Warning Letters And Close-Outs – April 2023

The US FDA released four device-related warning letters in April, involving alleged regulatory violations from Abbott, North American Diagnostics, Medivance and Synovo. The agency also closed out a 2021 Medtronic warning letter.

Warning Letters and Closeouts
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Check out Medtech Insight's US FDA Warning Letter Data Tracker here.

This chart lists medical device-related warning and close-out letters posted online by the US Food and Drug Administration in April 2023. The agency's close-out program publicly indicates when a manufacturer...

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