Investigators are sifting through records and testing a Massachusetts lab to
determine how a fungus associated with a form of meningitis worked its way into
products that should have been sterile.
"It's really 'CSI' stuff," says Eric Kastango, president and owner of ClincalIQ, a New Jersey-based consulting firm that aims to help the industry meet safety standards. "The microoganism in the vials is the same microoganism in the patients. The question is: How did it get in the vials in the pharmacy?"
The incident involves the New England Compounding Center (NECC) in Framingham, Mass., which is no stranger to regulator scrutiny. Records released Monday by the Massachusetts Department of Public Health indicate that the company has been the subject of several complaints and inspections since 1999.
In the current case, large shipments of injectable steroid formulated by NECC have sickened 308 people in 17 states and killed at least 23, according to figures updated on Tuesday by the US Centers for Disease Control in Atlanta. Some 14,000 patients in all may have received contaminated injections.
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"It's really 'CSI' stuff," says Eric Kastango, president and owner of ClincalIQ, a New Jersey-based consulting firm that aims to help the industry meet safety standards. "The microoganism in the vials is the same microoganism in the patients. The question is: How did it get in the vials in the pharmacy?"
The incident involves the New England Compounding Center (NECC) in Framingham, Mass., which is no stranger to regulator scrutiny. Records released Monday by the Massachusetts Department of Public Health indicate that the company has been the subject of several complaints and inspections since 1999.
In the current case, large shipments of injectable steroid formulated by NECC have sickened 308 people in 17 states and killed at least 23, according to figures updated on Tuesday by the US Centers for Disease Control in Atlanta. Some 14,000 patients in all may have received contaminated injections.
Read full article here
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