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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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North Fish Co Ltd 11/21/12

  

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

Public Health Service
Food and Drug Administration
 College Park, MD 20740

 

November 21, 2012
 
 WARNING LETTER
 
 
VIA EXPRESS DELIVERY
 
Peter Baranchook, President
North Fish Co., Ltd.
23 Six Point Rd.
Etobicoke (Toronto), Ontario M8Z 2X1,
Canada
 
Reference No. # 373978
 
Dear Mr. Baranchook:
 
The United States Food and Drug Administration (FDA) inspected your seafood processing facility North Fish Co., Ltd., located at 23 Six Point Rd., Etobicoke (Toronto), Ontario, Canada from June 19 through 21, 2012. During that inspection, we found that you had serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations, Part 123 (21 CFR 123). At the conclusion of the inspection, the FDA investigator issued an FDA-483, Inspectional Observations, listing the deviations found at your firm during the inspection. We acknowledge receipt of your response, sent via three separate emails on July 2, 2012.  Your response included various documents, including HACCP plans for (b)(4) (identified in the lower right hand side as “HACCP 3 Cold Smk Mackerel Page 1 of 4”). In addition, your firm provided product flow diagrams, hazard analyses for these products and descriptions of your corrective action reports. Our evaluation of the documentation revealed that the response was not adequate, as further described in this letter.
 
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 salted herring, dried salted white fish, and refrigerated cold smoked mackerel are adulterated, in that they have been prepared, packed, or held under conditions whereby they may have been rendered injurious to health. You may find the Act, the seafood HACCP regulation and the 4th Edition of the Fish and Fisheries Products Hazards and Controls Guidance (the Hazards Guide) through links in FDA's home page at www.fda.gov.  
 
The 4th Edition of the Hazards Guide can be found on our web site at: http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/Seafood/FishandFisheriesProductsHazardsandControlsGuide/default.htm
 
Please be advised that the HACCP documentation that your firm provided appears to be associated with fish that are (b)(4) in the finished form. Your firm did not address or provide any information to demonstrate control of Clostridium botulinum in (b)(4) including small fish (b)(4). Consequently, your carp and herring products, which are currently listed on the “Red” list of Import Alert #16-74, will remain subject to detention without physical examination. Moreover, any additional uneviscerated processed fish products will be subject to Import Alert #16-74.
 
Your significant deviations are as follows:
 
  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."
 
a.    Your firm’s HACCP plans for (b)(4) provided with your July 2nd response, do not list the hazard of Clostridium botulinum growth and toxin formation in your (b)(4). Our inspection revealed that your firm (b)(4) overnight at ambient temperatures prior to start of your first processing step, identified in these plans as (b)(4). The inspection further revealed that your firm may also begin processing when the fish are only (b)(4). Without complete (b)(4), Clostridium botulinum toxin formation is reasonably likely to occur during thawing and processing. We recommend including a thawing critical control point to control temperatures during the thawing process. We further recommend continuously monitoring and recording time and temperatures for the entire duration of the thawing cycle. In addition, we recommend (b)(4) before the start of any additional processing operations, such as the (b)(4), etc.  
 
b.    Your firm’s HACCP plan for (b)(4) provided with your July 2nd response, does not list the hazard of Clostridium botulinum growth and toxin formation at (b)(4). While this critical control point references (b)(4) the hazard of Clostridium botulinum growth and toxin formation during the (b)(4) materials is not identified. Again, we recommend including a separate (b)(4) critical control to control temperatures during the (b)(4) and continuously monitoring and recording the temperatures for the entire duration of the (b)(4). We also recommend complete (b)(4) before the start of any additional processing operations, such as (b)(4).
 
c.    Your firm’s HACCP plans for (b)(4) provided in your July 2nd response, do not list the hazard of parasites in the finished products that are received fresh and consumed raw, i.e., without any heat treatment. FDA recommends that firms control parasites by freezing the product for a sufficient time at adequately low temperatures to kill the parasites.
 
  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 plan for (b)(4) provided with your July 2nd response, does not list the critical control point of (b)(4) for controlling the food safety hazards of pathogen growth and scombrotoxin formation. 
 
