Content about Good manufacturing practice

January 13, 2014

The Food and Drug Administration has found possible violations of agency regulations at a manufacturing plant in India owned by drug maker Ranbaxy Labs, the company said Monday.

October 22, 2013

The Food and Drug Administration, in a complaint filed by the U.S. Department of Justice, on Monday sought a permanent injunction against the dietary supplement manufacturer James G. Cole; its president, James Cole; and its general manager, Julie Graves, following the company’s repeated distribution of unapproved drugs and adulterated dietary supplements in violation of the Federal Food, Drug and Cosmetic Act.

September 16, 2013

The Food and Drug Administration is barring the importation of drugs from another one of Ranbaxy Labs' plants in India, the agency said Monday.

July 19, 2013

The Council for Responsible Nutrition announced that Daniel Fabricant, director of the Division of Dietary Supplement Programs at the Food and Drug Administration, will be a keynote speaker at The Conference: CRN’s Annual Symposium for the Dietary Supplement Industry Sept. 18 to 21 in Park City, Utah.

February 15, 2013

U.S. marshals, acting on behalf of the Food and Drug Administration, on Thursday seized tainted products from Globe All Wellness in Hollywood, Fla.

February 11, 2013

A federal judge has ordered a California company and its owner to stop manufacturing and distributing drugs and dietary supplements in domestic commerce until their manufacturing operations comply with the Federal Food, Drug, and Cosmetic Act, the Food and Drug Administration reported.

January 17, 2013

The dietary supplement industry’s self-regulatory coalition, the SIDI Work Group, announced the release of its voluntary Dietary Supplement Component Supplier Qualification Guideline — a document designed to assist the industry in supply chain integrity, which is a requirement for complying with current good manufacturing practices.

October 26, 2012

The Food and Drug Administration on Thursday announced a pair of penal actions against companies operating outside of dietary supplement regulations.

July 13, 2012

The dietary supplement industry recently responded to a Senate query around why the dietary supplement industry is failing to live up to Food and Drug Administration regulations.

April 19, 2012

The Personal Care Products Council and the Safe Cosmetics Alliance has announced support for legislation to strengthen and modernize regulatory oversight of the industry and to create a greater role for the Food and Drug Administration in assessing the safety of personal care products.

January 20, 2012

For all the talk about generic drugs and their potential to save piles of money for the country’s healthcare system, it’s going to be a while before many of them actually reach consumers because of the Food and Drug Administration’s huge backlog of generic drug regulatory approval applications.


December 20, 2011

The Council for Responsible Nutrition and VIRGO on Tuesday announced details for an industrywide webinar to examine key elements of good manufacturing practices for dietary supplements and offer advice as to what the industry can do to improve its record of inspections.

December 12, 2011

Following months of meetings and negotiations with the drug and chemical industries, the Food and Drug Administration has released a draft of the goals of the Generic Drug User Fee Act.

December 2, 2011

At the request of the Food and Drug Administration, U.S. marshals on Thursday seized all dietary supplements manufactured by Syntec because of false claims made about the safety and effectiveness of their supplements in treating a number of diseases.

November 1, 2011

Drug maker Impax Labs reported sales of $119.8 million and profits of $20 million in third quarter 2011, according to an earnings report released Tuesday.

July 25, 2011


The Food and Drug Administration last month published long-awaited draft guidance on new dietary ingredients in the Federal Register.

June 14, 2011

ROCKVILLE, Md. — The Food and Drug Administration on Monday announced that a consent decree of condemnation, forfeiture and permanent injunction has been filed against H&P Industries, Triad Group and three individuals, which would prevent them from manufacturing and distributing products from their Hartland, Wis., facility, or any other location.

June 6, 2011

The Food and Drug Administration has found manufacturing issues at a plant owned by generic drug maker Impax Labs, the drug maker said Monday.

April 26, 2011

Taro said that the Food and Drug Administration has declared the drug maker's manufacturing facility in Canada as having acceptable regulatory status.

April 7, 2011

U.S. marshals have seized more than $6 million in products distributed by Triad Group at the company’s facility in Hartland, Wis., the Food and Drug Administration reported Wednesday.

January 19, 2011

A permanent injunction was granted to the federal government Tuesday against a contract manufacturer and distributor of prescription and over-the-counter products, as well as two of its executives.

October 26, 2010

U.S. Marshals earlier this month seized articles of prescription and over-the-counter drug products from Tri-Med...

September 12, 2010

Starting Monday, K-V Pharmaceutical will ship its first product since it withdrew several products in...

June 24, 2010

The Council for Responsible Nutrition on Friday noted that all dietary supplement manufacturers without exception...

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