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

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.