|Company:||Wa Hen Dou Fu Soy Sauce Corporation|
|Subject:||CGMP Manufacture, Processing, Packing or Holding Food/Adulterated|
|Issuer:||San Francisco District Office|
|Issued:||Feb. 21, 2012||Closed:||
Department of Health and Human Services
Public Health Service
Food and Drug Administration
San Francisco District
Return Receipt Requested
February 21, 2012
Mr. Peng Xiang Lin, Owner
Wa Hen Dou Fu Soy Sauce Corporation
2451 26 th ,Avenue
Sacramento, CA 95822-2269
Dear Mr. Lin:
The U.S. Food and Drug Administration (FDA) inspected your soy products manufacturing facility located at 2451 26 th Avenue, Sacramento, CA on September 14 th , 21 st , 22 nd , and 26 th , 2011. During the inspection, we performed environmental sampling (FDA sample# 714573) which, as discussed in more detail below, identified the presence of Salmonella species Poly B in your facility, including on a direct food-contact surface. In addition, we documented serious violations of the Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Food (CGMP) regulation for foods, Title 21, Code of Federal Regulations, Part 110 (21 CFR Part 110). Based on these violations and our findings of Salmonella species Poly B in your facility, we have determined that your soy products are adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act) [2l U.S.C. § 342(a)(4)] in that they were prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health.
In addition, we collected labels from some of your soy products. Our review of those labels found that your Hua Xing Seasoned Dou-Fu (Hard) and Soy Jello products are misbranded within the meaning of section 403 of the Act [21 U.S.C. § 343]. You may find the Act and FDA's regulations through links on FDA's home page at www.fda.gov .
Salmonella species Poly B is a pathogenic organism that can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy individuals may suffer short-term symptoms such as severe diarrhea, bloody diarrhea, fever, chills, abdominal discomfort, and occasionally vomiting.
During the inspection, FDA investigators collected an environmental sample (FDA sample #714573) that consisted of 15 swabs testing for Salmonella from various locations in your manufacturing facility. Four of these swabs tested positive for Salmonella species Poly B: Sub 1a (blue plastic strainer used to scoop soy milk curd, which is a direct food-contact surface), Sub 3a (water hose nozzle), Sub 9a (bottom of white bucket filled with ready-to-eat "soy jello" used to fill 16 oz. plastic containers), and Sub 11 a (stainless steel table adjacent to the waste bin underneath the soaking tank). The presence of Salmonella species Poly B in your facility indicates poor sanitary practices at your facility.
The investigators' observations were presented to you on form FDA-483, Inspectional Observations, at the conclusion of our inspection on September 26, 2011.
1. As required by 21 CFR 110.10(b)(5), you must maintain gloves, if they are used in food handling, in an intact, clean, and sanitary condition. However, our investigators observed the following during the inspection:
• An employee picked up a white five-gallon bucket filled with ready to-eat "soy jello" that had been resting directly on the floor. The employee's gloved hand came in direct contact with the bottom of the white bucket that had previously contacted the floor. The employee used the white five-gallon bucket to fill multiple 16 oz. plastic containers with "soy jello." The employee proceeded to pick up each plastic container by pinching the rim between two fingers, one finger contacting the interior of the container, and shake the filled containers while leveling the product. At no time during this process did the employee wash or sanitize her gloved hands.
FDA investigators subsequently environmentally swabbed the bottom of the white bucket referenced above. FDA sample results found the bottom of the white bucket positive for Salmonella species Poly B.
• An employee picked up a water hose that had been in contact with the floor. The employee's gloved hand came in direct contact with the portion of the hose that had been on the floor. The employee then proceeded to lay out a cloth lining, a food-contact surface, in a tofu form without first washing and sanitizing her gloved hands. The same employee was subsequently observed touching a rusted hydraulic pump lever and then touching tofu product without washing or sanitizing her gloved hands.
• An employee was observed handling the water hose nozzle and subsequently handling a blue plastic strainer used to scoop soy milk curd, without washing or sanitizing her gloved hands.
FDA investigators subsequently environmentally swabbed the water hose nozzle attached to the water hose and blue plastic strainer referenced above. FDA sample results found the water hose nozzle and blue plastic strainer positive for Salmonella species Poly B.
We acknowledge that on the last day of our inspection, you trained your employees on the use of gloves and how to avoid cross-contamination. We will verify the adequacy of your corrective action during our next inspection.
2. As required by 21 CFR 110.20(b)(7), you must provide, where necessary, adequate screening or other protection against pests. However, our investigators observed the following during the inspection:
• The front door of the main building was propped open at least two times each day of the inspection for a minimum of 30 minutes.
• During one day of the inspection, the roll-up door in the dry storage warehouse was opened approximately 6 inches off the ground.
• The unscreened door between the office and the processing room is left open during business hours.
3. As required by 21 CFR 110.35(c), you must take effective measures to exclude pests from the processing areas and to protect against the contamination of food on the premises by pests. However, our investigators observed at least eight dead cockroaches on the floor directly beneath cases of packaging materials along the east wall of the pasteurizing room. Our investigators also observed six live flies in the office area of the facility, which was separated from the processing room by an unscreened, open door.
We acknowledge that during the inspection, you swept the cockroaches off the floor and informed our investigators that pest control would be coming the following week. We will verify the adequacy of your corrective action during our next inspection.
4. As required by 21 CFR 110.20(b)(1), your plant and facilities must 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. However, our investigators observed maintenance materials and excess old and used equipment in the pasteurizing room, adjacent to food ingredients, such as sugar. In addition, bags of calcium sulfate were stored on the same shelving as packaging materials.
