Raaw Energy LLC — FDA Warning Letter, 2026-08-21: Adulterated Animal Foods/Misbranded
Letter issued · posted to fda.gov .
Subject as published: Adulterated Animal Foods/Misbranded
TL;DR
At a glance: FDA Center for Veterinary Medicine issued Warning Letter CMS #723820 to Raaw Energy LLC (967 Route 524, Adelphi, NJ) on August 21, 2026, citing adulterated animal food due to insanitary manufacturing conditions and pathogenic contamination. State sampling between December 2025 and April 2026 detected Salmonella, Listeria monocytogenes, and Campylobacter jejuni in multiple dog food product lots; FDA facility inspection (January 13-22, 2026) identified inadequate environmental pathogen controls, including overspray from floor-cleaning water contacting finished product. Raaw Energy voluntarily recalled all products manufactured July 17–December 23, 2025, and one lot from March 31, 2026; no written response to the FDA 483 had been received as of the warning letter date.
Argus analysis
# FDA Warning Letter Analysis: Raaw Energy LLC
## Facility and Violations
The FDA's Center for Veterinary Medicine issued a warning letter to Raaw Energy LLC, a pet food manufacturer in Adelphi, New Jersey, following an inspection conducted January 13–22, 2026. The inspection was triggered by a consumer complaint and state sampling results. Investigators documented multiple pathogen discoveries—including Salmonella, Listeria monocytogenes, and Campylobacter jejuni—in finished dog food products. The Connecticut and New Jersey departments of agriculture collected frozen, unopened samples that tested positive for these pathogens. Whole genome sequencing by the FDA revealed a genetically identical Listeria strain across products made with different recipes and no shared ingredients, indicating a facility-resident contamination source. The company voluntarily recalled products manufactured between July 17, 2025, and December 23, 2025, plus one lot from March 31, 2026. As of the warning letter date, the company had not responded to the initial FDA 483 inspection observations.
## Regulatory Citations
Violations centered on 21 CFR requirements for animal food safety. The products were deemed adulterated under FD&C Act Section 402(a)(3) because they were prepared, packed, or held under insanitary conditions and contained pathogens rendering them injurious to health. Specific deficiencies included inadequate environmental pathogen controls, equipment with rust and corrosion harborage sites, cracked and reused plastic totes without sanitization, pitted flooring that trapped standing water and blood, condensation dripping onto raw ingredients, and unrefrigerated transportation of non-shelf-stable frozen products across multiple states.
## Timeline and Compliance Watch Points
The company received notification of initial sample results on January 8 and 22, 2026, with a public advisory issued January 23, 2026. Follow-up NJDA sampling on April 7, 2026, found additional contamination. The FDA provided whole genome sequencing results February 11 and May 13, 2026, with an updated public advisory on May 22, 2026. Compliance officers should monitor whether Raaw Energy LLC submits a timely response to the FDA 483, confirms remediation of facility infrastructure and sanitation protocols, validates pathogen-control processes, and establishes proper temperature-control logistics before resuming operations.
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 Raaw Energy LLC MARCS-CMS 723820 — August 21, 2026 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: VIA EMAIL NO HARD COPY TO FOLLOW Product: Animal & Veterinary Food & Beverages Recipient: Recipient Name Kitt A. Schulman Recipient Title Owner Raaw Energy LLC 967 Route 524 Adelphi , NJ 07710-0276 United States (b)(6), (b)(7)(C) Issuing Office: Center for Veterinary Medicine United States WARNING LETTER CMS # 723820 August 21, 2026 Dear Kitt Schulman, The U.S. Food and Drug Administration (FDA) conducted an inspection of your pet food manufacturing facility located at 967 Route 524, Adelphi, New Jersey, from January 13 through January 22, 2026, following a consumer complaint and state sample results regarding your products. At the close of the inspection, you were issued a Form FDA 483, Inspectional Observations (FDA 483). As of the date of this letter, we have not received your written response to the FDA 483. During the inspection, the FDA investigator found evidence of significant violations of the Federal Food, Drug, and Cosmetic Act (FD&C Act). The observed conditions cause the animal food at your facility to be adulterated because the food was prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health. 1 Additionally, in response to the consumer complaint, the Connecticut Department of Agriculture (CDoAg) and New Jersey Department of Agriculture (NJDA) collected pet food product samples from the consumer and your facility. Analysis of the frozen, unopened pet food finished products revealed the presence of one or more pathogens: Salmonella, Listeria monocytogenes (L. monocytogenes), Campylobacter jejuni (C. jejuni). FDA notified you of these results on January 8 and 22, 2026, and issued a public advisory regarding these products on January 23, 2026. 2 On April 7, 2026, NJDA conducted follow-up sampling that found additional products contained L. monocytogenes. FDA notified you of the additional sample findings on May 13, 2026. FDA considers these products sampled by CDoAg and NJDA to be adulterated because they bear or contain a poisonous or deleterious substance which may render them injurious to health. 3 On May 22, 2026, FDA updated its public advisory, and you voluntarily recalled all products manufactured between July 17 and December 23, 2025, and one lot manufactured on March 31, 2026. The introduction or delivery for introduction into interstate commerce of any food that is adulterated is a prohibited act. 4 Furthermore, 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 is prohibited. 5 You may find the FD&C Act and FDA’s regulations through links on FDA’s homepage at www.fda.gov. Adulterated Animal Food Pathogen Fin…
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
- When did FDA issue the warning letter to Raaw Energy LLC?
- FDA issued the letter (MARCS-CMS 723820) on 2026-08-21 and posted it publicly on fda.gov on 2026-09-22.
- Is the FDA warning letter to Raaw Energy 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/raaw-energy-llc-723820-08212026.
- 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.
- What is the regulatory background for a Labeling / misbranded warning letter?
- 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.
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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). Raaw Energy LLC — FDA Warning Letter, 2026-08-21: Adulterated Animal Foods/Misbranded. Digital Empire Holdings LLC. Retrieved from https://argushq.ai/fda/warning-letter/fda-wl-raaw-energy-llc-2026-08-21-labeling
"Raaw Energy LLC — FDA Warning Letter, 2026-08-21: Adulterated Animal Foods/Misbranded." Argus HQ Research, Digital Empire Holdings LLC, 2026, argushq.ai/fda/warning-letter/fda-wl-raaw-energy-llc-2026-08-21-labeling.
Argus HQ Research. "Raaw Energy LLC — FDA Warning Letter, 2026-08-21: Adulterated Animal Foods/Misbranded." Digital Empire Holdings LLC. Accessed September 23, 2026. https://argushq.ai/fda/warning-letter/fda-wl-raaw-energy-llc-2026-08-21-labeling.
@misc{argushq_argushq_ai_fda_warning_letter_fda_wl_raaw_energy_llc_2026_08_21_labeling_2026,
title = {Raaw Energy LLC — FDA Warning Letter, 2026-08-21: Adulterated Animal Foods/Misbranded},
author = {{Argus HQ Research}},
year = {2026},
publisher = {Digital Empire Holdings LLC},
url = {https://argushq.ai/fda/warning-letter/fda-wl-raaw-energy-llc-2026-08-21-labeling},
note = {Accessed: September 23, 2026}
}