FDA: Drug Co. Knew About Mold, Bacteria Contamination

Months before the meningitis outbreak

By Newser Editors and Wire Services

Posted Oct 26, 2012 6:45 PM CDT

(Newser) – Staffers at a pharmacy linked to the deadly meningitis outbreak documented dozens of cases of mold and bacteria growing in rooms that were supposed to be sterile, according to federal health inspectors. In a preliminary report on conditions at the pharmacy, the US Food and Drug Administration said today that even when the contamination at New England Compounding Center exceeded the company's own safety levels, there is no evidence that staffers investigated or corrected the problem. The FDA uncovered some four dozen reports of potential contamination in company records, stretching back to January this year.

The report comes from an FDA inspection of the Framingham, Massachusetts-based company earlier this month after steroid injections made by the company were tied to an outbreak of fungal meningitis. FDA officials confirmed last week that the black fungus found in the company's vials was the same fungus that has sickened 338 people across the US, causing 25 deaths. The New England Compounding Center's lawyer said today the pharmacy "will review this report and will continue our cooperation with the FDA."

In this Thursday, Oct. 4, 2012, file photo, a sign requesting No Soliciting hangs on the door of the New England Compounding Center.
In this Thursday, Oct. 4, 2012, file photo, a sign requesting "No Soliciting" hangs on the door of the New England Compounding Center.   (AP Photo/Stephan Savoia, File)
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