FDA Warns CorePharma Over Manufacturing Issues

Law360, New York (August 11, 2010, 4:31 PM EDT) -- The U.S. Food and Drug Administration has warned pharmaceutical company CorePharma LLC about alleged problems with its manufacturing processes, including an incident where the company manufactured drugs in a room with only a curtain separating it from a working construction site.

CorePharma's quality control unit is either not doing its job, or has not been given the authority to, the FDA said in a letter made public Tuesday. The agency cited several alleged violations of good manufacturing practice at the company's Middlesex, N.J., drug plant....
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