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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.

A worker makes masks at Shanghai Dasheng Health Products Manufacturing Co., Ltd. in Shanghai, on 31 January, 2020
A worker makes masks at Shanghai Dasheng Health Products Manufacturing in Shanghai in January 2020 • Source: Alamy

The US Food and Drug Administration is warning health care workers to stop using N95 respirators from yet another Chinese manufacturer. While the agency had greatly relaxed import oversight of such masks at the start of the COVID-19 pandemic, it has been retightening regulations as domestic production has ramped up.

The FDA says Shanghai Dasheng Health Products Manufacturing Co. Ltd. didn’t implement, maintain and control a quality management system. As a result, the National Institute for Occupational Safety and Health...

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