Late yesterday, the Massachusetts Department of Public Health released its preliminary findings from an inspection it conducted of the New England Compounding Center. It reveals that the pharmacy at the center of the recent meningitis outbreak had some glaring safety problems.
Drugs produced by the New England Compounding Center were not put through the minimum procedures required to ensure sterility and were shipped to customers before the pharmacy’s own safety tests were completed, a state health official said Tuesday in announcing preliminary results of an inspection of the pharmacy at the heart of the nationwide meningitis outbreak.
Inspectors who visited the pharmacy in recent weeks found dirty lab equipment, a leaking boiler near the pharmacy’s “clean room,” and records that showed the pharmacy failed to properly maintain important sterilization tools, such as an autoclave, Madeleine Biondolillo, director of the state Bureau of Health Care Safety and Quality, said during a press conference Tuesday afternoon.
Read the full report
here. While these are only preliminary findings, state officials consider them egregious enough that they're already moving to make sure NECC never reopens. The state pharmacy board is seeking to revoke both NECC's license and the licenses of its three pharmacists, including those of the husband-and-wife team who run it, Barry and Lisa Cohen.
In addition to the leaky boiler and out-of-maintenance autoclaves, inspectors also found dirty floor mats and powder hoods. They also found that at least two of the lots on the recall list were sent out before being sterilized in accordance with the NECC's own sterilization procedures. One of them had a black substance in it; many of the infections have been connected to a black mold.
The report also reveals that NECC has problems beyond improper sterilization. Records indicate that it regularly sent compounded drugs to customers without first getting a specific prescription for a patient. If that's the case, the NECC was in violation of its license, and was operating as a manufacturer rather than as a compounder.
Believe it or not, losing its license may very well be the least of the NECC's problems. There are strong indications that the NECC is the target of a federal criminal investigation--one that may have been triggered in part by evidence it was handling drugs on the DEA's controlled-substances list even though it wasn't registered by the DEA. Among other things, the NECC may have handled cocaine and fetanyl.