Apparently the case of the New England Compounding Center as a focal point for a country-wide meningitis outbreak can get worse. In a just divulged 483, the FDA says it found a ‘greenish-black foreign matter’ on sterilization equipment and the clean room had its air conditioner shut off at night -- rather than maintaining a controlled temperature for meds stored within. Can it get worse? In a word, YES.
The Compounder & And Its Not-So Clean Room // Pharmalot.
So far, 25 people have died. The FDA inspected the NECC facility in Framingham, Massachusetts, several times over the past month and found mold and bacteria in dozens of places in a pair of clean rooms.Significantly, FDA inspectors found that 83 of 321 vials from one lot linked to the meningitis outbreak contained “greenish black foreign matter” and another 17 vials had “white filamentous material,” the report stated. The NECC tested one sample from the lot, which was sterile, but the FDA tested 50 vials from the same lot and found microbial growth. Ewwwwww!
Needless to say, critics of the agency are asking why it didn't shut these guys down before given the conditions -- and given the fact they were clearly distributing product over a wide area effectively acting as a small pharma company. No doubt the NECC will be sued into oblivion now but that's small solace for the 25 souls referenced above. More on the 483 here.
Also as reported in the Pharmalot blog, the State of Florida has apparently learned from the above mess and just suspended a compounder, Rejuvi Pharmaceuticals, in that State for a series of uncorrected violations. The suspension is the latest fallout from the scandal surrounding the New England Compounding Center.
Posted by Bruce Lehr Oct 29th 2012.
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