In the wake of a national meningitis outbreak possibly traced to the New England Compounding Center, a preliminary investigative report found multiple health and safety deficiencies in operating procedures at the Framingham pharmacy.
The NECC had not been inspected since May of 2011, according to preliminary findings from the Massachusetts Department of Health released on Tuesday.
“Upon beginning the joint on-site investigation of NECC early in this outbreak, DPH and FDA investigators identified serious deficiencies and significant violations of pharmacy law and regulations that clearly placed the public’s health and safety at risk,” the report stated.
One violation found the NECC mass-produced sterile injections for general use, when its pharmacy license only granted the NECC to compound patient-specific prescriptions.
“Manufacturing and distributing sterile products in bulk was not allowed under the terms of its (NECC) state pharmacy license,” according to the report. “If NECC was appropriately licensed as a manufacturer with the FDA, the company would have been subject to additional levels of scrutiny.”
Sterilization procedures at the center were also found to be sub-marginal, with products not sterilized for the minimum required 20 minutes.
Other violations included black particulate matter found in recalled vials, dirty powder hoods that workers wear for protection from chemicals and contaminant growth risks from a leaking boiler.
Three large lots of the steroid injection methylprednisolone acetate were identified as possibly containing meningitis.
The product was distributed to more than 14,000 patients in 23 states, according to report.
The Center for Disease Control and Food and Drug Administration confirmed the presence of a fungus in unopened vials of methylprednisolone acetate taken from the NECC, according to an FDA update issued Oct. 18.
“The laboratory confirmation further links steroid injections from these lots from NECC to the multi-state outbreak of fungal meningitis and joint infections,” according to the FDA update. “Testing on the other two implicated lots of methylprednisolone acetate and other NECC injectables continues.”
The outbreak has afflicted 297 individuals with meningitis in 16 states as of Oct. 23, according to the CDC. Twenty-three people have died from the outbreak.
In an FDA update issued on Oct. 22, the FDA advised patients who believe they have been injected with a NECC product on or after May 21 to be vigilant for signs of infection and to contact their health care providers if they are concerned.
Symptoms of meningitis include fever, headache, stiff neck and increased sensitivity to light.
The NECC voluntarily surrendered their operating license on Oct. 3 after the outbreak was discovered and has recalled all of its products that were produced in 2012.
On Monday the DPH requested three NECC pharmacists voluntarily and permanently surrender their license. If the pharmacists at the NECC do not comply, the DPH has been cleared to proceed with permanent suspension of their licenses.
“The department’s collaborative investigation with the FDA is comprehensive and will continue until investigators have all information needed to determine what, if any, further action should be taken against NECC and its leadership,” the report concluded.
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