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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

 
• By Shawn M. Schmitt

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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Checkout MedtechInsight'sUSFDAWarningLetterDataTracker here.

This chart lists device-related warning letters released by the US Food and Drug Administration in August 2021. If an inspection led to the warning letter, the location of the inspected...

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• By Brian Bossetta

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More from Compliance

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• By Brian Bossetta

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New Guidance From Canada’s HTA Agency On Submission Of AI-Driven Evidence

 
• By Neena Brizmohun

Recognizing that the evidence it receives in applications for health technology assessments will increasingly be informed by artificial intelligence, the CDA-AMC has clarified its expectations for companies that use AI methods in the generation and/or reporting of evidence.