Young Ocean, Inc 10/19/12
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Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
22215 26th Ave SE, Suite 210
Bothell, WA 98021
October 19, 2012
In reply refer to Warning Letter SEA 13-03
Kevin Y. Chae, President
Young Ocean, Inc.
20233 80th Avenue South
Kent, Washington 98032-1257
Dear Mr. Chae:
We conducted an inspection of your manufacturing facility located at 20233 80th
Avenue South, Kent, Washington, on April 24, May 8, 9, 11 and 17, 2012, and 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 salted pollock roe, frozen pollock roe IQF, fresh imitation crabmeat with vacuum pack and fresh fish (tuna, salmon, fluke, sea urchin roe) products are adulterated, in that they have been prepared, packed, or held under insanitary conditions whereby theymay have become contaminated with filth or 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 your response letter, dated May 31, 2012, concerning our investigator’s observations listed on the Inspectional Observations (Form FDA 483) issued to you at the close of the inspection. We address this response below as it relates to the noted observations.
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 like 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 your salted pollock roe and frozen pollock roe, IQF products to control the food safety hazard of pathogen growth.
Your response included HACCP plans for your salted pollock roe and frozen pollock roe, IQF products. Review of these HACCP plans reveals these plans are inadequate. For example, both HACCP plans identify a critical limit at the “Pick up thawed roe” critical control point which fails to meet the definition of a critical limit. 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”. Further, to monitor your identified critical limit, both HACCP plans indicate you will monitor the products for “Freshness”. Freshness is not a quantifiable factor, and not an acceptable factor in determining the safety of this product. This is not meant to be a comprehensive assessment of your HACCP plan.
2. You must have a HACCP plan that, at a minimum, lists monitoring procedures and their frequency for each critical control point, to comply with 21 CFR 123.6(c)(4). However, your HACCP plan for fresh imitation crab meat with vacuum pack lists a monitoring frequency at the “Storing in cooler” critical control point of “Once / day” that is not adequate to control the hazard of Clostridium botulinum toxin formation. In addition, this HACCP plan lists a monitoring frequency at the “Receiving” critical control point of “Each time”, that is not adequate for control of formation of Clostridium botulinum toxin.
Review of your written response determined your response is not adequate in that the monitoring frequencies for temperature at the “Storage in cooler” and “Receiving” critical control points in your updated HACCP plan for fresh imitation crab meat with vacuum pack remains unchanged.
3. Because you chose to include corrective action plans in your HACCP plans, your described corrective actions must be appropriate, to comply with 21 CFR 123.7(b). However, your corrective action plans are not appropriate. Specifically;
a. In your HACCP plan for fresh fish (tuna, salmon, fluke, sea urchin roe), the “Pick-up”, “Receiving and storing in cooler” and “Cutting in cutting room” critical control points list a corrective action of “add ice”. This corrective action is inadequate in that it fails to correct the cause of the deviation and fails to ensure adulterated products do not enter commerce.
b. In your HACCP plan for fresh imitation crab meat with vacuum pack, the “Receiving” and “Storing in cooler” critical control points list a corrective action plan of checking the freshness of the product. This corrective action is inadequate in that this corrective action fails to correct the cause of the deviation and fails to ensure adulterated products do not enter commerce.
Review of your written response determined your response is inadequate in that your corrective actions for the “Pick-up” and “Receiving & storing in cooler” critical control points identified in your HACCP plan for fresh fish (tuna, salmon, fluke, sea urchin roe) remains unchanged.
In addition, your updated HACCP plan for fresh imitation crab meat with vacuum pack submitted with your response lists a corrective action at the “Receiving” critical control point that is inadequate in that it remains unchanged.
4. You must monitor sanitation conditions and practices during processing with sufficient frequency to ensure compliance with Current Good Manufacturing Practice regulation in 21 CFR Part 110 to comply with 21 CFR 123.11(b). However, your firm did not monitor the exclusion of pests or cleanliness of food contact surfaces with sufficient frequency as evidenced by:
a. Exclusion of pests:
i. No less than 100 dry, hard apparent rodent excreta pellets (REPs) between pallets holding cases of sake along the northern wall of the warehouse within 25 feet of the area used to package raw, frozen pollock roe;
ii. No less than 80 dry, hard REPs in the northwest corner of the warehouse within 25 feet of the area used to package raw, frozen pollock roe;
iii. One deceased, decomposed, apparent rodent in a large size snap trap under a pallet holding dehydrated, shaved Bonito (fish) flakes in the northeast area of the warehouse within 30 feet of the are used to package raw, frozen pollock roe; and,
b. Condition and cleanliness of food contact surfaces:
i. Frozen pollock roe is processed on a wooden table; and,
ii. Residual product build up was observed on metal racks used to freeze raw pollock roe.
Your written response does not address what you have done to correct these sanitation conditions, or what you plan to do to prevent these conditions from recurring in the future.
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.
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) 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: Cynthia White, Compliance Officer, 22215 26th Avenue SE, Suite 210, Bothell, Washington 98021-4421. If you have questions regarding any issues in this letter, please contact Cynthia White at 425-302-0422.
Charles M. Breen
Washington State Department of Agriculture
Food Safety Program
P.O. Box 42560
Olympia, Washington 98504-2560