FDA Press Release
For Immediate Release: Abril 6, 2011
Media Inquiries: Shelly Burgess, 301-796-4651, email@example.com
Consumer Inquiries: 888-INFO-FDA
FDA acts to prevent contamination problems with Triad antiseptic products
EUA. Marshals seize drug products manufactured and distributed by Wisconsin firms
EUA. Marshals, at the request of the U.S. Food and Drug Administration, have seized more than $6 million in products distributed by Triad Group Inc., at the company’s facility in Hartland, Wis.
Triad Group and H & P Industries are owned and managed by the same parties. A variety of drug products were seized, including povidone-iodine and benzalkonium chloride antiseptic products, cough and cold products, nasal sprays, suppositories, medicated wipes, antifungal creams, hemorrhoidal wipes, in-process drug products, and raw materials.
“We took this action to stop Triad from continuing to distribute products, which may pose a risk to public health,” said Dara Corrigan, FDA associate commissioner for regulatory affairs.
The action follows the continued failure of H & P Industries to comply with the FDA’s current good manufacturing practice (cGMP) Normativa, which are intended to assure the safety, qualitat, and purity of manufactured drugs. Through this seizure, FDA seeks to prevent the company from distributing product that was manufactured in violation of federally mandated manufacturing requirements.
In connection with the seizure of the medical products and related items, the First Assistant United States Attorney for the Eastern District of Wisconsin, Gregory J. Haanstad, commended officials and staff of the Food & Drug Administration and the United States Marshals Service for their highly effective, focused, and collaborative work with the Office of the United States Attorney: “The seizures at the H & P Industries facility in Hartland reflect the continuing commitment of all federal law enforcement offices to ensure the safety and the security of our populations—and to safeguard against those whose disregard of professional obligations threaten to compromise public health and well-being.”
Since December 2010, H & P Industries has initiated three voluntary product recalls due to various types of bacterial contamination found in the products.
FDA completed its most recent inspection of H&P Industries on March 28, 2011. 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.
Seizure of drug products is an effective remedy when there is evidence of continued poor compliance with cGMP requirements. Following a drug product seizure, companies often agree to a wide range of changes and improvements to their drug manufacturing practices at their facilities.