FDA released new spreadsheets for FY 2015 (10/1/2014 – 9/30/2015) which have now been incorporated into my charts.

The total number of observations found during cGMP inspections at dietary supplement firms has declined from FY 2014 (the peak was in FY 2013). Production and Process Control (Subpart E) citations continue to dominate, consisting of ~30% of the problems found. In FY 2015, finished product specifications for identity, purity, strength, composition (and for limits on contaminants) remained the most frequent item (as it was in FY 2014) but by a greater margin. Identity testing of components, followed by batch record requirements, continue to top the list of inspectors’ favorite inspection findings.