The seizure took place at the Triad Group’s facility in Hartland, Wis. Triad Group distributes a variety of medical products for H&P Industries, which are owned and managed by the same parties.
Products seized included 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, according to an FDA news release.
The seizure follows the continued failure of H&P Industries to comply with the FDA’s current good manufacturing practice (cGMP) regulations, which are intended to assure the safety, quality and purity of manufactured drugs.
“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, in the news release.
Since Dec. 2010, H& P Industries has initiated three voluntary product recalls due to bacterial contamination found in the products. The most recent FDA inspection of H&P Industries in late March 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 and failure to take the proper measures to ensure the quality of incoming components.
Read the FDA news release about the seizure at Triad Group.
Read earlier related stories:
– FDA Under Fire From Senators Over Failed Action Concerning Contaminated Medical Wipes
– Triad to Shut Down Healthcare Line Following Recalls
– Triad Sterile Lubricating Jelly Recalled
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