RDM Express Inc. — FDA Warning Letter, 2026-09-11: CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated
Letter issued · posted to fda.gov .
Subject as published: CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated
TL;DR
The FDA issued a warning letter to RDM Express Inc. (CEO Boris Dinerman, San Francisco facility) on September 11, 2026, following an inspection conducted February 18–March 10, 2026, citing violations of current good manufacturing practice and hazard analysis requirements under 21 CFR Part 117. The agency determined the company's refrigerated ready-to-eat Fermented Cabbage/Sour Cabbage products are adulterated due to preparation, packing, or holding under insanitary conditions, and identified critical deficiencies including failure to identify and evaluate environmental pathogens (Listeria monocytogenes) and parasites/viruses in cranberry ingredients, inadequate sanitation monitoring and documentation, and insufficient employee hygiene verification. The letter also cited misbranding violations on labels for Russian Style Kvas Drink, Sour Cabbage, and Half Sour Pickles products under 21 CFR Part 101, and noted no written response to the FDA Form 483 issued at inspection conclusion.
Argus analysis
# FDA Warning Letter Analysis: RDM Express Inc.
**Company and Violations**
RDM Express Inc., a food manufacturer located in San Francisco, California, received a warning letter from the FDA's Human Foods Program on September 11, 2026, following an inspection conducted between February 18 and March 10, 2026. The FDA determined that the company's refrigerated, ready-to-eat fermented cabbage and related products were adulterated because they were prepared, packed, and held under insanitary conditions that may have resulted in contamination with filth or rendered them injurious to health. The inspection also identified labeling violations on Russian Style Kvas Drink, Sour Cabbage, and Half Sour Pickles products.
**Regulatory Citations**
The violations cited primarily involve 21 CFR Part 117 (Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls), specifically Subparts C, D, E, F, and G. These sections require food manufacturers to identify and evaluate known or reasonably foreseeable hazards, establish appropriate preventive controls, and implement monitoring and verification procedures. The FDA found that RDM Express failed to identify critical environmental hazards, including Listeria monocytogenes contamination and parasites/viruses in cranberry ingredients. Additionally, the company's sanitation procedures lacked documented monitoring, corrective actions, and verification steps. The FDA also cited labeling violations under 21 CFR Part 101.
**Next Steps and Industry Implications**
RDM Express must provide a written response to the FDA, though none had been received at the time of the letter. Compliance officers in fermented food production should monitor whether the company issues a recall of affected products and how it addresses environmental monitoring deficiencies and supplier verification protocols. The letter's emphasis on pathogen survival in acidic conditions—particularly Listeria monocytogenes persistence—signals heightened FDA scrutiny of pH-dependent safety claims in refrigerated fermented products across the industry.
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 RDM Express Inc. MARCS-CMS 729223 — September 11, 2026 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: VIA Electronic Mail Product: Food & Beverages Recipient: Recipient Name Mr. Boris Dinerman Recipient Title CEO RDM Express Inc. 2000 McKinnon Ave Bldg 427, Unit #12 San Francisco , CA 94124 United States (b)(6), (b)(7)(C) Issuing Office: Human Foods Program United States September 11, 2026 WARNING LETTER Re: CMS #729223 Dear Mr. Dinerman: The United States Food and Drug Administration (FDA) inspected your manufacturing facility, located at 2000 McKinnon Ave, Bldg 427, Unit #12, San Francisco, CA 94124, between February 18, 2026, and March 10, 2026. During our inspection of your facility, an FDA investigator found serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation (CGMP & PC rule), Title 21, Code of Federal Regulations, Part 117 (21 CFR Part 117). Based on FDA's inspectional findings and analytical results for finished product samples of your Fermented Cabbage, we have determined that your ready-to-eat (RTE) Fermented Cabbage/Sour Cabbage products are adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 342(a)(4)], 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. In addition, failure of the owner, operator, or agent in charge of a covered facility to comply with the preventive controls provisions of the CGMP & PC rule (located in Subparts A, C, D, E, F, and G of Part 117) is prohibited by section 301(uu) of the Act [21 U.S.C. § 331(uu)]. You may find the Act and FDA's regulations through links on FDA's website at www.fda.gov. Further, a review of the Russian Style Kvas Drink, Sour Cabbage, and Half Sour Pickles product labels collected during the inspection revealed significant violations of the labeling regulations for foods under 21 CFR Part 101. These violations render your product to be misbranded within the meaning of section 403 of the Act [21 U.S.C. § 343], as discussed below. At the conclusion of the inspection, the FDA investigator issued your facility a Form FDA 483 (FDA-483), Inspectional Observations. To date, FDA has not received your written response. After reviewing the inspectional findings, we are issuing this letter to advise you of FDA’s concerns. Hazard Analysis and Risk-Based Preventive Controls (21 CFR Part 117, Subpart C) 1. You did not identify and evaluate known or reasonably foreseeable hazards to determine whether they required preventive controls, as required by 21 CFR 117.130(a)(1). Specifically, you manufacture a refrigerated, RTE Fermented Cabbage/Sour Cabbage product. However, the hazard analysis in your document titled “Food Safety Plan for Acidified & Fermented Foods” d…
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 RDM Express Inc. cited for?
- The FDA Warning Letter to RDM Express Inc. (issuing office: Human Foods Program) cites: CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated. Classification: CGMP — Current Good Manufacturing Practice.
- When did FDA issue the warning letter to RDM Express Inc.?
- FDA issued the letter (MARCS-CMS 729223) on 2026-09-11 and posted it publicly on fda.gov on 2026-10-13.
- Is the FDA warning letter to RDM Express 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/rdm-express-inc-729223-09112026.
- 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). RDM Express Inc. — FDA Warning Letter, 2026-09-11: CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated. Digital Empire Holdings LLC. Retrieved from https://argushq.ai/fda/warning-letter/fda-wl-rdm-express-inc-2026-09-11-cgmp
"RDM Express Inc. — FDA Warning Letter, 2026-09-11: CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated." Argus HQ Research, Digital Empire Holdings LLC, 2026, argushq.ai/fda/warning-letter/fda-wl-rdm-express-inc-2026-09-11-cgmp.
Argus HQ Research. "RDM Express Inc. — FDA Warning Letter, 2026-09-11: CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated." Digital Empire Holdings LLC. Accessed October 14, 2026. https://argushq.ai/fda/warning-letter/fda-wl-rdm-express-inc-2026-09-11-cgmp.
@misc{argushq_argushq_ai_fda_warning_letter_fda_wl_rdm_express_inc_2026_09_11_cgmp_2026,
title = {RDM Express Inc. — FDA Warning Letter, 2026-09-11: CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated},
author = {{Argus HQ Research}},
year = {2026},
publisher = {Digital Empire Holdings LLC},
url = {https://argushq.ai/fda/warning-letter/fda-wl-rdm-express-inc-2026-09-11-cgmp},
note = {Accessed: October 14, 2026}
}