US FDA release a preliminary report on the New England Compounding Centre
The FDA have released a preliminary report on the New England Compounding Centre in response to the recent fungal meningitis outbreak. The 483 includes details that staff often turned off the cleanroom air conditioning overnight and that dust from a nearby recycling plant was getting into the facilities air conditioning system.
For those microbiologists among us, you may find this article interesting from The New England Journal of Medicine that looks at the mould, E. rostratum, that has been found to be primary pathogen, although other pathogens are likely to emerge.
Notably from this article, the authors state that: “It is encouraging to note that clinically apparent disease has developed in only a small percentage of exposed patients.” From the 483 it seems that the facility was a veritable cornucopia of microbial growth, it is perhaps “fortunate” that it was only the E. rostratum that got into the vials, and not something more virulent.
Finally, this article from the Boston Globe, details how Massachusetts Governor, Deval Patrick and his administration (and what his far more high profile predecessor dealt with the company in 2006) are dealing with the situation. Interestingly it is noted that 10 states in the US regularly perform surprise inspections of pharmacies. Massachusetts does not. Unannounced visits are to begin immediately.