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U.S. Department of Health and Human Services

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Enforcement Actions

Annasea International Hawaii, LLC 6/4/13

  

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 94501-7070
Telephone (510) 337-6700 

 

UNITED PARCEL SERVICE 
DELIVERY SIGNATURE REQUIRED
 
 
WARNING LETTER
 
 
June 4, 2013
 
Alex Tran, President  
Annasea International Hawaii LLC
15110 NE 90th Street, Suite 110
Redmond, WA 98052
 
Dear Mr. Tran:
 
We inspected your seafood processing facility located at 1151 Mapunapuna Street, C3 Honolulu, HI between the following dates:  February 21 and March 5, 2013.  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 seafood products, including ready-to-eat scombroid finfish including sashimi and poke made with cubed tuna, such as Wasabi Poke (Wasabi Tobikko), and vacuum packaged tuna loins 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.
 
Additionally, based on our label review of your “Wasabi Poke” product packaged for wholesale, we determined that the product is adulterated within the meaning of section 402(c) of the Act [21 U.S.C. § 342(c)] and misbranded within the meaning of section 403 of the Act [21 U.S.C. § 343]. 
 
We acknowledge the receipt of your letter, received March 13, 2013, in response to the form FDA 483, Inspectional Observations, issued to you on March 5, 2013.  However, your response is not adequate in that it did not include any revised HACCP plan for review.  To determine the adequacy of your response, we will need to evaluate your complete HACCP plans in their entirety.  The deviations listed in this letter are based on the inspection and our review of your firm’s HACCP plan for vacuum packaged tuna loins entitled “VACUUM PACKAGING HACCP PLAN FORM” and your firm’s HACCP plan for sashimi and poke with tuna (“Poke”) entitled “HACCP PLAN FOR SASHIMI-SCOMBROID & EXOTIC SPECIES” that were collected during the inspection.  
 
Seafood HACCP 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 “VACUUM PACKAGING HACCP PLAN FORM” does not list the food safety hazard of pathogen growth and toxin formation and your firm’s “HACCP PLAN FOR SASHIMI-SCOMBROID & EXOTIC SPECIES” does not list the food safety hazard of undeclared allergens.
 
During the inspection, your firm’s management informed our investigator that your vacuum packaged tuna, covered under your “VACUUM PACKAGING HACCP PLAN FORM”, are intended to be consumed raw or cooked. As such, your HACCP plan for “VACUUM PACKAGING HACCP PLAN FORM” should identify the hazard of pathogen growth as a result of time and temperature abuse in addition to scombrotoxin formation.  
 
With regard to the hazard of undeclared allergens, FDA has identified finfish as a major food allergen and consequently a food safety hazard that must be identified in your HACCP plans. Additionally, other allergenic ingredients such as soy or wheat in your finished products need to be considered and addressed in your HACCP plans, when necessary. We suggest that processors conduct a visual examination of their labels prior to use by comparing the label with product to be labeled including the ingredients and ingredients’ labels to ensure that all allergenic ingredients are accurately declared. In addition, your firm must declare the common and usual name of the fish as part of your control of the hazard. 
 
2.    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, your firm’s “HACCP PLAN FOR SASHIMI-SCOMBROID & EXOTIC SPECIES” lists critical limits at the “Receiving CCP 1” critical control point that are not adequate to control pathogen growth and scombrotoxin formation.
 
When a processor does not receive fish directly from the fishermen, FDA considers those processors to be “secondary” processors.  To control scombrotoxin formation in scombrotoxin-forming fish as a secondary processor, you need to implement controls to assure that the fish are transported under safe conditions.  Our inspection found that your firm receives ahi (tuna) transported (b)(4) and that your firm monitors (b)(4) incoming shipments of fish to meet the critical limit of “ (b)(4) ”.  In addition to monitoring internal temperatures, FDA recommends that your plan include a critical limit to assure the presence of sufficient ice (i.e., fish completely surrounded by ice) at the time of receipt.     

