FDA issues warning letter to Medtronic diabetes business
Medtronic said that it has been issued a warning letter from the US Food and Drug Administration (FDA) for its facility in Northridge, California, which serves as the headquarters for its diabetes business.
The warning letter is the result of an inspection concluded by the FDA in July 2021 pertaining to recalls of the MiniMed 600 series insulin infusion pump, and a remote controller device for MiniMed 508 and Paradigm pumps.
According to Medtronic, the FDA warning letter is focused on the lack of specific medical device quality system requirements at the Northridge facility with respect to risk assessment, complaint handling, corrective and preventive action, recalls of device, and adverse events reporting.
Sean Salmon — executive vice president and president of Medtronic Diabetes business said: “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.”
Medtronic said it will apply resources from across the company as well as use external experts for ensuring the most effective response to the FDA warning letter. The medical device company will put into force a variety of corrective actions and improvements in processes related to the FDA observations, and will continue reviewing the measures with the regulator.