# FDA 483 - US Hyperbaric Network LLC - May 06, 2025

Source: https://www.globalkeysolutions.net/records/483/us-hyperbaric-network-llc/796742d9-45d7-4fe3-90e6-b96539f724df

> FDA 483 for US Hyperbaric Network LLC on May 06, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: US Hyperbaric Network LLC
- Inspection Date: 2025-05-06
- Product Type: device
- Office Name: Florida District Office
- Summary: US Hyperbaric Network LLC in Sunrise, FL, a spec developer for Hyperbaric Chamber devices, was cited with two observations during an FDA inspection. The firm failed to establish a design history file demonstrating design development per 21 CFR 820 and did not maintain a complete device history record in accordance with the device master record. These deficiencies indicate significant issues with quality system documentation and control over their contract manufacturing processes.

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/ronald-ifraimov/b4ce8b79-3fa2-4862-b7a4-68e14e45d87a)

Company: https://www.globalkeysolutions.net/companies/us-hyperbaric-network-llc/6482e0c1-453f-4781-a47a-f60d1d8ab790

Office: https://www.globalkeysolutions.net/offices/florida-district-office/95b2a118-0b78-46e0-a54c-982bd7ce51c9