Inspections, Compliance, Enforcement, and Criminal Investigations
Shun Fung International Trading Inc.
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
|San Francisco District|
1431 Harbor Bay Parkway
Alameda. CA 94502-7070
August 11, 2010
Mr. Kwan Do Yu, Owner
Shun Fung International Trading, Inc. d/b/a Yummy Food Co.
2089 Ingalls Street
San Francisco, CA 94124
Dear Mr. Yu:
The Food and Drug Administration (FDA) conducted an inspection of your food manufacturing facility, located at 2089 Ingalls Street, San Francisco, CA, from March 31 through April 7, 2010. The inspection revealed serious violations of Title 21 of the Code of Federal Regulations (CFR) Part 110 - FDA’s Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Human Food (CGMP) regulations. Because your food products have been prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth, or may have been rendered injurious to health, the 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 U.S.C. § 342(a)(4)]. You may find the Act and FDA's regulations through links in FDA's home page at www.fda.gov.
The following deficiencies were observed by the investigator during the inspection:
1. Failure to handle equipment, containers, and utensils used to hold and store food in a manner that protects against contamination, as required by 21 CFR 110.80(b)(7). Specifically:
- A plastic strainer, placed directly on the floor, was being used to drain off liquid from boiled peanuts.
- The strainers containing the (b)(4) peanuts were then placed on plastic crates that had been previously placed directly on the floor. These crates were not washed or sanitized prior to the strainers being placed upon them.
- Roasting trays used to roast peanuts were placed directly on top of garbage cans to sweep debris from the trays. The trays were then filled with air dried peanuts without being cleaned or sanitized.
2. Failure 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 110.10(b). Specifically:
- Failure to maintain gloves used in food handling in an intact, clean, and sanitary condition, as required by 21 CFR 110.10(b)(5). Specifically:
A gloved employee used a hose to wash down the floor, directly touching the floor with his gloved hand in the process. The same employee then directly handled peanuts with the same gloved hand without changing, cleaning, or sanitizing the gloves.
A gloved employee swept the floor of the drying room using a broom and then moved peanuts from the drying room to the processing area, transferring the peanuts into a mixing bowl. The gloved employee then poured an aqueous solution over the peanuts and mixed the product by hand. The employee did not change, clean, or sanitize his gloves at any time during these events.
A gloved employee cleaned a mixing paddle in a sink, touching the faucet handle and sink sprayer with his gloved hand. The employee then rolled a mixing bowl containing dough into another production room and used the same gloved hands to scrape dough from the sides of the mixing bowl down into the main mixture of dough. The employee did not change, clean, or sanitize his gloves at any time during these events.
- Failure to confine the drinking of beverages to areas other than where food may be exposed or where equipment or utensils are washed, as required by 21 CFR 110.10(b)(8). Specifically, employees were drinking in the cooking room where the kettle and stove are located. One employee then placed a beverage on a shelf located directly over the sink where cooking utensils are washed.
3. Failure to hold and store toxic cleaning compounds and sanitizing agents in a manner that protects against contamination of food, food-contact surfaces, and food-packaging materials, as required by 21 CFR 110.35(b)(2), and failure to take any other necessary precautions to protect against contamination of food, food-contact surfaces, and food-packaging materials with foreign substances, as required by 21 CFR 110.10(b)(9). Specifically, cleanser with bleach was stored on a shelf over an open container of rinsed peanuts and a bottle of liquid cleaner was stored directly next to the same rinsed peanuts.
4. Failure to provide sufficient space for such placement of equipment and storage of materials as is necessary for the maintenance of sanitary operations and the production of safe food as required by 21 CFR 110.20(b)(1). Specifically, pallets of food and food ingredients were placed directly against the wall throughout the facility, including in the warehouse, the storage room, and the walk-in refrigerator/freezer, which does not allow for adequate cleaning of the facility or for effective monitoring for pest activity.
In addition, our review of the labeling for your products and other evidence collected by our investigator indicates that your firm's Yummy Food Co. brand Cup Cake product is misbranded under section 403(q) of the Act [21 U.S.C. § 343(q)]. Regulations implementing the food labeling requirements of the Act are found in Title 21, Code of Federal Regulations, Part 101 (21 CFR 101). Your Cup Cake product label does not contain nutrition facts information in an appropriate format as required by 21 CFR 101.9. Specifically:
- The product label does not include a statement of the number of grams of trans fat in a serving, as required by 21 CFR 101.9(c)(2)(ii). Additional information on trans fat labeling requirements can be found on our website at http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/FoodLabelingNutrition/ucm053479.htm
- The product label fails to declare the percent Daily Value (% DV) for fiber in accordance with 21 CFR 101.9(d)(7)(ii).
