Friday, March 28, 2014

Lowest Number of FDA Inspections Since 2008

FDAzilla has reported that the FDA conducted 39,774 inspections for the year ending 2013.

I guess on any given day, there are at least 109 auditing teams running around the world inspecting our GMP-regulated existence.

But it turns out that 39,774 inspections is a 5-year low for the FDA.  As FDAzilla puts it, this is the first time since 2008 that the FDA has dipped under 40,000 inspections per year.

Was it the government shutdown?  Was it the sequester?  Who knows?

As we ramp into prime inspection season (Q1/Q2 are known times when there's a lot of FDA activity), how are you guarding against getting dinged by the FDA?

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