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

Source: https://www.globalkeysolutions.net/records/483/drf-medical-group-inc/aaeee740-5754-4b58-b6e2-eb4215adda3c

> FDA 483 for DRF 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: DRF Medical Group Inc
- Inspection Date: 2015-09-24
- Product Type: device
- Office Name: Cincinnati District Office
- Summary: DRF Medical Group Inc in Louisville, KY was inspected from September 22-24, 2015. The inspection revealed a significant deficiency in the firm's quality system, specifically the absence of established and implemented procedures for corrective and preventive actions (CAPA). This indicates a fundamental weakness in addressing and preventing quality problems related to products and the quality system.

## 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/drf-medical-group-inc/016beaae-b46d-43a3-a00f-41f153695f15

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