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# Fresenius Kabi Oncology Pleads Guilty in Records Case
- URL: https://www.fdaweb.com/fresenius-kabi-oncology-pleads-guilty-in-records-case/
- Published: 2021-02-10T12:00:00.000Z
- Updated: 2026-09-14T16:46:16.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5148634

Fresenius Kabi Oncology is pleading guilty to concealing and destroying records before a 2013 FDA plant inspection and has agreed to pay $50 million in fines and forfeitures. The Department of Justice [says](https://www.justice.gov/opa/pr/indian-cancer-drug-manufacturer-agrees-plead-guilty-and-pay-50-million-concealing-and?ref=fdaweb.com) that a criminal information filed in Nevada federal court charges the company with violating the Federal Food, Drug, and Cosmetic Act by failing to provide certain records to FDA investigators. In addition to a $30 million fine and $20 million forfeiture, the company also agreed to implement a compliance and ethics program designed to prevent, detect, and correct violations of U.S. law relating to its manufacturing of cancer drugs for terminal patients.

Court documents show that Fresenius Kabi owned and operated a facility in Kalyani, West Bengal, India, that manufactured active pharmaceutical ingredients (APIs) used in various cancer drugs distributed in the U.S. The government alleges that before a 1/2013 FDA inspection at the facility, plant management directed employees to remove certain records from the premises and delete other records from computers that would have revealed the company was manufacturing APIs in contravention of FDA requirements. Plant employees removed computers, hardcopy documents, and other materials from the premises and deleted spreadsheets that contained evidence of the plant’s violative practices, the Justice Department says.