# FDA 483 - QED, Inc. - February 26, 2020

Source: https://www.globalkeysolutions.net/records/483/qed-inc/bf592b85-e7e2-4414-9d6c-fe1c1e3039ed

> FDA 483 for QED, Inc. on February 26, 2020. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: QED, Inc.
- Inspection Date: 2020-02-26
- Product Type: device
- Office Name: Cincinnati District Office
- Summary: QED, Inc., a medical device manufacturer in Lexington, KY, was cited for significant deficiencies in its quality system during an FDA inspection. The firm failed to adequately establish procedures for receiving, reviewing, and evaluating complaints. Additionally, records of complaint investigations were found to be incomplete, lacking required information.

## Related Documents

- [483 - 2025-04-11](https://www.globalkeysolutions.net/records/483/qed-inc/59b9a4be-5909-4a24-8787-0c75fd32d7b7)

## Related Officers

- [Shannon A. Gregory](https://www.globalkeysolutions.net/people/shannon-a-gregory/3e791321-dced-4e1d-89a1-3da91d577961)

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

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