A federal grand jury in California has indicted a Chinese national, Jia Bei Zhu, for his alleged involvement in running an unauthorized lab that facilitated the illegal manufacture and sale of hundreds of thousands of COVID-19 test kits in the United States. The operation, carried out through the companies Universal Meditech Incorporated (UMI) and Prestige Biotech Incorporated (PBI), reportedly brought in millions of dollars.

Zhu, a 62-year-old who previously resided in Clovis, has been charged with distributing adulterated and misbranded medical devices in violation of the federal Food, Drug, and Cosmetic Act. He also faces charges 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, Zhu allegedly sold hundreds of thousands of COVID-19 test kits to various companies across the United States. Both UMI and PBI, located in Fresno and Reedley respectively, operated without obtaining the required pre-market approval, pre-market clearance, emergency use authorization, or any applicable exemption from the FDA.

Prosecutors stated that UMI and PBI received millions of dollars from the sales of these unauthorized test kits. The investigation revealed that Zhu had reportedly made false statements to FDA officials, including claiming ignorance about the manufacturing and distribution histories of UMI and PBI.

If convicted, Zhu faces a maximum statutory penalty of three years in prison and a $250,000 fine for the charges related to adulterated and misbranded medical devices. For the false statements charge, he could face up to five years in prison and a $250,000 fine.

The suspicions surrounding Zhu's Universal Meditech Inc. lab in Reedley, California first arose in December 2022, when Reedley Code Enforcement Officer Jesalyn Harper noticed a green garden hose protruding from a hole at the facility and brought it to Zhu's attention as a code violation. Harper noticed several individuals wearing lab coats, identifying themselves as Chinese nationals.

Zhu was subsequently apprehended on October 19. Special Agent in Charge Robert Iwanicki of the FDA's Office of Criminal Investigations in Los Angeles warned that consumers who unwittingly used these misbranded COVID-19 tests faced the risk of receiving incorrect results, which could contribute to the further spread of the virus.

The case highlights the importance of adhering to regulations and obtaining proper authorization for medical devices, especially during a global health crisis. The indictment serves as a reminder that individuals who engage in unauthorized manufacturing and distribution can face severe legal consequences.