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WARNING LETTER

Suisan Company, Ltd MARCS-CMS 497820 —


Recipient:
Suisan Company, Ltd


United States

Issuing Office:
San Francisco District Office

United States


  

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

Public Health Service
Food and Drug Administration
 San Francisco District
1431 Harbor Bay Parkway
Alameda, CA 94502-7070
Telephone: (510) 337-6700 

 

Via UPS OVERNIGHT DELIVERY
SIGNATURE REQUIRED
 
WARNING LETTER
 
June 14, 2016
 
Glenn Hashimoto, President/CEO
Suisan Company, Ltd.
333 Kilauea Avenue, Suite 202
Hilo, Hawaii 96720                                       
 
Dear Mr. Hashimoto:
 
We inspected your seafood processing facility located at 93 Lihiwai Street, Hilo, Hawaii 96720 between the following dates: March 22 and March 24, 2016. 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). 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 fresh, refrigerated seafood products, including your histamine-forming fish, tuna, 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.
 
The deviations listed in this letter are based on observations we made during the inspection and our review of your revised HACCP plan for refrigerated, fresh histamine-forming fish (i.e.: tuna) intended for raw consumption, entitled “HACCP PLAN”, dated May 30, 2016, which was included in your post-inspectional response, dated May 31, 2016. We acknowledge some corrections addressed in your April 11th and May 31st responses; however, FDA determined that your HACCP plan is not adequate to control the significant hazards of histamine formation and pathogens.
 
Your significant violations are as follows:
 
1.    You must have a HACCP plan that, at a minimum, lists the critical limit 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:
 
a.    Your firm’s HACCP plan for histamine-forming fish intended for raw consumption lists a critical limit of “(b)(4)” at the Cold Storage Step, which is not adequate to control pathogen growth and toxin formation.
b.    Your firm’s HACCP plan for histamine-forming fish intended for raw consumption lists a critical limit of “(b)(4)”, which is not adequate to control histamine formation.
 
We acknowledge your HACCP plan specified “(b)(4)” as the operating limit; however, your critical limits as specified in the plan were not adequate.
 
The FDA recommends the following critical limits at cold storage control:
 
For refrigerated (not frozen) storage or processing of raw material, in-process product, or finished product: The product is held at a cooler temperature of 40°F (4.4°C) or below. Note that allowance for routine refrigeration defrost cycles may be necessary.  On the other hand, minor variations in cooler temperature measurements can be avoided by submerging the sensor for the temperature-recording device (e.g. temperature-recorder) in a liquid that mimics the characteristics of the product. Also note that critical limits during refrigerated storage that specify a cumulative time and temperature of exposure to temperatures above 40°F are not ordinarily suitable because of the difficulty in tracking the specific products and the specific cumulative temperature exposures that those products experience. The cumulative exposure for each product would then need to be determined prior to shipping. If you chose this approach, the critical limit for cumulative exposure to temperatures above 40°F should include the time during transit, refrigerated storage, and refrigerated and unrefrigerated processing; OR
If you choose to store products under ice: the product is completely and continuously surrounded by ice throughout the storage time.
 
Please refer to Chapter 7 (Scombrotoxin (Histamine) Formation) and Chapter12 (Pathogenic Bacteria and Toxin Formation as a Result of Time/Temperature Abuse) of the Fish and Fishery Products Hazards and Controls Guidance: Fourth Edition (the Hazards Guide), for additional information and guidance on appropriate control strategies for your operations.  
 
2.    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 histamine-forming fish (i.e.: tuna) lists a monitoring frequency at the “Cold Storage Step” critical control point that is not adequate to control histamine formation. Specifically, your monitoring by continuous digital temp lists a frequency of “(b)(4)”. The FDA recommends continuous monitoring during storage is accomplished by the device itself, with a visual check of the recorded data at least once per day.
 
3.    You included a corrective action plan in your HACCP plans; therefore, it must be appropriate to comply with 21 CFR 123.7(b). However:
 
a)     Your corrective action plan for tuna to control pathogenic bacteria growth and toxin formation at the “Cold Storage Step” critical control point is not appropriate. Specifically, stating: “(b)(4)” does not ensure that unsafe product will not reach consumers. For example, even if the product temperature is <>°F at the time you measured it, you will need to consider the cumulative time and temperatures of exposure over 40°F, including the time during transit and unrefrigerated processing, as well as refrigerated storage, in your evaluation of the product. 
b)     Your corrective action plan for tuna to control histamine formation at the “Cold Storage Step” critical control point is not appropriate. Specifically, stating:  “(b)(4)” does not ensure that unsafe product will not reach consumers. For example: you are basing this decision on the specified critical limit of the cooler storage’s exposure temperature is (b)(4) for an exposure time of (b)(4). However, you need to evaluate the cumulative time and temperatures of exposure over 40°F, including the time during transit and unrefrigerated processing, as well as refrigerated storage.   
 
We may take further action if you do not promptly correct these violations. For instance, we may take further action to seize your product(s) and/or enjoin your firm from operating.
 
This letter may not list all the violations at your facility. 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 110). You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations.
 
Our review also found the following: 
 
1)    We note that yourhazards analysis for refrigerated, fresh histamine-forming fish did not determine bacterial pathogens as a significant hazard at your “Receiving” steps. However, pathogen growth and toxin formation is likely to occur in the event of time and temperature abuse on the fishing vessel or prior to your receipt as a secondary processor. Your histamine-forming fish may be consumed without further cooking. As such, the HACCP plan needs to identify pathogen growth as a result of time and temperature abuse as a significant hazard in addition to histamine formation at the Receiving Critical Control Points.  
 
2)    Your verification procedures at the “Receiving (As primary processor)” critical control points in your HACCP plan for histamine-forming fish includes a sensory training specifically “(b)(4)”.  However, the FDA recommends that your firm ensures all current sensory examiners receive periodic refresher training as well.
 
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 domestic facility, FDA will assess and collect fees for re-inspection-related costs from the responsible party for the domestic 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 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. You should include in your response documentation such as at least five production days of HACCP and verification records, or other useful information that would assist us in evaluating your corrections. If you cannot complete all corrections before you respond, you should explain the reason for your delay and state when you will correct any remaining violations.
 
Please send your reply to the attention:
 
Lawton W. Lum                         
Director, Compliance Branch
U.S. Food and Drug Administration
San Francisco District
1431 Harbor Bay Parkway
Alameda, CA 94502
 
Please reference CMS # 497820in your response.
 
If you have any questions regarding any issues in this letter, please contact Juliane Jung-Lau, Compliance Officer, at 510-337-6793.
 
 
Sincerely,
/S/ 
Kathleen M. Lewis, J.D.
San Francisco District Director
   
cc: 
Kyle M. Sumner, Fish Division Manager
Suisan Company, Ltd.
93 Lihiwai Street
Hilo, Hawaii 96720

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