Incoming Inspection Issues Cited in Warning to Finnish Devicemaker

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.
The GMP Letter