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U.S. Department of Health and Human Services

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Enforcement Actions

Seoul Shik Poom Inc. 10/29/09

  

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

Public Health Service
Food and Drug Administration
 Waterview Corporate Center
10 Waterview Blvd., 3rd Floor
Parsippany, NJ 07054


Telephone (973) 331-4908


October 29, 2009

WARNING LETTER

CERTIFIED MAIL
RETURN RECEIPT REQUESTED

Mr. Joon Kab Kwon
Chairman and Chief Executive Officer
Seoul Shik Poom, Inc.
360 S. Van Brunt Street
Englewood, NJ 07631

                               File No.: 10-NWJ-01

Dear Mr. Kwon:

We inspected your seafood importer, warehouse, and repackaging facility located at 360 S. Van Brunt Street, Englewood, NJ, from 06/02/2009 through 06/19/2009. We found that you have serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations, Part 123 (21 CFR Part 123). The specific requirements for imported fish and fishery products are set out in 21 CFR 123.12. In accordance with 21 CFR 123.12(d), there must be evidence that all fish and fishery products offered for entry into the United States have been processed under conditions that comply with 21 CFR Part 123. If assurances do not exist that an imported fish or fishery product has been processed under conditions that are equivalent to those required of domestic processors under 21 CFR Part 123, the fish or fishery product will appear to be adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 342(a)(4)] and will be denied entry. In addition, in accordance with 21 CFR 123.6(g), your frozen salted and gutted mackerel and salted and' fermented wild anchovy are adulterated under Section 402(a)(4)of the Act. You may find the Act, the seafood HACCP regulation and the Fish and Fisheries Products Hazards & Controls Guidance through links in FDA's home page at www.fda.gov.

Your significant violations were as follows:
• Your firm does not have product specifications for your frozen salted and gutted mackerel and salted and fermented wild anchovy that specifically address the hazards of histamine and pathogens. You must have product specifications that are designed to ensure that the fish and fishery products you import are not injurious to health, to comply with 21 CFR 123.12 (a)(2)(i).

• Your firm failed to implement affirmative steps to ensure that your frozen salted and gutted mackerel and salted and fermented wild anchovy were processed in accordance with the seafood HACCP regulation. Under 21 CFR 123.12(a)(2)(ii), you must take affirmative steps to ensure that the fish and fishery products you import are processed in accordance with the seafood HACCP regulation. You must provide adequate evidence that all fish and fishery products offered for entry into the United States have been processed under conditions that are equivalent to those required of domestic processors, to comply with 21 CFR 123.12(d).

We also verified that, in addition to seafood, you repackage and distribute a wide variety of food products. We collected samples of Choripdong brand Apricots and Dried Sliced Radish, and you provided product labels of various products. Our laboratory analysis and review of your product labels revealed violations of the Act and FDA's Food Labeling regulations (21 CFR Part 101). As a result of these violations, several of your products are misbranded within the meaning of section 403 of the Act [21 U.S.C. § 343]. You can find the Act and the food labeling regulations through links on FDA's website at http://www.fda.gov.

Your significant violations were as follows:

• Your Choripdong brand Apricots product is misbranded within the meaning of section 403(k) of the Act [21 USC § 343(k)], because you failed to declare sulfites and their function as a preservative on the product label, which is required under 21 CFR 101.22(j). FDA's analysis of this product found 1956.5 ppm of sulfites titrimetrically, and a check revealed 2058.5 of ppm sulfites gravimetrically.

• Your Dried Slices of Radish product is misbranded within the meaning of section 403(f) of the Act [21 USC § 343(f)], because the ingredient statement is not in' English, which is required under 21 CFR 101.15(c)(1). It also is misbranded within the meaning of section 403(e)(2) of the Act [21 USC § 343(e)(2)], because the quantity of the contents is not listed in US customary units, which is required under 21 CFR 101.105(b)(1), and within the meaning of section 403(e)(1) [21 USC § 343(e)(1)], because it does not list the name and place of business of the manufacturer, packer, or distributor, which is required under 21 CFR 101.5(a).

