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Medtronic Receives FDA Warning Letter Over Recalled Insulin Pump

December 17, 2021

Medtronic has received a warning letter from the FDA for the company's Northridge, Calif.-based diabetes business.

The warning letter followed an FDA inspection that concluded in July relating to recalls of the company’s MiniMed 600 series insulin infusion pump and a remote controller device for its MiniMed 508 and Paradigm pumps.

The warning letter focused on medical device quality system requirements at the Northridge facility in the areas of risk assessment, corrective and preventive actions, complaint handling, device recalls and reporting of adverse events, the company said.

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