Inspections, Compliance, Enforcement, and Criminal Investigations
Blossom Enterprises LLC d/b/a Sea Blossom Seafoods 2/7/12
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
22201 23rd Drive SE
Bothell, WA 98021-4421
February 7, 2012
RETURN RECEIPT REQUESTED
In reply refer to Warning Letter SEA 12-13
Mr. Stephen M. Wilcox, Managing Member
Blossom Enterprises LLC
dba Sea Blossom Seafoods
3803 Giles Road NE
Olympia, Washington 98506-2446
Dear Mr. Wilcox:
We inspected your seafood processing facility, located at 3803 Giles Road NE, Olympia, Washington, on November 8, 9, and 21, 2011. 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 smoked salmon is adulterated, in that it 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:
1. 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 for “VacPak products processed between (b)(4) Deg F and (b)(4) deg F for (b)(4) minutes” lists the critical limits of “Smoking temperature above (b)(4) Deg F and below (b)(4) Deg F for (b)(4) minutes” at the Cold Smoking Critical Control Point are not adequate. These critical limits are not sufficient to control the food safety hazard of pathogen growth and toxin formation. Your smoked salmon does not ultimately reach temperatures for a sufficient period of time, i.e. 145˚F for at least 30 minutes as recommended for a hot smoked product, to destroy pathogens of public health concern, specifically Listeria monocytogenes. Alternatively, your product is not maintained below 90˚F, as recommended for a cold smoked product. For additional information related to hot and cold smoked products, please refer to pages 263 to 266 in the 4th Edition of the Hazards Guide, as well as Chapters 12 and 16.
We acknowledge your letter, dated December 12, 2011, received by our office on December 5, 2011, responding to the Inspectional Observations (form FDA 483). In your letter you state that the salting time of (b)(4) and the washing time of (b)(4) or less are added to the HACCP plan as controlling factors that may not completely eliminate Listeria, but that set conditions that impact Listeria’s chances of growth. The presence of wood smoke with its mix of anti bacteria compounds including Phenol, prevents Listeria growth (see reference previously provided). You also state that you propose to (b)(4) to address FDA concerns, stating that this would remove any Listeria that may be present on the fish as it enters the smoking step. Additional information will be needed to determine the adequacy of the practice to control the Listeria hazard. Such information should include concentration of the (b)(4), contact time and number of logs of destruction to the target organism (typically a minimum of six logs is needed). That information would then become part of the critical limits. In lieu of this scientific approach, the product should be adequately cooked e.g. during the smoking step, to control the hazard of Listeria monocytogenes.
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 reply to the Food and Drug Administration, Attention: Patricia A. Pinkerton, Compliance Officer, 22201 23rd Drive SE, Bothell, Washington 98021-4421. If you have questions regarding any issues in this letter, please contact Patricia Pinkerton at 425-483-4926.
Charles M. Breen