Tag Archives: 483 observations dietary supplements

FDA Releases FY2017 Inspection Observations


CFR # Description # Obs.
21 CFR 111.70(e) Specifications – identity, purity, strength, composition 92
21 CFR 111.103 Written procedures – quality control operations 73
21 CFR 111.553 Written procedures – product complaint 63
21 CFR 111.75(c) Specifications met – verify; finished batch 61
21 CFR 111.75(a)(2)(ii)(A) Component – qualify supplier 50
21 CFR 111.205(a) Master manufacturing record – each batch 50
21 CFR 111.255(b) Batch record – complete 47
21 CFR 111.453 Written procedures – holding 46
21 CFR 111.75(a)(1)(i) Component – verify identity, dietary ingredient 45
21 CFR 111.70(b)(2) Specifications-component purity, strength, composition


Late last year FDA released inspection observations (483 citations) for FY 2017.  The table above shows the top 10 dietary supplement (21 CFR Part 111 cGMP) inspection observations found during inspections in FY17.  Significantly, failure to verify the identity of all dietary ingredients has now dropped to 9th place, down from 2nd place in FY 2016.  Lack of established specifications for identity, purity, strength, and composition of finished dietary supplements continues to be a problem found at a large number of firms. Failing to establish written procedures for quality control operations moved up to #2. Subpart E observations (for Production and Process Control) together made up nearly 34% of the total observations by FDA inspectors, continuing the trend upward of the past few fiscal years.

FDA Releases FY 2016 Inspection Observations


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


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.

Sizing up the Dark Side: An overview of the NBJ Dark Issue

Date/Time: March 30, 2016, 2:00pm ET / 12:00 MT

Cost: $95


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:

Steve Mister
Council for Responsible
Todd Harrison
Supplements Lawyer
Risa Schulman
Science Consultant
Marian Boardley
GMP Specialist

Bring questions!

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.

FY2015: Dietary Supplement cGMPs – FDA Inspection Observations

FDA released new spreadsheets for FY 2015 (10/1/2014 – 9/30/2015) which have now been incorporated into my charts.


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.

FDA: Preliminary FY 2015 483 Data at Rocky Mountain DS Forum

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.

FY 2015 Form 483 preliminary

Note: there are a total of 11 CFR sections listed above (as presented by FDA representatives)

Webinar: FDA Inspections & Emerging cGMP Compliance Issues for Dietary Supplements

The American Herbal Products Association (AHPA) will present a two-hour educational webinar titled “FDA Inspections & Emerging cGMP Compliance Issues for Dietary Supplements – Recent 483s,” on Thursday, October 1, 2015, from 1:00-3:00p.m. ET.
A regularly occurring event and part of the association’s cGMP Compliance Series, this two-hour, webinar is designed to help those businesses in the dietary supplement industry understand the elements of 21 CFR 111/current Good Manufacturing Practices (cGMP) regulations that are most focused on during recent FDA inspections. This knowledge will assist business with better allocating their compliance resources.
Veteran industry legal experts will provide attendees with an insider’s view of current cGMP enforcement landscape. AHPA staff will offer a detailed analysis of the association’s repository of inspection data, widely regarded as the most in-depth in the industry and which includes actual FDA 483 Inspection reports, Observation forms, and establishment inspection reports (EIRs).
  • 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
A 20-30 minute Q&A session will follow the speaker’s presentations to allow attendees to anonymously ask specific questions about FDA inspections, enforcement actions, and related matters.

NEW! DIY Observation Charts…

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