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  5. International Marine Products, Inc. - 10/28/2014
  1. Warning Letters

WARNING LETTER

International Marine Products, Inc.


Recipient:
International Marine Products, Inc.


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 

 

UNITED PARCEL SERVICE 
DELIVERY SIGNATURE REQUIRED
 
 
WARNING LETTER
 
 
October 29, 2014
 
James Ho, CEO
International Marine Products, Inc.
500 East Seventh Street
Los Angeles, CA 90014
 
Dear Mr. Ho:
 
We inspected your seafood processing facility located at 1741 S. Mojave Road, Las Vegas, NV 89104 between the following dates:  August 25 to August 27, 2014.  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 ready-to-eat seafood products, including refrigerated, raw scombroid-forming tuna, refrigerated, raw salmon, vacuum-packaged yellowtail, refrigerated, canned crabmeat and refrigerated marinated anchovy fillets packed in oil, 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.
 
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,
 
a.    your firm does not have a HACCP plan for the receiving and storage of ready-to-eat pasteurized canned crabmeat to control the food safety hazard of Clostridium botulinum growth and toxin formation. growth and toxin formation.
 
b.    your firm does not have a HACCP plan for the receiving and storage of refrigerated ready-to-eat marinated anchovy fillets packed in oil to control the food safety hazards of histamine formation and pathogen growth, including, for example, Clostridium botulinum
 
Once you have conducted a hazard analysis for your seafood products, your HACCP plan must, at a minimum, list hazards that are reasonably likely to occur, and include appropriate critical control points, critical limits, monitoring procedures, recordkeeping activities, etc., to ensure that the food safety hazards are controlled to comply with 21 CFR 123.6(c).  
 
Please refer to Chapter 7 (Scrombrotoxin (Histamine) Formation), Chapter 12 (Pathogenic Bacteria Growth as a Result of Time and Temperature Abuse) and Chapter 13 (Clostridium botulinum Toxin Formation) of the 4th Edition of the Fish and Fisheries Products Hazards and Controls Guidance (the Hazards Guide) for guidance in determining the appropriate controls for your processing operations.
 
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,
 
a.    your firm’s HACCP plan “HAMMACHI YELLOWTAIL (VAC PACK)” for refrigerated ready-to-eat vacuum-packaged yellowtail lists a critical limit of ”(b)(4)" at the “Receiving” critical control point that is not adequate to control pathogens, Clostridium botulinum toxin formation, and scombrotoxin formation.
 
To control refrigerated, raw vacuum-packaged 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. According to your HACCP plan, your firm is (b)(4)”.  Our inspection found that your firm receives this product via (b)(4).  FDA recommends monitoring for an adequate quantity of cooling media that remain frozen to have maintained the product at 38°F or below throughout transit AND the internal temperature of a representative number of product containers at the time of delivery.
 
Please refer to pages 268-271 and 278 of Chapter 13 (Clostridium botulinum Toxin Formation) of the Hazards Guide for additional information as guidance.
 
b.    your firm’s HACCP plan “Fresh Salmon” for refrigerated, raw salmon lists a critical limit of “(b)(4)” at the “Receiving” critical control point that is not adequate to control pathogens.  
 
To control refrigerated raw ready-to-eat fishas 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.  Our inspection found that your firm receives refrigerated salmon (b)(4) as a secondary receiver. Your firm is monitoring for (b)(4) of fish received at your facility.  If you choose this control strategy, we recommend that your firm include in your HACCP plan the appropriate critical limit that reflects your operation.  For fish delivered under ice, FDA recommends you ensure the fish are completely surrounded by ice at the time of delivery.
 
Please refer to pages 220-221 of Chapter 12 (Pathogenic Bacteria Growth) of the Hazards Guide for additional information as guidance.
 
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 “Fresh Salmon” for refrigerated, raw salmon lists a monitoring procedure/frequency at the “Receiving” critical control point that is not adequate to control pathogens. Specifically, your monitoring procedure states to monitor the temperature of fish by “(b)(4)” at a frequency of “(b)(4)”, which is not adequate. For refrigerated raw ready-to-eat fish delivered under ice, FDA recommends monitoring for the adequacy of ice surrounding the product in a representative number of containers from throughout the shipment at the time of delivery for each lot received.  For fish delivered 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.
 
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 of ensuring an “(b)(4)” at the “Receiving” critical control point to control pathogens as listed in your HACCP plan “Fresh Salmon”. Specifically, our investigator observed from your receiving records that on at least five occasions, on 5/9/2014, 5/16/2014, 6/4/2014, 7/2/2014, and 7/23/2014, your firm received between (b)(4) cases of Atlantic Salmon on each occasion, but monitored the temperature of only 3 cases from each lot received. The minimum of (b)(4) received was not met according to your HACCP plan.
 
5.    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,
 
a.    your corrective action plan for refrigerated, raw tuna as listed in your HACCP plan “Fresh Large Tuna” to control histamine formation and pathogen growth at the “Storage” critical control point which states “(b)(4)is not appropriate. This corrective action plan does not resolve how the cause of the deviation will be corrected. 
 
b.    your corrective action plan for refrigerated raw salmon as listed in your HACCP plan “Fresh Salmon” to control pathogen growth at the “Storage” critical control point which states “(b)(4)” is not appropriate. This corrective action plan does not resolve how the cause of the deviation will be corrected. 
 
c.    your correctiveaction plan for vacuum packaged yellowtail as listed in your HACCP plan “HAMMACHI YELLOWTAIL (VAC PACK)”  to control Clostridium botulinum, histamine formation and pathogen growth at the “Cold Storage” critical control point which states “(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 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.
 
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, such as your hazard analyses.  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.
 
We also offer the following comments: We acknowledge that your HACCP plan for Fresh Salmon has “Cutting” as a CCP to control allergen hazards. However, we recommend that your HACCP plan includes a critical control point at this processing step to control the food safety hazard of pathogen growth as a result of time/temperature abuse in refrigerated, raw, ready-to-eat salmon. Our investigator observed that your firm was processing salmon for at least four hours at ambient temperatures ranging between 45.5 to 51°F during the inspection. In the absence of controls, cumulative time and temperature abuse conditions could occur during processing of your product and the processing step could contribute significantly to that cumulative abuse. Please refer to Appendix 4 of the Hazards Guide, specifically on page 421 for Table A-2: Time and Temperature Guidance for Controlling Pathogen Growth and Toxin Formation.
 
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 our CMS number 442840.
 
If you have any questions regarding any issue in this letter, please contact Juliane Jung-Lau, Compliance Officer at 510-337-6793.
 
Sincerely,
/S/ 
Kathleen M. Lewis, JD
San Francisco District Director   
      
 
cc:   
Eiji Ota, President
International Marine Products, Inc.
500 East Seventh Street
Los Angeles, CA 90014
 
Tadanobu Sato, Assistant Manager
International Marine Products, Inc.
1741 S. Mojave Road
Las Vegas, NV 89104-4503