It seems that this was more of a restaurant operation that was distributing product. Because they were distributing, the first thing they need to do, but failed, was registering their facility. Then they would file an attestation with FDA regarding their 'qualified' status. That did not occur either.
What follows in the report is a laundry list of GMP violations, any of which could result in signification food safety issues. Everything from lack of temperature control throughout the process to bad sanitation.
It is easy to overlook these small operations, but the same rules of food safety apply regardless of size.
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/tan-nam-corporation-708292-08252025
Tan Nam Corporation
MARCS-CMS 708292 — August 25, 2025
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/tan-nam-corporation-708292-08252025
Tan Nam Corporation
MARCS-CMS 708292 — August 25, 2025
Recipient:
Mr. Lee Trinh
Manager
Tan Nam Corporation
9014 Garvey Ave Ste J
Rosemead, CA 91770
United States
Issuing Office:
Human Foods Program
United States
August 25, 2025
WARNING LETTER
Re: CMS # 708292
Dear Mr. Trinh:
On February 27, 2025 through March 20, 2025, the United States Food and Drug Administration (FDA) conducted an inspection of your ready-to-eat (RTE) and ready-to-drink (RTD) soybean products facility, located at 9014 Garvey Ave Ste J, Rosemead, CA 91770. During our inspection of your facility, the FDA investigators observed serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food rule (CGMP & PC rule), Title 21, Code of Federal Regulations, Part 117 (21 CFR Part 117, subpart B). At the conclusion of the inspection, the FDA investigators issued a Form FDA 483 (FDA-483), Inspectional Observations, listing the deviations found at your facility.
Based on FDA’s inspectional findings, we have determined that the soybean products manufactured in your facility are adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 United States Codes (U.S.C.) § 342(a)(4)] because they were 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. You may find the Act and further information about the CGMP & PC rule through links on FDA’s homepage at www.fda.gov.
Further, we have reviewed the Fresh Soy Milk (No Sugar), Soybean Curd (Tofu) and Fresh Soybean Pudding product labels that were collected during the inspection and found significant violations of the labeling regulations for foods, 21 CFR Part 101. These violations cause your product to be misbranded within the meaning of section 403 of the Act [21 U.S.C. § 343], as discussed below.
We received your response to the FDA-483 on April 3, 2025, which consisted of seven photographs. We address the adequacy of your response below. Based on our review of the inspectional findings and the limited 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 have the following remaining concerns to the violations noted in this letter below.
Modified Requirements for Qualified Facilities (Subpart D)
Your facility meets the definition of a qualified facility1 under the Current Good Manufacturing Practice, Hazard Analysis, and Risk-based Preventive Controls for Human Food rule (CGMP & PCHF rule), Title 21, Code of Federal Regulations, Part 117 (21 CFR Part 117), and therefore is subject to the modified requirements in 21 CFR 117.201. A qualified facility is required to submit an attestation to FDA that the facility is a qualified facility (21 CFR 117.201(a)(1)). In addition, a qualified facility is required by 21 CFR 117.201(a)(2) to submit one of the two following attestations to FDA:
An attestation that you have identified the potential hazards associated with the food being produced, are implementing preventive controls to address the hazards, and are monitoring the performance of the preventive controls to ensure that such controls are effective; or
An attestation that the facility is in compliance with State, local, county, tribal, or other applicable non-Federal food safety law, including relevant laws and regulations of foreign countries, including an attestation based on licenses, inspection reports, certificates, permits, credentials, certification by an appropriate agency (such as a State department of agriculture), or other evidence of oversight.
To date you have not submitted such an attestation.
Current Good Manufacturing Practice (21 CFR Part 117, Subpart B)
1. You did not conduct all food manufacturing, processing, packing, 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 and RTD soybean products, including soy milk, soybean pudding and soybean curd, that are labeled as “PERISHABLE/KEEP REFRIGERATED,” but you do not have processes in place to monitor (b)(4) of soybeans or (b)(4) of finished products after (b)(4) to prevent microbial pathogen growth and/or toxin formation (such as Bacillus cereus) in these products.
a. (b)(4) of beans: On February 27, 2025, you told investigators that (b)(4). On March 13-14, 2025, investigators measured the temperature of the (b)(4) soybeans and found the temperature at (b)(4)°F at (b)(4) PM and (b)(4)°F at (b)(4) AM. The soybeans were (b)(4) for approximately (b)(4) hours and (b)(4) minutes at approximately (b)(4)°F. These soybeans were then used in the manufacture of your RTE Soybean Curd, RTD Soy Milk (unsweetened) and RTE Soybean Pudding on March 14, 2025.
