FDA Withdraws Approvals for Some Chinese Mask Makers
The Food and Drug Administration took away approvals for more than 60 mask makers in China to export masks similar to N95 into the U.S., The Wall Street Journal said in a May 7 report. The withdrawals are due to quality issues found by federal regulators with the imported products, the report said. The FDA last month said it would allow for imports of foreign respirators, including the KN95 from China (see 2004060052).
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An updated list of authorized respirator imports from China now only lists 14 manufacturers. The FDA updated an Emergency Use Authorization to reflect some issues with the imported respirators, it said in a May 7 notice. “The FDA is taking this public health action because a number of these respirators failed to demonstrate a minimum particulate filtration efficiency of 95 percent,” the agency said.
FDA also made other changes to its April 3 Emergency Use Authorization that allowed imports of the China-made masks. “The EUA is being revised so that only manufacturers can request to be added to Appendix A,” which lists the filtered faceplate respirator (FFR) manufacturers eligible for importation. “Importers will no longer be allowed to submit a request to add an FFR to Appendix A.”