FDA 483 - Illuminoss Medical Inc. - February 01, 2024

Illuminoss Medical Inc. in East Providence, RI, was inspected by the FDA from January 18 to February 1, 2024. The inspection revealed a significant issue with inadequate process validation for the Light Fiber Inspection System, which is used to test components of their Class II medical device. Specifically, the firm failed to adequately document data, rationale, and settings for this critical inspection process.