Tag Archive: CGMP

Jan 28

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 products until the company meets certain U.S. Food & Drug Administration (“FDA”) regulations and mandated standards (Current Good Manufacturing Practices or “CGMPs”). According to the FDA, the steps taken by the manufacturer in response to …

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Sep 02

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 Court for the Middle District of Georgia against a dietary supplement manufacturer. The Order prohibits the manufacturer from selling dietary supplements until they comply with FDA good manufacturing regulations and other applicable, federal requirements. In …

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Aug 18

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 Cheese Manufacturer and its owners under the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 332. The FDA seeks to prevent S. Serra Cheese Company, based in Clinton Township, Michigan from receiving, preparing, processing, …

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Oct 28

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 James G. Cole, a dietary supplement manufacturer based in Oregon, along with the company’s president, James G. Cole, and general manager, Julie D. Graves. The complaint was filed on the FDA’s behalf by the U.S …

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Jun 24

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 Start a Food Business” on its website. The article provides a brief overview of the requirements that a food business must comply with under the Federal Food, Drug, and Cosmetic Act (FDCA) and other FDA …

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Feb 20

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 of Globe All Wellness, LLC, a dietary supplement manufacturer based in Hollywood, Florida. Marshals seized what are alleged to be tainted dietary supplements, believing the products to be unsafe, as they may contain an undisclosed …

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Jan 30

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 of permanent injunction with Jonlly Fruits, Inc. (“Company”) and its President, Bartolo Pérez Román. Jonlly Fruits is a frozen fruit, juice, and vegetable manufacturing company located in Puerto Rico.  Under the consent decree, signed by …

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Jul 16

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 the United States to bear a Unique Device Identifier (“UDI”). According to the FDA, this UDI system could potentially improve availability and quality of information in medical device adverse event reporting and in the event …

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May 16

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 Respiratory Panel, a medical device used to detect causes of respiratory infection. Manufactured by Idaho Technology, Inc., the device is cleared for the simultaneous detection of both viral and bacterial causes of respiratory infection. The …

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May 08

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 Agency’s regulation of bottled water. Found here, the document details how the Agency works in conjunction with the Environmental Protection Agency (“EPA”) to ensure that drinking water is safe. While the EPA is primarily responsible …

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