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Warning Letter Roundup & Recap – March 19, 2019

 
• By Shawn M. Schmitt

Two makers of breast implants failed to comply with years-old FDA post-approval study orders, and TEI Biosciences Inc. – an Integra LifeSciences company – ran afoul of the US agency's Quality System Regulation in device-related warning letters released by FDA this week.

Warning Rubber Stamp

Checkout MedtechInsight'sUSFDAWarningLetterDataTracker here.

This chart lists warning letters released by US FDA the week of March 19, 2019. If an inspection led to the warning letter, the location of the inspected facility and...

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