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Most Common Problems Found During FDA Inspections in 2022
Episode 31123rd March 2023 • Global Medical Device Podcast powered by Greenlight Guru • Greenlight Guru + Medical Device Entrepreneurs
00:00:00 00:44:30

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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, Mike Drues joins the podcast to talk about the FDA's Fiscal Year Report for 2022 Inspections and discusses the most common problems found during these inspections.

Recurring guest Mike 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. Mike 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.

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

Memorable quotes from Mike 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.”


Mike Drues LinkedIn

Vascular Sciences

Etienne Nichols LinkedIn

Greenlight Guru Academy

MedTech Excellence Community

Greenlight Guru




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