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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Enforcement Actions

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Chu Minh Corp dba Chu Minh Tofu 8/1/12

  

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

Public Health Service
Food and Drug Administration
 
Seattle District
Pacific Region
22215 26th Avenue SE, Suite 210
Bothell, WA 98021-4421
 
Telephone:      425-402-0340
FAX:    425-402-0402

 

August 1, 2012
 
 
CERTIFIED MAIL
RETURN RECEIPT REQUESTED
 
In reply refer to Warning Letter SEA 12-29
 
Thanh-Nga T. Nguyen, Owner
Chu Minh Corp. dba Chu Minh Tofu
11208 1st Avenue South
Seattle, Washington 98168
 
WARNING LETTER
 
Dear Ms. Nguyen:
 
The Food and Drug Administration (FDA) conducted an inspection of your food manufacturing firm located at 6754 Martin Luther King Jr. Way South, Suite 104, Seattle, Washington, on March 19-21 and 27, 2012. During the inspection, the 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 “Chuminh Fresh and Delicious Soybean Drink, Sweetened” is adulterated within the meaning of section 402(c) of the Act [21 U.S.C. § 342(c)] because the product bears or contains a color additive, specifically FD&C Yellow No. 5, which is unsafe within the meaning of section 721(a) of the Act [21 U.S.C. § 379(a)].
 
Additionally, our review of the labeling for your “Chuminh Fresh Soybean Cake (Tofu),” “Chuminh Fried Soybean Cake (Tofu),” “Chuminh Fresh and Delicious Soybean Drink, Sweetened,” “Chuminh Fresh and Delicious Soybean Drink, Unsweetened,” and “Chuminh Fresh Soybean Pudding” revealed that these products are misbranded within the meaning of Section 403 of the Act [21 U.S.C. § 343] and the regulations for food labeling at 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. As required by 21 CFR 110.80(b)(2), you must manufacture, package and store food under conditions and controls necessary to minimize the potential for contamination. However,

a.    On March 19, 2012, one pigeon and one other bird were perched on the edge of an open metal vat containing soybeans soaking in water intended for production, which was stored outside the facility along the east side of the building. On March 20, 2012, six pigeons were standing on and around an open metal vat containing approximately (b)(4) pounds of soybeans soaking in water intended for production and eating the soybeans that were inside the vat outside the east side of the facility;

b.    On March 19, 2012, water continually dripped from the end of a red flexible hose onto the rest of the hose which was soiled with brown debris, and into a white plastic tote below it, which held between (b)(4) to (b)(4) pounds of soaking soybeans intended for production;

c.    On March 20, 2012, a production employee wearing black rubber boots used during production and typically stored outside the firm was observed standing on the edge of an uncovered gray plastic tote holding (b)(4) to (b)(4) pounds of soaking soybeans as he cleaned the walls of the production room; and

d.    On March 21, 2012, water splashed from a cleaning brush and a metal tray being scrubbed by an employee and into a white plastic tote holding (b)(4) to (b)(4) pounds of soaking soybeans intended for production.

2. As required by 21 CFR 110.80(b)(13), you must fill, assemble, and package food in a manner which protects food from contamination. However, on March 19, 2012,

a.    An employee touched his nose twice with his gloved hand and resumed handling ready-to-eat tofu pieces in the packaging room without washing his hands or changing his gloves;

b.    The street clothing shirt sleeves of a production employee came in direct contact with ready-to-eat (RTE) fresh tofu being cut prior to packaging in the packaging room; and

c.    Sliced RTE fresh tofu pieces were stored on a metal tray on top of a flattened cardboard covering a waste receptacle in the packaging room. The waste receptacle contained refuse such as used gloves and packaging material.

In addition, on March 21, 2012,

d.    The street clothing shirt sleeve of a production employee came in direct contact with RTE fried tofu as the tofu pieces were placed onto styrofoam trays in the packaging room.

3. As required by 21 CFR 110.80(b)(5), you must handle all work in-process in a manner that protects against contamination. However,

a.    On March 19, 2012, the sleeve of street clothes worn by a production employee came in direct contact with in-process fresh tofu as it was cut and handled before placing the pieces in a deep fryer; an employee touched their face with a gloved hand and then resumed handling in-process fresh tofu pieces at the deep fryer; and

b.    On March 20, 2012, an employee exited the production room to discard okara (leftover filtered solid product after soymilk is spun in a centrifuge) into a dumpster, touched the grimy surface of the east production room door handle, rinsed their gloved hands with water only, then touched the grimy surface of the separator power switch along the north wall and the bottom of a plastic bucket stored on the floor.  He then proceeded to manually handle in-process soybeans and a fabric filter used to hold soybeans in the separator with the same gloved hands without prior washing and sanitizing.

