Medtronic warning letter regarding insulin pump

DUBLIN, Dec. 15, 2021 /PRNewswire/ -- Medtronic pic (NYSE:MDT) today announced it received a warning letter from the U.S. Food and Drug Administration (FDA) on December 9 for the company's Northridge, California, facility, the headquarters for its Diabetes Business. The warning letter was issued following an inspection that concluded in July 2021 related to recalls of the MiniMed™ 600 series insulin infusion pump, and a remote controller device for MiniMed™ 508 and Paradigm™ pumps.

The warning letter focuses on the inadequacy of specific medical device quality system requirements at the Northridge facility in the areas of risk assessment, corrective and preventive action, complaint handling, device recalls, and reporting of adverse events.

"We are committed to fully resolving all observations as effectively and quickly as possible. Nothing is more important to us than providing the highest quality products to people living with diabetes," said Sean Salmon, executive vice president and president of the Diabetes business at Medtronic.

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