- Delivery Method:
- Via Express Delivery
- Food & Beverages
Recipient NameMr. Kyung Eun Kim
- Keum Han Industrial Co.
40-25 Nonggongdanji-Gil; Jumunjin-Eup
- Issuing Office:
- Center for Food Safety and Applied Nutrition (CFSAN)
May 19, 2020
Mr. Kyung Eun Kim:
The United States Food and Drug Administration (FDA) inspected your seafood processing facility, located at 40-25 Nonggongdanji-Gil; Jumunjin-Eup Gangreung-si, Gangwon-do, 25422 Korea (the Republic of) on February 17 – 18, 2020. During that inspection, 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 123). At the conclusion of the inspection, the FDA investigator issued an FDA 483, Inspectional Observations, listing the observations made at your firm. We acknowledge receipt of your response sent via email on March 9, 2020. Your response included revised HACCP plans for your ready-to-eat dried squid products, revised monitoring records, and a training document. However, your response was determined to be inadequate as further described in this letter.
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 ready-to-eat (RTE) dried squid products are adulterated, in that they have been prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health. 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 deviations are as follows:
1. You must conduct or have conducted for you a hazard analysis for each kind of fish and fishery product that you produce to determine whether there are food hazards that are reasonably likely to occur and have a HACCP plan that, at a minimum, lists the food safety hazards that are reasonably likely to occur, to comply with 21 CFR 123.6(a) and (c)(1). A food safety hazard is defined in 21 CFR Part 123.3(f) as "any biological, chemical, or physical property that may cause a food to be unsafe for human consumption." However, your firm’s revised HACCP plan for dried butter-flavored and bulgogi-flavored squid products, dated February 28, 2020, does not list the food safety hazard of undeclared allergens. Your butter-flavored and bulgogi-flavored dried squid products contain allergens, such as dairy and soy ingredients.
2. 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 plans for RTE dried squid products (seasoned, butter-flavored, and bulgogi-flavored), dated February 28, 2020, do not list a critical control point, or multiple critical control points, for unrefrigerated processing. Your firm receives cooked frozen squid and exposes the product to unrefrigerated processing for approximately (b)(4) hours at the following steps:
Due to the lengthy (b)(4) steps that your cooked ready-to-eat (RTE) squid products are exposed to, FDA recommends that your (b)(4) steps be conducted under refrigeration at 40°F (4.4°C) or below and your unrefrigerated processing steps during seasoning and drying be limited to 2 hours when temperatures exceed 70°F (21.1°C) to control pathogen growth and toxin formation. This cumulative time covers the seasoning and drying until the squid reaches a water activity of 0.85. If your firm were able to provide evidence that the critical limits at your (b)(4) step achieve a minimum 6 log reduction of L. monocytogenes, then the cumulative time for unrefrigerated processing should be 3 hours or less to control for the hazard of Staphylococcus aureus toxin which is not eliminated by cooking (i.e., (b)(4)).
3. 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 a critical control point to prevent, eliminate, or reduce to an acceptable level the occurrence of the identified food safety hazard. However, your firm’s revised HACCP plans submitted with your response list “(b)(4)” and “(b)(4)” as critical limits at the “(b)(4)” critical control point that are not adequate to control the hazard of pathogen growth and toxin formation, including Clostridium botulinum (C. botulinum) growth and toxin formation. During the inspection, a representative of your firm explained that your firm does not have evidence (e.g., scientific study) that the (b)(4) step critical limits control pathogen growth and toxin formation. FDA recommends your critical limits list the critical factors as established by a scientific study to achieve a minimum 6 log reduction of Listeria monocytogenes and C. botulinum.
We acknowledge your firm’s response to the FDA 483 that included revised HACCP plans for your seasoned, butter-flavored, and bulgogi-flavored dried squid products. However, your response did not include evidence (e.g., a scientific study) that the roasting process will eliminate the hazards of Listeria monocytogenes and C. botulinum.
You should respond in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific steps you are taking to correct these deviations. More specifically, your response should include documentation reflecting the changes you made, such as a copy of your revised HACCP plan or plans, process flow diagrams, hazard analysis, 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 information 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 your product is not in violation of the 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. For your information, 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. You may view this alert at: http://www.accessdata.fda.gov/cms_ia/ialist.html.
This letter may not list all the deviations at your facility. You are responsible for ensuring that your processing plant operates in compliance with the Act and all applicable regulations, including the seafood HACCP regulation and the Current Good Manufacturing Practice regulation (21 CFR 117 Subpart B). You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations.
Additionally, Section 743 of the 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 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 re-inspection fees (21 U.S.C. 379j-31(a)(2)(B)). The inspection noted in this letter identified noncompliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any re-inspection-related costs.
During the inspection, a representative of your firm indicated that your daily sanitation program consists of spraying machinery with compressed air and alcohol between production runs with a deep cleaning of processing equipment performed once per month, which is not adequate for protecting ready-to-eat products from contamination with pathogens. According to your response to the FDA 483, your revised sanitation procedure for products containing allergens includes a daily “(b)(4)” (b)(4).” However, your response doesn’t indicate these sanitation procedures will be implemented for all of your ready-to-eat dried squid products. Please provide further clarification about your sanitation procedures.
In addition, your response included a revised sanitation monitoring record which appears to include heading for all the required areas of sanitation; however, the entire document was not translated in English. Please provide a fully translated copy of your sanitation monitoring record with your response to this letter.
You should direct your written reply to Alyssa Piontkowski, Food and Drug Administration, Center for Food Safety and Applied Nutrition, 5001 Campus Drive, Office of Compliance (HFS-607), Division of Enforcement, College Park, Maryland 20740-3835. If you have any questions regarding this letter, you may contact Ms. Piontkowski via email at Alyssa.Clendenin@fda.hhs.gov. Please reference #607512 on any submissions and on the subject line of any emails to us.
William A. Correll
Office of Compliance
Center for Food Safety
and Applied Nutrition