FDA 483 - US Merchandise LLC - June 28, 2023

An FDA inspection of US Merchandise LLC, an initial importer in Westbury, NY, revealed two significant observations related to the lack of established written procedures. The firm failed to develop written Medical Device Report (MDR) procedures and also lacked procedures for receiving, reviewing, and evaluating customer complaints. These findings indicate a fundamental deficiency in the firm's quality system regarding post-market surveillance and complaint handling.