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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Osaki Suisan Co., Ltd. 12/5/13

  

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

Public Health Service
Food and Drug Administration
 
5100 Paint Branch Parkway
College Park, MD 20740 

 

December 5, 2013
 
WARNING LETTER
 
VIA EXPRESS DELIVERY
 
Osaki Suisan Co., Ltd
939 Kusatsukoh 1- Chome
Nishi-Ku
Osaka, Japan                                      
 
Re: #413910
 
Dear Sir/Madam:
 
In March 2013, an importer in the United States, Mutual Trading Company, Inc., requested removal from Import Alert #16-119, “Detention Without Physical Examination of Fish and Fishery Products for Import and Foreign Processor (Manuf) Combinations.” This importer was listed on Import Alert #16-119 with your firm, Osaki Suisan Co., Ltd. As part of the evidence provided with the request for removal from the alert, Mutual Trading Company, Inc., submitted to the U.S. Food and Drug Administration a copy of your firm’s seafood Hazard Analysis and Critical Control Point (HACCP) plan for your fish cake, along with a copy of your hazard analysis and the product flow diagram for this product. Our evaluation of your HACCP plan (copy attached) and supporting information found that this plan has serious deviations from the requirements of the seafood HACCP regulation, Title 21, Code of Federal Regulations, Part 123 (21 CFR 123).
 
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 fish cake product isadulterated within the meaning of the Act, in that the producthasbeen prepared, packed, or held under conditions whereby itmay 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 & 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 found the following serious deviations:
 
1.    You must have a HACCP plan that lists the food safety hazards that are reasonably likely to occur, to comply with 21 CFR 123.6(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 Fish Cake does not list the following food safety hazards:
 
a.    Clostridium botulinum growth and toxin formation 
 
Information provided in the process flow diagram, hazard analysis and the HACCP plan reveal that your firm is vacuum packaging the fish cakes. Vacuum packaging finished products creates an environment conducive to Clostridium botulinum growth and toxin formation. Consequently, your firm needs to identify this hazard in your HACCP plan.
 
Once your firm has identified Clostridium botulinum growth and toxin formation in your HACCP plan, your firm needs to adopt an adequate control strategy to prevent toxin formation. For example, FDA recommends either:
 
i.    Conducting a pasteurization process adequate to achieve a 6D process to inactivate Clostridium botulinum. Your firm’s HACCP plan includes a “(b)(4)” critical control point; however, the critical limit listed as “(b)(4)” is not adequate to achieve 6D process to inactivate Clostridium botulinum because the core temperature is below the minimum necessary to control toxin formation and because there is no corresponding critical limit for time. For example, FDA recommends a pasteurization process that achieves, at a minimum, an internal product temperature of 85°C for 51.8 minutes, established by a scientific study under worse case conditions (i.e., to ensure that the largest fish cake with the lowest initial temperature in each batch achieves the minimum process). 
 
Or
 
ii.    Freezing the products immediately following the heat sterilization step. Your firm’s process flow chart references a freezing step and your HACCP plan indicates that the intended method of storage and distribution of these products as “(b)(4).” For vacuum-packaged products intended to be stored and distributed frozen, FDA recommends that firms add a critical control point in the plan to ensure that each batch of labels includes handling instructions to keep frozen to control Clostridium botulinum growth and toxin formation. Additional handling instructions should also include instructions to thaw under refrigeration immediately before use. 
 
b.    Undeclared allergens:  
 
Finfish are a major food allergen and, consequently, a food safety hazard that must be identified in your HACCP plan. Additionally, other allergenic ingredients such as eggs or wheat should be addressed in your HACCP plan, when necessary. We suggest that processors conduct a visual examination of their labels prior to use by comparing the label with product ingredients to ensure that all allergenic ingredients are accurately declared in the ingredient statement.
 
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 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 Fish Cake lists critical limits for temperatures at the (b)(4)” critical control points that are not adequate to control the identified food safety hazard of pathogen growth. 
 
Your plan lists a critical limit temperature of (b)(4); however, for general pathogens or for vacuum-packaged products that receive a pasteurization process adequate to inactivate Clostridium botulinum, FDA recommends a critical limit temperature of 4.4° C or below. For vacuum-packaged products where the pasteurization process is not adequate to inactivate Clostridium botulinum, FDA recommends a critical limit temperature of 3.3°C or below.
 
3.    You must have a HACCP plan that, at a minimum, lists monitoring procedures and their frequency for each critical control point, to comply with 21 CFR 123.6(c)(4). However, your firm’s HACCP plan for Fish Cake lists a monitoring frequency at the “(b)(4)” critical control point that is not adequate to control the identified hazard of pathogen growth and toxin formation. Specifically, the monitoring frequency listed in the plan as “(b)(4)” does not provide an adequate frequency. FDA recommends the following when monitoring end process internal product temperatures:
 
a.    For batch cooking or pasteurization equipment, monitoring each batch
b.    For continuous cooking or pasteurization equipment, monitoring at least every 30 minutes, and whenever any changes in product-heating critical factors occur.
 
 
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.
 
You should respond in writing within 15 working days from your receipt of this letter. Your response should outline the specific things you are doing to correct these violations. More specifically, your response should include documentation, such as: a copy of any revised HACCP plan or plans; at least five (5) product days worth of monitoring records (complete sets for each of the five day’s worth of records) to demonstrate that you have implemented the revised plan(s); any verification records; and any other useful information that would assist us in evaluating your corrections. 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.
 
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.
 
Please send your reply to Food and Drug Administration, Attention: Sally M. Williams, Center for Food Safety and Applied Nutrition, Office of Compliance, Division of Enforcement, Food Adulteration Assessment Branch (HFS-607), 5100 Paint Branch Parkway, College Park, MD, 20740, U.S.A. You may also send any questions or the documentation via email to: Sally.williams@fda.hhs.gov.
 
 
Sincerely,
/S/
William A. Correll, Jr.
Acting Director
Office of Compliance
Center for Food Safety
     and Applied Nutrition