UIUC FDA Warning Letter

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Description

For this assignment, you will select an FDA Warning Letter from the list provided and complete a full root cause analysis. Based on this analysis, you will develop a corrective and preventive action plan (CAPA). When citing any resources, be sure to 

Steps

1. Select an FDA Warning letter from this list Download this list.

2. Using this CAPA template Download CAPA template, conduct and document a full root cause analysis.  

3. Based on this analysis, develop a corrective and preventive action plan in the same document.

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