| Public Health Service Food and Drug Administration |
San Francisco District |
Department of Health and Human ServicesWARNING LETTER
VIA UPS OVERNIGHT
SIGNATURE REQUIRED
Our Reference: 3004158971
July 6, 2011
Ai Hwa Huang, President/Owner
Sogo Foods Inc.
1610 S. De Anza Blvd.
San Jose, CA 95129-4608
Dear Mrs. Huang:
On September 29, September 30, and October 5, 2010, the U.S. Food and Drug Administration (FDA) conducted an inspection of your food manufacturing facility located at 1610 S. De Anza Blvd, San Jose, California. The inspection revealed that your Organic Sweetened Soy Bean Drink and Plain Pressed Tofu products are misbranded within the meaning of section 403 of the Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. § 343). Regulations implementing the food labeling requirements of the Act are found, in part, in Title 21, Code of Federal Regulations, Part 101 (21 CFR Part 101). Additionally, your products are adulterated within the meaning of section 402 of the Act (21 U.S.C. § 342) 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 heath. Current good manufacturing practice regulations for food are found in Title 21, Code of Federal Regulations, Part 110 (21 CFR 110). The Act and its implementing regulations can be found on FDA's webpage at www.FDA.gov.
Labeling
During the inspection of your firm, it was observed that you fail to label your Organic Sweetened Soy Bean Drink and Plain Pressed Tofu products. The labeling that was collected was not placed on the actual retail packaged products, but only on the refrigerator doors located at your retail store at the point of sale. Section 201(m) of the Act (21 U.S.C. 321(m)) defines “labeling” to mean all labels and other written, printed, or graphic matter (1) upon any article or any of its containers or wrappers, or (2) accompanying such article. Section 201(p) of the Act (21 U.S.C. 321(p)) defines the term “label” to mean a display of written, printed, or graphic matter upon the immediate container of an article. Under section 201(p) of the Act (21 U.S.C. 321(p)), a requirement made by or under the authority of the Act that any word, statement, or other information appear on the label shall not be considered to be complied with unless it appears on the outside container or wrapper, if any there be, of the retail package, or is easily legible through the outside container or wrapper.
Your Organic Sweetened Soy Bean Drink and Plain Pressed Tofu products are misbranded within the meaning of section 403(w) of the Act (21 U.S.C. 343(w)) in that the major food allergen, soy, is not declared on a package label in accordance with section 403(w)(1) of the Act.
Section 201(qq) of the Act (21 U.S.C. 321(qq)) defines milk, egg, fish, Crustacean shellfish, tree nuts, wheat, peanuts, and soybeans, as well as any food ingredient that contains protein derived from one of these foods, with the exception of highly refined oils, as "major food allergens." A food is misbranded if it is not a raw agricultural commodity and it is, or it contains an ingredient that bears or contains, a major food allergen, unless either:
• The word "Contains," followed by the name of the food source from which the major food allergen is derived, is printed immediately after or adjacent to the list of ingredients, section 403(w)(1)(A) of the Act (21 U.S.C. 343(w)(1)(A)), or
• The common or usual name of the major food allergen in the list of ingredients is followed in parentheses by the name of the food source from which the major food allergen is derived (e.g. “(wheat)”), except that the name of the food source is not required when either the common or usual name of the ingredient uses the name of the food source or the name of the food source appears elsewhere in the ingredient list (unless the name of the food source that appears elsewhere in the ingredient list appears as part of the name of an ingredient that is not a major food allergen), section 403(w)(1)(B) of the Act (21 U.S.C. 343(w)(1)(B)).
Your Organic Sweetened Soy Bean Drink product is misbranded within the meaning of 403(r)(1)(A) of the Act (21 U.S.C. § 343(r)(1)(A)), because the product labeling bears nutrient content claims but do not meet the requirements for the claims. Under section 403(r)(1)(A) of the Act, a claim that characterizes the level of any nutrient which is of the type required to be in the labeling of the food must be made in accordance with a regulation promulgated by the Secretary (or by delegation, FDA) authorizing the use of such a claim. Characterizing the level of a nutrient in food labeling of a product without complying with the specific requirements pertaining to nutrient content claims for that nutrient misbrands the product under section 403(r)(1)(A) of the Act.
