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WARNING LETTER

FY 18 - HAFE6 -07

VIA UPS 

July 19, 2018

 

Mr. Steven Seeto, Owner

Fortune Food Product Inc.

1821 S. Canalport Ave. Chicago, IL 60616-1027

 

 

Dear Mr. Steven Seeto:

 

The U.S. Food and Drug Administration (FDA) inspected your sprouting operation; and your tofu product and soybean noodle manufacturing operation located at 1821 S. Canalport Ave, Chicago IL 60616, from January 10, 2018 through February 1, 2018.  That inspection revealed serious violations of the Produce Safety regulation, Title 21, Code of Federal Regulations, Part 112 (21 CFR 112) and the Current Good Manufacturing Practice regulation (CGMPs), Title 21, Code of Federal Regulations, Part 110 (21 CFR 110). Your operation is a farm mixed-type facility because your sprout growing operation is within the definition of a farm and your tofu manufacturing operations are within the definition of a facility (see 21 CFR 1.227). Your farm is subject to Part 112 and your facility is subject to Part 110.  

 

The violations included significant evidence of rodent activity and insanitary conditions and practices in your farm mixed-type facility.  Additionally, during this inspection FDA collected a sample that documented rodent evidence throughout the farm mixed-type facility. Based on these findings, we have determined that your mung bean sprouts, tofu products, and soybean noodle 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 have been 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.  Further, your yellow tofu, spicy tofu, fried tofu pouches/triangles, and soybean noodle products are misbranded under section 403 of the Act [21 U.S.C. § 343], in that these products do not comply with the labeling requirements in 21 CFR 101. You can find the Act and its implementing regulations on the internet through links on the FDA web page at www.fda.gov. 

 

The inspection resulted in FDA’s issuance of a Form FDA-483, Inspectional Observations, listing the deviations found at your sprouting, tofu and soybean noodle operation at the conclusion of the inspection. We acknowledge receipt of your firm’s response on February 23, 2018 which included corrective actions you have implemented or plan to implement in response to the observations noted on the FDA-483. These corrective actions are addressed further below in this correspondence.

 

As mentioned above, your firm is subject to and in violation Section 419 of the Act [21 U.S.C. § 350h] and its implementing regulation in 21 CFR Part 112 (the Produce Safety Rule), in addition to the CGMP regulation (21 CFR 110).  The Produce Safety Rule specifically requires subject producers of covered produce to implement procedures, processes and practices that are reasonably necessary to prevent the introduction of known or reasonably foreseeable hazards, and to provide assurances that the produce is not adulterated under section 402 of the Act [21 U.S.C. § 342].  The findings described in this letter demonstrate your farm mixed-type facility’s sanitation problems and non-compliance with 21 CFR 112. It is a prohibited act under section 301(vv) of the Act [21 U.S.C. § 331(vv)], for the owner, operator, or agent in charge of an entity that produces or harvests covered raw agricultural commodities for sale in the United States to violate Section 419 of the Act, as implemented in 21 CFR Part 112. You can find the Act  and FDA's regulations through links in FDA's home page at http://www.fda.gov. In addition, Draft Guidance for Industry Compliance with and Recommendations for Implementation of the Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption for Sprout Operations is available here https://www.fda.gov/downloads/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/UCM537031.pdf.   

 

Produce Safety Rule Violations:

 

1.  You must handle harvested produce in a manner that protects against contamination with known or reasonably foreseeable hazards to comply with 21 CFR 112.113. However, our investigator observed an employee harvesting mung bean sprouts (which had fallen to the floor where employees were walking) and shoveling the sprouts directly to the (b)(4). The employee then used the same shovel to harvest mung bean sprouts from the harvest vessel. Production floors are known harborage sites for bacteria, including bacterial pathogens such as Listeria monocytogenes. Additionally, rodent activity was observed in various parts of your operation, including the adjacent tofu processing room. Pests and their filth, in conjunction with movement of workers and equipment, constitute likely sources and routes of contamination.

 

In your response dated February 22, 2018, you state that you will train all employees on aseptic technique and good manufacturing practices and that you are developing a written training schedule to be implemented immediately. However, you did not provide documentation, such as training agendas or certificates of completion. You also did not address how you will prevent the harvesting of sprouts from the floor.

 

2.  You must use equipment and tools that are of adequate design, construction, and workmanship to enable them to be adequately cleaned and maintained, to comply with 21 CFR 112.123(a). However, our investigator observed sprouts trapped in the gaps created by the separation between the (b)(4) and (b)(4) in the sprout (b)(4), after you stated that the (b)(4) was cleaned. There was also rough welding on the (b)(4) and (b)(4) in the sprout (b)(4). These conditions make proper cleaning and sanitization of the (b)(4) difficult. The sprout (b)(4) is used to rinse sprouts before they are placed into final packaging.

