February 9, 2021

India-based cancer drug manufacturer Fresenius Kabi Oncology Limited (FKOL) has agreed to pay $50 million in fines and forfeiture for failing to provide certain records to FDA investigators.  In violation of the Federal Food, Drug and Cosmetic Act, which helps ensure the purity and potency of drugs sold in the United States, FKOL actively obstructed a 2013 FDA inspection of one of its plants by removing and deleting manufacturing records.  As part of the settlement, FKOL has also agreed to implement a compliance and ethics program to prevent, detect, and correct any further violations of U.S. laws.  DOJ; USAO NV

Tagged in: FDA Fraud, Healthcare Fraud, Pharma Fraud,