www.fdanews.com/articles/162112-incoming-inspection-slips-lead-to-warning-for-finnish-devicemaker

Incoming Inspection Slips Lead to Warning for Finnish Devicemaker

January 31, 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.
Devices & Diagnostics Letter