# FDA 483 - Bridge to Life - June 27, 2025

Source: https://www.keypedia.com/records/483/bridge-to-life/485aa24f-1647-4be4-881f-4666da16ae9b

> FDA 483 for Bridge to Life on June 27, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Bridge to Life
- Inspection Date: 2025-06-27
- Product Type: device
- Office Name: Atlanta District Office
- Summary: An FDA inspection of Bridge to Life, a specification developer in Columbia, SC, identified one significant observation. The firm failed to perform design validation under actual or simulated use conditions for its (b)(4) cold storage solution, a Class II medical device. This indicates a deficiency in their design control processes.

## Related Officers

- [Gamal A. Norton](https://www.keypedia.com/people/gamal-a-norton/6b52c9e6-d579-4994-81ee-e734eb1f0a67)

Company: https://www.keypedia.com/companies/bridge-to-life/dc442340-5037-45f6-92e9-9e9d3d9cdc12

Office: https://www.keypedia.com/offices/atlanta-district-office/7586d99a-288e-49d1-8c3d-d88b7354b7a7