# 253 - FDA Is Making Big Changes to Its Inspection Approach

- Show: [Let's Combinate](https://hardwarepodcasts.com/podcast/lets-combinate)
- Published: 2026-09-07
- Length: 45m
- Page: https://hardwarepodcasts.com/podcast/lets-combinate/2026-09-07-253-fda-is-making-big-changes-to-its-inspection-approach
- Listen: https://podcasters.spotify.com/pod/show/letscombinate/episodes/253---FDA-Is-Making-Big-Changes-to-Its-Inspection-Approach-e3oe86q

## Summary

Eric Pittman, former Bioresearch Monitoring West Division Director at the FDA and now VP at Project Farma, explains the FDA's transition from a specialized program-aligned inspection model back to a broader, medical-product-specific generalist model under the new Office of Investigations and Inspections (OII). He details the operational differences between routine inspections under Section 704 and undercover investigations under Section 702, emphasizing that investigators prioritize human subject safety over minor regulatory technicalities. Pittman advises industry to focus on the FDA’s Investigations Operations Manual (IOM) and specific compliance programs rather than cosmetic facility improvements, noting that the end of QSIT has shifted focus to broader process evaluation.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/lets-combinate/2026-09-07-253-fda-is-making-big-changes-to-its-inspection-approach#t=0) Introduction: Eric Pittman and the FDA Inspection Model Shift
- [1:20](https://hardwarepodcasts.com/podcast/lets-combinate/2026-09-07-253-fda-is-making-big-changes-to-its-inspection-approach#t=80) Generalist vs. Specialist: The History of FDA Inspections
- [3:46](https://hardwarepodcasts.com/podcast/lets-combinate/2026-09-07-253-fda-is-making-big-changes-to-its-inspection-approach#t=226) Defining Bioresearch Monitoring (BIMO) and Its Scope
- [5:00](https://hardwarepodcasts.com/podcast/lets-combinate/2026-09-07-253-fda-is-making-big-changes-to-its-inspection-approach#t=300) Auditing Skills vs. Technical Expertise in Investigators
- [11:13](https://hardwarepodcasts.com/podcast/lets-combinate/2026-09-07-253-fda-is-making-big-changes-to-its-inspection-approach#t=673) Prioritizing Human Subject Safety Over Regulatory Gotchas
- [13:52](https://hardwarepodcasts.com/podcast/lets-combinate/2026-09-07-253-fda-is-making-big-changes-to-its-inspection-approach#t=832) The Volume of Inspections and the PIW Process
- [19:26](https://hardwarepodcasts.com/podcast/lets-combinate/2026-09-07-253-fda-is-making-big-changes-to-its-inspection-approach#t=1166) Why Investigators 'Phone Home' for Expertise
- [23:09](https://hardwarepodcasts.com/podcast/lets-combinate/2026-09-07-253-fda-is-making-big-changes-to-its-inspection-approach#t=1389) Restructuring ORA to OII and Supervisor Ratios
- [30:01](https://hardwarepodcasts.com/podcast/lets-combinate/2026-09-07-253-fda-is-making-big-changes-to-its-inspection-approach#t=1801) Inspections (704) vs. Investigations (702) Authority
- [32:41](https://hardwarepodcasts.com/podcast/lets-combinate/2026-09-07-253-fda-is-making-big-changes-to-its-inspection-approach#t=1961) Using the IOM and Compliance Programs for Preparation
- [43:46](https://hardwarepodcasts.com/podcast/lets-combinate/2026-09-07-253-fda-is-making-big-changes-to-its-inspection-approach#t=2626) What Companies Waste Time Preparing For

## Topics

- [Certification & compliance](https://hardwarepodcasts.com/topic/certification-and-compliance)
- [Quality & yield](https://hardwarepodcasts.com/topic/quality-and-yield)
- [Leadership, teams & culture](https://hardwarepodcasts.com/topic/leadership-and-culture)

## Most relevant to

large enterprises

## Mentioned

- FDA (company)
- Project Farma (company)
- Bioresearch Monitoring (other)
- Investigations Operations Manual (other)
- QSIT (other)
- Temple University (company)

## 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)
- [#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)
- [FDA is Expanding its Case for Quality Program... Should Your Company Participate?](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2019-11-26-fda-is-expanding-its-case-for-quality-program-should-your-company-participate) (Global Medical Device Podcast)
- [Auditing the Auditor](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-01-07-auditing-the-auditor) (Global Medical Device Podcast)
- [#474: Behind the QMSR Audits: The Top 5 FDA Citations & Risk Management Pitfalls](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2026-09-21-474-behind-the-qmsr-audits-the-top-5-fda-citations-risk-management-pitfalls) (Global Medical Device Podcast)

## Citing this page

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