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Violation Tracker Individual Record

Company: ACell, Inc.
Current Parent Company: Integra LifeSciences
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Penalty: $15,000,000
Year: 2019
Date: June 11, 2019
Offense Group: safety-related offenses
Primary Offense: drug or medical equipment safety violation
Secondary Offense: False Claims Act and related
Violation Description: ACell, Inc., a Maryland-based medical device manufacturer, pleaded guilty to charges relating to its MicroMatrix powder wound-dressing product--one misdemeanor count of failure and refusal to report a medical device removal in violation of the Federal Food, Drug, and Cosmetic Act. In addition, ACell agreed to settle allegations that it caused false claims to be submitted to federal health care programs for MicroMatrix, and to pay $15 million to resolve its criminal and civil liability arising from these matters.
Level of Government: federal
Action Type: agency action
Agency: U.S. Attorney-District of Maryland
Civil or Criminal Case: civil and criminal
HQ Country of Current Parent: USA
HQ State of Current Parent: New Jersey
Ownership Structure of Current Parent: publicly traded
Major Industry of Current Parent: medical equipment and supplies
Specific Industry of Current Parent: medical equipment
Source of Data: (click here)
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Current parent company note: Parent-subsidiary relationship is current as of the most recent revision listed in the Update Log.