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WARNING LETTER

Waves and Wine, Inc. MARCS-CMS 724861 —

Delivery Method:
VIA EMAIL NO HARD COPY TO FOLLOW
Product:
Animal & Veterinary
Drugs
Recipient:
Recipient Name
Troy Becker
Recipient Title
Owner and Chief Executive Officer
Waves and Wine, Inc.

(b)(6), (b)(7)(C)
United States

(b)(6), (b)(7)(C)
Issuing Office:
Center for Veterinary Medicine

United States

WARNING LETTER
CMS # 724861

July 6, 2026

Dear Troy Becker,

The U.S. Food and Drug Administration (FDA) conducted a compliance follow-up inspection of your pet food manufacturing facility, located at 181 Naples Street, Mendota, CA 93640-2030 from January 21 through January 30, 2026. FDA conducted this inspection as a compliance follow-up to an Untitled Letter dated July 22, 2025. At the close of the inspection, the investigators issued a Form FDA 483, Inspectional Observations. As of the date of this letter, you have not submitted a written response to the FDA 483.

During the inspection, the investigators found evidence of significant violations of FDA’s Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals requirements, Title 21, Code of Federal Regulations, Part 507 (21 CFR Part 507), which cause your products to be adulterated in that they were prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth, or whereby they may have been rendered injurious to health.1

The doing of any act to a food after shipment of the food and/or its components in interstate commerce and while the food is held for sale (whether or not the first sale) that results in the food being adulterated or misbranded is prohibited.2 Also, failure of the owner, operator, or agent in charge of a covered facility to comply with the hazard analysis and risk-based preventive control requirements of 21 CFR Part 507 is a prohibited act.3

You can find the FD&C Act and its associated regulations on the internet through links on the FDA’s web page at www.fda.gov.

Hazard Analysis and Risk-Based Preventive Controls Requirements
Your animal food facility is subject to the Hazard Analysis and Risk-Based Preventive Controls requirements found in 21 CFR Part 507, Subparts A, C, D, E, and F. During our inspection of your facility, the FDA Investigators observed evidence of significant violations of these requirements including the following:

1. You did not identify and implement a preventive control to provide assurances that any hazards requiring a preventive control will be significantly minimized or prevented and the animal food manufactured, processed, packed, or held by your facility will not be adulterated under section 402 of the FD&C Act, as required by 21 CFR 507.34(a)(1).

Your hazard analysis titled, “Raw Pet Food – Food Safety Plan FSP-001” dated August 20, 2025, identifies the biological hazards of Salmonella, Listeria monocytogenes (L. monocytogenes), and Shiga toxin-producing Escherichia Coli as hazards requiring a preventive control at multiple steps in your manufacturing process. Your preventive controls include monitoring (b)(4) temperature at the (b)(4) step, keeping processing and storage areas (b)(4) temperatures, sanitation, and the application of (b)(4) the (b)(4) step and (b)(4) the (b)(4) step during manufacturing. However, your preventive controls are not adequate as evidenced by your (b)(4) product testing that found L. monocytogenes in your frozen cat beef sliders, lot (b)(4) and your frozen dog beef patties, lot (b)(4).

2. You did not take appropriate corrective action when a preventive control, combination of preventive controls, or the food safety plan as a whole was found to be ineffective, to identify and correct the problem, reduce the likelihood he problem will recur, evaluate all affected animal food for safety, as necessary to prevent affected animal food from entering commerce, and when appropriate, reanalyze the food safety plan, as required by 21 CFR 507.42(b)(1)(ii) and 21 CFR 507.42(b)(2).

