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.
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 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.
The Dark Issue is the most talked about issue in NBJ history and we’re ready to talk about it some more. Join us March 30 at 2 p.m. eastern standard time for a webinar examining some of the biggest challenges facing the supplement industry. Topics to be discussed include:
Adulteration in the supply chain
Best use of scientific studies
Spiking in sports medicine
GMP violations and FDA Warning Letters
Retailers as gatekeepers
What the industry is doing to hold onto consumer trust
What a new approach to regulation could mean
The first quarterly webinar of 2016 will feature presentations and discussion with:
Council for Responsible
The presentations will be followed by what we expect to be a lively Q&A. The Dark Issue webinar is free to subscribers, or with a purchase of the Black Issue Extended Edition. Or buy a seat for $95.