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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Thanh Son Tofu Inc 10/6/10

  

Department of Health and Human Services logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
 
Los Angeles District
Pacific Region
19701 Fairchild
Irvine, CA 92612-2506
 
Telephone:    949-608-2900
FAX:    949-608-4415 

 

 
WARNING LETTER
 
 
CERTIFIED MAIL
RETURN RECEIPT REQUESTED
 
                                                                                                                                          W/L 01-11
October 6, 2010
 
Mr. Kevin H. Dang
Thanh Son Tofu, Inc.
9688 Westminster Avenue
Garden Grove, CA 92844-2904
 
Dear Mr. Dang:
 
The Food and Drug Administration (FDA) conducted an inspection of your food processing facility, located at 9688 Westminster Avenue, Garden Grove, CA, on April 15 & 16, 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 the food products produced in your facility, including soybean drink, fried tofu, soybean cake, and soybean pudding, 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, these 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)].   You can find the Act and FDA’s regulations through links in FDA’s home page at www.fda.gov.
 
At the conclusion of the inspection, you were issued a Form FDA-483 (copy enclosed), which delineated a number of significant violations. We acknowledge receipt of your response to the Form FDA-483 on May 19, 2010. However, your response did not adequately address the following violations:
 
1.  You must hold foods which can support the rapid growth of microorganisms in a manner that prevents the foods from becoming adulterated, to comply with 21 CFR 110.80(b)(3). However, your perishable soy beverages, fried tofu, fresh tofu, and fresh tofu pudding products were not kept refrigerated or held at or below an appropriate temperature as specified on the product labels and as required to prevent the products from becoming adulterated. These products were held and transported in an unrefrigerated van, and were placed for sale by your employees on your unrefrigerated ambient temperature racks, where they were displayed for extended periods of time. 
While your May 2010 response provides that all drivers will use time logs for each delivery, your response does not adequately explain how you will handle any products that are held at or below an appropriate temperature for an extended period of time. 

2.  You must maintain equipment and utensils used to manufacture foods in an acceptable condition through appropriate cleaning and sanitizing, as necessary, including taking apart equipment as necessary to clean and sanitize properly, to comply with 21 CFR 110.80(b)(1). However, we observed the following:

a.)    Prior to the start of soy beverage container filling operations on 04/15/10, the soy beverage holding tank, container filling plumbing, and container filling valve were visibly soiled with food residues from previous production days. Clean-In-Place (CIP) procedures had been used to clean this filling equipment after the previous uses, but these procedures did not remove all residue.
 
b.)    On 04/15/10, the interior of piping that is used to transfer soy beverage from a holding tank to the pasteurizers in an adjacent room was heavily caked with food residues; CIP procedures had been used to clean this piping after the previous uses, but these procedures did not remove all residue. 
 
c.)    Prior to the start of processing operations on 04/16/10, food residues were found on food contact surfaces of your soy product processing equipment including on the two solid/liquid separation screens and in the holding tank for the separated liquid. Soybean cakes made from this separated liquid are not subjected to additional thermal processing or any other means of pathogen reduction. The above described equipment had been cleaned using your CIP procedures after the previous use on 04/15/10, but these procedures did not remove all residue.
 
d.)   On 04/15/10, metal trays and plastic totes that are used to store in-process Ready-To-Eat (RTE) fresh and fried soybean cakes were visibly soiled with a build-up of food residues prior to being used to store the RTE soy products.
 
e.)    Prior to the start of operations on 04/15/10, the food contact surface of the soybean hopper that feeds your soybean grinder was visibly soiled.
 
f.)     Prior to the start of operations on 04/16/10, your soybean cake molds were visibly soiled with food residues; these molds had been manually cleaned after production on 04/15/10, but this cleaning process did not adequately remove all residue.
 
g.)    On 04/16/10, the stainless steel basket-like containers on your soy beverage filling tank were visibly soiled with food residues. These baskets had been manually cleaned after production on 04/15/10, but this cleaning process did not adequately remove all residue. These basket-like containers are used to store caps for your one-half gallon soy beverage containers. 
 
While your May 2010 response provides that you will train your employees to wash all equipment thoroughly, it does not provide enough detail regarding when and how this correction will be made to assess whether the correction adequately addresses the violations described above. 
 
3.   You must handle work-in-process in a manner that protects against contamination, to comply with 21 CFR 110.80(b)(5). However, an employee at the soybean cake coagulation station who was washing the floor by spraying water caused the water to splash from the floor onto in-process foods on at least four occasions on 04/15/10.
 
