FDA 483 - Merchsource LLC - October 22, 2025

An FDA inspection of Merchsource LLC in Irvine, CA, from October 14-22, 2025, revealed significant deficiencies in their quality system as a medical device specification developer. The firm lacked adequately established procedures for complaint handling, corrective and preventive actions, device history records, design history files, and document control. These issues indicate a systemic failure to maintain proper documentation and control over their medical device processes.