www.fdanews.com/articles/192648-washington-manufacturer-cited-for-missing-mdr-procedure
Washington Manufacturer Cited for Missing MDR Procedure
September 9, 2019
Seattle-based Elite Performance and Learning Center was hit with a Form 483 by the FDA, scolding the company for lacking a documented medical device reporting (MDR) procedure.
During an agency inspection, the investigator noted that the firm could not provide documentation to show it had developed a medical device reporting procedure.
Additionally, the firm didn’t have a documented complaint handling procedure in place for receiving, reviewing, managing and evaluating complaints.