Bloomberg the Company

Bloomberg Anywhere Login

Bloomberg

Connecting decision makers to a dynamic network of information, people and ideas, Bloomberg quickly and accurately delivers business and financial information, news and insight around the world.

Company

Financial Products

Enterprise Products

Media

Customer Support

  • Americas

    +1 212 318 2000

  • Europe, Middle East, & Africa

    +44 20 7330 7500

  • Asia Pacific

    +65 6212 1000

Follow Us

Industry Products

Medtronic Gets FDA Warning Letter for Colorado Plant

Don't Miss Out —
Follow us on:

June 29 (Bloomberg) -- 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.

To contact the reporter on this story: David Olmos in San Francisco at dolmos@bloomberg.net.

To contact the editor responsible for this story: Reg Gale at Rgale5@bloomberg.net

Please upgrade your Browser

Your browser is out-of-date. Please download one of these excellent browsers:

Chrome, Firefox, Safari, Opera or Internet Explorer.