The FDA issues warning letters as formal notifications to industry about violations that the FDA has documented during an inspection or investigation. The warning letters are publically available on the FDA website.
Reviewing the letters for finished pharmaceuticals is a powerful training tool and provides an insight into non-compliance trends occurring across finished pharmaceutical manufacturing.
PharmOut has reviewed the warning letters for finished pharmaceuticals for 2014 and 2015 to provide the following metrics as an insight into the non-compliance trends.
Total number of findings against subparts in 2014 & 2015
% Breakdown against subparts – Finished Pharmaceuticals 2015