A Dirty Business: The FDA Wipes Up A Wipemaker
4 CommentsBy Ed Silverman // June 13th, 2011 // 11:23 am
Two months after US Marshals seized a variety of products from a little-known company that was accused of making contaminated medical pads, the agency has filed a consent decree and permanent injunction against H&P Industries and a related company, the Triad Group, along with three executives that will prevent them from making and distributing any over-the-counter products.
Among the products covered by this move are povidone-iodine and benzalkonium chloride antiseptic products, cough and cold products, nasal sprays, suppositories, medicated wipes, antifungal creams, and hemorrhoidal wipes. Not until H&P and Triad can establish “an acceptable” quality assurance and quality control program will the agency allow manufacturing and distribution to resume (read the consent decree here).
The move comes five months after H&P and Triad Group recalled a huge amount of alcohol wipes and pads potentially contaminated with Bacillus cereus, which was blamed for serious infections and at least one death - a two-year-old boy in Texas. Triad also recalled potentially contaminated lubricating jelly used in medical procedures and exams, and iodine prep wipes. The episodes led to the seizures (see this).
“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,” FDA associate commish for regulatory affairs Dara Corrigan says in a get-tough statement. The agency had, in fact, been criticized for failling to move faster to thwart the problems, which alarmed parents nationwide.
Fears were heightened over the possibility that still other H&P and Triad products may be an issue, especially since these are found in hospitals and clinics, as well as many retailers, including Walgreen, Rite Aid, CVS and Safeway Stores. As an example, contamination was detected in antiseptic towlettes and in raw materials used to make OTC fiber products used as laxatives and to lower cholesterol.
Meanwhile, the FDA had inspected facilities dating back to early 2009 and found H&P failed to comply with the good manufacturing practices. And since last December, H&P has initiated five voluntary product recalls, including two because of bacterial contamination. A March 2011 inspection then found “multiple” violations, including continuing problems with an air handling system, failure to adequately investigate drug products that did not meet specifications, and failure to take appropriate measures to ensure the quality of incoming components, the agency states.
original industry insider
Hat tip to The Ventures:
http://www.youtube.com/watch?v=T8__EwAT8VM
Captain Jack
You know, there are FDA regulated companies out there that are responsible for assuring microbiological safety of products that have no managers nor supervisors with a background in microbiology. They test potable water by drinking a cup of it, and if they are alive the next day, it “passes”. Similarly, these decisionmakers will put decisions into the hands of Microbiologists that have many years of experience, but know nothing about how Microbiology relates to the safety of their product. They will use methods acceptable in, say, a hospital setting, in an FDA regulated setting. The above article would serve as an example. Decisionmakers (and these are not figments of my imagination) would deem it “common sense” to not need adequate testing on alcohol pads because these well overpaid, reckless Quality Leaders think alcohol kills everything. Not Bacillus…
FDA, you are failing. You are weak. Companies dance on your regulations. And you are often led to piles of dung and do nothing about it.
I want my $4 back.
CJ
harpy
so you’re saying FDA needs more money and power? I’d agree.
original industry insider
Spot on, Captain Jack. Your post reminds me of the crack inspectors who, after last year’s Deep Water Horizon oil spill certified that Gulf seafood was safe to eat because they were unable to smell petrol residue when then wafted the shellfish beneath their nostrils. The sad part is that I’m sure that there were many customers who simply accepted the word of the inspectors because the fish passed the “smell test”. I for one have imposed a personal moratorium on eating Gulf seafood for at least six years. Why six years? That time period represents three complete life cycles of the oyster, which should produce reasonable clean seafood.
I guess it would have been too high tech to whack off a piece of meat and test it for hydrocarbons.