Reedley Chinese Communist Party-Linked Lab: One Year Later – California Globe
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| Illegal COVID biolab, Reedley, CA. (Photo: Reedley code enforcement) |
Reedley Chinese Communist Party-Linked Lab: One Year Later – California Globe
apparently nobody (FBI, CDC) is responsible for national biodefense
It was exactly a year ago Saturday when officials with the City of Reedley executed a search warrant on what turned out to be a secret, Chinese Communist Party-linked laboratory in the middle of downtown.
In the past year, the owner of the lab has been arrested – he’s still in Fresno County jail facing federal charges. The California Department of Public Health (CDPH) has investigated the situation, the FBI has investigated, the FDA has investigated, Congress has investigated, and the CDC has investigated…kinda.
Even with all of that, the city still has a half-million illegal covid and pregnancy tests they are waiting for someone to take off of their hands.
Reedley City Manager has high praise for some involved in the convoluted process, from the city code enforcement officer Jesalyn Harper, who discovered the lab to Congressman Jim Acosta, who rattled federal agency cages, but is deeply troubled by the actions – or inactions – of some of the other government agencies, specifically the Centers for Disease Control – the CDC.
“It’s been very disappointing,” Zieba said. “I get the impression it has never been a high priority for them.”
In December, 2022, Harper noticed a garden hose going through a hole into a building that was supposed to be unoccupied. When she went in, she found a number of people working in, let’s just say, not terribly clean conditions.
Over the course a few visits, Harper found dead and dying testing mice, genetically modified to mimic human reactions, barely operating freezers and other equipment holding vials and other containers labeled as containing HIV, Chlamydia, and malaria, amongst others. She also found a refrigerator labeled “Ebola,” decaying equipment stored randomly in the warehouse, and tens of thousands of boxes of covid and pregnancy tests.
The city called the the Fresno County and the FBI. After two months, the FBI closed its investigation, saying it had not found weapons of mass destruction. In the meantime, the city had been desperately calling the CDC and other agencies to try to figure out what to do with the site even as employees, reportedly, kept feeding the mice (the garden hose was for the water) and boxing up covid tests for shipping.
The calls to the CDC were especially frustrating, Zieba said – in fact, she and Harper were actually hung up on at least once.
But during this agency frustration, the city plugged along and finally obtained the warrant they needed to properly search the premises and that is what they did March 16, 2023.
The conditions they found had, if anything, become worse. The mice were dying, chemicals were scattered randomly, and much of the electrical equipment housing the vials of purported diseases was running on jerry rigged power. A state vet was called to handle the mice – those alive were euthanized – and then in April the county health people paid a visit themselves.
The California Department of Public Health showed up on May 1 and, finally, the CDC paid a visit. The CDC team took photos, wandered around, did not test any of the vials – even those marked “HIV” – and left.
The CDC itself disputes the notion that it did not perform its job adequately:
“CDC refutes the charges that the agency did not respond to local requests for aid. Indeed, CDC has, and continues to be actively engaged, within its regulatory authorities, in the intergovernmental efforts to address issues surrounding the facility. At the request of state and local officials, CDC participated in approximately 40 calls with federal, state, and local partners to support the review of material in the Reedley building.
After state and local officials notified CDC of concerns in March, the California Department of Public Health determined that no onsite assistance was needed from CDC. In April, the Department of Public Health requested on-site assistance. We promptly responded and sent a team to the site. CDC was onsite for two and a half days and conducted an extensive review. CDC’s role in this review was limited to the parameters established by the county and state officials who requested assistance, and at whose invitation CDC was present.”
In November, new CDC director Mandy Cohen testified before Congress, saying roughly the same thing each of the three times she was asked about Reedley:
“When asked, we deployed and the congressional report contained a number of inaccuracies.”
The entire congressional report, which actually contains very few if any inaccuracies, can be found here: scc-reedley-report-11.15.pdf (house.gov)
Cohen said they found no “select agents,” (those are really nasty things; here’s the list – note Ebola is on the list though the CDC claims they were unaware of the refrigerator sign) but admitted they did not test anything, basically because it’s not what they do.
