Inspections, Compliance, Enforcement, and Criminal Investigations

New Zealand Seafood Marketing 10/1/15

  

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

Public Health Service
Food and Drug Administration
 Import Operations Branch
Los Angeles District
Long Beach Resident Post
One World Trade Center, Suite 300
Long Beach, CA 90831
Main Phone: (562) 256-7700
Fax: (562) 256-7701 

 

WARNING LETTER
 
 
VIA UNITED PARCEL SERVICE
SIGNATURE REQUIRED
 
 
October 1, 2015
            WL# 35-15
Ms. Toni Hall
New Zealand Seafood Marketing
4321 Boyle Avenue
Vernon, CA 90058
 
 
Dear Ms. Hall:
 
We inspected your seafood processing facility, located at 4321 Boyle Avenue, Vernon, CA 91733 on April 14, 2015, through April 17, 2015. 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 Part 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 fish and fishery products such as your tuna, swordfish, mahi mahi, rudder, wahoo, and smoked salmon 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.
 
We received your May 1, 2015, and May 12, 2015, email responses, which included an updated HACCP plan for your firm’s products, photos of the new baseboard in the packing room, and an updated Product Specification from one of your suppliers, (b)(4). Another revised HACCP plan was submitted on June 2, 2015, for your “Fresh-Low Risk Finfish,” “Smoke Salmon-High Risk,” and “Fresh-High Risk Finfish” products. Based on the review of the documents you provided, your fish and fishery products continue to be adulterated.
 
Your significant violations were as follows:
 
1.    You must have a HACCP that, at 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 June 2, 2015, “Fresh-High Risk Finfish” revised HACCP plan lists a critical limit, (b)(4)” at the (b)(4) critical control point that is not adequate to control the hazard of scombrotoxin (histamine) formation because it does not ensure that the fish were held under proper temperatures to control histamine for the entire duration of the transit period. FDA recommends that: 
  • For fish delivered refrigerated (not frozen): All lots received are accompanied by transportation records that show that the fish were held at or below an ambient or internal temperature of 40°F (4.4°C) throughout transit. Note that allowance for routine refrigeration defrost cycles may be necessary; OR
  • For fish delivered under ice: Fish are completely surrounded by ice at the time of delivery; OR 
  • For fish delivered under ice on an open-bed truck: Fish are stored completely surrounded by ice; AND The internal temperature of the fish at the time of delivery is 40°F (4.4°C) or below; OR
  • For fish delivered under chemical cooling media such as gel packs: There is an adequate quantity of cooling media that remain frozen to have maintained product at an internal temperature of 40°F (4.4°C) or below throughout transit; AND The internal temperature of the fish at the time of delivery is 40°F (4.4°C) or below; OR
  • For fish delivered refrigerated (not frozen) with a transit time (including all time outside a controlled temperature environment) of 4 hours or less (optional control strategy): Time of transit does not exceed 4 hours; AND internal temperature of the fish at the time of delivery does not exceed 40°F (4.4°C).
2.    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 revised HACCP plan for “Fresh- High Risk Finfish” provided with your June 2, 2015, response lists a monitoring procedure and frequency of (b)(4) at the (b)(4) critical control point that is not adequate to control scombrotoxin (histamine) formation. FDA recommends that you measure cooler temperature using a continuous temperature-recording device (e.g., a recording thermometer) and that 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 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 revised HACCP plan for “Smoke Salmon- High Risk” provided with your June 2, 2015, response lists a critical limit, (b)(4)” at the (b)(4) critical control point that is not adequate to control the food safety hazard of C. botulinum toxin formation because it does not ensure that the products are held at proper temperatures to control C. botulinum during refrigerated storage. FDA recommends that:
  • For fish or fishery products delivered refrigerated (not frozen): All lots received are accompanied by transportation records that show that the product was held at or below 40°F (4.4°C) throughout transit. Note that allowance for routine refrigeration defrost cycles may be necessary; OR
  • For products delivered under ice: Product is completely surrounded by ice at the time of delivery; OR
  • For products delivered under chemical cooling media, such as gel packs: There is an adequate quantity of cooling media that remain frozen to have maintained product at 40°F (4.4°C) or below throughout transit; AND The internal temperature of the product at the time of delivery is 40°F (4.4°C) or below; OR  
  • For products delivered refrigerated (not frozen) with a transit time (including all time outside a controlled temperature environment) of 4 hours or less (optional control strategy): Time of transit does not exceed 4 hours; AND Temperature of the product at the time of delivery does not exceed 40°F (4.4°C).
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 revised HACCP plan for “Smoke Salmon- High Risk” provided with your June 2, 2015, response lists a monitoring procedure and frequency of (b)(4) at the (b)(4) critical control point that is not adequate to control C. botulinum formation. FDA recommends that you monitor the temperature of the cooler using a continuous temperature-recording device (e.g., a recording thermometer) and that continuous monitoring during storage is accomplished by the device itself, with a visual check of the recorded data at least once per day.
 
5.    Since you chose to include corrective actions in your HACCP plan, your described corrective actions must be appropriate, to comply with 21 CFR 123.7(b). However, your corrective action plans include in your June 2, 2015, HACCP plans for “Smoke Salmon- High Risk” and “Fresh- High Risk Finfish” at the (b)(4) critical control points to control C. botulinum formation are not appropriate. FDA recommends that in addition to (b)(4), you also ensure that you have corrected the cause of the deviations by making repairs or adjustments to the malfunctioning cooler.
 
We may take further action if you do not promptly correct these violations. 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," seize your product(s) and/or enjoin your firm from further violating the Act.
 
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 HACCP and importer verification records and records that document the performance and results of your firm’s affirmative steps, 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.
 
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 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 for the fish or fishery products that you import into the United States. 
 
Please send your reply to:
 
Food and Drug Administration
Attention: Daniel Solis
Director Import Operations Branch
Los Angeles District
One World Trade Center, Suite 300
Long Beach, CA 90831
 
 
If you have questions regarding this letter, please contact Deborah Park, Compliance Officer at (562) 256-9212.
 
Sincerely,
/S/ 
Alonza E. Cruse, Director
Los Angeles District
  
 
Cc:      
David M. Mazzera, Chief
Food and Drug Branch
California Department of Public Health
PO Box 997435
1500 Capitol Ave., MS-7602
Sacramento, CA 95899-7413
 

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