The FDA has temporarily postponed all domestic routine surveillance inspections due to the coronavirus outbreak. These are facility inspections that the FDA traditionally conducts every few years based on a risk analysis. All domestic for-cause inspections will be evaluated and will proceed if mission-critical.
In a statement, FDA commissioner Stephen M. Mahn, M.D., said, “The FDA remains committed to using all available tools to oversee the safety and quality of FDA-regulated products for American patients and consumers. As this remains a dynamic situation, we will continue to assess and calibrate our approach as needed and we stand ready to resume any postponed inspections as soon as feasible.”
Related: FDA, USDA Respond to Coronavirus Outbreak; FDA Suspends Foreign Inspections.
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