FY 2016 Drug Inspection Summary


FY 2016 Drug Inspection Summary

From October 1, 2015 to September 30, 2016, 691 Form 483’s were issued to Drug Manufacturers, which resulted in 3,342 individual citations. The frequency of citations ordered by subpart of 21 CFR 211 provides the following insight as to inspection trends identified by FDA for Fiscal Year 2016.

FY 2016 Drug Inspection Summary

As you can see in the above table, Subpart I accounts for ~ 20% of all the identified citations.  Within the Laboratory Controls Subpart, 4 citation references accounted for 57.5% of the total findings.  The top 4 findings within the Laboratory Controls area are:

FY 2016 Drug Inspection Summary

Does your Laboratory Controls program have similar deficiencies?