FDA 483 - ENABLE BIOSCIENCES - October 17, 2024

ENABLE BIOSCIENCES in South San Francisco, CA, was inspected by the FDA from October 15-17, 2024. The inspection revealed that the firm has not established procedures for receiving, reviewing, and evaluating complaints for its Class II diagnostic product, a test for type I diabetes mellitus, which has been distributed since August 2022. This indicates a significant lapse in quality system controls for a medical device.