SOCRA CCRP Practice Exam

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What action is warranted when an FDA inspection classification is OAI?

  1. Further monitoring

  2. No action

  3. Significant corrective action

  4. Informal advisory meeting

The correct answer is: Significant corrective action

When an FDA inspection classification is OAI, this means that the inspection found significant issues that violate the Food, Drug, and Cosmetic Act. This requires significant corrective action, such as quarantining of products, recalling products, or submitting a formal response to the FDA explaining how the issues will be addressed. The other options are incorrect because further monitoring would not be sufficient to address the issues found, no action would not address the violations, and an informal advisory meeting would not be enough to address the significant issues found. Therefore, significant corrective action is warranted in this situation.

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