While your May 2010 response provides that you will instruct employees not to spray water during processing, it does not provide enough information for us to determine whether this correction is adequate. 
 
4.   All persons working in direct contact with food, food-contact surfaces, and food-packaging materials shall conform to hygienic practices while on duty to the extent necessary to protect against contamination of food by washing hands thoroughly and sanitizing if necessary in an adequate hand-washing facility before starting work, after each absence from work, and at any other time when the hands may have become soiled, to comply with 21 CFR 110.10(b)(3). However, employees handling RTE tofu products failed to wash their hands after performing activities during which their hands may have become soiled, including at least four occasions in which employees handled a hose that had been in contact with the wet floor, one occasion in which an employee handled visibly soiled control knobs for the soybean processing equipment, and one occasion in which an employee exited the facility to retrieve plastic crates used to store filled soy beverage containers.
 
While your May 2010 response provides that you will train employees to wash their hands so to prevent any contamination, it does not provide enough information for us to determine whether this correction is adequate. 
 
5. You must provide adequate and readily accessible toilet facilities to your employees, to comply with 21 CFR 110.37(d). This can be accomplished by maintaining the facilities in a sanitary condition and in good repair at all times. You must also provide adequate and convenient hand-washing facilities, to comply with 21 CFR 110.37(e). However, the toilet in the employee restroom was not in good repair, as it was leaking water from the base onto the floor, and the employee restroom was cluttered with equipment that blocked employees’ access to the restroom’s hand-washing facilities.
 
While your May 2010 response provides that you will address these issues, it does not provide enough information for us to determine whether correction has been achieved. 
           
6.   You must maintain buildings, fixtures, and other physical facilities in a sanitary condition and keep them in repair sufficient to prevent food from becoming adulterated, to comply with 21 CFR 110.35(a). However, the following conditions were found at your facility during the inspection:
 
a)   The tile floor of your processing room is in a state of disrepair, causing water to pool on the floor, which prevents the floor from being adequately cleaned.
 
b)   The metal baseboards in your processing room are loose and unsealed, which prevents them from being kept in good repair. On 04/15/10 the space behind these baseboards was infested with sewer fly like insects too numerous to count.
 
While your May 2010 response provides that you will address these issues, it does not provide enough information for us to determine whether correction has been achieved. 
 
7.   No pests shall be allowed in any area of a food plant, to comply with 21 CFR 110.35(c). However, on 04/15/10 there were fly-like insects too numerous to count in your processing room during the production of soybean cakes and soy beverage.
 
While your May 2010 response provides that you will address these issues, it does not provide enough information for us to determine whether correction has been achieved. 
 
8.   You must properly store equipment and remove litter and waste that may constitute an attractant, breeding place, or harborage area for pests, within the immediate vicinity of the plant buildings or structures, to comply with 21 CFR 110.20(a)(1). However, you are storing soybean waste in approximately 55 gallon plastic drums at the rear exterior of your processing facility in a manner that constitutes an attractant for pests, and you have two dumpsters in the same area that are also an attractant for pests. Specifically, on 04/15/10 there were open containers of soy waste in this area, and there was food waste and feces in the two dumpsters, all of which was within the immediate vicinity of the plant. There were fly-like insects too numerous to count in and around the waste containers and dumpsters.
 
While your May 2010 response provides that you will address these issues, it does not provide enough information for us to determine whether correction has been achieved. 
 
9.   You must provide adequate screening or other protection, where necessary, from pests entering your food facility to comply with 21 CFR 110.20(b)(7). However, the rear screen door of your processing area was open throughout the production day on 04/15/10.
 
While your May 2010 response provides that you will address this issue, it does not indicate that correction has actually been achieved.
 
10. The seams on all food-contact surfaces must be smoothly bonded or maintained so as to minimize accumulation of food particles, dirt, and organic matter and thus minimize the opportunity for growth of microorganisms, to comply with 21 CFR 110.40(b). However:
 
a)      There are rough welds on food contact surfaces, including your soybean cake molds and your soy beverage filling station holding tank, which allow the accumulation of food particles and other matter on these surfaces.
 
b)      On 04/15/10 a food contact seam inside your solid/liquid separator was torn open and plugged with visibly soiled plastic bags during processing. This seam was repaired by welding after production on 04/15/10, however, the new weld is not smoothly bonded.
 
While your May 2010 response provides that you will address this issue, it does not indicate that correction has actually been achieved.
 
