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Questions and Answers
Which agency conducts inspections to evaluate compliance with risk evaluation and mitigation strategies (REMS) requirements?
Which agency conducts inspections to evaluate compliance with risk evaluation and mitigation strategies (REMS) requirements?
- CDC
- EPA
- NIH
- FDA (correct)
How are inspections prioritized?
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?
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?
What does FDA review to evaluate compliance with legal and regulatory requirements?
What regulatory action can FDA take for noncompliance with REMS requirements?
What regulatory action can FDA take for noncompliance with REMS requirements?
Which section of the DMEPOS Quality Standards covers Financial Management?
Which section of the DMEPOS Quality Standards covers Financial Management?
Which section of the DMEPOS Quality Standards covers Performance Management?
Which section of the DMEPOS Quality Standards covers Performance Management?
Which section of the DMEPOS Quality Standards covers Product Safety?
Which section of the DMEPOS Quality Standards covers Product Safety?
Which section of the DMEPOS Quality Standards covers Information Management?
Which section of the DMEPOS Quality Standards covers Information Management?
Which section of the DMEPOS Quality Standards covers Human Resources Management?
Which section of the DMEPOS Quality Standards covers Human Resources Management?
True or false: The DMEPOS Quality Standards were effective starting on January 9, 2018.
True or false: The DMEPOS Quality Standards were effective starting on January 9, 2018.
True or false: The DMEPOS Quality Standards cover Supplier Business Services Requirements.
True or false: The DMEPOS Quality Standards cover Supplier Business Services Requirements.
True or false: The DMEPOS Quality Standards cover Product Safety.
True or false: The DMEPOS Quality Standards cover Product Safety.
True or false: The DMEPOS Quality Standards cover Information Management.
True or false: The DMEPOS Quality Standards cover Information Management.
True or false: The DMEPOS Quality Standards cover Consumer Services.
True or false: The DMEPOS Quality Standards cover Consumer Services.
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