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CGMP

Court Issues Injunction after FDA Warning Letter Issues Persist

On January 16th 2015, a California dietary supplement manufacturer, Health One Pharmaceuticals, Inc., was ordered to stop sales of its…

Dietary Supplement Company Prohibited from Operations After Ignoring FDA Warning Letter

On August 8, 2014, the U.S. Food and Drug Administration ("FDA") obtained a court order from the United States District…

Permanent Injunction Sought after Cheese Manufacturer Fails to Respond to FDA Warning Letter

On August 8, 2014, the U.S. Food and Drug Administration ("FDA") filed a Complaint for Permanent Injunction against a Michigan…

FDA Seeks Permanent Injunction against Oregon Dietary Supplement Company

On October 21, 2013, the U.S. Food and Drug Administration (“FDA”) announced that it is seeking a permanent injunction against…

FDA Publishes Overview of Regulatory Requirements for Food Businesses

On June 19, 2013, as part of Small Business Week, the U.S. Food and Drug Administration (FDA) published “How to…

Marshals Seize Supplements with Undeclared Drug Ingredients

On February 14, 2013, U.S. Marshals, acting on behalf of the U.S. Food and Drug Administration (FDA), raided the headquarters…

FDA Enjoins Beverage Maker’s Operations until it Complies with the FDCA

On January 25, 2013, the U.S. Food and Drug Administration (“FDA”) announced that it has entered into a consent decree…

FDA Proposes New Unique Identifier System for Medical Devices

On July 3, 2012, the U.S. Food and Drug Administration (“FDA”) announced its intention to require most medical devices in…

FDA Expands Use of Device to Detect both Viral and Bacterial Causes of Respiratory Infection

On May 15, 2012, the U.S. Food and Drug Administration (“FDA”) announced the clearance of expanded uses for the FilmArray…

FDA Explains its Regulation of Bottled Water

Recently, the U.S. Food and Drug Administration (“FDA”) published “Food Facts”, a document providing the public with information concerning the…