A federal grand jury in California has indicted a Chinese national for allegedly running an unauthorized lab that assisted in the illegal manufacture and sale of “hundreds of thousands of COVID-19 test kits” in the U.S., bringing in millions of dollars, federal prosecutors say.
Jia Bei Zhu, a 62-year-old who formerly lived in Clovis, has been charged with distributing adulterated and misbranded medical devices in violation of the federal Food, Drug, and Cosmetic Act and for making false statements to the Food and Drug Administration (FDA), according to the U.S. Attorney’s Office for the Eastern District of California.
“According to court documents, between January 2020 and March 2023, through the companies Universal Meditech Incorporated (UMI) and Prestige Biotech Incorporated (PBI), Zhu sold hundreds of thousands of COVID-19 test kits to companies throughout the United States,” prosecutors said in a statement.
“UMI and PBI were based in Fresno and Reedley and did not obtain pre-market approval, pre-market clearance, emergency use authorization, or other applicable exemption from the FDA as was required,” it added. “UMI and PBI received millions of dollars for the sales of the test kits.”