Problem
Imagine that you are the Organization's Compliance Officer and must submit a formal response in writing to the FDA. First, consider the violations outlined in the warning letter and identify areas for improvement in your Quality System; consider QSIT in your work.
Respond to the warning letter in writing. This response should include a summary of the areas for improvement and an actual response to the warning letter itself; your correspondence must describe the action(s) your organization will take to resolve the problems in the warning letter.