N95 respirator [Image from the FDA]
King Year Packaging and Printing Co. Ltd. (King Year) faces three counts of violating the Federal Food, Drug and Cosmetic Act (FDCA) and one felony count of making a false statement by filing misleading registration documents with the FDA. The criminal complaint was filed in Brooklyn (N.Y.) federal court.
N95 respirators are designed to filter out 95% of airborne particles and have been in high demand as personal protective equipment for healthcare providers caring for COVID-19 patients.
According to the complaint, from April 6, 2020, to April 21, 2020, King Year manufactured 495,200 defective and misbranded masks that it claimed to be N95 respirators and had them imported into the United States. King Year allegedly stamped the NIOSH and FDA logos on the packaging for its respirators although they were neither NIOSH-approved, nor 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, the charges said. 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.
“These charges demonstrate the continued commitment of the Department of Justice and our partners to aggressively pursue those who sell misbranded and defective personal protective equipment, whether they are located here or abroad,” said U.S. Attorney Craig Carpenito of the District of New Jersey in a news release. “We will aggressively investigate and charge manufacturers that put our medical professionals and first responders at risk in fighting this crisis.”
Carpenito heads the federal COVID-19 Hoarding and Price Gouging Task Force, which is working with the U.S. Department of Justice antitrust division and U.S. attorneys across the country as well as the FDA.
“The charges alleged in this complaint show a blatant disregard for the safety of American citizens,” added Douglas Korneski, acting FBI-Newark special agent in charge. “Had it not been for the actions of the investigative team, this defendant would have put first responders, hospital employees, and other front line workers directly in harm’s way with faulty equipment just to make a buck. The defendant tried to bypass the government’s regulations by misbranding the quality of the equipment being peddled. The FBI remains vigilant in the pursuit of criminals trying to exploit the current crisis.”
