# FDA 483 - DRE Medical Group Inc - February 21, 2019

Source: https://www.globalkeysolutions.net/records/483/dre-medical-group-inc/0587f253-d548-4f36-92bd-42f3ffc7f3f0

> FDA 483 for DRE Medical Group Inc on February 21, 2019. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: DRE Medical Group Inc
- Inspection Date: 2019-02-21
- Product Type: other
- Office Name: Cincinnati District Office
- Summary: An FDA inspection of DRB Medical Group Inc in Louisville, KY, conducted from February 12-21, 2019, identified a significant issue regarding the firm's complaint handling system. The inspection revealed that records of complaint investigations lacked required information, specifically inadequate documentation of investigation activities. This indicates a deficiency in the firm's quality system pertaining to complaint management.

## Related Documents

- [483 - 2015-09-24](https://www.globalkeysolutions.net/records/483/dre-medical-group-inc/9cb5d93d-d332-44af-96f7-daa0e21e2001)

## Related Officers

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

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