FDA 483 - World Merchant Inc. dba Orthoextent - April 16, 2025

An FDA inspection of World Merchant Inc. dba Orthoextent in Broadlands, VA, revealed significant and repeated deficiencies in its quality system for medical devices. The firm failed to establish and implement critical procedures for medical device reporting, complaints, purchasing, nonconformance, CAPA, distribution, and storage, many of which were promised after a previous inspection. Additionally, the company failed to ensure its medical device labels bore unique device identifiers (UDI) and did not provide required UDI information to the Global Unique Device Identification Database (GUDID).