5. As required by 21 CFR 110.35(a), the buildings, fixtures, and other physical facilities of your plant must be maintained in a sanitary condition and must be kept in repair sufficient to prevent food from becoming adulterated within the meaning of the Act. However, our investigators observed the west wall of the processing room with loose, peeling paint within approximately two feet of the soaking tank, grinders 1 & 2, and the holding tank.
6. As required· by 21 CFR 110.35(a), you must conduct cleaning and sanitizing of utensils and equipment in a manner that protects against contamination of food, food-contact surfaces, or food-packaging materials. However, during the inspection, you explained to investigators that you only use water for cleaning and sanitation, and do not use any cleaning or sanitizing agents in the processing room. Our findings of Salmonella on or near food-contact surfaces and very near to where food is exposed indicates a high risk for product contamination, and demonstrates that your cleaning and sanitation procedure using water alone is not effective for control of pathogens.
7. As required by 21 CFR 110.35(d), all food-contact surfaces, including utensils and food-contact surfaces of equipment, must be cleaned as frequently as necessary to protect against contamination of food. However, our investigators observed an employee standing on a stainless steel table. After he stepped down from the table, another employee placed a utensil directly on to the table while preparing for the next task and then picked up the utensil to continue processing your tofu product. At no time during this process was the table or utensil washed or sanitized.
FDA investigators subsequently environmentally swabbed the stainless steel table and found the table positive for Salmonella species Poly B.
Our review of your product labels found that your Hua Xing Seasoned Dou-Fu (Hard) and Soy Jello products are misbranded under section 403 of the Act [21 U.S.C. § 343]:
1. Your Hua Xing Seasoned Dou-Fu (Hard) product is 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 form at as defined in 21 FR 101.9. Specifically:
• The product label fails to declare a statement of the caloric content per serving, expressed to the nearest 5-calorie increment up to and including 50 calories, and 10-calorie increment above 50 calories, as required by 21 CFR 101.9(c)(1). Amounts less than 5 calories may be expressed as zero;
• The product label does not express Calories from Fat to the nearest 5-calorie increment, as required by 21 CFR 101.9(c)(1)(ii). Your product declares Calories from Fat as 33;
• The product label fails to declare the number of grams of trans fat in a serving, in accordance with 21 CFR 101.9(c)(2)(ii);
• The product label fails to declare the amount per serving of Vitamin C and Iron calculated as a percent of the Reference Daily Intake (21 CFR 101.9(c)(8)(iv)), as required by 21 CFR 101.9(c)(8)(ii);
• A hairline does not separate "Amount Per Serving" from the calorie statements required in 21 CFR 101.9(c)(1), and does not separate each nutrient and its corresponding percent Daily Value (DV) from the nutrient and percent DV above and below it, in accordance with 21 CFR 101.9(d)(1)(v);
• A listing of the percent DV for each nutrient is not provided under the reading"% DAILY VALUE," as required by 21 CFR 101.9(d)(7)(ii). The percent DV is only declared for Vitamin A and Calcium;
• The product label fails to separate the nutrient information for vitamins and minerals from information on other nutrients by a bar, as required by 21 CFR 101.9( d)(8); and
• The full footnote concerning percent daily values is not present as required by 21 CFR 101.9(d)(9). Product labels must include this footnote unless your product qualifies for the simplified nutrition labeling format set out in 21 CFR 101.9(t)(5) or the labeling exemption in 21 CFR 101.9(j)(13)(ii)(C) for foods in small packages.
Your firm may be eligible for certain exemptions from nutrition labeling requirements, such as the Small Business Nutrition Labeling Exemption. We recommend you review he nutrition labeling exemption in 21 CFR 101.9(1)(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 .
2. Your Hua Xing Seasoned Dou-Fu (Hard) and Soy Jello products are misbranded within the meaning of section 403(e)(2) of the Act [21 U.S.C. § 343(e)(2)] in that 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. Specifically, the net quantity of contents statements for or these products bear the term "or More" after the net weight which tends to exaggerate the amount of the food contained in the package (21 CFR 101.105(o)).
For additional information on General Food Labeling requirements go to
This letter may not list all the violations at your facility or in connection with your products. It is your responsibility to ensure compliance with the Act 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, are 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.
We also offer the following labeling comments and recommendations:
• The term "Hua Xing" in the ingredient statement is intervening material (21 CFR 101.2(e)) on your Hua Xing Seasoned Dou-Fu product. "Hua Xing" is not part of the common and usual name. of soy sauce, and therefore may not be included as part of the ingredient statement;
• We question whether "Soy Jello" is an appropriate statement of identity in accordance with 21 CFR 101.3(b) for soybean curd that contains the ingredients "Soybean, Water and Calcium Sulfate;"
• We encourage you to also declare the net weight in metric measure for your Hua Xing Seasoned Dou-Fu (Hard) and Soy Jello products [15 U.S.C. § 1453(a)(2) (Fair Packaging and Labeling Act)].
Please respond in writing within 15 working days from your receipt of this letter. Your response should outline the specific steps you are taking to correct these violations. Please include in your response documentation such as cleaning and sanitization records, revised sanitation standard operating procedures or improvements that specifically address control of pathogens such as Salmonella in your facility, employee training to minimize potential contamination of food, updated labels, or other useful information that would assist us in evaluating your corrections. If you cannot complete all corrections before you respond, please explain the reason for your delay and state when you will correct any remaining violations.
Please send your reply to Darlene B. Almogela, Director of Compliance at 1431 Harbor Bay Parkway, Alameda, CA 94502. If you have questions regarding any issues in this letter, please contact Brandon L. Bridgman, Compliance Officer, at (510) 337-6794.
Barbara J. Cassens
San Francisco District