Violation Tracker Individual Record

Company: 
Genzyme Corporation
Current Parent Company: 
Sanofi
Penalty: 
$32,587,439
Year: 
2015
Date: 
September 3, 2015
Offense Group: 
safety-related offenses
Primary Offense: 
drug or medical equipment safety violation
Violation Description: 

Genzyme Corporation, a wholly-owned biotechnology subsidiary of French pharmaceutical company Sanofi, agreed to resolve criminal charges that it violated the federal Food, Drug and Cosmetic Act with regard to the unlawful distribution of Seprafilm, a surgical device it marketed and promoted. As part of the agreed resolution, the department filed a two-count criminal information in the U.S. District Court for the Middle District of Florida charging that between 2005 and 2010, Genzyme caused a medical device to become adulterated and misbranded while being held for sale. The conduct occurred prior to Sanofi's acquisition of Genzyme, based in Cambridge, Massachusetts, in 2011. To resolve these charges, Genzyme agreed to enter into a deferred prosecution agreement with the government for a term of at least two years. As part of the agreement, Genzyme agreed to admit to and accept responsibility for the facts underlying the charges and pay a monetary penalty of $32,587,439.

Level of Government: 
federal
Action Type: 
agency action
Agency: 
Food and Drug Administration referral to the Justice Department
Civil or Criminal Case: 
criminal
Prosecution Agreement: 
deferred prosecution agreement
HQ Country of Parent: 
France
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.