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[November 2023 Issue] FDA Issues Guidance on Post-Warning Letter Meetings, Urges Firms to Treat Device Risk Management File as a ‘Living Document’ + Warning Letter Breakdown

We dive into a new FDA guidance, discuss how to act on FDA's risk management suggestions, and break down a warning letter citing numerous GMP deficiencies.

Welcome to Insider issue #19.

And a very warm welcome to the 342 new life science professionals who joined last month. If you haven’t already graduated to a paid subscription to unlock issues like this one, you can do so here.

In this month’s pharma segment, we explore the FDA's Draft Guidance on Post-Warning Letter Meetings under GDUFA III, which lays out a structured approach to navigate post-warning letter meetings effectively and, among other things, mandates a detailed CAPA plan and requires the submission of a complete meeting package.

In our device segment, we unpack an FDA official’s recent remarks suggesting device firms treat their risk management files as a 'living document.' At MedCon 2023, FDA investigator Thomas Peter emphasized that risk management is an ongoing journey, not just a destination. We discuss some ways device manufacturers can continuously update and adapt their risk files throughout the product lifecycle.

Lastly, we examine an FDA warning letter highlighting insufficient endotoxin testing and complaint investigations. The letter exposes serious non-compliance issues and highlights the consequences of not following manufacturing standards. We dissect the deficiencies and offer some lessons for self-assessment and proactive compliance assurance you can use right now.

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The FDA Group