A Chinese manufacturer was charged with producing and exporting to the United States in the midst of the COVID-19 pandemic over 140,000 misbranded and defective masks that falsely purported to be KN95 respirators. Crawford Technology Group (HK) Co. LTD. (Crawford) is charged by complaint with violating the Federal Food, Drug and Cosmetic Act (FDCA) for causing misbranded and substandard respirators that falsely purported to meet various filtration efficiency standards to be imported into the United States. In May 2020, Crawford, a digital electronics company based in Shenzhen, China, manufactured and sold 140,400 adulterated and misbranded KN95 filtering face piece respirators to Company-1 for import into the United States. The packaging for the respirators, as well as the respirators themselves, falsely indicated that they were 95 percent efficient at filtering harmful airborne particles. The respirators and their packaging also claimed that they complied with established standards in the European Union and China, which require at least 94 percent or 95 percent filtering efficiency, respectively. Crawford also advertised the respirators on its website under a tab labeled “epidemic” and claimed that their respirators have “4 layers of protection” and “Passed the national standard 2626-2000 test.” The page also says “KN95 Filtration reaches 95%,” “KN95 Filter Effect 95%,” and states that their respirators protect against “Severe Haze,” “Bacteria,” and “Dust.” These claims were false and misleading because the average filtering efficiency for the Crawford respirators was 22.33 percent, far below the required thresholds.
