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WARNING LETTER

Korean Food, Inc. MARCS-CMS 669241 —

Delivery Method:
UPS Overnight
Product:
Food & Beverages
Recipient:
Recipient Name
Ms. Sung Hee Pak
Recipient Title
Owner
Korean Food, Inc.

1311 Luke St
Irving, TX 75061
United States

Issuing Office:
Division of Human and Animal Food Operations West III

United States

January 8, 2024

WARNING LETTER

CMS #669241

Dear Ms. Pak:

The U.S. Food and Drug Administration (FDA) inspected your sprout and kimchi production facility located at 1311 Luke St, Irving, Texas on August 21 through August 25, 2023. Our inspection revealed serious violations of the Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption, Title 21, Code of Federal Regulations, Part 112 (21 CFR Part 112) (Produce Safety Rule) (PSR), specifically Subpart M – Sprouts, and the Food Labeling regulation, Title 21, Code of Federal Regulations, Part 101 (21 CFR Part 101).

Based on our inspectional findings and a subsequent review of your product labels collected during the inspection, we have determined that the soybean sprouts grown in your operation are adulterated within the meaning of Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 USC § 342(a)(4)], in that they were prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth or rendered injurious to health. Additionally, the labeling for the kimchi products manufactured in your facility are misbranded within the meaning of Section 403 of the Act [21 U.S.C. § 343(a)(1)]. Failure to comply with the PSR is a prohibited act under section 301(vv) of the Act [21 U.S.C. § 331(vv)]. You may find the Act and its implementing regulations through internet links on FDA's home page at http://www.fda.gov.

At the conclusion of our inspection, we to issued you a Form FDA 483, Inspectional Observations, listing observations found during our inspection. We received your responses via email on August 26, 2023; September 6, 2023; September 18, 2023; September 22, 2023; and September 24, 2023. We address your responses below.

Produce Safety Rule Violations

During the inspection, our investigator observed the following significant violations of the PSR, 21 CFR Part 112:

1. You did not establish and implement a written environmental monitoring plan that is designed to identify Listeria species or Listeria monocytogenes if it is present in your growing, harvesting, packing, and holding environment in accordance with the requirements of 21 CFR 112.145. During our inspection, our investigator found that you have not established a written environmental monitoring plan, and do not conduct any testing for Listeria species or Listeria monocytogenes in your growing, harvesting, packing, and holding environment. You stated that you were not aware of the requirement, and, to the best of your knowledge, you have never conducted environmental sampling in your operation’s history.

In your written response dated August 26, 2023, you stated you will conduct environmental testing and have a written record (b)(4). In your supplemental written response dated September 22, 2023, you provided a laboratory testing result. This testing result was for one sponge swab, taken from an operation table, which was analyzed for Listeria, and the result of that analysis was negative. The Produce Safety Rule requires environmental swabs to be collected from both food-contact and non‐food‐contact surfaces (21 CFR 112.145(c)(3)). Your written responses are not adequate to address this violation in that you have not provided any documentation related to your establishment and implementation of a written environmental monitoring plan that meets the requirements of 21 CFR 112.145.

2. You did not establish and implement a written sampling plan that identifies the number and location of samples (of spent sprout irrigation water (SSIW) or sprouts) to be collected for each production batch of sprouts to ensure that the collected samples are representative of the production batch when testing for contamination as specified in 21 CFR 112.147 and in accordance with 21 CFR 112.144(b). Production batch of sprouts means all sprouts that are started at the same time in a single growing unit. 21 CFR 112.3. You routinely plant soybean sprouts  (b)(4), and you stated that you harvest sprouts after approximately (b)(4). Each planting would be, at a minimum, one production batch of sprouts. However, you only test SSIW (b)(4) from a randomly selected batch. This is insufficient to ensure that representative samples of SSIW are collected for each production batch of sprouts.

In your written response dated August 26, 2023, you stated that you will talk to the lab and see if you can arrange (b)(4) testing schedule. In your supplemental written response dated September 22, 2023, you provided a laboratory testing result. This testing result was for a sample identified as “Sprout Water Pulled Out Today At 8 AM”, which was tested for Listeria monocytogenes and Salmonella. The testing results were negative for both pathogens. This sample was not analyzed for E. coli O157:H7 as required under 21 CFR 112.144(b), and the documentation did not identify a specific production batch of sprouts from which the sample was collected. Your written responses are not adequate to address this violation in that none of your written responses included documentation related to your establishment and implementation of a written sampling plan for collecting and testing SSIW or sprouts to meet the requirements of 21 CFR 112.147.

3. You did not clean and sanitize food contact surfaces used to grow sprouts before contact with sprouts or seeds for sprouting, as required by 21 CFR 112.143(b). Food contact surfaces means those surfaces that contact human food and those surfaces from which drainage, or other transfer, onto the food or onto surfaces that contact the food ordinarily occurs during the normal course of operations. Food contact surfaces include equipment and tools used during harvest, packing, and holding (See 21 CFR 112.3).

