KVK Research Inc, a generic pharmaceuticals 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.
“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 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.
Defendant: KVK Research Inc.
Criminal Charges: Two misdemeanor counts of introducing adulterated drugs into interstate commerce in violation of the Federal Food, Drug and Cosmetic Act (FDCA).
City and State: Philadelphia, Pennsylvania.
Exact Date: [No specific date provided]
Sentence or Outcome: KVK Research Inc. pleaded guilty and agreed to a proposed fine and forfeiture amount of $1.5 million.
Dollar Amounts: $1.5 million, $2 million.
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Key Facts
- State: Pennsylvania
- Category: Drug Trafficking|Fraud & Financial Crimes|Violent Crime
- Source: DOJ Press Release â†â€â€
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