# FDA 483 - DRE Medical Group Inc - September 24, 2015

Source: https://www.globalkeysolutions.net/records/483/dre-medical-group-inc/9cb5d93d-d332-44af-96f7-daa0e21e2001

> FDA 483 for DRE Medical Group Inc on September 24, 2015. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: DRE Medical Group Inc
- Inspection Date: 2015-09-24
- Product Type: device
- Office Name: Cincinnati District Office
- Summary: DRE Medical Group Inc, a device refurbisher, relabeler, and initial importer in Louisville, KY, was cited for significant deficiencies in its quality system. The inspection revealed a complete lack of established procedures for corrective and preventive actions, management reviews, and quality audits. These findings indicate a fundamental breakdown in the firm's quality management processes.

## Related Documents

- [483 - 2019-02-21](https://www.globalkeysolutions.net/records/483/dre-medical-group-inc/0587f253-d548-4f36-92bd-42f3ffc7f3f0)

## Related Officers

- [Consumer Safety Officer, Medical Device Specialist](https://www.globalkeysolutions.net/people/teresa-kastner/32a8d75e-770d-48cc-80e0-2eb5ad57e560)

Company: https://www.globalkeysolutions.net/companies/dre-medical-group-inc/e50ac3a0-76b3-4f86-b6a2-aa89f3216212

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