FDA Releases 2017 Inspection Classifications

FDA just released fiscal year 2017 inspection classification data.  The data show that inspections of dietary supplement firms appeared to have less problems in 2017 than prior years.  The rate of OAI (official action indicated) classifications dropped to less than 4%, compared with around 8% in FY 2016 for the project area Food Composition, Standards, Labeling and Economics, under which most 21 CFR Part 111 cGMP inspections occur (but see Disclaimer below before you celebrate, these figures may change over time).  Perhaps it is better to focus on the success rate – NAI (no action indicated, no 483 issued) inspections went up to over 60% of the total, compared with just over 50% in FY 2016.

FDA also announced they will now update inspections data on a monthly basis: “NEW: Beginning in mid-November 2017, the Inspections Classifications dataset will be updated monthly.

This is good news if you need to look up the status of any FDA-regulated firm in their online database (but bad news if, like me, you compile charts based on those datasets – now I have to update monthly!)

FDA Disclaimer: “The disclosure of this information is not intended to interfere with planned enforcement actions, therefore some information may be withheld from posting until such action is taken. Therefore, this database does not represent a comprehensive listing of all conducted inspections and should not be used a source to compile official counts.

Inspections are classified (see Inspection Classifications) to reflect the compliance status of a firm. Classifications are based upon findings identified during an inspection and Agency review for compliance. During the Agency assessment, classifications may be subject to change after a review of all relevant information. To maintain current knowledge of a firm’s compliance status, it may be important to recheck the Inspections Database for updates.”