Cohen added – astonishingly – that the CDC was less concerned about the lab because it had no proper lab equipment like safety hoods (the fanned glass cabinets you may remember from science class.)
That bears repeating: Cohen said they were less worried about the secret lab because it didn’t look like a regular proper safe normal lab.
Maybe not surprising; Cohen, when she was North Carolina state health director during the pandemic, would chat like a high school kid with other officials about what the public should be allowed to do:
That’s one of the nation’s top health officials – really.
At the November hearing, members of congress were taken aback by the CDC’s laissez faire attitude.
“Isn’t that (detecting threats) exactly what the CDC is for?” Rep. Dan Crenshaw (R-TX) asked.
Rep. Neal Dunn (R-FL) called the CDC response “inadequate and unprofessional” and expressed amazement that vials marked as containing nasty diseases like covid and Dengue went untested.
“The CDC is the first line of defense,” said an incredulous Dunn.
“The CDC has no understanding of the broader implications of the situation,” Zieba added.
And Zieba noted that the state – which “continues to tell us it’s no big deal” – decided not to even call the CDC for weeks. It turned out, since the CDC did little, not to matter much, luckily, but why the CDPH made that decision is unknown – the agency did not respond to requests for comment.
As the medical side of the investigation went forward, the financial side came under scrutiny.
The owner – David He or Jesse Zhu, he’s booked into Fresno jail as He (pronounced her) facing federal charges brought by the FDA of one count of lying to federal officials and two counts of mislabeling medical devices. – turned out to have not just a shady past but a pitch black past.
A purported dairy expert, He went to Canada from China where he stole bovine genetic testing research and ended up on the wrong end of civil judgement of more than $300 million dollars.
After fleeing Canada, the Chinese native set up shop in Fresno to import things like dodgy pregnancy tests from China, slap a “Made in the USA” label and re-sell them.
And, menacingly, He was/is part of the Chinese Communist Party’s “Military-Civil Fusion” program, and received millions in suspicious dollars from China while stealing American bio-technology, selling unlicensed pregnancy and COVID tests, and squirreling away thousands of vials of deadly pathogens. For a more detailed breakdown of the CCP ties, see here.
However, there may be a glimmer of hope on the horizon. A spokesman for Rep. Costa said his office is continuing to work through the Reedley situation, is following up on the November, 2023 Congressional findings, and they will “very soon” be releasing a proposal to address the entire matter and, as Zieba said, the “broader implications” of the discovery of a CCP-linked secret lab stocked full of infectious agents.
For now, though, Zieba still has about a half million covid and pregnancy tests left at the site that’s she’s not quite sure what to do with. Mr. He’s lawyer Anthony Capozzi said they remain the property of He’s company and that any disposal of them would still have to go through him (being He.)
So I guess a swap meet’s out of the question…
For a look at the lab itself, you can check out this special video report by The Epoch Times: https://www.theepochtimes.com/epochtv/behind-a-secret-chinese-biolab-in-california-special-coverage-5597768
According to the news report, investigators discovered an unauthorized and unlicensed medical lab operating in an abandoned warehouse in Reedley, California. The shocking findings included:
- Around 1,000 white lab mice, with 200 already dead, being kept in inhumane conditions for allegedly testing COVID-19 test kits.
- Thousands of vials containing hazardous materials like human blood, unidentified tissues, and unknown chemicals.
- At least 20 potentially infectious viral, bacterial, and parasitic agents being stored inadequately, including E.coli, malaria, and COVID-19.
- The lab, operating under the name Prestige Biotech, had no city approval and was supposed to be vacant.
An illicit, Chinese-owned lab fueled conspiracy theories. But officials say it posed no danger
SAN FRANCISCO (AP) — Jesalyn Harper, the only full-time code enforcement officer for the small, agricultural city of Reedley in California’s Central Valley, was responding to a complaint about vehicles parked in the loading dock of a cold-storage warehouse when she noticed a foul smell and saw a garden hose snaking into the old building.
