# FDA 483 - Photonic Health, LLC - March 24, 2022

Source: https://www.globalkeysolutions.net/records/483/photonic-health-llc/a1483f6e-e490-43d3-ade4-48415d799a9c

> FDA 483 for Photonic Health, LLC on March 24, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Photonic Health, LLC
- Inspection Date: 2022-03-24
- Product Type: device
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: Photonic Health, LLC, a medical device manufacturer in Ocala, FL, was inspected by the FDA from March 21-24, 2022. The inspection revealed significant deficiencies across multiple quality system areas, including inadequate procedures for design change, design validation, risk analysis, supplier management, acceptance activities, corrective and preventive actions, quality audits, and medical device reporting. Many of these issues were previously cited in a 2019 inspection and a 2020 letter, indicating a persistent lack of compliance.

## Related Documents

- [483 - 2019-05-17](https://www.globalkeysolutions.net/records/483/photonic-health-llc/e1bd2faa-bf7c-47de-94c3-a834d8653780)

## Related Officers

- [Brandon P. Thompson](https://www.globalkeysolutions.net/people/brandon-p-thompson/a4e7da4f-2e9c-497c-ae4c-9168a9678b91)
- [Joshua J. Silvestri](https://www.globalkeysolutions.net/people/joshua-j-silvestri/433e29b3-ce5f-44d2-9984-7a6cb61e1824)

Company: https://www.globalkeysolutions.net/companies/photonic-health-llc/17589ddb-a493-4947-921b-737b9878deed

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