FDA Warning Letter Recap, August 2021: On-Site Inspection Of Chinese Device Maker Uncovers Quality Systems Troubles
Also: Maker of COVID-19 tests gets 2 warning letters in 1 day
This is the first publicly released inspection-related warning letter sent to a Chinese company since the US FDA stopping sending investigators there in February 2020 because of the COVID-19 pandemic. A total of eight device-related missives were released by the agency in August.
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The US FDA sent the enforcement letter to China-based Lepu Medical Technologies roughly two months after the agency told health care providers to stop using COVID-19 tests made by the firm.
Device makers presented with an affidavit by the US FDA during a facility inspection should walk away as quickly as possible, King & Spalding partner Jessica Ringel advises.
The US agency has announced two additional webinars aimed at labs and manufacturers that are developing – or have developed – diagnostic tests for the coronavirus.