Inspections, Compliance, Enforcement, and Criminal Investigations
Fong Kee Tofu Company, Inc. 3/7/12
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
1431 Harbor Bay Parkway
VIA United Parcel Service
March 7, 2012
Yan Hui Fang, Chief Executive Officer
Fong Kee Tofu Company, Inc.
1135 Revere Avenue
San Francisco, California 94124
Dear Mr. Fang:
The Food and Drug Administration (FDA) conducted an inspection of your food manufacturing facility located at 1135 Revere Avenue, San Francisco, California on December 13 -21, 2011. During our inspection, FDA investigators documented serious violations of the Current Good Manufacturing Practice (CGMP) regulation for foods, Title 21, Code of Federal Regulations (CFR), Part 110 (21 CFR 110). These violations cause the food products produced in your facility to be adulterated within the meaning of Section 402(a)(4) [21 U.S.C. § 342(a)(4)] of the Federal Food, Drug, and Cosmetic Act (the Act), in that they have been prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth or rendered injurious to health. In addition, your tofu and "soy milk" products are misbranded within the meaning of section 403 of the Act [21 U.S.C. § 343] and its implementing regulations under Title 21, Code of Federal Regulations, Part 101 (21 CFR 101). You can find the Act and the FDA regulations through links in FDA's homepage at www.fda.gov.
Your significant violations are as follows:
1. You must take effective measure to exclude pests from the processing areas and to protect against the contamination of food on the premises by pests to meet the requirements of 21 CFR 110.35(c). However:
a. During the inspection, December 13 & 15, 2011, our investigators observed three pigeons inside the manufacturing plant, approximately 5 feet from the raw soybeans storage and approximately 10 feet from the area of manufacturing your firm's ready-to-eat bulk Firm Tofu.
b. On December 13 & 15, 2011, our investigators observed at least 20 live flies and gnats flying approximately 10 feet above the Firm Tofu manufacturing area during production.
2. Your plant and facilities must be constructed in such a manner as to allow floors, walls, and ceilings to be adequately cleaned and kept clean and kept in good repair in order to comply with 21 CFR 110.20(b)(4). However, on December 13, 15, & 19, 2011, our investigators observed the floor in the production area to have missing tiles, patched with different materials, and have uneven surface textures with build-up food debris. Additionally, the investigators observed thick black residue build-up, cracks and crumbles at the bottom of the brick wall of the walk-in cooler which is in close proximity to the in process and uncovered ready-to-eat finished product.
3. Employees working in direct contact with food, food-contact surfaces, and food packaging materials must 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, to meet the requirements of 21 CFR 110.10(b)(3). However, during our inspection, investigators observed two employees drive forklifts and pallet jacks and proceed to handle processed ready-to-eat tofu with the same gloves without washing with soap or sanitizing their gloved hands in between. One employee touched the tofu with ungloved hands, and placed the ready-to-eat tofu onto the packaging machine. Another employee with ungloved hands handle the ready-to-eat tofu right after operating the packaging machine without washing hands in between.
4. Your plumbing in the hand-washing facilities must be adequately installed and maintained to meet the requirements of 21 CFR 110.37(b). However, the only hand washing sink in the production area for employees to wash and sanitize their hands lacked a drain pipe that connects the sink bowl to the sewage pipe. The water coming from the sink drains directly to the floor near the soy milk dispenser and packaging area. This will constitute as a source of contamination to your ready-to eat finished product.
5. You must handle work-in-progress in a manner that protects against contamination, as required by 21 CFR 110.80(b)(5). However, on December 13 & 15, 2011, our investigators observed the plastic cooler drapes with black and green build-up residue scrape over the top of the uncovered tofu while being rolled on racks to and from the cooling area.
6. You must take effective measures to protect food transported by convey or from contamination, as required by 21 CFR 110.80(b)(6). However, our investigators observed light brown food debris build-up in the front and back of the main white convey or and the side of the white convey or that is in contact with Firm Tofu. Additionally, the rollers and the touch screen control panel and buttons appeared to have buildup of dirt and debris residues.
