FDA acts to prevent contamination problems with Triad antiseptic products
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.
A variety of drug products were seized, including povidone-iodine and benzalkonium chloride antiseptic products, cough-cold products, nasal sprays, suppositories, medicated wipes, antifungal creams, hemorrhoidal wipes, in-process drug products and raw materials.
The action follows the continued failure of H & P Industries — owned and managed by the same party as Triad Group — to comply with the FDA’s current good manufacturing practice regulations.
Since December 2010, H & P Industries has initiated three voluntary product recalls due to various types of bacterial contamination found in the products.
The FDA completed its most recent inspection of H & P Industries on March 28. The inspection found multiple violations of cGMP requirements, including continuing problems with the air handling system, failure to adequately investigate drug products that did not meet specifications affecting the majority of the products manufactured at the facility and failure to take the proper measures to ensure the quality of incoming components.
GNC closes IPO
PITTSBURGH — GNC Holdings on Wednesday announced the closing of its initial public offering of 25.9 million shares of its Class A common stock at a public offering price of $16 per share. GNC’s Class A common stock began trading Friday, April 1, on the New York Stock Exchange under the ticker symbol "GNC."
Of the shares offered, 16 million were issued and sold by the company, and 9.9 million shares were sold by selling stockholders. The shares sold by the selling stockholders included 3.4 million shares sold pursuant to the underwriters’ option to purchase additional shares.
As of early morning trading on Thursday, GNC shares were selling for $17.73.
New app offers diabetics meal planning tips
WALTHAM, Mass. — Quantia has partnered with dietitian and diabetes educator Hope Warshaw to develop EatSmart, a mobile diabetes application.
EatSmart, currently a free download available for the iPhone, Android, smartphones, tablets and the Web, is an app that provides those affected by or at risk for Type 2 diabetes with simple meal planning tips and tricks.
“EatSmart is a major breakthrough application that takes my voice, passion and step-by-step practical approach to helping people transition their eating habits and makes them available to people across the country,” Warshaw said. “EatSmart extends the delivery of diabetes meal planning information beyond the exam room and diabetes education programs and puts the knowledge literally into the persons’ or care providers’ hands to access when and where they need it and to reinforce information and support essential behavior change.”
For more information, visit Eatsmart.quantiacare.com.