Articles Tagged with Good Manufacturing Process

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The DOJ reported today that SB Pharmco Puerto Rico Inc., a subsidiary of GlaxoSmithKline, pleaded guilty to False Claims Act charges and agreed to a fine totaling $750 million. The total includes a criminal fine of $150 million and a civil False Claims Act fine of $600 million.

This case represents the first time the False Claims Act has been used to combat violations of FDA manufacturing standards. Continue reading