Monday, December 10, 2012
An Alabama woman is the first to file a suit from that state.
A 14th person has filed a lawsuit in Boston against Framingham-based New England Compounding Center, which is linked to a meningitis outbreak that has killed 36 people and sickened 541. The Boston Herald reported that a 31-year-old woman said she suffered temporary hearing loss and a painfully bloated face from an injection she received this summer at one of Alabama’s largest hospitals. The suit is the first from Alabama. The CDC is expected to release updated outbreak numbers today. The meningitis outbreak has led to the permanent closure of New England Compounding Center, and set inspectors' sights on Westborough-based Ameridose, which has the same owners. Ameridose has not been implicated in the outbreak. For full coverage of the NECC…
Wednesday, November 14, 2012
Appearing in front of the House Energy and Commerce Committee, the co-owner of NECC refused to answer question on the meningitis outbreak connected with his company.
Wrentham resident and co-founder of the New England Compound Center (NECC) Barry Cadden refused to speak during a congressional hearing today on the meningitis outbreak linked to his Framingham-based company. Being asked multiple questions by the House Energy and Commerce Committee, the NECC co-owner simply said said, "Under advice of counsel, I respectfully decline to answer under basis of my constitutional rights and privileges, including the Fifth Amendment." The House Energy and Commerce Committee convened the first hearing to examine the outbreak that has sickened about 440 people and caused 32 deaths across the country. Cadden said he would invoke his Fifth Amendment right to not answer questions to avoid self-incrimination. Since …
Thursday, November 8, 2012
The Westborough-based company has been closed while cooperating with an FDA investigation.
Ameridose, the Westborough facility that shares owners with the Framingham company connected to a national meningitis outbreak, handed out hundreds of layoff notices today. The Boston Globe is reporting that the layoffs, which will start Friday, affect 650 workers at Ameridose and 140 at its affiliated marketing company, Medical Sales Management. Ameridose has been closed, and will remain closed until Nov. 19, to let the FDA inspect the facility. Ameridose has not been directly implicated in the meningitis outbreak. Its sister company, the Framingham-based New England Compounding Center, had its license revoked and is blamed for producing steroid injections that caused 31 deaths and 424 cases of fungal meningitis and joint infections. …
Saturday, October 27, 2012
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 …
Friday, October 26, 2012
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 …
Thursday, October 11, 2012
The Framingham-based New England Compounding Center produced a steroid linked to a deadly meningitis outbreak, which has killed 12 people and infected 130 others across 10 states.
New England Compunding Center, which has been tied to the national memingitis outbreak, may have misled regulators and completed work beyond its state license, said Massachusetts Gov. Deval Patrick. The Framingham-based specialty pharmacy produced a steroid, that health officials believe killed 12 people, infected 130 others across 10 states, with a fungal meningitis. The governor told reporters Wednesday, "What they were supposed to be doing is filling specific prescriptions for specific patients, as I think any of us would understand a pharmacy to do. What they were doing instead is making big batches and selling them out of state as a manufacturer would and that is certainly outside of their state license." While the compounding …
George Lewis
3:29 pm on Monday, December 10, 2012
Not much has been said about Alaunus Pharmaceutical LLC. It's another company of theirs in the business of developing pharmaceuticals at the same 687 Waverly Street address as New England Compounding Center. more ›