Following raids; seizures; at least six lawsuits; complaints of serious illnesses; failed inspections; a number of massive recalls for <"https://www.yourlawyer.com/practice_areas/defective_medical_devices">tainted alcohol wipes, swabs and other medical products; and, worst of all, the death of two-year-old Harrison Kothari, H&P Industries Inc. and the Triad Group now say that a permanent injunction filed by the Food & Drug Administration (FDA) is an important step toward building their medical products business.
The firms, based in Wisconsin, have been accused of manufacturing and distributing alcohol products that were allegedly tainted with deadly bacteria and which have led to serious reactions in already compromised patients, including the death of Harrison. The dangerous bacteria linked to the products—Bacillus cereus and Elizabethkingia meningoseptica—can lead to deadly infections.
“This is the all-important first step in resuming our manufacturing operations,” said Eric Haertle, president of H&P Industries, in a press release issued yesterday, quoted MSNBC. “We are fully committed to addressing FDA’s concerns and rebuilding the confidence of the customers we have served for so many years,†Haertle added.
Previously, the U.S. Marshalls raided the H&P Industries/Triad Group facility in Hartland, Wisconsin, seizing $6 million of drug products. Meanwhile when the US Food & Drug Administration (FDA) completed an inspection of the facility in March, the inspection revealed 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.
The FDA previously asked H&P to stop manufacturing and distributing; it did not comply. H&P finally shut down operations shortly after the U.S. Marshalls descended on the plant. The firms described the shutdown as “voluntary.â€
The permanent injunction decree was filed last week by the U.S. Department of Justice’s Office of Consumer Protection Litigation and the U.S. District Court of the Eastern District of Wisconsin against H&P Industries Inc. and the Triad Group. The injunction was signed by Judge Aaron E. Goodstein and means that neither firm will be able to “manufacture or distribute drugs or any medical devices until they have established acceptable quality assurance” in conformity with the cGMP, said Shelly Burgess, FDA spokeswoman, quoted MSNBC.
The decree calls for H&P Industries and Triad Group to pay for and hire an independent expert in cGMP and develop a work plan. Manufacturing and production can not resume until that expert and the FDA decide the firm are in compliance with the law, said MSNBC. Also, the expert will continue to monitor the firms for five years; if compliance is not maintained, the five year periods begins again, according to the decree.
“This action is necessary to ensure that the companies operate in full compliance with federal quality standards and do not pose a risk to patients,” said Dara Corrigan, the FDA’s associate commissioner for regulatory affairs, quoted MSNBC
FDA officials admitted, by letter to senators Michael Bennet (Democrat-Colorado) and Lamar Alexander (Republican-Tennessee) they should have taken “stronger action sooner,†wrote MSNBC.
