Indian drugmaker to pay $50mn in fine for destroying records before FDA inspection, Health News, ET HealthWorld

Washington: An Indian drug manufacturer has agreed to plead guilty to concealing and destroying records prior to a 2013 US Food and Drug Administration‘s inspection of its plant and pay USD 50 million in fines and forfeiture, the Department of Justice has announced

In a criminal information filed in federal court in the District of Nevada and unsealed on Tuesday, Fresenius Kabi Oncology Limited (FKOL) was charged with violating the Federal Food, Drug and Cosmetic Act by failing to provide certain records to Food and Drug Administration‘s (FDA) investigators.

As part of a criminal resolution, FKOL agreed to plead guilty to the misdemeanour offense, pay a criminal fine of USD 30 million, and forfeit an additional USD 20 million.

FKOL also agreed to implement a compliance and ethics programme designed to prevent, detect, and correct violations of US law relating to FKOL’s manufacture of cancer drugs intended for terminally ill patients, a media release said.

“By hiding and deleting manufacturing records, FKOL sought to obstruct the FDA’s regulatory authority and prevent the FDA from doing its job of ensuring the purity and potency of drugs intended for US consumers,” said Acting Assistant Attorney General

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