A woman in a lab coat answered her knock, and behind her were two others in plastic gloves and blue surgical masks, packing pregnancy tests for shipping. Harper said they spoke broken English and told her they were from China. Walking through the lab, she found dozens of refrigerators and ultralow-temperature freezers hooked to illegal wiring; vials of blood and jars of urine in shelves and plastic containers; and about 1,000 white lab mice being kept in crowded, soiled containers.
The women said the owner lived in China, provided a phone number and email address and asked her to leave. Alarmed by what she saw, Harper, whose work mostly entails ensuring people have permits for yard sales and are keeping their lawns mowed, contacted Fresno County health officials and then the FBI.
The discovery last December launched investigations by federal, state and local authorities who found no criminal activity at the medical lab owned by Prestige Biotech Inc., a company registered in Las Vegas, and no evidence of a threat to public health or national security. Nonetheless, it was just the beginning of a case that this summer fueled fears, rumors and conspiracy theories online about China purportedly trying to engineer biological weapons in rural America.
During a March inspection of the lab in Reedley, a city of about 25,000 people some 200 miles (320 kilometers) southeast of San Francisco, officials did find infectious agents in the refrigerators including E. coli, coronavirus, malaria, hepatitis B and C, dengue, chlamydia, human herpes, rubella and HIV.
But the federal Centers for Disease Control and Prevention said there was no sign that the lab was illegally in possession of the materials or had select agents or toxins that could be used as bioweapons.
“CDC has taken no further action in this matter,” the agency said in an email to The Associated Press, referring further questions to county and state officials.
After company representatives stopped communicating with city and county officials, they got a court order to shut down the operation, euthanized the mice and cleaned the biological materials. Officials thought that would be the end of it.
Then on July 25, the Mid Valley Times, a local online news outlet, published a story about the lab that quoted court documents saying a representative of Prestige Biotech, which makes pregnancy and coronavirus tests sold online, told officials in March that the mice had been genetically modified to catch and carry the virus that causes COVID-19.
That was likely a miscommunication by Prestige Biotech representative Wang Zhaolin, whose English is not perfect, Harper said.
“She stated that the mice were bred, and then she hesitated and said they were modified to carry COVID,” Harper said Zhaolin told her and other officials. After the lab was shut down, she added, Wang stopped cooperating with them.
Wang’s comment prompted Reedley authorities to hire Nina Hahn, a vet formerly contracted by the Lawrence Berkeley National Laboratory, to examine the mice. Hahn found they had not been injected with any infectious agent and were simply used to grow COVID-19 antibody cells to make testing kits. She also determined they were not subjected to experimentation, Harper said.
But that hasn’t stopped the furor, however.
After the Mid Valley Times article, national media outlets published stories saying the lab had bioengineered mice to carry COVID-19. A Fresno city official questioned the lab’s proximity to Lemoore Naval Air Station, about 35 miles (55 kilometers) away in neighboring Kings County. In a war with China, the official said, fighter jets would deploy from the base.
Last week House Speaker Kevin McCarthy, a California Republican who represents a Congressional district neighboring Reedley’s, said during a visit to a nearby town that he plans to raise concerns over the “very disturbing” case with colleagues on the Select Committee on China and follow up with the FBI.
“My concern is to get to the bottom of what happened here but to also look at where this is happening in other parts of this country as well,” McCarthy said.
Lok Siu, a professor of Asian American and Asian diaspora studies at the University of California, Berkeley, said the fears being fanned online reflect anti-Chinese sentiments that have existed in the United States for centuries and were heightened during the pandemic.
Siu said some people wrongfully assume all ethnic Chinese or Chinese-owned businesses have ties to the Chinese state. “They’re not given the ability to act as responsible or irresponsible individuals,” she added.
In Reedley, where the laboratory failed to officially register, officials took a dim view of the operation.
“They were bad actors. They never came to the city and they moved in in the middle of the night. Those are pretty big elements that tell us they did not want us to know they were here,” said Nicole Zieba, Reedley’s city manager.
The California Department of Public Health said in a statement that all clinical laboratories must get state a license to operate and Prestige Biotech does not have one. The CDPH said its investigation is ongoing.
