# Top 3 Most Cited Issues in Medical Device Inspections from FDA FY2020

- Show: [Global Medical Device Podcast](https://hardwarepodcasts.com/podcast/global-medical-device-podcast)
- Published: 2021-06-14
- Length: 34m
- Episode: 213
- Page: https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-06-14-top-3-most-cited-issues-in-medical-device-inspections-from-fda-fy2020
- Listen: https://podcast.greenlight.guru/episode/top-3-most-cited-issues-in-medical-device-inspections-from-fda-fy2020

## Summary

Jon Speer, founder of Greenlight Guru, interviews Mike Drues, president of Vascular Sciences, about the FDA's FY2020 inspection data for medical device quality systems. They analyze the top three most cited 483 observations: CAPA, complaints, and design controls, noting that these accounted for approximately 35% of all findings. Drues and Speer discuss the critical failure of manufacturers to document procedures, investigate complaints, and use production-equivalent devices for validation, emphasizing that these are basic regulatory requirements rather than complex nuances.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-06-14-top-3-most-cited-issues-in-medical-device-inspections-from-fda-fy2020#t=0) Introduction and FY2020 Inspection Volume
- [5:07](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-06-14-top-3-most-cited-issues-in-medical-device-inspections-from-fda-fy2020#t=307) Analysis of Top Cited Issue: CAPA Failures
- [13:18](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-06-14-top-3-most-cited-issues-in-medical-device-inspections-from-fda-fy2020#t=798) Analysis of Second Cited Issue: Complaints
- [19:49](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-06-14-top-3-most-cited-issues-in-medical-device-inspections-from-fda-fy2020#t=1189) Analysis of Third Cited Issue: Design Controls
- [24:53](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-06-14-top-3-most-cited-issues-in-medical-device-inspections-from-fda-fy2020#t=1493) Purchasing Controls and QMS Implementation Strategy
- [28:06](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-06-14-top-3-most-cited-issues-in-medical-device-inspections-from-fda-fy2020#t=1686) Proactive Prevention and Final Advice

## Topics

- [Quality & yield](https://hardwarepodcasts.com/topic/quality-and-yield)
- [Certification & compliance](https://hardwarepodcasts.com/topic/certification-and-compliance)
- [Design for manufacturing & NPI](https://hardwarepodcasts.com/topic/design-for-manufacturing)

## Most relevant to

established companies

## Mentioned

- Greenlight Guru (company)
- Vascular Sciences (company)
- FDA (other)
- 21 CFR Part 820 (other)

## Related episodes from other shows

- [155 - FDA Compliance Programs, Program 7536.000: CDER vs. CDRH led Inspections, Mock PAI's, Supplier Management, and What is a Manufacturer? with Laurie Auerbach](https://hardwarepodcasts.com/podcast/lets-combinate/2024-09-25-155-fda-compliance-programs-program-7536-000-cder-vs-cdrh-led-inspections-mock-p) (Let's Combinate)
- [201 - Inside a $300M FDA Remediation, Lessons from Zimmer to EpiPen Warning Letters, 99.999% Reliability and Quality 4.0](https://hardwarepodcasts.com/podcast/lets-combinate/2025-08-13-201-inside-a-300m-fda-remediation-lessons-from-zimmer-to-epipen-warning-letters) (Let's Combinate)
- [217 - 5 Fixable Problems Holding Back Drug–Device Programs](https://hardwarepodcasts.com/podcast/lets-combinate/2025-12-10-217-5-fixable-problems-holding-back-drug-device-programs) (Let's Combinate)
- [123 - Uncovering HUGE Quality Issues, Inspection Readiness in 2024, Data Integrity, AlCOA+/PIC/S and Critical Thinking in Quality Management with Peter Baker](https://hardwarepodcasts.com/podcast/lets-combinate/2024-02-14-123-uncovering-huge-quality-issues-inspection-readiness-in-2024-data-integrity-a) (Let's Combinate)
- [178 - CAPA Face-Off: Pharma vs. MedTech – Key Differences You Need to Know](https://hardwarepodcasts.com/podcast/lets-combinate/2025-03-05-178-capa-face-off-pharma-vs-medtech-key-differences-you-need-to-know) (Let's Combinate)

## Citing this page

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