Bacillus cereus is a spore-forming bacterium commonly found in soil and raw agricultural commodities, such as soybeans. While (b)(4) effectively destroys its vegetative cells, the spores are notably heat-resistant and can survive standard (b)(4) processes. Under favorable conditions—particularly when foods are held at temperatures between (b)(4)°C and (b)(4)°C ((b)(4)°F to (b)(4)°F)—these spores can germinate into vegetative cells, proliferate, and produce toxins that may lead to foodborne illness.
The soybeans were (b)(4) for (b)(4) hours at ambient temperatures ranging from (b)(4)°F to (b)(4)°F ((b)(4)°C to (b)(4)°C). This temperature range is ideal for B. cereus spores to germinate and multiply. Extended exposure within this range significantly increases the risk of toxin production. Furthermore, inadequate (b)(4) practices of several ready-to-eat (RTE) cooked products, including Soybean Curd, Soy Milk (No Sugar, Fresh Soybean Pudding, and Fried Soybean Curd, were also observed. Specifically, the (b)(4) of RTE food products was not adequately monitored, and observations (as discussed further below) suggest that the products could have remained at ambient temperatures for an extended period.
The prolonged (b)(4) of soybeans at temperatures conducive to B. cereus growth coupled with unmonitored (b)(4) procedures could potentially allow the growth of Bacillus cereus, which can present a significant food safety hazard.
FDA recommends referencing Appendix 3, Table 3-B of our Hazard Analysis and Risk-Based Preventive Controls for Human Foods Draft Guidance for Industry, which explains that for the potential hazardous conditions of growth and toxin formation of Bacillus cereus (associated with soybeans), the maximum cumulative exposure time for product temperatures between 60-70°F is six (6) hours.
b. (b)(4) after (b)(4): your finished products (b)(4) at ambient temperatures. On March 14, 2025, investigators observed that you do not monitor nor do you control for cooling of your finished products after (b)(4). For example:
i. RTE Soybean Curd: packaged soybean curd was measured at internal temperatures of (b)(4)°F at (b)(4) AM and (b)(4)°F at (b)(4) AM prior to loading into a delivery van that distributes your products at ambient, unrefrigerated temperatures.
ii. RTD Soy Milk (No Sugar): bottled soy milk was measured at (b)(4)°F at (b)(4) AM through (b)(4)°F at (b)(4) AM prior to loading into a delivery van that distributes your products at ambient, unrefrigerated temperatures.
iii. RTE Fresh Soybean Pudding: packaged soybean pudding was measured at (b)(4)°F at (b)(4) AM through (b)(4)°F at (b)(4) AM prior to loading into a delivery van that distributes your products at ambient, unrefrigerated temperatures.
iv. RTE Fried Soybean Curd: the fried soybean curd was observed (b)(4) on a rack at ambient temperatures after (b)(4), with internal product temperatures of (b)(4)°F at (b)(4) AM, though (b)(4)°F at (b)(4) AM. After packaging, the Fried Soybean Curd continued to (b)(4) at ambient temperatures, and was measured with internal product temperatures of (b)(4)°F at (b)(4) AM and (b)(4)°F at (b)(4) AM prior to loading into a delivery van that distributes your products at ambient, unrefrigerated temperatures.
FDA recommends referencing Appendix 3, Table 3-C of our Hazard Analysis and Risk-Based Preventive Controls for Human Foods Draft Guidance for Industry, which explains that exposure time for cooked, RTE food products should be:
Limited to 4 hours if food is held at an internal temperature above 80°F, so long as no more than one of those hours is above 70°F.
Limited to 1 hour if food is held at an internal temperature above 80°F, if the above does not apply.
