Newark, NJ–A Chinese manufacturer was charged today with producing and exporting to the United States in the midst of the COVID-19 pandemic nearly half a million misbranded and defective masks that falsely purported to be N95 respirators, U.S. Attorneys Craig Carpenito, District of New Jersey, and Richard P. Donoghue, Eastern District of New York, announced.
King Year Packaging and Printing Co. Ltd. (King Year) is charged by complaint with three counts of violating the Federal Food, Drug and Cosmetic Act (FDCA) for causing misbranded and substandard respirators that falsely purported to meet the N95 standard to be imported into the United States. The complaint also charges the defendant with one felony count of making a false statement by filing misleading registration documents with the U.S. Food and Drug Administration (FDA). The criminal complaint was filed in Brooklyn federal court.
According to the complaint:
From April 6, 2020, to April 21, 2020, King Year manufactured 495,200 defective and misbranded masks that claimed to be N95 respirators, and caused those defective products to be imported into the United States. King Year stamped the NIOSH and FDA logos on the packaging for its respirators, appealing directly to healthcare personnel, when in fact, its respirators were not NIOSH-approved, nor were they approved, cleared, or otherwise authorized by the FDA. King Year’s respirators also were embroidered with “N95,” even though they fell well below the minimum 95 percent filtration standard.
King Year’s misbranded and defective products had the potential to deceive U.S. consumers, including healthcare workers and first responders, into believing they were purchasing authentic N95 respirators, and put them at risk. To cover up the poor quality of its respirators, King Year disseminated false documents attesting to their authenticity and filed a fraudulent registration statement with the FDA.
Each charge carries a maximum fine of $500,000 or the greater of twice the gross gain or twice the gross loss from the offense