Specifically, your product bears the claim, “High Protein.” To qualify as a “high” source, the food must contain 20 percent or more of the Reference Daily Intake (RDI) or the Daily Reference Value (DRV) per Reference Amount Customarily Consumed (RACC). The RACC for a beverage is 8 fl oz (21 CFR 101.12(b)). Protein claims are based on the percent daily value (%DV) as corrected for protein quality (21 CFR 101.9(c)(7)(i)). At minimum a product must contain 10g of protein per RACC to qualify as a “high” protein source, based on a 50g DRV for protein (21 CFR 101.9(c)(7)(iii)). Your product states that it contains 7g of protein. Assuming this value is corrected for protein quality, your product contains no more than 14% DV of protein. Therefore, your product does not meet the requirements for a “high” protein nutrient content claim as defined in 21 CFR 101.54(b).
Additionally, the labeling for your product bears the claim, “Low Calorie.” A “low calorie” claim may be made if a food has a RACC greater than 30g or greater than 2 tablespoons and does not provide more than 40 calories per RACC (21 CFR 101.60(b)(2)(i)(A)). According to your labeling, your product contains 130 calories; therefore your product does not meet the requirement of a “low calorie” food.
Your Organic Sweetened Soy Bean Drink and Plain Pressed Tofu products are also misbranded within the meaning of section 403(i)(1) of the Act (21 U.S.C. § 343(i)(1)), because your products fail to bear a label with a statement of identity as required by 21 CFR 101.3.
Your Organic Sweetened Soy Bean Drink and Plain Pressed Tofu products are also misbranded within the meaning of 403(i)(2) of the Act (21 U.S.C. § 343(i)(2)) because they are fabricated from two or more ingredients and they fail to bear a label that list the common or usual name of each ingredient. Additionally, during the inspection, one of the firm’s employees was observed adding sugar to your Organic Sweetened Soy Bean Drink product; however, the finished product label does not declare sugar as an ingredient.
Your Organic Sweetened Soy Bean Drink and Plain Pressed Tofu products are misbranded within the meaning of section 403(e) of the Act (21 U.S.C. § 343(e)) in that the packages do not bear a label with the name and place of business of the manufacturer, packer, or distributor in accordance with 21 CFR 101.5; and they fail to bear an accurate statement of the net quantity of contents in terms of weight, measure, or numerical count as required by 21 CFR 101.105.
Your Organic Sweetened Soy Bean Drink and Plain Pressed Tofu products are further misbranded within the meaning of Section 403(q) of the Act (21 U.S.C. § 343(q)) because they fail to bear nutrition information on the package label specified in 21 CFR 101.9. However, even if the labeling you place at point of purchase were on your product, the nutrition information would not be declared in accordance with 21 CFR 101.9. For example:
• Organic Sweetened Soy Bean Drink:
o The serving size declaration for this product, "1 cup" is not expressed in the proper common household measure for a beverage in accordance with 21 CFR 101.9(b) and 21 CFR 101.12(b).The proper serving size statement is "8 fl oz (240mL)” for your product.
o The Trans fat content is not declared as required (21 CFR 101.9(c)(2)(ii)).
o The %DV for protein is not declared as required (21 CFR 101.9(c)(7)(i)). While this information is not required for all products, it is required when a product bears a protein claim.
• Plain Pressed Tofu:
o The protein content is not declared as required (21 CFR 101.9(c)(7)).
o A %DV for Trans fat is improperly declared. There is no established daily value for the Trans fat; therefore a product should not contain a %DV for the nutrient.
o The nutrition facts are not formatted in accordance with 21 CFR 101.9(d).
CGMP
We found significant violations of the Current Good Manufacturing Practice (CGMP) regulations for food, Title 21, Code of Federal Regulations, Part 110 (21 CFR 110).
Processes and controls:
1. All reasonable precautions must be taken to ensure that production procedures do not contribute contamination from any source, as required by 21 CFR 110.80.
a. On September 29, 2010, our investigators observed (b)(4) being used as processing devices in the manufacturing of tofu. An employee was observed directly touching the (b)(4) handles with his bare hands and in between handling the (b)(4) and directly contacting in-process tofu. One of the (b)(4), a " (b)(4)," was observed to leak oily substances on its sides.
We acknowledge your response letter, which states that gloves for (b)(4) have been prepared. However, this does not fully address the above noted violation. Your response letter did not address the leak of oily substance that could contaminate the food. Also, a similar observation had been made during a previous inspection of your facility (April 2009).
b. On September 29, 2010, our investigators observed that an employee placed a strainer directly onto the production floor, in close proximity to a floor drain, and proceeded to use the strainer for filtering the liquid from a bucket of soybeans while sitting on the floor. Then, the employee picked up the strainer, allowed the liquid to be filtered off, poured the remaining soybeans into a hopper, and then placed the bottom of the strainer directly on top of the soybeans. Your firm uses these soybeans as a main ingredient in your soy milk and tofu products.
