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.
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.”
If you have been a recipient of a Form 483 from FDA, you may be familiar with the fact that the citations for specific cGMPs are not included on the form at the end of an inspection (unlike Warning Letters). Some time ago I created a reverse lookup form so that you can type in partial text from the 483 and display matching citations for dietary supplement inspections. I just expanded this page to include reverse lookups for 21 CFR Parts 211 (drugs), 117 (FSMA, foods) and the old food cGMPs, Part 110. There are currently very few citations for 117, but I expect more to be released for FY 2017, later this Fall.
Reports include data on recalls, Warning Letters, inspections, Form 483 observations and tainted products (products that are sold as dietary supplements but may contain one or more prescription drugs). They include charts showing classes of recalls, score of actual inspection outcomes vs. typical inspection outcomes, and inspection citations and classifications if released by FDA1.
Cost for a report on one firm starts at $19.99. In some cases, you will be able to combine multiple firms or firm names on a single report at a discount rate. I accept PayPal, and all major credit cards via PayPal (you do not need a PayPal account)
Queries for Recalls and SAERs from data posted by OpenFDA are still free!
1 If FDA regulatory action is pending, or FDA has not yet inspected a firm, there may be no data available in my database. You will get a preliminary assessment of available data on the firm before you pay for the report.
Despite continued bemoaning of lack of compliance in the dietary supplement industry, along with ‘dark issues’ of business journals and generally bad press, in fact, data released by FDA show that dietary supplement firms’ track record during some inspections may actually be improving.
The total number of inspections in the project area covering most dietary supplement inspections declined in FY 2016, but the percentage of inspections resulting in a ‘No Action Indicated’ (NAI) classification went up, while the number of inspections resulting in ‘Official Action Indicated’ (OAI) declined again in FY 2016 to 35 firms in total (see chart above). What this means is that FDA have been issuing less 483s in this project area at the conclusion of their inspections, and that they are not having to take follow-up actions, such as Warning Letters, as often as they were doing previously. This trend continues the progress of the previous two fiscal years with more than 50% of firms getting clean inspections in this area. Clearly more room for improvement exists.
The second chart shows the percentage of inspections for each classification on a 100% scale, which illustrates year-on-year improvement by eliminating the variation in the total number of inspections per year.
NDI III: Roadmap to a Viable NDI Policy
Thursday, Feb. 9, 2017
Salt Lake City
After all of the reading, review and research, the 2016 NDI guidance comments are in. But what should industry do about serious technical issues and product categories? What can it expect from the incoming administration and FDA?
Join an outstanding faculty at this one-day conference produced by the United Natural Products Alliance (UNPA), which will provide actionable updates on the final piece of the Dietary Supplement Health and Education Act (DSHEA) regulatory legacy, including:
NDI guidance comments
Industry’s place in the new administration
FDA’s 2017 enforcement priorities
Key technical issues, including synthetic botanicals, nanotechnology, probiotics and more
The old dietary ingredients list
A go-forward action plan
To view/download the conference program, click here.
Loren Israelsen, President, UNPA
Susan Winkler, Chief Risk Management Officer, Leavitt Partners
FDA has just released inspection observations for FY 2016. Preliminary data (see chart above) show that the total number of inspectional observations for dietary supplement cGMPs rose in FY 2016, having declined for the previous several fiscal years.
The most commonly cited observation in FY 2016 was once again failure to set appropriate specifications for finished dietary supplements, namely 21 CFR Sect. 111.70(e) Specifications – identity, purity, strength, composition.