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Mold, and in some cases, an overgrowth of bacteria was detected in different areas of the New England Compounding Center's two "clean rooms" nearly 90 times since January, the Food and Drug Administration report said.
Clean rooms are intended to be sterile environments in which drugs are produced.
Despite the warnings from its own monitors, the FDA report says the compounding center did not investigate the reports of the contamination nor is there documented evidence it worked to decontaminate the affected areas.
Tainted medications from the compounding center have been blamed for the outbreak of fungal meningitis that has caused 25 deaths and 338 illnesses.
The FDA's preliminary findings were released following an inspection of the compounding center this month. In addition to documented reports of bacterial contamination, FDA investigators observed "greenish black foreign matter" and "white filamentous material" in vials of methylprednisolone acetate -- the steroid linked to the meningitis outbreak.
The Framingham, Massachusetts-based compounding center acknowledged receiving the report Friday, but declined to comment beyond saying it will review the findings.
"We will follow the existing regulatory process and provide our comments to the FDA after we have had adequate time for a complete review of the report," the company statement said.
The FDA report comes the same week that the Massachusetts Board of Registration in Pharmacy voted to revoke permanently the compounding center's license to operate in the state as well as the licenses of the company's three principal pharmacists.
A damning nine-page report released Tuesday by the same state board "identified serious deficiencies and significant violations of pharmacy law and regulations that clearly placed the public's health at risk."
Federal authorities have launched a criminal investigation into the center's safety practices.
Authorities were first alerted to the outbreak when a cluster of six rare fungal meningitis cases were reported in Tennessee on September 24. The patients shared several risk factors, including an epidural injection of a steroid -- methylprednisolone acetate 80 mg/ml preservative free -- that had been compounded at the center.
Since then, the outbreak has grown to 18 states.
Friday, October 26 2012, 06:41 PM CDT
Miss. chooses new firm to run Woodville prison
May 18, 2013 20:50 GMT
WOODVILLE, Miss. (AP) -- Mississippi officials have picked a new company to run the Wilkinson County Correctional Facility.
Utah-based Management and Training Corp. announced Friday that the Mississippi Department of Corrections has chosen it to run the 1,000-bed prison starting July 1, the Natchez Democrat reports (http://bit.ly/10MvOGv).
Corrections Corporation of America, based in Nashville, Tenn., had run the prison since 1998. MTC says it will keep "the vast majority" of employees.
MTC will get a five-year contract to run the prison with two one-year options. Last year, officials chose MTC to take over East Mississippi Correctional Facility, the Walnut Grove Correctional Facility and the Marshall County Correctional Facility from the GEO Group. MTC won 10-year contracts for each.
CCA still runs the Tallahatchie County Correctional Facility and the Adams County Correctional Center in Mississippi.
Information from: The Natchez Democrat, http://www.natchezdemocrat.com/
Gauge of US economy's future health up in April
WASHINGTON (AP) -- A measure of the U.S. economy's future health rose in solidly in April, buoyed by a sharp rise in applications to build new homes and apartments.
BC-US--Dow Record-Three Personal Stories, 1st Ld-Writethru,1173
Dow Record: Three tales of ups, downs and changes
AP Photo FX102, FX103
Eds: With BC-US--Dow Record. Adds photos.
By SCOTT MAYEROWITZ
AP Business Writer
NEW YORK (AP) -- When the Dow first crossed 14,000, investors were overjoyed. ...
IN THE NEWS: LABOR GROUP SAYS CONDITIONS AT APPLE PLANTS IMPROVING
WASHINGTON (AP) -- A labor group Apple joined to assess working conditions at three manufacturing plants in China, where its products are made, says conditions are getting better.
ON THIN ICE?
ANCHORAGE, Alaska (AP) -- He was already on thin ice with the law when he failed to meet the conditions of his probation.