Feds: NECC Knew Conditions Were Not Sterile
Mold and other bacteria was found not only by the inspectors, but by staff at NECC.
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After a raid of the New England Compounding Center earlier this month, federal inspectors said members of the NECC staff knew the conditions were not sterile.
According to Fox 25, in the past year, dozens of cases of mold and bacteria were documented in supposed sterile rooms. Inspectors said there is no sign the pharmacy did anything with these reports; no signs of investigation or cleanup were noted.
Yesterday, the FDA issued a copy of the FDA Form 483, which found problems with New England Compounding Center.
According to Fox, NECC responded to the FDA's report:
"We received the Food and Drug Administration's Form 483 earlier today. We will review this report and will continue our cooperation with the FDA. We will follow the existing regulatory process and provide our comments to the FDA after we have had adequate time for a complete review of the report."
Earlier this week, the FDA released a list of customers, who received products from NECC in Framingham on or after May 21.
The fungus has been linked to a deadly meningitis outbreak that has infected more than 300 in 17 states and killed 23 individuals. NECC has maintained the steroids were not distributed in Framingham or Massachusetts.
Click here to find all of Framingham Patch’s coverage of NECC and the meningitis outbreak.
Cheryl Tully Stoll
10:49 am on Saturday, October 27, 2012
23 people dead, hundreds very ill and possibly dying themselves, thousands living in fear that they will be next. Add to that tens of thousands of others terrified that a family member or close friend will die from this gross negligence.
Criminal charges need to be brought in this case and the government needs to make sure that these conditions don't exist in any other facility in the country.
Senior citizens are discouraged from going to Canada to get their medications more affordably with the excuse that Canada's quality control practices aren't as strict as ours. Wow, things must be REALLY bad in Canada!
It's scary enough to have to go to a hospital or clinic to have something injected into your spine; based on this situation, how many people will now forgo needed treatment because of additional fear?
How many families will end up in bankruptcy due to the medical expenses associated with trying to treat this virtually unknown condition? There’s no way that the company or the distribution chain could possibly carry enough insurance to cover the expenses associated with this outbreak and it will take victims years to receive any compensation regardless.
Based on additional information that is coming forward on a daily basis, it is clear that a broad-based criminal investigation is needed. Perhaps for once we could see the guilty parties plead guilty and save taxpayers money and help grieving families receive some closure expeditiously.
Barry Ponzio
11:50 pm on Monday, January 7, 2013
Management knew the risks and knew how bad the end results could be and they still disregarded any safety measures all for the allmighty dollar . These crooks deserve a long prison sentence.
LittleRedFacedRonzio
5:25 pm on Tuesday, April 9, 2013
If you don't break the rules you don't make the coin. I prefer to break the rules in this world. Rules breakers make the coin and hinest people get fired. I should know cause I fired them. They are on unemployment and I still get a check. Like I said rule breakers win. I break the rules