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