4. As required by 21 CFR 110.80(b)(7), you must construct, handle and maintain equipment, containers and utensils used to convey, hold and store food in a manner that protects against contamination. However, on March 20, 2012,

a.    Seven plastic colanders were stored unprotected on an inverted plastic bucket outside the facility along the west wall in an area accessible to insect, rodent or avian activity.  An employee selected one of these colanders, and then used the colander to scoop soaking soybeans from plastic totes.  The colander was not cleaned with detergent or sanitized prior to use; and

b.    A red hose was observed dragged across the production room floor.  This hose was later observed in contact with a blue colander which was subsequently submerged into a plastic tote filled with soaking soybeans.  The red hose was not observed cleaned and sanitized prior to use.

5. As required by 21 CFR 110.80(b)(1), you must maintain equipment in acceptable condition through appropriate cleaning and sanitizing. However, our investigators observed food product build-up inside two plastic wheeled totes, one of which was then filled with boiling soymilk for coagulation.  Food product residue was observed inside the metal chute of two separators after the equipment was cleaned and prior to use in production.

6. As required by 21 CFR 110.35(c), you must take effective measures to exclude pests from the processing area and protect against the contamination of food on the premises by pests. However,

a.    On March 19, 2012, a live insect was on the floor underneath the hand wash sink along the North wall of the packaging room; two live flies were in the packaging room;

b.    On March 19, 2012, at least thirty-five rodent excreta pellets were under the hand-wash sink in the employee restroom;

c.    On March 20, 2012, a live insect was observed on the pressure gauge for the tofu presses along the south wall of the production room; on March 21, 2012, a live fly was on the side of a metal tray within two inches of fried tofu pieces stored in the same tray in the packaging room; a live insect and a dead insect were on the floor in the south east corner of the packaging room; and

d.    On March 21, 2012, 13 rodent excreta pellets were in the southwest corner of the packaging room between and under two file cabinets; at least 20 rodent excreta pellets on the floor to wall juncture of the southwest corner of the packaging room; one dead rodent was under the water-heater framework in the southeast corner of the packaging room; one live and one dead insect were on the floor in the southwest corner of the packaging room.

7. As required by 21 CFR 110.20(b)(7), you must provide, where necessary, adequate screening or other protection against pests.  However,

a.    For three and one half hours on March 19, one and three quarters hours on March 20, and three and one quarter hours on March 21, 2012, the unscreened east production room door was partially open with at least a one inch wide gap to the outside.  On March 19 and 20, 2012, the dumpster located outside of this door was open during the same time frame;

b.    On March 19, 2012, two pigeons and three other birds were standing on the ground outside the opened unscreened east production room door while tofu was being fried inside the room;

c.    On March 20, 2012, the unscreened east pedestrian door in the packaging room was open for approximately fifty-five minutes.  When closed, a three eighths of an inch gap extends three feet from the floor along the side the door;

d.    A one-quarter inch gap exists between the west pedestrian door leading to the outside of the facility in the packaging room and the door frame; and

e.    A gap approximately two inches in width and 15 inches in height exists on the north side of the air conditioning unit located on the west wall near the southwest corner of the packaging room.

8. As required by 21 CFR 110.20(b)(4), your facility must be constructed so that floors can be adequately cleaned and kept clean and in good repair. However, our investigators observed:

a.    One crack at least one inch wide by three feet in length near the northwest corner in front of the boilers and separators;

b.    Cracked cement and uneven worn flooring within three feet surrounding the floor drain near the east wall of the production room;

c.    Six cracked floor tiles measuring one foot square around the tray wrapper in the northeast corner of the packaging room; and

d.    Cracked and missing sections of tile in the northwest corner of the packing room around the retail cooler.

9. As required by 21 CFR 110.37(b), your plumbing must be of adequate size and design and adequately installed and maintained. However our investigators observed standing water approximately one-quarter inch deep encompassing approximately eighty percent of the production room floor. The floor drain along the east wall was backed up and contained standing water.  

