• The Acheson Group

How Serious Is FDA about Environmental Sampling? Don't Wait to Get a Warning Letter to Find Out

Updated: Nov 22, 2018


How Serious Is FDA about Environmental Sampling? Don't Wait to Get a Warning Letter to Find Ou

Have you had an FDA Preventive Controls inspection yet – with its all-out environmental sampling "swab-a-thons"?  If not – and if you're thinking that it's not really that serious or different than past inspections, you may want to rethink that

.

As noted in a recent Food Safety News article: "A California sprout processor, a Denver fish processor and a New York seafood importer are all on notice from the Food and Drug Administration for violations of the federal Food, Drug & Cosmetic Act. Two of the three facilities confirmed positive test results for Listeria, after environmental samples were taken during FDA inspection, and sent to laboratory analysis for pathogen testing."


If you didn't catch it on a quick read-through, let me repeat a key sentence for emphasis:


"Two of the three facilities confirmed positive test results for Listeria, after environmental samples were taken during FDA inspection, and sent to laboratory analysis for pathogen testing."


FDA is serious. Inspectors are taking samples and they are sending them for analysis. And with the 150-200 swabs being taken per facility, if you are not taking and testing just as many samples from equipment, surfaces, and even drains on a regular basis, you are likely to have an unpleasant surprise when FDA comes by to inspect and swb. That surprise can then be significantly compounded by FDA's use of whole genome sequencing (WGS) which can link a pathogen strain found in your plant today with a strain found in other facilities or in the past – or future. Take, for example, the Blue Bell Listeria contamination in which the use of WGS enabled FDA to match the strain to that of multiple plants and to illnesses going back five years.


But, because we all know that you can't test safety into a food product, it is critical that you are not simply monitoring the environment, you are implementing preventive controls, along with reactive root-cause analysis and corrective action as needed, for a complete environmental control program. (If you're not sure if your program will pass an FDA inspection, give us a call, we can help.)


While the top concern should, of course, be preventing Listeria (and other pathogenic) contamination of your food products for the safety of your consumers, there is also an associated business concern. As the FSN article goes on to state, not only did FDA send warning letters to the facilities, it "posted them for public view in recent days." This is nothing new, warning letters are always publicly posted, but it is something of which you need to be aware – particularly with the ever-increasing social media attention to food contamination and recalls.


It is interesting that the warning letters cited in the article were issued as far back as May, but only recently were posted. Which means – don't think you're off the publicity hook if an FDA citing doesn't show up online right away. It may take FDA a while to post them, but the letters will be posted "for public view." It also is important to note that while FDA may take months for public posting, you typically have only 15 working days to respond when you receive a warning letter. That response is to specify what has been done for both corrective action and preventive controls for any violations, and/or planned actions, completion date, and reason for delay if corrective action has not yet been able to be completed. Failure to do so, or to correct the violations, can result in FDA action such as product seizure, facility shutdown, etc.


So, FDA is conducting preventive controls inspections; inspectors are taking samples and they are testing them through whole genome sequencing. How serious is FDA? I, personally, would not want to find out through a warning letter.

About The Acheson Group (TAG)

Led by Former FDA Associate Commissioner for Foods Dr. David Acheson, TAG is a food safety consulting group that provides guidance and expertise worldwide for companies throughout the food supply chain. With in-depth industry knowledge combined with real-world experience, TAG's team of food safety experts help companies more effectively mitigate risk, improve operational efficiencies, and ensure regulatory and standards compliance. www.AchesonGroup.com

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