WARNING LETTER

Binh Minh Tofu MARCS-CMS 728787 — August 18, 2026

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 and Clostridium perfringens in these products. You also stated your tofu products are delivered in an (b)(4) truck with delivery times (b)(4).

On March 4, 2026, the FDA investigator observed the following cooling processes:

Plastic - wrapped tofu was (b)(4), which were then placed (b)(4). You stated this process was developed over (b)(4) and (b)(4) the tofu to an (b)(4) within (b)(4). Our investigator measured the following temperatures:
o Batch 1: (b)(4) after (b)(4)
o Batch 2: (b)(4)
You then (b)(4). Then, (b)(4) the (b)(4). The investigator marked two packages of tofu as “X” and “O” and measured the following internal product temperatures:

Time Elapsed	Tofu "X" Temperature (Time)	Tofu "O" Temperature (Time)	Status
(b)(4)	(b)(4)	(b)(4)	(b)(4)

Our investigator also observed when the tofu was moved into the cooler that the cooler thermometer measured the air temperature (b)(4) than the FDA calibrated thermometer. Instruments used for measuring, regulating, or recording temperatures that control or prevent the growth of undesirable microorganisms in food must be accurate and precise and adequately maintained as required per 21 CFR 117.40(f).

Improper cooling of cooked foods creates food safety hazards due to the potential for germination of pathogenic spore-forming bacteria such as Clostridium perfringens and Bacillus cereus, which may be present in food ingredients. As a cooked product cools, it will reach temperatures that allow for spore germination and outgrowth. The U.S. Food Code specifies the application of a two-part cooling protocol to cool foods safely and keep bacteria in the lag phase. In the first stage, food is cooled from 135°F (57°C) to 70°F (21°C) within two hours. This first stage is critical because harmful bacteria grow most rapidly in this temperature range. In the second stage, food is cooled from 70°F (21°C), to 41°F (5°C) within an additional four hours (see Draft Guidance for Industry: Hazard Analysis and Risk-Based Preventive Controls for Human Food Chapter 4: Preventive Controls).

Your written response described a revised cooling procedure in which (b)(4) of freshly made tofu (at approximately (b)(4)) will be placed (b)(4) to cool to (b)(4), then transferred (b)(4) to reach an internal product temperature of around (b)(4). The tofu will then be (b)(4), placed into (b)(4) with ice, and stored (b)(4) until delivery to customers.

Your response is not scientifically supported. You did not provide time and temperature data to demonstrate your cooling process achieves the claimed temperature reductions. The temperature monitoring performed by our investigator during the inspection contradicts your descriptions in that the cooling from approximately (b)(4) to approximately (b)(4) required 3 to 3.5 hours, not the (b)(4) you claim it takes to reach (b)(4). In addition, photographs taken during the inspection show inconsistent ice distribution in (b)(4), with some containing scattered ice, some with tofu sitting on top of ice, and some with no visible ice. Without evidence demonstrating the complete cooling timeline from 170°F to 40°F, including the (b)(4) in the cooler, your proposed method does not demonstrate adequate controls to minimize bacterial pathogen growth and toxin formation. Furthermore, you stated you calibrated the walk-in cooler thermometer but provided no calibration documentation to support the corrective action.

2. You did not clean and sanitize your utensils or equipment in a manner that protects against contamination of food, food-contact surfaces, or food packaging materials, as required by 21 CFR 117.35(a). Specifically, your cleaning and sanitation operations resulted in contamination of food, food-contact surfaces, and food packaging materials, including but not limited to:

On March 2, 2026, an employee cleaned tofu press molds (direct food contact surfaces) using (b)(4) rinse, scrubbing with (b)(4) from the (b)(4), rinsing again with (b)(4), and applying (b)(4), then stored them (b)(4). The employee then picked up a pot that had been sitting on top of a floor drain with tofu residue between the grates and rinsed it on top of the tofu press. Water spray from the high-pressure hose ricocheted onto the sanitized tofu molds. The same contamination occurred while cleaning cheesecloths in this area. The employee confirmed the molds were ready for use. Further, you do not perform additional pre-production sanitation.
On March 2, 2026, two (b)(4) scrubbers used during sanitation were on the floor approximately 1-2 feet from the floor drains. One scrubber was picked up and used to clean food-contact surfaces of the extractor, post-cook soymilk containers, and post-cook tofu press molds.
On March 2, 2026, while an employee rinsed the soymilk extractor, high-pressure spray from the hose ricocheted through an approximately 3x4 foot wall gap onto plastic bins used to hold unpackaged RTE tofu (retail) and packaged tofu (wholesale). Further, you do not use detergent to clean these bins; they are only rinsed and scrubbed with (b)(4) before applying (b)(4).
On March 2, 2026, an employee hung the nozzle of the high-pressure hose on multiple surfaces throughout sanitation, including on a cleaned and sanitized tofu press mold.
On March 4, 2026, the packaging table was cleaned with (b)(4) scrubber and (b)(4) before (b)(4) was sprayed on top. This table is used to package exposed RTE fresh tofu in clear plastic wrap.
On March 2 and March 4, 2026, you also did not sufficiently clean and sanitize your utensils and equipment, as evidenced by tofu residue observed on at least two tofu press molds after cleaning.

Furthermore, once utensils and equipment are appropriately cleaned, they must be appropriately sanitized and maintained in an adequate condition, in accordance with 21 CFR 117.35(d). On March 2, 2026, even after the investigator measured the sanitizer at (b)(4) and notified management, an employee continued to apply (b)(4) to sanitize equipment. Management did not adjust the sanitizer concentration to 200ppm until FDA questioned management about their corrective action plan.

Debris observed on food contact surfaces and backsplash onto cleaned equipment and utensils was observed during the 2022 FDA inspection.

In your written response, you committed to using (b)(4) as part of your cleaning process before a sanitizing step for all cooking equipment, separating sanitized items from non-sanitized items, no longer storing (b)(4) scrubbers on the floor, and no longer hanging hose nozzles on clean and sanitized equipment. We acknowledge these as appropriate corrective actions; however, you did not identify how you will store sanitized utensils and small pieces of equipment while cleaning and sanitizing other utensils and equipment and did not identify where scrubbers will be stored and hoses will be hung. Furthermore, you did not address the improper handling of hoses which caused overspray and backsplash on numerous occasions during the inspection.

In addition, you stated the tofu press molds were recleaned and sanitized but did not provide supporting information to show that cleaning was effective and all debris was removed. You stated you purchased test strips and are using them daily but did not provide evidence of use or that your sanitizer is consistently at an appropriate concentration for use. Furthermore, you stated you sealed the wall to prevent water from splashing into the packing room but did not provide supporting information to demonstrate how or whether the wall was completely sealed.

3. You did not take reasonable measures and precautions to ensure that all persons working in direct contact with food, food-contact surfaces, and food-packaging materials conform to hygienic practices while on duty to the extent necessary to protect against contamination of food, as required by 21 CFR 117.10(b). Specifically, investigators observed and documented multiple instances of poor hygienic practices, including but not limited to:

On March 4, 2026, an employee touched multiple non-food contact surfaces with gloved hands, including the tofu press knob with apparent residue, a valve handle on the cooked soymilk pipe, the lid of the ice machine, and water in the finished product ice bath tank. Then, the employee rinsed their gloves with a high-pressure hose. The spray of water ricocheted off the gloves and into an open container of cooked soymilk that was used to make RTE fresh tofu.
Throughout the inspection, the cooler handles were sticky and had apparent food residue. On March 4, 2026, an employee touched one handle with their gloved hand and then only rinsed their gloves with water before continuing to manufacture RTE fresh tofu. You stated the cooler handles are cleaned once a week with a (b)(4) and a (b)(4).
On March 2, 2026, a packaging employee was wearing bracelets on their wrist. At least 2 bracelets touched the RTE fresh tofu during packaging.

Lack of handwashing and changing gloves after touching insanitary objects was observed during the 2022 FDA inspection and mentioned in the 2012 FDA Warning Letter.

