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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Shinhan F&B Co., Ltd. 11/2/12

  

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

Public Health Service
Food and Drug Administration
 College Park, MD 20740

 

November 2, 2012
 
WARNING LETTER
 
VIA EXPRESS DELIVERY
 
Mr. Gwang-woo Choi, President
Shinhan F&B Co., Ltd.
11-3, Sangpoom Ri
Sanbook-Myeon Yeoju-kun
Gyounggi-do
Republic of Korea
 
Re: 363458
 
Dear Mr. Choi:
 
We inspected your seafood processing facility Shinhan F&B Co. Ltd., located at 11-3, Sangpoom Ri, Sanbook-Myeon Yeoju-kun, Gyounggi-do, Republic of Korea, on May 10 and 11, 2012. During that 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, Part 123 (21 CFR 123). At the conclusion of the inspection, FDA issued an FDA-483, Inspectional Observations, listing the deviations found at your firm. This letter describes our current concerns and provides information on next steps you can take. 
 
We acknowledge receipt of your response, dated June 8, 2012, that included updated monitoring records and revised product labels. However, your response was incomplete. For example, you did not provide a revised HACCP plan for your frozen vacuum-packaged roasted squid products. As a result, we have continuing concerns with your HACCP program as further described in this letter.
 
In accordance with 21 CFR 123.6(g), failure of a processor to have and implement a HACCP plan that complies with this section, or otherwise operate in accordance with the requirements of 21 CFR part 123, renders the fishery products adulterated within the meaning of section 402(a)(4) of the U.S. Federal Food, Drug and Cosmetic Act (the Act), [21 USC 342(a)(4)]. Accordingly, your firm’s frozen vacuum-packaged roasted squid products are adulterated within the meaning of the Act, in that the products have been prepared, packed, or held under conditions whereby it may have been rendered injurious to health. You may find the Act, the seafood HACCP regulation and the 4th Edition of the Fish and Fisheries Products Hazards and Controls Guidance (the Hazards Guide) through links in FDA's home page at www.fda.gov.  The Hazards Guide can be found on our web site at: http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/Seafood/FishandFisheriesProductsHazardsandControlsGuide/default.htm
 
We note the following serious deviations:
 
  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 safety 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 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 HACCP plan for frozen vacuum packaged roasted squid does not list the food safety hazards of Clostridium botulinum growth and potential toxin formation.  
 
Our inspection noted that your frozen roasted squid is vacuum packaged. Vacuum packaging creates anaerobic conditions conducive to Clostridium botulinum growth and toxin formation when products are exposed to moderate temperature abuse. Consequently, FDA recommends that firms distributing frozen vacuum packaged products include handling instructions on each label such as “Keep Frozen" and "Important: Thaw Under Refrigeration Immediately Before Use.” Additionally, FDA recommends that firms include a critical control point in their HACCP plans to ensure that these handling instructions are listed on each label.  
 
  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 frozen vacuum packaged roasted squid does not list the critical control point of cooling for controlling the food safety hazard of pathogen growth as a result of post-process contamination after the cooking step. 
 
Our investigator observed that your firm (b)(4). FDA recommends the firm cool products, following a cook process, from an internal temperature of 57.2° C to  21.1°C within 2 hours and further cool the products to 4.4° C within an additional 4 hours. 
 
We acknowledge that your June 8th response states that you have included (b)(4) as a critical control point in your plan; however, your firm did not provide a revised HACCP plan.
 
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 HACCP plan for frozen vacuum packaged roasted squid products does not list critical limits at the “(b)(4)” critical control point adequate to control your identified hazard of Listeria monocytogenes
 
Your firm’s HACCP plan lists various temperature and time critical limits without identifying what these critical limits represent. Your monitoring procedures indicate that your firm is monitoring the equipment temperature, time of cook, and the surface temperature of the products. Your plan needs to correlate what is being monitored to ensure that each piece of squid receives an adequate cook process (i.e., adequate cook time and temperature) to ensure the pathogen hazard, particularly Listeria monocytogenes, is addressed through cooking. 
 
FDA recommends that firms list critical limits to ensure that the scheduled cook process achieves a 6 log (6D) reduction of the identified pathogen. Our investigator observed that your roaster equipment is a belted system. For a belted system, you should consider establishing limits related to ambient temperatures within the cooking apparatus coupled with adequate cook times and/or belt speeds. In addition, your firm should assess other critical factors that may influence the cook process, such as the size of the squid, batch size, and initial temperature, to ensure that the cook process consistently achieves the 6D reduction under worse case conditions. 
 
4. You must have a HACCP plan that, at a minimum, lists monitoring procedures and their frequencies for each critical control point to comply with 21 CFR 123.6(c)(4). However, your firm’s HACCP plan for frozen vacuum packaged roasted squid products does not list monitoring frequencies at the “(b)(4)” critical control point adequate to control the hazard of Listeria monocytogenes
 
Specifically, for the monitoring cycle, your plan states that you monitor temperature of cooking equipment “(b)(4).” This frequency is not adequate because it does not ensure that each piece of product achieves an adequate cook temperature. Moreover, your plan does not list how you intend to monitor the cooking times and temperatures. FDA recommends continuous monitoring and recording of the equipment temperatures using a temperature recording device placed at the coldest spot within the cooking equipment. Additionally, your firm may need to monitor belt speeds to ensure adequacy of the cook process.
 
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 Good Manufacturing Practice regulation (21 CFR 110). You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations.
 
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. Your response should include documentation, such as a copy of any revised HACCP plans; at least five (5) product days worth of monitoring records to demonstrate that you have implemented the revised plan; any verification records; and any other useful information that would assist us in evaluating your corrections.   If you cannot complete all corrections within fifteen days, you should explain the reason for your delay and state when you will correct any remaining violations.
 
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
 
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 the re-inspection fees (21 U.S.C. 379j-31(a)(2)(B)). For a foreign facility, FDA will assess and collect fees for re-inspection-related costs from the U.S. Agent for the foreign facility. 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. You should consider providing your US Agent with a copy of this letter.
 
Please send your reply to Denise Beuttenmuller, Consumer Safety Officer, Food and Drug Administration, Office of Compliance, Division of Enforcement, Food Adulteration Assessment Branch (HFS-607), 5100 Paint Branch Parkway, College Park, MD 20740 U.S.A. If you have any questions regarding this letter, you may contact Ms. Beuttenmuller via email at denise.beuttenmuller@fda.hhs.gov.
 
Sincerely,
/S/
Michael Roosevelt
Acting Director
Office of Compliance
Center for Food Safety
     and Applied Nutrition