FDA 483 - Lucid Diagnostics, Inc. - March 21, 2022

An FDA inspection of Lucid Diagnostics, Inc. in Foxborough, MA, a medical device manufacturer, identified a significant issue with the firm's complaint handling procedures. Specifically, the company failed to adequately establish and follow procedures for receiving, reviewing, and evaluating complaints, leading to an insufficient investigation of an alleged EsoCheck balloon deflation problem. This indicates a deficiency in their quality system regarding post-market surveillance and complaint management.