Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
|Baltimore District Office|
6000 Metro Drive, Suite 101
Baltimore, MD 21215
Telephone: (410) 779-5455
FAX: (410) 779-5707
CMS # 480928
December 3, 2015
Mr. Ju Bong Nam, Owner
Nam & Nam, Inc. t/a Sam Sung Tofu
409 Morse Street, NE
Washington, DC 20002
Dear Mr. Nam:
The Food and Drug Administration (FDA) conducted an inspection of your tofu manufacturing facility located at 409 Morse Street, NE, Washington, DC 20002 from June 18, 2015 through June 23, 2015. During the inspection, we found significant violations within the Current Good Manufacturing Practices (21 CFR 110) and Food Labeling (21 CFR 101) regulations. Accordingly, it was determined that your firm’s tofu products are adulterated within the meaning of 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (“the Act”) [21 U.S.C. § 342(a)(4)], in that they have been prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth, or whereby they may have been rendered injurious to health. Further, FDA conducted a label review of your 50 piece, bulk-packaged tofu and found significant violations of the labeling regulations for foods (21 CFR 101). These violations cause your bulk-packaged foods to be misbranded within the meaning of section 403 of the Act [21 U.S.C. § 343].
(b)(3)(A) You may find the Act and its implementing regulations through links on FDA’s home page at www.fda.gov.
Specifically, our inspection of your facility revealed the following violations:
1. You failed to conduct cleaning and sanitizing operations for utensils and equipment in a manner that protects against contamination of food-contact surfaces, as per 21 CFR 110.35(a). During the current inspection, it was observed that your firm does not perform a sanitizing step on manufacturing equipment used to process tofu.
2. You failed to provide employees with adequate toilet facilities, as per 21 CFR 110.37(d). During the current inspection, a toilet with a trash receptacle was observed full of used toilet paper located in the restroom. A firm employee stated that the toilet cannot flush toilet paper. Furthermore, no hand washing sink is located in your restroom.
3. Employees at your firm did not wash and sanitize hands thoroughly in an adequate hand-washing facility after each absence from the work station and at any time their hands may have become soiled or contaminated, as per 21 CFR 110.10(b)(3). During the current inspection, employees were observed leaving their workstations and returning to their workstations to process tofu prior to any hand-washing.
4. Plumbing at your firm constitutes a source of contamination to food, water supplies, equipment, and utensils, as per 21 CFR 110.37(b)(3). During the current inspection, a water leak was observed in the manufacturing area, leaking water from the ceiling onto the floor approximately three (3) feet from uncovered tofu.
5. You failed to properly store toxic cleaning compounds in a manner that protects against contamination of food and food-packaging materials, as per 21 CFR 110.35(b)(2). During the current inspection, an open container of cleaning compound labeled in part, “DANGER Harmful if swallowed” was observed to be stored beside finished tofu product.
1. Your 50 piece, bulk-packaged tofu is misbranded within the meaning of section 403(w) of the Act, 21 U.S.C. § 343(w), in that the finished product label fails to declare the major food allergens, soy (soybeans) as required by section 403(w)(1) of the Act.
Section 201(qq) of the Act, 21 U.S.C. § 321(qq), defines a major food allergen as milk, egg, fish, Crustacean shellfish, tree nuts, wheat, peanuts, and soybeans, as well as any food ingredient that contains protein derived from one of these foods, with the exception of highly refined oils, as “major food allergens.” 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:
- 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
- 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 (e.g. “(wheat)”), 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 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)].
Your bulk tofu is packaged in a cardboard container lined with plastic and fails to declare the presence of the major food allergen soy.
2. Your 50 piece, bulk-packaged tofu is misbranded within the meaning of section 403(i)(2) [21 U.S.C. § 343(i)(2)] in that it is fabricated from two or more ingredients and each ingredient is not declared on the label, as required by 21 CFR 101.4. For example, your 50 piece, bulk-packaged tofu is manufactured using soybeans and calcium sulfate; however, you fail to list both of these ingredients on your finished product label.
3. Your 50 piece, bulk-packaged tofu is misbranded within the meaning of section 403(i)(1) of the Act [21 U.S.C. § 343(i)(1)] in that the product label fails to bear the common or usual name of the food. For example, the product label fails to declare a statement of identity as required by 21 CFR 101.3.
4. Your 50 piece, bulk-packaged tofu is misbranded within the meaning of section 403(e)(1) of the Act [21 U.S.C. § 343(e)(1)] in that the product label fails to list the place of business of the manufacturer, packer, or distributor in accordance with 21 CFR 101.5.
5. Your 50 piece, bulk-packaged tofu is misbranded within the meaning of section 403(e)(2) of the Act [21 U.S.C. § 343(e)(2)] in that the product label fails to declare the net quantity of contents on the principal display panel as required by 21 CFR 101.105.
This letter is not an all-inclusive list of violations at your facility. It is your responsibility to ensure that your products comply with the FD&C Act and FDA’s implementing regulations. Failure to promptly correct the violations specified above may result in enforcement action without further notice, including, without limitation, seizure or injunction.
Section 743 of the FD&C 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 FD&C 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 FD&C Act. Accordingly, FDA may assess fees to cover any re-inspection-related costs.
You should respond in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific things you have done or plan to do to correct these violations and prevent their recurrence. You should include in your response documentation and other useful information that would assist us in evaluating your corrections. If you cannot complete all corrections within 15 working days, you should explain the reason for your delay and the timeframe within which the remaining corrections will be completed.
Please send your reply to the U.S. Food and Drug Administration, Attention: David P. Rice, Compliance Officer at the address above. If you have questions regarding any issues in this letter, please contact Mr. Rice by phone at 410-779-5463 or by email at email@example.com.
Baltimore District Office