Fresenius Kabi Oncology

History

2021: Recognition of destruction of data on violations at the plant

On March 9, 2021, it became known that the Indian company Fresenius Kabi Oncology, which produces ingredients for cancer drugs, admitted to destroying and concealing documents about industrial irregularities in anticipation of an FDA inspection in January 2013.

According to a statement by the US Department of Justice, the company owns and operates a plant in Indian Kalyani. It produces active pharmaceutical ingredients used in "various cancer products" distributed in the United States.

Fresenius Kabi Oncology will pay $50 million to destroy data on violations at its plant

The FDA inspected the Indian plant in 2013. Prior to the inspection, Fresenius Kabi deleted and destroyed records that would have shown that it produced ingredients in violation of FDA requirements, the US Department of Justice said.

In particular, according to a statement by the US Department of Justice, employees of the Fresenius Kabi Oncology plant in Kalyani removed computers, paper documents and other materials from the premises, as well as deleted spreadsheets containing evidence of violations by the plant. After the audit, the firm received a warning letter from the FDA in July 2013 detailing numerous violations observed by inspectors during their January visit to Kalyani. Among the problems identified by the FDA was the practice of mixing failed batches of active pharmaceutical substances (AFS) with batches that have passed the specification so that final impurity tests comply with the documentation.

In addition, Fresenius Kabi Oncology employees used test and "demonstration" data chromatographs ones that were actually introduced before the samples were analyzed, and "used to conclude that the batches met the specification," the FDA indicated.

During the inspection, the company also repeatedly detained, refused, limited or did not provide information to FDA inspectors, the US regulatory department wrote.

The Kalyani plant was again mentioned also in a December 2017 FDA letter^[1] for failing to investigate and document non-specification results; here inspectors found about 248 cases of interruption of chromatographic sequences, not justified by a malfunction of the apparatus or other problems. In a 2017 letter, inadequate testing procedures were also found.

Noting the deficiencies identified in the 2013 warning letter, the FDA said in 2017 that "these recurring failures indicate inadequate supervision and control of the drug manufacturing facility."^[2]

Fresenius Kabi Oncology pleaded guilty to violating the Federal Food, Drug and Cosmetic Act. She will pay the American government a total of $50 million, including a fine of $30 million and confiscation of property for $20 million. Fresenius Kabi Oncology also agreed to implement a regulatory and ethical compliance program to meet U.S. standards.

The behavior of Fresenius Kabi Oncology Limited put patients at risk. The Department of Justice will continue to work with the FDA to prosecute drugmakers who obstruct these checks, said Brian Boynton, Acting Assistant Attorney General of the Civil Affairs Division of the Department of Justice.

The company itself claims that employees who did not provide the FDA with the necessary information were fired in 2013.

Notes