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

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.