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Doctor, Clinic Owner and Staff Charged with Falsifying Clinical Trial Data

Doctor, Clinic Owner and Staff Charged with Falsifying Clinical Trial Data
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Indian Cancer Drug Manufacturer Agrees To Plead Guilty And Pay $50 Million For Concealing And Destroying Records In Advance Of FDA Inspection

Indian Cancer Drug Manufacturer Agrees To Plead Guilty And Pay $50 Million For Concealing And Destroying Records In Advance Of FDA Inspection
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LAS VEGAS, Nev. – Indian drug manufacturer Fresenius Kabi Oncology Limited (FKOL) has agreed to plead guilty to concealing and destroying records prior to a 2013 U.S. Food and Drug Administration (FDA) plant inspection and pay $50 million in fines and forfeiture, the Department of Justice announced today.
In a criminal information filed in federal court in the District of Nevada and unsealed today, the United States charged FKOL with violating the Federal Food, Drug and Cosmetic Act by failing to provide certain records to FDA investigators. As part of a criminal resolution, FKOL agreed to plead guilty to the misdemeanor offense, pay a criminal fine of $30 million, and forfeit an additional $20 million. FKOL also agreed to implement a compliance and ethics program designed to prevent, detect, and correct violations ....

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FKOL to pay $50mn for destroying records ahead of an FDA Inspection

Fresenius Kabi Oncology Ltd (FKOL) pleaded guilty to concealing and destroying records prior to a 2013FDA inspection of its Kalyani plant. ....

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