7. Your equipment, containers and utensils used to convey and hold and store food must be maintained in a manner that protects against contamination, as required by 21 CFR 110.80(b)(7). However, our investigators observed black residues which appeared to be buildup of dirt and debris on the interior surfaces of the perforated plastic bins used to hold processed fried tofu; light brown residue in the horizontal rails of the metal racks used to hold the metals trays for Firm tofu; and brown residues in the label rollers, control buttons, and touch screen controller of the final product packaging machine. Additionally,we observed light brown yellow residue build-up in the interior of the pipes and nozzles of the soy milk tank. These pipes and nozzles are used to dispense ready to drink Soy Milk.
8. You must take effective measures to protect against the inclusion of metal or other extraneous material in food, as required by 21 CFR 110.80(b)(8). However, on December 13, 15, & 19, 2011, our investigators observed that the white side convey or belt that comes in direct contact with Firm Tofu has a missing piece of plastic with several metal staples. Additionally, we observed paint chips throughout the exterior of your 3 soybean grinders.
1. Your bulk packaged Firm Fried Tofu and Soy Bean Cake products are misbranded within the meaning of section 403(w) of the Act [21 U.S.C. § 343(w)] in that they fail to declare all major food allergens present in this product.
Section 201 (qq) of the Act [21 U.S.C. § 321 (qq)] defines as "major food allergens" milk, egg, fish, crustacean shellfish, tree nuts, wheat, peanuts, and soybeans, as well as any food ingredients containing proteins derived from one of these foods, with the exception of highly refined oils or ingredients derived from such oils. 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:
a. 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
b. 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, 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 that 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)].
Soy: Your bulk packaged Fried Firm Tofu is made with soybeans; however it is packaged in unlabeled plastic bags and fails to declare the presence of the major food allergen soy.
Wheat: Your Soy Bean Cake product is manufactured using soy sauce, which contains wheat.
2. The bulk packaged fried tofu is misbranded within the meaning of section 403(i)(1) in that this product fails to bear an adequate common or usual name of the food as required by 21 CFR 101.3. Specifically, your bulk packaged Fried Firm Tofu is packaged in unlabeled plastic bags.
3. The Soy Bean Cake and bulk packaged fried tofu products are misbranded within the meaning of section 403(i)(2) in that they are fabricated from two or more ingredients, but the labels fail to bear the common or usual name of each ingredient as required by 21 CFR 101.4. Specifically:
a. The bulk packaged Fried firm Tofu is packaged in unlabeled plastic bags and does not declare any ingredients.
b. The Soy Bean Cake product label fails to declare the sub-ingredients of the soy sauce ingredient. The requirement to list these component ingredients (or "sub-ingredients") may be met by either parenthetically listing the component ingredients after the common or usual name of the main ingredient [21 CFR 101.4(b)(2)(i)], or by listing the component ingredients without listing the ingredient itself [21 CFR 101.4(b)(2)(ii)]. Under the first alternative, the component ingredients must be listed in descending order of predominance within the multi-component ingredient; and under the second alternative, the component ingredients must be listed in descending order of predominance in the finished food.
4. The Fried Firm Tofu, Soy Bean Cake, and Fresh "Soy Milk" Sweet products are misbranded within the meaning of section 403(q) of the Act in that the nutrition facts information is not declared in accordance with 21 CFR 101.9. Specifically:
a. Your Fresh Soy Milk Sweet product does not declare nutrition facts information as required by 21 CFR 101.9.
b. Your retail packaged firm Tofu and Soy Bean Cake product labels do not declare the number of grams of trans fat in a serving of these products or if a statement of the trans fat content is not required, your product does not contain the statement "Not a significant source of trans fat" at the bottom of the table of nutrient values, as required by 21 CFR 101.9(c)(2)(ii). For additional information on trans fat labeling requirements go to http://www.FDA.gov/Food/GuidanceComplianceRegulatoryInformation/Guidancedocuments/FoodLabelingNutrition/ucmO53479.htm
c. The sodium content of your Soy Bean Cake product is not rounded to the nearest 10-milligram increment [21 CFR 101.9(c)(4)].
d. Your Soy Bean Cake product label does not declare the number of milligrams of cholesterol in a serving of these products or if a statement of the cholesterol content is not required, your product does not contain the statement "Not a significant source of cholesterol" at the bottom of the table of nutrient values, as required by 21 CFR 101.9(c)(3).
e. Your Soy Bean Cake product does not declare a visual unit of measure for the serving size in accordance with 21 CFR 101.9(b)(5)(iii).
f. Your retail packaged Firm Tofu product label fails to declare the serving size in common household measure as required by 21 CFR 10.19(b)(5).Your label declares "85g" as the 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 101.90)(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://linfo1.cfsan.fda.gov/nle/clientllogin.cfm. We have no record of your firm having filed a Small Business Nutrition Labeling Exemption Notice.
