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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Roy's Fishery 3/5/13

  

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
 
 
March 5, 2013
 
Rory L. Koi, Operations Manager  
Roy’s Fishery
95-5801 Mamalahoa Highway
Naalehu, HI 96772
 
Dear Mr. Koi:
 
We inspected your seafood processing facility located at 95-5801 Mamalahoa Highway Naalehu, HI between the following dates:  October 22 and 25, 2012.  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 frozen, ready-to-eat scombroid finfish, smoked tuna and smoked marlin, and dried mackerel scad (opelu), 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 the inspection and our review of your firm’s HACCP Plan for smoked marlin and tuna entitled “Smoked Marlin & Ahi” and your firm’s HACCP Plan for Dried Mackerel Scad entitled “Dried Opelu” that were collected during the inspection.
 
Your significant violations 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 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 plans for “Smoked Marlin & Ahi” and “Dried Opelu” do not list the food safety hazards of Clostridium botulinum (C. botulinum) growth and toxin formation and undeclared allergens. 

With regard to the hazard of Clostridium botulinum, please be advised that there are several different recommended strategies for control of toxin formation. For products that are intended to be held frozen until use, FDA recommends all finished product labels contain a “keep frozen” statement and also include safe handling instructions such as (e.g., “Important, keep frozen until used, thaw under refrigeration immediately before use.” However, we note the label for your Smoked Marlin indicates “Keep refrigerated.” Refrigerated products will need a secondary barrier in addition to refrigeration to control toxin formation as a result of time and temperature abuse. Your firm should refer to Chapter 13 (Clostridium botulinum Toxin Formation) of the 4th Edition of the Fish and Fisheries Products Hazards and Controls Guidance (the Hazards Guide) for information on recommended control strategies related to Clostridium botulinum for both refrigerated and frozen products. 
 
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 addressed 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 when labeling allergens.  Please refer to Chapter 19 (Undeclared Major Food Allergens) of the 4th Edition the Hazards Guide for guidance in determining the appropriate controls for your process. The FDA Fish List can provide a reference list for what FDA considers the common and usual name for specific fish species.
 
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 plan for Smoked Marlin & Ahi does not list the critical control point of thawing for controlling the food safety hazard of histamine formation during the thawing process of frozen fish.
 
FDA recommends that previously frozen scombrotoxin-forming fish or fishery products not be exposed to ambient temperatures above 40ºF (4.4ºC) for more than 12 hours, cumulatively throughout processing, when at any time temperatures are above 70ºF (21.1ºC); OR 24 hours cumulative, when the fish are not exposed to ambient temperatures above 70ºF (21.1ºC) at any point. Time/temperature exposures during thawing must be considered along with other processing steps when determining cumulative exposures.
 
Please refer to Chapter 7 (Histamine Formation) of the 4th Edition of the Hazards Guide for guidance in determining the appropriate controls for your process.
 
3.  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 Dried Opelu:
 
a.       lists critical limits at the “Brining” critical control point that are not adequate to control pathogen growth and toxin formation. Your critical limits include a (b)(4); consequently, your firm needs to ensure that the fish are held at appropriate temperatures to prevent the hazard of pathogen growth and toxin formation (i.e., including the potential for growth and toxin formation from the salt tolerant Staphylococcus aureus organism). FDA recommends that the fish are continuously held at 50° F or below for the entire duration of the brining step.
 
b.      lists critical limits at the “Drying” critical control point that are not adequate to control the pathogen growth and toxin formation.  Your plan lists that you intend “(b)(4)” however, no value is provided for (b)(4).  Moreover, our inspection found that your firm is drying fish for (b)(4).  FDA does not recommend sun drying because we are unaware of any means to control the temperatures when drying occurs in this manner.  Consequently, unless your brining step (i.e., that occurs prior to this drying step) had resulted  in an adequate WPS or Aw to control pathogen growth/toxin formation, time and temperatures controls must be in place at this processing step until your product achieves an adequate Aw that controls the hazard of pathogen growth and potential toxin formation. For example, your drying process should achieve an Aw of 0.85 or less within 2 hours since exposure temperatures have not been controlled to prevent pathogen growth/toxin formation.
 
For guidance in establishing adequate monitoring procedures, corrective action plan, verification procedures, and record-keeping that are applicable to your critical limits as a primary processor of drying fish to control pathogen growth and toxin formation as a result of inadequate drying, please refer to Chapter 14 of the 4th Edition of the Hazards Guide.
 
4.  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 Smoked Marlin & Ahi lists a monitoring procedure/frequency at the “Smoker” critical control point that is not adequate to control histamine formation and pathogen growth and toxin formation.  Your firm smokes the fish for (b)(4).  FDA recommends the use of a continuous temperature-recording device (e.g., a recording thermometer) equipped with three temperature-sensing probes to continuously monitor the temperature during the whole smoking process. 
 
For guidance in establishing adequate monitoring procedures, corrective action plan, verification procedures, and record-keeping that are applicable to your critical limits as a primary processor of hot smoking fish to control pathogen growth and toxin formation, please refer to Chapter 12 of the 4th Edition of the Hazards Guide.
 
5.  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 “Chill & Storage” critical control point to control histamine formation as listed in your HACCP plan for Smoked Marlin & Ahi.  Specifically, our investigator observed that your firm’s chiller storage has no continuous data logger installed or in use for monitoring its temperature.  
 
6.  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 at the “Smoker” critical control point to control pathogen growth and toxin formation as listed in your HACCP plan for Smoked Marlin. Specifically, our inspection found that on August 14, September 6, and September 27, 2012, your firm processed smoked marlin and failed to have smoker records documenting the smoker temperature was set at (b)(4) as specified as your critical limit. 
 
7.  Because you chose to include a corrective action plan in your HACCP plans, your described corrective actions must be appropriate to comply with 21 CFR 123.7(b).  However, your combined corrective action plan for Smoked Marlin & Ahi to control histamine formation at the “Chill & Storage” and “Smoker” critical control points listed as “(b)(4)” is not appropriate. Your firm will not have the critical limit parameters necessary to make an evaluation of the time and temperatures above 40 degrees F. Specifically, your firm is not continuously monitoring the temperature of the fish during Chill storage. Consequently, your firm will not have the “time” parameter to reflect how long the fish were exposed to temperatures above 40 degrees F. You also have not specified the parameters if you test the product and what specific test you intend to conduct.  Smoking will not resolve the formation of histamine once it has formed. Additionally, your corrective action plan does not resolve how the cause of the deviation will be corrected. 
 
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. 
 
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.
 
We note that you have hand-written amendments on your HACCP Plans, dated September 17, 2009, which you made during our inspection. We recommend that you update your plans and reassess the adequacy of them at least annually.
 
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 copies of any revised HACCP plans, HACCP monitoring records to demonstrate that you have implemented the revised plans, any verification records, 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, 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.
 
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 387960 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/ 
Judy L. Strojny
San Francisco District Director, Acting   
      
 
cc:       
Roy H. Koi, Owner
Roy’s Fishery
95-5801 Mamalahoa Highway
Naalehu, HI 96772