FRESNO (KTNV) — A Chinese man is facing several charges after being accused of manufacturing, importing, selling, and distributing hundreds of thousands of mislabeled COVID-19 test kits, HIV test kits, pregnancy test kits, and clinical urinalysis test kits.
Court documents state this happened between Dec. 2020 and March 2023 through companies called Universal Meditech Incorporated and Prestige Biotech Incorporated.
According to court records, the 62-year-old man goes by four different names: Jia Bei Zhu, Jesse Zhu, Qiang He, and David He.
FDA records state UMI first registered as a medical device manufacturer with the FDA in Nov. 2015 and that their registration lapsed in 2022 and is no longer permitted to manufacture or import any in vitro diagnostic test kits in the United States. Investigators added that any test kits made after that are considered misbranded medical devices.
In Nov. 2022, California officials notified UMI they were going to inspect the Fresno facility to make sure everything was up to code after a fire at the facility. However, FDA officials then received an email from UMI stating the company had gone out of business and sold its assets to PBI, a company that was formed in Las Vegas.
Justice Department officials state during the investigation, they found 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.
According to the Justice Department, 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 Emergency Use Authorization to manufacture and distribute COVID-19 test kits.
Investigators state Zhu made several false statements to FDA officials including his name, that he was hired by UMI as a COVID-19 consultant in 2021, that he was hired by PBI to communicate with government agencies and dispose of property at the warehouse as requested by those agencies, that he didn't know anything about the manufacturing or distribution histories for UMI or PBI, and he knew nothing about the Amazon webpage.
Zhu is facing several charges including making false statements and for manufacturing and distributing misbranded medical devices.
Justice Department officials said if convicted, Zhu is facing up to three years in prison for the misbranding charge and up to five years in prison for the false statements charge. He's scheduled to appear in a California court on Friday.
