Medtronic plc reported in a press release that they 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 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.
To ensure the most effective response to the warning letter, Medtronic will apply resources from across the company and utilize external experts. The company is implementing a range of corrective actions and process improvements related to the observations and will continue reviewing these actions with the FDA.
Medtronic is not recommending any action by patients or their healthcare providers as a result of this warning letter.
