FDA Warning Letter Management Guide



FDA issues a Warning Letter to tell you that you do not comply with FDA legal requirements. You have 15 working days to tell FDA how you will bring yourself into compliance. This requires drafting a plan that will map out your future with the FDA. If you do not, you face the possible actions identified in the Warning Letter without further notice. The actions can be costly and cast a cloud on the firm’s reputation. The threat of action is quite real.

Responding to a Warning Letter within 15 days requires a disciplined a strategically crafted approach. If you do not make a credible response in a timely manner, you will face a long and expensive road to regulatory recovery. Warning Letters have a significant impact on sophisticated firms and small firms alike. By understanding FDA’s Warning Letter process, you can intelligently work through what seems to be a trial by fire. You can avoid dangerous pitfalls and counter-product approaches. You need to understand what a Warning Letter really is, what you need to do about it and how to avoid a regulatory disaster.

Why you should attend:

Managing a Warning Letter should happen even before you receive it. There are basic tools you can use to prepare a response before a Warning Letter arrives. You also need to understand how an inspection or even a marketing practice can put you in jeopardy with FDA and generate a Warning Letter. At a minimum, this kind of prior planning reduces the mental compression of a 15 day deadline. It is critical that you see how your response commits you to FDA.

What you promise to do and how you do it become significant factors in your regulatory future. If you have already received a Warning Letter, you understand how a lack of planning ends up being a costly mistake. Your management of a Warning Letter unavoidably has an immediate and long term effect on your relationship with FDA. Prior planning pays off in this regard

Areas to be Covered:

Preparing for a Warning Letter,
Understanding what the Warning Letter says
How to respond
How to work with FDA staff
Planning your future with FDA

Who will Benefit:

Regulatory Affairs Professionals
Legal counsel
Director of Business Operations
Director of Manufacturing
Marketing executives
You as a competitor

Casper E. Uldriks

Casper (Cap) Uldriks brings over 32 years of experience from the FDA. He specialized in the FDA’s medical device program as a field investigator, served as a senior manager in the Office of Compliance and as an Associate Center Director for the Center for Devices and Radiological Health. He developed enforcement actions and participated in the implementation of new statutory requirements. He is recognized as an exceptional and energetic speaker. His comments are candid, straightforward and of practical value. He understands how FDA thinks, operates and where it is headed. Cap is the President of Encore Insight LLC, a consulting and training service for FDA law and operations.


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  • Presentation Handout in .pdf format
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