Episode 53: Leveraging the FDA's Warning Letters with Michael Tyo

Automating Quality

Welcome to Automating Quality, the Life Sciences centric show that bridges the gap between automation and quality management systems. In this episode, guest Michael Tyo discusses how warning letters can be leveraged as a source of information on the FDA’s current areas of focus and how monitoring them can help avoid the FDA’s attention.

Key Takeaways

01:04: Michael introduces himself and his background

02:21: How can companies use warning letters as a source of information on the FDA’s current area of focus

04:31: Michael shares a statistical analysis he conducted on warning letters in 2023

08:52: How warning letters give you an idea of what happened at the company

12:31: Understanding warning letters helps companies avoid the FDA’s attention

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