FDA Cites Waves and Wine, Inc. in 2026-07-06 Warning Letter — CGMP/Hazard Analysis/Risk-Based Preventive Controls for Food for Animals (PCAF)/Adulterated
Letter issued · posted to fda.gov .
Subject as published: CGMP/Hazard Analysis/Risk-Based Preventive Controls for Food for Animals (PCAF)/Adulterated
TL;DR
FDA Center for Veterinary Medicine issued Warning Letter CMS # 724861 to Waves and Wine, Inc. (Owner Troy Becker) on July 6, 2026, following a compliance follow-up inspection of the facility at 181 Naples Street, Mendota, CA from January 21–30, 2026. The inspection found significant violations of Current Good Manufacturing Practice and Hazard Analysis/Risk-Based Preventive Controls for Food for Animals (21 CFR Part 507), including: inadequate preventive controls for Salmonella, L. monocytogenes, and Shiga toxin-producing E. coli (evidenced by L. monocytogenes detected in frozen cat beef sliders and dog beef patties); failure to take appropriate corrective action when preventive controls proved ineffective, including inability to document how process changes would prevent pathogen contamination or verify that affected products were properly evaluated before distribution; and failure to conduct adequate supplier verification activities as required. The products are deemed adulterated due to potential preparation, packing, or holding under insanitary conditions.
Argus analysis
# FDA Warning Letter Analysis: Waves and Wine, Inc.
**Company and Findings**
Waves and Wine, Inc., a pet food manufacturer in Mendota, California, received a Warning Letter from the FDA's Center for Veterinary Medicine on July 6, 2026, following a compliance follow-up inspection conducted January 21–30, 2026. The inspection traced back to an Untitled Letter issued July 22, 2025. FDA investigators found evidence of significant violations in current good manufacturing practice (CGMP) and hazard analysis requirements that rendered the company's animal food products potentially adulterated due to preparation, packing, and storage under insanitary conditions. The company had not submitted a written response to the Form FDA 483 (Inspectional Observations) issued at inspection close.
**Regulatory Citations and Implications**
The violations centered on 21 CFR Part 507 (Hazard Analysis and Risk-Based Preventive Controls for Food for Animals). Specific deficiencies included: failure to identify adequate preventive controls for pathogens including Listeria monocytogenes and Salmonella (21 CFR 507.34); failure to take appropriate corrective action when preventive controls proved ineffective (21 CFR 507.42); inadequate supplier verification activities and documentation (21 CFR 507.115); insufficient product testing procedures and verification (21 CFR 507.49); and failure to validate that identified preventive controls adequately control identified hazards (21 CFR 507.47). These citations reflect systematic gaps in food safety documentation, microbial testing protocols, and supplier auditing practices.
**Response Timeline and Industry Watch Points**
Compliance officers in pet food manufacturing should monitor for Waves and Wine's response submission and any follow-up enforcement actions. FDA typically expects a timely written response addressing each cited violation. Peer companies should note the agency's emphasis on documented annual onsite supplier audits for hazards posing serious adverse health consequences, particularly for raw pet food operations. The case underscores that customer-agreed testing frequencies are insufficient—manufacturers bear independent responsibility for verification procedures regardless of contractual arrangements.
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
CGMP citations typically reference 21 CFR Part 211 (drugs) or 21 CFR Part 600 (biologics). Common subjects include identity testing of incoming components (211.84), validated cleaning procedures (211.67), and stability program design (211.166).
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 Waves and Wine, Inc. MARCS-CMS 724861 — July 06, 2026 More Warning Letters Warning Letters About Warning and Close-Out Letters 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.…
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 Waves and Wine, Inc. cited for?
- The FDA Warning Letter to Waves and Wine, Inc. (issuing office: Center for Veterinary Medicine) cites: CGMP/Hazard Analysis/Risk-Based Preventive Controls for Food for Animals (PCAF)/Adulterated. Classification: CGMP — Current Good Manufacturing Practice.
- When did FDA issue the warning letter to Waves and Wine, Inc.?
- FDA issued the letter (MARCS-CMS 724861) on 2026-07-06 and posted it publicly on fda.gov on 2026-08-18.
- Is the FDA warning letter to Waves and Wine, Inc. 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/waves-and-wine-inc-724861-07062026.
- 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). FDA Cites Waves and Wine, Inc. in 2026-07-06 Warning Letter — CGMP/Hazard Analysis/Risk-Based Preventive Controls for Food for Animals (PCAF)/Adulterated. Digital Empire Holdings LLC. Retrieved from https://argushq.ai/fda/warning-letter/fda-wl-waves-and-wine-inc-2026-07-06-cgmp
"FDA Cites Waves and Wine, Inc. in 2026-07-06 Warning Letter — CGMP/Hazard Analysis/Risk-Based Preventive Controls for Food for Animals (PCAF)/Adulterated." Argus HQ Research, Digital Empire Holdings LLC, 2026, argushq.ai/fda/warning-letter/fda-wl-waves-and-wine-inc-2026-07-06-cgmp.
Argus HQ Research. "FDA Cites Waves and Wine, Inc. in 2026-07-06 Warning Letter — CGMP/Hazard Analysis/Risk-Based Preventive Controls for Food for Animals (PCAF)/Adulterated." Digital Empire Holdings LLC. Accessed August 19, 2026. https://argushq.ai/fda/warning-letter/fda-wl-waves-and-wine-inc-2026-07-06-cgmp.
@misc{argushq_argushq_ai_fda_warning_letter_fda_wl_waves_and_wine_inc_2026_07_06_cgmp_2026,
title = {FDA Cites Waves and Wine, Inc. in 2026-07-06 Warning Letter — CGMP/Hazard Analysis/Risk-Based Preventive Controls for Food for Animals (PCAF)/Adulterated},
author = {{Argus HQ Research}},
year = {2026},
publisher = {Digital Empire Holdings LLC},
url = {https://argushq.ai/fda/warning-letter/fda-wl-waves-and-wine-inc-2026-07-06-cgmp},
note = {Accessed: August 19, 2026}
}