FDA 483 - INTUITY MEDICAL INC - May 19, 2022

An FDA inspection of INTUITY MEDICAL INC in Fremont, CA, revealed significant deficiencies in their quality system. The firm failed to establish and adequately implement procedures for receiving, reviewing, and evaluating complaints, leading to untimely complaint closures. Additionally, the company did not adequately establish or implement corrective and preventive action (CAPA) procedures, failing to initiate a CAPA despite known issues with complaint handling.