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Pharmaceuticals, Medical Devices

Effectively Responding to FDA 483s and Warning Letters

About the Course

No company wants to receive an FDA 483 or Warning Letter for adverse findings after an FDA inspection, but it does happen. This online training course explains the basic principles of FDA 483s and the use of Warning Letters to provide feedback on compliance concerns. Topics in this course include: FDA 483, Response, Warning Letter, Response Process, and Avoiding Mistakes. After completing this course, learners will be able to describe key aspects of written responses to both FDA 483s and Warning Letters, and recognize the importance of both of these documents.