A Chinese national has been apprehended for operating an illicit clandestine bio-laboratory in California, as announced by the U.S. Department of Justice (DOJ).
The individual in question, Jia Bei Zhu, aged 62, has been identified as the proprietor of an unauthorized laboratory located in central California. This discovery has raised significant concerns regarding potential Chinese activities related to biological weapons experiments on American soil.
Zhu, who also goes by the aliases Jesse Zhu, Qiang He, and David He, was taken into custody on charges of operating without the required permits for manufacturing COVID-19, pregnancy, and HIV testing kits, along with mislabeling some of these kits.
The arrest took place on Thursday following an investigation conducted by the U.S. Food and Drug Administration, as reported by the U.S. Attorney’s Office for the Eastern District of California. Additionally, Zhu is facing charges of making false statements.
It is essential to clarify that these charges pertain to violations of federal health regulations and are unrelated to unfounded online conspiracy theories suggesting China’s involvement in developing biological weapons within rural America.
Zhu is a Chinese citizen who previously resided in Clovis, California, according to the official statement issued by the U.S. Attorney’s Office.
“As part of his scheme, the defendant changed his name, the names of his companies, and their locations,” U.S. Attorney Talbert said.
“The disarray at the Reedley lab led to the glare of publicity he was trying to avoid, and the ensuing investigation unraveled his efforts to circumvent the requirements that are designed to ensure that medical devices are safe and effective.”
“Providing materially false information to FDA inspectors regarding medical device manufacturing and distribution impedes the agency’s ability to protect public health, especially when those false statements relate to unauthorized and misbranded COVID-19 tests. Consumers who unknowingly use these misbranded COVID tests run the risk of incorrect results about their COVID status, which can lead to further spread of the virus,” said Special Agent in Charge Robert M. Iwanicki, FDA Office of Criminal Investigations Los Angeles Field Office.
“We will continue to investigate and bring to justice those who jeopardize the health of U.S. consumers.”
According to court documents, between December 2020 and March 2023, Zhu and others were involved in the manufacturing, importation, sale, and distribution of hundreds of thousands of COVID-19 test kits, along with test kits designed for HIV, pregnancy, clinical urinalysis, and various other medical conditions in both the United States and China.
These activities were conducted through the companies Universal Meditech Incorporated (UMI) and Prestige Biotech Incorporated (PBI), with locations in Fresno and Reedley.
UMI and PBI failed to secure the necessary authorizations required to manufacture and distribute these test kits and also mislabeled certain test kits. When questioned by officials from the U.S. Food and Drug Administration (FDA), Zhu provided false information regarding his identity, ownership and control of UMI and PBI, and the operations of these companies.
In a related development, the Reedley Code Enforcement office received a complaint about a warehouse in Reedley using non-permitted plumbing visible from outside the building. Subsequently, code enforcement officials visited the warehouse and observed various types of in vitro diagnostic test kits, related manufacturing equipment, and shipping supplies.
Further inquiry revealed that UMI initially registered as a medical device manufacturer with the FDA in November 2015 in Tulare and subsequently relocated to Fresno in 2018. However, FDA records indicate that the registration lapsed in 2022, making the company ineligible to manufacture or import in vitro diagnostic test kits in the United States. Any test kits manufactured or imported after this date are considered misbranded medical devices.
To manufacture, import, and distribute COVID-19 test kits in the United States during the pandemic, a company was required to apply for and receive an Emergency Use Authorization (EUA) from the FDA. FDA records reveal that UMI sought an EUA for its COVID-19 test kits but was unsuccessful due to significant deficiencies in its test studies.
In November 2022, Fresno County officials informed UMI that an inspection of its Fresno facility was imminent to ensure compliance following a fire at the site. Subsequently, FDA officials received an email from UMI’s attorney stating that the company had ceased operations and sold its assets to PBI, a newly established firm based in Las Vegas, Nevada.
PBI had never registered with the FDA to manufacture or import in vitro diagnostic test kits in the United States and had not received an EUA for the production and distribution of COVID-19 test kits. Consequently, any such test kits would be considered misbranded medical devices.
During the course of the investigation, Zhu provided several false statements to FDA officials. This included providing a different name, claiming to have been hired as a COVID-19 consultant by UMI in 2021, asserting that he was employed by PBI for a brief period solely to liaise with government agencies and dispose of warehouse property, denying any knowledge of the manufacturing or distribution history of UMI or PBI, and professing ignorance of an Amazon webpage displaying PBI-branded pregnancy test kits for sale or a shipment of 47,500 pregnancy test kits from China to UMI at an address in Las Vegas.
The case resulted from an investigation conducted by the FDA Office of Criminal Investigations, with assistance from the Federal Bureau of Investigation and the California Department of Public Health – Food and Drug Branch. Assistant U.S. Attorneys Joseph D. Barton, Arelis M. Clemente, and Henry Z. Carbajal III are responsible for prosecuting the case.
In the event of a conviction, Zhu could face a maximum statutory penalty of three years in prison for the charge related to misbranding medical devices and an additional five years for the false statements charge.
