Each year, FDA dishes out hundreds of citations to food companies in the form of warning letters (Form 483s), and each subsequent year publishes the data on the FDA website. Want to see if a supplier of yours received a warning letter from FDA within the last ten years? Curious what the most commonly cited cGMP violation is? Chances are, you can find the answer on the FDA website.
According to FDA's FY2015 Inspections Citations, 6,116 human food cGMP citations were issued to 1,231 food facilities. The average number of citations per firm was 5, with 63% of firms receiving 5 citations or less, 88% of firms receiving less than 10 citations, and 99% of firms receiving less than 25 citations.
As seen in the chart to the left, citations involving regulations under the cGMP's "Sanitary Operations" totaled the most citations, accounting for 1,381 (22.6%) cGMP violations. Warehousing and distribution citations were negligible.
The most human food cGMP citations issued to a single company in FY2015 was 75. The next highest was 34.
Top 5 cGMP Violations
As shown in Table A below, (2) Sanitary Operations cGMP citations accounted for more than 50% of FY2015's most common cGMP violations and 16.5% of the total number of cGMP citations.
When considering how many facilities nationwide are built decades ago and many companies are slow to budget facility improvements (which can be cost-prohibitive and not necessarily have an immediate or direct impact on revenue), the top most cited cGMP violation makes sense. However, this number should be a warning to companies that are starting in or expanding into existing facilities, or building new facilities. It should encourage them to approach facility design not just as an opportunity to think long term in terms of capacity and scaling, but also with respect to creating a facility that is safer by design. Examples of "safer by design" includes installing hand sinks at entries into high risk processing areas and allowing space between equipment to permit easy access for cleaning.
Top cGMP citations by Section
Below are tables breaking out cGMP citations and frequency by section, starting with the section with the highest number of citations. I have excluded the Warehousing & Distribution table because the number of regulations and citations are so few.
#1 - Top 5 Sanitary Operations cGMP Citations
#2 - Top 5 Processes & Controls cGMP Citations
*Important Note: Citations issues under 21 CFR 110.80 consisted of the following:
#3 - Top 5 Plant & Grounds cGMP Citations
#4 - Top 5 Sanitary Facilities & Controls cGMP Citations
#5 - Top 5 Personnel cGMP Citations
#6 - Top 5 Equipment & Utensils cGMP Citations
- The data from FY2015 indicates that the most common cGMP violations involve sanitation failures, inadequate pest control, and failures by firms to design and maintain their facilities in order to ensure a sanitary environment.
- While citations involving sanitary operations failures totaled the most of any cGMP section, the number of citations by section was fairly evenly distributed for the top 4 cGMP sections, with personnel cGMP citations slightly behind.
- While 5 was the average number of citations per firm, FDA did not report the size of the companies it was inspecting in the data it provided. It may be safe to assume that small- and medium-size facilities had a higher average number of citations than large firms, which tend to dedicate larger budgets to food safety and more often conform with industry-set standards that go beyond regulatory requirements (e.g. Global Food Safety Initiative benchmark schemes, 3rd party audits).
- All effort should be made by companies to address all GMPs. A good starting point is by identifying weak points in a facility and investing in fixing the high priority issues first.
About the Data
Disclaimer: The data in this article is limited to what FDA publishes, which may be incomplete. In some data sets, only electronic submissions are made public while manual submissions are not. Limitations notwithstanding, it is the author's belief that these trends provide a valuable window into inspection trends by FDA and common cGMP issues facing food facilities.
The data for this article was downloaded directly from FDA's website and was filtered to focus exclusively on human food cGMP violations. The data can be accessed here.
If you are interested in digging deeper, you can obtain more information by diving directly into the warning letters. Here is a link to FDA's warning letter advanced search webpage.
About the Author
Charlie Kalish is Co-Founder of Food Safety Guides, a food safety and quality systems consulting firm headquartered in San Francisco and San Diego.
Charlie is an FSPCA Lead Instructor on multiple FSMA rules and a consultant and trainer to food companies across the United States and Australia. In addition to food safety, Charlie also consults and trains businesses on how to leverage cloud-based softwares and project management tools to streamline food safety plan development and implementation.