Inspections, Compliance, Enforcement, and Criminal Investigations
Leong Kuba Sea Products, Inc. 2/16/11
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
Los Angeles District
RETURN RECEIPT REQUESTED
February 16, 2011
Mr. Glen Y. Kuba, President
Leong Kuba Sea Products, Inc.
6230 Marindustry Dr
San Diego, CA 92121-2538
Dear Mr. Kuba:
We inspected your seafood processing facility, located at 6230 Marindustry Dr, San Diego, CA 92121-2538 on November 29 to December 02, 2010. 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 (cGMP) regulation for foods, Title 21, Code of Federal Regulations, 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).
Accordingly, your ready-to-eat (RTE) Ahi tuna and tuna sashimi, canned crabmeat, and other various seafood products as identified below 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 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 RTE raw salmon intended for sushi to control the food safety hazard of parasites.
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 firm's following HACCP plans list inadequate monitoring procedures.
► Your "Vacuum packed Smoked Salmon and Smoked Trout and Pasteurized Crabmeat" HACCP Plan lists a monitoring procedure at the storage/processing critical control point that is not adequate to control Clostridium botulinum growth and toxin formation. Your plan states that your cooler temperature will not exceed 40°F for longer than (b)(4) minutes during defrost. Controlling time at elevated temperatures is critical to control the growth and toxin production by C. botulinum. Particularly in the pasteurized crabmeat, strict temperature control during refrigerated storage is necessary. Since you are aware that the cooler temperatures are greater than 40°F during the defrost cycles, you should include another control mechanism to ensure that the product temperature is not rising above 40°F every time the defrost cycle occurs. Otherwise, you will need to take a corrective action every time the cooler cycles above 40° F.
► Your "Tuna Sashimi RTE" and "Mahi Mahi, Tunas-Ahi, Yellowtail" HACCP plans list a monitoring procedure at the receiving critical control point that is not adequate to control Histamine formation. Your plan states that you will check internal temperatures at receipt. Product temperatures taken at receipt do not provide an adequate safety assurance of transportation conditions when products have been transported for extended periods (e.g. greater than 4 hours).
3. 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 plans for your "Vacuum packed smoked salmon and smoked trout and pasteurized crabmeat" HACCP plan lists a corrective action at the receiving critical control point to control Clostridium botulinum that is not appropriate. Your plan lists that you will evaluate the amount of time the product was exposed to temperatures above 40°F, however your critical limits listed at this critical control point do not include a "time" parameter.
In addition, your corrective action plan for "Tuna Sashimi RTE" and "Mahi mahi, Tunas-Ahi, Yellowtail" at the receiving critical control point to control histamine is not appropriate because they do not ensure that an unsafe product does not reach the consumer or correct the problem that caused the critical limit deviation.
4. You must implement product specifications and an affirmative step which ensures that the fish and fishery products you import are processed in accordance with the seafood HACCP regulation, to comply with 21 CFR 123.12 (a)(2)(ii). However, your firm does not have adequate product specifications or affirmative steps for your imported chub salmon, oysters, and Clams from Canada.
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 film 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. Please note that some of the deviations listed above are based on your response to the FDA 483 dated December 16, 2010.
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:
U.S. Food and Drug Administration
Attn: Blake Bevill
Director, Compliance Branch
Los Angeles District
Irvine, CA 92612-2506
If you have questions regarding any issues in this letter, please contact Dr. Raymond W. Brullo, Compliance Officer at (949) 608-2918.
Alonza E. Cruse
Los Angeles District