U.S. health regulator flags concerns at Medtronic’s diabetes business

Signage is seen outside of the Food and Drug Administration (FDA) headquarters in White Oak, Maryland, U.S., August 29, 2020. REUTERS/Andrew Kelly

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Dec 15 (Reuters) – The U.S. health regulator has issued a warning letter to Medtronic Plc (MDT.N) highlighting certain concerns related to medical device quality management at its diabetes business, the company said on Wednesday.

Medtronic’s shares were down 6% at $104.95 in early trading, hitting their lowest in over a year.

The Food and Drug Administration’s (FDA) letter focused on inadequacies in areas including risk assessment, complaint handling and device recalls at Medtronic’s facility in Northridge, California, the company said.

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The company is speedily addressing the FDA’s concerns and reviewing its actions with the agency, it added.

Medtronic, in a filing, said it did not expect an…

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