5. Your bulk packaged Fried Firm Tofu product is misbranded within the meaning of section 403(e) of the Act [21 U.S.C. § 343(e)] in that the package does not bear the name and place of business of the manufacturer, packer, or distributor in accordance with 21 CFR 101.5; and it fails 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.
We also offer the following comments regarding your product labels:
• Your Soy Bean Cake product label declares the net weight of the product to be 7 oz. However, your Nutrition Facts Panels declares the number of servings per container to be 5 and the serving size to be 3 oz. Based on the information provided on your label, a consumer would expect the product to contain 15 oz. of Soy Bean Cake (5 servings per container x 3 oz. per serving= 15 oz. per container). Either your declaration of net weight or servings per container is incorrect.
• Your Firm Tofu product label declares the net weight of the product as 16 oz. and declares the serving size as 85 g; however, the number of servings per container is declared as "variable" In accordance with 21 CFR 101.9(b)(8)(iii), the use of the term "varied" for the number servings per container is for random weight products. Your Firm Tofu product is not a random weight product as each piece of this product that you produce weighs approximately the same.
• Your retail packaged Firm Tofu and Soy Bean Cake products 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)(2), 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.
• Our investigators noted that based on a statement from firm management that your manufacturing processes remain the same as the ones observed during a previous inspection; therefore, Suppressor 3110 and/or Suppressor 3568 continue to be used in the production of your "soy milk" and tofu products. These ingredients must be declared on your product labels in accordance with 21 CFR 101.4 unless the ingredients are incidental additives that are present in the food at insignificant levels and do not have any technical or functional effect in that food in accordance with 21 CFR 101.100(a)(3).
• Your Fresh Soy Milk Sweet product uses the term "milk" as apart of the common or usual name. Milk is a standardized food defined in 21 CFR 131.110 as the lacteal secretion, practically free from colostrum, obtained by the complete milking of one or more healthy cows. Therefore, we do not consider "soy milk" to be an appropriate common or usual name because your product does not contain "milk." We consider "soy drink" or "soy beverage," however as acceptable common or usual names for such products.
FOOD FACILITY REGISTRATION
We have determined that 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, your facility has not registered with FDA, despite the fact that you were provided with information on how to register in the Untitled Letter previously issued to your firm as well as during the close-out meeting for the most recent inspection.
As a responsible official of a facility that manufactures/processes, packs, or holds food for human or animal consumption in the United States, you are responsible for ensuring that your overall operation and the products you distribute are in compliance with the law.
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 maybe 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
Fong Kee Tofu Company, Inc.
San Francisco, California
When completed, the form maybe 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.
Please notify this office in writing within fifteen (15) working days from the date you receive this letter of the specific steps you have taken to correct the noted violations, including an explanation of how you plan to prevent these violations, or similar violations, from occurring again. Include documentation of the corrective action you have taken. If your planned corrections will occur overtime,please include at timetable for implementation of those corrections. If corrective action cannot be completed within 15 working days, state the reason for the delay and the time within which the corrections will be completed.
Your written response should be directed to:
Darlene B. Almogela
Director of Compliance
1431 Harbor Bay Parkway
Alameda, California 94052
Refer to the Unique Identification Number (CMS case 268776) when replying.
If you have any questions about the content of this letter please contact Mr. Lawton W. Lum, Compliance Officer at (510) 337-6792.
This letter is not intended to be an all-inclusive list of the violations at your facility. It is your responsibility to ensure compliance with applicable laws and regulations administered by FDA. The specific violations noted in this letter and in the Inspectional Observations, Form FDA 483 (FDA 483), issued at the closeout of the inspection may be symptomatic of serious problems in your firm's manufacturing systems. You should investigate and determine the causes of the violations and take prompt actions to correct the violations to bring your products into compliance. Failure to promptly correct these violations may result in legal action without further notice including seizure and injunction.
Barbara J. Cassen