 

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 SASHIMI-SCOMBROID & EXOTIC SPECIES” lists a monitoring procedure/frequencies at the “Storage CCP 2” and “Storage CCP 6” critical control points that are not adequate to control pathogen growth and scombrotoxin formation. Specifically, FDA recommends when temperatures are monitored during storage that firms need to continuously monitored and record temperatures with a daily review of the temperature data recorder records. A monitoring frequency of “ (b)(4) ” as listed in your plan does not provide an equivalent assurance of safety.  
 
FDA recommends the use of a continuous temperature-recording device (e.g. a recording thermometer) for refrigerated storage, with a visual check of the recorded data at least once per day.
 
4.    You must implement the monitoring procedures and frequency that you have listed in your HACCP plan, to comply with 21 CFR 123.6(b) and (c)(4).  However, your firm did not follow the monitoring procedure and frequency for “(b)(4) ” using a “ (b)(4) at your “Storage” and “Finished Product Cooler Storage” critical control points to control scombrotoxin formation as listed in your “VACUUM PACKAGING HACCP PLAN FORM”.  Specifically, our investigator observed that your firm’s chiller storage has no continuous data logger installed or in use for monitoring its temperature.  

5.   You must implement the record keeping system that you listed in your HACCP plan, to comply with 21 CFR 123.6(b) and (c)(7). However, your firm did not record monitoring observations of “ (b)(4) ” by “ (b)(4) at your “Receiving” critical control point to control scobrotoxin formation as listed in your “VACUUM PACKAGING HACCP PLAN FORM.” Specifically, our inspection found that on February 20 and 25, 2013, your firm received shipments of scombroid finfish, including Big Eye Tuna, and failed to failed to have receiving records documenting the  (b)(4) as specified as your critical limit. 

6.    You must maintain sanitation control records that, at a minimum, document monitoring and corrections set out in 21 CFR 123.11(b), to comply with 21 CFR 123.11(c). However, your firm did not maintain sanitation monitoring records for the proper labeling, storage, and use of toxic compounds, and for the control of employee health conditions required for the processing of ready-to-eat Tuna on February 20, 2013 and February 25, 2013.

Labeling Deviations
 
The significant violations for the labeling of your “Wasabi Poke” product include, but are not limited to, the following:
 
1.    Your “Wasabi Poke” product is adulterated within the meaning of section 402(c) of the Act [21 U.S.C. § 342(c)] because the product bears or contains a color additive which is unsafe within the meaning of section 721(a) of the Act [21 USC § 379(a)]. Section 721(a) deems a color additive to be unsafe unless its use is in conformity with the color additive’s listing regulation. Specifically, the listing regulation for FD&C Yellow No. 5 requires that the color additive be listed by that name in the ingredient list on the labels of foods for human use [21 CFR 74.705(d)(2)]. Your product is manufactured with the ingredient “green tobikko” which contains FD&C Yellow #5; however, the label for the finished product fails to declare the presence of FD&C Yellow #5 in the ingredient statement.
 
2.    Your Wasabi Poke product is misbranded within the meaning of section 403(w) of the Act, 21 U.S.C. § 343(w), because the label fails to declare all major food allergens present in the product, as required by section 403(w)(1) of the Act. 
 
Section 201(qq) of the Act, 21 U.S.C. § 321(qq), defines a major food allergen as milk, egg, fish, Crustacean shellfish, tree nuts, wheat, peanuts, and soybeans, as well as any food ingredient that contains protein derived from one of these foods, with certain exceptions, e.g., highly refined oils derived from a major food allergen.  A food is misbranded if it is not a raw agricultural commodity and it is, or it contains, an ingredient that bears or contains, a major food allergen, unless either:
  • The word “Contains,” followed by the name of the food source from which the major food allergen is derived, is printed immediately after or is adjacent to the list of ingredients [section 403(w)(1)(A) of the Act, 21 U.S.C. § 343(w)(1)(A)], or
  • The common or usual name of the major food allergen in the list of ingredients is followed in parentheses by the name of the food source from which the major food allergen is derived, except that the name of the food source is not required when either the common or usual name of the ingredient uses the name of the food source or the name of the food source appears elsewhere in the ingredient list (unless the name of the food source that appears elsewhere in the ingredient list appears as part of the name of an ingredient that is not a major food allergen) [section 403(w)(1)(B) of the Act, 21 U.S.C. § 343(w)(1)(B)].
 