 

Your response letter dated February 22, 2018, states that you have implemented an environmental monitoring program to determine if your sprout (b)(4) equipment can be adequately cleaned and maintained. While environmental monitoring must be designed to identify L. monocytogenes if it is present in your environment and will help determine whether your cleaning and sanitizing measures are effective, sampling is not a substitute for adequate design, construction and workmanship to enable the equipment and tools used in food production to be properly cleaned and sanitized.  You add that the (b)(4) will be tested (b)(4), and that equipment found to be faulty will be repaired or replaced. Equipment you use to produce your mung bean sprouts should be maintained in good repair to enable adequate cleaning and sanitization of the equipment.  We also note that 21 CFR 112.144(a) and 112.145(c)(2) require environmental sampling be conducted during production, and testing the (b)(4) does not meet the requirement to test the environment “during production”.  Please also see number 4, below.

 

3.  You must adequately maintain agricultural water distribution systems to prevent water distribution systems from being a source of contamination to comply with 21 CFR 112.42(b). However, the hose that delivers water to your sprout irrigation system had holes patched with tape which appeared to be falling apart. You then explained that you had never inspected your water system to identify conditions that are likely to introduce hazards to your sprout operations.

 

Your response letter dated February 22, 2018, states that you have implemented a maintenance schedule and that repairs will be made and records kept. You also mention that you were waiting for a reply from the supplier for replacement parts. No documentation of maintenance or repairs was submitted.

 

4.  You must test the growing, harvesting, packing, and holding environment for Listeria species or L. monocytogenes to comply with 21 CFR 112.144(a). However, you have not collected environmental sampling of your mung bean sprout growing, harvesting, packing, and holding environment. We collected environmental samples of your operation and found Listeria welshimeri in the bristles of a broom, located in the sprout production room.

 

In your response dated February 22, 2018, you provided your newly implemented environmental sampling program. You did not provide documentation of implementation, such as collection records or sampling results showing your implementation of environmental sampling in your operation.

 

5.  You must take those measures reasonably necessary to protect covered produce, food contact surfaces, and food-packing materials from contamination by pests in buildings, including routine monitoring for pests as necessary and appropriate, to comply with 21 CFR 112.128(a). However, we observed rodent activity throughout your operation. Specifically, we witnessed live rodents and found rodent excreta pellets throughout the raw storage room, where mung beans and soybeans are stored.

 

Your response dated February 22, 2018, states that you have implemented a cleaning and sanitization schedule and have initiated upgrades and repairs to your operation to prevent pest entry. You also stated that you have (b)(4). Other than a photo of pallets (b)(4) by (b)(4), you did not submit any documentation showing repairs or pest control reports showing pest activity levels. Also see number 1, below, in the CGMP violations section of this letter.

 

CGMP Violations:

 

1.  You must also take effective measures to exclude pests from the manufacturing, processing, packing, and holding areas and to protect against the contamination of food on the premises by pests, to comply with 21 CFR 110.35(c). In the tofu production area, we witnessed a live rodent cross the production floor and found rodent excreta pellets near water tank #1. All your tofu and soybean noodles are manufactured in this area. Additionally, while cleaning the (b)(4) you use to store yellow tofu after dehydrating, you placed the (b)(4) directly onto this processing room floor. We also observed live cockroaches on the (b)(4) hinges, inside of the (b)(4) used to dehydrate uncovered spicy and yellow tofu.

 

Your response dated February 22, 2018, states that you have implemented a cleaning and sanitization schedule and have initiated upgrades and repairs to your operation to prevent pest entry. You also stated that you have (b)(4). Other than a photo of pallets (b)(4) by (b)(4), you did not submit any documentation showing repairs or pest control reports showing pest activity levels.

 

2.  You must provide hand washing facilities that are adequate and convenient to comply with 21 CFR 110.37(e). Compliance with this requirement may be accomplished by providing effective hand-washing and sanitizing preparations and sanitary towel service or suitable drying devices. However, the handwashing sinks in the tofu production room lacked soap and hand towels. Your firm’s employees were observed using their bare hands to pack spicy tofu into clear plastic bags.

 

Your response letter dated February 22, 2018, did not address the failure to provide soap and towels at the tofu production room hand washing stations.

