e3-4176-9039-988378f65c22