Double Whammy: Lepu Medical’s Class I COVID-19 Diagnostics Recall Followed By FDA Warning Letter
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.
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FDA Warning Letter Recap, August 2021: On-Site Inspection Of Chinese Device Maker Uncovers Quality Systems Troubles
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.
The US FDA released two warning letters in May related to the sale of unapproved COVID-19 tests.
The US FDA released five warning letters in April, all addressed to companies selling COVID-19 tests without agency clearance, approval or authorization.