Medtronic has received a warning letter from the FDA that details issues found during a recent inspection of the company’s diabetes headquarters.
FDA representatives finished inspecting the facility—located in Northridge, California—in July 2021. The inspection was part of the agency’s response to past recalls of Medtronic’s MiniMed 600 series insulin infusion pump and a remote controller for the MiniMed 508 and Paradigm pumps.
The letter highlighted specific issues related to how the Northridge facility handles risk assessment, corrective and preventive action, complaint handling, device recalls and the reporting of adverse events. Medtronic has said it will use significant company resources to correct these issues and work closely with the FDA.
“We are committed to fully resolving all observations as effectively and quickly as possible,” Sean Salmon, executive vice president and president of Medtronic’s diabetes business, said in a prepared statement. “Nothing is more important to us than providing the highest quality products to people living with diabetes.”
Medtronic has said that patients and healthcare providers do not need to take any actions at this time.
The company’s stock immediately began to drop once news spread of the warning letter; it is down 6.9% at the time of this writing.
Michael has more than 16 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.