FRESNO, CA - On Thursday, October 19th, the Department of Justice (DOJ) announced its arrest of 62-year-old Jia Bei Zhu, owner of an unauthorized California biolab that fueled conspiracy theories about COVID-19 and bio-weapons.
Zhu was arrested after an investigation by the U.S. Food and Drug Administration (FDA) concluded that he did not obtain the proper permits to manufacture tests for COVID-19, pregnancy and HIV, and for the mislabeling of some of the kits. He has also been charged with making false statements.
Zhu, aka Jesse Zhu, aka Qiang He, aka David He is a citizen of China who formerly resided in Clovis, California.
According to U.S. Attorney Phillip A. Talbert, "As part of his scheme, the defendant changed his name, the names of his companies, and their locations. The disarray of the Reedley lab led to the glare of publicity he was trying to avoid and the ensuring investigation unraveled his efforts to circumvent the requirements that are designed to ensure that medical devices are safe and effective."
The charges deal specifically with federal health regulations and nothing related to the online conspiracy theories about China purportedly trying to engineer biological weapons in rural America.
Court documents allege that between December 2020 and March 2023, Zhu and others manufactured, imported, sold and distributed hundreds of thousands of COVID-19 test kits as well as tests for HIV, pregnancy and other conditions in the U.S. and China.
According to the DOJ, "They did so through the companies Universal Meditech Incorporated (UMI) and Prestige Biotech Incorporated (PBI), which were based in Fresno and Reedley."
UMI and PBI both reportedly did not obtain the required authorizations to manufacture and distribute the test kits. They also allegedly mislabeled some of the test kits. The DOJ said that when questioned by investigators, Zhu made false statements about his identity, his ownership of UMI and PBI as well as the activities under both manufacturing companies.
The criminal complaint stated that Reedley Code Enforcement officials received a complaint regarding a warehouse in Reedley for using "non-permitted plumbing" that was apparently visible from outside the warehouse.
The next day, code enforcement officials went to the warehouse and saw various types of in-vitro diagnostic test kits, related manufacturing equipment and shipping supplies.
Upon further investigation, officials found that UMI first registered as a medical device manufacturer with the FDA in November of 2015 in Tulare and moved to Fresno in 2018.
However, according to the DOJ, "FDA records show that its registration lapsed in 2022 and it is no longer permitted to manufacture or import any in-vitro diagnostic kits in the United States. Any test kits that the company manufactured or imported after that date are considered misbranded medical devices."
Special Agent in Charge Robert M. Iwanicki with the FDA Office of Criminal Investigations Los Angeles Field Office said, "Providing materially false information to FDA inspectors regarding medical device manufacturing and distribution impedes the agency's ability to protect public health ... We will continue to investigate and bring to justice those who jeopardize the health of U.S. consumers."
In convicted, Zhu faces a maximum statutory penalty of three years in prison for the misbranding of medical devices charge and five more years in prison for the false statements charge.
Zhu was arrested after an investigation by the U.S. Food and Drug Administration (FDA) concluded that he did not obtain the proper permits to manufacture tests for COVID-19, pregnancy and HIV, and for the mislabeling of some of the kits. He has also been charged with making false statements.
Zhu, aka Jesse Zhu, aka Qiang He, aka David He is a citizen of China who formerly resided in Clovis, California.
According to U.S. Attorney Phillip A. Talbert, "As part of his scheme, the defendant changed his name, the names of his companies, and their locations. The disarray of the Reedley lab led to the glare of publicity he was trying to avoid and the ensuring investigation unraveled his efforts to circumvent the requirements that are designed to ensure that medical devices are safe and effective."
The charges deal specifically with federal health regulations and nothing related to the online conspiracy theories about China purportedly trying to engineer biological weapons in rural America.
Court documents allege that between December 2020 and March 2023, Zhu and others manufactured, imported, sold and distributed hundreds of thousands of COVID-19 test kits as well as tests for HIV, pregnancy and other conditions in the U.S. and China.
According to the DOJ, "They did so through the companies Universal Meditech Incorporated (UMI) and Prestige Biotech Incorporated (PBI), which were based in Fresno and Reedley."
UMI and PBI both reportedly did not obtain the required authorizations to manufacture and distribute the test kits. They also allegedly mislabeled some of the test kits. The DOJ said that when questioned by investigators, Zhu made false statements about his identity, his ownership of UMI and PBI as well as the activities under both manufacturing companies.
The criminal complaint stated that Reedley Code Enforcement officials received a complaint regarding a warehouse in Reedley for using "non-permitted plumbing" that was apparently visible from outside the warehouse.
The next day, code enforcement officials went to the warehouse and saw various types of in-vitro diagnostic test kits, related manufacturing equipment and shipping supplies.
Upon further investigation, officials found that UMI first registered as a medical device manufacturer with the FDA in November of 2015 in Tulare and moved to Fresno in 2018.
However, according to the DOJ, "FDA records show that its registration lapsed in 2022 and it is no longer permitted to manufacture or import any in-vitro diagnostic kits in the United States. Any test kits that the company manufactured or imported after that date are considered misbranded medical devices."
Special Agent in Charge Robert M. Iwanicki with the FDA Office of Criminal Investigations Los Angeles Field Office said, "Providing materially false information to FDA inspectors regarding medical device manufacturing and distribution impedes the agency's ability to protect public health ... We will continue to investigate and bring to justice those who jeopardize the health of U.S. consumers."
In convicted, Zhu faces a maximum statutory penalty of three years in prison for the misbranding of medical devices charge and five more years in prison for the false statements charge.
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