On May 7, the US Food and Drug Administration (FDA) said it had withdrawn N95 mask permits from more than 65 Chinese manufacturing companies after discovering a large number of low-quality products.
Withdrawn more than 65 manufacturing companies, all of which are among the 80 Chinese mask manufacturing companies authorized by the FDA on April 3. On April 3, the FDA made a decision in the “Usable Emergency Disposal (EUA) for disposable filter respirator manufactured in China that has not been approved by NIOSH (National Institute of Occupational Safety and Health)”. The regulation allows the import of masks from Chinese mask manufacturers that have not been tested by NIOSH but have been reviewed by independent laboratories. Mask manufacturers should demonstrate that they meet the standards of the US Centers for Disease Control and Prevention, which requires filtering 95% of particles 0.3 microns or larger, Including the new coronavirus.
For the reasons for this withdrawal, the FDA explained that the filtering effect of these masks did not meet the standards. Of the 11 N95 masks tested by the FDA authorized to be sold to hospitals, 7 masks failed. The NIOSH test found that the mask made by a disqualified Chinese company only filtered 24% -35% of the particulate matter, which is far lower than the standard for filtering 95% particulate matter required by N95 masks. In addition, the relevant agencies also inspected some unapproved N95 mask products. The FDA stated that one of the masks only filtered about 1% of the particulate matter.
According to the New York Times, the inspection of these masks began a few weeks ago, but the results were not released until May 7, “It is not clear why there was such a delay. It is also unclear how many masks were sold to Medical workers in the United States and whereabouts. “A spokesperson for the FBI did not give a clear response when asked about the issue.
Practitioners of a testing and consulting agency said in an interview with Interface News that companies whose organizations helped to enter the FDA’s EUA list were also revoked. “There may be two reasons for this phenomenon: one is that the quality of the products sent by the enterprise for inspection and the quality of the exported products are inconsistent; the second is that the standards are different.”
Although the FDA’s emergency use authorization also requires sample testing, the above-mentioned practitioners said that when the company’s product is submitted for inspection, its agency will also instruct to use the best product, vacuum packaging for inspection. And the second point, the analysis may also be that the testing standards and testing methods of domestic laboratories and US laboratories are different, resulting in differences in test results.
Many of the companies whose licenses were revoked were not originally specialized in the production of medical protective equipment. “The profit of medical masks is high, unlike the price of one or two pieces of civilian masks. The export price of medical masks is seven or eight. Some of them are sold for about 30 yuan(about 5 dollars). “The high profits make the company eager to try, but at the same time, the swarming has also caused a mixed situation in the market.