Specifically, on November (b)(4), 2025, you manufactured Cat Beef Sliders, lot (b)(4), and Dog Beef Patties, lot (b)(4), respectively, that tested positive for L. monocytogenes. Your root cause analysis resulting from these positive tests stated, “This product is a RAW process pet food and carries inherent risks as it does not undergo a (b)(4) kill step.” Your corrective action was to (b)(4) the amount of (b)(4) added to each batch. You could not provide any documentation or explanation as to how this change to your process will significantly minimize or prevent L. monocytogenes in your products. Your report also recommended a (b)(4) with (b)(4), to review (b)(4), but you were unable to provide any information to verify (b)(4) occurred. You did not demonstrate that your completed corrective actions reduced the likelihood that your finished products will be contaminated with L. monocytogenes.

Additionally, your corrective action report states the positive products manufactured in (b)(4) would be “(b)(4). Samples will be sent out to verify it is not pathogen adulterated.” You could not provide any documents showing the affected products were (b)(4), and that sampling of the (b)(4) product was conducted and analyzed. You did not adequately evaluate affected animal food for safety to ensure the animal food is safe prior to entering commerce.

3. You did not determine and conduct appropriate supplier verification activities and satisfy all documentation requirements, as required by 21 CFR 507.115(a)(2).

Specifically, you identify “PC-(b)(4) Approved Supplier Program” in your “Raw Material – Hazard Analysis” for your raw and cooked pet food and treats as a preventive control for pathogens, Highly Pathogenic Avian Influenza (HPAI) virus (specifically H5N1), (b)(4). You have identified (b)(4) internal audits, review of supplier performance, and review of open Corrective Action Reports as verification activities for your supply-chain control program per your “Approved Supplier Program” dated October 14, 2025. You could not provide documentation of any verification activities conducted by your firm or by your suppliers. You provided one Letter of Guarantee for one of your beef suppliers, dated January 1, 2025, but this Letter of Guarantee is not an appropriate verification activity because it does not adequately demonstrate your supplier is significantly minimizing or preventing the pathogen hazards you have identified in your hazard analysis.

Furthermore, unless there is a written determination otherwise, when a supply-chain applied control is used for a hazard for which there is a reasonable probability that exposure to the hazard will result in serious adverse health consequences or death to humans or animals (SAHCODHA), the appropriate supplier verification activity is an annual onsite audit of the supplier, as required by 21 CFR 507.130(b). Salmonella, H5N1, and nutrient toxicity or deficiency are hazards with the reasonable probability to cause SAHCODHA. You did not provide documentation of annual onsite audits for your suppliers during the inspection, and you do not have a written justification for accepting letters of guarantee and/or certificates of analysis from ingredient suppliers in lieu of an annual onsite audit of your suppliers.

4. You did not verify that your preventive controls are consistently implemented and are effectively and significantly minimizing or preventing the hazards through the use of product testing for a pathogen or other hazard, as required by 21 CFR 507.49(a)(2).

Specifically, you identify (b)(4) product testing as the verification activity for multiple process preventive controls, but your “SOP QM 017, Product Sampling, Inspection and Analysis” procedure does not include adequate product testing procedures. Your product testing procedure does not adequately outline sampling frequency and sample identification to effectively and significantly minimize or prevent hazards. Your SOP states that “sampling frequency and target pathogens are determined following customer agreement.” While you identify how you will develop a composite sample for a particular batch, you do not specify the procedures for identifying samples, including their relationship to specific lots of product, or for the frequency of sampling of your (b)(4) product. For example, you do not conduct any microbial testing for products you manufacture for (b)(4), or for any (b)(4) products you produce. Regardless of any specifications you have accepted via customer agreement, you are responsible for conducting verification of implementation and effectiveness procedures for all animal food you produce.

5. You did not validate that the preventive control you identified in accordance with 21 CFR 507.34 is adequate to control the hazard as appropriate to the nature of the preventive control and its role in your facility’s food safety system, as required by 21 CFR 507.47(a).

