FDA Inspections and REMS Requirements
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Questions and Answers

Which agency conducts inspections to evaluate compliance with risk evaluation and mitigation strategies (REMS) requirements?

  • CDC
  • EPA
  • NIH
  • FDA (correct)

    • How are inspections prioritized?

  • Randomly
  • Using a risk-based approach (correct)
  • By geographic location
  • By size of the company

    • What enforcement actions can be taken if issues found during REMS inspections are not corrected?

  • Product recall
  • License suspension
  • Warning letters (correct)
  • All of the above

    • What does FDA review to evaluate compliance with legal and regulatory requirements?

    <p>REMS assessment reports</p> Signup and view all the answers

    What regulatory action can FDA take for noncompliance with REMS requirements?

    <p>All of the above</p> Signup and view all the answers

    Which section of the DMEPOS Quality Standards covers Financial Management?

    <p>Section B: Financial Management</p> Signup and view all the answers

    Which section of the DMEPOS Quality Standards covers Performance Management?

    <p>Section E: Performance Management</p> Signup and view all the answers

    Which section of the DMEPOS Quality Standards covers Product Safety?

    <p>Section F: Product Safety</p> Signup and view all the answers

    Which section of the DMEPOS Quality Standards covers Information Management?

    <p>Section G: Information Management</p> Signup and view all the answers

    Which section of the DMEPOS Quality Standards covers Human Resources Management?

    <p>Section C: Human Resources Management</p> Signup and view all the answers

    True or false: The DMEPOS Quality Standards were effective starting on January 9, 2018.

    <p>True</p> Signup and view all the answers

    True or false: The DMEPOS Quality Standards cover Supplier Business Services Requirements.

    <p>True</p> Signup and view all the answers

    True or false: The DMEPOS Quality Standards cover Product Safety.

    <p>True</p> Signup and view all the answers

    True or false: The DMEPOS Quality Standards cover Information Management.

    <p>True</p> Signup and view all the answers

    True or false: The DMEPOS Quality Standards cover Consumer Services.

    <p>True</p> Signup and view all the answers

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