Tag Archives: FDA inspections

FDA Inspection Citations: FSMA

I recently uploaded the latest FDA 483 citations spreadsheet which includes an increasing number of citations for FSMA-related inspections (as defined by 21 CFR  Part 117).  The data are current thru 2/15/2018.    At present the list of most popular observations resembles the old 110 food cGMPs, but there are 10 citations (out of a total of 856 under the new FSMA cGMPs) for problems with hazard analysis and control, indicating FDA is starting to require hazard analysis and food safety plans (if indicated by the hazard analysis, i.e. 117.130(a)(1) Your hazard analysis did not identify a known or reasonably foreseeable hazard that required a preventive control.)

If you are subject to the FSMA regulations on Preventive Controls, this might be a good time to start working on them!

CFR # Short Description Long Description Frequency Cited
117.1 Personnel You did not take a reasonable measure and precaution related to personnel practices. 78
117.4 Equipment and Utensils – Design and Maintenance Your equipment and utensils were not designed and constructed to be adequately cleaned or maintained to protect against contamination. 66
117.35(c) Pest Control You did not exclude pests from your food plant to protect against contamination of food. 54
117.37 Sanitary Facilities and Control Your plant did not have adequate sanitary facilities and accommodations. 47
117.80(c) Manufacturing, Processing, Packing, Holding – Controls You did not conduct operations under conditions and controls necessary to minimize the potential for contamination of food. 42
117.35(a) Sanitary Operations – Plant Maintenance You did not maintain your plant in a clean and sanitary condition and keep your plant in repair. 29
117.35(a) Sanitary Operations – Plant Sanitation You did not clean and sanitize your utensils or equipment in a manner that protects against contamination. 25
117.35(d) Sanitation of food contact surfaces – frequency You did not clean and sanitize your utensils or equipment as frequently as necessary to protect against contamination of food. 25
117.35(e) Sanitation of non-food contact surfaces – frequency You did not clean your non-food contact surface in a manner and as frequently as necessary to protect against contamination. 24
117.20(b) Plant Construction and Design Your plant was not constructed to facilitate maintenance and sanitary operations. 20
117.35(a) Sanitary Operations – Plant Maintenance You did not keep your plant in repair. 19
117.20(a) Grounds You did not keep the grounds around your plant in a condition that would protect against the contamination of food. 16
117.35(b)(1) Cleaning and sanitizing substances- safe and adequate You did not ensure that your cleaning compounds and sanitizing agents are safe and adequate under the conditions of use. 16
117.80(c) Manufacturing, Processing, Packing, Holding – Controls You did not conduct operations under conditions and controls necessary to minimize the potential for growth of microorganisms and contamination of food. 16
117.20(b) Plant Construction and Design Your plant was not constructed and designed to facilitate maintenance and sanitary operations. 16
117.35(a) Sanitary Operations – Plant Maintenance You did not maintain your plant in a clean and sanitary condition. 15
117.93 Storage and Transportation You did not store or transport food, including ingredients, under conditions that protect against contamination. 12
117.130(a)(1) Hazard Analysis – Identification of Hazard Your hazard analysis did not identify a known or reasonably foreseeable hazard that required a preventive control. 10
117.20(b) Plant Construction and Design Your plant was not designed to facilitate maintenance and sanitary operations. 10

Note: My Top 25 dietary supplement citations chart now reflects 483 data up to mid-February 2018, and will continue to reflect the latest data as it is posted by FDA.

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

44

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 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.

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.

BySubpart-cGMP-21CFR111

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 releases updated Inspection Classifications for FY 2015

FY2015-1

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.

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).
Topics:
  • 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
Presenters:
  • Tony Young, Kleinfeld, Kaplan & Becker/AHPA General Counsel
  • Marian Boardley, Marian Boardley Consulting, LLC
  • Merle Zimmermann, Ph.D., AHPA
Moderator:
  • 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