FDA Releases FY 2016 Inspection Classifications
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.
Charts for other FDA project areas can be found at my web site.
All charts are © Marian Boardley Consulting LLC. Please ask for permission before using. Thanks!
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
- Jim Thomas, Program Director, ETC Group
- Larisa Pavlick, VP, Regulatory & Compliance, UNPA
- Marian Boardley, Independent Consultant
- Skye Lininger, CEO, Healthnotes Inc.
…plus others to be announced
To view/download speaker bios, click here.
EARLY BIRD REGISTRATION: Save $100 until Dec. 31, 2016!
Regular registration: $795.
UNPA member registration: $525.
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.
The number and frequency of Warning Letters issued to dietary supplement firms involving New Dietary Ingredients appears to be increasing. The above chart shows spikes in Warning Letters issued by FDA to DS firms, many of which correspond to FDA actions against specific NDIs.
Classifications for FDA inspections during the first half of FY 2016 (Oct 2015 thru March 2016) were released by FDA a few weeks back. The above chart shows inspection outcomes under CFSAN (which includes foods and dietary supplements). The number of 483s issued in the area of “Food Composition, Standards, Labeling and Economics” continues to decline slightly — just short of 60% of inspections in that area now result in no 483 being issued. Most DS inspections occur in that project area, along with “Foodborne Biological Hazards” (which also applies to regular food facilities.) See more by clicking on the chart.
I will be speaking at SupplySide West and attending many events Monday – Friday in Las Vegas. If you would like to schedule a specific appointment please contact me. I hope to run into many of you at the AHPA reception or committee meetings!
I will be speaking along with 3 other presenters at this workshop on
Wednesday, October 05, 1:30 PM – 4:30 PM
Laboratory testing of ingredients and finished goods is top-of-mind in the natural products industry. Beyond the media coverage of testing methods lie a host of concerns from qualifying and selecting an appropriate laboratory partner to method validation, audits and supply chain integrity. Explore the current state of affairs and join the discussion around how appropriate testing and information sharing throughout the product development process is critical to efficacy and safety.
- What should a laboratory audit entail and can a lab meet specific testing needs
- The GMP testing requirements and their impact on manufacturers and marketers
- Supply chain management and the role of testing throughout the chain
This morning, instead of writing documentation, I was observing the transit of Mercury. Mercury is the small dot against the bright solar background, that you can see at about 7 o’clock, the larger smudge above center is a sunspot. As observed from Utah, the transit started before dawn, and due to rain and cloud, I could not see the sun until around 9:45am. but then the skies cleared and I had a great view!
Many thanks to Ken Kolb, who gave me a Meade 4.5″ reflector on Saturday, I was able to see the transit really well. The above photo was taken of the projected sun image with my iPhone.
Note: NEVER LOOK DIRECTLY AT THE SUN THRU A TELESCOPE without using appropriate filters or projection techniques.
I encourage everyone involved in the dietary supplement industry to attend this forum, it is second to none at providing up-to-date, accurate, non-biased, non-commercial, practical information on how you can meet your FDA compliance obligations. Previous forums have had lots of great Q&A sessions where you get to learn from members of the audience as well as from the excellent and knowledgeable presenters. The location can’t be beat! – Marian.
The organizers say:
“Based on the successes of the 2012 -2015 Forums, we would like to invite you once again to join us in Boulder, Colorado in 2016.
From FDA representation to industry panels to manufacturing insights, the 2016 program promises to continue our goal of educational excellence for the dietary supplement industry.
Some of this year’s speakers are:
- FDA Denver District Panel [invited]
- Howard Gurney, Executive Director, USANA Health Sciences
- Loren Israelsen, President, UNPA
- Joy Joseph, Principal, Joy’s QM System, Inc.
- Dean Kramer, President, Provident Nutraceuticals/OMPI
- Justin Prochnow, Attorney, Greenberg Traurig LLP
- Roy Upton, Executive Director, American Herbal Pharmacopoeia
To register, go to www.regonline.com/rmdsf2016
We look forward to seeing you this fall!”
Save the Date: September 15-16, 2016
Hotel Boulderado, Boulder, Colorado