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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Ocean Beauty Seafoods, LLC 7/22/13


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 Avenue SE, Suite 210
Bothell, WA 98021-4425
Telephone:   425-302-0340
FAX:   425-302-0404 


July 22, 2013
In reply refer to Warning Letter SEA 13-24
Mark Palmer, President          
Ocean Beauty Seafoods, LLC
1100 West Ewing Street        
Seattle, Washington 98119
Dear Mr. Palmer:
We conducted an inspection of your manufacturing facility located at 14651 172nd Drive, SE, Monroe, Washington on January 31, February 1, 4, 8, 13, 22, and 26, 2013. 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 hot and cold smoked salmon products are adulterated, in that they have been prepared, packed, or held under insanitary conditions whereby itmay 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:
  1. You must conduct all food processing under conditions and controls as necessary to minimize the potential for growth of microorganisms and to ensure that other factors do not contribute to the decomposition or contamination of food, to comply with 21 CFR 110.80(b)(2). However, environmental sampling conducted during our current inspection revealed eight sub-samples collected that were positive for Listeria monocytogenes, and were determined by a two enzyme PFGE analysis, to be indistinguishable from positive FDA environmental samples collected on October 24, 2011, and April 21, 2005. One additional sub-sample collected during the inspection was positive for Listeria monocytogenes and was determined, by a two enzyme PFGE analysis, to be indistinguishable from the Listeria monocytogenes identified in your finished product, lot code 7425A2298B by the Florida Department of Agriculture on or about January 13, 2012. Further, your implemented corrective actions described as aggressive cleaning following positive Listeria species samples is not adequate as evidence by your continual detection of Listeria within your facility.
We acknowledge your response letter, dated March 15, 2013, received by our office on March 20, 2013, responding to the Inspectional Observations (Form FDA 483) issued to you at the close of the inspection. A review of this letter found the response to be partially adequate. Your response contained no information pertaining to how you identify non-stationary equipment such as mats and carts to ensure your re-test of this equipment is made to the appropriate piece of equipment.   Further, you have not specified how the “(b)(4)” hallway will be constructed. Specifically, we cannot determine, from the information provided, if this hallway will be completely self-contained. Finally, you have provided SSOPs identified as “work-in-progress’. As provided, these documents cannot be evaluated as a completed corrective action, and you have not provided documentation of the implementation of the SSOPs.
Additionally, we have the following comments related to the document entitled “Revised and Enhanced Listeria Environmental Monitoring & Control Plan” that your firm provided with your response:
  • To further prevent the hazard of cross contamination from the movement of the food and employee practices you should have designated equipment for each room, employees wear protective equipment that is designed for the task and designated for the specific processing area, and limit employees’ movement in the facility.
  • You should include a rotation of sanitizers on a regular basis to ensure continued efficacy by preventing the establishment of resistant populations of bacteria.
  • Your plan should include a description of exact locations of areas to be sampled for environmental testing. At a minimum the plan is to include routine testing and a description of exact locations of areas that have been identified as positive from environmental testing including: 


o   Cooler C2; the floor, repaired floor seams, floor drain, evaporator, door frame, pin bone table and carts
o   Skin and trim room; skinner machines, floor, repaired floor seams and floor drain
o   Floor mats, drains, carts and etc.
  • It is not appropriate to freeze environmental or products samples before analysis. Environmental and product samples should be collected, packed and immediately shipped. The plan should include information on the procedure of packing and shipping with a description of how you will ensure the samples will not be temperature and time abused during shipment.


  1. You must conduct a hazard analysis 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 critical control points to comply with 21 CFR 123.6 (a) and (c) (2).   A critical control point is defined in 21 CFR 123.3(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 revised HACCP plan for “cold smoked vacuum packaged salmon” provided with your March 20th response does not list a critical control point for thawing of your raw material salmon necessary to control pathogen growth and potential toxin formation.
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. 
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 and 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.
Please send your reply to the Food and Drug Administration, Attention: Cynthia White, Compliance Officer, 22215 26th Avenue SE, Suite 210, Bothell, Washington 98021-4425. If you have questions regarding any issues in this letter, please contact Cynthia White at 425-302-0422. 
Charles M. Breen
District Director
cc: Ms. Diane M. Miller, Plant Manger
      Ocean Beauty Seafoods, LLC
      14651 172nd Drive, SE
      Monroe, Washington 98272-1076
      Washington State Department of Agriculture
      Food Safety Program
      P. O. Box 42560
      Olympia, Washington 98504-2560
      Seafood Inspection Program
      1315 East-West Highway
      Silver Spring, Maryland 20910