Leading Issues from FDA Inspections (or History Repeating Itself)—Mike on Medtech

Leading Issues from FDA Inspections (or History Repeating Itself)—Mike on Medtech

Mike Drues and Sean Fenske discuss why medical device manufacturers continue to rack up the same types of 483s from FDA inspections.

By Sean Fenske, Editor-in-Chief04.04.23
In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we look at the 483s and warning letters that resulted from FDA inspections in 2022. The list is alarmingly similar to previous years and the discussion explores why that’s the case. The discussion also centers around ways device manufacturers can avoid making many of these same mistakes that get other companies into trouble with the agency. Specifically, the following questions are addressed:

  • Can run through the top reasons for 483s and warning letters?
  • Can you provide some examples of CAPA problems and offer suggestions for avoiding them?
  • Like CAPAs, design controls accounted for more than 12% of the list. Can you provide examples of these violations and suggestions on how to avoid them?
  • Third among the top was complaint handling, almost 11% of all violations. Do you have examples of these and tips for avoiding them?
  • Are these top three problems really identical to what we’ve seen in previous years? Are these the same mistakes again?
  • What are the most important takeaways with regard to today’s discussion?

Listen to this discussion and see if you might be vulnerable to a 483 upon your next inspection. If you’d like to share thoughts, ask questions, or have a suggestion for a future topic for us to cover, please reach out to me at sfenske@rodmanmedia.com and we’ll see if we want to address your ideas/inquiries/suggestions in a future episode.

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