# FDA 483 - Photonic Health, LLC - May 17, 2019

Source: https://www.keypedia.com/records/483/photonic-health-llc/e1bd2faa-bf7c-47de-94c3-a834d8653780

> FDA 483 for Photonic Health, LLC on May 17, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Photonic Health, LLC
- Inspection Date: 2019-05-17
- Product Type: device
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: PHONONIC HEALTH, LLC, a medical device specification developer in Ocala, FL, was cited for numerous quality system deficiencies during an FDA inspection. The observations primarily concern inadequate procedures and documentation related to design controls, purchasing, acceptance activities, corrective and preventive actions, complaint handling, and quality audits. The firm also lacked documented design risk analysis and written Medical Device Reporting (MDR) procedures.

## Related Documents

- [483 - 2022-03-24](https://www.keypedia.com/records/483/photonic-health-llc/a1483f6e-e490-43d3-ade4-48415d799a9c)

## Related Officers

- [Principal ](https://www.keypedia.com/people/richard-k-vogel/3ddd8bff-24fd-40ee-b0a7-fb5333a520f5)

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

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