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,
a. Your cleaning and sanitation operations resulting in contamination of food, food-contact surfaces, and food packaging materials, including but not limited to:
i. On February 28, 2025, during sanitation, investigators observed an employee using a broom to push excess water from the bathroom toward drains located in the soy milk packaging area. This activity caused the water from the bathroom floor to be splashed onto the exterior clean, uncapped, bottles used to package the RTD soy milk.
ii. On March 14, 2025, investigators observed an employee cleaning the soy milk filter on the ground in the manufacturing area during production. The employee rinsed the filter under sink water and returned it to the filtering machine to process additional RTD Fresh Soy Milk (unsweetened) without sanitizing.
iii. On February 27, 28 and March 7, 2025, investigators observed employees disposing large amounts of gray-colored warewashing water onto the floor, causing water splashing to splash onto surrounding RTE processing equipment and near open RTE products sitting on the floor.
b. You did not sufficiently clean and sanitize your utensils and equipment, resulting in food residues and debris on the following equipment and utensils after cleaning and sanitation and prior to use in production, including but not limited to:
i. Metal tofu forming equipment (metal molds and presses) on February 27, 2025.
ii. Interior surfaces of holes in the white plastic boards used to help form RTE Soybean Curd on February 27, 2025.
iii. Interior surfaces of the pipe used to transfer soybeans to the Soy Processing Machine (Tofu Making Machine) on February 27, 2025, and interior and exterior surfaces of the conveyance pipe attached to the Soy Processing Machine (Tofu Making Machine) on March 7, 2025.
Furthermore, once you appropriately clean your utensils and equipment, you must appropriately sanitize them to maintain them in an adequate condition, in accordance with 21 CFR 117.80(c)(1). You must clean and sanitize in accordance with the chemical manufacturer’s directions for use, including appropriate concentrations.
i. On February 28, 2025, during sanitation, investigators observed an employee using a broom to push excess water from the bathroom toward drains located in the soy milk packaging area. This activity caused the water from the bathroom floor to be splashed onto the exterior clean, uncapped, bottles used to package the RTD soy milk.
ii. On March 14, 2025, investigators observed an employee cleaning the soy milk filter on the ground in the manufacturing area during production. The employee rinsed the filter under sink water and returned it to the filtering machine to process additional RTD Fresh Soy Milk (unsweetened) without sanitizing.
iii. On February 27, 28 and March 7, 2025, investigators observed employees disposing large amounts of gray-colored warewashing water onto the floor, causing water splashing to splash onto surrounding RTE processing equipment and near open RTE products sitting on the floor.
b. You did not sufficiently clean and sanitize your utensils and equipment, resulting in food residues and debris on the following equipment and utensils after cleaning and sanitation and prior to use in production, including but not limited to:
i. Metal tofu forming equipment (metal molds and presses) on February 27, 2025.
ii. Interior surfaces of holes in the white plastic boards used to help form RTE Soybean Curd on February 27, 2025.
iii. Interior surfaces of the pipe used to transfer soybeans to the Soy Processing Machine (Tofu Making Machine) on February 27, 2025, and interior and exterior surfaces of the conveyance pipe attached to the Soy Processing Machine (Tofu Making Machine) on March 7, 2025.
Furthermore, once you appropriately clean your utensils and equipment, you must appropriately sanitize them to maintain them in an adequate condition, in accordance with 21 CFR 117.80(c)(1). You must clean and sanitize in accordance with the chemical manufacturer’s directions for use, including appropriate concentrations.
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:
a. On February 28, 2025, an employee donned a pair of dirty green rubber gloves with residues, touched the interior of a pot, and then helped pour RTE soy liquid into the pot for manufacturing RTE fresh soybean pudding. Investigators later observed that these gloves were only rinsed with water and were not otherwise cleaned and sanitized.
b. On February 27, 2025, an employee removed a piece of trash from the dumpster outside of the facility, then returned to handling the clean and sanitized equipment used in the production of RTE soy products on February 28, 2025, without washing and sanitizing their hands.
c. On February 28, 2025, an employee with cuts and bandages on their hands and arms was observed manufacturing RTE soybean products.
d. On February 28, 2025, an employee used the end of a pencil with a build-up of residue and debris to operate the Soy Processing Machine (Tofu Making Machine), then returned to helping with the RTE soy product manufacturing without washing and sanitizing their hands. Investigators also observed that the pencil was positioned against the machine and hanging off of the operating panel, which also contained a build-up of food residue and debris.
