WARNING LETTER

Viva Raw LLC MARCS-CMS 727259 — August 05, 2026

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 sequencing (WGS) conducted on the bacteria isolates found in your products and the comparison of those isolates to a public database of previously collected isolates maintained by the National Center for Biotechnology Information (NCBI). FDA’s WGS bioinformatic review determined the Salmonella Enteritidis isolates recovered from samples (b)(4) and (b)(4) were found within a genetic cluster consisting of (b)(4) clinical isolates, which indicates that this strain has the potential to cause human illness.

The Salmonella and L. monocytogenes found in the three finished pet food products described above causes them to be adulterated because the Salmonella and L. monocytogenes are poisonous or deleterious substances which may render the food injurious to health.³ Salmonella and L. monocytogenes are pathogenic bacterium that can cause serious and sometimes fatal infections in both humans and animals. Pets like dogs and cats can become infected by eating contaminated pet foods and humans can become infected by handling contaminated pet foods or having contact with infected pets or their feces. Infections can be especially serious in pregnant women, elderly people, and others with weakened immune systems.

Evaluation of Corrective Actions
We received your Corrective Action Preventive Action Report for the recalled lots of pet food as part of correspondence from you dated October 1, 2025, which included a root cause investigation and corrective actions you have taken. You have not provided any additional correspondence directly to the FDA. However, correspondence from your contract manufacturer indicates you are continuing to make changes in collaboration with your contract manufacturer, including changing your identified preventive control. The updated corrective actions include implementation of high-pressure processing of packaged animal food products as a preventive control for biological hazards. However, we are unable to fully evaluate the adequacy of your corrective actions because you did not provide documentation supporting that this preventive control has been implemented.

Conclusion

This letter is not intended to be an all-inclusive statement of violations that may exist at your facility or in connection with your products. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that you comply with all requirements of federal law and FDA regulations.

This letter notifies you of our concerns and provides you an opportunity to address them. You should take prompt action to correct any violations. Failure to adequately address this matter may lead to regulatory action, or where appropriate, legal action.

For more information about FDA’s current thinking, see:

For Industry | FDA (https://www.fda.gov/animal-veterinary/resources-you/industry)

Within fifteen (15) working days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to correct any violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective actions within fifteen (15) working days, state the reason for the delay and the time within which you will complete the correction. If you believe your products are not in violation of the FD&C Act and FDA regulations, include your reasoning and any supporting information for our consideration.

The Food & Drug Administration, Center for Veterinary Medicine, Office of Surveillance and Compliance is encouraging electronic submission of any response you choose to submit to this letter. We encourage you to submit files up to 100 megabytes in a single email, and to divide files greater than 100 megabytes so they may be submitted as smaller files in separate emails. If you submit electronic correspondence, please ensure that your facility’s name, the CMS number at the top of this letter, and the inspection location are included in your correspondence. We intend to issue an electronic acknowledgement upon receipt of your email.

Please direct your electronic correspondence to Compliance Officer Andrew J. Howard at Andrew.Howard@fda.hhs.gov. If you have questions regarding this letter, please contact Compliance Officer Andrew J. Howard by telephone at (410) 779-5125, or by the email listed above.

/S/

Isaac K. Carney
Director of Food Compliance, Office of Surveillance and Compliance
Center for Veterinary Medicine
U.S. Food and Drug Administration

Cc:
(b)(6), (b)(7)(C)
North Carolina Department of Agriculture and Consumer Services
4400 Reedy Creek Road
Raleigh, NC 27607
(b)(6), (b)(7)(C)

________________________________

1 See Section 402(a)(1) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) [21 U.S.C. § 342(a)(1)].

2 See Section 301(a) of the FD&C Act [21 U.S.C. § 331(a)].

3 See Section 402(a)(1) of the FD&C Act [21 U.S.C. § 342(a)(1)].