Simplifying Global Compliance
The QMN Weekly Bulletin
Quality / Medical Devices
Incoming Inspection Issues Cited in Warning to Finnish Devicemaker
Feb. 28, 2014
Mega Electronics, maker of the FemiScan Home Trainer incontinence device and the ME6000 biomonitor device, received an FDA warning letter for incoming inspection shortfalls and other quality issues. During an Aug. 26-29 inspection of its Kuopio, Finland, plant, the devicemaker did not have a rationale for the sample size it chose for incoming inspections.
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