SOCRA CCRP Practice Exam

What outcome does a NAI classification from the FDA signify for a facility?

1. The facility must immediately cease operations

2. The facility has met FDA standards and practices

3. The facility requires minor adjustments

4. The facility must respond with a corrective action plan

The correct answer is: The facility has met FDA standards and practices

A NAI (No Action Indicated) classification from the FDA signifies that the facility has met all FDA standards and practices, meaning it is in compliance and can continue operating. Option A, requiring immediate cessation of operations, is incorrect because a NAI classification indicates that there are no significant violations or issues that require immediate action. Option C, requiring minor adjustments, is also incorrect because a NAI classification indicates that the facility is already in compliance and does not require any adjustments. Option D, requiring a corrective action plan, is incorrect because a NAI classification signifies that no action is needed from the facility.