NEW Regulatory Action Reports Now Available Online

Regulatory Action Reports (click link for an example) are now available for individual firms as an automated service on my website.

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.

The data are culled from various FDA databases and OpenFDA and updated regularly as new data are issued by FDA.  Access the query form at:  https://www.marianboardley.com/research/

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)

PayPal Acceptance Mark

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.

2017 Rocky Mountain Dietary Supplement Forum – October 10-11 Boulder, CO

2017 Rocky Mountain Dietary Supplement Forum – October 10-11 Boulder, CO – dates and agenda announced.

Rocky Mountain Dietary Supplement Forum
Rocky Mountain – fall aspen leaves.

New Avenues for the Dietary Supplement Industry

Tuesday, October 10 & Wednesday, October 11, 2017
Hotel Boulderado
2115 13th Street
Boulder, Colorado 80302
United States

303-442-4344

 

 

FDA inspections show improvement among Dietary Supplement Firms in 2016

 

CFSAN Classifications 1

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.

 

CFSAN Classifications 2

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!

UNPA NDI III: Roadmap to a Viable NDI Policy

UNPA NDI III Conference

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.

CONFERENCE FACULTY

  • 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.

REGISTRATION

EARLY BIRD REGISTRATION: Save $100 until Dec. 31, 2016!

Regular registration: $795. $895

UNPA member registration: $525. $625

FDA Releases FY 2016 Inspection Observations

FDA

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.

More Charts

FDA Releases Partial FY 2016 Inspection Classifications

2016classification(part)

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.