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The company has pleaded guilty to violating the Federal Food, Drug and Cosmetic Act by failing to provide certain records to FDA investigators and will pay a criminal fine of $30 million, and forfeit an additional $20 million.
The United States Department of Justice announced on Feb. 9, 2021 that Fresenius Kabi Oncology Limited (FKOL), an oncology drug manufacturer, has agreed to plead guilty to concealing and destroying records preceding a 2013 FDA plant inspection and pay $50 million in fines and forfeiture.
According to a Department of Justice press release, court documents showed FKOL owned a manufacturing plant in Kalyani, West Bengal, India, that produced active pharmaceutical ingredients used in cancer drug products distributed to the US. Prior to a January 2013 FDA inspection of the facility, the documents report that FKOL plant management asked employees to remove specific records from the property and delete other records from computers that showed FKOL was manufacturing drug ingredients in violation of FDA requirements. Employees removed computers, hardcopy documents, and other materials and deleted spreadsheets that showed the plant’s violations, the press release said.
FKOL has pleaded guilty to violating the Federal Food, Drug, and Cosmetic Act by failing to provide certain records to FDA investigators and will pay a criminal fine of $30 million, and forfeit an additional $20 million, according to the press release. FKOL will also establish a compliance and ethics program for the prevention, detection, and correction of violations of US law in relation to the company’s manufacturing of cancer drugs for terminally ill patients.
“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 Brian Boynton of the Justice Department’s Civil Division, in the press release. “FKOL’s conduct put vulnerable patients at risk. The Department of Justice will continue to work with FDA to prosecute drug manufacturers who obstruct these inspections.”
“Pharmaceutical companies that obstruct FDA inspections jeopardize patient safety,” said US Attorney Nicholas A. Trutanich for the District of Nevada, in the press release. “Maintaining the integrity of records and data is a critical part of drug manufacturing, and our office will continue prosecuting those that obstruct FDA inspections by destroying records or other means.”
“FDA inspections of pharmaceutical manufacturing facilities help ensure the strength, quality, and purity of our medicines. Any attempt to obstruct or interfere with these inspections threatens the public health,” added Judy McMeekin, associate commissioner for Regulatory Affairs of the FDA. “We will continue to aggressively investigate and present any such obstruction for prosecution.”