 

3.  Cleaning and sanitizing of utensils and equipment must be conducted in a manner that protects against contamination of food, food-contact surfaces, or food-packaging materials, to comply with 21 CFR 110.35(a). However, (b)(4) you use to store yellow tofu after dehydrating, were seen placed directly onto the processing room floor during the rinse step in the post sanitation process. Employees coming from various sections of the facility walk on this floor (including in the tofu processing area) and rodent activity was seen on this floor, during the inspection.

 

Your response dated February 22, 2018, states that you have implemented a cleaning and sanitization schedule, and have retrained employees on aseptic technique and GMPs. However, you did not provide a description of the changes made to your cleaning and sanitizing procedures, or how your training addressed the need to protect clean equipment from contact with the floor.

 

Misbranding Violations:

 

During our inspection, we reviewed the labeling of your yellow tofu, spicy tofu, fried tofu pouches/triangles, and soybean noodle products and determined that these products are misbranded foods under section 403 of the Act [21 U.S.C. § 343] in that the labels for these products do not comply with the labeling requirements in 21 CFR 101.

 

1.  Your Yellow Tofu, Spicy Tofu, Fried Tofu pouches, and Soybean Noodle products are misbranded within the meaning of Section 403(q) of the Act [21 U.S.C. 343(q)] in that the nutrition facts information is not in an appropriate format as defined in 21 CFR 101.9. Specifically,

 

Yellow Tofu

• There is no declaration of the amount of trans fat present in the product in accordance with 21 CFR 101.9(c)(2)(ii).
• For the yellow tofu, based on the declared net weight of 340 g, the visual unit of measure for the serving size declaration is not accurate. The reference amount for tofu is 85g, and the label declares “3 oz. (84g/about 1/3 package).” However, a third of the package would be approximately 113g. One-fourth may be a more accurate representation. 21 CFR 101.9(b)(5).
• Based on the net weight declaration of 340 g, the servings per package declaration of “3” is not accurate. 21 CFR 101.9(b)(8).
• “Servings Per Package” must be “Servings Per Container” in accordance with 21 CFR 101.9(d)(3).

Spicy Tofu

• There is no declaration of the amount of trans fat present in the product in accordance with 21 CFR 101.9(c)(2)(ii).
• “Servings Per Package” must be “Servings Per Container” in accordance with 21 CFR 101.9(d)(3).

Fried Tofu Pouches 

• There is no declaration of the amount of trans fat present in the product in accordance with 21 CFR 101.9(c)(2)(ii).
• The serving size is declared as “5 pouches (78g/ about 1 ½ package).” However, the serving size is not in accordance with 21 CFR 101.9(b)(6), which requires that a product that is packaged and sold individually and that contains less than 200 percent of the applicable reference amount shall be considered to be a single-serving container, and the entire content of the product shall be labeled as one serving. The RACC for tofu is 85 g. The net weight of the package is 113g. Therefore, the package contains less than 200 percent of the reference amount and is a single-serving container. We note that all of the nutrition information is incorrect because it is based on the wrong serving size.
• “Servings Per Package” must be “Servings Per Container” in accordance with 21 CFR 101.9(d)(3). However, we note that this information is not required for single serving containers when this information is stated in the net quantity of contents declaration.

Soybean Noodle

• There is no declaration of the amount of trans fat present in the product in accordance with 21 CFR 101.9(c)(2)(ii).
• The serving size is declared as “3 oz. (84g/about 1/3 package).” However, the serving size is not in accordance with 21 CFR 101.9(b)(2) and 21 CFR 101.12(b), Table 2, product category “Pastas, plain 140 g prepared; 55 dry.” Based on label statements, it appears the food is prepared rather than dry, but in either case, the serving size is not based on the appropriate RACC. Therefore, the nutrition information is also incorrect.
• “Servings Per Package” must be “Servings Per Container” in accordance with 21 CFR 101.9(d)(3).

2.  Your Yellow Tofu, Spicy Tofu, Fried Tofu pouches/triangles, and Soybean Noodle products are misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] because they are fabricated from two or more ingredients, but the labels fail to bear an accurate list of all the ingredients by common or usual name in descending order of predominance by weight as well as all sub-ingredients, as required by 21 CFR 101.4. For example,

• Your Yellow Tofu product label fails to declare calcium sulfate as  an ingredient per an employee of your firm, this ingredient is used in the manufacturing of this product.
• Your Spicy Tofu product label fails to declare, molasses, calcium sulfate, and glucono delta lactone as ingredients; per an employee of your firm, these ingredients are used in the manufacturing of this product.
• Your Fried Tofu pouches/triangles product labels fail to declare calcium sulfate and glucono delta lactone as ingredients; per an employee of your firm, these ingredients are used in the manufacturing of this product.
• Your Soybean Noodle product label fails to declare calcium sulfate and glucono delta lactone as ingredients; per an employee of your firm, these ingredients are used in the manufacturing of this product. In addition, based on the information provided by your firm, the product is not made with vegetable oil, but vegetable shortening instead.

