FDA Warns St. Jude Medical About Manufacturing and Quality Control Problems

FDA issues warning over cardiac defibrillator leads' manufacture.

The Wall Street Journal (1/15, Weaver, Subscription Publication, 2.29M) reports St. Jude Medical, in a regulatory filing Monday, said it had received a warning letter from the Food and Drug Administration about problems related to the manufacturing practices and quality-control methods used at its heart-rhythm unit in Sylmar, California, where its Durata defibrillator leads are manufactured. In the warning letter, the FDA says it will refrain from approving any new heart-device lines produced at the Sylmar facility until St. Jude provides documentation, showing it has corrected the problems adequately.

        According to the AP (1/15), St. Jude said in the regulatory filing that it is "working to correct the problems" at the California plant, and it "does not expect the citation to affect its financial results." The St. Paul, Minnesota-based medical device manufacturer also pointed out that FDA did not ask the company to "recall any products," and that the agency is allowing it to "continue manufacturing and shipping products" from the Sylmar facility.

        Bloomberg News (1/15, Edney, 1M) adds that FDA warning letter, which was dated Jan. 11, "doesn't affect its Durata cable used for defibrillators or any of the company's other medical products," St. Jude said in the SEC filing.

        Reuters (1/15) notes that in October, St. Jude issued a statement saying it was expecting the FDA warning letter after agency inspectors noted inconsistencies both in the way the company manufactured the defibrillators, and how it documented the production process at the Sylmar facility.

        The Minneapolis Star Tribune (1/15, Walsh, 335K) says FDA inspectors conducted the audit at the facility "from Sept. 25 to Oct. 17, 2012," after which, they promptly filed Form 483 detailing production violations, such as the "number of tests performed on Durata leads and the facility's record-keeping." Additionally, the Star Tribune notes that St. Jude "did not release a copy" of the Jan. 11 warning letter, and it is not yet available on the FDA's website, but spokesperson Sarah Clark-Lynn said it will be made public the next time the agency posts documents online.

        Meanwhile, Minnesota Public Radio (1/15, Moylan) on its website quotes Morningstar analyst Debbie Wang as saying, "We don't think this FDA warning letter is a big deal for St. Jude because the firm does not currently have any major products from the Sylmar facility awaiting regulatory approval." Wang also emphasized that the FDA did not include any safety-related concerns in the Jan. 11 warning letter; and she noted that St. Jude is presently, conducting business "as usual."