Medtronic Gets FDA Warning Letter Over Facility Issue

By Matt Grossman

Medtronic PLC received a warning letter from the Food and Drug Administration after a facility inspection earlier this year, the company said Wednesday.

The letter focused on inadequacy in specific medical device quality system requirements at a facility in Northridge, Calif., that is the headquarters for Medtronic's diabetes business. The letter cited concerns around risk assessment, corrective and preventive action, complaint handling, device recalls, and reporting of adverse events, Medtronic said.

"We are committed to fully resolving all observations as effectively and quickly as possible," Sean Salmon, president of Medtronic's diabetes business, said.

The FDA inspection, in July, was related to recalls of Medtronic diabetes devices.

Medtronic said patients and healthcare providers don't need to take any action because of the letter.

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(END) Dow Jones Newswires

12-15-21 0723ET