| Public Health Service Food and Drug Administration |
| Los Angeles District 19701 Fairchild Irvine, California 92612-2506 Telephone (949) 608-2900 Fax (949) 608-4415 |
Department of Health and Human Services
WARNING LETTER
CERTIFIED MAIL
RETURN RECEIPT REQUESTED
November 9, 2011
WL 06-12
Young W. Kim, CEO
Ocean Group Inc.
DBA Ocean Fresh Fish & Seafood Marketing
1100 S. Santa Fe Ave.
Los Angeles,CA 90021-1743
Dear Mr. Kim:
We inspected your seafood processing and importer establishment, located at 1100 S. Santa Fe Ave., Los Angeles, CA on July 5 through July 12, 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 (21 CFR Part 123), and the Current Good Manufacturing Practice regulation for foods, Title 21, Code of Federal Regulations, Part 110 (21 CFR Part 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).
As an importer of fish or fishery products, you must operate in accordance with the requirements of 21 CFR 123.12. In accordance with 21 CFR 123.12(d), there must be evidence that all fish and fishery products offered for entry into the United States have been processed under conditions that comply with 21 CFR Part 123. If assurances do not exist that the imported fish or fishery products have been processed under conditions equivalent to those required of domestic processors under 21 CFR Part 123, the fish or fishery products will appear to be adulterated under Section 402(a)(4) of the Act, 21 U.S.C. §342(a)(4).
Accordingly, your fish and fishery 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.
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 have a HACCP plan that, at a minimum, lists the food safety hazards that are reasonably likely to occur, to comply with 21 CFR 123.6 (a) and (c) (1). A food safety hazard is defined in 21 CFR 123.3(f) as "any biological, chemical, or physical property that may cause a food to be unsafe for human consumption." However, your revised HACCP plans provided in your response to the 483 dated 09/27/2011 for "fresh tuna" and "fresh aquaculture salmon," which are products intended for raw consumption, fail to identify the hazard of pathogens at the Receiving critical control point.
Moreover, all of your revised HACCP plans dated 09/27/2011, including the plan for "fresh vacuumed imitation crab meat, fresh vacuumed yellowtail hamachi, and canned pasteurized blue crab meat," fail to identify the hazard of undeclared allergens (i.e., to ensure proper labeling of the species of fish).
2. You must implement an affirmative step designed to ensure that the fish and fishery products that you import into the United States were processed in accordance with the requirements of FDA's seafood HACCP regulations, to comply with 123.12(a)(2)(ii). However, your film did not implement an affirmative step for the importation of Jack Mackerel from Japan, fresh whole Atlantic salmon from Canada, and fresh salmon from United Kingdom.
We acknowledge your written response dated 7/26/11; however, your response is inadequate because no supporting evidence of your corrections was provided for our review. Be advised that it is your responsibility to ensure that all fish and fishery products you import and the processors who process them meet FDA's requirements.
3. 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). Specifically,
• your firm's HACCP plan for fresh raw ready-to-eat tuna lists a monitoring frequency at the Storing critical control point that is not adequate to control histamine formation and pathogen growth and toxin formation. If you intend to solely control product temperatures by monitoring ambient temperatures, you should use a continuous temperature monitoring device and perform a visual check of the data once daily.
• your firm's HACCP plan for fresh vacuumed imitation crabmeat, fresh vacuumed yellowtail hamachi, and canned pasteurized blue crabmeat does not list the monitoring procedure at the Receiving critical control point for Yellowtail. Specifically,
o Because you listed that the products will be transported in less than 4 hours, you should monitor the start and finish of transport time from the time the yellowtail is removed from the shipper's cooler until receipt.
o Your plan fails to list how temperatures will be monitored during transport. Time Temperature Indicators (TTIs) are tools for the final consumer (the one who opens the package) to use to determine if the product has been exposed to unsafe conditions. FDA does not require that processors who receive vacuum packed seafood to monitor products for the presence of TTIs at Receiving. FDA currently recommends that transport and storage conditions be monitored either continuously through data loggers or by adequacy of ice, etc. Checking TTIs at receiving cannot be considered an equivalent control.
o At the Storing CCP, the monitoring frequency of "Three times daily" is not adequate. FDA recommends use of a continuous temperature monitoring device and performing a visual check of the data once daily.
4. 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 action plan for fresh raw ready-to-eat tuna, salmon, fresh vacuum packaged yellowtail hamachi, fresh vacuumed imitation crab meat, and canned pasteurized blue crab meat, at the Receiving and Storing critical control points are not appropriate for the following reasons. Specifically,
• Your HACCP plan for fresh raw ready-to-eat tuna at the Receiving critical control point, fails to list corrective actions to address the cause of the deviation.
• Your HACCP plan for salmon at the Storing critical control point the corrective action of "Hold for evaluation" is inadequate. Your plan should specify what will be evaluated (e.g. time/temperature exposures).
• Your HACCP Plan covering fresh vacuum packaged yellowtail hamachi, fresh vacuumed imitation crab meat, and canned pasteurized blue crab meat;
o at the Receiving Crab Meat critical control point and Receiving Yellowtail Hamachi critical control point, the corrective action of "hold for evaluation" is inadequate. You should define what will be evaluated. Furthermore, you failed to include the discontinuation of the supplier until evidence of change is obtained, hence, failed to address the cause of the deviation.
We may take further action if you do not promptly correct these violations. For instance, we may take further action to refuse admission of your imported fish or fishery products under Section 801(a) of the Act (21 U.S.C. §381(a)), including placing them on "detention without physical examination," seize your product(s) and/or enjoin your firm from further violating the Act.
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 importer verification records, records that document the performance and results of your firm's affirmative steps, HACCP and verification records associated with your activities as a domestic processor, 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 seafood importer establishment 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 for your fish or fishery products, including those that you import into the United States.
Your reply should be sent to the following address:
Blake Bevill
Director, Compliance Branch
U.S. Food and Drug Administration
19701 Fairchild
Irvine, CA 92612-2506
If you have questions regarding this letter, please contact Ms. Jessica Mu, Compliance Officer at 949-608-4477.
Sincerely,
/S/
Alonza E. Cruse
District Director
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