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Washington Manufacturer Cited for Missing MDR Procedure
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.
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