FDA 483 - Reko Dental LLC dba MDC Dental - March 21, 2023
Discuss this record with AI
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.
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.
ID · fa719d67-a2ab-4cb4-922c-213a907dd25b