King Year Packaging and Printing Co. Ltd manufactured 495,200 faulty and misbranded masks that claimed to be N95 respirators and sent the products to the United States for sale, prosecutors said. The masks, however, fell well below N95 filtration standards, the department added.
Prosecutors said the masks appealed directly to health professionals, with the packaging containing logos of the Food and Drug Administration (FDA) and the National Institute for Occupational Safety and Health, when it was not approved by those two agencies.
“The charges alleged in this complaint show a blatant disregard for the safety of American citizens,” Acting FBI-Newark Special Agent in Charge Douglas Korneski said in a statement.
According to the complaint, the manufacturer spread false documents attesting to the authenticity of the purported N95 respirators and filed a fraudulent registration statement with the FDA.
In a complaint filed at a federal court in Brooklyn, the Chinese company was charged with three counts of violating the Federal Food, Drug and Cosmetic Act, and one felony count of making a false statement, the department said.
For each charge, King Year faces a maximum fine of $500,000 or the greater for twice the gross gain or twice the gross loss from the sale of the faulty masks.
The charges come as part of a federal effort to stem the influx of counterfeit and substandard medical gear entering into the country during the pandemic.
In early May, the FDA barred more than 60 N95-type mask manufacturers in China from exporting to the United States, after testing found that many of their products far short of quality standards.
In April, Missouri recalled thousands of KN95 masks from China that had been distributed to first responders, after testing found that that they did not meet standards.
Outside of the United States, a slew of countries, from Finland to the Netherlands, have in recent months recalled or sent back faulty masks, test kits, and protective suits from Chinese manufacturers.