Federal agents arrested a representative of a Reedley clandestine biolab operator on charges of manufacturing and distributing counterfeit medical devices and making false statements to investigators.
A federal criminal complaint against Jia Bei Zhu, a Chinese resident who once lived in Clovis, was unsealed following his arrest. He also had multiple aliases, including Jesse Zhu, Qiang He and David He, the U.S. Department of Justice said in an update Thursday.
Zhu, 62, is scheduled to make an initial appearance Friday afternoon in U.S. District Court in Fresno. The case is being investigated by the U.S. Food and Drug Administration’s Los Angeles Criminal Investigation Division.
The charges appear to be limited to the manufacture and distribution of medical testing kits, including COVID-19 tests. In multiple email exchanges with the Fresno County Health Department, Zhu, who goes by the pseudonym David He, claimed to be a representative of Universal Meditech Inc. and Prestige Biotech Inc., the two companies behind the laboratory, which were not Operating illegally without a business license. From a large warehouse in downtown Reedley.
After City of Reedley code inspectors learned of the lab in December 2022, subsequent inspections found dozens of freezers and refrigerators in the warehouse filled with a variety of bacteria, viruses and parasites, including COVID-19, Chlamydia, E. coli, Streptococcus, hepatitis virus, etc. B and C, human herpes, HIV (the virus that causes AIDS), rubella and malaria.
“As part of his scheme, the defendant changed his name, the name of his business and its location,” U.S. Attorney Philip Talbot said in a statement after Zhu’s arrest. “The chaos at Ridley’s lab resulted in the public attention he sought to avoid, and the subsequent investigation revealed his efforts to circumvent requirements designed to ensure medical devices are safe and effective.”
Inspectors from the city of Reedley, Fresno County and state and federal health agencies discovered thousands of various test kits in a warehouse at 850 I Street in downtown Reedley.
An affidavit filed by FDA Special Agent Jeffrey Maurice alleges that Zhu and others “manufactured, sold and distributed thousands of COVID-19 IVD (in vitro diagnostic) test kits, as well as IVD testing kits for HIV, pregnancy, clinical urinalysis and other conditions, available across the U.S. through Universal Meditech and Prestige Biotech.
However, the affidavit adds, “UMI and PBI did not obtain the necessary authorizations to manufacture and distribute the test kits and mislabeled some of the test kits, which caused the test kits to be labeled medical under federal law. Mislabeling of devices.”
“When FDA officials discovered these activities, Zhu made false statements to officials,” Morris added. “This includes Zhu’s identity, his ownership and control of UMI and PBI, and information about UMI and PBI’s activities.”
Talbot said Thursday that if convicted, Zhu could face up to three years in prison for mislabeling a medical device and up to five years in prison for a charge of making false statements to investigators.