FDA 483 - Merits Health Products, Inc. - February 27, 2025

Merits Health Products, Inc. in Fort Myers, FL, was cited for significant deficiencies in its quality system during an FDA inspection. The firm failed to adequately establish and implement procedures for corrective and preventive actions (CAPA) and for receiving, reviewing, and evaluating complaints. Additionally, the firm did not identify and report complaints that were reportable under Medical Device Reporting regulations, specifically concerning malfunctioning powered wheelchair seats.