We acknowledge your response letter, which states that you have warned your employee not to place the strainer on the ground and pour off the remaining soybeans from the container. We will verify that this insanitary production procedure has been corrected during our next inspection.
2. Equipment and utensils and finished food containers must be maintained in an acceptable condition through appropriate cleaning and sanitizing, as necessary, as required by 21 CFR 110.80(b). However, our investigators observed the appearance of leftover tofu matter in one of the holes of the tofu press boards. This observation was made after cleaning had been performed.
We acknowledge your response letter, which states that you have replaced the cutting board used to press tofu to ensure there are no more holes in it. During the inspection, our investigator observed several cutting boards with holes in them. Your response mentions one cutting board was replaced. However, it does not address how you will prevent the problem for all of your firm’s perforated cutting boards used to press tofu. Your response does not address how you will ensure effective cleaning and sanitizing of your equipment and utensils.
Personnel:
3. All persons working in direct contact with food, food-contact surfaces, and food-packaging materials must conform to hygienic practices while on duty to the extent necessary to protect against contamination of food, as required by 21 CFR 110.10(b).
a. One method for maintaining cleanliness is for employees to wear outer garments suitable to the operation in a manner that protects against the contamination of food, food-contact surfaces, or food-packaging materials (21 CFR 110.10(b)(1)). However, our investigators observed employees’ soiled aprons directly touching the food and food contact surfaces while the employees were handling in-process tofu.
The employees wore these same aprons in between tasks of performing sanitation duties, touching trash receptacles, and handling in-process product.
We acknowledge your response letter stating that you have evaluated the existing working procedures of making tofu and provided modification of the procedures to minimize the chance of the employee’s apron in touching the food product; however, you have not addressed the problem that your employees wear soiled aprons during processing. We recommend that employees change their aprons once they have become heavily soiled to avoid product contamination.
b. Another method for maintaining cleanliness is to wash hands thoroughly and sanitize, as necessary, in an adequate hand-washing facility before starting work, after each absence from the work station, and at any other time when the hands may have become soiled or contaminated (21 CFR 110.10(b)(3)). However, on September 29, 2010, our investigators observed several employees performing multiple tasks between sanitation operations and directly contacting in-process food without properly washing their hands. As examples, one employee had just taken out the trash, used only water without soap or sanitizer, and then proceeded to directly handle processed tofu skins with bare hands. One employee was observed to scratch his forearm with ungloved hands, touch the trash, perform another task, and then, without washing and sanitizing his hands, directly handle ready to eat tofu skins. Moreover, four employees were observed returning from lunch break, only rinsing their hands with water without using soap or sanitizer, and then proceeding to begin work, processing food.
We acknowledge your response letter stating that employees received one-on-one training to wash their hands by applying soap and rubbing their hands under running water for more than 20 seconds, that you are requiring them to wash their hands before preparing food, and that you will advise them every two weeks. However, you have not fully addressed the above noted violation and ensured that the problem will not recur. You have not addressed the need for employees to wash their hands before resuming food preparation if, during food preparation, they touch items such as trash.
c. A third method for maintaining cleanliness is for employees to wear hair nets or other hair restraints where appropriate (21 CFR 110.10(b)(6)). However, on September 29, 2010, our investigators observed approximately four employees without hair restraints while working. One employee in particular was manufacturing tofu skins and cutting ready-to-eat tofu.
We acknowledge your response letter stating that employees are required to wear hair nets or hats when they enter the food processing area and that you will personally enforce this. We will verify your corrections during our next inspection. Similar observations of poor employee hygienic practices have been made in a previous inspection of your facility (April 2009).
d. Another method for maintaining cleanliness is to confine the following activities to areas other than where food may be exposed or where equipment or utensils are washed: eating food, chewing gum, drinking beverages, or using tobacco (21 CFR 110.10(b)(8)). However, on September 29, 2010, our investigators observed an employee drinking a beverage while processing tofu.
We acknowledge your response letter stating that drinks are not allowed in the food processing area anymore. We will verify this during our next inspection. Similar observations of poor employee hygienic practices have been made in a previous inspection of your facility (April 2009).
