Categorized | Product Safety

FDA’S patience with St. Jude Medical grows thin

In continuing coverage, the New York Times (1/16, B2, Meier, Subscription Publication, 1.68M) reports that the Food and Drug Administration “on Tuesday released a sharply worded warning letter to St. Jude Medical, in which it said it might soon fine or take other actions against the company for failing to address agency concerns” about the manufacturing practices the medical device company uses to produce its Durata defibrillator leads. In the warning letter, dated Jan. 10, the agency said that St. Jude had “failed to address a variety of concerns about the component” that were noted during an audit by FDA inspectors at the company’s heart-rhythm unit in Sylmar, California. In a Jan. 11 SEC filing, St. Jude indicated that it was “giving the highest priority to fully remediating” the FDA’s concerns. But the Times says that wording in the FDA warning letter suggests the agency is running out of “patience with St. Jude.”

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