Government inspectors knew of sterilization problems at a Wisconsin company that makes alcohol swabs and related health care items 18 months before the company recalled its products in January, msnbc.com reports.
The company, Triad Group, is the target of a wrongful death lawsuit filed by the parents of a 2-year-old Houston boy who succumbed to an infection that, the plaintiffs say, was contracted from the manufacturer’s tainted products.
Triad’s recall, and the suit, involved potential contamination of the company’s over-the-counter wipes with the pathogen known as Bacillus cereus, which normally is associated with foodborne illnesses. According to msnbc.com, Food and Drug Administration inspectors were aware as early as July 2009 that something was amiss at Triad’s plant in Hartland, Wisc.
“Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not followed,” officials wrote in inspection reports. But there is no record that the FDA sent warning letters to Triad, which typically are used to prod firms to comply with safety regulations.
The inspection documents, known as FDA Form 483s, did not mention specific contamination of the swabs or pads with Bacillus cereus but questioned the gamma radiation process Triad was using to sterilize its products. The documents also said shipments of Triad Plus BZK prep pads that failed to meet specifications were sent to distributors.
In a lawsuit filed Feb. 13, the parents of Harrison Kothari cited Triad’s wipes in the toddler’s death on Dec. 1 from acute bacterial meningitis. “Some or all of Triad’s alcohol prep pads, swabs and swabsticks were contaminated with Bacillus cereus,” Sandra and Shanoop Kothari said.
A second lawsuit was filed last week by Donovan Joseph Postich, a 55-year-old Tennessee ironworker, who alleges he was infected with Bacillus cereus after he used Triad wipes last September to prepare his skin for injections with a hepatitis medication. The infection, he says, led to cardiac complications that forced him to undergo open-heart surgery.
Postich is suing both Triad and biotech giant Genentech, which packaged the wipes with the medication he used.
Triad voluntarily recalled millions of wipes Jan. 5 and the FDA conducted another investigation of the company’s plant two days later. An FDA spokesman said that inspection revealed “several deviations from our current good manufacturing regulations.” But he also said that, before the recall, the agency had received no reports of adverse events related to Triad alcohol prep products.
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