Andover Townsman, Andover, MA

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October 23, 2012

Records detail issues at firm linked to meningitis

BOSTON (AP) — A congressional committee on Monday sought a decade’s worth of records from the company at the center of a deadly meningitis outbreak as new documents detailed problems an outside assessment firm found at the company in 2006.

The Massachusetts ocuments, obtained by the Associated Press under a public records request, say investigators in 2006 found inadequate contamination control and no written standard operating procedures for using equipment, among other problems, at the New England Compounding Center. The problems were corrected that year, and a state inspection in May 2011 as the company prepared to update its facilities found no such issues.

The outbreak of meningitis, an inflammation of the lining of the brain and spinal cord, has sickened nearly 300 people, including 23 who died, in more than a dozen states. Each victim had received a steroid shot, mostly for back pain. Federal health officials matched the shots produced by the company to the outbreak after finding a deadly fungus in more than 50 unopened vials there but have not said how the shots were contaminated.

In a letter sent Monday to a lawyer for NECC, the House Committee on Energy and Commerce said it seeks nearly 10 years of documents about safety and quality issues at the company. It indicates that as far back as 2002 and 2003 officials from the Food and Drug Administration and the state conducted joint probes of the company after receiving a report about a steroid shot. Those probes preceded a 2004 joint investigation of the center by FDA and the Massachusetts Board of Registration in Pharmacy.

In January 2006, based on several complaints, the company signed with state regulators a consent agreement in which it agreed to a full inspection of its drug compounding practices by investigators.

The company’s encounters with regulators have been reported since the outbreak began, but state pharmacy board documents released Monday offer a new level of detail. They show the inspection by Illinois-based Pharmaceutical Systems Inc. found “significant gaps” in procedures and a lack of required documentation at the NECC facility in Framingham, just west of Boston.

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