Content about Good manufacturing practice

February 14, 2014

Global public health organization NSF International has launched the NSF Cosmetics and Personal Care Program to provide auditing, training, product testing, claim substantiation and certification services to enable manufacturers to improve the quality and safety of their products, and retailers to strengthen the oversight of their cosmetic and personal care suppliers, the organization announced on Friday.

ANN ARBOR, Mich. — Global public health organization NSF International has launched the NSF Cosmetics and Personal Care Program to provide auditing, training, product testing, claim substantiation and certification services to enable manufacturers to improve the quality and safety of their products, and retailers to strengthen the oversight of their cosmetic and personal care suppliers, the organization announced on Friday.

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.

GURGAON, India — 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.

Ranbaxy said it received a Form 483 from the FDA, a statement issued to a company's management after it has inspected a plant and found conditions that may violate the agency's regulations, and that products produced therein could be hazardous to people who use them. The plant in question is in Toansa, in India's Punjab region.

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.

SILVER SPRING, Md. — 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.

SILVER SPRING, Md. – 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.

WASHINGTON — The Council for Responsible Nutrition on Thursday 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.

SILVER SPRING, Md. — U.S. marshals, acting on behalf of the Food and Drug Administration, on Thursday seized tainted products from Globe All Wellness in Hollywood, Fla. The products may be unsafe because they contain an undisclosed active pharmaceutical ingredient.

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.

SILVER SPRING, Md. — 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 Friday. 

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.

WASHINGTON — The dietary supplement industry’s self-regulatory coalition, the SIDI Work Group, on Thursday 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.

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

A federal judge granted the FDA a permanent injunction against Truman Berst, doing business as Alternative Health & Herbs Remedies of Albany, Ore., for selling products represented as herbs and supplements with claims for treating diseases.

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.

WASHINGTON — 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.

WASHINGTON — 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.


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.

WASHINGTON — 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. 

Moderated by Duffy MacKay, CRN VP scientific and regulatory affairs, the webinar will help companies better understand the intricacies of GMPs and will offer tips and best practices for passing Food and Drug Administration 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.

WASHINGTON — 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.

HILLSBORO, Wis. — 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.

HAYWARD, Calif. — 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.

The latest sales figures represented a $12.2 million increase over third quarter 2010, while profits were $4.2 million higher.

July 25, 2011


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


The Food and Drug Administration last month published long-awaited draft guidance on new dietary ingredients in the Federal Register. Once finalized, the guidance will establish an additional pillar of credibility to the dietary supplement industry and help counter criticism that the FDA does not regulate the safety of supplement products — that is, if the FDA doesn’t force supplements off the shelf that are already on the shelf today. 


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.

HAYWARD, Calif. — 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.

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

The drug maker said it diligently worked to resolve issues noted in an FDA warning letter dated Feb. 5, 2009. The regulatory agency reinspected the manufacturing facility last February.

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.

SILVER SPRING, Md. — 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.

“We took this action to stop Triad from continuing to distribute products [that] may pose a risk to public health,” stated Dara Corrigan, FDA associate commissioner for regulatory affairs.

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.

SILVER SPRING, Md. — 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...

ST. LOUIS Starting Monday, K-V Pharmaceutical will ship its first product since it withdrew several products in 2008 and 2009 due to manufacturing problems, the drug maker said.

K-V said the Food and Drug Administration had given it approval to ship its Micro-K potassium chloride product following the completion of inspections of its manufacturing plant.

June 24, 2010

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