4. You failed to provide adequate and readily accessible toilet facilities maintained in a sanitary condition, as required by 21 CFR 110.37(d). Specifically, on February 28 and March 7, 2025, investigators observed that the restroom had approximately (b)(4) inches of standing water pooling around the toilet. Investigators observed employees walking through the water in the restroom, then proceeding to the processing areas where RTE soy products are manufactured and packaged, and where food contact surfaces are washed (e.g. filter scrubbed on the floor).
5. 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:
a. On February 28, 2025, a coiled rope tied to a yellow bucket containing water on one end and to a pole/handle used to weigh down RTE Soybean Curds during forming. The rope was observed with residue and build-up, and investigators observed that these ropes were not cleaned during sanitation. Employees were observed handling the rope each time they formed a block of RTE Soybean Curds, then returning to handling other RTE Soybean Curds without washing and sanitizing their hands. b. On February 28, 2025, the top of a cut blue plastic water jug used as a funnel for the soybeans and water mixture prior to processing through the grinder of the Soy Processing Machine (Tofu Making Machine). Investigators observed divots and chips along the top rim of the plastic jug with residues and debris in them.
c. On February 27, 2025, the mesh filter used in direct contact with the soy milk during processing was beginning to deteriorate, exposing the underlying wire mesh and causing the screen material to break off. Investigators also observed that the exposed mesh was not easily cleanable and that food residue and debris remained trapped inside the holes in the mesh.
6. Your plant was not constructed in such a manner so that floors may be adequately cleaned and kept clean and kept in good repair, and that drip condensate from fixtures, ducts and pipes does not contaminate food and food-contact surfaces, as required by 21 CFR 117.20(b)(4). Specifically,
a. On February 28, 2025, investigators observed pitting and deterioration of the flooring throughout the processing and packaging room, and water pooling inside of the holes in the floor directly around the soy processing machine and the RTE Soybean Curd forming table.
b. On March 7, 2025, investigators observed condensation dripping from the ceiling onto several pieces of equipment, including metal forming molds used in the production of RTE Soybean Curd. You informed investigators that these pieces of equipment were cleaned, sanitized and ready for production on the following day.
7. You did not exclude pests from your food plant to protect against contamination of food, as required by 21 CFR 117.35(c). Specifically, investigators observed two apparent live cockroaches in the retail area, where ingredients and finished products are stored, and in the manufacturing room next to the Soy Processing Machine.
We acknowledge receipt of your response to the FDA-483 received by our office on April 3, 2025, which includes seven (7) photographs of clean containers of defoamer and vanilla, clean gloves and knives, and other utensils. Your FDA-483 response is not adequate because it does not address the majority of the findings, and does not indicate any changes to your manufacturing, processing, storage or distribution process, to your cleaning and sanitizing processes, or to your employee practices.
Misbranding
1. Your TAN NAM Fresh Soy Milk (No Sugar) product is misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that the product is fabricated 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,
During the inspection, our investigator was informed that your Fresh Soy Milk (No Sugar) product contains vanilla. As per the formulation observed during the manufacture of this product, the product is manufactured using vanilla; however, the product label fails to declare this ingredient in the ingredient statement as required by 21 CFR 101.4(a).
2. Your TAN NAM Fresh Soy Milk (No Sugar) product 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 added vanilla flavor is an artificial flavor and the label failed to declare the ingredient and that it contained an artificial flavor (21 CFR 101.22(c)).
3. Your TAN NAM Soybean Curd (Tofu), Fresh Soy Milk (No Sugar), and Fresh Soybean Pudding 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) is not in a correct format, as required by 21 CFR 101.9. For example,
The labels lack declaration for added sugars, as required by 21 CFR 101.9(c)(6)(iii).
