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FDA Inspection Data Insights: Sponsor Inspections

As noted in a previous post, FDA publishes data about inspections and inspection citations (findings) on its website.  The data does not differentiate among different inspectee types, but using Google searches and a bit of guesswork we have categorized inspectees so we can interrogate the data more closely.  FDA has published a disclaimer about these data, noting that they may not be complete; we’ll add our caveat that our additions to the dataset may include errors.  As Douglas Hubbard says in his book How to Measure Anything:  Finding the Value of Intangibles in Business, some data is better than no data at all, as long as you understand its limitations.

We were curious, first of all, to see whether the number of sponsor Bioresearch Monitoring Organization (BIMO) inspections had dropped precipitously during the pandemic.  Below is a chart of sponsor inspections from fiscal year 2009 to 2021, further categorized by inspection outcome:  No Action Indicated (NAI), Voluntary Action Indicated (VAI), or Official Action Indicated (OAI).

As we expected, sponsor inspections declined in fiscal years 2020 and 2021 compared to 2018 and 2019. (FDA’s fiscal year starts in October of the previous calendar year.) What’s interesting, though, is that even with the pandemic, FDA performed more BIMO sponsor inspections in each of those years than it did in any single year from 2009 to 2017.

Equally interesting:  the number of sponsor inspections classified as “Official Action Indicated” is extremely low – two inspections in 2009, one each from 2012 to 2015, then a run of five years with none, until 2021 broke the streak with one OAI sponsor inspection.

What happened in 2018 to increase the number of sponsor inspections?  This chart tells the tale:

The number of foreign sponsor inspections started increasing in 2018, with a large percentage taking place in India.

Looking at domestic inspections only, we see that the trend in numbers of sponsor inspections is increasing, even with the pandemic.

Bottom line:  Although BIMO foreign sponsor inspections dropped during the pandemic, domestic sponsor inspections dropped slightly in 2020 and increased to pre-pandemic levels in 2021. Sponsor inspections with the outcome of Official Action Indicated, though, remain rare.

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