Abbott Diabetes Care, Inc.December 4, 2017

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

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Record Details

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.

Company: Abbott Diabetes Care, Inc.
Inspection Date: December 4, 2017
Product Type: Device
Office: Division of Human and Animal Food Operations - West V
Person: Quynh Strandberg (Regulatory Review Officer)

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ID · 5e5fee94-c995-44a4-896a-f44017b5bc8e