Violation Tracker Individual Record

Company: 
Fresenius Kabi Oncology Limited
Current Parent Company: 
Fresenius
Penalty: 
$50,000,000
Year: 
2021
Date: 
February 9, 2021
Offense Group: 
safety-related offenses
Primary Offense: 
drug or medical equipment safety violation
Violation Description: 

Indian drug manufacturer Fresenius Kabi Oncology Limited (FKOL) agreed to plead guilty to concealing and destroying records prior to a 2013 U.S. Food and Drug Administration (FDA) inspection and pay $50 million in fines and forfeiture.

Level of Government: 
federal
Action Type: 
agency action
Agency: 
Justice Department Civil Division
Civil or Criminal Case: 
criminal
HQ Country of Parent: 
Germany
Ownership Structure of Parent: 
publicly traded
Major Industry of Parent: 
healthcare services
Specific Industry of Parent: 
healthcare services
Source Notes: 
If an online information source is not working, check the Violation Tracker Data Sources page for an updated link.
Parent company note: 
Parent-subsidiary relationship is current as of the most recent revision listed in the Update Log.