FDA warning letter cites quality-system and injury-reporting failures for Galaxy bronchoscopes

Noah Medical/Galaxy

After inspecting Noah's San Jose site in late 2024, the FDA found Galaxy scopes and accessories adulterated because manufacturing controls fell short of good practice. It also cited the company for reporting serious patient injuries late or not at all. A warning letter does not halt sales but requires fixes the FDA must accept.

• Inspection ran 28 October to 26 November 2024 at 2075 Zanker Road, San Jose.
• Gaps cited: corrective actions, complaint investigations (including bleeding and collapsed-lung cases), design validation, shelf-life sterility testing.
• Two serious injury complaints were reported late or not reported.
• The written adverse-event reporting procedure lacked key definitions.