- Josephson's Smokehouse
- Issuing Office:
- Seattle District Office
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Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
22215 26th Ave SE, Suite 210
Bothell, WA 98021
Telephone: 425-302-0340FAX: 425-302-0402
March 17, 2014
In reply refer to Warning Letter SEA 14-07
Michael A. Josephson, Owner
106 Marine Drive
Astoria, Oregon 97103
Dear Mr. Josephson:
We inspected your seafood processing facility, located at 106 Marine Drive, Astoria, Oregon, on November 18, 2013 through November 22, 2013. We additionally visited your facility on November 27, 2013 through December 2, 2013. 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 vacuum packaged, hot smoked fish products are adulterated, in that they have been prepared, packed, or held under insanitary conditions whereby theymay have been rendered injurious to health. Additionally, we have reviewed your product labeling and found that your labeling causes your vacuum packaged, hot smoked fish products to be misbranded within the meaning of Section 403(a)(1) of the Act, 21 U.S.C. § 343(a)(1). You may find the Act, the seafood HACCP regulation and the 4th
Edition of FDA’s Fish and Fisheries Products Hazards & Controls Guidance through links in FDA's home page at www.fda.gov
We received your letter dated December 8, 2013, written in response to the Form FDA 483, Inspectional Observations, issued to you on November 22, 2013. Your response is partially adequate in that you have promised or initiated corrections. However, you did not provide sufficient detailed evidence to support implementation of the corrections. In addition, further review of the documentation obtained during the inspection revealed the following:
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 vacuum packaged, hot smoked fish does not list the critical control points of marinating to control the identified hazard of pathogen growth, but more specifically Staphylococcus aureus growth and toxin formation. Your firm explained that following the brining process, your fish products are submerged in a marinade for up to (b)(4). Your firm needs to ensure that the fish are continuously held at adequate (i.e., refrigerated) conditions during the extended time period used for marinating. Solutions with marinating ingredients will likely reduce competing bacteria which may permit growth and toxin formation from Staphylococcus aureus (i.e., a salt tolerance organism) in the absence of temperature controls.
2. 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 plan for vacuum packaged, hot smoked fish does not list critical limits at the following critical control points:
a. “brining” critical control point for temperature to control pathogen growth (and histamine in your scombroid species). Your firm conducts the brining process for some of your products for (b)(4) to (b)(4) hours. These products are at risk for pathogen growth, specifically from Staphylococcus aureus during this extended time period in the absence of proper temperature controls.
b. “brining” critical control point associated with fish species and portion sizes to ensure that each fish portion, of each species of fish achieves an adequate water phase salt level during the brine. In addition to brine time and brine strength, fish species and portion size will have a direct impact on the finished product results (i.e., achieving an adequate final water phase salt in each portion).
c. “cooling” critical control point (i.e., cooling following the cooking/smoking process) to control pathogen growth. In addition to ensuring that your cooler temperature is maintained at 40° F, your firm needs to ensure rapid cooling of the product. FDA recommends that the products are cooled to 70° F within 2 hours to 40° F within an additional 4 hours.
1. Your Hot Smoked Wine-Maple Salmon product is misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] because it is fabricated from two or more ingredients but the labeling fails to bear a complete list of all of the ingredients by common or usual name in descending order of predominance by weight, as well as sub-ingredients, as required by 21 CFR 101.4. Specifically, your Hot Smoked Wine-Maple Salmon contains soy sauce, which is a multi-ingredient food. However, the label does not declare the presence of the sub-ingredients in this multi-component food in accordance with 21 CFR 101.4(b)(2).
The requirement to list component ingredients (or “sub-ingredients”) may be met by either parenthetically listing the component ingredients after the common or usual name of the multi-component ingredient, or by listing the component ingredients without listing the multi-component ingredient itself. Under the first alternative, the component ingredients must be listed in descending order of predominance within the multi-component ingredient; and under the second alternative, the component ingredients must be listed in descending order of predominance in the finished food [21 CFR 101.4(b)(2)].
2. Your Hot Smoked Garlic Pepper Salmon, Hot Smoked Wine-Maple Salmon, Hot Smoked Spring Chinook Salmon and Hot Smoked Peppered Atlantic Salmon products are misbranded within the meaning of section 403(q) of the Act [21 U.S.C. § 343(q)] because your products fail to bear nutrition information on the package label as specified in 21 CFR 101.9.
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. We may take further action if you do not promptly correct these violations. For instance, we may take further action to seize your product(s) and/or enjoin your firm from operating.
We also note the following comments:
- Your firm’s HACCP plan lists as verification at the “brining” critical control point that you will conduct (b)(4) testing for water phase salt (WPS) to achieve a value of 3.5. However, (b)(4) testing does not ensure that each batch of fish achieves an adequate WPS level. For example neither the “smoking/drying,” the “smoking/cooking” critical control points or the processing parameters list a WPS for the end product. This should be defined as a critical limit value that will result from the processing parameters in the HACCP plan or as an end product result to be verified in the verification procedures.
- Your firm’s HACCP plan for vacuum packaged, hot smoked fish identifies the hazard of “histamine,” associated with your scombroid species. When conducting your hazard analysis, your firm should assess the need for additional critical control points to control histamine formation during those time periods when the fish are exposed to unrefrigerated conditions. For example, your firm should consider critical control points such as receipt of fresh fish, thawing of frozen fish, brining, marinating, and processing steps such as heading or gutting, etc., to address cumulative time and temperature exposures to unrefrigerated conditions.
- Any flavors used in the brining and marinating process (e.g. “maple flavoring”) must be declared in accordance with 21 CFR 101.22. For example, if the "mixed hardwood smoke" in your salmon products is an added flavor ingredient, it must be declared in accordance with 21 CFR 101.22 (e.g. “mixed hardwood smoke flavor”).
- According to your supplier's label for the Atlantic Salmon, which was purchased on November 18, 2013, from (b)(4), the salmon is raised with feed containing Canthaxanthin and Astaxanthin (Colour). In accordance with 21 CFR 101.22(k), the label of a food to which any coloring has been added must declare the coloring in the statement of ingredients.
- The net quantity of contents for your Hot Smoked Garlic Pepper Salmon, Hot Smoked Wine-Maple Salmon, Hot Smoked Spring Chinook Salmon and Hot Smoked Peppered Atlantic Salmon products are not declared in accordance with 21 CFR 101.105(a), (b), (d) and (f). Specifically, the product labels collected at the time of inspection declare “NET WT. 0.425”. The declaration of net quantity of contents should be expressed in terms of avoirdupois pound and ounce and the declaration shall appear as a distinct item on the principal display panel placed within the bottom 30 percent of the area of the label panel. In addition, a decimal fraction shall not be carried out to more than two places.
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 a revised HACCP plan, copies of monitoring and/or verification records and any 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.
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 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 send your reply to the Food and Drug Administration, Attention: Jessica L. Kocian, Compliance Officer at 22215 26th Avenue SE, Suite 210, Bothell, Washington 98021. If you have questions regarding any issues in this letter, please contact Jessica Kocian at 425-302-0444.
Ann M. Adams, PhD
Acting District Director
cc: Oregon Department of Agriculture
Food Safety Division
635 Capitol Street NE
Salem, Oregon 97301
Seafood Inspection Program
USDC, NOAA, NMFS
1315 East-West Highway
Silver Spring, Maryland 20910
Division of Seafood Safety (HFS-315)
FDA, Office of Food Safety
5100 Pain Branch Parkway
College Park, Maryland 20740