An Indian drug manufacturer will pay $50 million in fines and forfeiture after pleading guilty to hiding and destroying records ahead of a 2013 plant inspection by the Food and Drug Administration.
The United States charged Fresenius Kabi Oncology Limited last month with violating the Federal Food, Drug, and Cosmetic Act by failing to provide certain records to FDA investigators.
The company was sentenced to pay the fines on Tuesday.
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“By concealing and destroying drug manufacturing records, FKOL undermined FDA’s regulatory authority and placed vulnerable consumers at risk,” Brian Boynton, acting Assistant Attorney General of the Justice Department’s Civil Division, said. “Today’s sentence holds the company accountable for its past conduct and seeks to ensure it will fully comply with its obligations to the FDA going forward.”
The company pleaded guilty in February to the misdemeanor offense as part of a criminal resolution, in which they paid a fine of $30 million, a forfeiture of $20 million, and agreed to implement a compliance and ethics program designed to prevent, detect, and correct violations of federal law as it relates to the company’s manufacture of cancer drugs intended for terminally ill patients.
FKOL owned and operated a manufacturing plant in Kalyani, West Bengal, India, that manufactured active pharmaceutical ingredients used in various cancer drug products distributed across the United States, according to the Justice Department.
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Prior to the scheduled 2013 inspection of the facility, plant management directed employees to remove certain records from the premises and delete others from computers that would have shown that the company was manufacturing drug ingredients that did not meet FDA requirements.
The records removed included computers, hard copy documents, and other materials from the plant, in addition to spreadsheets that contained evidence of the plant’s unlawful practices.
