Tuesday, November 13, 2012

Not good!

Meningitis outbreak: Inspectors find bird flying through Ameridose pharmacy

FDA inspectors found a Massachusetts drug company that has supplied dozens of Tennessee health-care facilities failed to properly test for the sterility of its products and did not investigate multiple complaints, including one case categorized as life-threatening.

The 20-page report on Ameridose LLC issued Monday listed multiple violations of federal regulations. Inspectors even reported seeing a bird flying through a storage area for sterile drugs.

Ameridose, based in Westborough, Mass., has the same owners as the New England Compounding Center, which has been blamed for a nationwide outbreak of fungal meningitis that has killed 31 patients, including 13 in Tennessee.

The company late last month issued a voluntary recall of all its unused products.


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