FDA 483 - Reko Dental LLC dba MDC Dental - March 21, 2023

Reko Dental LLC dba MDC Dental in Gardena, CA, was inspected as a Complaint File Establishment. The inspection revealed significant deficiencies in the firm's complaint handling system, including a lack of written procedures, no quality agreement with its international manufacturing site regarding complaint responsibilities, and no complaint log. These issues indicate a failure to adequately establish and maintain a system for receiving, reviewing, and evaluating complaints.