FDA Warns Medtronic Unit Over Handling Of User Complaints

Law360, Washington (August 21, 2012, 5:59 PM EDT) -- Medtronic Inc.'s neuromodulation unit was hit with a warning letter from the U.S. Food and Drug Administration that was made public Tuesday over issues stemming from the company's complaint handling processes and risk mitigation plans.

The FDA's letter, dated July 17, listed several issues with Medtronic's ability to receive and process customer complaints, saying the company failed to transfer information from initial calls to its written records and that it needs to retrain and re-evaluate its efforts in order to create a complaint system.

The agency...
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