Medtronic said it has received a warning letter from the U.S. Food and Drug Administration (FDA) for the company's Northridge, CA, facility, which is the headquarters for the company’s diabetes business.
The warning letter was issued following an inspection by the FDA that concluded in July 2021 and was related to recalls of the MiniMed 600 series insulin infusion pump, and a remote controller device for MiniMed 508 and Paradigm pumps.
Medtronic said 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.”
The company also said it "is implementing a range of corrective actions and process improvements related to the observations and will continue reviewing these actions with the FDA.”
In addition to insulin pump systems, the company also markets a continuous glucose monitoring system, a smart insulin pen, and other products.