SOCRA CCRP Practice Exam

What is created by the FDA after an inspection visit and submitted to the center that requested it?

1. Establishment Inspection Report

2. Notice of Compliance

3. Certificate of Approval

4. Regulatory Review Letter

The correct answer is: Establishment Inspection Report

After an inspection visit, the FDA creates an Establishment Inspection Report (EIR) and submits it to the requesting center. This report contains detailed findings and observations from the inspection, including any deficiencies or non-compliance issues. This is an important document that helps both the FDA and the requesting center to ensure that all necessary regulations and standards are being met. B The Notice of Compliance is not created by the FDA after an inspection visit. This notification typically comes from the FDA to a drug manufacturer, indicating that the required pre-marketing requirements have been met and the product may now be marketed in the US. C: The Certificate of Approval is not created by the FDA after an inspection visit. This certificate is typically issued by the FDA to a drug manufacturer after a drug is approved for use in the US. D: The Regulatory Review Letter is not created by the FDA after an inspection