FDA finds no evidence of vast quality-control errors at Mylan manufacturing plant

7/28/2009

PITTSBURGH A Food and Drug Administration inspection of a plant owned by generic drug maker Mylan has turned up no evidence of widespread manufacturing violations reported Sunday in the Pittsburgh Post-Gazette, Mylan announced Tuesday.

The Post-Gazette published an investigative report Sunday alleging that workers at Mylan’s plant in Morgantown, W.Va., had ignored and deleted computerized warnings of problems with drugs and the equipment used to manufacture them, based on leaked internal documents.

The company contacted the FDA, prompting the agency to visit the Morgantown plant. Mylan said the FDA found a “minor” deviation in standard operating procedures, but that the company had corrected the problem.

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