3.  Your Yellow Tofu, Spicy Tofu, Fried Tofu pouches/triangles, and Soybean Noodle products are misbranded within the meaning of Section 403(f) of the Act [21 U.S.C. 343(f)] because the product labels declare information in a foreign language but fail to provide all required information in that foreign language. In accordance with 21 CFR 101.15(c), if a product label contains any representation in a foreign language or foreign characters, all words, statements, and other information required by or under authority of the Act to appear on the label must appear in the foreign language. Specifically, the nutrition information is not provided in the foreign language.

 

We have reviewed your response letter dated February 22, 2018. The response did not include any information regarding labels or labeling. You did not provide corrected labels.

 

We have determined that your farm mixed-type facility is subject to the registration requirement in § 415 of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 350d, and our implementing regulation at 21 CFR Part 1, Subpart H. (b)(3)(A). The failure to register a facility as required is a prohibited act under § 301(dd) of the Act, 21 U.S.C. § 331(dd). (b)(3)(A).

 

(b)(3)(A)

 

This letter may not list all the violations at your operation. You are responsible for ensuring that your processing plant operates in compliance with the Act, labeling regulations (21 CFR 101), Current Good Manufacturing Practice regulation (21 CFR Part 110), and the Produce Safety regulation (21 CFR Part 112). You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations.

 

We may take further action if you do not promptly correct these violations.  For instance, we may take further action to seize your product(s) and/or enjoin your firm from operating.

We offer the following comments:

• During our inspection, you stated that you did not use a seed treatment on your mung beans prior to sprouting. In your response dated February 22, 2018, you state that you now treat your mung beans with (b)(4). You also submitted a document titled “SANITARY CERTIFICATE” which includes a statement that the subject seed lot was tested by (b)(4) and determined negative for Salmonella, Listeria monocytogenes, and E. coli O157, and referred to the provision allowing sprout growers to rely on prior treatment of seeds to fulfill this requirement. The document you provided is not a Certificate of Conformance, as permitted under 21 CFR 112.142(e)(2) because it does not indicate that the seeds have been treated for pathogen reduction using a scientifically valid method to reduce microorganisms of public health significance prior to your receiving them, and it does not state that treated mung bean seeds were handled and packaged following the treatment in a manner that minimizes the potential for contamination. Furthermore, a tag found on the bags of mung beans indicates that the seeds have not been subject to any treatment. 21 CFR 112.142(e)(1) requires that you must treat your seeds for sprouting with a scientifically valid method to reduce microorganisms of public health significance. Based on your response, we cannot evaluate whether you have adequately implemented a seed treatment. If you have, we request more information about your seed treatment process, including documentation of your scientifically valid treatment of mung bean seeds to reduce microorganisms of public health significance in the mung bean seeds. A “scientifically valid” method is an approach that is based on scientific information, data, or results published in, for example, scientific journals, references, text books, or proprietary research.
• During our inspection, an employee who oversees your operation stated that your firm did not conduct any training of your sprout operation employees.  21 CFR 112.21(a) requires that you provide adequate training at sufficient frequency to all personnel who handle covered produce or food contact surfaces. In your response letter dated February 22, 2018, you state that you will be implementing training soon. Additionally, you provided a training record for training in the use of hairnets and gloves. You did not provide any other evidence such as a training schedule, training logs, or training forms to indicate additional necessary training will be taking place.

You should respond in writing within fifteen (15) working days from your receipt of this letter.  Your response should outline the specific things you are doing to correct these violations.  You should include in your response documentation, such as photographs verifying corrections, environmental monitoring records and sampling results, pest control records, training records, work orders for equipment and repairs, sanitation and maintenance procedures and schedules, and labels or labeling.  If you cannot complete all corrections before you respond, you should explain the reason for your delay and state when you will correct any remaining violations. We will verify the adequacy of your corrective actions during our next inspection of your operation. If you do not believe that your products are 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:  Lauren Crivellone, 550 W. Jackson Blvd, Chicago, IL 60661.  If you have questions regarding any issues in this letter, please contact Ms. Crivellone at (312) 596-4157 or via email at Lauren.Crivellone@fda.hhs.gov.

 

Sincerely,

/S/

William R. Weissinger, MS

Chicago District Director

Division of Human and Animal Food

Operations Division 6 East