The Food and Drug Administration sends warning letters to entities under its jurisdiction as part of its enforcement activities. Some letters are not posted for public view until weeks or months after they are sent. Business owners have 15 days to respond to FDA warning letters. Warning letters often are not issued until a company has been given months to years to correct problems.
Korean Food Inc.
Irving, TX
A food firm in Texas is on notice from the U.S. Food and Drug Administration for violations in their production facility. These violations include not establishing or having implemented a written environmental monitoring plan that is designed to identify Listeria species or Listeria monocytogenes if it is present in their growing, harvesting, packing, and holding environment.
In a Jan. 8, 2024 warning letter, the FDA described an Aug. 21-25, 2023, inspection of Korean Feed Inc.’s sprout and kimchi production facility in Irving, TX.
FDA investigators found serious violations of the Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption. After the inspection, the FDA investigator issued a Form FDA-483, Inspectional Observations, listing deviations found at the facility.
Some of the significant violations are as follows:
Produce Safety Rule Violations
During the inspection, FDA investigators observed the following significant violations of the Produce Safety Rule:
1. The firm 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 their growing, harvesting, packing, and holding environment. During FDA inspection, investigators found that they have not established a written environmental monitoring plan, and do not conduct any testing for Listeria species or Listeria monocytogenes in their growing, harvesting, packing, and holding environment. The firm stated that they were not aware of the requirement, and, to the best of their knowledge, they have never conducted environmental sampling in their operation’s history.
2. The firm 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. Production batch of sprouts means all sprouts that are started at the same time in a single growing unit. They routinely plant soybean sprouts (redacted by FDA), and they stated that they harvest sprouts after approximately (redacted by FDA). Each planting would be, at a minimum, one production batch of sprouts. However, they only test SSIW (redacted by FDA) from a randomly selected batch. This is insufficient to ensure that representative samples of SSIW are collected for each production batch of sprouts.
3. The firm did not clean and sanitize food contact surfaces used to grow sprouts before contact with sprouts or seeds for sprouting. 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.
During the facility’s cleaning operation, FDA investigators observed the following:
- An employee sprayed a (redacted by FDA) liquid on the sprout washer and spinner that was not properly cleaned, as evidenced by soil on the equipment. They 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, they did not know what the (redacted by FDA) liquid was or the directions for use, as they 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 (redacted by FDA)‐drying processes.
- The sprout irrigation machine was covered with foil that was torn and soiled with a black/brown residue in growing room (redacted by FDA). Soybean sprouts were observed growing in (redacted by FDA) underneath this foil, and water was observed dripping from the irrigation machine.
4. The firm 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. (Redacted by FDA) 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 (redacted by FDA) holding sprouts and is splashed into the (redacted by FDA) holding sprouts while employees walk around. Additionally, the floor of the production area is not maintained, in that it is a rough, pitted, unsealed surface. The floor is not able to be adequately cleaned and sanitized.
Misbranding Violations
1. The GO‐HYANG MAK KIMCHI, 16 oz., 32 oz., half-gallon, and gallon container sizes, and the Radish Leaves Kimchi products are misbranded, in that the finished product labels fail to declare the major food allergen, sand lance and, seasonally, wheat.
2. The GO‐HYANG MAK KIMCHI and Radish Leaves Kimchi products are misbranded because the labels for the 16 oz., 32 oz., half-gallon, and 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, 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 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-ounce Go‐Hyang Mak Kimchi and for the Radish Leaves Kimchi, the labels declare the ingredient “M.S.G.” 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.
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 because each label fails to declare:
a. The correct number of servings per container. 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.
c. The nutrients using the format and nutrients required to be declared. 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. The firm’s GO‐HYANG MAK KIMCHI and Radish Leaves Kimchi products are misbranded 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.
b. Their Radish Leaves Kimchi product label fails to list all required statements in English.
5. The firm’s Radish Leaves Kimchi products are misbranded because:
a. Regulation does not provide for the use of check boxes for different net quantity of contents statement.
b. Regulation 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.
The full warning letter can be viewed here.
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