Several Prestige Biotech representatives including attorney Michael Lin in Las Vegas did not respond to emailed requests for comment sent by AP.
There were also questions from some about why the federal investigation was not made public until the Mid Valley Times reported on it.
Zieba said that early on, state and federal officials advised the city to not share information with the public about the lab, which had been operating illegally in the city since October 22, because the investigation was still ongoing.
And after California’s Department of Toxic Substances Control checked the air and water and found no threat, she decided to heed that advice.
“It was fairly quickly apparent to us that there was nothing airborne, nothing in the water, nothing in the sewer system, so our public was safe,” Zieba said. “Had there been any hazard to their safety, we would have immediately notified the public.”
Reedley officials said what has been most concerning about the discovery was finding out there is no single government entity overseeing private medical laboratories.
“What’s frustrating is that we’re focusing on these myths, bioengineered weapons and stuff like that, rather than the real issue, the lack of regulation of these private labs,” Harper said.
Chinese-owned lab was in Tulare before Fresno, then Reedley. What happened inside?
Nina Salazar was happy to have a job when she worked for three years at a Chinese-owned laboratory in Tulare that made disease and drug test kits – the same lab that was shut down in Reedley after Covid-19 and more than 20 infectious agents were found in refrigerators in the ramshackle facility that was operating without proper permits.
Salazar, who lives in Visalia, told The Fresno Bee that she was a lab tech for Universal Meditech Inc. at its location at 2375 E. Tulare Ave. from 2015 into 2018. During that time, she and about 15 other employees assembled pregnancy, diabetes and drug test kits, she said.
“I was so excited because I had a job,” she said. “It felt important because we got to wear lab coats and stuff.”
But there was something that seemed “odd and shady” about the place, too, she said. There were occasional problems with paychecks, “and when (managers) would come to do visits for investors, they would have to get people from outside to come in and work on the production line” to make the laboratory seem more economically viable, she said.
Then there were the chemicals that Salazar and co-workers handled but were never identified to them. “We had to make this purple liquid for tests; we had to mix the chemicals; we had to cook it,” she said. “They only told us that it had to be a special fluid, perfectly made for the test strips.”
“But they never told us what the chemicals were,” She said. “They spoke Chinese a lot, so we didn’t know what they were saying.” She said not knowing what the chemicals were was concerning.
That was five years ago. Now Universal Meditech and an associated company, Prestige Biotech Inc., are under investigation by local agencies in Reedley and Fresno County, as well as other state and federal agencies, over its presence in Reedley.
A city code-enforcement officer responded to an anonymous tip last December about an unlicensed business operating in an old cold-storage warehouse. That led to the discovery of dozens of freezers and refrigerators full of vials of blood, serum and tissue samples; cartons and containers of various chemicals; stored medical lab equipment; and hundreds of lab mice that were in such distress and neglect that they ultimately had to be euthanized.
Those revelations resulted in the shutdown of the Reedley operation in March and subsequent months of clearing the warehouse of a host of biological agents, chemicals and more – a cleanup and abatement process that is expected to continue into October.
Reedley is but the latest city where Universal Meditech or Prestige Biotech decided to set up operations in the central San Joaquin Valley over the past eight years.
Universal Meditech operated first in Tulare from 2015 into 2018, and then in Fresno from late 2018 until late 2022, when it moved operations to Reedley. There, the company moved into a leased warehouse on I Street, never bothering to get a city business license or obtain permits for electrical wiring and other building modifications, the city has said. Nor did it have the necessary permits from Fresno County for handling and disposing of medical or hazardous waste, officials have confirmed.
A long and winding road
In Tulare, city officials said they never experienced any problems or enforcement issues, city spokesperson Josh McDonnell told The Bee on Tuesday. “They were appropriately licensed, they pulled building permits for a firewall and (Americans with Disabilities Act) compliance, and electrical work for a small packaging machine.”
“It was all very standard stuff. Apparently they were doing actual assembly of medical devices,” McDonnell added. “As far as we know, that’s what they did. And then they were gone.”
