Fresenius Kabi Oncology fell afoul of the FDA in 2013 when the agency discovered employees had hidden records before a manufacturing inspection. Now, the drug ingredients manufacturer is admitting fault—and has reached a deal with the U.S. Department of Justice to put the investigation to bed.
The Fresenius Kabi unit agreed to pay a $30 million fine, forfeit another $20 million and plead guilty to concealing and destroying records ahead of a 2013 FDA inspection in Kalyani, India, Justice Department prosecutors said.
The company also promised to set up compliance and ethics programs to prevent future violations in its cancer drug manufacturing process—including regular reports to the DOJ, Germany’s Fresenius Kabi said in its own statement.
The company “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,” Brian Boynton, DOJ acting assistant attorney general, said in a release.
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Those records would have exposed manufacturing that fell short of FDA standards, court documents said—and by impeding the agency’s inspection, Fresenius Kabi Oncology “put vulnerable patients at risk,” Boynton continued.
The investigation hinges on a manufacturing plant in Kalyani, India, that turns out ingredients for cancer drugs that ultimately make their way to the U.S. The government alleges that plant managers told employees to purge records showing its manufacturing operations broke with FDA requirements.
Before the FDA inspectors arrived, Kalyani staffers deleted damaging spreadsheets and removed computers, hard-copy files and other materials from the plant itself, the documents said.
The FDA slapped Fresenius' Kalyani plant with a warning letter after that 2013 inspection and dinged the plant again in 2017, citing "repeated failures" that suggested the "facility’s oversight and control over the manufacture of drugs is inadequate."
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Fresenius Kabi Oncology was swift to notify the FDA when it discovered some of its Kalyani employees had hindered the inspection, parent company Fresenius Kabi said in a release. Those staffers broke Fresenius’ compliance standards, code of conduct and values—and promptly lost their jobs. Fresenius made the events public in July of 2013.
Products made at the Kalyani plant were within specifications and corrective actions were put in place years ago, Fresenius Kabi said. Since then, the plant has been fully operational; it continues to produce ingredients for drugs made in the U.S. to treat U.S. patients, Matthias Link, SVP of corporate communications at Fresenius Kabi, said via email.
Fresenius Kabi Oncology wasn't immediately available for comment.
“While we are pleased to have reached this resolution, we regret that such events happened years ago in one of our plants,” Mats Henriksson, CEO of Fresenius Kabi, said in a statement. “In line with our commitment to highest ethical and quality standards, we immediately and consequently took all necessary measures to remedy the situation in full cooperation with the authorities.”