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FDA Warns Abbott Device Manufacturing Plant in California By Zachary Brennan - Published 13 April 2017

The warning letter sent Wednesday from the US Food and Drug Administration (FDA) details four observations on failures related to corrective and preventive actions (CAPAs), controls, design verification and design validation.

Categories: News, US, FDA, Due Diligence, Medical Devices, Quality

Tags: warning letter, Abbott, St. Jude Medical, ICDs, CRT-Ds