FDA Finds Sanitation Lapses At Pharmacy Linked To Outbreak

Law360, New York (October 26, 2012, 7:51 PM EDT) -- U.S. Food and Drug Administration inspectors concluded Friday that the New England Compounding Center, the pharmacy linked to a deadly meningitis outbreak, may have violated federal law through its failure to maintain a sanitary environment at its facility.

The FDA sent a observational report, a so-called Form 483, to the Framingham, Mass.-based pharmacy after finding foreign material in injectable drugs during a series of inspections in October. The agency issues the document when it has observed conditions at a facility it believes may violate the Federal...
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