Following a series of current good manufacturing practice (cGMP) violations, the U.S. Food & Drug Administration (FDA) has entered a consent decree to shut down two Pennsylvania dietary supplement companies. The injunction was filed in November 2011 against ATF Fitness Products Inc., Manufacturing ATF Dedicated Excellence, Inc. (MADE), and James G. Vercellotti, owner and operator of both establishments. The FDA’s action was the first of its kind to be taken against a large dietary supplement company for failure to comply with cGMPs.
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What’s the problem?
March 16, 2012 – This week, the Justice Department announced that the United States has entered a consent decree against James G. Vercellotti to shut down his businesses until federal health regulators can reinspect the establishments and determine that they no longer violate the Food, Drug and Cosmetic Act (FDCA).
“Almost by definition, consumers purchase dietary supplements to enhance and improve their health,” said Stuart Delery, acting assistant general for the Civil Division. “The Department of Justice took this action because consumers must, at the very least, be assured that they are buying what they think they are buying, and that the products are safe.”
FDA inspectors found numerous cGMP violations with Vercellotti’s businesses, including:
- failure to clean manufacturing equipment;
- failure to maintain proper records concerning the ingredients of the supplements;
- failure to label products correctly;
- failure to notify the FDA of possible adverse events involving consumers who used the defendants’ supplements.
“Through this consent decree, we will ensure that the public is protected from purchasing and consuming tainted supplements and misbranded products,” said David Hickton, U.S. Attorney for the Western District of Pennsylvania.
Federal health regulators have noted a history of violations against both ATF Fitness Products and MADE dating back to 2011. As a result of the cumulative violations, the Justice Department filed suit, seeking a permanent injunction against Vercellotti and his companies.
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Free Dietary Supplement Lawsuit Evaluation: If you or a loved one has been injured by a dietary supplement, you should contact our law firm immediately. You may be entitled to compensation by filing a dietary supplement injury suit and we can help.