Warning Letter Record: Viva Raw LLC (2026-08-05) — Adulterated Animal Foods/Misbranded
Letter issued · posted to fda.gov .
Subject as published: Adulterated Animal Foods/Misbranded
TL;DR
Key takeaway: **FDA Warning Letter to Viva Raw LLC (CMS #727259, August 5, 2026)** The FDA Center for Veterinary Medicine issued a warning letter to Viva Raw LLC (Charlotte, NC) after the North Carolina Department of Agriculture and Consumer Services collected samples on August 11, 2025, that tested positive for *Salmonella Enteritidis* in two products (Pure Chicken Pet Food Mixer and Chunked Chicken Dog Food) and *Listeria monocytogenes* in one product (Ground Turkey & Beef Puppy Food), rendering them adulterated. Whole genome sequencing indicated the *Salmonella Enteritidis* isolates matched a genetic cluster linked to clinical human illness; the company initiated a Class I recall on August 25, 2025, and proposed high-pressure processing as a preventive control, but FDA stated it could not fully evaluate adequacy of corrective actions due to insufficient documentation of implementation.
Argus analysis
# FDA Warning Letter: Viva Raw LLC — Pathogenic Bacteria in Pet Foods
Viva Raw LLC, a Charlotte, North Carolina-based pet food distributor, received a warning letter from FDA's Center for Veterinary Medicine on August 5, 2026, following the detection of Salmonella and Listeria monocytogenes in finished products. The North Carolina Department of Agriculture and Consumer Services collected samples in August 2025 from products at a third-party distributor; three lots tested positive for these pathogens. FDA's subsequent inspection of the contract manufacturer confirmed that Viva Raw functions as the responsible owner-label distributor, overseeing ingredient procurement, formulation, and interstate distribution. The company acknowledged shared responsibility for food safety oversight with its manufacturing partner.
The violations center on 21 CFR Section 402(a)(1) of the Federal Food, Drug, and Cosmetic Act, which defines adulterated food as containing poisonous or deleterious substances that may render it injurious to health. Whole genome sequencing conducted by FDA identified the Salmonella Enteritidis isolates as belonging to a genetic cluster linked to clinical human illnesses, heightening concern. Both Salmonella and Listeria monocytogenes pose serious infection risks to humans and animals, with particular danger to pregnant women, elderly individuals, and immunocompromised populations through direct consumption or indirect contact.
Viva Raw initiated a Class I recall on August 25, 2025, and submitted corrective action plans on October 1, 2025, proposing high-pressure processing of packaged products as a preventive control. However, FDA noted insufficient documentation demonstrating implementation of this preventive measure. The company must respond within 15 working days with detailed corrective steps and supporting documentation. Industry peers should monitor whether Viva Raw provides adequate implementation evidence and whether FDA pursues additional regulatory action if documentation remains incomplete.
Severity context
High severity. Typically QSR / device CGMP, adulterated-drug, or significant labeling matters — usually drives a documented corrective and preventive action (CAPA) program.
Regulatory background
Labeling letters cite 21 USC 343 (food), 21 USC 352 (drugs), or 21 USC 352 (devices). Most are resolved by SKU-level copy revision within the 15-business-day response window.
What peer compliance teams typically do next
Most compliance officers at peer companies use a Warning Letter against a named entity as a checklist for their own CAPA program. Common steps: pull the verbatim FDA letter; map each cited 21 CFR section against the team’s SOP library; confirm CAPA coverage; brief the QMR (Quality Management Review) on whether the cited subject matter is in scope for the next internal audit. The 15-business-day response window applies to the cited entity, not to peers — but a documented internal review against the cited subjects is what regulators expect to see if a peer is later inspected on the same topic.