During the inspection, you provided marketing brochures, university studies, and research papers to support your use of (b)(4) as preventive controls that will effectively control pathogen hazards in your pet food. However, the study parameters in these documents are not applicable to your firm’s manufacturing process. For example, your application of (b)(4) occurs at the (b)(4). The (b)(4) study you provided from (b)(4) titled, “(b)(4)” applied (b)(4) to (b)(4) which were (b)(4). Such a study pertaining to (b)(4) is not applicable to (b)(4) and other protein.

Furthermore, the documents you provided did not demonstrate that, when properly implemented, your combination of preventive controls will effectively control pathogen hazards, as required by 21 CFR 507.47(b)(2), which is also evidenced by your (b)(4) findings of L. monocytogenes in your frozen cat beef sliders, lot (b)(4) and your frozen dog beef patties, lot (b)(4).

Current Good Manufacturing Practice (CGMP) Requirements
Your animal food facility is subject to the CGMP requirements found in 21 CFR Part 507, Subparts A, B, and F. During the inspection of your facility, the FDA Investigators observed evidence of significant violations of these requirements, including:

6. The management of your establishment failed to ensure that adequate precautions are taken so that plant operations do not contribute to contamination of animal food, animal food-contact surfaces, and animal food packaging materials, as required by 21 CFR 507.25(a)(5). Specifically:

a) On January 21, January 26, and January 28, 2026, the FDA Investigators observed employees wearing (b)(4) gloves while opening and handling cardboard boxes containing proteins and vegetables. These employees were then handling raw protein ingredients without changing their gloves, which could result in cross-contamination of these ingredients from the non animal food contact surfaces. These ingredients were manufactured into finished products that did not undergo further processing to eliminate pathogens.
b) On (b)(4), in-process, gently cooked, and in-process raw pet foods that have not undergone further processing to eliminate pathogens were stored directly next to each other in (b)(4) carts prior to patty formation, increasing the possibility of cross-contamination between the raw products and gently cooked products.
c) On January 26, 2026, the underside of a bar over the conveyor belt next to the opening of the (b)(4) had apparent condensation that was dripping directly onto finished product (lightly cooked turkey for dogs, Lot # (b)(4)), prior to freezing and packaging.
d) On January 28, 2026, during maintenance of cleaned and sanitized equipment, the maintenance employees were observed touching insanitary objects while re-assembling the equipment prior to production. However, not all equipment and food contact surfaces, such as conveyor belts and (b)(4) augers were adequately cleaned and sanitized after the performance of maintenance and prior to production.
e) On January 28, 2026, the applicator for the (b)(4) mixer used in the application of the (b)(4) was laid against a wall that was not cleaned and sanitized. The nozzle was not cleaned prior to the start of production.

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 any violation may lead to regulatory, or where appropriate, legal action.

We have the following comment:

We remind you of the FDA’s January 17, 2025, communication determining that cat and dog food manufacturers who are subject to the hazard analysis requirements of 21 CFR Part 507 and using uncooked or unpasteurized materials derived from poultry or cattle (e.g., uncooked meat, unpasteurized milk or unpasteurized eggs) are required to reanalyze their food safety plans to include HPAI virus (specifically H5N1) as a known or reasonably foreseeable hazard.4

For more information about FDA’s current thinking on the requirements of 21 CFR Part 507, see:

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

Within 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 15 working days, state the reason for the delay and the time within which you will complete the correction. If you believe that you have complied with the FD&C Act and FDA regulations, include your reasoning and any supporting information for our consideration.

The FDA, CVM, 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 Stephen Rabe at stephen.rabe@fda.hhs.gov. If you have questions regarding this letter, please contact Compliance Officer Stephen Rabe by telephone at 513-322-0660, or by the email 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), (b)(5)

________________

1 See Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) [21 U.S.C. § 342(a)(4)], and 21 CFR 507.1(a)(1)(ii).

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

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

4 https://www.fda.gov/animal-veterinary/cvm-updates/cat-and-dog-food-manufacturers-required-consider-h5n1-food-safety-plans

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