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

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.

What does that mean for industry and how should we use the new program to prepare?

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.

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.

IN THIS EPISODE

• What replaced QSIT and where to find it

• Why Part III is a useful starting point for industry

• How FDA reorganized inspection coverage into six QMS areas

• How product risks and risk management documentation help guide record selection

• What’s coming in the QMSR inspection readiness series

TIMESTAMPS

00:00 QSIT is gone: What changed with QMSR

00:50 The new FDA inspection program

01:39 The four-part inspection readiness series

02:47 Eric Pittman: Where industry should start

04:14 Will FDA publish a new QSIT guide?

05:06 Comparing the old and new inspection approaches

05:47 Four major subsystems to six QMS areas

06:57 Inspection models and record selection

07:37 Risk, controls, and inspection evidence

08:08 What’s next in the series

THE SERIES

1. QSIT to QMSR: Understanding the new inspection program

2. Inspection models, coverage, and record selection

3. The six QMS areas and how they connect

4. Inspection readiness: Preparing people, processes, and records, with lessons from early QMSR warning letters

RESOURCES

FDA Compliance Program 7382.850 — Inspection of Medical Device Manufacturers

Part III begins on page 20. Attachment A details the QMS areas, elements, and requirements.

https://www.fda.gov/media/80195/download

FDA Investigations Operations Manual — Chapter 5

https://www.fda.gov/media/166533/download

FDA QMSR Frequently Asked Questions

https://www.fda.gov/medical-devices/quality-management-system-regulation-qmsr/quality-management-system-regulation-frequently-asked-questions

ABOUT SUBHI SAADEH

Subhi Saadeh is the Founder and Principal of Let’s Combinate, a consultant, auditor, and trainer specializing in drug-device combination products, medical devices, and pharmaceutical quality systems. His experience spans quality, R&D, and commercialization, with a focus on design controls, supplier quality, inspection readiness, and translating regulatory expectations into practical execution.

Subhi is an ISO 13485 Lead Auditor and an ASQ Certified Quality Auditor and Certified Quality Engineer.

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