FDA 483 - US Hyperbaric Network LLC - May 06, 2025
Discuss this record with AI
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.
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.
ID · 796742d9-45d7-4fe3-90e6-b96539f724df