Controversies
Controversies tied to this brand in public sources. A listing is not a finding of fault.
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2021
U.S. criminal resolution over Kalyani records
Fresenius Kabi Oncology Limited agreed to pay $50 million in fines and forfeiture after pleading guilty to concealing and destroying records relevant to an FDA inspection.
2019
Foreign bribery settlement involving Fresenius Medical Care
Fresenius Medical Care agreed to pay approximately $231 million to resolve U.S. Department of Justice and SEC allegations involving bribery and improper payments used to obtain business in Angola, Saudi Arabia, Morocco, and Spain.
2015
Faulty insulin syringes and patient death
Fresenius Kabi and Calea UK were fined in the United Kingdom after syringes supplied to a hospital contained saline rather than insulin. A coroner found the resulting diabetic ketoacidosis to be a major contributory factor in Neil Judge’s death.
2013
Kalyani manufacturing and quality-control investigation
Fresenius Kabi Oncology’s Kalyani, India, facility faced regulatory scrutiny after employees concealed or destroyed records before an FDA inspection. The matter ultimately resulted in a U.S. criminal resolution and compliance obligations.
2012
Hydroxyethyl starch legal-threat controversy
Fresenius Kabi was criticized after reportedly threatening legal action against researcher Anders Perner following publication of research raising safety concerns about hydroxyethyl starch in severe sepsis. European regulators subsequently required suspension measures for HES products.