FDA Warns Swedish IVD Manufacturer
By Zachary Brennan -
Published 10 October 2017
The US Food and Drug Administration (FDA) on Tuesday released a warning letter sent 20 September to Malmo, Sweden-based Euro Diagnostica AB, which manufactures multiple class II in vitro diagnostic (IVD) devices.
Categories: News, Europe, US, CDRH, Compliance, Due Diligence, In vitro diagnostics, Medical Devices, Quality
Tags: FDA warning letters, IVD manufacturer warning letter, Euro Diagnostica