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Violation Tracker Individual Record

Company: KVK Research Inc. and KVK Tech Inc.
Penalty: $3,500,000
Year: 2024
Date: March 6, 2024
Offense Group: safety-related offenses
Primary Offense: drug or medical equipment safety violation
Secondary Offense: False Claims Act and related
Violation Description: KVK Research Inc., a generic drug manufacturer in Bucks County, Pennsylvania, pleaded guilty to criminal charges that it introduced adulterated drugs into interstate commerce. Pursuant to a plea agreement, KVK Research agreed to a fine and forfeiture amount of $1.5 million. Its affiliate KVK Tech Inc. agreed to a three-year deferred prosecution agreement (DPA) that will allow the company to avoid conviction on the charges in the information if it complies with the terms of the agreement. Additionally, KVK Tech agreed to pay $2 million to resolve its civil liability under the False Claims Act arising from the company's failure to exercise appropriate controls as required by current good manufacturing practice regulations, which caused KVK Tech to introduce into interstate commerce drugs deemed to be adulterated.
Level of Government: federal
Action Type: agency action
Agency: Justice Department Civil Division
Civil or Criminal Case: civil and criminal
Prosecution Agreement: deferred prosecution agreement
Facility State: Pennsylvania
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.