Did FDA Miss Clues in New England Compounding Audits?

Did FDA Miss Clues in New England Compounding Audits?

December 13th, 2012 // 2:05 pm @


Two months ago, the FDA inspected the New England Compounding Center, the pharmacy that has been linked to 590 cases of fungal meningitis, including 37 deaths (see this), and found a variety of disturbing conditions. These included ‘greenish-black foreign matter’ on sterilization equipment and air conditioning that was turned off each night despite the need to control room temperatures (back story with link to FDA report).

Similarly, the Massachusetts Department of Public Health conducted its own inspection in October and ran across some of the same things, such as a leaking boiler adjacent to the a clean room and wet floor surfaces, including a “tacky mat” that were soiled with black debris (here is the state report).

Nonetheless, more than a dozen people who have filed federal lawsuits against the NECC, which is located alongside a recycling plant that is owned by one of the two individuals who also run the compounder, received permission from a judge to conduct their own inspection (here is the order). Why? The plaintiffs believe the regulators may have missed some important pieces of evidence.

In an affidavit filed in the litigation, Tom Irmiter of Forensic Building Science, who has been retained by the plaintiffs to conduct the inspection, maintains there is no evidence that the FDA and state inspectors examined the overall condition of the building as a potential contributor to the contamination. And so he proposes to dissect the walls, ceiling, roof and foundation (here is the affidavit).

“Here’s an entity undergoing tremendous turmoil. We believe the preliminary (state) report that was issued is missing some things that may yield some other signs,” says Mark Zamora, an attorney for Chad Green, who claims he developed a joint infection and abscess due to an NECC medicine. “The FDA conducted testing of the vials, a baseline test for contaminants in May and released an eight-page inspection and observation report, which I think candidly revealed an overwhelmed agency struggling to come with an outbreak.

“But no one has access to raw data and we think they missed some things. For example, the garbage dump is yards from the facility. They didn’t examine the HVAC. We’re concerned with what may be found in the clean room. I think they did a decent job of explaining source contamination of product itself. But for us, we want to know how how did the material get in the vials? And if it’s the vial, did it come from the company that supplied the product or from the company that made the finished product?”

Such a move is predictable, but could also yield some interesting clues that might underscore the need for modifying regulatory inspections. As the attorney notes, the existence of contamination is obviously a key element of any inspection, but learning how the contamination occurred is equally crucial. A leaky boiler and the failure to use air conditioning may have been culprits here, but maybe there is more to the story

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