During your facility’s cleaning operation, our investigator observed the following:

  • An employee sprayed a (b)(4) liquid on the sprout washer and spinner that was not properly cleaned, as evidenced by soil on the equipment. You identified this liquid as a sanitizer. Cleaning must be done before sanitizing because sanitizing is generally not effective unless the surface is cleaned first. In addition, you did not know what the (b)(4) liquid was or the directions for use, as you had discarded the original container.
  • Black organic residues present on the exit panel of the sprout washer and on the lid edge of the sprout spinner. Sprouts were observed touching these areas during the washing and (b)(4)‐drying processes.
  • The sprout irrigation machine was covered with foil that was torn and soiled with a black/brown residue in growing room (b)(4). Soybean sprouts were observed growing in (b)(4) underneath this foil, and water was observed dripping from the irrigation machine.

In your written response dated August 26, 2023, you stated that you will write down the cleaning and sanitation procedures. You stated that the (b)(4) liquid sanitizer has been discontinued, you have replaced it with something else, and will use it to the proper dilution. You stated that the edge of the sprout spinner has been cleaned thoroughly and the irrigation machine will be regularly repaired, cleaned, and sanitized.

In your written response dated September 6, 2023, you provided a written cleaning procedure and a photograph of the sprout washer, which you identified as having been cleaned with soap and sanitized. To date, you have not provided documentation demonstrating corrective action taken to address the condition of the sprout irrigation machine. We reviewed your responses and are unable to assess the adequacy of your responses. We will evaluate the adequacy of your corrective action in the next inspection.

4. You did not provide adequate drainage in all areas where normal operations release or discharge water or other liquid waste on the ground or floor of the building, as required by 21 CFR 112.126(a)(2). (b)(4) used for collecting soybean sprouts were stored on a low‐lying shelf/rack over a clogged drain near the sprout washer. Water from the sprout washer, the hand sink in the production area, and the hose that employees were observed to use to wash their hands, was observed to discharge directly onto this floor. Water from these sources pools on the floor contacting the bottom of (b)(4) holding sprouts and is splashed into the (b)(4) holding sprouts while employees walk around. Additionally, the floor of the production area is not maintained in accordance with 21 CFR 112.126(a)(1), in that it is a rough, pitted, unsealed surface. The floor is not able to be adequately cleaned and sanitized.

In your written response dated August 26, 2023, you stated that you moved the (b)(4) to a high shelf and will retrain your staff on hand hygiene. In your written response dated September 6, 2023, you provided photographs of taller racks. In addition, you provided written procedures for cleaning and sanitizing, employee health and hygiene, personnel requirements, and hand washing, which you stated you would have your employees read. You have not included, as a part of your response, a corrective action that addresses the clogged drain or pooling water on the production floor. Furthermore, your responses do not provide a corrective action to addresses the discharge of water from the handwashing sink onto your production room floor, which affects equipment and tools that you store close to the floor. We will evaluate the adequacy of your corrective action in the next inspection.

Misbranding Violations

1. The GO‐HYANG MAK KIMCHI, 16 oz., 32 oz., ½ Gallon, and 1 Gallon container sizes, and the Radish Leaves Kimchi products are misbranded within the meaning of section 403(w) of the Act [21 U.S.C. § 343(w)], in that the finished product labels fail to declare the major food allergen, sand lance and, seasonally, wheat, as required by section 403(w)(1) of the Act.

Section 201(qq) of the Act [21 U.S.C. § 321(qq)], defines milk, egg, fish, Crustacean shellfish, tree nuts, wheat, peanuts, soybeans, and sesame, 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 under section 403(w) of the Act 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., Whey (Milk)), except 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)].

Specifically, during the inspection, investigators were told that Salted Anchovy was listed as an ingredient from “Sand Lance Fish Sauce”; however, the “Sand Lance Fish Sauce” ingredient does not contain anchovies and you fail to declare the sand lance ingredient on the finished product labels. Further, you mention that you sometimes use Oyster Sauce as an ingredient, which is made with the major food allergen, wheat. However, your labels declare oyster sauce, but fail to declare the wheat ingredient.

2. The GO‐HYANG MAK KIMCHI and Radish Leaves Kimchi products are misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] because the labels for the 16 oz., 32 oz., ½ Gallon, and 1 Gallon container sizes:

a. When the kimchi products do have oyster sauce as an ingredient, then the sub‐ingredients of the oyster sauce must be declared in accordance with 21 CFR 101.4(b)(2). According to 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 [21 CFR 101.4(b)(2)(i)], or by listing the component ingredients without listing the ingredient itself [21 CFR 101.4(b)(2)(ii)]. Under the first alternative, the component ingredients must be listed in descending order of 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.
b. For the 32 oz. Go‐Hyang Mak Kimchi and for the Radish Leaves Kimchi, the labels declare the ingredient “M.S.G.” In accordance with 21 CFR 101.22(h)(5), any monosodium glutamate used as an ingredient in food must be declared by its common or usual name, monosodium glutamate.
c. The Radish Leaves Kimchi product does not list radish leaves as part of its ingredient, as required by 21 CFR 101.4(a).
d. The oyster sauce and salted anchovies must be declared only when they are added as ingredients.

