Drugmaker Fined for Distributing Adulterated Drugs With Foreign-Made API
Generic drugmaker KVK Research pleaded guilty last week to charges that it "introduced adulterated drugs into interstate commerce" in violation of the Federal Food, Drug and Cosmetic Act, agreeing to pay $1.5 million in fines and forfeiture, DOJ announced.
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Under a three-year deferred prosecution agreement, the company will be subject to a compliance program meant to detect violations of federal regulations regarding current good manufacturing processes, DOJ said last week. KVK also will have to engage an independent compliance monitor to limit the chance of future violations, the agency said.
KVK admitted that from 2011 to 2013, it introduced into interstate commerce at least 62 batches of "adulterated hydroxyzine tablets" made with an active pharmaceutical ingredient from a foreign facility. The company also agreed to pay $2 million to settle charges it violated the False Claims Act due to its "failure to exercise appropriate controls as required by current good manufacturing practice regulations."