# FDA 483 - Myriad Medical, LLC - October 17, 2019

Source: https://www.globalkeysolutions.net/records/483/myriad-medical-llc/b5ec830e-a01c-4535-ad1a-4bbc60ae4e27

> FDA 483 for Myriad Medical, LLC on October 17, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Myriad Medical, LLC
- Inspection Date: 2019-10-17
- Product Type: device
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: An FDA inspection of Myriad Medical Llc, a medical device manufacturer in Tampa, FL, revealed significant deficiencies in their quality system. The firm failed to establish and implement adequate procedures for corrective and preventive actions, complaint handling, medical device reporting, supplier controls, and quality audits. Additionally, the design history file for their Prostate Caddy device lacked necessary validation and verification records, indicating a broad lack of compliance with regulatory requirements.

## Related Documents

- [483 - 2023-08-17](https://www.globalkeysolutions.net/records/483/myriad-medical-llc/d67d8988-8091-499a-a692-aaf4549176bf)

## Related Officers

- [Joshua J. Silvestri](https://www.globalkeysolutions.net/people/joshua-j-silvestri/433e29b3-ce5f-44d2-9984-7a6cb61e1824)

Company: https://www.globalkeysolutions.net/companies/myriad-medical-llc/0e456b7a-bb81-4651-a9e4-fe20b3016640

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