PHILADELPHIA, PA — KVK Research Inc., a Bucks County-based generic drug manufacturer, pleaded guilty this week to criminal charges of introducing adulterated drugs into interstate commerce, announced United States Attorney Jacqueline C. Romero.
Just north of Philadelphia, this generic drug manufacturer and its parent company, KVK Tech Inc., face two misdemeanor counts for violating the Federal Food, Drug, and Cosmetic Act (FDCA). The charges, filed in the federal court in Philadelphia, led to KVK Research’s guilty plea and an agreed fine and forfeiture amounting to $1.5 million.
In an unexpected turn, KVK Tech managed to escape conviction on the charges by consenting to a three-year deferred prosecution agreement (DPA) that stipulates the implementation of a compliance program. Designed to prevent violations of federal regulations and promote good manufacturing processes, this program marks a necessary step in safeguarding production quality. As part of the DPA, the company will also have to employ an independent compliance monitor to evaluate and ensure the effectiveness of their corporate compliance program.
Overseeing the proceedings, U.S. District Judge Harvey Bartle III accepted KVK Research’s plea.
Attorney Romero expressed solidarity with consumers, acknowledging their expectations of manufacturers adhering to FDA regulations. She stressed that the introduction of adulterated drugs into interstate commerce threatened patient safety. Romero further reiterated her office’s commitment to holding manufacturers accountable for their unlawful actions and their compliance with safety measures.
George Scavdis, Special Agent in Charge of the FDA Office of Criminal Investigations, warned against evading the FDA process, pledging to protect public health by continuing their investigations. “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.
During the guilty plea and agreement with the DPA, the companies conceded that between January 2011 and October 2013, they had introduced at least 62 batches of adulterated hydroxyzine tablets into interstate commerce. The tablets contained an active pharmaceutical ingredient (API) sourced from a foreign facility which KVK Tech failed to declare to the FDA or seek their authorization for.
KVK Tech also admitted to manufacturing prescription drugs without appropriate computer and system controls between February and April 2019. This violation of good manufacturing practices regulations resulted in the drugs being considered adulterated by law.
Furthermore, KVK Tech consented to pay an additional $2 million to settle its civil liability under the False Claims Act. This was due to the company’s failure to maintain appropriate controls, causing KVK Tech to distribute adulterated drugs into interstate commerce.
The Justice Department and other federal agencies united in their efforts to hold manufacturers accountable for their violations, protecting the health of the public, and particularly the U.S. military members and their families. The case was investigated by the FDA’s Office of Criminal Investigations.
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