An Overview of Food Safety Regulatory Violations Found in Foodborne Outbreak-Linked Warning Letters Issued by the United States Food and Drug Administration.

Brett Weed, Christina K Carstens, Mallorye Lovett, Leslie Hintz, Stelios Viazis

Abstract read

In one paragraph

Article in Food protection trends, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it

0cells of the map it votes in

0citing papers in PubMed

–field-weighted citation impact

1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

5 authors.

Brett WeedHuman Foods Program, United States Food and Drug Administration, College Park, MD, 20740, USA.

Christina K CarstensHuman Foods Program, United States Food and Drug Administration, College Park, MD, 20740, USA.

Mallorye LovettHuman Foods Program, United States Food and Drug Administration, College Park, MD, 20740, USA.

Leslie HintzHuman Foods Program, United States Food and Drug Administration, College Park, MD, 20740, USA.

Stelios ViazisHuman Foods Program, United States Food and Drug Administration, College Park, MD, 20740, USA.

Funding

Intramural FDA HHS FD999999

6 · The paper itself

Abstract

The United States Food and Drug Administration (FDA), in collaboration with federal, state, and local partners, identifies, responds to, and prevents outbreaks linked to FDA-regulated products. If FDA determines a firm is not in compliance with applicable FDA requirements, the firm may be informed through a Warning Letter (WL). This study provides an overview of the WLs issued to firms that were involved in FDA-led multistate foodborne outbreak investigations. WLs, issued from January 2018 through August 2023, were obtained from the FDA.gov website. Twenty-two of these WLs were issued to domestic firms after the conclusion of foodborne outbreak investigations. Forty-six regulatory citations were identified across the WLs, with 1-8 violations per WL. Microbial pathogens accounted for the food safety hazards cited in all but one letter, with

Identifiers

PMID41660548

PMCPMC12879044

What OpenQuestion holds

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.