Medtronic Inc., the world’s largest medical device maker, said it received a warning letter from U.S. regulators about reporting requirements and handling of complaints at its Louisville, Colorado, plant.
The warning letter followed a Food and Drug Administration inspection of Medtronic’s Surgical Technologies plant in Colorado in January and February, Medtronic spokesman Brian Henry said today in an e-mail. The FDA cited “internal procedures for design controls, complaint handling and medical device reporting,” among other issues, Henry said.
Minneapolis-based Medtronic has responded in writing to the FDA’s letter, Henry said. The Surgical Technologies unit makes hardware and software for use during surgical procedures, according to Medtronic’s website. The warning letter is not publicly available, Erica Jefferson, an FDA spokeswoman, said in an e-mail.
“We are working diligently to respond to the FDA on all issues and to ensure any additional actions necessary to resolve the concerns are in place as quickly as possible,” Henry said in the e-mail.
Medtronic disclosed the FDA action in a regulatory filing.
The company’s shares declined 66 cents, or 1.8 percent, to $36.21 at 4 p.m. in New York Stock Exchange composite trading. Medtronic has dropped 18 percent this year.