In your written response, you stated employees were instructed to replace their gloves after touching the cooler handles before they continue to manufacture RTE fresh tofu. However, you did not address the need to wash hands and/or change gloves after touching other insanitary surfaces. Further, you did not address that hands and/or gloves need to be washed at a hand-washing station and not rinsed with a high pressure hose to prevent backsplash onto product, food contact surfaces, and packaging materials. In addition, you explained the cooler handles will be cleaned and sanitized (b)(4) and that all other handles and knobs would be covered with clean plastic (b)(4) production and (b)(4) production. However, you did not explain how wrapping handles/knobs in plastic will prevent debris from forming on them during production. Therefore, the risk remains that employees may continue to touch insanitary surfaces and fail to wash their hands and/or change their gloves before handling food or food-contact surfaces.

In addition, you stated all employees were instructed to remove or cover jewelry while handling RTE products. All unsecured jewelry and hand jewelry that can not be adequately sanitized should be removed. If such hand jewelry cannot be removed, it may be covered by material which can be maintained in an intact, clean and sanitary condition and that effectively protects against contamination as allowed per 21 CFR 117.10(b)(4). However, you did not indicate whether you purchased longer gloves and/or disposable sleeves to ensure coverage of unremovable hand jewelry. During the inspection, the disposable gloves appeared to reach only to the wrist, leaving the bracelets exposed.

4. Your plant equipment and utensils used in manufacturing and processing are not designed and of such material and workmanship as to be adequately cleanable, and adequately maintained to protect against contamination, as required by 21 CFR 117.40(a). Specifically, investigators observed:

The soymilk cooking piping system has a (b)(4) through which cooked soymilk may flow upward toward the collection tank or downward toward a closed valve. During sanitation cycle, when (b)(4) water and sanitizer are run through the pipe system, the lower valve is closed, creating an approximately (b)(4)-long section below the (b)(4) that does not receive adequate turbulent flow during cleaning. This design prevents the system from being maintained in an appropriate clean and sanitary condition.

In addition, the investigators observed multiple damaged utensils and pieces of small equipment:

An approximate 0.5-inch crack in the interior (FCS) side of a strainer used to scoop RTE tofu curds into the tofu press mold.
At least two tofu press molds with at least two cracks each, measuring approximately 0.5-inches long. These molds were lined with cheesecloths and used to press curdled RTE soymilk into tofu.
An approximately 3-inch-long crack in the side of (b)(4) bucket used to scoop the (b)(4) solution into the cooked RTE soymilk. The solution was leaking out of this crack as it was being poured into the soymilk.
At least two containers used to hold RTE soymilk had rough circular welds on the inner direct FCS.

In your written response, you stated that the valve on top of the soymilk cooking piping system is always open to allow water to flush out during cleaning. However, you did not provide documentation to support this statement, such as piping and instrumentation diagrams showing the complete system configuration, cleaning validation studies demonstrating adequate cleaning of the questioned section, or standard operating procedures specifying valve positions during each cleaning step. Even if opening the top valve allows water to enter the lower section, you have not demonstrated that this creates sufficient flow velocity through the (b)(4) section to achieve the turbulent conditions needed for clean-in-place systems. Turbulent flow is necessary to effectively remove product residues and biofilms.The (b)(4) section contacts cooked soymilk, a ready-to-eat product that receives no additional kill step. Any microbial contamination from inadequately cleaned piping would be directly incorporated into the finished product. Soymilk is a high-protein, near-neutral pH product that supports rapid microbial growth. Dead spots in such systems are known to harbor biofilms that can serve as persistent sources of contamination, including potential pathogens.

Furthermore, you stated you repaired the cracks in the tofu molds, replaced the (b)(4) and (b)(4) bucket and smoothed the welds in cooked soymilk containers. Although these appear to be appropriate corrective actions, you did not provide evidence of implementation.

5. You did not maintain buildings, fixtures, and other physical facilities in a clean and sanitary condition, and in repair adequate to prevent food from being adulterated, as required by 21 CFR 117.35(a). Specifically, our investigators observed the following:

On March 2 and March 4, 2026, the floor in the production and packaging areas was worn to the aggregate with standing water. At least (b)(4) were observed in the floor, with the largest areas of exposed aggregate measuring 5”x10”, 10”x10” and 18”x 27” in the production area. Further, splashing was observed during production and sanitation.
On March 2 and March 4, 2026, a 2”x 48” opening in the wall behind the packaging table used for RTE fried tofu, above where the (b)(4).
On March 2, 2026, two doorframes between (b)(4) area and (b)(4), and between (b)(4) and (b)(4) areas were decaying with apparent gaps along the bottom.
On March 4, 2026, a 0.75” x 33” gap along the (b)(4) of the (b)(4) area door leading to the (b)(4), where there was spillage around the (b)(4) tank and clutter around a storage container.
On March 4, 2026, peeling paint along the ceiling above the fried tofu packaging table.

