Inspections, Compliance, Enforcement, and Criminal Investigations
Ocean Beauty Seafoods, Inc.
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
22201 23rd Drive SE
Bothell, WA 98021-4421
December 16, 2008
VIA CERTIFIED MAIL
RETURN RECEIPT REQUESTED
In reply refer to Warning Letter SEA 09-06
Mark Palmer, President
Ocean Beauty Seafoods, Inc.
1100 W. Ewing Street
P.O. Box 70739
Seattle, Washington 98127-1539
Dear Mr. Palmer:
We inspected your seafood processing facility, located at 1100 W. Ewing Street, Seattle, Washington, on June 25-26, 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 (2,1 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 pouched, refrigerated, pasteurized crab meat and fresh scombroid species 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 www.fda.gov. We acknowledge the receipt of responses dated July 3, 2008, and September 17, 2008, from Jim Yonker, Director, Corporate Food Safety. This letter incorporates the information provided in those responses.
Your significant violations were 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 pouched, refrigerated, pasteurized crabmeat to control the food safety hazard of Clostridium botulinum. Your firm responded to this observation of concern on July 3, 2008, stating that a HACCP plan was completed and implemented. As follow-up to that July 3rd response, FDA requested, via a telephone conference, a copy of that HACCP plan and five days of monitoring records to verify implementation of the plan. However, your September 17, 2008, response provided as follow-up to that FDA request did not include a HACCP plan for your pouched refrigerated, pasteurized crabmeat product.
2. Because you chose to include a corrective action plan in your HACCP plan, your described corrective actions must be appropriate, to comply with 21 CFR 123.7(b). However, your corrective actions for your fresh scombroid species of fish at the "Storage" critical control points as listed in the HACCP plan provided to FDA in your September 17th response are not appropriate. Specifically, your firm will be unable to implement the corrective actions listed as: "If core temperature reached (b)(4) deg. F for no more than (b)(4), then isolate, ice adequately and monitor temp.... " Your firm's monitoring procedures at the "Storage" critical control points indicate that you will be monitoring temperatures and cooling media at least (b)(4) during plant operations. Consequently, you may not have any information related to temperatures and cooling media between those (b)(4) or during those times when your firm is not in operation. These time lapses between the (b)(4) checks, as well as when you are not in operation are expected to be greater than the maximum time of (b)(4) as listed in your corrective action plans. We also recommend that your firm check the surface flesh of the fish under these conditions since the surface layers are expected to heat more rapidly than the interior core layers of the fish as the ice melts or the gel-packs thaw.
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). We acknowledge that your firm indicated in your response dated July 3, 2008, that corrections have been made to the extensive number of sanitation deviations observed during the inspection. We will verify the adequacy of those corrections during our next inspection of your facility. However, your firm's response did not address deviations associated with the protection of food, food packaging material, and food contact surfaces from adulteration with condensate, as evidenced by:
a. A ceiling cooling unit in the value added room was observed with condensate dripping into a drip pan. The drip pan was broken allowing the condensate to drip onto the stainless steel carts used to store product during processing. There was no indication in either response that this was repaired.
b. An ammonia pipe on the ceiling in the receiving area was observed with condensate dripping into a drip pan. The drip pan was broken allowing the condensate to drip onto packaging materials for fin.ished product. There was no indication in either response that this was repaired.
We may take further action if you do not promptly correct these violations. For instance,we may take further action to seize your products 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 riot 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: Lisa M. Elrand, Compliance Officer, 22201 23rd Drive SE, Bothell, WA 98021-4421. If you have any questions regarding this letter, please contact Ms. Elrand at (425) 483-4913.
Chales M. Breen