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…