A drug manufacturer in India has been fined $50m for hiding and erasing records ahead of an inspection by the United States Food and Drug Administration (FDA).
The deception occurred at a drug manufacturing plant in Kalyani, West Bengal, that makes active pharmaceutical ingredients (APIs) used in several different cancer drugs distributed to terminally ill patients in the US.
The plant, which was owned and operated by Fresenius Kabi Oncology Limited (FKOL), was due to undergo an FDA inspection in January 2013. According to documents filed in a federal court in the District of Nevada, records proving that drugs were being manufactured in contravention of FDA requirements were removed from the facility or deleted from the plant’s computers before the inspection took place.
The concealment and erasure of records was carried out by employees at the behest of FKOL management.
“Kalyani plant employees removed computers, hard copy documents, and other materials from the plant and deleted spreadsheets that contained evidence of the plant’s non-compliant practices,” said a spokesperson for the Department of Justice.
The United States charged FKOL with the misdemeanor offense of violating the Federal Food, Drug and Cosmetic Act by failing to provide certain records to FDA investigators.
To resolve the charges, FKOL agreed to plead guilty to the offense. On March 23, the company was sentenced to pay a criminal fine of $30m by US District Judge Jennifer Dorsey, who further ordered FKOL to forfeit $20m.
FKOL was also ordered to implement an ethics and compliance program that will detect, prevent, and correct any future violations of US law relating to the company’s manufacture of cancer drugs intended for terminally ill patients.
The case was investigated by the FDA Office of Criminal Investigations, Los Angeles Field Office, with the assistance of the Central Bureau of Investigation in India.
Acting US Attorney Christopher Chiou said his office was committed to holding accountable companies that disregard FDA regulations and put consumers’ health at risk.
“Together with our agency partners, we will continue to ensure that drug manufacturers fully comply with their obligations to maintain the integrity of records and data,” said Chiou.