# FDA 483 - RUA Medical (Irvine) - October 18, 2018

Source: https://www.globalkeysolutions.net/records/483/rua-medical-irvine/76c3d9db-49cf-40dd-9e27-b979da667f7b

> FDA 483 for RUA Medical (Irvine) on October 18, 2018. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: RUA Medical (Irvine)
- Inspection Date: 2018-10-18
- Product Type: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: RUA Medical (Irvine) received a Form FDA 483 following an inspection from October 15-18, 2018. The inspection identified one observation concerning the firm's quality audit procedures. Specifically, the procedures were not adequately established to evaluate the effectiveness of the quality system, including record completeness, accuracy, and review processes.

## Related Documents

- [483 - 2018-10-18](https://www.globalkeysolutions.net/records/483/rua-medical-irvine/908686ff-0ec1-43ae-9e08-238b21ff4f2c)

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/john-a-sciacchitano/9f8f49bf-1971-449e-972e-b516418ea78e)

Company: https://www.globalkeysolutions.net/companies/rua-medical-irvine/71f77a45-4f96-4cdf-90a2-7eda4cb96bb1

Office: https://www.globalkeysolutions.net/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd