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.

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