Company: Winchester Bay Fisheries, LLC
Subject: Seafood HACCP/CGMP for Foods/Adulterated
Issuer: Seattle District Office
Issued: Nov. 19, 2007 Closed:
Not applicable.
Source ucm076578 Archive Code:

Winchester Bay Fisheries, LLC 19-Nov-07

Department of Health and Human Services

Public Health Service
Food and Drug Administration

Seattle District
Pacific Region
22201 23rd Drive SE
Bothell, WA 98021-4421

Telephone: 425-486-8788
FAX: 425-483-4996

November 19, 2007


In reply refer to Warning Letter SEA 09-05

Steven A. Sanders, Owner
Brian A. Reeves, Owner
Winchester Bay Fisheries, LLC
182 Bay Front Loop
Winchester Bay, Oregon 97467


Dear Messers Sanders and Reeves:

We inspected your seafood processing facility, located at 182 Bay Front Loop, Winchester Bay, Oregon, on September 22 and 23, 2008. 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 CFR123.6(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, including the sanitation control procedures under 21 CFR 123.11, 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. ยง 342(a)(4). Accordingly, your fresh/frozen Albacore tuna and canned alder smoked Albacore tuna products are adulterated, in that they have been prepared, packed, or held under insanitary conditions whereby they 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

Your significant violations were as follows:

1. You must conductor have conducted for you a hazard analysis to determine whether there are food safety hazards that are reasonably likely to occur and have and implement a HACCP plan that, at a minimum, lists the critical control points, to comply with 21 CFR 123.6(c)(2). A critical control point is defined in 21 CFR123.3(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 fresh/frozen Albacore tuna HACCP plan, which covers the canned smoked Albacore tuna product you process, fails to list a critical control point to control reasonably likely hazards. Specifically, your plan does not list your "Brining" step as a critical control point to control the food safety hazards of histamine formation and Staphylococcus aureus growth and toxin formation.

Your smoked canned Albacore tuna process includes a (b)(4) brining step during which histamine formation and Staphylococcus aureus growth and toxin formation are reasonably likely to occur. FDA recommends that the product be maintained at or below 40 degrees F during the brining stage and that your firm either monitor brine temperatures at the start of the brining process and at least every two hours for the entire duration of the (b)(4) brine step; OR use equipment capable of continuously monitoring the temperature of your cooler during the brining step, with a daily review of the temperature monitoring record and a daily check of the equipment.

2. You must have a HACCP plan that lists monitoring procedures and their frequencies for each critical control point, to comply with 21 CFR 123.6 (c)(4). However, your firm's HACCP plan for fresh/frozen Albacore tuna lists monitoring procedures/frequencies at the refrigerated storage critical control point that are not adequate to control histamine formation because they are not consistent with your listed critical limits. Specifically, your refrigerated storage critical control point lists monitoring procedures and frequencies of visually checking that product is covered in ice, while your critical limit is listed as "temp. not to exceed 40 degrees." Your listed monitoring procedures do not include monitoring actual cooler temperatures and so you will be unable to monitor temperatures to ensure they do not exceed 40 degrees.

3. 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 proper labeling, storage, and use of toxic compounds with sufficient frequency to ensure compliance with the current good manufacturing practice requirements in 21 CFR Part 110, as evidenced by improper labeling of toxic compounds. Specifically, three bottles of chemicals, which your firm claimed to contain alcohol, were observed in the processing room without labels, in violation of 21 CFR 123.11(b)(6).

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.

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 written reply to the Food and Drug Administration, Attention: Michael J. Donovan, Compliance Officer, 22201 23rd Drive SE, Bothell, WA 98021-4421. If you have any questions regarding this letter, please contact Mr. Donovan at (425) 483-4906.



Charles M. Breen
District Director

Copy of FDA483

cc: OSDA, with disclosure statement