FDA 483 - Remel Cleveland, a Division of Remel Inc. - February 03, 2025

Remel Inc. in Oakwood Village, OH, a medical device software manufacturer, was inspected by the FDA. The inspection revealed significant deficiencies in the firm's corrective and preventive action (CAPA) system, particularly concerning the incomplete analysis and inadequate description of cause codes for complaint data. Additionally, the firm's product risk management was found to be inadequate, with outdated risk analysis documents and discrepancies in assigning potential severity levels for identified harms related to their medical device software.