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U.S. Department of Health and Human Services

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Enforcement Actions

Sharkco Seafood International L.L.C. 11/20/12

  

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

Public Health Service
Food and Drug Administration
 
New Orleans District
404 BNA Drive
Building 200 – Suite 500
Nashville, TN 37217
Telephone: (615) 366-7801
FAX:   (615) 366-7802 

 

November 20, 2012
 
WARNING LETTER NO. 2013-NOL-02
 
 
UNITED PARCEL SERVICE
DELIVERY SIGNATURE REQUESTED
 
Tuan Q. Nguyen
Sharkco Seafood International, LLC.
707 Jump Basin Road
Highway 23 South
Venice, Louisiana 70091
 
Dear Mr. Nguyen:
 
On August 8, 2012, a U.S. Food and Drug Administration (FDA) investigator inspected your seafood processing facility, located at 707 Jump Basin Road, Highway 23 South, Venice, Louisiana.  We found 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 fish and shrimp are adulterated, as 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 (Fish Guide) through links on FDA's Internet home page at www.fda.gov.
 
We received your response, dated August 13, 2012, concerning our investigator’s observations noted on the August 8, 2012, FORM FDA 483, Inspectional Observations, (FDA 483) issued to you. Your responses are addressed below in relation to each of the noted violations. Your significant violations were as follows:
 
1.    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 (CCP), to comply with 21 CFR 123. 6(a) and (c)(2). A CCP 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 with product description “Bandit, Bee Liner, Big Cat, Black Drum, Black Grouper, Black Mullet, Black Tip Shark, Channel Mullet, Cobia, Croaker, Flounder, Gag Grouper, Gar, Hake, Lane Snapper, Mako, Sheephead, and Tripletail”, does not list the CCP of Storage for controlling the food safety hazard of pathogenic bacteria growth and toxin formation; and,
  • Your firm’s HACCP plan with product description “White and Brown Shrimp” does not list the CCP of Storage for controlling the food safety hazard of pathogenic bacteria growth and toxin formation.  
Please refer to Chapter 12 of the Fish Guide for additional information related to the formation and growth of pathogenic bacteria for appropriate control strategies for your process.
 
We reviewed your response and found it inadequate. A section of a HACCP plan included in your response has written at the top of the page “For Fish & Shrimp. both.” The plan’s sole verification process, which states “Review monitoring, corrective action, and verification,” is unclear and appears incomplete. The plan does not include verification via measuring internal temperatures of the fish or shrimp to ensure the adequacy of visual checks for the presence of ice. Verification is especially important since your firm only monitors for the presence of ice and does not monitor cooler temperature. Furthermore, it does not appear your firm has taken into consideration the cumulative effect of time and temperature. Referring to the associated form, “Daily Record for Adequacy of Ice During Cold Storage,” it is not evident how long a “Lot” or “Container” of fish or shrimp is stored. The example of the form provided in your response documents “Lot No./Container No.” number 1 in trailer (b)(4) or (b)(4) from August 8 through 13, 2012. It is unclear whether Lot No./Container No. 1 is the same lot or container or different lots or containers throughout this time period.  In addition, the type of seafood product being stored is not identified.  Additionally, the plan is not signed and does not include: product description; method of storage and distribution; or, intended use.
 
2.    You must conduct or have conducted a hazard analysis for each kind of fish and fishery product 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, which includes bee liner (i.e. snapper), black grouper, gag grouper, and lane snapper, does not list the food safety hazard of ciguatera toxin.

Please refer to Chapter 6 of the Fish Guide for additional information related to the formation of natural toxins for appropriate control strategies for your process.

We reviewed your response and found it inadequate.  A section of a HACCP plan included in your response has written at the bottom of the page “For Fish that harvest between LA & Texas line.” The section lists the food safety hazard of ciguatera fish poisoning; however, it does not appear to be written specifically for your firm and operation. For instance, the plan mentions a “Receiving record”; yet, an example of a “Receiving record” is not included with your response. Additionally, the plan is not signed and does not include: product description; method of storage and distribution; or, intended use. 
 
We may take further action if you do not promptly correct these violations. For instance, we may take further action to seize your products and/or enjoin your firm from operating.
 
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 complete HACCP and verification records, 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 your facility operates in compliance with the Act, the seafood HACCP regulation (21 CFR 123) and the Current Good Manufacturing Practice regulation (21 CFR 110). You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations.
 
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.
 
Please send your reply to the U.S. Food and Drug Administration, Attention: Rebecca A. Asente, Compliance Officer, at the address above. If you have questions regarding any issue in this letter, please contact Ms. Asente at (504) 832-1290 extension 1104.
                                                                                   
 
Sincerely,
/S/ 
Patricia K. Schafer
District Director
New Orleans District
 
 
cc:    
Khai Q. Nguyen
Sharkco Seafood International, LLC.
707 Jump Basin Road
Highway 23 South
Venice, Louisiana 70091
 
Jena W. Smith
Baldwin Haspel Burke & Mayer, LLC
2200 Energy Centre
1100 Poydras Street
New Orleans, Louisiana 70091