FDA Recall of contaminated antiseptics

Source: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm249706.htm

FDA Press Release

For Immediate Release: Квітень 6, 2011
Media Inquiries: Shelly Burgess, 301-796-4651, shelly.burgess@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA

FDA acts to prevent contamination problems with Triad antiseptic products
США. Marshals seize drug products manufactured and distributed by Wisconsin firms

США. Marshals, at the request of the U.S. Управління з продовольства і медикаментів, 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) правила, which are intended to assure the safety, якість, 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.

У зв'язку із захопленням медичних виробів і супутніх товарів, Перший помічник прокурора Сполучених Штатів для Східного округу штату Вісконсін, Грегорі J. місто Haan, Commended посадові особи і співробітники Продовольчої & Медикаментів і Служба судових приставів США за їх високу ефективність, зосереджені, і спільна робота з Управлінням прокурора Сполучених Штатів: "Напади на H & P Industries об'єкта в Хартленд відображають незмінну прихильність всіх федеральних відомств правоохоронних органів з метою забезпечення безпеки і безпеки наших "населення, і для захисту від тих, чиє нехтування професійними обов'язками загрожують поставити під загрозу безпеку громадського здоров'я та благополуччя.

З грудня 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.