Excerpt from the FDA Warning Letter (public domain, 17 USC §105)
WARNING LETTER Viva Raw LLC MARCS-CMS 727259 — August 05, 2026 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: VIA EMAIL NO HARD COPY TO FOLLOW Product: Food & Beverages Recipient: Recipient Name Zach X. Ao, Co-Founder/Owner Recipient Title Jennifer Barbara Wu, Co-Founder/Owner Viva Raw LLC 1300 South Blvd, Suite 30025 Charlotte , NC 28203-4280 United States (b)(6), (b)(7)(C) Issuing Office: Center for Veterinary Medicine United States WARNING LETTER CMS # 727259 August 5, 2026 Dear Mr. Ao and Ms. Wu, On August 11, 2025, North Carolina Department of Agriculture and Consumer Services (NCDACS), in cooperation with the U.S. Food and Drug Administration (FDA), collected samples of Viva Raw LLC finished products at a third-party wholesale distributor. The unopened samples described below were analyzed by NCDACS and found to contain Salmonella or Listeria monocytogenes. Based on analytical results, these products are adulterated because they bear or contain a poisonous or deleterious substance which may render them injurious to health. 1 During an inspection of the contract manufacturer of your products between August 25 through August 29, 2025, the FDA investigator determined you are the own label distributor of Viva Raw products, and you are responsible for procuring ingredients, product formulation, and distributing finished products into interstate commerce. Additionally, you acknowledged to the FDA investigator that you share responsibility with the contract manufacturer for overseeing food safety. The introduction or delivery for introduction into interstate commerce of any food that is adulterated is a prohibited act. 2 We acknowledge that you initiated a Class I recall on August 25, 2025, of the below products and additional products manufactured on the same production dates. Additionally, we received proposed corrections in your recall correspondence dated October 1, 2025, and discuss them below. You may find the Federal Food, Drug, and Cosmetic Act (FD&C Act) and FDA’s regulations through links on FDA’s homepage at www.fda.gov. Adulterated Animal Food NCDACS collected samples of three Viva Raw finished products prior to a joint FDA and NCDACS inspection of your contract manufacturer in August 2025. FDA reviewed and concurred with the NCDACS sample collection and analytical report packages. You were notified of the following analytical results by NCDACS on a teleconference call on August 21, 2025: Sample (b)(4) , Viva Raw Pure Chicken Pet Food Mixer, lot (b)(4) , was found to contain Salmonella Enteritidis. Sample (b)(4) , Viva Raw Chunked Chicken Dog Food, lot (b)(4) , was found to contain Salmonella Enteritidis. Sample (b)(4) , Viva Raw Ground Turkey & Beef Puppy Food, lot (b)(4) , was found to contain L. monocytogenes . Additionally, FDA and NCDACS held a teleconference with you and the contract manufacturer on September 11, 2025. We presented bioinformatic information regarding whole genome sequenc…
Excerpt only. The full verbatim Warning Letter is the source of truth — always read the original before regulatory decisions.
The verbatim FDA Warning Letter is the source of truth. Always read the original before acting on any analysis or summary on this page.
Read the full letter on fda.gov ↗Frequently asked questions
- What FDA violations was Viva Raw LLC cited for?
- The FDA Warning Letter to Viva Raw LLC (issuing office: Center for Veterinary Medicine) cites: Adulterated Animal Foods/Misbranded. Classification: Labeling / misbranded.
- When did FDA issue the warning letter to Viva Raw LLC?
- FDA issued the letter (MARCS-CMS 727259) on 2026-08-05 and posted it publicly on fda.gov on 2026-09-22.
- Is the FDA warning letter to Viva Raw LLC publicly available?
- Yes. The full verbatim letter is published at fda.gov. Argus HQ links directly to the source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/viva-raw-llc-727259-08052026.
- What does a "high" severity rating mean for this letter?
- High severity. Typically QSR / device CGMP, adulterated-drug, or significant labeling matters — usually drives a documented corrective and preventive action (CAPA) program.
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methodology
The analysis above is produced by Anthropic Claude Haiku 4.5 against the verbatim FDA Warning Letter excerpt and is brand-voice lint-checked before publish. The TL;DR is the same summary that ships in the customer email digest. Severity is auto-classified by Argus from the subject string and letter body using rules documented in lib/ingestion/fda-warning-letters.ts.
Argus HQ is informational only. Summaries and analyses are AI-generated and may contain errors, misclassifications, or omissions. Verify against the FDA source URL above. Argus HQ is not a law firm, accounting firm, or regulatory agency, and provides no legal, accounting, financial, medical, or regulatory advice.
Compiled by Argus HQ Research from FDA primary sources · Reviewed by Andy Gaber, Founder
Cite this record
Reusing this data in reporting or research? Here’s a ready-made citation.
Argus HQ Research (2026). Warning Letter Record: Viva Raw LLC (2026-08-05) — Adulterated Animal Foods/Misbranded. Digital Empire Holdings LLC. Retrieved from https://argushq.ai/fda/warning-letter/fda-wl-viva-raw-llc-2026-08-05-labeling
"Warning Letter Record: Viva Raw LLC (2026-08-05) — Adulterated Animal Foods/Misbranded." Argus HQ Research, Digital Empire Holdings LLC, 2026, argushq.ai/fda/warning-letter/fda-wl-viva-raw-llc-2026-08-05-labeling.
Argus HQ Research. "Warning Letter Record: Viva Raw LLC (2026-08-05) — Adulterated Animal Foods/Misbranded." Digital Empire Holdings LLC. Accessed September 23, 2026. https://argushq.ai/fda/warning-letter/fda-wl-viva-raw-llc-2026-08-05-labeling.
@misc{argushq_argushq_ai_fda_warning_letter_fda_wl_viva_raw_llc_2026_08_05_labeling_2026,
title = {Warning Letter Record: Viva Raw LLC (2026-08-05) — Adulterated Animal Foods/Misbranded},
author = {{Argus HQ Research}},
year = {2026},
publisher = {Digital Empire Holdings LLC},
url = {https://argushq.ai/fda/warning-letter/fda-wl-viva-raw-llc-2026-08-05-labeling},
note = {Accessed: September 23, 2026}
}