If the company was dealing with medical waste that might be expected from a medical lab, it was doing so without a permit from the Tulare County Department of Public Health.
Carrie Monteiro, a spokesperson for the county health department, said the Environmental Health Division oversees permitting for medical labs and other facilities that generate medical waste. “Upon review we were not able to find any record of Universal Meditech Inc. or any medical waste generator permits for that company,” she said. “Unfortunately, we don’t have any information as we have no record of any health permits being applied for or issued for Universal Meditech Inc. for a lab location in Tulare County.”
By August 2018, by Universal Meditech was approved to move into a building on East Fortune Avenue in south Fresno, according to information provided by the city of Fresno. The company operated its laboratory facility there until moving out in December.
A fire in August 2020 led to the discovery of unpermitted lab walls and unapproved electrical wiring in the Fresno facility. Within days of the fire, an environmental health inspector with the Fresno County Department of Public Health inspected the building along with Fresno city fire and code enforcement officials, and they determined that the lab did not have a required hazardous materials business plan or county permit for storage of hazardous chemicals, said Joe Prado, the county health department’s assistant director.
In a presentation Tuesday to the Fresno County Board of Supervisors, Prado said the company did complete the needed steps to secure its hazardous materials permit on Sept. 1, 2020.
For more than two years, the lab apparently flew under the radar of city and county officials – in part the result of the city of Fresno cutting back on its inspections during the COVID-19 pandemic. In October 2022, however, Fresno’s fire and code enforcement inspectors notified the county health department about chemicals being stored at the lab.
Prado said Tuesday that the company was evasive throughout November 2022 in responding to requests from the health department for specific information about the chemicals being used and stored at the lab, until ultimately on Nov. 29 a representative of the property landlord told county officials that they had a court date to evict Universal Meditech from the premises.
By Dec. 27, the company had moved out of the building, according to information provided by the city of Fresno.
A surreptitious move to Reedley
Nicole Zieba, Reedley’s city manager, told Fresno County supervisors on Tuesday that the company slipped into town and set up storage of its laboratory materials without getting a business license.
“They were bad actors. They did not want us to know they were here,” Zieba said. “That’s why they moved in under cover of night. That’s why they never came to seek a business permit.”
But, she added, the investigation by Reedley’s code enforcement officers and county and state health officials has revealed that the former cold-storage space was being used for little more than storage of equipment, medical devices, biological agents and samples, chemicals and lab mice that apparently had been hastily moved from the Fresno facility.
Since March, several different abatement actions have taken place at the Reedley warehouse:
- On March 16, county, city and state officials conducted an inspection of the building under a warrant issued by a Fresno County Superior Court judge. During that visit, agents from the Food & Drug Branch of the state’s Department of Public Health embargoed cartons of unapproved medical test kits and medical supplies, and Reedley’s code enforcement team declared the building unsafe to occupy.
- On April 12, a state veterinarian contractor and Reedley’s code enforcement officer used a new warrant to euthanize the mice, which after the building closure were being fed and watered by a city worker. A prior inspection of the mice determined that they were not actively being used for experiments, but were severely neglected and in distress.
- From May 2 through May 4, under a county Health Officer Order, county and city inspectors, along with representatives of the U.S. Centers for Disease Control, the state Department of Public Health and the U.S. Food & Drug Administration conducted another inspection of the site. That inspection led to a determination that the freezers and refrigerators contained more than 20 different bacterial, viral and parasitic biological agents including COVID-19, malaria, Hepatitis B and C, chlamydia, human herpes, E. coli, streptococcus, HIV (the virus that causes AIDS), and rubella, among others.
- From July 5 through July 7, with another court order, county health officials and a licensed contractor went through the dozens of refrigerators and freezers to remove and take away the biological materials for destruction.
- On July 28, the city began its own abatement operation to remove the refrigerators, freezers, furniture, fixtures and laboratory machinery, and Tuesday was the final day of that effort, Zieba told county supervisors. The process continues to find more biological materials but “we are not uncovering infectious diseases and all of that,” she said. “What we’re uncovering … is that we’re opening drawers and finding jars of urine and peed-on pregnancy tests. That’s considered a biological.”
