Medical device company Medtronic is facing scrutiny after the company revealed that the FDA sent it a warning about the “inadequacy of specific medical device quality systems” in its Northridge, Calif. facility. 

The company has pledged to remedy the issue by applying internal and external resources, and implementing corrective actions. However, what those resources and actions are were not disclosed. 

"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," Sean Salmon, executive vice president and president of the diabetes business at Medtronic, said in a statement. 

In a release, Medtronic said that patients and providers do not need to take any action at this time. 

According to Medtronic, the agency sent the letter after an inspection related to the recall of its MiniMed 600 and remote controller device for its MiniMed 508 and Paradigm pumps. 

WHY IT MATTERS 

Medtronic, a publicly traded company, saw its shares decline by 6% following the FDA warning letter, according to CNBC. During the company’s Q2 earnings call in November, it revealed that it beat its EPS by $0.03, but missed its revenue expectations by $136.46 million.

THE LARGER TREND 

This isn’t Medtronic’s first brush with the FDA. Earlier this year, the FDA announced that Medtronic recalled its MiniMed Insulin Pumps due to incorrect insulin dosing. Customers were given a replacement insulin pump as a result. 

In 2019, the FDA issued an alert stating that some insulin pumps from Medtronic were vulnerable to hackers who could remotely gain access to them. As a result, the company recalled its MiniMed 508 and MiniMed Paradigm series insulin pumps.