Floors worn to the aggregate with standing water, holes in walls and peeling paint were also observed during the 2022 FDA inspection.

You stated in your written response that you repaired all pits in the floors, gaps in the walls, peeling paint, and damaged doorframes, sealed the gap along the door, and cleaned the outdoor area. While these are appropriate corrective actions, you did not provide evidence of implementation, such as photographs of each repair or other documentation.

Misbranding Violations

1. Your Fresh Tofu Pudding with Ginger Syrup product (pandan flavor) is misbranded within the meaning of section 403(k) of the Act [21 U.S.C. § 343(k)] because the product bears or contains an artificial coloring, flavoring, or a chemical preservative but does not bear labeling stating that fact. Specifically, the label does not state the fact that the product contains an artificial flavor and artificial color additives FD&C Yellow 5 and Blue 1 as required in 21 CFR 101.22(h) and (k).

2. Your Fresh Tofu Pudding with Ginger Syrup and Daily Fresh Soybean Cake “fresh tofu” products are misbranded within the meaning of section 403(a)(1) of the Act [21 U.S.C. § 343(a)(1)] in that the labeling is false or misleading. For example, your Daily Fresh Soybean Cake “fresh tofu” and Fresh Tofu Pudding with Ginger Syrup products are labeled as "fresh" in the statement of identity. The use of the word "fresh" on these products implies that these products are unprocessed or unpreserved. However, these products fail to meet the definition of fresh as outlined in 21 CFR 101.95(a) because they are not in their raw state and have been subjected to a form of (b)(4) processing.

3. Your Daily Fresh Soybean Cake “fresh tofu”, Fresh Tofu Pudding with Ginger Syrup, Fried Tofu, Unsweetened Soymilk, and Sweetened Soymilk products are misbranded within the meaning of section 403(q) of the Act [21 U.S.C. § 343(q)] in that the nutrition information (e.g. Nutrition Facts Label) does not meet the requirements in 21 CFR 101.9. For example, mandatory nutrients such as added sugars, vitamins and minerals such as vitamin D and potassium are not declared as required in 21 CFR 101.9(c), and the footnote is not in accordance with 21 CFR 101.9(d)(9).

In addition, the serving size for the Fresh Tofu Pudding with Ginger Syrup product is not based on the Reference Amount Customarily Consumed (RACC), as required in 21 CFR 101.9(b)(2). Specifically, the RACC for pudding under the “Desserts” product category is ½ cup. The Fresh Tofu Pudding with Ginger Syrup product label declares a serving size of “1 cup (200g).” As such, all of the serving information is incorrect. Based on a ½ cup serving (100g) and the net weight of 32 oz (907g), the product would contain 9 servings.

4. Your Daily Fresh Soybean Cake “fresh tofu”, Fresh Tofu Pudding with Ginger Syrup, Fried Tofu, Unsweetened Soymilk, and Sweetened Soymilk products are misbranded within the meaning of section 403(f) of the Act [21 U.S.C. § 343(f)] because the finished product labels contain information in two languages but do not repeat all the required information in both languages. For example, the Nutrition Facts information, ingredients, and net weight must be declared in both languages as required by 21 CFR 101.15(c)(2).

5. Your Fried Tofu, Fresh Tofu Pudding with Ginger Syrup, Unsweetened Soymilk, Sweetened Soymilk, and Daily Fresh Soybean Cake “fresh tofu” products are misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that the products are (b)(4) from two or more ingredients, and the common or usual name of each ingredient is not declared on the label, as required under 21 CFR 101.4. Specifically:

Your Fresh Tofu Pudding with Ginger Syrup product does not declare the ginger ingredient.
We note that your firm uses the same label for the Fresh Tofu Pudding with Ginger Syrup in regular and pandan flavor. However, the product label does not declare the pandan flavor and dye mixture ingredient and its sub-ingredients, which includes artificial pandan flavor, FD&C Yellow 5 and Blue 1.
Your Fresh Tofu Pudding with Ginger Syrup, Unsweetened Soymilk, Sweetened Soymilk, and Daily Fresh Soybean Cake “fresh tofu” products declare “Soybeans (Non-GMO)” which is not a common or usual name of an ingredient.

