483
Bridge to LifeFDA 483 - Bridge to Life - June 27, 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.
Record Details
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.
- Office
- Atlanta District Office
- Person
Open in Dashboard
ID · 485aa24f-1647-4be4-881f-4666da16ae9b