FDA Comes Down On Another Chinese N95 Manufacturer
The US agency says Shanghai Dasheng didn’t put a quality management system in place, and as a result has lost NIOSH approval for its N95 respirators. The agency told health care workers to stop using the masks.
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In an ongoing trend, the US agency announced it revoked a number of emergency use authorizations at the behest of manufacturers.
The US FDA says the 11 companies were selling masks without agency clearance, approval or authorization. A total of 13 device-related missives were released by the FDA in July.
The US agency says there are now at least 6,400 NIOSH-approved respirators or configurations that can sufficiently meet the domestic supply needs of health care workers.