FRESNO - Jia Bei Zhu, aka Jesse Zhu, aka Qiang He, aka David He, 62, a citizen of China who formerly resided in Clovis, was arrested today on a criminal complaint for manufacturing and distributing misbranded medical devices in violation of the federal Food, Drug, and Cosmetic Act (FDCA) and for making false statements to the Food and Drug Administration (FDA), U.S. Attorney Phillip A. Talbert announced.

“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 manufactured, imported, sold, and distributed hundreds of thousands of COVID-19 test kits, in addition to test kits for HIV, pregnancy, clinical urinalysis, and other conditions in the United States and China. 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 did not obtain the required authorizations to manufacture and distribute the test kits and mislabeled some of the test kits. When questioned by FDA officials, Zhu made false statements about his identity, his ownership and control of UMI and PBI, and the activities of UMI and PBI.

According to the criminal complaint, Reedley Code Enforcement officials received a complaint regarding a warehouse in Reedley for using non-permitted plumbing that was visible from outside the warehouse. When code enforcement officials went to the warehouse the next day, they saw various types of in vitro diagnostic test kits, related manufacturing equipment, and shipping supplies.

Further investigation found that UMI first registered as a medical device manufacturer with the FDA in November 2015 in Tulare and moved to Fresno in 2018. FDA records show that its registration lapsed in 2022, and it is no longer permitted to manufacture or import any in vitro diagnostic test kits in the United States. Any test kits that the company manufactured or imported after that date are considered misbranded medical devices.

To manufacture, import, and distribute COVID-19 test kits in the United States during the pandemic, a company must have applied for and ultimately received an Emergency Use Authorization (EUA) from the FDA. According to FDA records, UMI applied for an EUA for its COVID-19 test kits but never received it due to major deficiencies in UMI’s test studies.

In November 2022, Fresno County officials notified UMI that they would inspect UMI’s Fresno facility to ensure everything was up to code following a fire that occurred at the facility. FDA officials then received an email from UMI’s attorney saying that the company had gone out of business and sold its assets to PBI. This company was formed in Las Vegas, Nevada. PBI was never registered with the FDA to manufacture or import any in vitro diagnostic test kits in the United States and never received an EUA to manufacture and distribute COVID-19 test kits. Therefore, any such test kits would be misbranded medical devices.

According to the criminal complaint, during the investigation, Zhu made several false statements to FDA officials, including that his name was Qiang “David” He, that UMI hired him as a COVID-19 consultant in 2021, that PBI hired him just a couple of weeks ago to communicate with government agencies and dispose of property at the warehouse as requested by those agencies; that he did not know anything about the manufacturing or distribution histories for UMI or PBI; and that he knew nothing about an Amazon webpage showing 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.

If 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. Any sentence, however, would be determined at the discretion of the court after considering any applicable statutory factors and the Federal Sentencing Guidelines, which consider several variables.

The charges are only allegations; the defendant is presumed innocent until and unless proven guilty beyond a reasonable doubt.