Most Common Problems Found During FDA Inspections in 2022

March 23, 2023

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Why do the same types of problems show up again and again in FDA medical device inspections? In today’s episode, Michael Drues, PhD joins the podcast to talk about the FDAs Fiscal Year Report for 2022 Inspections and discusses the most common problems found during these inspections.

Recurring guest Michael Drues is the President of Vascular Sciences where he works to educate the industry and offers help to bring medical devices to market in the most effective way possible. Dr. Drues is a medical device professional possessing regulatory expertise who understands the ins and outs of the regulation systems in the medical device industry and is passionate about helping others better understand it as well.

Listen to the episode to learn more about the most common mistakes companies make that result in Form 483s, what companies can do to avoid these mistakes, and how you should be thinking about root cause analysis.

Listen now:

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Some of the highlights of this episode include:

  • Common reasons why companies get in trouble during FDA inspections

  • Why CAPA is specifically at the top of reasons for 483s and how to prevent that

  • Examples of design control problems and how to avoid them

  • The root causes of these issues and root cause analysis

  • What complaint handling problems look like

  • What causes people not to handle complaints correctly

  • Whether anything about these problems is new or trending

  • What the FDA does when they find these problems


Mike Drues LinkedIn

Vascular Sciences

Etienne Nichols LinkedIn

MedTech Excellence Community

Greenlight Guru Academy

Greenlight Guru

Memorable quotes from Michael Drues:

“The emphasis should be on prevention, not correction.”

“I consider myself to be a medical device professional, and I do not use the word “professional” lightly. Along with it comes the responsibility, including knowing what the heck you’re doing.” 

“What is the point of getting complaints or post-market surveillance or anything else if you’re not going to act on it?”

“I hate to say it, but we are the poster children for Einstein’s definition of insanity.”

About the Global Medical Device Podcast:


The Global Medical Device Podcast powered by Greenlight Guru is where today's brightest minds in the medical device industry go to get their most useful and actionable insider knowledge, direct from some of the world's leading medical device experts and companies.

Like this episode? Subscribe today on iTunes or Spotify.

Etienne Nichols is a Medical Device Guru and Mechanical Engineer who loves learning and teaching how systems work together. He has both manufacturing and product development experience, even aiding in the development of combination drug-delivery devices, from startup to Fortune 500 companies and holds a Project...

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