3. The GO‐HYANG MAK KIMCHI and Radish Leaves Kimchi products are misbranded within the meaning of section 403(q) of the Act [21 U.S.C. § 343(q)] because each label fails to declare:

a. The correct number of servings per container in accordance with 21 CFR 101.9(b)(8). The number of servings must be calculated from the serving size and the total contents of the package. The labels for the GO‐HYANG MAK KIMCHI products list 10 servings per container for all sizes of product while Radish Leaves Kimchi lists 22 servings per container. The serving size on each product is 30 g which is 300 grams (30g multiplied by 10 servings) or approximately 10.5 ounces for the GO‐HYANG MAK KIMCHI product and 660 grams (30g multiplied by 22 servings) or approximately 23 ounces for the Radish Leaves Kimchi product. Therefore, none of the labels list the correct number of servings per container.
b. The serving size is not expressed in a common household measure that is appropriate to the food, as required by 21 CFR 101.9(b)(1).
c. The nutrients using the format and nutrients required to be declared in accordance with 21 CFR 101.9(c) and (d). For example, the nutrition facts information is not in the current format and therefore does not declare all of the required nutrients, vitamins and minerals, their quantitative amounts, and the correct footnote.

4. Your GO‐HYANG MAK KIMCHI and Radish Leaves Kimchi products are misbranded within the meaning of section 403(f) of the Act [21 U.S.C. §343(f)] because:

a. The GO‐HYANG MAK KIMCHI product label contains information in a foreign language; therefore, all required information must be in both languages (i.e., the English language as well as the foreign language). For example, the Nutrition Facts label must be declared in both the foreign language and English as required by 21 CFR 101.15(c)(2).
b. Your Radish Leaves Kimchi product label fails to list all required statements in English as required by 21 CFR 101.15(c)(1).

5. Your Radish Leaves Kimchi products are misbranded within the meaning of section 403(e)(2) of the Act [21 U.S.C. §343(e)(2)] because:

a. 21 CFR 101.7 does not provide for the use of check boxes for different net quantity of contents statement.
b. 21 CFR 101.7(f) requires that it must appear as a distinct item on the principal display panel and be placed within the bottom 30 percent of the area of the label panel in lines generally parallel to the base on which the package rests as it is designed to be displayed.

This letter is not intended to be an all‐inclusive statement of violations that may exist in connection with your products. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations.

This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address this matter may result in legal action including, without limitation, seizure and injunction.

We also offer the following comments regarding the labeling of your products:

1. Your GO‐HYANG MAK KIMCHI product labels include the following statement: “ALLERGEN INFORMATION CONTAINS SHRIMP & SHELLFISH.” If this statement is intended to be advisory in nature, then it must be truthful and not misleading to the consumer. If this statement is intended to be the “Contains” statement provided for in section 403(w) of the Act, we advise you that:
• Only “Contains” is the acceptable statement phrase.
• You must list all of the major food allergens present in the product.
• You must list the major food allergen or the source of the major food allergen by the common or usual name of the source ingredient or if it is a fish, the actual type of fish. For example, you may not call or list the major food allergen as “fish” but must state “sand lance.”
• It must appear on the label immediately after or adjacent to, and in the same type (i.e., print or font) size as that used for the ingredient list.

2. The GO‐HYANG MAK KIMCHI product label fails to bear an accurate statement of the net quantity of contents within the bottom 30 percent of the area of the label panel, as required by 21 CFR 101.7(f).

Please notify FDA in writing, within 15 working days of receipt of this letter, of the specific steps you have taken to address any violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective actions within 15 working days, state the reason for the delay and the time within which you will do so. If you believe that your products are not in violation of the Act, include your reasoning and any supporting information for our consideration.

Your written response should be sent to René R. Ramirez, Compliance Officer, U.S. Food and Drug Administration, 1201 North Main Street, Suite 7200, Dallas, TX 75202. If you have questions regarding any issues in this letter, please contact Mr. Ramirez at rene.ramirez@fda.hhs.gov or (210) 308‐1425.

Sincerely,
/S/

Edmundo Garcia, Jr.
Program Division Director HAF West 3

Cc:

Texas Department of State Health Services
Lori Woznicki, M.P.H.
Food and Drug Inspections Branch Manager
1100 West 49th Street
Austin, TX 78756

 
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