256 - The New FDA Inspection Playbook: Where to Start with QMSR

<p>QMSR became effective on February 2, 2026. Alongside that change, FDA retired the Quality System Inspection Technique (QSIT) and began using the inspection process described in Compliance Program 7382.850.</p><p><br /></p><p>What does that mean for industry and how should we use the new program to prepare?</p><p><br /></p><p>In this episode of Let’s Combinate: Drugs + Devices, Subhi Saadeh introduces a four-part series on QMSR inspection readiness. We compare QSIT’s four major inspection subsystems with the new program’s six QMS areas, explore how risk informs inspection coverage, and identify where industry should start reading.</p><p><br /></p><p>The episode also features an excerpt from Subhi’s conversation with Eric Pittman, a former FDA investigator who spent a decade as editor-in-chief of FDA’s Investigations Operations Manual.</p><p><br /></p><p>IN THIS EPISODE</p><p>• What replaced QSIT and where to find it</p><p>• Why Part III is a useful starting point for industry</p><p>• How FDA reorganized inspection coverage into six QMS areas</p><p>• How product risks and risk management documentation help guide record selection</p><p>• What’s coming in the QMSR inspection readiness series</p><p><br /></p><p>TIMESTAMPS</p><p>00:00 QSIT is gone: What changed with QMSR</p><p>00:50 The new FDA inspection program</p><p>01:39 The four-part inspection readiness series</p><p>02:47 Eric Pittman: Where industry should start</p><p>04:14 Will FDA publish a new QSIT guide?</p><p>05:06 Comparing the old and new inspection approaches</p><p>05:47 Four major subsystems to six QMS areas</p><p>06:57 Inspection models and record selection</p><p>07:37 Risk, controls, and inspection evidence</p><p>08:08 What’s next in the series</p><p><br /></p><p>THE SERIES</p><p>1. QSIT to QMSR: Understanding the new inspection program</p><p>2. Inspection models, coverage, and record selection</p><p>3. The six QMS areas and how they connect</p><p>4. Inspection readiness: Preparing people, processes, and records, with lessons from early QMSR warning letters</p><p><br /></p><p>RESOURCES</p><p><br /></p><p>FDA Compliance Program 7382.850 — Inspection of Medical Device Manufacturers</p><p>Part III begins on page 20. Attachment A details the QMS areas, elements, and requirements.</p><p>https://www.fda.gov/media/80195/download</p><p><br /></p><p>FDA Investigations Operations Manual — Chapter 5</p><p>https://www.fda.gov/media/166533/download</p><p><br /></p><p>FDA QMSR Frequently Asked Questions</