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  5. Two Rivers Smoked Fish LLC - 03/18/2015
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Two Rivers Smoked Fish LLC

Two Rivers Smoked Fish 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 98021-4425
Telephone:      425-302-0340
FAX:    425-302-0402 


March 18, 2015
In reply refer to Warning Letter SEA 15-10
Joshua Flade, President
Two Rivers Smoked Fish, LLC
4306 Glenbrook Drive, Unit A
Hailey, Idaho 83333
Dear Mr. Flade:
We inspected your seafood processing facility, located at 4306 Glenbrook Drive, Unit A, Hailey, Idaho, on February 2, 3, and 5, 2015. We found that you have serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations (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 Smoked Steelhead, Smoked Trout, and Smoked Salmon products are adulterated, in that they have been prepared, packed, or held under insanitary conditions whereby theymay have been rendered injurious to health. You may find the Act, the seafood HACCP regulation, and the Fish and Fisheries Products Hazards & Controls Guidance through links in FDA's home page at www.fda.gov.
We received a letter from Mr. Tanner J. Ellis, Part Owner, Two Rivers Smoked Fish, LLC, dated February 10, 2015, written in response to the FDA 483, Inspectional Observations, issued to Mr. Ellis, on February 5, 2015. This response is partially adequate in that he has promised or initiated corrections; however, insufficient detailed evidence was provided to support implementation of the corrections. 
Your significant violations were as follows: 
1.    You must fully document in your records all corrective actions taken, to comply with 21 CFR 123.7(d). However, you did not document that a corrective action was taken when you deviated from your critical limit of “internal temp. of fish held at or above (b)(4)F for at least (b)(4) min.” for smoked trout, batch 3641, at the Smoking/Cooking critical control point (CCP) to control the food safety hazards of Clostridium botulinum and pathogen survival.
Your response is inadequate in that it does not address the concern of the lack of records for the corrective action. 
2.    You must take an appropriate corrective action when a deviation from a critical limit occurs, to comply with 21 CFR 123.7(a). Your firm did not take a corrective action to control the food safety hazards of Clostridium botulinum and pathogen growth when your process for smoked trout, batch 3642, deviated from your critical limit at the Smoking/Cooking CCP.  The critical limit identified in your “Trout Fillets Hot Smoked and Vacuum Packaged” HACCP plan for this CCP is an internal product temperature of (b)(4)F for (b)(4) minutes.  The temperature recording chart for batch 3642, smoked trout, on December 30, 2014, indicates an internal temperature for this product of (b)(4) F for less than 15 minutes.
Your response is inadequate in that it appears that your firm is relying on visual observation of the cook, rather than relying on the temperature recording chart.
3.    You must implement the record keeping system that you listed in your HACCP plan, to comply with 21 CFR 123.6(b) and (c)(7). However, your firm did not record monitoring observations at the “Cooling after Smoking” CCP to control pathogen recontamination listed in your “Trout Fillets Hot Smoked and Vacuum Packaged” HACCP plan.   
In your response, you stated that you will be monitoring the surface temperature of the fish by using a “temperature gun.” Your response is not adequate in that you have not identified a minimum or maximum temperature value for this product at any stage of cooling post cooking, nor have you identified how you will assess the internal temperature of the product. 
4.    To comply with 21 CFR 123.10, you must have an individual who has successfully completed training in the application of HACCP principles to fish and fishery product processing that is at least equivalent to that received under a standardized curriculum recognized as adequate by the U.S. Food and Drug Administration or who may otherwise be qualified through job experience to perform the following functions: 1) the development of the HACCP plan, as required by 21 CFR 123.6(b); 2) the reassessment and modification of the HACCP plan in accordance with the corrective action procedures specified in 21 CFR 123.7(c)(5); 3) the reassessment and modification of the HACCP plan in accordance with the verification activities specified in 21 CFR 123.8(a)(1); 4) the reassessment and modification of the hazard analysis in accordance with the verification activities specified in 21 CFR 123.8(c); and 5) perform the record review required by 21 CFR 123.8(a)(3).  Mr. Ellis verbally confirmed that there is currently no one associated with your firm that has completed the required HACCP training or is HACCP-qualified through job experience.
Your response is inadequate in that it does not specify who will be attending the training. In addition, it does not address who will be responsible for the HACCP oversight until an employee has been trained. 
5.    You did not review your critical control point monitoring records within one week of the records were made, to comply with 21 CFR 123.8(a)(3). Specifically, your production record titled “Processing Schedule” for hot smoked trout batches 3641, dated December 29, 2014, and 3642, dated December 30, 2014, were not reviewed, signed, and dated within one week of the record being made. 
In your response, you stated that you have trained (b)(4) employees to properly read these records, and affirm that these records comply with your HACCP plans. Your response is inadequate in that you have not indicated that the review of these records will be conducted by someone who has been HACCP trained, or the interim actions you plan to implement for monitoring record review until at least one individual at your firm has completed HACCP training.
We may take further action if you do not promptly correct these violations. For instance, we may take further action to seize your products and/or enjoin your firm from operating.
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 domestic facility, FDA will assess and collect fees for re-inspection-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 re-inspection-related costs.
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 HACCP and verification records, 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.
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.
Please send your reply to the Food and Drug Administration, Attention: Patricia A. Pinkerton, Compliance Officer, at 22215 26th Avenue SE, Suite 210, Bothell, Washington 98021. If you have any questions regarding any issues in this letter, please contact Patricia Pinkerton at 425-302-0428. 
Miriam R. Burbach
District Director 
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