FDA 483 - Sportarredo Group S. C. - December 19, 2024

An FDA inspection of Sportarredo Group S. C., a manufacturer of tanning beds located in Gruaro, Venice, Italy, identified one significant observation. The firm failed to adequately maintain device history records, specifically by not including or referring to UV radiation warning labels and recommended exposure schedules for multiple tanning bed units. This indicates a deficiency in their quality system for device documentation.