SOCRA CCRP Practice Exam

Why might an investigator receive a Notice of Initiation of Disqualification Proceedings and Opportunity to Explain (NIDPOE)?

1. For exceeding the inspection budget

2. For failing to follow FDA guidelines

3. For missing inspection deadlines

4. For outstanding performance

The correct answer is: For failing to follow FDA guidelines

An inspector may receive a NIDPOE for failing to follow FDA guidelines. This is because failing to comply with these guidelines can directly impact the safety and effectiveness of the product being inspected. Options A, C, and D are incorrect because they do not directly pertain to FDA guidelines and their enforcement. Exceeding the inspection budget may be a performance issue, but it is not a direct violation of FDA guidelines. Missing inspection deadlines may also be a performance issue, but it does not directly address the quality and accuracy of the inspection itself. Outstanding performance, while desirable, does not address any specific regulatory requirements that an inspector must adhere to. Therefore, the Correct answer is B.