Content about Good manufacturing practice

February 15, 2013
FDA seizes tainted product from Florida's Globe All Wellness

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
Titan Medical Enterprises shut down after violating drug, supplement good manufacturing practices

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
SIDI Work Group releases voluntary supplier qualification guidelines

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
FDA cracks down on violators of dietary supplement regulations

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

July 13, 2012
Supplement industry responds to Senate query on alleged GMP compliance shortcomings

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
Personal Care Products Council applauds legislation that advances federal oversight

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
GDUFA reduces wait time for generics

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
Webinar: CRN, VIRGO to bridge GMP gap between industry action and FDA expectations

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
FDA releases draft of GDUFA goals

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
U.S. marshals seize supplements marketed as drugs

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
Impax reports sales, profit increases in third quarter

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
Industry reaction mixed to NDI draft guidance


The Food and Drug Administration last month published long-awaited draft guidance on new dietary ingredients in the Federal Register.

June 14, 2011
FDA bars H&P Industries, Triad Group from manufacturing, distributing OTC products

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
FDA finds manufacturing issues at Impax's Hayward, Calif., plant

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 resolves FDA warning letter

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
FDA acts to prevent contamination problems with Triad antiseptic products

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
Government obtains permanent injunction against Deltex

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
FDA: Tri-Med selling unapproved, adulterated drugs

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

September 12, 2010
K-V to ship first product since 2009 manufacturing problems

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

June 24, 2010
CRN: Dietary supplement manufacturers must be GMP-compliant

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

June 24, 2010
Dietary supplement industry gets its due with GMP requirements

The dietary supplement industry is free at last from any major news organization making any...

November 8, 2009
FDA warns consumers on using sexual enhancement products

This kind of news is more notable for what it doesn’t mean than what it...

August 28, 2007
Markwins reassures consumers regarding product quality

Amid the recent media focus regarding several products originating in China, Markwins International Corp., a...

June 30, 2007
ECRM Vitamins, Minerals and Supplements/Diet 2007

The Food and Drug Administration last month published the good manufacturing practices for the dietary supplement industry, most significantly requiring all dietary supplement manufacturers to test and qualify their raw ingredient sources. The GMPs could help boost consumer confidence, and consequently sales, in an industry where confidence has waned in the past few years. However, it was almost anticlimactic as the industry prepares to mull through the 800-plus pages of the GMP document.

© 2013 Drug Store News. All Rights Reserved.