In the coming weeks, the U.S. Environmental Protection Agency will be moving in to deal with the laboratory chemicals that remain in the warehouse. “These are chemicals that are commonly found in legal labs; nothing unusual has been found,” Zieba said.
After that will come the U.S. FDA and the state health department’s Food & Drug Branch. “What we’ll have remaining in that warehouse are probably a half a million pregnancy test kits and COVID test kits, some of which are unauthorized,” Zieba said.
Battling rumor and misinformation
Fresno City Councilmember Garry Bredefeld, in a July 31 press conference, accused county health officials and the county Board of Supervisors of covering up information about the lab, and complained that in the wake of the COVID-19 pandemic that they had a duty to inform the public as early as March.
In that press event, Bredefeld asserted that the lab was “producing COVID-19” and injecting mice with the virus. He compared the lab to the laboratory in Wuhan, China, that some have blamed for engineering the virus that led to the pandemic.
On Tuesday, several supervisors took issue with Bredefeld’s statements. Supervisor Brian Pacheco criticized Bredefeld for “making a lot of accusations against this board and members of the community that were simply inaccurate.”
“It seems to me that the responsible person would have gotten the facts before holding a press conference with inaccurate information to scare the public and for more self-promotion,” Pacheco added.
Pacheco noted that for more than two years after the 2020 fire revealed code violations at Universal Meditech’s Fresno location, the laboratory operated unabated.
Zieba and Prado said that state and federal agencies had urged them not to go public with the investigations. “They made it very clear to us that their protocols were not to address ongoing investigations,” Prado told the board on Tuesday.
Zieba added that “when the FBI and CDC and everybody else in the alphabet soup of state and federal agencies tells you, ‘We cannot even comment on whether we’re doing an investigation (and) you cannot comment,’ when they tell you that … you’re not going to defy the FBI.”
She told supervisors that there was “no evidence” that workers were manipulating viruses at the lab; Zieba also told The Bee that there was no evidence at the Reedley warehouse of any operations actively dealing with viruses or anything scientific. The city’s code enforcement officer, Jesalyn Harper, previously told The Bee that there was no production of COVID-19 or experimentation on mice, contrary to what Bredefeld had asserted in his July 31 press conference.
Supervisor Steve Brandau, against whom Bredefeld is running for the District 2 seat on the county board, thanked Zieba and Prado for their presentation Tuesday, “yet I don’t believe it will deter for one minute those who are politically motivated and the sycophants that follow them.”
Bredefeld doubled down on his criticism of the county on Tuesday afternoon and his assertions about activities at the warehouse. “Since at least March, the Board of Supervisors hid information from the public that a ‘Wuhan-type’ Chinese biological lab in Reedley was involved in injecting mice to ‘catch and carry COVID-19” and other diseases, Bredefeld said in a statement to The Bee.
“Last week they blamed the FBI for not telling the public. This week they blame (California Gov. Gavin) Newsom’s administration,” he added.
Bredefeld also blasted Brandau for calling “those who support me wanting transparency from the county ‘sycophants,’ which is an attack on his very own constituents who don’t want to be lied to and want information about a dangerous Chinese lab in their own community.”
This story was originally published August 8, 2023, 8:38 PM.
Lifelong Valley resident Tim Sheehan has worked as a reporter and editor in the region since 1986, and has been with The Fresno Bee since 1998. He is currently The Bee’s data reporter and also covers California’s high-speed rail project and other transportation issues. He grew up in Madera, has a journalism degree from Fresno State and a master’s degree in leadership studies from Fresno Pacific University. Support my work with a digital subscription
Arrest Made in Central California Bio-Lab Investigation
FRESNO, Calif. — 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 were going to 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, a company that 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 he was hired by UMI as a COVID-19 consultant in 2021; that he was hired by PBI 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.
This case is the product of an investigation 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 prosecuting this case.
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 consideration of any applicable statutory factors and the Federal Sentencing Guidelines, which take into account a number of variables. The charges are only allegations; the defendant is presumed innocent until and unless proven guilty beyond a reasonable doubt.
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