11.  You must use water which is safe and of adequate sanitary quality in food and on food-contact surfaces to comply with 21 CFR 110.37(a). However, the ion exchange tank of your water softening system is open to the atmosphere, and there was particulate matter in the rock salt inside the ion exchange tank, which could cause contamination of your water supply.
 
While your May 2010 response provides that you will address this issue, it does not indicate that correction has actually been achieved.
 
12.  Plumbing used in your food processing plant must be of adequate size and design and adequately installed and maintained to avoid constituting a source of contamination to food, water supplies, equipment, or utensils or creating an unsanitary condition to comply with 21 CFR 110.37(b)(3). However, during the inspection an open end hose was lying in pooled water of the processing room floor, which could result in contamination of the hose. This hose was then used to rinse food contact surfaces.
 
13.  You must take effective measures to protect against the inclusion of metals in food to be comply with 21 CFR 110.80(b)(8). However, food contact surfaces, a soy product filter tank and filter frame, were damaged and appeared to be missing metal fragments. You have no metal detector or other means of ensuring that there are no metal fragments in your products.
 
While your May 2010 response provides that you will address this issue, it does not indicate that correction has actually been achieved.
 
14.  You must use equipment and utensils that preclude the adulteration of food with any contaminants and must maintain food contact surfaces to protect food from being contaminated by any source, including unlawful indirect food additives, to comply with 21 CFR 110.40(a). However, cardboard-like material was used as a food contact surface to store RTE fried soybean cake. Such a material does not protect food from being contaminated.
 
While your May 2010 response provides that you will address these issues, it does not provide enough information for us to determine whether correction has been achieved. 
 
Misbranded Food
 
In addition, our review of the labeling for your products and other evidence collected by our investigator indicates that your THANH SON TOFU® “Fresh Soybean Pudding,” “Fried Tofu,” and “Soybean Cake” products are misbranded within the meaning of section 403 of the Act [21 U.S.C. § 343]. Regulations implementing the food labeling requirements of the Act are found in Title 21, Code of Federal Regulations, Part 101 (21 CFR Part 101). Your firm’s labeling violations include:
 
1.   Your Fried Tofu, Fresh Soybean Pudding, and Soybean Cake 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 required by 21 CFR 101.9. Specifically: 
 
a)   Your product labels fail to declare the amount of trans fat as required by 21 CFR 101.9(c)(2)(ii).
 
b)   Your Fried Tofu and Soybean Cake product labels fail to declare the amount of sugars as required by 21 CFR 101.9(c)(6)(ii).
 
c)   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. 
 
d)   The serving size declaration for your Fried Tofu and Soybean Cake products is not expressed in common household measure as required by 21 CFR 101.9(b)(5). The serving size must be determined and declared based on the reference amounts customarily consumed set forth in 21 CFR 101.12(b). Specifically, the serving size for cakes should be declared as “_ pieces ( _ g),” rather than in ounces.
 
e)   The product label does not accurately declare the net weight and number of servings per container for your Fried Tofu and Fresh Soybean Pudding products, as required by 21 CFR 101.9. For example, your soybean pudding declares a serving size of ½ cup (112g) and 4 servings per container, which would make the net weight 16 oz.; however the declared net weight is 32 oz.
 
The above violations are not meant to be an all-inclusive list of violations at your facility or in your labeling. It is your responsibility to ensure that all of your products are in compliance with applicable laws and regulations. You should take prompt action to correct all of the violations noted in this letter. Failure to promptly correct these violations may result in regulatory action without further notice, such as seizure and/or injunction.
 
Please 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. 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.
 
We also have the following comments regarding your product labels:
 
1.    Your labels contain information in English, Chinese, and Vietnamese languages, but do not appear to repeat all of the required label information in all of these languages. Under 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. 
 
2.   The net quantity of contents statement for the Fried Tofu and Soybean cake products do not meet the requirements in 21 CFR 101.105(j)(3). Specifically, these products bear the statements “WEIGHT 8 OZ.” and “WEIGHT 12 OZ.,” which do not include the term “Net.”
 
Your written reply should be addressed to:
 
Blake Bevill
Director, Compliance Branch
U.S. Food and Drug Administration
19701 Fairchild Rd.
Irvine, California 92612-2506
 
If you have questions regarding any issue in this letter, please contact Robert B. McNab, Compliance Officer, at (949) 608-4409.
 
Sincerely,
/S/
Alonza E. Cruse
District Director
 
Cc:      
California Department of Public Health
Food and Drug Branch
1500 Capitol Avenue, MS-7602
P.O. Box 997413
Sacramento, CA 95899-7413