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Medical Devices / Inspections and Audits

Ultrasound Medical Devices Falls Short on Managing Complaints

Aug. 30, 2018

An FDA inspection in May found that Ann Arbor, Mich.-based Ultrasound Medical Devices had not established procedures for receiving, reviewing and evaluating complaints.

“Your firm had not evaluated any customer service communications you have received since May 1, 2016,” the agency said, noting that during the inspection, the firm’s management investigated several service tickets, 11 of which were customer complaints tagged as “routine support/maintenance.”

None of the reports were forwarded to the quality manager or dealt with in a timely manner, the FDA said. The 483 report noted that some complaints were logged up to four months after they were received.

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