# FDA 483 - R-Med Inc - February 23, 2018

Source: https://www.keypedia.com/records/483/r-med-inc/3d97d299-86cc-4dbd-bddf-f824714e3451

> FDA 483 for R-Med Inc on February 23, 2018. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: R-Med Inc
- Inspection Date: 2018-02-23
- Product Type: device
- Office Name: Division of Pharmaceutical Quality Operations III
- Summary: R-Med Inc. in Oregon, OH, a medical device manufacturer, was inspected and received 11 observations. The inspection revealed significant deficiencies across its quality system, including inadequate control of nonconforming product, poor complaint handling, and a complete lack of design history files, risk analysis, device history records, and device master records for its disposable plugs. The firm also lacked established procedures for design changes, incoming product acceptance, statistical techniques, quality audits, and management reviews, indicating a pervasive failure to maintain a suitable and effective quality system.

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## Related Officers

- [David J. Gasparovich](https://www.keypedia.com/people/david-j-gasparovich/478888db-d4b3-481a-89f5-ee234a160f07)

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

Office: https://www.keypedia.com/offices/division-of-pharmaceutical-quality-operations-iii/45bc2d0d-d731-4955-aeb5-59aa0b76e4f0