FDA 483 - Iridex Corporation - September 20, 2023

Iridex Corporation, a medical device manufacturer in Mountain View, CA, was cited for significant deficiencies in its complaint handling, corrective and preventive action (CAPA) system, and adverse event reporting. The inspection revealed failures to investigate complaints, conduct proper complaint trending, and ensure complete and timely submission of MEDWATCH reports, indicating a systemic breakdown in quality system processes.