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When it comes to food production, the FDA inspectors are plant employees who are financially liable for any lost revenue that results from incorrectly-requiested line stoppages. Usually, the inspector is a minimum wage employee, to whom the FDA sends a "congratulations, inspector" letter. Why does such lunacy exist? Lobbyists is the answer. the FDA review and approval process can be expedited via certain paths, depending upon the safety risks or life-saving capabilities of a drug or device. Unfortunately, the FDA reapplies the same statistical analyses to virtually every report. Couple that with it being a massively underfunded agency (Only about 20 of their 200 some odd scheduled inspections were actually performed in 2014.), you can see how their effectiveness is hampered.

For perspective, the EU CE approval process is a comparative breeze, but the US effectively ignores products with CE marks.