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WARNING LETTER

Eden F&C Co., Ltd MARCS-CMS 694712 —

Delivery Method:
Via Express Delivery and Electronic Mail
Product:
Food & Beverages
Recipient:
Recipient Name
Jinmin Kim
Recipient Title
CEO
Eden F&C Co., Ltd

6381 Nambu-Ro
Naebung-Myeon
Boeun-gun
Chungcheongbuk-do
28900
South Korea

whsuk1@daum.net
Issuing Office:
Human Foods Program

United States

November 6, 2024

WARNING LETTER

Re: CMS # 694712

Dear Mr. Jinmin Kim,

The United States Food and Drug Administration (FDA) conducted an inspection of your seafood processing facility, located at 6381 Nambu-Ro, Naebung-Myeon, Boeun, Chungcheongbuk, Korea (the Republic of) 28900 on April 26, 2024. This inspection covered the processing of ready-to-eat (RTE) seafood-containing corn dog products. During the inspection, we found that you had serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations (21 CFR Part 123). At the conclusion of the inspection, the FDA investigator issued a Form FDA-483, Inspectional Observations, listing a deviation found at your firm. We received your responses via email on May 14, 16, August 4, and 5, 2024, which included a revised Hazard Analysis Critical Control Point (HACCP) plan, as well as implementation records. After reviewing the inspectional findings and your responses to the observation listed in the Form FDA-483, we are issuing this letter to advise you of FDA’s continuing concerns and provide detailed information describing the findings at your facility.

In accordance with 21 CFR 123.6(g), failure of a processor of fish or fishery products to have and implement a HACCP plan that complies with this section or otherwise operate in accordance with the requirements of Part 123, renders the fish or fishery products adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug and Cosmetic Act (the Act), 21 U.S.C. § 342(a)(4). Accordingly, your RTE seafood-containing corn dog products are adulterated in that they have been prepared, packed, or held under conditions whereby they may have been rendered injurious to health. You may find the Act, the seafood HACCP regulation and FDA’s June 2022 Edition of the Fish and Fisheries Products Hazards & Controls Guidance (the Hazards Guide) through links in FDA's home page at www.fda.gov. The June 2022 Edition of the Hazards Guide can be found on our web site at: https://www.fda .gov/food/seafood-guidance-documents-regulatory-information/fish-and-fishery-products-hazards-and-controls.

Your significant violations are as follows:

1. You must conduct a hazard analysis to determine whether there are food safety hazards that are reasonably likely to occur and have a HACCP plan that, at a minimum, lists the critical control points, to comply with 21 CFR 123.6(a) and (c)(2). A critical control point is defined in 21 CFR 123.3(b) as a "point, step, or procedure in a food process at which control can be applied and a food safety hazard can as a result be prevented, eliminated, or reduced to acceptable levels." However, your firm’s HACCP plan for your frozen fish sausage corn dogs does not list a critical control point (CCP) at the (b)(4) step of receiving cooked vacuum-packed fish sausages, as received in refrigerated trucks from your supplier, to control for the food safety hazard of non-proteolytic Clostridium botulinum (C. botulinum) growth and toxin formation.

Although your response email dated May 14, 2024, includes a “(b)(4)”, that identifies fish sausage are received from your supplier through refrigerated trucks “(b)(4)”, this criterion is not adequate to control for the food safety hazard of non-proteolytic C. botulinum growth and toxin formation. Your receiving critical controls points (CCPs) should list a critical limit that ensures the ambient temperature of the refrigeration unit of the truck is maintained below 3.3°C (38°F) throughout transit, with continuous temperature monitoring.

2. You must have a HACCP plan that, at a minimum, lists the critical limits that must be met, to comply with 21 CFR 123.6 (c)(3). A critical limit is defined in 21 CFR 123.3(c) as "the maximum or minimum value to which a physical, biological, or chemical parameter must be controlled at critical control point to prevent, eliminate, or reduce to an acceptable level the occurrence of the identified food safety hazard." However, your firm’s HACCP plan for your frozen fish sausage corn dogs lists a critical limit of “(b)(4)” at the “(b)(4)” critical control point (CCP 4B) that is not adequate to control for the food safety hazard of non-proteolytic C. botulinum growth and toxin formation, as applicable to your cooked vacuum-packed products. FDA recommends your “Storage process” CCP list a critical limit that ensures the ambient temperature of the cooler is below 3.3°C (38°F), with continuous temperature monitoring, and at least a daily visual check of the recorded data.

