FDA Warns Medtronic Over Manufacturing Guideline Violations

The Food and Drug Administration (FDA) warned device maker Medtronic that some of its medical devices violated manufacturing and quality rules that could lead to patient injuries.

The FDA warning letter dated July 17 said violations included Medtronic’s failure to establish adequate procedures for corrective and preventative action and for receiving and evaluating complaints, according to Reuters.

The agency also concluded that the company’s response to the issues was insufficient and asked it to take immediate action to address the violations or face regulatory action.

The FDA also said it will not approve any device that belongs to the device class related to the violations until corrective actions are taken, according to Reuters. 

If you or a loved one has been harmed by an unsafe medical device, contact Sokolove Law for a free legal consultation and to find out if a product liability lawyermay be able to help you. For legal assistance, please call 800-581-6358.

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