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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Ocean Food Company Limited 1/26/12


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

Public Health Service
Food and Drug Administration
 College Park, MD 


Warning Letter
I.D. # 262274
JAN 26 2012 
James Fernando, Quality Assurance Supervisor
Ocean Food Company Limited
3 Turbina Avenue
Toronto, Ontario
Dear Mr. Fernando:
In response to a request by the United States Food and Drug Administration for a copy of your firm’s HACCP plan or plans for your various fish and fishery products, as well as any additional supporting documents that would be helpful for our Agency in evaluating your HACCP program, your firm responded by email on September 14 and October 10, 2011, with the requested documents. The responses included a list of your firm’s various pasteurized fish and fishery products, two un-named HACCP plans (i.e., one with the identified hazard of Listeria monocytogenes and the other with the identified hazard of Clostridium botulinum), and some additional supporting documentation. Our evaluation of the two HACCP plans and the additional supporting documentation revealed serious deviations from the requirements 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 various pasteurized fish and fishery products are adulterated, in that they have been prepared, packed, or held 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 and Controls Guidance:  4th Edition (the Hazard Guide) through links in FDA’s home page at www.fda.gov.  
We note the following deviations:
  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 two HACCP plans for your various pasteurized fish and fishery products do not list the food safety hazard of “Undeclared Major Food Allergens”. Please refer to Chapter 19 of the 4th Edition of the Hazard Guide for additional information.
  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, 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 plans for your various pasteurized fish and fishery products do not list the critical control points of,
    1. cooling following the pasteurization process for controlling the food safety hazard associated with introduction of pathogens after pasteurization (i.e., post process contamination). Please refer to Chapter 18 of the 4th Edition of the Hazard Guide for additional information. 
    1. label review to control the food safety hazard of Clostridium botulinum in the products that are packaged in oxygen impermeable materials or reduced oxygen packages (i.e., associated with the HACCP plan that identifies the hazard of Clostridium botulinum”). All of your firm’s finished products appear to be labeled to “Keep Frozen” however, in order to ensure control of the hazard of Clostridium botulinum toxin formation, your firm needs to include an additional statement on your labels such as, “Important, keep frozen until used, thaw under refrigeration immediately before use”. In addition, your firm needs to include a critical control point to monitor the presence of these statements on each batch of labels. Please refer to Chapter 13 of the 4th Edition of the Hazard Guide for additional information.
  1. Because you chose to include a corrective action plan in your HACCP plan, your described corrective actions must be appropriate, to comply with 21 CFR 123.7(b). However, your corrective actions listed in your plans for your various pasteurized fish and fishery products do not include corrective actions that ensure that adulterated products do not enter commerce. 
Additional concerns:
  1. Your firm is monitoring the (b)(4)” critical control point using End-Point Internal Product Temperature (EPIPT). This approach is suitable when you have conducted a scientific study to validate that the EPIPT that you have selected will provide an appropriate reduction in the number of target pathogens in the slowest heating unit or portion of product under the worst set of heating conditions covered by the study. In addition EPIPT may not be an option when the object is control of Clostridium botulinum type E and non-proteolytic types B and F spores because these spores are extremely heat resistant making this type of measurement impractical. Please see page 319, in Chapter 19 of the 4th Edition of the Hazard Guide for additional information. 
  1. There appears to be a need for a “Thawing” critical control point in your HACCP plans. We note that your Hazard Analysis references a (b)(4) step, but this step is not included as a critical control point in either of your HACCP plans. We suggest that your firm re-evaluate your hazard analysis and the potential need for a (b)(4) (i.e., thawing) critical control point for thawing any of your frozen ingredients used in the manufacturing of your finished fish and fishery products to control the food safety hazard of pathogen growth and potential toxin formation, including Clostridium botulinum toxin formation. Thawing of vacuum packaged or reduced oxygen packaged products, including any raw materials and rework that has been vacuum packaged, will pose a hazard for toxin formation due to the potential for time and temperature abuse.
  1. There may be a need to identify the food safety hazard of Staphylococcus aureus growth and toxin formation following the broiling and frying steps. Staphylococcus aureus toxin, once formed, is heat stable. Thus any toxin that forms as a result of significant handling, coupled with time and temperature abuse especially following the preliminary broiling or the frying operations, conducted prior to the pasteurization, will not be denatured during the pasteurization process. 
You should respond in writing within thirty (30) working days from your receipt of this letter. Your response should outline the specific things you are doing to correct these violations. Your response should include documentation that would assist us in evaluating your corrections, such as a copy of any revised HACCP plans, at least five (5) product days worth of monitoring records to demonstrate that you have implemented the revised plan or plans, any verification records, and any other useful information. If you cannot complete all corrections within thirty (30) days, you should explain the reason for your delay and state when you will correct any remaining violations.
If you do not respond or if we find your response inadequate, we may take further action.  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 (DWPE). FDA’s DWPE is an administrative procedure whereby products offered for import into the United States may be detained without physical examination upon entry. DWPE information may be conveyed in FDA’s Import Alerts. For your information, an example of an Import Alert that conveys information specific to foreign firms that are not in compliance with the seafood HACCP regulation [21 CFR Part 123] is Import Alert #16-120. This alert can be found on FDA’s web site at: http://www.accessdata.fda.gov/cms_ia/importalert_25.html
This letter may not list all the deviations at your facility. You are responsible for ensuring that your processing plant operates in compliance with the Act, the Seafood HACCP regulations, and the current Good Manufacturing Practice regulations (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 Food and Drug Administration, Attention:  Mildred Benjamin, Consumer Safety Officer, Office of Compliance, Division of Enforcement, Manufacturing and Storage Adulteration Branch (HFS-607), 5100 Paint Branch Parkway, College Park, MD 20740 U.S.A. If you have any questions regarding this letter, you may contact Ms. Benjamin via email at Mildred.Benjamin@fda.hhs.gov 
Michael Roosevelt
Acting Director
Office of Compliance
Center for Food Safety

and Applied Nutrition