Basic Search  |  Summaries  |  Advanced Search

Violation Tracker Individual Record

Company: Fresenius Kabi Oncology Limited
Current Parent Company: Fresenius SE & Co.
Parent at the Time of the Penalty Announcement:  subscribe to see this data field
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 Current Parent: Germany
Ownership Structure of Current Parent: publicly traded
Major Industry of Current Parent: healthcare services
Specific Industry of Current Parent: dialysis services
Source of Data: (click here)
Source Notes: If an online information source is not working, check the Violation Tracker Data Sources page for an updated link.
Current parent company note: Parent-subsidiary relationship is current as of the most recent revision listed in the Update Log.