Jia Bei Zhu, the operator of the illegal Reedley biolab, was indicted by a federal grand jury on three counts.
U.S. Attorney Phillip Talbert announced that the grand jury returned the indictment on Thursday.
The big picture: Zhu is 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).
- A Chinese national and former Clovis resident, Zhu also goes by the aliases Jesse Zhu, Qiang He and David He.
- If he is convicted, he faces a maximum of three years in prison and a $250,000 fine for the adulterated and misbranding of medical devices charges, and five years in prison and a $250,000 fine for the false statements charge.
Go deeper: Court documents revealed that Zhu sold hundreds of thousands of COVID-19 test kits to companies throughout the nation through companies Universal Meditech Incorporated and Prestige Biotech Incorporated from January 2020 to March 2023.
- Both companies never received pre-market approval, pre-market clearance, emergency use authorization or other applicable exemptions from the FDA.
- The companies made millions of dollars from selling the test kits.
- Zhu made false statements to FDA officials, including that his name was Qiang “David” He, that he was hired by Universal Meditech as a COVID-19 consultant in 2021, that he was hired by Prestige Biotech just a couple of weeks before meeting with the FDA and that he did not know anything about the manufacturing or distribution histories for both companies.