The Mischaracterization of a 483

I often cringe when I see how badly the popular press mischaracterizes food related issues. Some reporters do better jobs than others, but I have become accustomed to the confusion and sensationalism perpetuated in the media. It’s no surprise that high profile outbreaks have caught the attention of the general public and press. What does surprise me is the perpetuation of these misinformed myths within the food safety community. Looking back on my college experience, I realize that I may be holding food safety professionals to an unreasonable standard. I didn’t learn about 483s in school, and the distinction between L. monocytogenes and Listeria spp. meant little until I did my graduate research on the pathogen (not spp!). So rather than continue to fume with frustration, I thought I’d give my take on 483s.

First, a 483 is never a good thing, and should always be taken seriously. Although a firm is not required to respond to a 483 in writing, I always suggest they do. A written response demonstrates that the firm takes the inspection and the findings seriously. It also gives the firm an opportunity to show how they have addressed the observations. If the Agency perceives that the firm is disregarding the agency’s findings, this could lead to a warning letter. So to be clear—warning letters are way worse than 483s.

It’s important to realize that not all 483s are the same! There are 2 classifications: OAI (Official Action Indicated) and VAI (Voluntary Action Indicated). Again, neither are “good”, but obviously an OIA signals that the Agency has grave concerns. A 483 from a recent inspection linked to an outbreak was a VAI- which still requires immediate attention, but indicates that the issues were of a less serious nature (relatively speaking). For reference, according to FDA’s data dashboard, in 2024 FDA did 11,442 inspections that were NAI (no action indicated), 4,323 inspections classified as VAI, and 417 that were OAI. There were also 146 warning letters. So, about 30% of inspections last year resulted in a 483, the vast majority of which were VAI.

In terms of process, a 483 is issued immediately at the conclusion of an inspection (in some cases it is later amended). When I have seen some ridiculous things on 483s and escalated them to the attention of the Agency, I’ve been told that these are “just the investigators observations”. This provides me with little comfort because they are still on record. Without seeing the firms response/defense, you’re only seeing one side of the story.

This leads me to the content of a 483, and putting the observations in context. Two big categories I often see are GMPs and records. It’s difficult to deduce from a 483 whether the observation of a GMP violation is representative of a systemic training issue (including issues resulting from poor food safety culture), or simply reflects that people aren’t perfect (especially if they are nervous because regulators are watching). GMP issues need to be corrected- but often don’t present an imminent threat to the product. Not signing off on records is another common one. Again, it’s tough to tell if people are inattentive, which could lead to serious food safety issues, or if there was just an error and something was missed. (this is where I hope digital systems can help provide alerts and reminders and flag missing items or inconsistencies).

I’ve seen several 483s from fresh-cut produce operations that include observations of pooling water. I’m thinking these people are not familiar with fresh-cut operations. There is always water!

A recently published 483 included criticisms of finding Listeria on non-product contact surfaces. There is so much to unpack on this that I will start a new blog. But briefly: when FDA updated their draft guidance years ago, it was intended to encourage the industry to test for Listeria. Obviously, the best way to avoid having a record of positive findings is to simply not test. To cite a company for positives (especially without the context of the total number of swabs done) is counterproductive to the seek and destroy approach! Secondarily, I understand why the popular press thinks “Listeria” is monocytogenes. But it’s not!! I’ll save more for the next blog. Bottom line, it is absolutely appropriate to find the indicator in a plant. Zero positives would have been way more concerning.

I do love FDA’s Data Dashboard. Because when I see a 483, I’m able to look at the firms inspection history. The recently publicized 483 has led to sensational (and grossly inaccurate) headlines. Looking in the data dashboard, the facility has been inspected pretty regularly – about every 3 years, for more than a decade- and every other inspection was NAI (e.g, no issues). It’s hard to imagine that problems appeared overnight. Instead we should question whether the association with an outbreak leads to more scrutiny during an inspection. And then, as we look at the inspection findings, we should question whether they could or would contribute to an outbreak. In produce, Listeria outbreaks (due to mono not spp!) are generally associated with facilities (but there have been exceptions). But to find the source of zoonotic pathogens (STECs and Salmonella), the inquiry usually has to look further back in the supply chain. So while findings on a 483 must be addressed, they don’t always provide the “smoking gun” that the media makes them out to be.

To be clear, I do not intend to diminish the gravity of a 483- but I do urge food safety professionals to read them (and not just the media headlines or stories) and give them some critical thought before jumping to conclusions.