FDA 483 - Renalytix AI, Inc. - April 11, 2025

An FDA inspection of Renalytix AI, Inc. in New York, NY, identified two significant issues. The firm's complaint management procedures were found to be inadequate, specifically lacking mention of uniform and timely complaint processing. Additionally, the company had not implemented written Medical Device Reporting (MDR) procedures and could not provide proof of an active Electronic Submission Gateway account for electronic MDR submissions.