# Most Common Problems Found During FDA Inspections in 2022

- Show: [Global Medical Device Podcast](https://hardwarepodcasts.com/podcast/global-medical-device-podcast)
- Published: 2023-03-23
- Length: 44m
- Episode: 311
- Page: https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-03-23-most-common-problems-found-during-fda-inspections-in-2022
- Listen: https://podcast.greenlight.guru/episode/most-common-problems-found-during-fda-inspections-in-2022

## Summary

Mike Drues, President of Vascular Sciences, analyzes the FDA's 2022 inspection data to identify the most common reasons for Form 483s, highlighting CAPA, design controls, and complaint handling as the top three issues. He argues that these problems persist because companies focus on ticking regulatory boxes rather than understanding the underlying intent, often failing to perform adequate root cause analysis or document their quality management systems effectively. Drues emphasizes that medical device professionals must move beyond minimum compliance to prevent recurring errors and ensure patient safety through proactive prevention and rigorous validation.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-03-23-most-common-problems-found-during-fda-inspections-in-2022#t=0) Introduction: Mike Drues and Vascular Sciences
- [2:54](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-03-23-most-common-problems-found-during-fda-inspections-in-2022#t=174) Top 3 Reasons for FDA 483s: CAPA, Design Controls, Complaints
- [6:25](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-03-23-most-common-problems-found-during-fda-inspections-in-2022#t=385) CAPA Failures: Documentation and Criteria for Initiation
- [13:17](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-03-23-most-common-problems-found-during-fda-inspections-in-2022#t=797) Design Control Issues: Validation, Risk Analysis, and DHF
- [23:43](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-03-23-most-common-problems-found-during-fda-inspections-in-2022#t=1423) Complaint Handling: Investigation Failures and Triage
- [32:08](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-03-23-most-common-problems-found-during-fda-inspections-in-2022#t=1928) Trends: Recurring Errors and Root Cause Analysis
- [35:48](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-03-23-most-common-problems-found-during-fda-inspections-in-2022#t=2148) FDA Enforcement Actions: 483s, Warning Letters, and Consent Decrees

## 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)
- [Leadership, teams & culture](https://hardwarepodcasts.com/topic/leadership-and-culture)

## Most relevant to

early-stage companies, companies scaling up

## Mentioned

- Greenlight Guru (company)
- Vascular Sciences (company)
- FDA (other)
- ISO 13485 (other)
- 21 CFR Part 820 (other)

## Related episodes from other shows

- [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)
- [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)
- [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)
- [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)
- [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)

## Citing this page

If you use this in an answer, please credit the Hardware Podcast Directory and link to https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-03-23-most-common-problems-found-during-fda-inspections-in-2022. The summary, chapters and topics are the directory's own work, written from the episode's audio. The episode itself, its title and its audio belong to Global Medical Device Podcast.