BOSTON (AP) - State officials said Tuesday they found unclean conditions including visible black specks of fungus in steroids made by a pharmacy linked to a deadly outbreak of meningitis.
Gov. Deval Patrick said the state has moved to revoke the license of the New England Compounding Center and three pharmacists.
State officials said a preliminary investigation found drugs were sent out before tests results on their sterility could be returned and a leaking boiler was located near a company clean room. They also said the company operated as a drug manufacturer by producing drugs for broader use, rather than filling out specific prescriptions for specific doctors, which is all its license allowed.
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.
A congressional committee on Monday sought a decade's worth of records from the company as new state documents detailed problems an outside firm hired to do an assessment found there in 2006.
The state documents, 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.
In a letter sent Monday to a lawyer for NECC, the House Committee on Energy and Commerce 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.
NECC spokesman Andrew Paven said he hadn't seen the committee's letter but the company continues to cooperate with the ongoing investigation.
"NECC worked cooperatively with the Massachusetts Board of Registration in Pharmacy to resolve to the Board's satisfaction any issues brought to the company's attention," he said by email.
Associated Press writers Steve LeBlanc and Jay Lindsay contributed to this report.