- Bluefin Seafoods Corporation
- Issuing Office:
- Cincinnati District Office
| || |
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
| ||Cincinnati District Office|
6751 Steger Drive
Cincinnati, OH 45237-3097
Telephone: (513) 679-2700
FAX: (513) 679-2761
January 13, 2015
Warning Letter CIN-15-448131-12
Kenneth N. Berry, Jr.
Bluefin Seafoods Corporation
617 East Washington St.
Louisville, KY 40202
Dear Mr. Berry:
We inspected your seafood processing facility located at 617 E. Washington Street, Louisville, Kentucky on December 1 – 5, 2014. We also reviewed the letter dated December 11, 2014, from Cory W. Mollak responding to the FDA 483 List of Observations issued on December 5, 2014. 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, and the Current Good Manufacturing Practice regulation for foods, Title 21, Code of Federal Regulations, Part 110 (21 CFR 123 & 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). Accordingly, your fish and fishery products such as finfish and crustacean shellfish are adulterated, in that they have been prepared, packed, or held under insanitary conditions whereby it may 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
Your significant violations 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 and you must have and implement a written HACCP plan to control any food safety hazards that are reasonably likely to occur, to comply with 21 CFR 123.6(a) and (b). However, your firm does not have a HACCP plan for crustacean shellfish to control the food safety hazard of undeclared major food allergens.
- Your “Allergen HACCP Plan 2014” which you submitted with your letter dated December 11, 2014 addresses the control of the hazard of undeclared major food allergens in finfish only. You have not addressed the control of that hazard in crustacean shellfish.
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 “Histamine HACCP Plan 2014” lists a critical limit at the (b)(4) critical control point that is not adequate to control the hazard of histamine formation.
- You list the quantity of (b)(4) as one of the acceptable critical limits. FDA recommends at the (b)(4) critical control point that the product be held in a cooler with a temperature of 40⁰F (4.4⁰C) or below, or that you verify that ice is completely surrounding the product.
3. You must have a HACCP plan that, at a minimum, lists the monitoring procedures and their frequency for each critical control point, to comply with 21 CFR 123.6(c)(4). However, your firm’s HACCP plan “Histamine HACCP Plan 2014” lists a monitoring procedure at the (b)(4) critical control point that is not adequate to control the hazard of histamine formation.
- You list a monitoring procedure of “. . . (b)(4)” with “(b)(4)”. FDA recommends at the (b)(4) critical control point that you monitor the ice or chemical coolants in a representative number of containers (e.g. cartons and totes) from throughout the shipment and that the number of containers be specified in the plan. FDA further recommends that the internal temperature of the fish be taken in a representative number of fish from throughout the shipment and that the number of fish or fillets be specified in the plan.
The issues and violations described above are not meant to be an inclusive list of 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 110). You also have a responsibility to use procedures to prevent further violations of the Federal Food, Drug, and Cosmetic Act and all applicable regulations.
You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in regulatory action without further notice, including, without limitation, seizure and injunction of adulterated products under sections 302 and 304 of the Act [21 U.S.C. §§ 332 and 334].
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 noncompliances materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any re-inspection-related costs.
Within fifteen (15) working days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to correct these violations. You should include in your response, documentation such as copies of the revised HACCP plans, 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.
Your written response should be sent to Stephen J. Rabe, Compliance Officer, U.S. Food and Drug Administration, 6751 Steger Drive, Cincinnati, OH 45237. If you have any questions about this letter, please contact Compliance Officer Rabe at 513-679-2700 Ext. 2163.
Toniette K. Williams
Acting District Director
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