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

Source: https://www.keypedia.com/records/483/sportarredo-group-s-c/0f240ca4-37cf-47ea-ba9a-4e3cc6649ec5

> FDA 483 for Sportarredo Group S. C. on December 19, 2024. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Sportarredo Group S. C.
- Inspection Date: 2024-12-19
- Product Type: device
- Office Name: Office of Inspections and Investigations
- Summary: 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.

## Related Officers

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Company: https://www.keypedia.com/companies/sportarredo-group-s-c/94136a04-dbaa-458b-bad9-405c7098dc10

Office: https://www.keypedia.com/offices/office-of-inspections-and-investigations/7dd0b904-a3df-46bc-a7b2-70ddb6f809c8