The Food and Drug Administration (FDA) announces that a consent decree of condemnation, forfeiture, and permanent injunction has been filed against H&P Industries Inc., The Triad Group Inc., and three individuals that would prevent them from manufacturing and distributing products from their Hartland, Wis., facility, or any other location.
The Triad Group distributes and H&P Industries manufactures a variety of over-the-counter drug products including povidone-iodine and benzalkonium chloride antiseptic products, cough and cold products, nasal sprays, suppositories, medicated wipes, antifungal creams, and hemorrhoidal wipes.
Under the decree, the defendants cannot resume manufacturing and distributing drugs or medical devices until they establish an acceptable Quality Assurance and Quality Control program to ensure that all products manufactured in their facilities comply with federal standards for quality and have the identity, purity, potency and safety they are expected or are represented to possess.
The defendants are required to retain at their own expense an independent current good manufacturing practice (cGMP) expert and develop a work plan that governs their implementation of corrective actions. The defendants cannot resume operations until both their cGMP expert and the FDA determine that they are in compliance with the law.
If the defendants violate the decree, FDA may order them to cease manufacturing, recall products, and take other corrective action, including levying fines of $15,000 for each day and an additional $15,000 for each violation of the law.
"This action is necessary to ensure that the companies operate in full compliance with federal quality standards and do not pose a risk to patients," says Dara Corrigan, the FDAs associate commissioner for regulatory affairs.
FDA inspections from 2009 to 2011 determined that H&P failed to comply with the FDAs cGMP regulations, which are intended to assure the safety, quality, and purity of manufactured drugs. Since December 2010, H&P has initiated five voluntary product recalls, including two because of bacterial contamination of their products. The FDAs most recent inspection of H&P, completed on March 28, 2011, found multiple cGMP violations, including continuing problems with an air handling system, failure to adequately investigate drug products that did not meet specifications, and failure to take appropriate measures to ensure the quality of incoming components.
In April 2011, U.S. Marshals, at the request of FDA, seized more than $6 million in products held at the Triad Group and H&P Industries Hartland facility. Under the decree, the seized products are condemned and forfeited to the United States. The defendants, after posting a $4 million bond with the court, may seek FDAs approval to "recondition" the seized articles. If the defendants proposals are unacceptable to FDA, however, the company is obligated to destroy them at its own expense.
The decree, filed by the U.S. Department of Justices Office of Consumer Protection Litigation and the U.S. Attorneys Office for the Eastern District of Wisconsin, will become effective upon entry by the court.