FDA 483 - J&T Health and Wellness LLC - October 18, 2023

J&T Health and Wellness LLC, a manufacturer of tanning devices in Saint Petersburg, FL, was cited for multiple significant deficiencies in its quality system. The inspection revealed inadequate procedures and implementation across critical areas such as design change control, complaint handling, corrective and preventive actions, risk analysis, nonconforming product control, equipment calibration, device history records, and software validation. These issues indicate a systemic failure to ensure the safety and quality of their medical devices.