The U.S. Food and Drug Administration has filed a consent decree of condemnation, forfeiture, and permanent injunction against H&P Industries, The Triad Group and three individuals that will prevent them from manufacturing and distributing products from their Hartland, Wis., facility or any other location, according to an FDA news release.
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.
Under the decree, the groups cannot manufacture or distribute any products until they establish an acceptable quality control program that ensures compliance with federal standards for quality. They are also required to hire an independent current good manufacturing practice expert and develop a work plan that governs their implementation of corrective actions. Failure to meet these requirements would lead to financial penalties.
Since Dec. 2010, H&P Industries issued five voluntary product recalls due to bacterial contamination found in its products, including medical wipes and pads. The FDA also discovered H&P committed other 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 seized more than $6 million in products held at the Triad Group and H&P Industries Hartland facility.
Read the news release about the FDA's consent decree against H&P Industries and the Triad Group.
Related Articles on H&P Industries and the Triad Group:
Manufacturer of Recalled Medical Wipes Ceases Production Following Seizure by U.S. Marshals
FDA Under Fire From Senators Over Failed Action Concerning Contaminated Medical Wipes
H&P Issues Voluntary Recall of Povidine Iodine Prep Pads Due to Microbial Infection
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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.
Under the decree, the groups cannot manufacture or distribute any products until they establish an acceptable quality control program that ensures compliance with federal standards for quality. They are also required to hire an independent current good manufacturing practice expert and develop a work plan that governs their implementation of corrective actions. Failure to meet these requirements would lead to financial penalties.
Since Dec. 2010, H&P Industries issued five voluntary product recalls due to bacterial contamination found in its products, including medical wipes and pads. The FDA also discovered H&P committed other 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 seized more than $6 million in products held at the Triad Group and H&P Industries Hartland facility.
Read the news release about the FDA's consent decree against H&P Industries and the Triad Group.
Related Articles on H&P Industries and the Triad Group:
Manufacturer of Recalled Medical Wipes Ceases Production Following Seizure by U.S. Marshals
FDA Under Fire From Senators Over Failed Action Concerning Contaminated Medical Wipes
H&P Issues Voluntary Recall of Povidine Iodine Prep Pads Due to Microbial Infection
