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Lake Fish Company Inc

Lake Fish Company Inc

United States

Issuing Office:
Cincinnati District Office

United States


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

Public Health Service
Food and Drug Administration
Cincinnati District Office
Central Region
6751 Steger Drive
Cincinnati, OH 45237-3097
Telephone: (513) 679-2700
FAX: (513) 679-2775


February 17, 2016
Via United Parcel Service
Dale D. Trent, President
Lake Fish Company, Inc.
1014 W. Water Street
Sandusky, Ohio 44870
Warning Letter
Dear Mr. Trent:
We inspected your seafood processing and importer establishment, located at 1014 West Water Street, Sandusky, OH on December 15, 18 and 22, 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, Part 123 (21 CFR Part 123), and the Current Good Manufacturing Practice regulation for foods, Title 21, Code of Federal Regulations, Part 110 (21 CFR Part 110). 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). 
As an importer of fish or fishery products, you must operate in accordance with the requirements of 21 CFR 123.12. In accordance with 21 CFR 123.12(d), there must be evidence that all fish and fishery products offered for entry into the United States have been processed under conditions that comply with 21 CFR Part 123. If assurances do not exist that the imported fish or fishery products have been processed under conditions equivalent to those required of domestic processors under 21 CFR Part 123, the fish or fishery products will appear to be adulterated under Section 402(a)(4) of the Act, 21 U.S.C. §342(a)(4). 
Accordingly, your seafood products are adulterated, in that they havebeen 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 acknowledge receipt of your letter dated January 11, 2016, responding to the FDA 483, Inspectional Observations issued to you on December 22, 2015. This letter will become part of your official file. 
Your response is inadequate because you have not implemented corrective actions or provided substantive proof of the corrective actions to be taken at your facility. Violations revealed during the inspection include, but are not limited to the following:
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.” However, your firm’s HACCP plan does not list the food safety hazards of pesticides and undeclared major food allergens. 
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 parameters 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 does not list a critical limit at the receiving critical control point to control environmental chemical contaminants. Your HACCP plans critical limit is “Harvested from approved source.”  Your firm receives a letter from the fishermen that states they fish from an approved source. This does not ensure the fish was harvested from waters that were not contaminated from environmental chemical contaminants and pesticides. 
3.    You must have a HACCP plan that, at a minimum, lists monitoring procedures and their frequency for each critical control point, to comply with 21 CFR 123.6(c)(4). However, your firms HACCP plan lists a monitoring frequency at the receiving critical control point that is not adequate to control chemical contamination. Specifically, your plan lists a monitoring frequency of “annually.” The water condition should be monitored more frequently to ensure the critical limit is met. 
4.    You must implement the record keeping system that you have listed in your HACCP plan, to comply with 21 CFR 123.6(b). However, you do not have the records you listed on the HACCP plan at the receiving and packing critical control points. Specifically;
  • You did not monitor any of your shipments for the presence of ice. 
  • Your notebook “Shipping Records” used to document your packing critical control point does not contain any information related to labeling. 
5.   You must monitor sanitation conditions and practices during processing with sufficient frequency to ensure compliance with current good manufacturing practice requirements in 21 CFR Part 110, to comply with 21 CFR 123.11(b). However, your firm did not monitor the safety of water that comes into contact with food contact surfaces, hand sanitizing, and prevention of cross-contamination from insanitary objects. Specifically,
    • You do not document the strength of the chlorine solution used to sanitize work tables and cutting boards.
    • The automated fish scaler was unclean from fish scales and fish residue after it was reportedly cleaned.
    • No paper towels or a hand washing signage located at the hand washing sink in the processing room.
    6.    You must implement an affirmative step which ensures that the fish and fishery product(s) you import are processed in accordance with the seafood HACCP Regulation, to comply with 21 CFR123.12(a)(2)(ii). However, your firm did not perform an affirmative step for your fresh and frozen fish manufactured by Taylor Fish Company and All Temp Foods located in Ontario, Canada.
    7.    Predetermined corrective action plans when included in a firm’s HACCP plan, to be taken whenever there is a deviation from a critical limit, must be appropriate to comply with 21 CFR 123.7(b). However, your corrective action plan at the Receiving and Packing critical control points to control bacterial growth, chemical and labeling respectively is not appropriate. The corrective actions listed in your HACCP plan do not ensure the cause of the deviations was corrected or the actions you will take on the affected product.   
    8.      Your HACCP plan must include on-going verification activities including a records review, to comply with 21 CFR 123.8. Your HACCP plan does not include a reassessment of the HACCP plan or a review of critical control point monitoring records. Additionally, the verification activity to control bacterial growth by using ice at the receiving critical control point is “manager” and the verification activity to control labeling at the packing critical control point is “annual letter review.” Your verification activities do not verify that the critical control points were met.
    We may take further action if you do not promptly correct these violations. 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," seize your product(s) and/or enjoin your firm from further violating the Act.
    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 importer verification records, records that document the performance and results of your firm’s affirmative steps, HACCP and verification records associated with your activities as a domestic processor, 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 seafood importer establishment operates in compliance with the Act and 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 for your fish or fishery products, including those that you import into the United States.
    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.
    Please send your reply to the Food and Drug Administration, Attention: Allison C. Hunter, Compliance Officer, U.S. Food & Drug Administration, 6751 Steger Drive, Cincinnati, OH 45237. If you have questions regarding any issues in this letter, please contact Compliance Officer Hunterat (513) 679-2700 X2134 or allison.hunter@fda.hhs.gov.
    Steven B. Barber
    District Director
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