FDA Releases FY 2016 Inspection Classifications

Despite continued bemoaning of lack of compliance in the dietary supplement industry, along with ‘dark issues’ of business journals and generally bad press, in fact, data released by FDA show that dietary supplement firms’ track record during some inspections may actually be improving.

The total number of inspections in the project area covering most dietary supplement inspections declined in FY 2016, but the percentage of inspections resulting in a ‘No Action Indicated’  (NAI) classification went up, while the number of inspections resulting in ‘Official Action Indicated’ (OAI)  declined again in FY 2016 to 35 firms in total (see chart above).  What this means is that FDA have been issuing less 483s in this project area at the conclusion of their inspections, and that they are not having to take follow-up actions, such as Warning Letters, as often as they were doing previously.  This trend continues the progress of the previous two fiscal years with more than 50% of firms getting clean inspections in this area.  Clearly more room for improvement exists.

The second chart shows the percentage of inspections for each classification on a 100% scale, which illustrates year-on-year improvement by eliminating the variation in the total number of inspections per year.

Charts for other FDA project areas can be found at my web site.

All charts are © Marian Boardley Consulting LLC.  Please ask for permission before using.  Thanks!