FY 2015 FDA Inspection Summary

FDA Inspection Trends, FY 2015



Did you know that in FY 2015 the US FDA completed 5,615 GMP inspections of registered drug and device establishments?  The total number of inspections has decreased by 6.3% since FY 2013.  However, the number of foreign inspections as a percent of total inspections per fiscal year have risen from 18.97% in FY 2013 to 27.8% if FY 2105.

FY 2015 Inspections

Adapted from 2016 Annual Report on Inspections of Establishments in FY 2015

The above inspections resulted in ~1008 Form 483’s issued to Medical Device Manufactures and ~678 Form 483’s issued to Drug Manufacturers.  Medical Devices accounted for ~22.7% of the Form 483’s issued by the 9-FDA centers, and Drug manufacturers accounted for ~14.3%.

The Form 483’s issued to the drug manufacturers resulted in over 3,600 individual citations.  The top 10 citations, accounting for 27% of all issued citations) are identified in the below figure and table:

top 10 citations in FY 2015 Graph

Figure and Table: Adapted from Inspection Observation Summaries FY 2015.

top 10 citatation FY 2015 Table

Food for Thought:  With 27% of the 3,600 citations attributed to these 10 individual items, does my organization have similar problems?  Should data be used to inform our auditing process?  Is this a common or special cause?

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