What are the documents that SFDA has the right to request which support the closure process for Field Safety Corrective Actions?
Question
What are the documents that SFDA has the right to request which support the closure process for Field Safety Corrective Actions?
Answer
. Acknowledgement of the Authorized Representative (AR) to inform the users when the Field Safety Notice is issued, and the preventive and corrective actions related to it.
. Acknowledgement of the health care provider to complete the corrective action.
. Maintenance/service report.
. Any other document according to the type of the Field Safety Notice and the corrective action.
