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.
The total number of observations found during cGMP inspections at dietary supplement firms has declined from FY 2014 (the peak was in FY 2013). Production and Process Control (Subpart E) citations continue to dominate, consisting of ~30% of the problems found. In FY 2015, finished product specifications for identity, purity, strength, composition (and for limits on contaminants) remained the most frequent item (as it was in FY 2014) but by a greater margin. Identity testing of components, followed by batch record requirements, continue to top the list of inspectors’ favorite inspection findings.
For those of you who track this stuff, FDA just released new inspections classifications data that can be found at: http://www.fda.gov/ICECI/Inspections/ucm222557.htm
The above chart shows FY2015 inspection classifications in all CFSAN project areas (foods, cosmetics, dietary supplements) and their outcomes (OAI – Official Action Indicated; VAI – Voluntary Action Indicated; NAI – No Action Indicated) OAI and VAI means that a 483 was issued in a particular project area, NAI means basically a clean inspection.
Based on preliminary FY 2015 data released by FDA’s Denver District at the Rocky Mountain Dietary Supplement Forum in Boulder, Colo. last week, Form-483 citations are down overall for dietary supplement firms, and there has been a shift from focusing on identity testing of ingredients (although this is still a very common and important finding) toward observations related to setting specifications for finished products. This trend continues from FY 2014. Data are preliminary because FY 2015 was not yet closed when the data were gathered (closes Sept 30, 2015). I will be publishing complete FY 2015 figures when they become available from FDA’s website. In the meantime, here is a chart based on last week’s data and historical 483 observations from 2009-2014, ordering is based on preliminary FY 2015 frequency.
Note: there are a total of 11 CFR sections listed above (as presented by FDA representatives)
- What aspects of the cGMP are you responsible for during an inspection?
- FDA “Hot buttons” during inspections and what can be done to prepare as well as mitigate
- Detailed analysis of recent (2014-present) FDA inspection reports
- What the inspection reports teach and how to appropriately respond to a Form FDA 483
- Answers to your questions during the Q&A session
- Tony Young, Kleinfeld, Kaplan & Becker/AHPA General Counsel
- Marian Boardley, Marian Boardley Consulting, LLC
- Merle Zimmermann, Ph.D., AHPA
- Jane Wilson, AHPA
I just created a new “DIY” style chart (see example for “appropriate test” below) for dietary supplement 483 observations. Enter your search term(s) here based on any 483 description text, press Search and the chart will render auto-magically based on the frequency of FDA observations. The colors are random, so you can press Search again to get a new look if you don’t like the first one. Enjoy!
There is no charge for use of the charts, but please credit me if you publish: © 2015 Marian Boardley Consulting LLC