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

- Show: [Let's Combinate](https://hardwarepodcasts.com/podcast/lets-combinate)
- Published: 2025-12-24
- Length: 25m
- Page: https://hardwarepodcasts.com/podcast/lets-combinate/2025-12-24-219-fda-precheck-and-the-future-of-inspections-pai-to-pre-readiness
- Listen: https://podcasters.spotify.com/pod/show/letscombinate/episodes/219---FDA-PreCheck-and-the-Future-of-Inspections-PAI-to-Pre-Readiness-e3cnf3c

## Summary

Host Subhi Saadeh and guest Ben Locwin discuss the FDA's evolving approach to Pre-Approval Inspections (PAIs) and Pre-License Inspections (PLIs), focusing on the industry's push to decouple inspection timing from approval decisions to avoid Complete Response Letters (CRLs). They analyze the FDA's new PreCheck program, designed to accelerate the regulatory review of onshored pharmaceutical manufacturing facilities, and compare US regulatory strategies with those of the EMA and MHRA.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/lets-combinate/2025-12-24-219-fda-precheck-and-the-future-of-inspections-pai-to-pre-readiness#t=0) Introduction and Guest Welcome
- [0:48](https://hardwarepodcasts.com/podcast/lets-combinate/2025-12-24-219-fda-precheck-and-the-future-of-inspections-pai-to-pre-readiness#t=48) Decoupling Inspections from Approval
- [3:03](https://hardwarepodcasts.com/podcast/lets-combinate/2025-12-24-219-fda-precheck-and-the-future-of-inspections-pai-to-pre-readiness#t=183) Complete Response Letters and Industry Impact
- [5:23](https://hardwarepodcasts.com/podcast/lets-combinate/2025-12-24-219-fda-precheck-and-the-future-of-inspections-pai-to-pre-readiness#t=323) Unannounced Inspections and Economic Trade-offs
- [12:34](https://hardwarepodcasts.com/podcast/lets-combinate/2025-12-24-219-fda-precheck-and-the-future-of-inspections-pai-to-pre-readiness#t=754) The FDA PreCheck Program for Onshoring
- [22:51](https://hardwarepodcasts.com/podcast/lets-combinate/2025-12-24-219-fda-precheck-and-the-future-of-inspections-pai-to-pre-readiness#t=1371) Global Regulatory Landscape and EMA/MHRA

## Topics

- [Certification & compliance](https://hardwarepodcasts.com/topic/certification-and-compliance)
- [Policy, trade & tariffs](https://hardwarepodcasts.com/topic/policy-trade-and-tariffs)
- [Scaling production](https://hardwarepodcasts.com/topic/scaling-production)

## Most relevant to

large enterprises

## Mentioned

- FDA (company)
- Eli Lilly (company)
- J and J (company)
- Merck (company)
- EMA (company)
- MHRA (company)
- PreCheck (other)
- Complete Response Letter (other)
- DMF Type 5 (other)

## Related episodes from other shows

- [Preparing for Remote and On-Site Inspections and Audits](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-02-24-preparing-for-remote-and-on-site-inspections-and-audits) (Global Medical Device Podcast)
- [Preparing Your Pre-Submission with the Content FDA Wants to See](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-06-23-preparing-your-pre-submission-with-the-content-fda-wants-to-see) (Global Medical Device Podcast)
- [#341: What NOT to say to FDA](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-10-25-341-what-not-to-say-to-fda) (Global Medical Device Podcast)
- [#342: Planning an FDA Submission](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-11-02-342-planning-an-fda-submission) (Global Medical Device Podcast)
- [Post-Pandemic Readiness: Preparing for the Aftermath of COVID-19 on the Medical Device Industry](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-12-23-post-pandemic-readiness-preparing-for-the-aftermath-of-covid-19-on-the-medical-d) (Global Medical Device Podcast)

## Citing this page

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