The labels lack declaration for the required vitamins and minerals, vitamin D and potassium, as required by 21 CFR 101.9(c)(8)(ii).
The calorie declaration is not shown bolded and in larger print size, as required by 21 CFR 101.9(d)(1)(iii).
The footnote is not as required by 21 CFR 101.9(d)(9).
4. Your TAN NAM Fresh Soy Milk (No Sugar) and Soybean Curd (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. Specifically:
• Your Fresh Soy Milk (No Sugar) product declares “No Sugar.” During the inspection, our investigator was informed that the Fresh Soy Milk (No Sugar) product does not contain sugar; however, sugar is declared as an ingredient on the label.
• Your Soybean Curd (Tofu) product label declares salt; however, during the inspection, our investigator was informed that salt is no longer added to the product.
5. Your TAN NAM Soybean Curd (Tofu), Fresh Soy Milk (No Sugar), and Fresh Soybean Pudding products are misbranded within the meaning of section 403(f) of the Act [21 U.S.C. §343(f)]. Specifically, the label contains information in two foreign languages; therefore, all words, statements, and other information required by or under the Act must appear thereon in the foreign languages in accordance with 21 CFR 101.15(c)(2).
6. Your TAN NAM Fresh Soybean Pudding product is misbranded within the meaning of section 403(e)(2) of the Act [21 U.S.C. 343(e)(2)] in that the label fails to bear a declaration of the net quantity of contents as required in 21 CFR 101.7(a).
Failure to Register
We have determined that your facility has failed to register your facility. Your facility is subject to the registration requirement in section 415 of the Act [21 U.S.C. § 350d), and FDA's implementing regulation at 21 CFR Part 1, Subpart H [21 CFR 1.225 -1.243]. The failure to register a facility as required is a prohibited act under section 301(dd) of the Act [21 U.S.C. § 331(dd)]. Our records indicate that, to date, this facility has not been registered with FDA.
The owner, operator, or agent in charge of your facility, or an individual authorized by this facility's owner, operator, or agent in charge, must register the facility with FDA immediately.
Registration may be accomplished on-line at http://www.access.fda.gov. We strongly encourage the use of electronic registration because it will result in an automatic confirmation of registration and automatic issuance of a registration number.
Alternatively, the owner, operator or agent in charge of this facility, or an individual authorized by the facility's owner, operator, or agent in charge, may register the facility by mail or fax (e.g., if you do not have reasonable access to the Internet) using FDA's food facility registration form, Form 3537. This form may be obtained by calling the FDA industry Systems Help Desk at 1-800 216-7331 or 301-575-0156, or by writing to the agency at the following address:
U.S. Food and Drug Administration, HFS-681
5600 Fishers Lane
Rockville, MD 20857
When completed, the form may be faxed to (301) 436-2804 or mailed to the address above. FDA will process registrations submitted by mail or fax and provide a facility's registration number using the same method used to submit the registration to FDA.
The violations cited in this letter are not intended to be an all-inclusive list 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 facility 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 do so may result in legal action without further notice, including, without limitation, seizure, injunction, or administrative action for suspension of food facility registration if criteria and conditions warrant.
Please notify FDA in writing, within 15 working days of receipt of this letter, of the specific steps and corrections you have taken and 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 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 the Food and Drug Administration, Attention: Elodie X. Tong-Lin, 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 U.S.A. If you have any questions regarding any issues in this letter, please contact Elodie X. Tong-Lin via email at: Elodie.Tong-Lin@fda.hhs.gov. Please include reference #CMS 708292 on any submissions and within the subject line of any email correspondence to the agency.
Sincerely,
/S/
Maria S. Knirk, J.D., M.B.A.
