Top 483s of 2020—Mike on Medtech

Top 483s of 2020—Mike on Medtech

Mike Drues and Sean Fenske discuss the issues medical device manufacturers had during inspections last year.

By Sean Fenske, Editor-in-Chief06.08.21
In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we discuss the 483s medical device manufacturing facilities received in 2020. The list comes from the FDA and points to trends among device manufacturers that the quality systems companies have in place may not be used adequately. Actions to take to avoid such concerns in the future are addressed as well as best practices device makers should consider. Specifically, the following questions are addressed:

  • If every company is required to have a quality management system in place, how does this happen?
  • Is there something to be said about the FDA’s numbers given how many companies are registered with the FDA for the manufacture of medical devices?
  • So if CAPA, complaint handling, and design controls represent approximately a third of the 483s issued in 2020, what are the other two thirds.
  • What are your tips and suggestions for companies to avoid these types of citations?
  • Do you think the pandemic had any impact on these numbers? Were some companies ill-prepared for a virtual inspection with the FDA?

Listen to this episode and see what you think of the top 483s in 2020. 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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