# FDA 483 - RS Medical - February 27, 2020

Source: https://www.keypedia.com/records/483/rs-medical/bf2dffcb-f936-4e95-9c11-1d892759a351

> FDA 483 for RS Medical on February 27, 2020. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: RS Medical
- Inspection Date: 2020-02-27
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - West VI
- Summary: International Rehabilitative Sciences, Inc. in Vancouver, WA, a manufacturer of Class I and Class II medical devices, was inspected by the FDA from February 24-27, 2020. The inspection revealed significant deficiencies in the firm's quality system, primarily concerning the inadequate establishment and implementation of various procedures. Observations included issues with document control, device history records, complaint handling, nonconforming product control, and corrective and preventive actions.

## Related Officers

- [investigator](https://www.keypedia.com/people/christopher-s-genther/e71df42c-9adf-4a78-93e5-c364dcc06b35)
- [Investigator](https://www.keypedia.com/people/alexandria-l-capuano/f76c710a-613f-42b2-8958-1292fa329112)

Company: https://www.keypedia.com/companies/rs-medical/4fbbbeb8-3f03-4a08-a8de-eabbb5a1fc90

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-west-vi/6e5a2a08-f464-4979-a759-7b0383370822