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Medical Devices / Inspections and Audits

FDA Brings Back More Staff for Inspection Activities

Jan. 17, 2019
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FDA Commissioner Scott Gottlieb announced said that approximately 400 staff members would return to their posts, mostly for inspection-related tasks, including about 100 for inspections of high risk medical device manufacturing facilities.

“About 400 total staff are being engaged in this mobilization. The vast majority are inspectors and others are professionals who work in support inspectors,” he said.

The expanded activities include surveillance and response for serious recalls, and inspection activities beyond “for-cause” inspections, to include foreign and domestic surveillance inspections focused on the highest risk products and facilities.

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