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FDA halts production of some medical devices

A series of products manufactured by a medical device manufacturer named Sybaritic Inc. have come under scrutiny after reports alleging that they were not cleared for approval by the U.S. Food and Drug Administration (FDA). Sybaritic makes medical products for skin and spa treatments and has agreed to stop production of the product in the United States until they are in compliance with FDA quality standards. While the company did not agree with the FDA allegations, they stated that they are cooperating with the FDA to resolve the issues raised in its complaint. The stop production agreement came after a consent decree reached between the U.S. Department of Justice and three of the medical device manufacturer’s top executives. The U.S. Department of Justice filed for an injunction last year and has said that companies need to comply with laws that are in place to protect consumer health from dangerous products.

Click here to read more about the FDA issues with some medical devices.