The FDA regulatory inspections charts on my web site are now upgraded and using statistics directly from the FDA Data Dashboard API. This means that the data are now updated automatically and charts will always show the latest available information from FDA.

As you can see from the above chart, the pandemic has affected the number of inspections, and drastically reduced the number of Form 483 observations that FDA has been making during inspections in fiscal years 2020 and 2021. Routine inspections have now resumed, however!

This chart now allows you to toggle between different regulations, for example you can look at the citations issued under FSMA cGMPs 21 CFR Part 117.  The only regulation that has continued to increase in number of citations during the past two years is FSVP (Foreign Supplier Verification Program) where remote inspections have continued during COVID-19 (see below)

Charts © Marian Boardley Consulting LLC 2021. Please contact me for usage.