Inspections, Compliance, Enforcement, and Criminal Investigations
C.V. Indotropic Fishery 11/7/07
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
November 7, 2007
VIA OVERNIGHT MAIL
C.V. Indotropic Fishery
JI Raya Km 9
P.O. Box 129
Desa Biak, Kec. Luwuk, Kab. Banggai
Sulawesi Tengeh, Indonesia
On August 14-16, 2007, a representative of the United States Food and Drug Administration (FDA) conducted an inspection of a fish and fishery products importer located in the United States, Hawaii International Seafoods, Inc., Honolulu, Hawaii, to assess that importer's compliance with the United States' Seafood Hazard Analysis and Critical Control Point (HACCP) Regulation, Title 21, Code of Federal Regulations, Part 123 (21 CFR 123), referred to as the seafood HACCP regulation. That importer was found to be importing various fish and fishery products from your processing facility. During the inspection of that importer, we collected a copy of your firm's HACCP plan for scarlet snapper and grouper. Our review of that HACCP plan (copy attached) revealed that it contains serious deviations from the requirements of the seafood HACCP regulation.
In accordance with 21 CFR 123.6(g), failure of a processor to have and implement a HACCP plan that complies with 21 CFR Part 123, or otherwise operate in accordance with the requirements of 21 CFR part 123, renders that processor's fishery products adulterated within the meaning of 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 scarlet snapper and grouper are adulterated within the meaning 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 and the seafood HACCP regulation through links in FDA's home page at www.fda.gov.
We note the following deviations in your seafood HACCP plan:
o 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." Scarlet snapper (Lutjanus sanguineus) and grouper both pose a hazard for ciguatera poisoning; however your HACCP plan for these products does not list ciguatera as a potential food safety hazard. Contamination of fish with this natural toxin from the harvest area can cause consumer illness. Control of this hazard by the primary processor who receives the fish directly from the harvest vessels is essential in preventing the distribution of potentially contaminated fish. To control ciguatera poisoning, FDA recommends that no fish be harvested from an area where there is a current problem with ciguatera. For more information on the hazard associated with ciguatera, please refer to the Fish and Fisheries Products Hazards and Controls Guidance: Third Edition, Chapter 6, found at: www.cfsan.fda.gov/~comm/haccp4.html.
You should respond in writing within thirty (30) 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 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 30 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 (i.e., snapper and grouper) 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 may be 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 [21 CFR Part 123] 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 the deviations at your facility. You are responsible for ensuring that your processing plant operates in compliance with the Act, the Seafood HACCP regulation, and the Good Manufacturing Practice regulation (21 CFR 11 0). You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations.
Please send your reply to 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@hhs.fda.gov.
Joseph R. Baca
Office of Compliance
Center for Food Safety and Applied Nutrition