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

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. 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.

Jeffrey Newman is a whistleblower lawyer whose firm represents whistleblowers in healthcare fraud under the False Claims Act (FCA) also whistleblower claims brought under the SEC whistleblower program for violations of securities regulations including insider trading cases. He also handles cases involving evasion of US sanctions against China, Iran and Russia and other sanctioned entities and he can be reached at Jeff@JeffNewmanLaw.com or at 617-823-3217