Quality Systems, Management Issues Garner Warning to Ultrasound Maker

January 4, 2013
Reports of poor quality system compliance practices triggered a warning letter for ultrasound maker Parks Medical Electronics. The nine-observation letter, issued by the FDA’s Seattle district office, followed a July 30 to Aug. 17 inspection of the Aloha, Ore., company, which concluded with a 10-observation Form 483.
Devices & Diagnostics Letter