• Your Choripdong brand Green Whole Pea (2 lbs.) product is misbranded within the meaning of section 403(q)(2)(A) of the Act [21 USC § 343(q)(2)(A)], because the amount of trans fat is not declared on the Nutrition Facts panel, which is required under 21 CFR 101.9(c)(2)(ii). Your Choripdong brand Pecan (10 oz.) product also is misbranded within the meaning of section 403(q)(2)(A) of the Act, because its Nutrition Facts panel lists "trans" fat but does not include a statement of the number of grams per serving, as required under 21 CFR 101.9(c)(ii).

• Your Choripdong brand Green Whole Pea (2 lbs.) and Pecan (10 oz.) products are misbranded within the meaning of section 403(e)(1) [21 USC § 343(e)(1)] as well. As stated above, 21 CFR 101.5(a) requires the label of a packaged food to list the name and place of business of the manufacturer, packer, or distributor. While the labels of both products list your business name as distributor, they do not list your current business address.

• Your (b)(4) Fresh Tuna product is misbranded within the meaning of section 403(a)(1) of the Act [21 U.S.C. 343(a)(1)], because it is canned tuna product that is labeled "fresh." Your use of the word "fresh" implies that this product is unprocessed or unpreserved. However, the product fails to meet definition of fresh as outlined in 21 CFR 101.95(a), because it is not in its raw state and has been subjected to either a form of thermal processing or another form of preservation.

• Your (b)(4) Fresh Tuna product is also misbranded within the meaning of section 403(w) of the Act [21 U.S.C. 343(w)] in that the label states shellfish extract as an ingredient, but fails to declare the major food allergens present in this product as required by section 403(w)(1). Section 201 (qq) of the Act [21 U.S.C. 321 (qq)] defines "major food allergens" 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. 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. " shellfish (Crustacean shellfish)"), 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 (b)(4) Fresh Tuna product is misbranded under section 403(i) of the Act [21 U.S.C. 343(i)] as well in that the label fails to bear a complete list of all of the ingredients by common or usual name in descending order of predominance by weight.
As examples, sea tangle extract and savory seasoning powder are listed as ingredients on the label of your (b)(4) Fresh Tuna product. If either ingredient is made of two or more ingredients, you must list the component ingredients in accordance with 21 CFR 101.4(b)(2). 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, or by listing the component ingredients without listing the ingredient itself. Under the first alternative, the component ingredients must be listed in descending order of the 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.

We may take further action if you do not promptly correct these violations. For instance, we may take further action to refuse to admit your imported fish or fishery products under Section 801 (a) of the Act [21 U.S.C. § 381 (a)], place them on "detention without physical examination," seize your product(s), and/or enjoin your firm from operating.

You should 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. You should include in your response documentation, such as corrected HACCP and importer verification records, records that document the performance and results of your firm's affirmative steps, labeling,· or other useful information that would assist us in evaluating your corrections. If, you cannot complete all corrections before you respond, you should explain the reason for your delay and state when you will correct any remaining violations.

This letter may not list all the violations at your facility. You are responsible for ensuring that the seafood importer aspect of your establishment operates in compliance with the Act and the seafood HACCP regulation (21 CFR Part 123). You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations for the fish or fishery products that you import into the United States. Also, the above violations relating to labeling requirements are not meant to be an all-inclusive list of deficiencies that may exist on any of your product labeling. It is your responsibility to ensure that your labels comply with each applicable requirement of the Act and FDA regulations.

Please send your reply to the Food and Drug Administration, New Jersey District Office, 10 Waterview Blvd., 3rd Floor, Parsippany, New Jersey 07054, Attention: Kerry A. Donovan, Compliance Officer. If you have questions regarding any issues in this letter, please contact Ms. Donovan at 973-331-4908.

Sincerely,

/s/

Diana Amador-Toro
District Director
New Jersey District