BOSTON (FOX 25 / MyFoxBoston.com) – During a press conference held on Tuesday, Massachusetts Governor Deval Patrick addressed several concerns surrounding the Framingham firm linked to the nationwide outbreak of meningitis, as well as steps the Commonwealth will take in order to prevent similar indiscretions.
Gov. Patrick discussed the ongoing investigation into the practices of the New England Compounding Center in Framingham. The center's sister companies Ameridose and its partnering distributor Alanis Pharmaceutical have also come under fire in light of the investigation. All three companies have ceased operations.
At the onset of the investigation, which began at the beginning of October, officials believed that three lots of a specific injectable steroid had been contaminated.
The FDA determined that the NECC was acting beyond the scope of its license and had actually become more of a manufacturer.
On 13 different occasions, the NECC shipped orders before receiving results that the lot was sterile, reports the Department of Public Health. NECC reportedly shipped some lots as early as 11 days before receiving results.
The Dept. of Public Health found that the center's process of sterilization was not in accordance with industry standards.
The DPH also reported that visible black matter was seen in several vials that had been recalled and returned to the Framingham facility. The black matter was in fact the fungal contaminant linked to the outbreak.
Investigators also found that NECC did not comply with other safety standards, including levels of cleanliness to prevent contamination in several areas of the facility. Investigators found a leaky boiler in an environment where contamination could have occurred; however, the investigators have yet to definitively pinpoint the source of contamination.
A federal and criminal investigation has been launched into NECC's practices.
Gov. Patrick plans on forming a special commission to oversee the rapidly expanding pharmaceutical industry in Massachusetts.
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