3 Theories Why FDA Inspections are Down 25%

 

Based on our latest data, we’re seeing a major downturn in FDA inspections this year.  Possibly 25%. Check out the chart above.  As you can see, the lagging in late 2013 makes sense with the sequestration (started October 1), but look at the green 2014 trend line – what do you think is going on? Here are a few theories:

  1. Increased resources on International inspections – Could it be that the increased attention on international inspections is drawing more resources overseas? This may result in more first-time inspections, longer inspections, and just more time getting back and forth. Look at this chart we tweeted out a few weeks ago – inspections in Portugal, India, China, France, and Japan are all up 30% or more.  On the FDAzilla side, we are definitely seeing an increase in international customers.
  2. Increased resources to other areas – Could it be that the FDA is diverting some of their resources to other areas?  PMAs are getting approved almost twice as fast as 2013, and the number of PMAs has risen dramatically from this time last year.  Yet, I’m not sold on this theory yet – aren’t these different kinds of FDA resources and talent? Plus, 2013 could be the fluke year, not 2014 (see this chart)
  3. Longer, more intense, less frequent inspections – we’re digging into the data to find out if this is true, but combined with #1 above, this one is possible, and the most feasible theory?
  4. Inaccurate Data – We’ve been asking the FDA for this data the same way for years, and so we’re pretty confident that the data is correct.  Yet, it is possible that the reporting of inspection data into the FDA’s databases is somehow experiencing a dramatic lag.

What do you think is going on?

Learn more about how FDAzilla can help you achieve your quality and inspection preparation goals: get 483sInspector ProfilesEnforcement Analytics, and GMP Regulatory Intelligence.


Some other FDA 483 resources of interest:
Free, searchable FDA Inspections/483s Dashboard, just updated
FDA InspectorRank
FDAzilla Inspection Readiness Toolkit
More FDA 483 Coverage

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