FDA 483 - Illuminoss Medical Inc. - September 24, 2019

Illuminoss Medical, a medical device manufacturer in East Providence, RI, was cited for multiple quality system deficiencies during an FDA inspection. The observations primarily concern failures in Medical Device Reporting (MDR), control of nonconforming product, supplier qualification, equipment suitability, and complaint handling procedures. These issues indicate a lack of adequate controls to ensure product quality and compliance with regulatory requirements.