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483
•Sportarredo Group S. C.•December 19, 2024

Sportarredo Group S. C. – FDA 483, Dec 19, 2024

Record Details

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.

Company
Sportarredo Group S. C.
Inspection date
December 19, 2024
Product type
device
Office
Office of Inspections and Investigations
Person
  • Nabil Nakhoul
View Company Profile

ID · 0f240ca4-37cf-47ea-ba9a-4e3cc6649ec5

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