# FDA 483 - R-Med Inc - April 23, 2025

Source: https://www.keypedia.com/records/483/r-med-inc/6106af55-2623-4fb5-a832-7e75fa78a123

> FDA 483 for R-Med Inc on April 23, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: R-Med Inc
- Inspection Date: 2025-04-23
- Product Type: device
- Office Name: Cincinnati District Office
- Summary: R-Med Inc, a medical device manufacturer in Oregon, OH, was inspected by the FDA and received 10 observations, all of which were repeat observations from a previous inspection. The inspection revealed significant deficiencies across multiple quality system areas, including inadequate complaint handling, control of nonconforming product, missing design and device history records, insufficient risk analysis, and a complete lack of quality audits and management reviews. These findings indicate severe and persistent non-compliance with quality system regulations.

## Related Documents

- [483 - 2018-02-23](https://www.keypedia.com/records/483/r-med-inc/3d97d299-86cc-4dbd-bddf-f824714e3451)

## Related Officers

- [Amber M. Capello-Jones](https://www.keypedia.com/people/amber-m-capello-jones/d34f92a0-d580-4028-9d31-c6cd7c13ce0f)

Company: https://www.keypedia.com/companies/r-med-inc/0e1c6a92-86dd-4fa7-a842-82b8e7d86718

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