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# KVK Paying $3.5 Million in Guilty Plea
- URL: https://www.fdaweb.com/kvk-paying-3-5-million-in-guilty-plea/
- Published: 2024-03-07T12:00:00.000Z
- Updated: 2026-09-14T14:24:51.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5156501

KVK Research, Inc., a generic drug manufacturer in Bucks County, PA, has pleaded guilty to criminal charges that it introduced adulterated drugs into interstate commerce and consequently it has agreed to pay a $1.5 million penalty on those charges and $2 million to resolve civil liability under the False Claims Act. A Department of Justice [news release](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/press-releases/generic-pharmaceuticals-manufacturer-pleads-guilty-agrees-15-million-criminal-penalty-distributing?ref=fdaweb.com) says KVK Research affiliate KVK Tech agreed to a three-year deferred prosecution agreement that allows it to avoid conviction on the charges if it complies with the agreement’s terms, including implementing a compliance program to prevent and detect violations of federal regulations on current good manufacturing practices and engaging an independent compliance monitor to evaluate the company’s corporate compliance program to address and reduce the risk of future violations.

Under the plea agreement, the companies admitted that between 1/2011 and 10/2013, KVK Tech introduced into interstate commerce at least 62 batches of adulterated hydroxyzine tablets that were manufactured with an active pharmaceutical ingredient made at a foreign facility. The release says KVK Tech failed to notify FDA or seek agency authorization to use that facility as a source for the drug’s active ingredient. The companies also admitted that between 2/27/2019 and 4/16/2019 KVK Tech manufactured prescription drugs while failing to exercise appropriate controls over computer and related systems as required by current good manufacturing practice regulations, rendering the drugs adulterated, the release says.