# FDA 483 - Klyo Medical Systems, Inc. - July 18, 2019

Source: https://www.keypedia.com/records/483/klyo-medical-systems-inc/a5f4e97f-4d6e-4f7f-8da3-4ced9232c3a3

> FDA 483 for Klyo Medical Systems, Inc. on July 18, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Klyo Medical Systems, Inc.
- Inspection Date: 2019-07-18
- Product Type: device
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: Klyn, Medical Systems, Inc. in Doral, FL, a medical device manufacturer, was cited for two observations during an FDA inspection. The firm failed to maintain adequate written Medical Device Reporting (MDR) procedures to ensure all reportable events are submitted to the FDA. Additionally, their quality audit procedures were not adequately established, specifically regarding the scope of internal audits to cover all applicable areas and demonstrate compliance with 21 CFR Part 820.

## Related Officers

- [investigator](https://www.keypedia.com/people/stanley-b-eugene/4708f43e-0592-4c24-b276-d9f9092788a3)

Company: https://www.keypedia.com/companies/klyo-medical-systems-inc/17f5a5d9-8b48-4aef-9f40-8fb97f002f35

Office: https://www.keypedia.com/offices/office-of-medical-device-and-radiological-health-division-ii/ae9bd439-479a-420d-9dd8-9fe1fc0863d6