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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

Executive Summary

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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