Your labels fail to declare the following major food allergens:
  • Soy and wheat: Wasabi Poke is made with soy sauce that soybeans and wheat flour
  • Tuna: Wasabi Poke is made with Bigeye or Yellowfin Tuna
  • Silversides: Green tobikko, an ingredient in the Wasabi Poke contains Silversides roe
 
Further guidance and information on food allergens can be accessed on FDA’s website at http://www.fda.gov/Food/IngredientsPackagingLabeling/FoodAllergens/default.htm.
 
3.    Your “Wasabi Poke” product is misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that it is fabricated from two or more ingredients, but the labeling fails to bear a complete list of all the ingredients by common or usual name in descending order of predominance by weight as well as all sub-ingredients, as required by 21 CFR 101.4. Specifically, your “Wasabi Poke” product, a multi-ingredient food, does not declare any ingredients.
 
4.    Your “Wasabi Poke” product is misbranded within the meaning of section 403(k) of the Act [21 U.S.C. § 343(k)] because the product bears or contains an artificial flavoring, coloring, or chemical preservative. In accordance with 21 CFR 101.22(k), the label of a food to which any coloring has been added shall declare the coloring in the statement of ingredients. Your product is manufactured with “green tobikko” an ingredient containing certified color additive FD&C Yellow #5 and certified color additive FD&C Blue #1; however, the product label does not identify the presence of the color additives. Under 21 CFR 101.22(k)(1), certified colors must be declared by the name of the color additive listed in the applicable regulation in part 74 or part 82 of this chapter. The common or usual name may be abbreviated to omit the "FD&C" prefix and the term "No." (e.g. Yellow 5).
 
5.    Your “Wasabi Poke” product is misbranded within the meaning of Section 403(e)(1) of the Act [21 U.S.C. § 343(e)] in that the package does not bear the name and place of business of the manufacturer, packer or distributor in accordance with 21 CFR 101.5.
 
6.    Your “Wasabi Poke” product is misbranded within the meaning of Section 403(e)(2) of the Act [21 U.S.C. § 343(e)(2)] in that the package fails to declare the net quantity of contents, as required under 21 CFR 101.105.
 
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. 
 
In addition to the above noted deviations, our investigator observed the product labeled as “WASABI POKE”, indicated by your firm to be produced under “HACCP PLAN FOR SASHIMI-SCOMBROID & EXOTIC SPECIES,” consists of raw tuna cubes with other ingredients that are placed in individually sealed and taped plastic bags.  These individually taped and sealed bags are then placed in a larger taped and sealed plastic bag.  Because the double packaging does not appear to allow oxygen flow, it may potentially create an environment conducive for Clostridium botulinum growth and toxin formation.  
 
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 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 copies of any revised HACCP plans, at least five (5) product days worth of HACCP monitoring records to demonstrate that you have implemented the revised plans, any verification records, copies of revised labels for the products that your firm manufactures and distributes, and 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.
 
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 and all applicable regulations, including the seafood HACCP regulation (21 CFR Part 123), the Current Good Manufacturing Practice regulation (21 CFR Part 110), and the food labeling regulations (21 CFR Part 101). You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations.
 
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 the CMS number 395141 in your response.
 
If you have any questions regarding any issue in this letter, please contact Juliane Jung-Lau, Compliance Officer at 510-337-6793.
 
Sincerely,
/S/ 
Elizabeth A. Kage
San Francisco District Director, Acting   
      
 
cc:       
Brandis K. Tanaka, General Manager
Annasea International Hawaii LLC
1151 Mapunapuna Street, C3
Honolulu, HI 96819-4455