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  5. Skipanon Brand Seafoods, LLC - 06/23/2016
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WARNING LETTER

Skipanon Brand Seafoods, LLC Jun 23, 2016

Skipanon Brand Seafoods, LLC - 06/23/2016


Recipient:
Skipanon Brand Seafoods, LLC


United States

Issuing Office:
Seattle District Office

United States


  

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

Public Health Service
Food and Drug Administration
 
Seattle District
Pacific Region
22215 26th Ave SE, Suite 210
Bothell, WA 98021
 
Telephone:         425-302-0340
FAX:         425-302-0402 

 

June 23, 2016
 
CERTIFIED MAIL
RETURN RECEIPT REQUESTED
 
In reply refer to Warning Letter SEA 16-13
 
Mark F. Kujala, Owner and Managing Member
Skipanon Brand Seafoods, LLC
P.O. Box 400
Warrenton, Oregon 97146
 
WARNING LETTER
 
Dear Mr. Kujala:
 
The U.S. Food and Drug Administration (FDA) conducted an inspection of your seafood processing facility, Skipanon Brand Seafoods, LLC, located at 590 SE Third Street, Warrenton, Oregon, on August 26, 31, September 1, 17, 24, 25, 28, 29, October 5, 6, 8, 16, and November 10, 2015. The inspection found that your firm manufactures frozen, vacuum packed smoked salmon and tuna, and the following low-acid fishery products in hermetically sealed containers: smoked, plain, and seasoned salmon and tuna; smoked catfish, and walleye; black cod, razor clams and sardines. 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 Frozen Canned Albacore Tuna and Frozen Canned and Smoked Albacore Tuna are adulterated, in that they have been prepared, packed, or held under insanitary conditions whereby theymay have been rendered injurious to health.
 
Furthermore, during the inspection, our investigators collected labels of your products. Our review of the labels indicate that your firm’s “Albacore Tuna,” “Smoked Peppered Chinook Salmon,” “Smoked Chinook Salmon,” “Chinook Salmon,” “Smoked Sockeye Salmon,” and “Smoked Coho Salmon” products are misbranded within the meaning of Section 403 of the Act [21 U.S.C. § 343] and its implementing regulations in 21 CFR Part 101.
 
You can find the Act and the fish and fishery product and food labeling regulations through links in FDA’s homepage at http://www.fda.gov.
 
We received your letter, dated November 30, 2015, regarding our investigator’s observations noted on the Form FDA 483, Inspectional Observations, issued to you at the close of the inspection. We also received your reconditioning proposal dated December 9, 2015, and accompanying revised product labels. We acknowledge that you ceased operations from November 9 through 23, 2015, as a result of an inspection conducted by the Oregon Department of Agriculture.  We address responses below, in relation to each of the noted violations. 
 
The significant violations include the following: 
 
Seafood HACCP
 
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 Frozen Canned Albacore Tuna and Frozen Canned and Smoked Albacore Tuna do not include a critical control point to address the food safety hazard of undeclared allergens. 
 
We acknowledge that you have included updated HACCP plans for the above referenced seafood products in your response letter dated November 30, 2015. While the updated HACCP plans do include a critical control point to address the food safety hazard of undeclared allergens, the new plans do not list the critical control point of smoking for controlling the food safety hazard of scombrotoxin (histamine) formation.
 
2.    You must implement the recordkeeping system that you have listed in your HACCP plan, to comply with 21 CFR 123.6(b) and (c)(7).  However, your firm did not record observations of the time and temperature during the “Thawing, butchering, and precook staging” and “Thawing, butchering, brining, smoking, and pre-cook staging” critical control points to control for the hazard of histamine formation listed in your HACCP plans for Frozen Canned Albacore Tuna and Frozen Canned and Smoked Albacore Tuna, respectively. 
 
We acknowledge that you have included updated HACCP monitoring records in your response letter dated November 30, 2015. However, the supplied monitoring records do not indicate production date(s), the date(s) that the observations were made, or who completed the record.
 
