FDA Tries To Wipe Up A Wipe Maker
1 CommentBy Ed Silverman // April 5th, 2011 // 7:54 am
After nearly two years of failed inspection reports and an order last week from the FDA to halt production and distribution, a little-known company that was accused of making contaminated medical pads and wipes shut its doors yesterday. But the move came only after US Marshals showed up with seizure orders, as MSNBC notes.
The move came three months after H&P Industries and a related company, 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 (look here). Triad also recalled potentially contaminated lubricating jelly used in medical procedures and exams, and iodine prep wipes (see this).
The episode has raised questions about the FDA handling of the problems at the company. As you can see here, the FDA first found quality control issues involving sterility and contamination in July 2009 and then again in May 2010 (read this). Yet H&P and Triad continued with business as usual, prompting two US Senators last week to chastise the agency for its oversight, or lack thereof (read this).
The chain of events also sparked concerns that still other products may be an issue, especially since the products are found in hospitals and clinics, as well as numerous retailers around the country, including Walgreen, Rite Aid, CVS and Safeway Stores (see this). Sure enough, the FDA late yesterday posted results of yet another inspection showing still more contaminated products were found.
For instance, contamination was detected in antiseptic towlettes and in raw materials used to make over-the-counter fiber products used as laxatives and to lower cholesterol (see this). And there were batches of over-the-counter products failed to pass stability tests or meet standards for active ingredients, including hemorrhoidal suppositories and Triad PVP Swabsticks.
The FDA also found problems with the “high purity” water system and wrote that “equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate design to facilitate operations for its intended use and cleaning and maintenance.” Meanwhile, the FDA identified pad material and foil packaging used in alcohol prep wipes as the potential cause of the contamination, with implications for other products. “The impact to other products manufactured with the same or similar pad and foil was not assessed,” the inspectors wrote.
In other words, the problems were systemic. Of course, this creates a void and if it is filled, to any extent, by a supplier that is harder to oversee - pick your country - imagine the difficulties the FDA will have ensuring that contaminated wipes do not kill anyone. Meanwhile, we have asked H&P for comment and will update you accordingly.
AnnePME
Ed, Thanks for noting that if the FDA pushes too hard, this company could go overseas or an overseas company based in a country where there is less FDA oversight might gain a competitive advantage.