219 - FDA PreCheck and the Future of Inspections: PAI to Pre-Readiness

In this episode of Let’s Combinate: Drugs + Devices, host Subhi Saadeh is joined by Ben Locwin to break down what’s changing in FDA pre-approval and pre-license inspections—and why the “inspection side” of approval is becoming a bigger conversation.They cover how PAIs and PLIs fit into the approval pathway, why Complete Response Letters (CRLs) can be driven by inspection outcomes, and what it would mean to “decouple” approval decisions from inspection timing. The conversation also explores the pros and cons of unannounced inspections, the realities of FDA capacity and scheduling, and how FDA’s PreCheck program is shaping the onshoring/manufacturing-readiness narrative in the U.S. Finally, they zoom out to compare international inspection approaches and what global trends could signal for industry.What you’ll learn-The difference between Pre-Approval Inspections (PAIs) and Pre-License Inspections (PLIs)-How inspection outcomes can lead to CRLs—even when the application looks strong on paper-Why industry is talking about decoupling approval from PAI timing-The idea behind FDA PreCheck and what “facility readiness” looks like-Unannounced inspections: where they help, where they create risk-How inspection expectations compare across global regulatorsChapters00:00 Introduction and Guest Welcome00:10 Understanding Pre-Approval and Pre-License Inspections01:54 Challenges and Industry Perspectives03:08 FDA Complete Response Letters (CRLs)05:23 Unannounced Inspections: Pros and Cons08:55 Economic and Regulatory Considerations12:37 Onshoring and the PreCheck Program22:51 Global Regulatory Landscape25:11 Conclusion and FarewellBen Locwin is a Healthcare Executive, MMA fighter, Jiu Jtisu pro and Quality and Regulatory SME working in medical devices, pharma and other regulated industries.Subhi Saadeh is a Quality Professional and host of Let's Combinate. With a background in Quality, Manufacturing Operations and R&D he's worked in Large Medical Device/Pharma organizations to support the development and launch of Hardware Devices, Disposable Devices, and Combination Products for Vaccines, Generics, and Biologics. Subhi serves currently as the International Committee Chair for the Combination Products Coalition(CPC) and as a member of ASTM Committee E55 and also served as a committee member on AAMI's Combination Products Committee.For questions, inquiries or suggestions please reach out at letscombinate.com or on the show's LinkedIn Page.