- The serving size in the Nutrition Facts panel of the product label is not declared in accordance with 21 CFR 101.9(b)(2)(i)(A). The label lists the serving size as “1 piece (37G).” The Reference Amount Customarily Consumed (RACC) for cupcakes is 80 g (21 CFR 101.12(b), Table 2). Since the weight of 1 piece of the Cup Cake product is less than 50 percent of the RACC, the serving size should be declared as “2 pieces (74 g).” The nutrition values and servings per container information provided in the labeling of the Cup Cake product must be based on this serving size.
Your firm may be eligible for certain exemptions from nutrition labeling requirements, such as the Small Business Nutrition Labeling Exemption. We recommend you review the nutrition labeling exemptions in 21 CFR 101.9(j)(18) [or see http://www.fda.gov/Food/LabelingNutrition/FoodLabelingGuidanceRegulatoryInformation/SmallBusinessNutritionLabelingExemption/default.htm] for information on filing for an annual exemption. The application may be submitted online at: https://info1.cfsan.fda.gov/nle/client/login.cfm. We have no record of your firm having filed a Small Business Nutrition Labeling Exemption Notice.
We also note that your Cup Cake and Roasted Peanut product labels contain information in at least two languages, but do not repeat all the required label information in both languages. 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.
We acknowledge that you provided our investigator with proposed revised labels for your Cup Cake and Roasted Peanut products to correct additional labeling deviations identified during the inspection. We have reviewed these labels and offer the following comments:
- During the inspection, our investigator informed you that your Cup Cake and Roasted Peanut products contained major food allergens that were not declared on the ingredient statements for these products in accordance with section 403(w) of the Act [21 U.S.C. § 343(w)]. Based upon our review, your revised labels appropriately declare the major food allergens associated with these products. In your response, you should indicate whether you are currently using the revised labels declaring all of the major food allergens.
- At the time of the inspection, your Cup Cake and Roasted Peanut labels did not declare each ingredient contained in the product as required by 21 CFR 101.4. Based on our review, your revised Roasted Peanut label adequately declares the ingredients in the product. However, your revised Cup Cake label declares “Cream Cake Mix” as an ingredient in the product, which is not the common or usual name for that ingredient. In addition, all of the ingredients contained in the “Cream Cake Mix” are not declared on the finished product label, as required by 21 CFR 101.4(b)(2).
- The ingredient statement for your revised Cup Cake label includes numeric designations after some ingredients (e.g., “cellulose gum R13326”) which should not be included in the ingredient statement. Under 21 CFR 101.2(e), all information required to appear on the information panel shall appear in one place without intervening material. These numeric designations are considered intervening material.
- The original and revised labels for the Cup Cake and Roasted Peanut products declare the address of the firm as “S.F., CA.” This statement of the firm’s place of business is not declared in accordance with 21 CFR 101.5(d), which provides that the statement of the place of business should include the street address, city, state, and zip code, but that the street address may be omitted if it is shown in a current city directory or telephone directory.
- The Nutrition Facts panels for the original and the revised labels of the Cup Cake product do not meet the requirements of 21 CFR 101.9(d). The labels include the unauthorized abbreviation “Servings Per Cont.” In addition, the Nutrition Facts panel is not set-off in a box.
- The ingredient statements for the revised Cup Cake and Roasted Peanut product labels have numerous spelling and punctuation errors such as truncated words, missing close parentheses, and extra and/or missing commas. For example, we question the spelling of “Bean Crud” in the Roasted Peanut product label.
- 21 CFR 101.3 requires that the principal display panel of a package bear a statement of identity of the product, which should be in terms of either: (1) the name specified in or required by any federal law; (2) the common or usual name of the food; or (3) an appropriately descriptive term or fanciful name commonly used by the public. Please ensure that the statement of identity of your “Roasted Peanut” product meets these requirements in light of the fact that the product is made with soybean curd.
We recommend that you revise these proposed Cup Cake and Roasted Peanut labels based on the above comments and begin immediate use of the corrected product labels.
This letter is not intended to be an all-inclusive list of the violations at your facility. It is your responsibility to ensure that you operate your facility in compliance with the Act, the CGMP regulations (21 CFR 110), and the food labeling regulations (21 CFR 101). We may take further action if you do not promptly correct these violations. For instance, we may seize your product(s) and/or enjoin your firm from operating.
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 copies of the new labels for the products that your firm manufactures, or other useful information that would assist us in evaluating your corrections. 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.
Please send your reply to the U.S. Food and Drug Administration, Attention: Russell A. Campbell, Compliance Officer, 1431 Harbor Bay Parkway, Alameda, CA 94502. If you have questions regarding any issues in this letter, please contact Mr. Campbell at (510) 337-6861.
Barbara J. Cassens
San Francisco District
U.S. Food and Drug Administration