10. As required by 21 CFR Part 110.20(b)(1), your facility must provide sufficient space for placement of equipment and storage of materials as is necessary for the maintenance of sanitary operations and the production of safe food. However, aprons worn by production employees are stored in the employee restroom and on the wall exterior to the facility near the east production room door; black rubber boots worn by production employees were stored on the ground outside of the facility under a table along the west side of the building; plastic tubs, plastic crates, cardboard boxes, brooms and mops and empty paper ingredient bags were stored outside along the east wall of the facility; plastic crates, cardboard boxes, wood beams, and a ladder were stored outside along the west wall of the facility.

Misbranding

11. Your “Chuminh Tofu Fried Soybean Cake (Tofu)” and your green colored and uncolored “Chuminh Fresh and Delicious Soybean Drink, Sweetened” products are misbranded within the meaning of section 403(i)(2) of the Act [21 USC 343(i)(2)] because they are fabricated from two or more ingredients, but the labeling fails to bear a complete list of all the ingredients by common or usual name, as well as sub-ingredients, in descending order of predominance by weight, as required by 21 CFR 101.4(a)(1).  Specifically:
 
a.    The ingredient statement for your “Chuminh Tofu Fried Soybean Cake (Tofu)” product includes corn oil, however, the product is made with soybean oil rather than corn oil. Therefore the ingredient statement must declare soybean oil rather than corn oil; and
 
b.    The ingredient statements for your un-colored and green colored “Chuminh Fresh and Delicious Soybean Drink, Sweetened” products do not declare the ingredient “sugar”.
 
12. Your green colored “Chuminh Fresh and Delicious Soybean Drink, Sweetened” product is adulterated within the meaning of section 402(c) of the Act [21 U.S.C. § 342(c)] because the product bears or contains a color additive which is unsafe within the meaning of section 721(a) of the Act [21 U.S.C. § 379(a)]. Section 721(a) deems a color additive to be unsafe unless its use is in conformity with the color additive’s listing regulation. Specifically, the listing regulation for FD&C Yellow No. 5 requires that the color additive be listed by that name in the ingredient list on the labels of foods for human use [21 CFR 74.705(d)(2)]. Your green colored “Chuminh Fresh and Delicious Soybean Drink, Sweetened” product is manufactured with the ingredient “Pandan Screwpine Flavored Paste” which contains FD&C Yellow #5; however, the label for the finished product fails to declare the presence of FD&C Yellow #5 in the ingredient statements.

13. Your green colored “Chuminh Fresh and Delicious Soybean Drink, Sweetened” product is misbranded within the meaning of section 403(k) of the Act [21 U.S.C. § 343(k)] because it contains an artificial flavoring, coloring, or chemical preservative, and fails to bear labeling stating that fact.  Your product is manufactured with the ingredient “Pandan Screwpine Flavored Paste” which contains certified color additives FD&C Yellow #5 and FD&C Blue #1, as well as artificial flavor; however, your finished product label fails to identify the presence of these ingredients.  In accordance with 21 CFR 101.22(k), the label of a food to which any coloring has been added shall declare the coloring in the statement of ingredients.  Under 21 CFR 101.22(k)(1), certified colors must be declared by the name of the color additive listed in the applicable regulation in part 74 or part 82 of this chapter.  The common or usual name may be abbreviated to omit the "FD&C" prefix and the term “No.” (e.g., Yellow 5).

14. Your “Chuminh Fresh Soybean Cake (Tofu),” “Chuminh Fried Soybean Cake (Tofu),” green colored and uncolored “Chuminh Fresh and Delicious Soybean Drink, Sweetened,” and “Chuminh Fresh and Delicious Soybean Drink, Unsweetened” products are misbranded within the meaning of Section 403(a)(1) of the Act [21 U.S.C. § 343(a)(1)] in that they contain false or misleading information.  Specifically,
 
a.    The nutrition facts panels for your green colored and uncolored “Chuminh Fresh and Delicious Soybean Drink, Sweetened” product and your “Chuminh Fresh and Delicious Soybean Drink, Unsweetened” product contain conflicting information. Your “Chuminh Fresh and Delicious Soybean Drink, Unsweetened” product declares “Calories” as 150, “Total Carbohydrate” as 24 g, “Sugar” as 0 g, “Dietary Fiber” as 0g, and “Other Carbohydrate” as 2 g. The declared amount of total carbohydrate for the unsweetened product (24 g) is incorrectly declared as greater than the sum of the sugar, dietary fiber, and other carbohydrate declarations (2 g). Additionally, your green colored and uncolored “Chuminh Fresh and Delicious Soybean Drink, Sweetened” product declares “Total Fat” as 2.5 g, “Calories” as 150, “Total Carbohydrate” as 2 g, “Sugar” as 22 g, “Dietary Fiber” as 0g, “Other Carbohydrate” as 2 g, and “Protein” as 8 g.  The amount of declared sugars in the sweetened product (22 g) is incorrectly declared as greater than the amount of declared total carbohydrate (2 g). Further, although the sweetened product declares “Calories” as 150, based on the declared amounts of total fat (2.5 g), total carbohydrate (2 g), and protein (8 g), there would be approximately 60 calories in a serving of the sweetened product; and
 
