The U.S. health regulator has issued a warning letter to Medtronic Plc, highlighting certain concerns related to medical device quality management at its diabetes business, the company said on Wednesday. Medtronic’s shares were down 6 percent 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. 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 impact to its third-quarter or full-year 2022 adjusted profit outlook issued previously. However, at the diabetes unit, it has forecast a decline in organic revenue citing uncertainty on timing of U.S. product approvals, among other things. For the unit, it expects a decline in the high-single …
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