Additional Information About NECC and Ameridose Continues as FDA Inspection Report is Released
Posted Oct 26 2012 11:27pm
It appears that cleanliness of the clean rooms is what lead to the fungus contamination as well as some of the related articles used in the clean rooms to sterilize. I read somewhere that they turned off the air conditioning from 8 pm to 5 am and that sounded strange. In my prior life in sales I have seen and been in a few clean rooms and the rules are pretty stringent for cleanliness and everyone wears a mask and hair net or cap while inside the room, even if not working in the room. If the air conditioning was in fact turned off for several hours that could explain how some of the mold and fungus may have has a little acceleration to grow as everyone that I had ever been inside was pretty cold. So far the death toll is 25. NECC was supplying hospital compounded drugs that were either less expensive or sometimes hard to get. There was also leaking water from a boiler and if that sat long enough something could have been going on there as well.
When you read this full article it sounds like business was booming as a few years ago Ameridose was formed by the owners of NECC and licensed by the FDA to provide drugs and compounds beyond the areas of operation that NECC could supply. Now the FDA is asking hospitals to follow up with patients that received any injectable drug from NECC. The company has a past of violations and complaints with violating standards for a couple compounds. BD
Interviews with former NECC employees and its customers, and a review of internal documents and newly-released state records, paint a picture of a company whose rapid growth was marred almost since its inception by breaches of regulations governing compounding practices. They also show how regulators failed to punish the company despite repeated violations of the rules.
As far back as 1999, barely a year after NECC was formed, the Massachusetts Board of Registration in Pharmacy responded to a complaint from a pharmacist alleging that Barry J. Cadden, chief pharmacist and co-owner of NECC, had improperly provided a healthcare provider with prescription blanks. The Board voted to issue an informal, non-disciplinary reprimand.
The U.S. Food and Drug Administration, which had warned NECC of violations in 2006, declined to comment on the specifics of the case due to an ongoing investigation. However, it has said a lack of clear federal authority over compounding pharmacies has inhibited its ability to take aggressive action.
NECC thrived on the demand. By the time the company surrendered its license on October 3, NECC was supplying hundreds of hospitals across the country, according to a list of customers released by the FDA.
The FDA said on Friday it had found "greenish black foreign matter" in 83 of the 321 vials of steroid linked to the meningitis outbreak. It also said an early October inspection had found bacteria and mold within two "clean rooms" used for production of sterile drug products at NECC.