October 9, 2025
In 2025, the U.S. Food and Drug Administration (FDA) has continued its crackdown on Foreign Supplier Verification Program (FSVP) violations, issuing multiple warning letters to food importers for lapses in compliance. These FSVP violations 2025 cases highlight ongoing risks in the global food supply chain, especially amid high-profile food safety incidents like the recent Listeria outbreak in prepared meals. As part of the Food Safety Modernization Act (FSMA), the FSVP mandates that U.S. importers develop, maintain, and follow verification programs for foods from foreign suppliers to protect public health.
The FSVP encompasses critical steps such as:
- Identifying potential hazards in imported foods
- Conducting hazard analyses to evaluate supplier performance and food-specific risks
- Implementing supplier verification activities and corrective actions
This updated guide reviews the most prevalent FDA warning letters food industry issues from 2025, integrates lessons from the ongoing Listeria outbreak 2025, and explores how automated quality management systems (QMS) can mitigate imported food risks and ensure food safety compliance.
The 2025 Listeria Outbreak: A Wake-Up Call for FSVP Compliance
The year 2025 has seen a major multistate Listeria monocytogenes outbreak linked to ready-to-eat prepared meals, underscoring vulnerabilities in complex supply chains that often rely on imported ingredients. As of September 25, 2025, the Centers for Disease Control and Prevention (CDC) reported 20 illnesses across 15 states, with four deaths—one each in Illinois, Michigan, Texas, and Utah. The outbreak, first detected in June, expanded in September to include additional products like bowtie pasta salads and beef meatball marinara linguine from FreshRealm, with contamination traced to pasta supplied by Nate’s Fine Foods.
While not directly tied to a single foreign supplier in public reports, this incident illustrates how lapses in supplier verification can amplify risks from imported pasta, sauces, or other components common in prepared foods. The FDA and USDA issued recalls on September 30, 2025, for potentially contaminated items sold at Albertsons Companies stores nationwide. This outbreak has sickened vulnerable populations, including pregnant individuals and the elderly, emphasizing why robust FSVP programs are essential for hazard identification and rapid response in global food supply chain safety.
The Number One FSVP Violation: No Program in Place
The most frequent FSVP violations 2025 involve importers operating without any FSVP whatsoever—a trend persisting from prior years. In the first half of 2025 alone, the FDA issued warning letters to at least four companies for this core failure, affecting a range of products from mushrooms to fresh produce.
For instance:
- Zest US Wholesale Inc. (Anaheim, CA) was cited for lacking an FSVP for imported milk chocolate bars with peanuts, pistachio spread cream, and coconut almond truffles from unspecified foreign sources. The company also failed to register as a food facility.
- Xin Ao International Group Corp. (Staten Island, NY) imported seafood mushrooms and enoki mushrooms without an FSVP, risking detention under FDA Import Alert #99-41 for unverified high-risk foods.
- Gongora USA Corp. (Chula Vista, CA) and San Juan Produce LLC (McAllen, TX) both overlooked FSMA requirements for fresh produce imports like cucumbers, squash, husk tomatoes, carrots, and cilantro—items potentially classified as “covered produce” under the Produce Safety Rule.
In September 2025, Ever Rich Foods LLC received a warning letter for importing Indian sweets (e.g., Sweet Kala Jamoon, Kaju Pista Roll, Motichoor Ladoo) without developing or following an FSVP, despite prior inspections in 2023 and 2024. These cases echo misconceptions, such as assuming equivalence to U.S. standards exempts importers or that “very small importer” status waives obligations.
Even for countries with comparable food safety systems, importers must adhere to modified FSVP rules under 21 CFR 1.513, including documenting supplier standing with foreign authorities. “Very small importers” (under 21 CFR 1.512) still require written supplier assurances every two years and proof of their status. The absence of an FDA-provided FSVP template exacerbates these issues, compounded by insufficient internal expertise.
Essential documents for FSVP inspections include:
- Food safety certifications
- Product specifications
- Hazard and food safety plans
- Allergen and additive compliance records
- Laboratory analyses and sanitation logs
- FDA-compliant labeling
Reviewing and Assessing Foreign Supplier Hazard Analyses
FDA warning letters in 2025, including those to produce importers like Gongora and San Juan, often flag undocumented reviews of supplier hazard analyses. Under FSMA, importers must evaluate each imported food for hazards needing controls, documenting:
- Review and assessment of the supplier’s analysis
- Qualification of the individual or entity performing it
This step is vital in preventing outbreaks like the 2025 Listeria incident, where unverified ingredients in prepared meals evaded early detection.
Approval Processes for Foreign Suppliers
Supplier approval remains a hotspot for violations, as seen in letters to Zest US and Xin Ao, where evaluations ignored food risks and supplier performance. Importers must:
- Establish written procedures for approving suppliers based on risk assessments
- Document verification activities and frequencies pre-import
- Review any third-party evaluations for qualification
Failure here, as in the Ever Rich case, leaves supply chains exposed to contaminants like Listeria.
Delayed Responses to FDA Form 483 Observations
Timeliness is key: Many 2025 warning letters stemmed from unaddressed Form 483 observations, with responses due within 15 days. Companies like Zest US received no-credit for non-responses, escalating to formal warnings. Proactive documentation can prevent escalation.
FSVP Compliance: Leveraging QMS for 2025 and Beyond
Manual processes fall short against rising imported food risks, especially post-Listeria outbreak. An enterprise QMS automates FSVP management, ensuring:
- Centralized storage of FSVP documents, hazard analyses, and qualified personnel records
- Dynamic approved supplier lists (ASL) with performance tracking and scorecards
- Automated verification scheduling, corrective actions, and SCAR tracking
- Rapid 15-day responses to FDA observations via integrated reporting
- Risk assessments linking supplier issues to outbreaks, with alerts for non-performers
By streamlining onboarding, training, and audits, QMS tools directly counter 2025 violations and fortify against future threats like Listeria in global ingredients.
Conclusion: Strengthening Food Safety Compliance in 2025
FDA warning letters food industry trends in 2025 reaffirm documentation gaps, inadequate hazard reviews, and lax supplier approvals as top FSVP pitfalls—issues amplified by the devastating Listeria outbreak 2025 in prepared meals. Without FDA templates, importers need robust training and tools. Adopting a QMS not only curbs violations but sustains proactive food import compliance, safeguarding consumers from supply chain hazards. Stay vigilant: Regular audits and supplier audits are your best defense in an era of heightened scrutiny.
About the Author
Stephanie Ojeda is Director of Product Management for the Life Sciences industry at AssurX. Stephanie brings more than 18 years of leading quality assurance functions in a variety of industries, including pharmaceutical, biotech, medical device, food & beverage, and manufacturing.