Misbranding
 
1.    Your “Albacore Tuna,” “Smoked Peppered Chinook Salmon,” “Smoked Chinook Salmon,” “Chinook Salmon,” “Smoked Sockeye Salmon,” and “Smoked Coho Salmon” products are misbranded within the meaning of section 403(q) of the Act [21 U.S.C. § 343(q)] and the requirements under 21 CFR 101.9. For example,
  • The “Smoked Peppered Chinook Salmon,” “Smoked Chinook Salmon,” and “Smoked Coho Salmon” product labels fail to declare an appropriate serving size in a common household measure as required by 21 CFR 101.9(b)(7) and 101.12(b), Table 2.  The product labels declare 1 ¾ oz.; however, the appropriate serving size for fish, shellfish, or game meat, canned in ounces is 2 oz.
  • The product labels fail to declare the heading % Daily Value as required by 21 CFR 101.9(d)(6).
  • The product labels fail to declare a percent daily value for Total Carbohydrates and Fiber as required by 21 CFR 101.9(d)(7)(ii).
We acknowledge that you included revised labels in your reconditioning proposal dated   December 9, 2015. However, your revised labels still include the above-mentioned violations. Additionally, your revised product labels declare “omega 3” in the Nutrition Facts Panel.  No nutrients or food components other than those listed under 21 CFR 101.9(c) may be included within the Nutrition Facts Panel. Further, your revised labels for your “Smoked Peppered Chinook Salmon,” “Smoked Chinook Salmon,” and “Smoked Coho Salmon” products fail to declare Calcium and Iron as required by 21 CFR 101.9(c)(8). Finally, the revised product label for your “Smoked Peppered Chinook Salmon” product fails to declare each ingredient on the product label as required under section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] and by 21 CFR 101.4.  For example, the revised product label fails to declare “pepper” in the ingredient statement as required by 21 CFR 101.4(b)(2).
 
The violations cited in this letter are not intended to be an all-inclusive statement of violations that exist at your facility. You should take prompt action to correct all of the violations noted in this letter. Failure to promptly correct these violations may result in regulatory action.  For instance, we may take further action to seize your products and/or enjoin your firm from operating.
 
In addition, during our review of your November 30, 2015 response letter we noted that your firm’s revised HACCP plan for Frozen Hot-Smoked Vacuum Packed Albacore Tuna lists a critical limit at the “Butchering” critical control point that appears to be intended to cover all cumulative time and temperature exposures during unrefrigerated processing for the hazard of histamine formation. However, this is not clearly stated in the plan. We suggest the HACCP plan clearly state all of the processing steps that are included in the cumulative time and temperature exposure limits.
 