According to 21 CFR 101.4(b)(2), the requirement to list these component ingredients (or “sub-ingredients”) may be met by either parenthetically listing the component ingredients after the common or usual name of the main ingredient [21 CFR 101.4(b)(2)(i)], or by listing the component ingredients without listing the ingredient itself [21 CFR 101.4(b)(2)(ii)]. Under the first alternative, the component ingredients must be listed in descending order of predominance within the multi-component ingredient; and under the second alternative, the component ingredients must be listed in descending order of predominance in the finished food.

6. Your Fresh Tofu Pudding with Ginger Syrup product is misbranded within the meaning of section 403(i)(1) of the Act [21 U.S.C. § 343(i)(1)] in that the product label fails to bear the common or usual name of the food. Specifically, your Fresh Tofu Pudding with Ginger Syrup product made with the pandan flavor and dye mixture ingredient fails to bear an appropriate common or usual name to distinguish it from the Fresh Tofu Pudding with Ginger Syrup product that is made without the pandan ingredient.

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 your firm complies with all requirements of federal law, including applicable FDA regulations.

This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address this matter may result in legal action including, without limitation, seizure, injunction, or administrative action for suspension of food facility registration if criteria and conditions warrant.

In addition to the above violations, we offer the following comments:

For the Fresh Tofu Pudding with Ginger Syrup (pandan flavor) product, the label contains a color additive which is unsafe within the meaning of section 721(a) of the Act [21 U.S.C. § 379e(a)]. Section 721(a) deems a color additive to be unsafe unless its use is in conformity with the color additive listing regulation. Specifically, the listing regulation for FD&C Yellow No. 5 requires that this certified color additive be listed as “FD&C Yellow No. 5” in the ingredient list on the labels of foods for human use that contain FD&C Yellow No. 5 [21 CFR 74.705(d)(2)]. During the inspection, our investigator was informed that you use pandan flavoring to manufacture your Fresh Tofu Pudding with Ginger Syrup (pandan flavor) product. The pandan flavoring label declares in part “FD&C Yellow 5”; however, your finished product label for your Fresh Tofu Pudding with Ginger Syrup (pandan flavor) product does not declare any color additives. On March 6, 2026, you informed the investigator that you discontinued the Fresh Tofu Pudding with Ginger Syrup (pandan flavor) product and will only make the regular tofu pudding moving forward. The implementation and sustainability of your corrections will be evaluated during the next FDA inspection.
For the Unsweetened Soymilk product, the label bears the net quantity of contents statement “64 OZ. (1.89)”. In accordance with 21 CFR 101.7(a), if a food is liquid, the statement shall generally be in terms of fluid measure, such as fluid ounce. Furthermore, if the statement “(1.89)” is intended to be the net quantity of contents in terms of the metric system, then it is missing the unit of measure (21 CFR 101.7(p)).

Please notify FDA in writing within fifteen (15) working days of receipt of this letter of the specific steps you have taken to address 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 fifteen (15) working days, state the reason for the delay and the time within which you will do so. If you believe that your products are not in violation of the Act, include your reasoning and any supporting information for our consideration.

Please send your reply to: HFP-OCE-ConventionalFoods@fda.hhs.gov, copying Kimberly Lichter, Compliance Officer at kimberly.lichter@fda.hhs.gov or by hardcopy to Food and Drug Administration, Attention: Kimberly Lichter, Compliance Officer, Human Foods Program – Office of Compliance and Enforcement, Office of Enforcement – Division of Conventional Foods Enforcement (HFS-607), 5001 Campus Drive, College Park, MD 20740. If you have any questions regarding this letter, you may contact Kimberly Lichter, Compliance Officer, via email at Kimberly.Lichter@fda.hhs.gov. Please include reference CMS # 728787 on any submissions and within the subject line of any email correspondence to the agency.

Sincerely,
/S/

Maria S. Knirk, JD MBA
Director
Office of Enforcement
Office of Compliance and Enforcement
Human Foods Program