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FDA Uncovers Problems at NECC

The Framingham facility is at the center of a deadly meningitis outbreak.

The FDA has issued a copy of the FDA Form 483, which found problems with New England Compounding Center.

The FDA cited a problem as the Framingham company's “ability to maintain its clean room, which is the enclosed space that is designed and maintained to have a controlled environment with low levels of airborne particles and surface contamination.”

In a press release, the FDA reported:  

Production of sterile drug products in a properly functioning and maintained clean room reduces the risk of the introduction of microbial contamination into the drug during processing, including filling into its final container.  

The FDA issues a 483 at the end of an inspection when the investigators believe that they observed conditions or practices that, in their judgment, may indicate violations of the Federal Food, Drug, and Cosmetic Act, or related regulations.

The 483 does not constitute a final FDA determination that any observation listed on the 483 is a violation of the Federal Food, Drug, and Cosmetic Act or any related regulations.

The FDA considers the 483 along with an Establishment Inspection Report (EIR), prepared by FDA investigators, and any other relevant information, including any responses received by the company. The agency then considers whether further action, if any, is appropriate. The inspection report for NECC has not been completed and is not being shared at this time. 

The FDA continues to work closely with the U.S. Centers for Disease Control and Prevention and state partners, including the Massachusetts Board of Registration in Pharmacy, to investigate the outbreak of fungal meningitis among patients who received NECC’s compounded preservative-free methylprednisolone acetate (80mg/ml), an injectable steroid.

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.

Michael Schuttenberg October 26, 2012 at 07:29 PM
Was a bit disappointed in this report----the whole point is the FDA's findings, as documented in the 483. It's a public document available from the FDA's www, so I really wish you would have included a link to the full report, to save me the extra clicks and searching to get it myself. NECC obviously has some major issues, and telling the reading public what a 483 is, but not telling anything about the contents of this particular 483, is somewhat of a disservice.
James Tougas October 26, 2012 at 08:04 PM
What's the risk level of this airborne fungus escaping the facility and infecting neighbors of NECC in Framingham?
Claudia Berdecio October 27, 2012 at 12:57 AM
That 483 FDA Report isLengthy. Here is the link: http://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofGlobalRegulatoryOperationsandPolicy/ORA/ORAElectronicReadingRoom/UCM325980.pdf
tenn33 October 27, 2012 at 12:04 PM
25 are dead not 23 http://abcnews.go.com/Health/Wellness/meningitis-outbreak-331-cases-25-deaths/story?id=17570870#.UIvNeIWcFEU
Barry Ponzio January 08, 2013 at 04:38 AM
When will employees be forced under oath. No one will cover up for these moronic NECC management fools if faced with federal prison hanging over their heads

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