3 Theories Why FDA Inspections are Down 25%

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3 Theories Why FDA Inspections are Down 25%

By |2016-07-08T14:03:42-05:00July 30th, 2014|cGMP Quality Assurance and FDA 483s, FDA, FDA Inspections, Form FDA 483|


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?

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  1. Tony Chen August 1, 2014 at 7:19 am - Reply

    Someone from industry sent this to me today, confirming the focus on international inspections:

    Read it directly from FDA’s China country director:

    “Americans benefit greatly from medical products produced by other countries. Approximately 40 percent of finished drugs in the United States come from overseas, as well as more than 50 percent of all medical devices. About 80 percent of the manufacturers of active pharmaceutical ingredients are located outside the United States…

    As China’s role on the global stage expands, FDA has significantly increased drug and medical device inspections there, but we need to continue to strengthen our efforts. FDA is currently working to use Congressionally-appropriated funding to increase from eight to 27 the number of U.S. staff it posts in China.” – See more at: http://blogs.fda.gov/fdavoice/index.php/2014/04/fda-works-with-china-to-ensure-medical-product-safety#sthash.8pIGtzvm.dpuf

  2. Tony Chen August 1, 2014 at 7:22 am - Reply

    Another point on foreign inspections:

    If you look at pages 152-153 of FDA’s own budget report, the increase in international inspections is forecasted
    Notes: “For investigators hired with FY 2014 BA funding received through the Office of International Programs (OIP) for the China Import Safety Initiative, the full performance year is FY 2016. During the full performance year (FY 2016), the FY 2014 funding increase for inspections will allow OIP to conduct an additional 120 foreign human drug safety inspections.”

    “The FY 2013 planned mix of domestic versus foreign GMP inspections shifts quite a few more inspections into the foreign arena, with a corresponding decrease to domestic GMP inspections in comparison to the FY 2012 actuals, but the overall coverage is not changing. This is being done to achieve greater parity of the foreign versus domestic inspections and thus level out the inspection coverage.”

  3. anonymous August 26, 2014 at 6:53 am - Reply

    Great info, we’ve noticed the same trends and believe the international inspections are more resource-intensive.

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