Feds Raid Offices of Newtown Pharmaceutical Company KVK Tech

Feds Raid Offices of Newtown Pharmaceutical Company KVK Tech

https://patch.com/pennsylvania/newtown-pa/feds-raid-offices-newtown-pharmaceutical-company-kvk-tech

The raids came less than two months after two executives of the generic drug manufacturer were charged with conspiracy to defraud the FDA​.

NEWTOWN, PA — Federal agents served search warrants at the offices of a Bucks County pharmaceutical company Thursday morning in connection with ongoing investigations into the company’s alleged conspiracy to defraud the U.S. Food and Drug Administration.

Around 7 a.m., the Newtown Township Police Department assisted federal agents from the FDA, Homeland Security, the Department of Labor, Health and Human Services and other federal branches with three search warrants at each of the KVK Tech facilities located within Newtown Township: 100 Campus Drive, 110 Terry Drive and 114 Pheasant Run.

The warrants were executed simultaneously at 7 a.m. at all three sites, police said.

The raid comes less than two months after two executives of the generic drug manufacturer were charged with conspiracy to defraud the FDA. Murty Vepuri, 69, and Ashvin Panchal 50, were charged in June by the U.S. Attorney’s Office with distributing unapproved drugs and misleading the agency by concealing information about its products.

From October 2010 through at least March 2015, Vepuri and Panchal, the company’s de facto owner and head of quality assurance, respectively, conspired to defraud the U.S. by impeding, impairing, and defeating FDA’s mission to protect the health and safety of the public by ensuring that drugs marketed and distributed in the U.S. are safe and effective for their intended uses, according to the June indictment filed by federal prosecutors.

Vepuri, who previously owned a drug company in New Jersey that was subject to a restraining order due to FDA violations, is charged with hiding his involvement in the Newtown company by placing its ownership in private trusts to benefit his children. Vepuri then allegedly represented to the FDA that he was merely an advisor or consultant to KVK Tech, when in reality he exercised unchecked authority over the company, federal prosecutors said.

Under his control, the company ignored regulatory requirements that had the potential to slow the manufacture, distribution and sale of its drugs, authorities said. Vepuri and Panchal are also charged with having provided false explanations to the FDA when inspectors identified violations. Often, Vepuri and Panchal attributed regulatory failures to a mistake or misunderstanding, and the company would falsely assure the FDA that violations had been addressed when they knew no corrective and preventative actions had been taken, the U.S. Attorney’s Office said.

The indictment highlighted the company’s conduct with regard to Hydroxyzine, a prescription drug to treat anxiety, for which Vepuri purchased an ingredient made in Mexico that was not an FDA-approved source, authorities said.

If convicted, Vepuri and Panchal each face a maximum possible sentence of five years in prison, three years of supervised release, a $250,000 fine and other financial penalties including forfeiture. KVK Tech faces fines up to $4 million and other financial penalties such as forfeiture and probation. The parties also face mandatory exclusion from participating in federal programs.

All public information regarding the specifics of the warrants are being referred to the U.S. Food and Drug Administration, Office of Criminal Investigations Philadelphia office, at 215-597-4390.

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