Sanitary operations:
4. Buildings, fixtures, and other physical facilities of the plant shall be maintained in a sanitary condition and shall be kept in repair sufficient to prevent food from becoming adulterated within the meaning of the Act, as required by 21 CFR 110.35(a). However, on September 29, 2010, our investigators observed mold-like growth on the ceiling where tofu skins were being processed and directly above the tofu skin processing area. Also, our investigators observed mold-like growth on an insulated pipe directly above finished tofu product.
We acknowledge your response letter, which states that you have cleaned the tofu skin processing area and observe no more mold. We also acknowledge your response letter states that the pipe above the grinder has been replaced. However, you have not addressed how you will ensure that the problem will not recur. Please provide documentation of any procedures you put in place to ensure that the problem will not recur.
Plant and grounds:
5. The grounds about a food plant under the control of the operator must be kept in a condition that will protect against the contamination of food. The methods for adequate maintenance of grounds include adequately draining areas that may contribute contamination to food by foot-borne filth (21 CFR 110.20(a)). However, on September 29, 2010, our investigators observed pooling water directly in front of your firm’s walk-in food storage refrigerator in the manufacturing room. Employees were observed walking through the pooling water to enter and exit the walk-in refrigerator.
We acknowledge your response letter stating you will look for a contractor to either redo the floor or build a water drain to the floor drainer to resolve the problem as soon as possible. Please provide an update of the current status in addressing this problem.
6. As required by 21 CFR 110.35(a), buildings, fixtures and other physical facilities of the plant shall be maintained in a sanitary condition and shall be kept in repair sufficient to prevent food from becoming adulterated. Also, cleaning and sanitizing of utensils and equipment shall be conducted in a manner that protects against contamination of food or food packaging. However, on September 29, 2010, our investigators observed condensate dripping onto the floor from a stained crack in the ceiling of the walk-in refrigerator used to store food. They also observed three in-use fans directly blowing onto trays of ready-to-eat fried tofu, with thick brown fuzz and rust-like filth covering the fan blades and other components of the fan.
We acknowledge your response letter stating the landlord has been notified about the problem with your walk-in refrigerator ceiling and that you will cover the food inside the walk-in refrigerator with either lids or wrap. Covering food items is an adequate correction to protect the exposed food; however, notifying your landlord does not sufficiently ensure the dripping condensate on ceiling problem will be corrected.
We also acknowledge your response letter stating your fan blades, cages and other fan components have been cleaned. However, you have not addressed how you will ensure the problem will not recur. We recommend regular cleaning of the fan blades, cages and other components to avoid contamination of product. Please provide documentation of any procedures you put in place to ensure that the problem will not recur.
Equipment and utensils:
7. All plant equipment and utensils shall be so designed and of such material and workmanship as to be adequately cleanable, and shall be properly maintained, as required by 21 CFR 110.40(a). However, our investigators observed that the currently in-use tofu grinder, which is used as a direct food-contact surface for tofu production, was rusty in appearance at the spout and surrounding areas.
We acknowledge your response letter stating the spout of the grinder had been painted outside and rust had been sanded off the surface. You state that you bought a sander to clean the area. This will not be effective if the surface below the corroded areas is not food grade material. It is your responsibility to ensure there is no leachable lead or other contaminants below the sanded areas which may be potential contaminants to food directly contacting the areas.
This letter is not intended to be an all-inclusive list of violations that may exist at your facility or with respect to your products. You are responsible for ensuring that your facility and your products are in compliance with the Act and applicable regulations. Failure to implement corrective action of these violations and prevent their recurrence may result in regulatory action by FDA without further notice, which could include seizure and/or injunction.
Within fifteen (15) working days of your receipt of this letter, please notify this office in writing of the current status of your corrective actions and the specific steps that you have taken to correct the noted violations. You should include documentation that would assist us in evaluating your corrections. If you cannot complete all corrections before you respond, we expect that you will explain the reason for your delay and state the time within which you will complete the remaining corrections.
Please send your reply to the attention:
Darlene Almogela
Director, Compliance Branch
U.S. Food and Drug Administration
San Francisco District
1431 Harbor Bay Parkway
Alameda, CA 94502
If you have any questions regarding any issues in this letter, please contact Ms. Almogela at 510-337-6769 or Juliane Jung-Lau, Compliance Officer, at (510) 337-6793.
Sincerely,
Barbara J. Cassens
San Francisco District Director
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