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  5. Neilsen Seafood - 542428 - 12/19/2017
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Neilsen Seafood MARCS-CMS 542428 —

Recipient Name
Timothy O. Neilsen
Neilsen Seafood

16091 Heron Bay Loop Rd East
Coden, AL 36523
United States

Issuing Office:
Cincinnati District Office

United States



Black HHS-Blue FDA Logo



Cincinnati District Office
6751 Steger Drive
Cincinnati, OH 45237
Telephone: (513) 679-2700
FAX: (513) 679-2772


Warning Letter
VIA UPS                                                       
December 19, 2017
Timothy O. Neilsen, Owner
Timothy Neilsen Seafood
16091 Heron Bay Loop Rd East
Coden, AL 36523
Dear Mr. Neilsen:
We inspected your seafood processing facility, located at 16091 Heron Bay Loop Road East, Coden, AL 36523 on November 2-3, 6-7, 2017. 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 refrigerated, ready-to-eat crab meat is adulterated, in that is has 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 were as follows:
  • You must conduct, or have conducted for you, hazard analysis for each kind of fish or 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 refrigerated, ready-to-eat crab meat to control the food safety hazards of environmental chemical contaminants, pathogenic bacterial growth due to temperature abuse, pathogenic bacterial survival through cooking or pasteurizing, allergens, and metal inclusion. 
Once you have conducted a hazard analysis for your seafood products, your HACCP plan must, at a minimum, list hazards that are reasonably likely to occur, and include appropriate critical control points, critical limits, monitoring procedures, recordkeeping activities, etc., to ensure that the food safety hazards are controlled to comply with 123.6(c).
Please refer to the Fish and Fishery Products Hazards and Controls Guidance: Fourth Edition (the Hazards Guide), including Chapter 9 (Environmental Controls), Chapter 12 (Pathogenic Bacterial Growth and Toxin Formation as a Result of Time and Temperature Abuse), Chapter 16 (Pathogenic Bacterial Survival Through Cooking or Pasteurization), Chapter 19 (Undeclared Major Food Allergens), and Chapter 20 (Metal Inclusion) for guidance in determining the appropriate controls for your processing operations.
  • You must maintain sanitation control records that, at a minimum, document monitoring and corrections set out in 21 CFR 123.11(b), to comply with 21 CFR 123.11(c). However, your firm did not maintain sanitation monitoring records for the maintenance of hand washing, hand sanitizing, and toilet facilities; protection of food, food packaging material, and food contact surfaces from adulteration with lubricants, fuel, pesticides, cleaning compounds, sanitizing agents, condensate, and other chemical, physical, and biological contaminants; proper labeling, storage, and use of toxic compounds; and control of employee health conditions that could result in the microbiological contamination of food, food packaging materials, and food contact surfaces. Specifically, your “(b)(4)” records do not contain documentation of the aforementioned sanitation controls.
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 mean all expenses, including administrative expenses, incurred in connection with FDA’s arranging, conducting, and evaluating the results of the inspection and assessing and collecting the 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 inspected 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.
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). 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. 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.
Please send your reply to the Food and Drug Administration, Attention: Andrew J. Lang, Compliance Officer, Cincinnati District Office, 6751 Steger Drive, Cincinnati, OH 45237. If you have questions regarding any issues in this letter, please contact Andrew J. Lang at 513-679-2700 x2117.
Steven B. Barber
Director, Division V
Office of Human and Animal Food Operations – East
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