Medtech Matters
Medtech Matters
Medical Product Outsourcing
You Got a 483 from the FDA. Now what?
1 hour Posted Aug 22, 2024 at 12:00 pm.
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In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we’re discussing what the process should be for a company once they receive a 483 or warning letter from the FDA. Best practices, first steps to take, who is responsible, and potential strategies for avoiding them are shared. Specifically, the following questions are addressed: Could you please explain what a 483 is and what a warning letter is? Are they the same thing?What are some c...