Acting Director
Office of Enforcement
Office of Compliance and Enforcement
Human Foods Program
cc: Mr. Michael To, Owner/Founder
Michael2To@gmail.com
_______________________
a. On February 28, 2025, an employee donned a pair of dirty green rubber gloves with residues, touched the interior of a pot, and then helped pour RTE soy liquid into the pot for manufacturing RTE fresh soybean pudding. Investigators later observed that these gloves were only rinsed with water and were not otherwise cleaned and sanitized.
b. On February 27, 2025, an employee removed a piece of trash from the dumpster outside of the facility, then returned to handling the clean and sanitized equipment used in the production of RTE soy products on February 28, 2025, without washing and sanitizing their hands.
c. On February 28, 2025, an employee with cuts and bandages on their hands and arms was observed manufacturing RTE soybean products.
d. On February 28, 2025, an employee used the end of a pencil with a build-up of residue and debris to operate the Soy Processing Machine (Tofu Making Machine), then returned to helping with the RTE soy product manufacturing without washing and sanitizing their hands. Investigators also observed that the pencil was positioned against the machine and hanging off of the operating panel, which also contained a build-up of food residue and debris.
4. You failed to provide adequate and readily accessible toilet facilities maintained in a sanitary condition, as required by 21 CFR 110.37(d). Specifically, on February 28 and March 7, 2025, investigators observed that the restroom had approximately (b)(4) inches of standing water pooling around the toilet. Investigators observed employees walking through the water in the restroom, then proceeding to the processing areas where RTE soy products are manufactured and packaged, and where food contact surfaces are washed (e.g. filter scrubbed on the floor).
5. 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:
a. On February 28, 2025, a coiled rope tied to a yellow bucket containing water on one end and to a pole/handle used to weigh down RTE Soybean Curds during forming. The rope was observed with residue and build-up, and investigators observed that these ropes were not cleaned during sanitation. Employees were observed handling the rope each time they formed a block of RTE Soybean Curds, then returning to handling other RTE Soybean Curds without washing and sanitizing their hands. b. On February 28, 2025, the top of a cut blue plastic water jug used as a funnel for the soybeans and water mixture prior to processing through the grinder of the Soy Processing Machine (Tofu Making Machine). Investigators observed divots and chips along the top rim of the plastic jug with residues and debris in them.
c. On February 27, 2025, the mesh filter used in direct contact with the soy milk during processing was beginning to deteriorate, exposing the underlying wire mesh and causing the screen material to break off. Investigators also observed that the exposed mesh was not easily cleanable and that food residue and debris remained trapped inside the holes in the mesh.
6. Your plant was not constructed in such a manner so that floors may be adequately cleaned and kept clean and kept in good repair, and that drip condensate from fixtures, ducts and pipes does not contaminate food and food-contact surfaces, as required by 21 CFR 117.20(b)(4). Specifically,
a. On February 28, 2025, investigators observed pitting and deterioration of the flooring throughout the processing and packaging room, and water pooling inside of the holes in the floor directly around the soy processing machine and the RTE Soybean Curd forming table.
b. On March 7, 2025, investigators observed condensation dripping from the ceiling onto several pieces of equipment, including metal forming molds used in the production of RTE Soybean Curd. You informed investigators that these pieces of equipment were cleaned, sanitized and ready for production on the following day.
7. You did not exclude pests from your food plant to protect against contamination of food, as required by 21 CFR 117.35(c). Specifically, investigators observed two apparent live cockroaches in the retail area, where ingredients and finished products are stored, and in the manufacturing room next to the Soy Processing Machine.
We acknowledge receipt of your response to the FDA-483 received by our office on April 3, 2025, which includes seven (7) photographs of clean containers of defoamer and vanilla, clean gloves and knives, and other utensils. Your FDA-483 response is not adequate because it does not address the majority of the findings, and does not indicate any changes to your manufacturing, processing, storage or distribution process, to your cleaning and sanitizing processes, or to your employee practices.
Misbranding
1. Your TAN NAM Fresh Soy Milk (No Sugar) product is misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that the product is fabricated 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,
During the inspection, our investigator was informed that your Fresh Soy Milk (No Sugar) product contains vanilla. As per the formulation observed during the manufacture of this product, the product is manufactured using vanilla; however, the product label fails to declare this ingredient in the ingredient statement as required by 21 CFR 101.4(a).
2. Your TAN NAM Fresh Soy Milk (No Sugar) product 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 added vanilla flavor is an artificial flavor and the label failed to declare the ingredient and that it contained an artificial flavor (21 CFR 101.22(c)).
