Missouriwatcher
Editor, Senior Moderator
June 13, 2011:
The U.S. Food and Drug Administration announced today 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...
FDA inspections from 2009 to 2011 determined that H&P failed to comply with the FDA?s 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 FDA?s 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...
The decree, filed by the U.S. Department of Justice?s Office of Consumer Protection Litigation and the U.S. Attorney?s Office for the Eastern District of Wisconsin, will become effective upon entry by the court.
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm258864.htm
The U.S. Food and Drug Administration announced today 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...
FDA inspections from 2009 to 2011 determined that H&P failed to comply with the FDA?s 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 FDA?s 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...
The decree, filed by the U.S. Department of Justice?s Office of Consumer Protection Litigation and the U.S. Attorney?s Office for the Eastern District of Wisconsin, will become effective upon entry by the court.
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm258864.htm
