Chinese Citizen Indicted for Distributing Adulterated COVID-19 Test Kits in the U.S.
Jia Bei Zhu, a Chinese citizen formerly residing in Clovis, California, has been indicted by a federal grand jury on three counts related to distributing adulterated and misbranded medical devices, violating the federal Food, Drug, and Cosmetic Act, and making false statements to the Food and Drug Administration (FDA). Zhu, also known as Jesse Zhu, allegedly sold hundreds of thousands of COVID-19 test kits to U.S. companies without obtaining the required FDA approvals through his companies Universal Meditech Incorporated (UMI) and Prestige Biotech Incorporated (PBI). This article provides an overview of the indictment, the charges against Zhu, and the potential legal consequences he may face.
Background of the Indictment:
Jia Bei Zhu, aka Jesse Zhu, is charged with distributing adulterated and misbranded COVID-19 test kits in violation of the federal Food, Drug, and Cosmetic Act.
The indictment also includes charges for making false statements to the FDA during their investigation into Zhu's activities.
Allegations Against Zhu:
Between January 2020 and March 2023, Zhu, through UMI and PBI, sold COVID-19 test kits to U.S. companies without obtaining necessary FDA approvals.
UMI and PBI, based in Fresno and Reedley, California, allegedly received millions of dollars for the sales of these test kits.
False Statements to the FDA:
Zhu is accused of making false statements to FDA officials during their investigation, including providing a false name (Qiang "David" He) and false information about his role at UMI and PBI.
False statements included claims of being a COVID-19 consultant and having limited knowledge about the manufacturing and distribution histories of UMI and PBI.
Investigation and Prosecution:
The case is a result of an investigation by the FDA Office of Criminal Investigations, with assistance from the FBI 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 the case.
Potential Penalties:
If convicted, Zhu faces a maximum statutory penalty of three years in prison and a $250,000 fine for charges related to the adulterated and misbranded medical devices.
The false statements charge carries a maximum penalty of five years in prison and a $250,000 fine.
Presumption of Innocence:
Zhu is presumed innocent until proven guilty beyond a reasonable doubt. The charges are allegations, and any sentence would be determined by the court after considering applicable statutory factors and sentencing guidelines.
Conclusion:
The indictment against Jia Bei Zhu highlights the importance of complying with FDA regulations for medical devices, especially during public health crises like the COVID-19 pandemic. Legal proceedings will determine Zhu's guilt or innocence, emphasizing the significance of obtaining proper approvals for medical products.
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