U.S. Marshalls this week seized $6 million worth of medical products from H&P Industries Inc., which does business as Triad Group, at the behest of the U.S. Food & Drug Administration (FDA). The raid was prompted by the failure of H & P Industries to comply with the FDAâ€™s current good manufacturing practice (cGMP) regulations,
Over the past few months, Triad Group has issued several massive recalls of tainted <"https://www.yourlawyer.com/practice_areas/defective_medical_devices">alcohol prep pads, alcohol swabs, and alcohol swabsticks, and other products, sold under various brand names because of potential contamination with the bacteria Bacillus cereus. Last month, H&P Industries issued a Povidine Iodine Prep Pad recall because of concerns that they could be contaminated with Elizabethkingia meningoseptica, a type of bacteria associated with flesh eating bacteria disease, meningitis in newborn infants and pneumonia in patients on ventilators.
The U.S. Marshalls raided the H&P Industries/Triad Group facility in Hartland, Wisconsin on Wednesday. A variety of drug products were seized, including 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.
The FDA said it completed its most recent inspection of the facility on March 28, 2011. The inspection 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 affecting the majority of the products manufactured at the facility; and failure to take the proper measures to ensure the quality of incoming components.
“We took this action to stop Triad from continuing to distribute products which may pose a risk to public health,” Dara Corrigan, FDA commissioner for regulatory affairs, said in a statement.
The FDA had earlier asked H&P Industries to stop manufacturing and distributing products because of the problems, but it did not comply. As we reported earlier this week, H&P Industries finally shut down operations shortly after the U.S. Marshalls descended on the plant. H&P officials, however, characterized the shutdown as â€œvoluntary.â€
In addition to the recalls and product seizure, Triad Group and H&P Industries have also been named in at least three lawsuits that claim the tainted products caused serious injuries and deaths. One of the lawsuits blames tainted Triad wipes for the death of a 2-year-old boy. That suit claims the wipes were the likely source of bacterial meningitis that killed the child.
Many of the recalled products, which bore the Triad brand name and various other private labels, were sold at drugstores and grocery stores, including Walgreens, CVS and Walmart. They were also widely used in hospitals and clinics. For information about specific brands of recalled alcohol wipes, click here. For information about brands of recalled povidone iodine wipes, click here.