# FDA 483 - Sunshine USA, LLC - August 17, 2023

Source: https://www.keypedia.com/records/483/sunshine-usa-llc/0f253985-8276-453b-b0c5-99c447b8ebf8

> FDA 483 for Sunshine USA, LLC on August 17, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Sunshine USA, LLC
- Inspection Date: 2023-08-17
- Product Type: device
- Office Name: New Orleans District Office
- Summary: An FDA inspection of Sunshine USA, LLC, a manufacturer of suntan beds in Kingsport, TN, revealed significant deficiencies in their quality management system. Observations included the absence of device master records, inadequate device history records, and failures in quality auditing, equipment calibration, training procedures, and complaint handling processes.

## Related Documents

- [483 - 2025-04-28](https://www.keypedia.com/records/483/sunshine-usa-llc/63adf5ff-3890-4001-b17f-0167a61026eb)

## Related Officers

- [Benjamin E. Bowen](https://www.keypedia.com/people/benjamin-e-bowen/7fdc5755-0d5d-45c9-93a0-3cb928156c1d)

Company: https://www.keypedia.com/companies/sunshine-usa-llc/4724638f-82f9-4efc-b8ca-eafefada4cf8

Office: https://www.keypedia.com/offices/new-orleans-district-office/95352142-b992-4e06-849d-d7483c0959ea