FDA 483 & Warning Letters

We’ll Guide You at Every Step

Need Help Responding to an FDA 483?

  • We will work with you to write an appropriate response to any warning letters you’ve received, structure it in a format the FDA expects, and submit it before the deadline.
  • We will conduct a mock inspection after you’ve remediated the observations made by the FDA as described in your 483 response.
  • We will examine each response and verify you have done exactly what you said you would do.
  • We will then communicate the results of this inspection to the FDA as part of your close-out letter to demonstrate that you’ve taken the 483 letters seriously by bringing in a third party to help you remediate.
  • A 483 does not have to lead to serious business interruptions. You just need to have the right partner to work through what needs to be done.
Need help with FDA 483 & Warning Letters?

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Your journey to a successful regulatory submission and your LEAN Quality System begins here

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