Feds: NECC Knew Conditions Were Not Sterile
Mold and other bacteria was found not only by the inspectors, but by staff at NECC.
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.