Investigation Uncovers Chinese National's Illegal COVID-19 Test Manufacturing and Reedley Lab's Regulatory Gaps

A Chinese national, Jia Bei Zhu, has been indicted by a federal grand jury in California for allegedly operating an unauthorized lab that manufactured and sold hundreds of thousands of illegal COVID-19 test kits in the United States, generating millions of dollars. Zhu has been charged with distributing adulterated and misbranded medical devices, as well as making false statements to the FDA. The companies involved, Universal Meditech Incorporated (UMI) and Prestige Biotech Incorporated (PBI), did not obtain the necessary approvals from the FDA. If convicted, Zhu could face up to three years in prison and a $250,000 fine for the medical device charges, and up to five years in prison and a $250,000 fine for the false statements charge.