Based on preliminary FY 2015 data released by FDA’s Denver District at the Rocky Mountain Dietary Supplement Forum in Boulder, Colo. last week, Form-483 citations are down overall for dietary supplement firms, and there has been a shift from focusing on identity testing of ingredients (although this is still a very common and important finding) toward observations related to setting specifications for finished products.  This trend continues from FY 2014.  Data are preliminary because FY 2015 was not yet closed when the data were gathered (closes Sept 30, 2015).  I will be publishing complete FY 2015 figures when they become available from FDA’s website.  In the meantime, here is a chart based on last week’s data and historical 483 observations from 2009-2014, ordering is based on preliminary FY 2015 frequency.

Note: there are a total of 11 CFR sections listed above (as presented by FDA representatives)