3. Your TAN NAM Soybean Curd (Tofu), Fresh Soy Milk (No Sugar), and Fresh Soybean Pudding 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) is not in a correct format, as required by 21 CFR 101.9. For example,
The labels lack declaration for added sugars, as required by 21 CFR 101.9(c)(6)(iii).
The labels lack declaration for the required vitamins and minerals, vitamin D and potassium, as required by 21 CFR 101.9(c)(8)(ii).
The calorie declaration is not shown bolded and in larger print size, as required by 21 CFR 101.9(d)(1)(iii).
The footnote is not as required by 21 CFR 101.9(d)(9).
4. Your TAN NAM Fresh Soy Milk (No Sugar) and Soybean Curd (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. Specifically:
• Your Fresh Soy Milk (No Sugar) product declares “No Sugar.” During the inspection, our investigator was informed that the Fresh Soy Milk (No Sugar) product does not contain sugar; however, sugar is declared as an ingredient on the label.
• Your Soybean Curd (Tofu) product label declares salt; however, during the inspection, our investigator was informed that salt is no longer added to the product.
5. Your TAN NAM Soybean Curd (Tofu), Fresh Soy Milk (No Sugar), and Fresh Soybean Pudding products are misbranded within the meaning of section 403(f) of the Act [21 U.S.C. §343(f)]. Specifically, the label contains information in two foreign languages; therefore, all words, statements, and other information required by or under the Act must appear thereon in the foreign languages in accordance with 21 CFR 101.15(c)(2).
6. Your TAN NAM Fresh Soybean Pudding product is misbranded within the meaning of section 403(e)(2) of the Act [21 U.S.C. 343(e)(2)] in that the label fails to bear a declaration of the net quantity of contents as required in 21 CFR 101.7(a).
Failure to Register
We have determined that your facility has failed to register your facility. Your facility is subject to the registration requirement in section 415 of the Act [21 U.S.C. § 350d), and FDA's implementing regulation at 21 CFR Part 1, Subpart H [21 CFR 1.225 -1.243]. The failure to register a facility as required is a prohibited act under section 301(dd) of the Act [21 U.S.C. § 331(dd)]. Our records indicate that, to date, this facility has not been registered with FDA.
The owner, operator, or agent in charge of your facility, or an individual authorized by this facility's owner, operator, or agent in charge, must register the facility with FDA immediately.
Registration may be accomplished on-line at http://www.access.fda.gov. We strongly encourage the use of electronic registration because it will result in an automatic confirmation of registration and automatic issuance of a registration number.
Alternatively, the owner, operator or agent in charge of this facility, or an individual authorized by the facility's owner, operator, or agent in charge, may register the facility by mail or fax (e.g., if you do not have reasonable access to the Internet) using FDA's food facility registration form, Form 3537. This form may be obtained by calling the FDA industry Systems Help Desk at 1-800 216-7331 or 301-575-0156, or by writing to the agency at the following address:
U.S. Food and Drug Administration, HFS-681
5600 Fishers Lane
Rockville, MD 20857
When completed, the form may be faxed to (301) 436-2804 or mailed to the address above. FDA will process registrations submitted by mail or fax and provide a facility's registration number using the same method used to submit the registration to FDA.
The violations cited in this letter are not intended to be an all-inclusive list 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 facility 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 do so may result in legal action without further notice, including, without limitation, seizure, injunction, or administrative action for suspension of food facility registration if criteria and conditions warrant.
Please notify FDA in writing, within 15 working days of receipt of this letter, of the specific steps and corrections you have taken and 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 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 the Food and Drug Administration, Attention: Elodie X. Tong-Lin, 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 U.S.A. If you have any questions regarding any issues in this letter, please contact Elodie X. Tong-Lin via email at: Elodie.Tong-Lin@fda.hhs.gov. Please include reference #CMS 708292 on any submissions and within the subject line of any email correspondence to the agency.
Sincerely,
/S/
Maria S. Knirk, J.D., M.B.A.
Acting Director
Office of Enforcement
Office of Compliance and Enforcement
Human Foods Program
cc: Mr. Michael To, Owner/Founder
Michael2To@gmail.com
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