'Meaningless' FDA Certificates Are Used To Tout Dubious Face Masks
When the order of 100,000 masks arrived at an unnamed factory for use in protecting workers against COVID-19, they were covered in dirt, dust and mysterious stains. In short, they were "not fit to be used," according to a complaint filed with the Food and Drug Administration in late March.
The masks came from Shenzhen Newstar Optical Electronic Technology, a company in Shenzhen, China, that appears to primarily make LED displays. Because the report was filed in the FDA database for medical device problems, the complainant's name and other facts have been redacted.
"When i started to question them, they provided me with a fda certificate (dated april 7th 2020) in an attempt to silent [sic] me," the complainant wrote. The certificate had a date in the future on it. It was still March at the time.
When the COVID-19 pandemic left facilities scrambling for surgical masks, new manufacturers stepped up to meet demand and turn a profit. But the mix of first-time manufacturers and first-time buyers has led to confusion and concerns about quality.
Many sellers are touting FDA certificates of registration as evidence their masks can be trusted, say people
