FDA 483 - Luminelle Inc - February 21, 2023

Luminelle Inc. in Raleigh, NC, was inspected by the FDA, revealing significant deficiencies in its quality system for medical devices. The inspection found failures in medical device reporting, complaint handling, risk analysis, design verification, supplier management, management review, and personnel training. These issues indicate a systemic breakdown in ensuring the safety and effectiveness of their Luminelle DTx Hysteroscopy/Cystoscopy System.