Our inspection revealed that your firm conducts a (b)(4), following the (b)(4). FDA recommends that temperatures be maintained below 40⁰F (4.4⁰C). Moreover, we recommend continuous monitoring and recording of the temperatures for the entire duration of the (b)(4)
 
  1. 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 HACCP plans submitted with your July 2nd response for (b)(4) list inadequate critical limits at the following critical control points (CCPs) to control the identified hazards.
 
a.    Your HACCP plan for (b)(4) does not list critical limits at the following critical control points:
 
1)    At the (b)(4) critical control point adequate to control the identified hazard of Clostridium botulinum in the finished product. The processing time at this critical control point is listed as (b)(4); however, there is no corresponding critical limit for temperature. FDA recommends that temperatures be maintained below 40⁰F (4.4⁰C). Moreover, we recommend continuous monitoring and recording of the temperatures for the entire duration of the (b)(4).
 
2)    At the (b)(4) CCP adequate to the identified hazard of Clostridium botulinum.   Your plan lists (b)(4); however, there is no corresponding critical limit for temperature. FDA recommends that firms ensure that fish temperatures are cooled from the (b)(4) of 18°C (64°F) to 4.4°C (40°F) (b)(4).
 
b.    Your HACCP plans for (b)(4) does not list a temperature critical limit at the (b)(4) critical control point to control the identified hazard of Clostridium botulinum in the finished product. The processing time at this critical control point is listed as (b)(4); however, there is no corresponding critical limit for temperature. FDA recommends that temperatures be maintained below 40⁰F (4.4⁰C). Moreover, we recommend continuous monitoring and recording of temperatures for the entire duration of the (b)(4).
 
c.    Your HACCP plan for (b)(4) does not list critical limits as follows:
 
1)    At the (b)(4) critical control point to control the identified hazard of Clostridium botulinum in the finished product. The processing time at this critical control point is listed as (b)(4); however, there is no corresponding critical limit for temperature. FDA recommends that temperatures be maintained below 40⁰F (4.4⁰C). Moreover, we recommend continuous monitoring and recording of the temperatures for the entire duration of the (b)(4).
 
2)    Does not list a final (b)(4) to control pathogen growth. Your plan indicates that some products are (b)(4). These products that are intended to be stored at (b)(4) adequate to control pathogen growth when held at ambient temperatures. FDA recommends a final WPS level of 20% or an Aw of 0.85.
 
  1. 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 HACCP plan for (b)(4) provided with your July 2nd response does not list monitoring procedures at the (b)(4) critical control point that are adequate to control the identified hazard of Clostridium botulinum in the finished product. 
 
Your plan indicates that your firm is monitoring internal temperature of the fish. However, FDA does not consider monitoring internal temperatures an adequate control for (b)(4) because the surface temperature of the fish needs to be controlled and, consequently, the (b)(4) temperature needs to be the entity that is monitored. We recommend a monitoring procedure associated with the (b)(4) temperature with equipment capable of continuously monitoring and recording the ambient temperature of the (b)(4) to ensure that temperatures do not exceed 90⁰F (32.2⁰C).
 
Additionally, we note that the monitoring frequency listed in your HACCP plan for (b)(4) at the (b)(4) lists (b)(4) control the indentified hazard of scombrotoxin formation. FDA recommends that, rather than referencing a (b)(4), your HACCP plan identify the use of a temperature-indicating device, monitoring at least every (b)(4) in order to record the time when fish are exposed to temperatures between 40⁰F (4.4⁰C) and 70⁰F (21.1⁰C) and/or any exposures to temperatures above 70⁰F (21.1⁰C). FDA recommends that when temperatures exceed 70⁰F (21.1⁰C) that the cumulative exposure time should be limited to no more than 12 hours.
 
You should respond in writing within 15 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, such as: a copy of any revised HACCP plan or plans; at least five (5) complete 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 that would assist us in evaluating your corrections.   If you cannot complete all corrections within 15 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 is Import Alert #16-120. You may view this alert at: http://www.accessdata.fda.gov/cms_ia/ialist.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 and all applicable regulations, including the Seafood HACCP regulation and the 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.
 
Additionally, 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 foreign facility, FDA will assess and collect fees for re-inspection-related costs from the U.S. Agent for the foreign 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 consider providing a copy of this letter to your U.S. Agent.
 
Please send your reply to Food and Drug Administration, Attention: Mildred Benjamin, Consumer Safety Officer, Office of Compliance, Division of Enforcement, Food Adulteration Assessment 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 
 
Sincerely,
/S/
Michael W. Roosevelt
Acting Director
Office of Compliance
Center for Food Safety
and Applied Nutrition