Indian Drugmaker to Pay $50 Million in Fines, Forfeiture in U.S. for Irregularities
Fresenius Kabi Oncology Limited admitted that it was guilty of the charge of violating the Federal Food, Drug and Cosmetic Act by failing to provide certain records to the U.S. Food and Drug Administration investigators and would pay a criminal fine of $30 million and $20 million in forfeitures, according to the Justice Department. (Xinhua/IANS photo)
NEW YORK – A cancer drugmaker in India has admitted to destroying and concealing records before an inspection of its plant in West Bengal by U.S. authorities and has agreed to pay $50 million in fines and forfeitures, according to the Justice Department.
The admission made by Fresenius Kabi Oncology Limited was made public in the federal court in Las Vegas, Nevada, Feb. 9, the department said.
The company admitted that it was guilty of the charge of violating the Federal Food, Drug and Cosmetic Act by failing to provide certain records to the U.S. Food and Drug Administration investigators and would pay a criminal fine of $30 million and $20 million in forfeitures, according to the department.
Acting Assistant Attorney General Brian Boynton said: “FKOL’s conduct put vulnerable patients at risk.
“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 U.S. consumers.”
The department acknowledged the help of India’s Central Bureau of Investigation, saying it “provided invaluable assistance to U.S. authorities in the investigation of this matter.”
Just before an FDA inspection of its manufacturing facility in Kalyani, West Bengal, in 2013, the drugmaker “management directed employees to remove certain records from the premises and delete other records from computers that would have revealed FKOL was manufacturing drug ingredients in contravention of FDA requirements,” according to court documents.
Its employees removed computers, hardcopy documents, and other materials from the premises and deleted spreadsheets that had evidence of the plant’s violations, according to court documents.
The department said that at the Kalyani plant, FKOL made active pharmaceutical ingredients (APIs) used in various cancer drug products distributed in the U.S.
FKOL appears to have connections to a German multinational company although it is listed on the National Stock Exchange in India.
A “warning letter” was sent by the FDA on Dec. 4, 2017 about the findings of an FDA inspection that year of the FKOL’s Kalyani plant to Mats Henrikkson, CEO of Fresenius Kabi, in Bad Homburg, Germany.
According to the company history on FKOL’s website, it began as a part of Dabur Pharma and in 2008, “the Burman family, promoters of the Dabur Pharma Group, divested its entire stake in Dabur Pharma Ltd. to Fresenius Kabi, a business segment of Fresenius SE & Co. KGaA, a German Multinational with business interests across the globe.”