b.    The nutrition facts panels for your “Chuminh Fresh Soybean Cake (Tofu)” product and your “Chuminh Fried Soybean Cake (Tofu)” product contain conflicting information. Both products declare “Calories from Fat” as “40” and “Total Fat” as “14 g”. Based on the declared amount of total fat, there would be approximately 130 calories from fat in a serving of either product. Additionally, both products declare “Calories” as 250, “Total Fat” as 14 g, “Total Carbohydrate” as 19 g, and “Protein” as 24 g. Based on the declared amounts of total fat (14 g), total carbohydrate (19 g), and protein (24 g), there would be approximately 300 calories in a serving of either product. 

15. Your “Chuminh Fresh Soybean Cake (Tofu)”, “Chuminh Fried Soybean Cake (Tofu)”, green colored and uncolored “Chuminh Fresh and Delicious Soybean Drink, Sweetened”, “Chuminh Fresh and Delicious Soybean Drink, Unsweetened”, and “Chuminh Fresh Soybean Pudding” 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 defined in 21 CFR 101.9. For example:

a.    Trans fat is not declared for any of the product labels [21 CFR 101.9(c)(2)(ii)];
b.    Your “Fresh and Delicious Soybean Drink, Unsweetened” and “Fresh and Delicious Soybean Drink, Sweetened” product labels do not declare Cholesterol [21 CFR 101.9(c)(3)];
c.    Your “Chuminh Fresh Soybean Cake (Tofu)” and “Chuminh Fried Soybean Cake (Tofu)” product labels fail to declare “Sugars” [21 CFR 101.9(c)(6)(ii)];
d.    Your “Chuminh Fresh Soybean Cake (Tofu)” and “Chuminh Fried Soybean Cake (Tofu)” product labels fail to include the percent daily value for protein as required when the label bears a nutrient content claim for protein [21 CFR 101.9(c)(7)(i)];
e.    Your green colored and uncolored “Chuminh Fresh and Delicious Soybean Drink, Sweetened” and the “Chuminh Fresh and Delicious Soybean Drink, Unsweetened” product labels do not declare the amount of Iron and Calcium [21 CFR 101.9(c)(8)(ii)]; and
f.    The serving size declaration for all of your product labels is not expressed in common household measure in accordance with 21 CFR 101.9(b)(5) and 21 CFR 101.12(b). For example, the reference amount customarily consumed for bean cake (tofu) is 85 g. A sample label statement is “__ pieces (g)” for discrete pieces, and “3 oz (84 g/visual unit of measure)” for bulk products. Furthermore, the soybean drink products incorrectly use a 32 oz serving size, rather than 8 oz.

16. Your “Chuminh Fresh Soybean Cake (Tofu)”, “Chuminh Fried Soybean Cake (Tofu)”, green colored and uncolored “Chuminh Fresh and Delicious Soybean Drink, Sweetened”, “Chuminh Fresh and Delicious Soybean Drink, Unsweetened”, and “Chuminh Fresh Soybean Pudding” products are misbranded within the meaning of section 403(f) of the Act [21 U.S.C. § 343(f)] because the product labels contain information in 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.

This letter may not list all the violations at your facility. You are responsible for ensuring that your food facility operates in compliance with the Act and the Current Good Manufacturing Practice regulations (21 CFR 110) and the Food Labeling regulations (21 CFR 101). You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations.
 
Failure to implement lasting corrective action of these violations may result in regulatory action being initiated by FDA without further notice. For example, we may take further action to seize your products and/or enjoin your firm from operating.
 
