When the FDA Inspector Comes, what are the Chances of a Really Bad Outcome?
It’s generally nerve-wracking when the US Food and Drug Administration (FDA) shows up at your door for an inspection. Even if you’re confident that everything is in good shape, the specter of Murphy’s Law lurks around every corner.
To ensure compliance with regulations, the FDA conducts inspections of all registered establishments. Once the inspection is closed out, it is categorized in one of three ways based on the objectionable conditions noted (if any):
NAI - No Action Indicated
VAI - Voluntary Action Indicated
OAI - Official Action Indicated
NAI and VAI indicate that only minor objections were noted, whereas OAI indicates that significant objectionable conditions that warrant FDA sanctions were cited. So it’s the OAI inspections that make the headlines, and that no one wants to experience first-hand, but how often do these occur?
Using The SOFIETM System for Regulatory Intelligence, we took a look at the data. The chart below shows the number of NAI, VAI and OAI outcomes for all US FDA districts for the years 2009-2013. These are inspections of all FDA-regulated industries including drugs, devices, biologics, veterinary, food and cosmetics.
* Note that there are possibly some inspections from 2013 that have yet to be closed out and so these numbers may be incomplete.*
It’s clear that each year the bulk of inspections end up being NAI or VAI, and relatively few inspections meet the requirements for OAI. Also, note the peak in the number of inspections in 2011. A closer look at the numbers of OAI inspections better demonstrates the variability from year to year:
If we consider the percentage of inspections that are classified as OAI, we find that it’s fewer than 4%. It’s also apparent that the percentage of inspections that receive the NAI classification is increasing over time, while both VAI and OAI are decreasing slightly.
While this provides an average rate for the entire country (all FDA districts), it’s not necessarily consistent from one district to another. Let’s consider some particular districts over that same period of time. For this analysis, we looked at the percentage of OAI findings for five districts that conduct a lot of inspections, specifically:
Los Angeles (LOS)
New England (NWE)
Here we see that in 2009 the Los Angeles district had roughly twice the rate of OAI outcomes as compared to the other districts, but that it has since decreased to a more comparable rate. Note the interesting blips in Dallas in 2012 and Minneapolis in 2011. And while 2013 showed an increase in the rate of OAI for the New England district, the remaining four districts all showed decreasing rates, following the trend for all districts.
Bishop, Sharon DeGrove. “When the FDA Inspector Comes, What Are the Chances of a Really Bad Outcome?” Regulatory Affairs Professionals Society (RAPS), 21 Oct. 2014, www.raps.org/regulatory-focus%E2%84%A2/news-articles/2014/10/when-the-fda-inspector-comes,-what-are-the-chances-of-a-really-bad-outcome.