# FDA 483 - J&T Health and Wellness LLC - July 30, 2021

Source: https://www.keypedia.com/records/483/jt-health-and-wellness-llc/2ebd9ed2-6672-4312-a38b-7886280d66ca

> FDA 483 for J&T Health and Wellness LLC on July 30, 2021. Product: device. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: J&T Health and Wellness LLC
- Inspection Date: 2021-07-30
- Product Type: device
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: An FDA inspection of ProSun International, LLC, a medical device and electronic product manufacturer in Saint Petersburg, FL, revealed significant deficiencies across its quality system. The firm failed to adequately establish and implement procedures for corrective and preventive actions, documentation control, training, equipment calibration, and environmental controls. These issues led to concerns regarding product quality, including the use of incorrect UV lamps and potential over-exposure risks for tanning bed devices.

## Related Documents

- [483 - 2023-10-18](https://www.keypedia.com/records/483/jt-health-and-wellness-llc/e7d7a8d8-2577-40ca-8d9c-cf9106d7dcd1)

## Related Officers

- [Recall Coordinator](https://www.keypedia.com/people/emma-schaefer/10299982-dce6-4fea-a3e9-8167030b0331)
- [Joshua J. Silvestri](https://www.keypedia.com/people/joshua-j-silvestri/433e29b3-ce5f-44d2-9984-7a6cb61e1824)

Company: https://www.keypedia.com/companies/jt-health-and-wellness-llc/97f71881-c9be-41f6-81e5-59d568b453bf

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