Inspections, Compliance, Enforcement, and Criminal Investigations
Citra Mina Seafood Corporation 11/8/2008
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
ID. # 11687
October 8, 2008
VIA OVERNIGHT MAIL
CITRA MINA Seafood Corporation
Lot No. 5,
GSC Fish Port Complex
General Santos City,
Telephone: (083) 380-1188
On June 5,6,9, and 10, 2008, a representative of the United States Food and Drug Administration (FDA) conducted an inspection of a fish and fishery products importer in the United States; King Tuna, Inc. dba Gj Fresh LLC located at 418 S. Central Avenue, Los Angeles, CA 90013. That importer was found to be importing Yellowfin Tuna from your processing facility. During the inspection of that importer, we collected a copy of your firm's HACCP plan for your "Frozen Smoke Treated Species (Yellowfin and Bigeye, Marlin & Mahi Mahi)," which are intended to be eaten raw or to be fully cooked by the consumer. Our evaluation of that HACCP plan (copy attached) revealed that the plan demonstrates serious deviations from the requirements of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations, Part 123 (21 CFR Part 123).
In accordance with 21 CFR 123.6(g), failure of a processor to have and implement a HACCP plan that complies with 21 CFR 123.6, or otherwise to operate in accordance with the requirements of21 CFR Part 123, renders its fishery products adulterated under section 402(a)(4) of the U.S. Federal Food, Drug, and Cosmetic Act (the Act), [21 USC § 342(a)(4)]. Accordingly, your firm's smoke-treated fish, (Yellowfin tuna, Bigeye tuna, Marlin, and Mahi Mahi), which are intended for raw consumption or for further cooking by the consumer, are adulterated under § 402(a)(4) of the Act, in that the products have been prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth, or whereby they may have been rendered injurious to health. You may find the Act, the seafood HACCP regulation, and FDA's Fish and Fisheries Products Hazards and Controls Guidance: 3rd Edition (the Hazard Guide) through links in FDA's home page at www.fda.gov.
We note the following violations in your seafood HACCP plan:
1. You must conduct or have conducted for you a hazard analysis for each kind of fish and fishery product that you process to determine whether there are food safety hazards that are reasonably likely to occur, and have and implement a HACCP plan that lists the food safety hazards that are reasonably likely to occur. 21 CFR l23.6(a) and (c)(1). A food safety hazard is defined in 21 CFR l23.3(f) as "any biological, chemical, or physical property that may cause a food to be unsafe for human consumption." Your firm's HACCP plan for "Frozen Smoke Treated Species (Yellowfin and Bigeye, Marlin & Mahi Mahi)" does not list the food safety hazard of pathogen growth and toxin formation in raw product intended to be consumed raw, for example product intended for sushi or sashimi.
2. To comply with 21 CFR l23.6(c)(4), your HACCP plan must list monitoring procedures, and their frequency, for each critical control point. However, your firm's HACCP plan for "Frozen Smoke Treated Species (Yellowfin and Bigeye, Marlin & Mahi Mahi)" does not list monitoring procedures adequate to control histamine associated with the critical control point of receiving (after on-board handling). Checking that fish were adequately iced, as listed in your plan, is not sufficient to ensure that the fish were captured and stored in a manner to prevent histamine development. We recommend reviewing boat records to provide you information about on-board handling practices, such as: (a) the method of capture; (b) the date and time of landing; (c) where applicable, the air and water temperatures at the time of landing onboard the vessel; (d) method of cooling and temperature of cooling media; (e) date and time cooling began; (f) the cooling rates; and (g) records indicating the presence of adequate ice surrounding the fish during storage on-board the vessel.
As an additional comment, we note that your firm's hazard analysis worksheet indicates that the steps associated with your smoke treatment, such as the "injection of smoke" and the subsequent "packing in polyethylene bags," are not necessary critical control points to be included in your HACCP plan. Your analysis notes this is because "the process is done quickly, lag time and room temperature is monitored." Please be advised that in order to prevent excessive histamine development, we recommend that processors assess any potential steps or processes that may result in time and temperature abuse via exposure to high temperatures for extended time periods. Your analysis' reference to monitoring lag time and room temperature implies that the smoke treatment steps may, in fact, lead to histamine development if left uncontrolled. Consequently, we suggest that you conduct a more thorough hazard analysis to determine whether there is any potential for time and temperature abuse during the smoke treatment.
For more information related to the hazard of pathogen growth in ready to eat products, please refer to the Fish and Fisheries Products Hazards and Controls Guidance, Third Edition, Chapter 12, found at: www.cfsan.fda.gov/-comm/haccp4.html. For more information related to the hazard of histamine development, please refer to Chapter 7.
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. Your response should include documentation, such as: a copy of any revised HACCP plans; at least five (5) product days worth of monitoring records to demonstrate that you have implemented the revised plan; any verification records; and any other useful information that would assist us in evaluating your corrections. If you cannot complete all corrections within fifteen (15) days, you should explain the reason for your delay and state when you will correct any remaining violations.
If you do not respond or if we find your response inadequate, we may take further action. 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 (DWPE). FDA's DWPE is an administrative procedure whereby products offered for import into the United States may be detained without physical examination upon entry. DWPE information maybe conveyed in FDA's Import Alerts. For your information, an example of an Import Alert that conveys information specific to foreign firms that are not in compliance with the seafood HACCP regulation is Import Alert #16-120. This alert can be found on FDA's web site at: http://www.fda.gov/ora/fiars/ora import ia16120.html
This letter may not list all your deviations from the requirements of the Act or applicable regulations. You are responsible for ensuring that your processing plant operates in compliance with the Act, the Seafood HACCP regulation, and the current Good Manufacturing Practice regulations (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: Mildred Benjamin, Consumer Safety Officer, Office of Compliance, Division of Enforcement, Manufacturing and Storage Adulteration Branch (HFS-607), 5100 Paint Branch Parkway, College Park, MD 20740 U.S.A. If you have any questions regarding this letter, you may contact Ms. Benjamin by phone at (301) 436-1424 or via email at Mildred.Benjamin@fda.hhs.gov
Office of Compliance
Center for Food Safety and Applied Nutrition
U.S. Food and Drug Administration