We also note the following comments about your product labels:
  • Your “Chuminh Tofu Fresh Soybean Pudding” product contains separately packaged syrup and pudding ingredients.  However, only the pudding ingredient contains complete labeling information, including nutrition facts information.  If one label is to be used to label both ingredients in the product, it should include complete information for both ingredients, including nutrition facts information and net weight information, and must represent the product as packaged.  For example, the nutrition label declares “sugars” as “0 g”, however, the Tofu Syrup declares “sugar” as an ingredient. 
  • Your green colored and uncolored “Chuminh Fresh and Delicious Soybean Drink, Sweetened”, “Chuminh Fresh and Delicious Soybean Drink, Unsweetened”, “Chuminh Tofu Fried Soybean Cake (Tofu)”, and “Chuminh Tofu Fresh Soybean Cake (Tofu)” product labels do not declare the net weight of the product in both metric (grams, kilograms, milliliters, liters) and U.S. Customary System (ounces, pounds, fluid ounces) terms as required under the Act [21 U.S.C. § 343(e)(2)],as well as, the Fair Packaging and Labeling Act (FPLA) [15 U.S.C. §1453(a)(2)].  
  • Your “Chuminh Fresh and Delicious Soybean Drink, Unsweetened” and green colored and uncolored “Chuminh Fresh and Delicious Soybean Drink, Sweetened” nutrition labels misspell “Monounsaturated fat” (“Monosaturated Fat”) on the nutrition label. 
  • Your “Chuminh Fresh Soybean Pudding” nutrition label misspells “Saturated fat” (“Satuyrated Fat”), and is not indented as required in 21 CFR 101.9(c)(2)(i). 
  • The name of the manufacturer is missing on your “Chuminh Fresh Soybean Pudding” label, in accordance with 21 CFR 101.5. Only the address is declared.
  • Your “Chuminh Fresh Soybean Pudding” nutrition label declares “calcium” as one of the ingredients. “Calcium” is not a common or usual name for an ingredient in accordance with 21 CFR 101.4(b).
  • Your colored and uncolored “Chuminh Fresh and Delicious Soybean Drink, Sweetened” products and the “Chuminh Fresh and Delicious Soybean Drink, Unsweetened” product Nutrition Facts Panel is not set off within a box contained by hairlines, and is not properly formatted. [21 CFR 101.9(d)];
  • Your “Chuminh Fresh Soybean Pudding” product nutrition label declares “0 g” as the % daily value for dietary fiber, which is not in accordance with 21 CFR 101.9(c)(9).
  • The placement of the footnote, “*Percent daily values are based on a 2000 calorie diet” for all your product labels should be placed beneath the list of vitamins and minerals and should be separated from that list by a hairline. [21 CFR 101.9(d)(9)].
  • Your “Chuminh Fresh and Delicious Soybean Drink, Sweetened” product would be expected to contain greater calories compared to the “Chuminh Fresh and Delicious Soybean Drink, Unsweetened” product resulting from the presence of an additional 22g of sugar in the sweetened product; however, both products are identical in the declared amount of calories.
  • Your “Chuminh Fried Soybean Cake (Tofu)” product, which uses soybean oil, would be expected to contain more fat and calories than your “Chuminh Fresh Soybean Cake (Tofu)” product, which does not contain soybean oil; however, both products are identical in the declared amount of all nutrients.
 
We request that you notify this office in writing, within 15 working days from your receipt of this letter, of the current status of your corrective actions and the specific steps you have taken to correct the noted violations. In your response, include documentation such as certification of actions performed by a licensed exterminator, other actions performed to control unauthorized entrance of pests, plans on how you intend to protect food products from possible contamination, and/or any other useful information 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 when you will correct any remaining violations.
 
Section 743 of the Act (21 U.S.C. 379j-31) authorizes FDA to assess and collect fees to cover FDA’s costs for certain activities, including re-inspection-related costs. A re-inspection is one or more inspections conducted subsequent to an inspection that identified noncompliance materially related to a food safety requirement of the Act, specifically to determine whether compliance has been achieved. Re-inspection-related costs means all expenses, including administrative expenses, incurred in connection with FDA’s arranging, conducting, and evaluating the results of the re-inspection and assessing and collecting the re-inspection fees (21 U.S.C. 379j-31(a)(2)(B)). For a domestic facility, FDA will assess and collect fees for re-inspection-related costs from the responsible party for the domestic facility.  The inspection noted in this letter identified noncompliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any re-inspection-related costs.
 
Please send your reply to the Food and Drug Administration, Attention: Cynthia White, Compliance Officer, 22215 26th Avenue SE, Suite 210, Bothell, Washington 98021-4421. If you have questions regarding any issue in this letter, please contact Cynthia White at (425) 302-0422.
 
                                                                             
Sincerely,
/S/ 
Charles M. Breen
District Director
 
cc:  Washington State Department of Agriculture
       Food Safety Program
       P.O. Box 42560
       Olympia, Washington 98504-2560

 

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