Violation Tracker Individual Record

Company: 
Ranbaxy USA Inc.
Current Parent Company: 
Sun Pharmaceuticals
Penalty: 
$500,000,000
Year: 
2013
Date: 
May 13, 2013
Offense Group: 
safety-related offenses
Primary Offense: 
drug or medical equipment safety violation
Violation Description: 

In the largest drug safety settlement to date with a generic drug manufacturer, Ranbaxy USA Inc. , a subsidiary of Indian generic pharmaceutical manufacturer Ranbaxy Laboratories Limited, pleaded guilty to felony charges relating to the manufacture and distribution of certain adulterated drugs made at two of Ranbaxy's manufacturing facilities in India. Ranbaxy also agreed to pay a criminal fine and forfeiture totaling $150 million and to settle civil claims under the False Claims Act and related State laws for $350 million.

Level of Government: 
federal
Action Type: 
agency action
Agency: 
Food and Drug Administration referral to the Justice Department
Civil or Criminal Case: 
civil and criminal
HQ Country of Parent: 
India
Ownership Structure of Parent: 
publicly traded
Major Industry of Parent: 
pharmaceuticals
Specific Industry of Parent: 
pharmaceuticals
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.