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Press Release

Generic Pharmaceuticals Manufacturer Pleads Guilty, Agrees to $1.5 Million Criminal Penalty for Distributing Adulterated Drugs and $2 Million to Resolve Civil Liability under the False Claims Act

For Immediate Release
Office of Public Affairs

KVK Research Inc., a generic drug manufacturer in Bucks County, Pennsylvania, pleaded guilty today to criminal charges that it introduced adulterated drugs into interstate commerce.

A criminal information filed in federal court in Philadelphia charged KVK Research and its corporate affiliate, KVK Tech Inc., with two misdemeanor counts of introducing adulterated drugs into interstate commerce in violation of the Federal Food, Drug and Cosmetic Act (FDCA). Pursuant to a plea agreement, KVK Research pleaded guilty to the information and agreed to a proposed fine and forfeiture amount of $1.5 million.

KVK Tech 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, which include implementation of a compliance program designed to prevent and detect violations of federal regulations regarding current good manufacturing processes. The DPA also requires KVK Tech to engage an independent compliance monitor to evaluate the company’s corporate compliance program to address and reduce the risk of future violations.

U.S. District Judge Harvey Bartle III presided over the KVK Research plea hearing.

“Consumers have a right to expect that the drugs they purchase are safe and manufactured in compliance with the FDCA and FDA regulations,” said Principal Deputy Assistant Attorney General Brian M. Boynton, head of the Justice Department’s Civil Division. “The Justice Department will continue to work with FDA to prosecute companies that put consumers at risk by selling adulterated drugs.”

“Consumers in this District expect that manufacturers will adhere to FDA regulations,” said U.S. Attorney Jacqueline C. Romero for the Eastern District of Pennsylvania. “When adulterated drugs are introduced into interstate commerce, that conduct has the potential to jeopardize patient safety. This case exemplifies my office’s commitment to holding manufacturers responsible for their crimes, as well as refocusing efforts on the company’s compliance to prevent future illegal conduct. In this case, the joint efforts between the office’s criminal and civil divisions to hold defendants accountable also returned money to those federal agencies affected by the defendants’ conduct.”

“The FDA’s requirements for manufacturing generic drugs are designed to ensure that patients receive safe and effective medical treatments. Evading the FDA process and distributing adulterated drugs to U.S. consumers will not be tolerated,” said Special Agent in Charge George Scavdis of the FDA Office of Criminal Investigations, Metro Washington Field Office. “We will continue to investigate and protect the public health of the nation.”

As part of the plea agreement and the DPA, the companies admitted that between January 2011 and October 2013, KVK Tech introduced into interstate commerce at least 62 batches of adulterated hydroxyzine tablets. The tablets were manufactured with an active pharmaceutical ingredient (API) made at a foreign facility. KVK Tech failed to notify FDA or seek FDA authorization to use that facility as a source of API for its hydroxyzine products. The companies also admitted that between Feb. 27, 2019, and April 16, 2019, KVK Tech manufactured prescription drugs while failing to exercise appropriate controls over computer and related systems as required by current good manufacturing practices regulations. Under federal law, such drugs are deemed to be adulterated.

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. During the Feb. 27, 2019, through April 16, 2019, time period, KVK Tech sold the adulterated pharmaceuticals, which resulted in alleged false claims submitted to the TRICARE program, Federal Employees Health Benefits Program (FEHBP), Veterans Administration (VA) and Department of Labor, Office of Workers Compensation Programs (DOL-OWCP), in violation of the False Claims Act.

“Protecting the welfare of our nation’s military members and their families is a priority for the Defense Criminal Investigative Service (DCIS), the law enforcement arm of the Department of Defense Office of Inspector General,” said Acting Special Agent in Charge Brian J. Solecki of the DCIS Northeast Field Office. “The introduction of adulterated pharmaceuticals into the TRICARE system endangers the lives of American service members and threatens our military readiness. The DCIS is committed to working with the Justice Department and our law enforcement partners to ensure that companies who engage in fraudulent activity, at the expense of the U.S. military, are investigated and prosecuted.”

“We expect manufacturers to comply with all federal laws and regulations when they are serving federal health care recipients,” said Deputy Assistant Inspector General for Investigations Conrad J. Quarles of the Office of Personnel Management Office of the Inspector General. “We applaud our investigative staff, and our law enforcement partners for their hard work protecting FEHBP enrollees and their families.”

FDA’s Office of Criminal Investigations investigated the case.

Assistant Director Ross S. Goldstein and Trial Attorney Alisha Crovetto of the Civil Division’s Consumer Protection Branch and Assistant U.S. Attorneys M. Beth Leahy and Patrick Murray for the Eastern District of Pennsylvania are prosecuting the case. Deputy Chief Charlene Keller Fullmer, Assistant U.S. Attorney Anthony D. Scicchitano and Auditor Dawn Wiggins for the Eastern District of Pennsylvania handled the civil case.

Additional information about the Consumer Protection Branch and its enforcement efforts can be found at

Except to the extent that the defendants’ admissions are part of its criminal resolution, the claims resolved by the civil settlement are allegations only and there has been no determination of liability.

Updated March 6, 2024

Consumer Protection
False Claims Act
Press Release Number: 24-255