Medtronic wraps up response to FDA warning letter over quality issues at diabetes HQ

Nearly a year-and-a-half after receiving a warning letter from the FDA detailing a list of quality control issues at the Los Angeles-area headquarters of its diabetes business, Medtronic said it has finally resolved all of the regulator’s concerns.

The medtech giant announced the news Tuesday. It noted in the company release that all restrictions the FDA had imposed since issuing the December 2021 letter have been lifted, thanks to a host of both remedial and more proactive actions that Medtronic has taken to address the agency’s concerns and further improve its quality control operations.

“We’re very thankful to the agency for working with us so collaboratively to ensure we’re able to work as quickly as possible to address the needs of the diabetes community,” Que Dallara, president of the diabetes business and an executive VP at Medtronic, said in the announcement.

“Clearing this latest regulatory milestone allows us to focus on what’s most important—delivering innovations that address unmet needs for the individuals with diabetes we have the privilege to serve,” Dallara continued. “It’s an honor that we never take for granted, and our commitment is to ensure we’re putting patients first and prioritizing safety and quality above all.”

The letter, which was issued Dec. 9, 2021, came after an inspection the FDA had conducted of the Northridge, California, facility the previous July—which in turn had been sparked by a pair of Class I recalls in 2018 and 2019 concerning Medtronic’s MiniMed insulin pumps and controllers.

The FDA grouped its many concerns with the facility’s operations under four main umbrellas. The letter accused Medtronic of failing to put necessary procedures for corrective and preventive actions into place; to review, evaluate or investigate hundreds of complaints regarding a component of some MiniMed pumps; to report to the FDA a serious injury associated with one of its devices within 30 days of becoming aware of the complaint; and to report to the regulator that such an injury is likely to happen again if the same or a similar device malfunctions again.

In a December 2021 response, Medtronic pledged to “apply resources from across the company and utilize external experts” to resolve all of the listed issues.

The warning letter—and its associated regulatory restrictions—created a sizable roadblock in Medtronic’s diabetes business.

Perhaps most heavily affected was its MiniMed 780G pump, which the company had submitted for FDA approval in the spring of 2021, nearly a year after it had already received CE mark approval in Europe. It wasn’t until this month that the FDA finally signed off on the insulin pump, long after Medtronic had warned that the warning letter could delay the approval.

With that long-awaited green light now secured, Medtronic said it will begin rolling out the newest MiniMed system later this summer.