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U.S. Department of Health and Human Services

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Enforcement Actions

Pacific Harvest Seafoods, Inc. 5/1/13

  

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
 
 
May 1, 2013
 
Michael E. Litchko, President
Pacific Harvest Seafoods, Inc.
800 Salinas Road
San Juan Bautista, CA 95045
 
Dear Mr. Litchko:
 
We inspected your seafood processing facility located at 800 Salinas Road, San Juan Bautista, CA 95045 between the following dates:  March 27 to March 29, 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 fresh, refrigerated scombroid finfish Mahi Mahi and ready-to-eat refrigerated, cooked Dungeness Crabmeat in hermetically sealed containers, 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 Mahi Mahi entitled “Fresh Tuna, Mahi and Ono” that was collected during the inspection.
 
Your significant violations are as follows:
 
  1. You must conduct a hazard analysis to determine whether there are food safety hazards that are reasonably likely to occur and you must have a written HACCP plan to control the food safety hazards that are reasonably likely to occur, to comply with 21 CFR 123.6(a) and (b).  However, your firm does not have a HACCP plan for the receiving and storage of ready-to-eat refrigerated, cooked Dungeness Crabmeat in hermetically sealed containers, to control the food safety hazard of Clostridium botulinum growth and toxin formation. Specifically, our investigator observed these fishery products in your cooler during the inspection.
 
When conducting your hazard analysis, your firm should assess those steps that are reasonably likely to result in Clostridium botulinum growth and toxin formation due to time/temperature abuse.  For example, receipt of refrigerated products will likely be critical to ensure that proper temperatures were maintained during the transit period to your facility.  In addition, refrigerated finished product storage will likely be critical to ensure proper temperatures are maintained during extended storage periods. Please refer to Chapter 13 of the Fish and Fishery Products Hazards and Controls Guidance: Fourth Edition (the Hazards Guide) for additional information related to Clostridium botulinum growth and toxin formation for appropriate control strategies for your processing operations.
 
  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 plan “Fresh Tuna, Mahi and Ono” for refrigerated Mahi Mahi does not list the food safety 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 plan. 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 of the Hazards Guide for guidance in determining the appropriate controls for your processing operations.
 
  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, your firm’s HACCP plan “Fresh Tuna, Mahi and Ono” for refrigerated Mahi Mahi lists a critical limit of “(b)(4)” at the “Receiving” critical control point that is not adequate to control histamine formation.
 
To control histamine formation in scombrotoxin-forming fish as a secondary processor, you must have adequate transit control of fish delivered to your facility. Your critical limit as specified on your HACCP plan is not adequate. Additionally, we recommend that your firm include in your HACCP plan the appropriate critical limit that reflects your operation. During our inspection, your warehouse manager informed our investigator that the firm monitors Mahi Mahi for (b)(4) upon receipt. However, our inspection found that a shipment of Mahi Mahi your firm received on March 20, 2013 was delivered by (b)(4) truck and your firm documented the monitoring of (b)(4) of the incoming shipment; not for (b)(4).  
 
Adequate transit control strategies as recommended on page 137 of the Hazards Guide include:
 
  • For fish delivered refrigerated (not frozen) with a transit time (including all time outside a controlled temperature environment) of 4 hours or less, FDA recommends your critical limit indicate the Time of transit does not exceed 4 hours AND the internal temperature of the fish at the time of delivery does not exceed 40ºF (4.4ºC). 
  • For fish delivered under ice, FDA recommends you ensure the fish are completely surrounded by ice at the time of delivery. 
  • For fish delivered under ice on an open-bed truck, FDA recommends the fish are stored completely surrounded by ice AND the internal temperature of the fish at the time of delivery is 40ºF or below (taken for a representative number of fish in the lot.)  
 
Please refer to Chapter 7 of the Hazards Guide for additional information related to the hazard of Scrombrotoxin (Histamine) Formation and appropriate control strategies for receiving and storing of your products according to your operations.
 
  1. 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,
  1. your firm’s HACCP plan “Fresh Tuna, Mahi and Ono” for refrigerated Mahi Mahi lists a monitoring procedure/frequency at the “Receiving” critical control point that is not adequate to control scombrotoxin formation. Specifically, your monitoring procedure states to monitor the “(b)(4)” and by the “(b)(4)” is not adequate. For scombrotoxin-forming fish delivered under ice, FDA recommends monitoring for the adequacy of ice surrounding the product at the time of delivery. For scombrotoxin-forming fish delivered refrigerated (not frozen) with a transit time of 4 hours or less, FDA recommends monitoring for the date and time fish were removed from a controlled temperature environment before shipment and the date and time delivered AND the internal temperature of a representative number of fish at the time of delivery.
  2. your firm’s HACCP plan “Fresh Tuna, Mahi and Ono” for refrigerated Mahi Mahi lists a monitoring procedure/frequency at the “Chilled Storage” critical control point that is not adequate to control scombrotoxin formation and pathogen growth. Specifically, your monitoring to ensure “(b)(4)” by the “(b)(4)” at a frequency of “(b)(4)” is not adequate. 
 
While visually checking for adequacy of ice on product may be an acceptable monitoring procedure for a specific critical limit, this particular monitoring procedure is not applicable for your critical limit of ensuring that (b)(4) as specified on your HACCP plan. For refrigerated storage, FDA recommends the use of a continuous temperature-recording device (e.g. a recording thermometer), with a visual check of the recorded data at least once per day. Alternatively, for product stored under ice, FDA recommends monitoring with sufficient frequency to ensure the product is completely and continuously surrounded by ice throughout the storage time.  Our investigator noted on two occasions during the inspection, March 27 and March 29, scombrotoxin finfish, including Mahi Mahi fillets, were being stored in your cooler without ice on the products.
 
  1. 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,
 
  1. your corrective action plan for “Fresh Tuna, Mahi and Ono” to control scombrotoxin (histamine) formation at the “Receiving” critical control point including “(b)(4)” is not appropriate. This corrective action plan does not resolve how the cause of the deviation will be corrected. 
  2. your corrective action plan for “Fresh Tuna, Mahi and Ono” to control scombrotoxin (histamine) formation at the “Chilled Storage” critical control point of “(b)(4)” is not appropriate. This 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 your HACCP Plan for “Fresh Tuna, Mahi and Ono” provided to our investigator during our inspection was dated November 3, 2010. 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, at least five (5) product days worth of 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 396447 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