3. Because you chose to include a corrective action plan in your HACCP plan, your described corrective actions must be appropriate, to comply with 21 CFR 123.7(b). However, your corrective action plan for your frozen fish sausage corn dogs at the “(b)(4)” critical control point (CCP 4B) to control for the food safety hazard of non-proteolytic C. botulinum growth and toxin formation is not appropriate to ensure that that the affected products do not enter interstate commerce. FDA recommends that your corrective actions additionally list to chill and hold the cooked vacuum packaged fish sausage until a food safety evaluation of the cumulative time and temperature exposures is evaluated for potential pathogen growth and toxin formation, including C. botulinum, and that any unsafe product is discarded.

The violations cited in this letter are not intended to be an all-inclusive list of the violations that exist at your facility or in connection with your products. You are responsible for investigating and determining the causes of the violations identified above and for preventing their recurrence or the occurrence of other violations. You should take prompt action to correct or implement corrections to the violations cited in this letter. You are responsible for ensuring that your processing plant operates in compliance with the Act, the seafood HACCP regulation (21 CFR Part 123), and the Current Good Manufacturing Practice regulation (21 CFR Part 117, Subpart B). You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations.

In addition to the above, we also offer the following comment:

Vacuum packaging is considered reduced oxygen packaging (ROP), because the packaging is vacuum sealed, and the normal exchange of oxygen is prevented. By reducing or preventing the exchange of normal ambient oxygen with the environment in the package, a processor introduces the food safety hazard of C. botulinum. There are two different types of C. botulinum; non-proteolytics which grow at a minimum temperature of 3.3°C (38°F) and proteolytics which have a minimum growth temperature of 10°C (50°F). FDA recommends listing critical limits for ambient temperature below 3.3°C (38°F) during transit and for refrigerated storage of ROP fish sausage because your supplier indicated the fish sausage is cooked to 75°C (167°F), before it is vacuum packaged, and did not provide any product formulation information (e.g., water activity, pH or water phase salt) or additional thermal processing that will control non-proteolytic C. botulinum. If your fish sausage supplier can provide you with information that demonstrates control of non-proteolytic C. botulinum, then a critical limit for an ambient temperature of (b)(4) or less would be adequate for transit and storage. For more information on controlling C. botulinum, see Chapter 13 of FDA’s Fish and Fisheries Hazards and Controls Guidance, specifically page 278.

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 taking to correct these violations. More specifically, your response should include documentation such as your revised HACCP plan, five (5) consecutive days of completed monitoring records (i.e., complete sets of monitoring records for the production of 5 production date codes of products) to demonstrate implementation of the plan, and any additional that you wish to supply that provides assurance of your intent to fully comply now and in the future with the seafood HACCP regulation. If you cannot complete all corrections within 15 days, you should explain the reason for your delay and state when you will correct any remaining violations. If you believe that the foods you import are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration.

If you do not respond or if we find your response inadequate, we may take further action. For instance, we may take further action to refuse admission of your imported fish or fishery products under Section 801(a) of the Act (21 U.S.C. § 381(a)), including placing them on detention without physical examination (DWPE). FDA’s DWPE is an administrative procedure whereby products offered for import into the United States may be detained without physical examination upon entry. DWPE information may be conveyed in FDA’s Import Alerts. An example of an Import Alert that conveys information specific to foreign firms that are not in compliance with the seafood HACCP regulation is Import Alert #16-120, “Detention Without Physical Examination of Fish/Fishery Products from Foreign Processors (Mfrs.) Not in Compliance with Seafood HACCP". You may view this alert at: http://www.accessdata. fda.gov/cms_ia/ialist.html.

Please send your reply to the Food and Drug Administration via email to HFP-OCE-ConventionalFoods@fda. hhs.gov. If sending a response by mail, address to Food and Drug Administration Human Foods Program – Office of Compliance and Enforcement, Office of Enforcement – Division of Conventional Foods (HFS-607), 5001 Campus Drive, College Park, MD 20740 U.S.A. If you have any questions regarding any issues in this letter, please contact HFP-OCE-ConventionalFoods@fda.hhs.gov, and include reference CMS # 694712 on any submissions and within the subject line of any correspondences to us.

Sincerely,
/S/

Maria S. Knirk, JD MBA
Acting Director, Office of Enforcement
Office of Compliance and Enforcement
Human Foods Program

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