FDA 483 - Abbott Diabetes Care, Inc. - December 04, 2017

An FDA inspection of Abbott Diabetes Care, Inc. in Alameda, CA, revealed inadequate procedures for receiving, reviewing, and evaluating complaints. The firm failed to adequately investigate an MDR-related complaint for a FreeStyle Libre Pro Flash Glucose Monitoring System Sensor, specifically by not reviewing Device History Records or testing retained product. This indicates a deficiency in their complaint management process for medical devices.