The attached file contains several warning letter excerpts. For the purposes of this assignment, we’ll say that these citations comprise one warning letter to an investigator. Your assignment is to draft a response letter from the perspective of the investigator. Provide a response to each of the citations; in your response be sure to describe both how you will fix the issue (corrective action) and put measures in place to prevent it in the future (preventive action). The response should be in letter format with an introduction and conclusion.
Part 2: 5 Pages
Select a warning letter from the FDA database that is, in part, relative to the concepts we’ve covered in this class. Your assignment is to draft a response to that warning letter from the perspective of the investigator. Provide a response to each of the citations; in your response be sure to describe both how you will address the issue (corrective action) and put measures in place to prevent it in the future (preventative action). FDA Warning Letter database:
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/
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Formatting
Title Page
Citation
Outline
