Binh Minh Tofu — FDA Warning Letter, 2026-08-18: CGMP/Hazard Analysis/Risk-Based Preventive Controls for Food/Adulterated
Letter issued · posted to fda.gov .
Subject as published: CGMP/Hazard Analysis/Risk-Based Preventive Controls for Food/Adulterated
TL;DR
At a glance: The FDA issued a warning letter to Binh Minh Tofu (CMS #728787) on August 18, 2026, following an inspection conducted March 2-6, 2026 at its San Jose, California facility, citing serious violations of Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls regulations (21 CFR Part 117). The agency determined that the firm's ready-to-eat fresh tofu products are adulterated because they were prepared under insanitary conditions that may allow contamination with filth or render products injurious to health, and that products are misbranded due to labeling violations (21 CFR Part 101). Specifically, the FDA found inadequate cooling processes for cooked tofu that fail to prevent potential growth of pathogenic bacteria such as *Clostridium perfringens* and *Bacillus cereus*, inaccurate temperature monitoring equipment, and that the firm's proposed corrective actions lack scientific support and time-temperature data.
Argus analysis
# FDA Warning Letter Analysis: Binh Minh Tofu
**Company and Findings**
Binh Minh Tofu, owned by Mr. Anhduc H. Nguyen and located in San Jose, California, received a warning letter from the FDA's Human Foods Program on August 18, 2026, following an inspection conducted March 2–6, 2026. The facility manufactures ready-to-eat tofu products, including fresh soybean cake, fried tofu, and fresh tofu pudding. The FDA determined that the company's fresh tofu products are adulterated due to preparation under insanitary conditions and are misbranded due to labeling violations. The agency identified serious violations of current good manufacturing practices and hazard analysis requirements under 21 CFR Part 117.
**Regulatory Citations**
The primary violations cite 21 CFR 117.80(c)(2), which requires manufacturing under conditions minimizing microbial growth and contamination. Binh Minh Tofu lacked adequate cooling processes for ready-to-eat products, creating risk for pathogenic bacteria like *Clostridium perfringens* and *Bacillus cereus*. The FDA also cited 21 CFR 117.35(a) and 117.35(d) regarding equipment sanitation. The company's cleaning procedures allowed cross-contamination: high-pressure water spray ricocheted onto sanitized surfaces, floor-stored scrubbers contacted food-contact equipment, and inadequate sanitizer concentrations persisted despite FDA notification. Additionally, 21 CFR 117.40(f) violations involved inaccurate cooler thermometry.
**Timeline and Industry Implications**
The company responded to the FDA's Form 483 on March 21, 2026, but the FDA rejected proposed corrective actions as unsupported by time-temperature data. Compliance officers in food manufacturing should anticipate FDA follow-up inspections to verify implementation. Critical monitoring points include documented cooling protocols meeting Food Code standards (135°F to 70°F within two hours; 70°F to 41°F within four hours), calibrated temperature-monitoring equipment, physical separation of sanitized and non-sanitized items, and detergent-based pre-sanitation procedures. Non-compliance with warning letter responses typically triggers product seizures or injunction proceedings.
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 Binh Minh Tofu MARCS-CMS 728787 — August 18, 2026 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: VIA Electronic Mail Product: Food & Beverages Recipient: Recipient Name Mr. Anhduc H. Nguyen Recipient Title Owner Binh Minh Tofu 1180 Tully Rd, Ste C San Jose , CA 95122-3068 United States (b)(6), (b)(7)(C) Issuing Office: Human Foods Program United States August 18, 2026 WARNING LETTER Re: CMS # 728787 Dear Mr. Nguyen: The United States Food and Drug Administration (FDA) inspected your food manufacturing facility located at 1180 Tully Rd, Suites A, B, and C, San Jose, CA 95122, from March 2 through March 6, 2026. Your firm manufactures ready-to-eat (RTE) Daily Fresh Soybean Cake “fresh tofu”, Fried Tofu, Fresh Tofu Pudding With Ginger Syrup and Soymilk. During our inspection, the 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, we have determined that your RTE Daily Fresh Soybean Cake “fresh tofu” manufactured in your facility is adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 United States Code (U.S.C.) § 342(a)(4)] in that it 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. Further, we found significant violations of the labeling regulations for foods, 21 CFR Part 101. These violations cause your products described below to be misbranded within the meaning of section 403 of the Act [21 U.S.C. § 343]. You may find the Act and further information about the CGMP & PC rule through links on FDA’s homepage at www.fda.gov. At the conclusion of the inspection, the FDA investigator issued your facility a Form FDA 483 (FDA-483), Inspectional Observations. We received your written response to the FDA-483 on March 21, 2026, describing corrective actions you have taken. Based on our review of the inspectional findings and your response, we are issuing this letter to advise you of FDA’s continuing concerns and to provide detailed information describing the findings at your facility. We discuss your response below. Current Good Manufacturing Practice (21 CFR Part 117, Subpart B) 1. You did not conduct all food manufacturing, processing, packaging, and holding under conditions and controls necessary to minimize the potential for the growth or survival of microorganisms, contamination of food, and deterioration of food, as required by 21 CFR 117.80(c)(2). Specifically, you manufacture RTE Fresh Soybean Cake (fresh tofu) but do not have processes in place to monitor cooling of the finished products after cooking to prevent microbial pathogen growth and/or toxin formation, such as Bacillus cereus an…
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 Binh Minh Tofu?
- FDA issued the letter (MARCS-CMS 728787) on 2026-08-18 and posted it publicly on fda.gov on 2026-09-22.
- Is the FDA warning letter to Binh Minh Tofu 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/binh-minh-tofu-728787-08182026.
- 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 CGMP — Current Good Manufacturing Practice warning letter?
- 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).
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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). Binh Minh Tofu — FDA Warning Letter, 2026-08-18: CGMP/Hazard Analysis/Risk-Based Preventive Controls for Food/Adulterated. Digital Empire Holdings LLC. Retrieved from https://argushq.ai/fda/warning-letter/fda-wl-binh-minh-tofu-2026-08-18-cgmp
"Binh Minh Tofu — FDA Warning Letter, 2026-08-18: CGMP/Hazard Analysis/Risk-Based Preventive Controls for Food/Adulterated." Argus HQ Research, Digital Empire Holdings LLC, 2026, argushq.ai/fda/warning-letter/fda-wl-binh-minh-tofu-2026-08-18-cgmp.
Argus HQ Research. "Binh Minh Tofu — FDA Warning Letter, 2026-08-18: CGMP/Hazard Analysis/Risk-Based Preventive Controls for Food/Adulterated." Digital Empire Holdings LLC. Accessed September 23, 2026. https://argushq.ai/fda/warning-letter/fda-wl-binh-minh-tofu-2026-08-18-cgmp.
@misc{argushq_argushq_ai_fda_warning_letter_fda_wl_binh_minh_tofu_2026_08_18_cgmp_2026,
title = {Binh Minh Tofu — FDA Warning Letter, 2026-08-18: CGMP/Hazard Analysis/Risk-Based Preventive Controls for Food/Adulterated},
author = {{Argus HQ Research}},
year = {2026},
publisher = {Digital Empire Holdings LLC},
url = {https://argushq.ai/fda/warning-letter/fda-wl-binh-minh-tofu-2026-08-18-cgmp},
note = {Accessed: September 23, 2026}
}