e-Profile Login and ID Quick Search
FDA Takes Action Against OTC Product Manufacturer and Distributor Due to cGMP Violations
FDA has taken action against two entities and three individuals that prohibits them from manufacturing or distributing over-the-counter (OTC) drug products until they establish an acceptable quality assurance and quality control program. Specifically, FDA has announced that on June 13, 2011, a consent decree of condemnation, forfeiture, and permanent injunction was 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, WI, facility, or any other location. The Triad Group distributes and H&P Industries manufactures OTC drug products such as 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 an acceptable quality assurance and quality control program is established 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 consent decree has been filed following several FDA inspections that found failure to comply with current good manufacturing practice (cGMP), five voluntary recalls initiated by H&P, including two due to bacterial contamination of products, and a recent FDA inspection of H&P that found multiple cGMP violations. Additional details about the requirements under the decree are included in an FDA press release.
