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St. jude Medical Inc. 从粮食与药物管理局收到警告信

Joan Trombetti, Writer | April 24, 2009
Safire ablation catheter
A warning letter from the Food and Drug Administration was sent to St. Jude Medical Inc., a maker of medical devices, because of problems at a Minnesota manufacturing plant.

The FDA found faulty record-keeping at the company that makes Safire ablation catheters, according to a disclosure filed with the Securities and Exchange Commission. The surgical devices use heat to destroy diseased or damaged tissue and correct irregular heartbeats.

St. Jude Medical says the devices contributed $6 million in worldwide sales last year, or just half a percent of its $1.1 billion in total revenue.

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FDA inspectors visited the site multiple times in December and issued the warning to the company just recently.

The FDA will not approve new devices to be manufactured at the plant until the company fixes the problems, and St. Jude says it has taken steps to correct them and has shared this information with the FDA.

Chief Executive Dan Starks said Wednesday the warning letter is "embarrassing," but would not affect the rollout of any new products.