Do FDA Investigators meet with the Competent Authority while in-country to discuss the inspection?

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FDA Investigators are fact finders and are not in the best position to discuss policy matters. In addition, FDA Investigators are assigned regulatory inspections on a very tight schedule while in your country and their schedules do not provide sufficient time to travel to the Competent Authority’s headquarters to participate in policy meetings. The Competent Authority is always welcome to accompany FDA during inspections and to observe the opening and close-out meeting that FDA holds with the facility’s management and in this way they can hear first-hand the purpose and scope of the inspection, the relevant program guidance for the inspection, and the inspection observations.

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