cGMP Violations Result in $3.5M in Penalties for PA Drug Manufacturer

Manufacturing and distributing adulterated drugs for nearly a decade – some of which originated in a foreign country without FDA authorization – has brought $3.5 million in penalties to a Pennsylvania generic pharmaceutical company.

The litany of charges against KVK Tech and affiliate KVK Research released last week with the company’s guilty plea in the Eastern District of Pennsylvania federal court, also includes alleged false claims submitted to healthcare programs for U.S. military members through admitting to introducing at least 62 batches of adulterated hydroxyzine tablets into interstate commerce between January 2011 and October 2013.  

The company agreed to a three-year Deferred Prosecution Agreement (DPA) allowing it to avoid conviction if it complies with agreement terms that include operating with an independent compliance monitor for the next three years that would detect and prevent violating federal regulations. The DPA did not erase a fine for the company, which agreed to pay $2 million for violating the False Claims Act.   

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