Further, because you chose to include a corrective action plan in your revised HACCP plans for Frozen Canned Tuna; Fresh Canned Tuna; Smoked and Canned Frozen Tuna; Frozen Canned Sardines; Hot Smoked Salmon Frozen vacuum-packed; and Canned Smoked Steelhead, Catfish, Walleye, Black Cod, Salmon, and Sturgeon, your described corrective actions must be appropriate to comply with 21 CFR 123.7(b). However,
  • Your corrective action plan for your revised HACCP plans for Frozen Canned Tuna; Fresh Canned Tuna; Smoked and Canned Frozen Tuna; and Frozen Canned Sardines at the refrigerated storage critical control point to control for histamine lists a corrective action of “Move to freezer/and or add ice” and “Hold and evaluate based on total time and temperature exposure”; however, your corrective action does not state that affected product will not enter interstate commerce or that the cause of the deviation will be corrected. 
  • Your corrective action plan for your revised HACCP plans for Hot Smoked Salmon Frozen vacuum-packed; and Canned Smoked Steelhead, Catfish, Walleye, Black Cod, Salmon, and Sturgeon at the refrigerated storage critical control point to control for pathogenic bacteria growth and toxin formation lists a corrective action of “Move to freezer/and or add ice” and “Hold and evaluate based on total time and temperature exposure”; however, your corrective action does not state that affected product will not enter interstate commerce or that the cause of the deviation will be corrected.
  • Your corrective action plan listed in your revised HACCP plan for Frozen Canned Tuna at the “Butchering, Packing, Pre-cook staging” critical control point states “Mark batch and perform histamine analysis on a minimum of (b)(4) cans in affected batch” and “Destroy the entire batch if any sample exceeds (b)(4) ppm histamine.” Depending on batch/lot size, analysis of only (b)(4) cans may be insufficient. We recommend that histamine analyses be performed on at least 60 subsamples of every batch/lot of tuna prior to canning and retorting.
  • Your corrective action plan listed in your revised HACCP plan for Smoked and Frozen Canned Tuna at the “Butchering” and “Canning and pre-cook staging” critical control points states “Mark batch and perform histamine analysis on a minimum of (b)(4) cans in affected batch” and “Destroy the entire batch if any sample exceeds (b)(4) ppm histamine.”  Depending on batch/lot size, analysis of only (b)(4) cans may be insufficient. We recommend that histamine analyses be performed on at least 60 subsamples of every batch/lot of tuna prior to canning and retorting.
  • Your corrective action plan listed in your revised HACCP plans for Frozen Canned Sardines and Smoked and Frozen Canned Tuna at the “Thawing frozen tuna under refrigeration” critical control point lists “Mark batch and perform histamine analysis on a minimum of (b)(4) cans in affected batch” and “Destroy the entire batch if any sample exceeds (b)(4) ppm histamine.” We note that the critical control point for thawing lists tuna as the product being monitored in your HACCP plan for Frozen Canned Sardines.  Further, depending on batch/lot size, analysis of only (b)(4) cans may be insufficient. We recommend that histamine analyses be performed on at least 60 subsamples of every batch/lot of tuna prior to canning and retorting.  
We also note the following comments about your products labels:
  • The product labels fail to use the correct format for the vitamin and mineral declarations.  Under 21 CFR 101.9(d)(8), nutrient information for vitamins and minerals must be separated from information on other nutrients by a bar as provided under this regulation.
  • The net weight of the “Smoked Coho Salmon” is 156g, with each serving being 49 grams; however, the “servings per container” declaration is only two. Two 49 gram servings would only be 98 grams of the product.
  • The “Smoked Chinook Salmon” and “Smoked Peppered Chinook Salmon” product labels each declare “3+” servings. However, the declaration of “+” is not provided for under 21 CFR 101.9(b)(8).
  • The “Smoked Coho Salmon” and “Smoked Peppered Chinook Salmon” product labels declare “Mixed Hardwood Smoke” and the “Smoked Sockeye Salmon” product label declares “Natural Hardwood Smoke” in the ingredient statements. Because these statements describe the smoking process, and not ingredients, they must not be listed as ingredients in the ingredient statement required under 21 CFR 101.4. 
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 reinspection-related costs. A reinspection 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. Reinspection-related costs means all expenses, including administrative expenses, incurred in connection with FDA’s arranging, conducting, and evaluating the results of the reinspection and assessing and collecting the reinspection fees (21 U.S.C. 379j-31(a)(2)(B)). For a domestic facility, FDA will assess and collect fees for reinspection-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 reinspection-related costs.
 
You should respond in writing within fifteen (15) working days of receiving this letter of the steps you have taken to bring your firm into compliance with the law. Your response should include each step that has been taken or will be taken to correct the violations and prevent their recurrence. You should also include in your response any documentation 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.
 
Please send your response to the U.S. Food and Drug Administration, Seattle District, 22215 26th Avenue SE, Suite 210, Bothell, Washington, 98021-4421, to the attention of LCDR Cynthia White, Compliance Officer. If you have any questions regarding this letter, please contact LCDR White at (425) 302-0422.
 
 
Sincerely,
/S/ 
Miriam R. Burbach
District Director
 
cc:   Oregon Department of Agriculture
       Food Safety Division
       635 Capitol Street NE
       Salem, Oregon 97301