Seapak O.C.I. 11/28/12
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Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
College Park, MD 20740
November 28, 2012
VIA EXPRESS DELIVERY
Ms. Debbie Beemer
P.O. Box 723
Reference No. # 378238
Dear Ms. Beemer:
We inspected your seafood processing facility Seapak O.C.I., located at 1620 B Old Beach Road, Masset, Canada, on June 21-22, 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, FDA issued an FDA-483, Inspectional Observations, listing the deviations found at your firm. We acknowledge receipt of your response, dated July 6, 2012, that included a corrective action report and revised HACCP plans for your Frozen Vacuum Packed Raw Fish, Cold Smoked Fish and Hot Smoked Fish. We have assessed the response and have continuing concerns 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 frozen vacuum packed raw salmon and halibut fillets, frozen vacuum packed hot smoked fish fillets, and frozen vacuum-packed cold smoked fish fillets are adulterated, in that they have been prepared, packed, or held under conditions whereby they may have been rendered injurious to health.
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, 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 revised HACCP plans do not list the following food safety hazards:
- Your HACCP plan for frozen vacuum packed raw fish fails to identify the hazard of Clostridium botulinum at the processing step where vacuum packaged product is held (b)(4) before being frozen. During the inspection, your firm was observed (b)(4). At this step, Clostridium botulinum toxin formation is reasonably likely in the absence of strict temperature control. FDA recommends continuously monitoring the cooler storage temperature and ensuring the temperature does not exceed 3.3°C.
- Your HACCP plan for cold smoked fish fails to identify hazard of parasites in your cold smoked, ready-to-eat product. Although your hazard analysis worksheet references parasites and indicates control of the parasites through freezing, your firm needs to identify the hazard in your HACCP plan and, once identified, include the (b)(4) as a critical control point to control the hazard.
2. 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 be prevented, eliminated, or reduced to acceptable levels.” However, your firm’s revised HACCP plans do not list the appropriate critical control points, as follows:
- Hot smoked ((b)(4) step with new devices)
o Your HACCP plan fails to list cooling as a critical control point to control the hazard of pathogen growth and toxin formation. FDA recommends the product be cooled from an internal temperature of 57.2°C to 21.1°C within 2 hours with further cooling from 21.1°C to 4.4°C within an additional 4 hours. Monitoring procedures should include length of cooling cycle and internal temperature of the products at least every 2 hours.
o Your HACCP plan fails to list finished product cooler storage of your refrigerated ready-to-eat products as a critical control point to control the hazard of pathogen growth and toxin formation. FDA recommends your firm control this hazard by ensuring the cooler storage temperature is continuously monitored and does not exceed 4.4°C.
o Your HACCP plan fails to list (b)(4) as a critical control point to control the hazard of pathogen growth and toxin formation, specifically Staphylococcus aureus. Your firm should be monitoring the salt:fish ratio and (b)(4).
o Your HACCP plan fails to list a critical control point for the overnight cooler storage of your vacuum packaged products (b)(4) as a critical control point to control the hazard of pathogen growth and toxin formation, including Clostridium botulinum. FDA recommends controlling this hazard by ensuring the cooler storage temperature is continuously monitored and does not exceed 3.3°C.
o Your HACCP plan fails to list (b)(4) as a critical control point to control the hazard of pathogen growth and toxin formation, specifically Staphylococcus aureus. Your firm should be monitoring the salt:fish ratio and (b)(4) at this step.
o Your HACCP plan fails to list a critical control point for the holding and storage of products to control the hazard of pathogen growth and toxin formation. According to your process, the products are (b)(4) and in the cooler both during and after the cooling process. FDA recommends your firm ensure the cooler storage temperature is continuously monitored and does not exceed 4.4°C.
3. You must have a HACCP plan that, at a minimum, lists the critical limits that must be met, to comply with 21 CFR 123.3(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 for cold smoked fish lists a critical limit of (b)(4) critical control point. This time and temperature combination is not adequate to control pathogen growth and toxin formation.
The products are (b)(4) to control pathogens and, therefore, your firm needs adequate time and/or temperature controls during (b)(4). Because (b)(4), FDA recommends your firm ensure that the cooler storage temperature is continuously monitored and does not exceed 4.4°C
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) 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. You should consider providing your US Agent with a copy of this letter.
Please send your reply to Food and Drug Administration, Attention: Standra Purnell, 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.
Michael W. Roosevelt
Office of Compliance
Center for Food Safety
and Applied Nutrition