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

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 Salmonellarepresenting the majority of hazards. Two citations were issued most frequently: deficiencies in Foreign Supplier Verification Plans, and failure to identify and evaluate hazards requiring a preventive control. FDA is committed to protecting the nation’s food supply, and WLs help achieve prompt voluntary compliance. Understanding the regulatory violations identified during outbreak investigations may help the food industry and regulators alike focus prevention efforts and reduce the burden of foodborne illness.