UPDATE 2-Medtronic gets FDA warning letter after inspection
* FDA inspection was at Mounds View, Minn., facility
* Medtronic to answer warning letter in 15 days
* Has taken some actions to address FDA concerns
* Shares down 51 cents to $39.69 (Adds detail, updates shares)
CHICAGO, Nov 18 (Reuters) - Medtronic Inc. (MDT.N) confirmed on Wednesday it had received a warning letter from U.S. health regulators calling for corrective actions based on an inspection of its Mounds View, Minnesota, facility, the headquarters of its cardiac rhythm management (CRM) business, the company's largest unit.
The letter from the Food and Drug Administration comes in the wake of problems Medtronic has had with its leads that are used with implantable cardioverter defibrillators, known as ICDs.
The FDA issued the warning letter after it completed its inspection of the facility in August.
A spokesman said the letter addressed, among other things, corrective and preventive action, a review and documentation of field action recommendations, supplier qualification and controls, and medical device reporting timeliness.
The company, which competes with St. Jude Medical (STJ.N) and Boston Scientific (BSX.N) in the CRM market, said it will respond to the letter within 15 days, as required.
Medtronic said the FDA noted in its letter that the company's promised corrective actions appeared to be adequate to resolve the issues raised in the letter.
The company added that it has already begun to implement changes and put procedures in place related to each of the observations cited during the inspection, and additional actions that may be required will be in place as quickly as possible.
Medtronic has plants that make CRM products in Arizona, Puerto Rico and Switzerland. It also manufactures components in the Minnesota and will soon open a manufacturing facility in Singapore.
Medtronic shares were off 51 cents, or 1.27 percent, at $39.69 in morning New York Stock Exchange trading. (Reporting by Debra Sherman; Editing by Lisa Von Ahn, Dave Zimmerman, Gunna Dickson)
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