Crystal Cove Seafood / Pt. Panca Mitra Multiperdana

Department of Health and Human Services	Public Health Service Food and Drug Administration
	College Park, MD

Warning Letter

I.D. # 87666

January 13, 2010

VIA OVERNIGHT MAIL

P. T. Panca Mitra MultiPerdana

J1. Raya Banyuwangi

Km 10

Situbondo, East Java

Indonesia

Dear Sir/Madame:

On October 30 and November 5, 2009, 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: Crystal Cove Seafood Corporation, located at 109 south Tyson Avenue, Floral Park, New York, 11001-1822. That importer was found to be importing Frozen Cooked Shrimp from your processing facility. During the inspection of that importer, we collected a copy of your firm’s HACCP plan for your “Frozen Cooked shrimp”. Our evaluation of that HACCP plan (copy attached) revealed 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 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 Frozen Cooked Shrimp 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 and Controls Guidance: 3rd Edition (the Hazard Guide) through links in FDA’s home page at www.fda.gov.

We note the following deviations in your seafood HACCP plan:

You must have a HACCP plan that, at a minimum, lists the critical limits that must be met at each of the critical control points, to comply with 21 CFR 123.6(c)(3). 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 critical control point to prevent, eliminate, or reduce to an acceptable level the occurrence of the identified food safety hazard.” However, your firm’s HACCP plan for “Frozen Cooked Shrimp” does not list adequate critical limits at the “Cooking” and “Cooling” critical control points. Specifically,

o At the “Cooking” critical control point, the plan does not list a critical limit value for “Time” to control “Bacteria.” Your HACCP plan lists the critical limit for temperature of the cooker as “temperature (b)(4) and indicates “Time/RPM”; however no true critical limit value is provided in association with this “Time/RPM”. Moreover, this reference to “Time/RPM” implies that your firm will monitor the time of cook by a stop watch or by a belt speed.

FDA recommends that the time and temperature cook process achieves a 6D process for inactivation of Listeria monocytogenes for this type of product. Please refer to Table #A-3 (Appendix 4: Pathogen Table) in the Fish and Fisheries Products Hazards and Controls Guidance: 3rd Edition for specific times and corresponding internal temperatures necessary to achieve inactivation of Listeria monocytogenes. In conjunction with the use of Table #A-3, we recommend that your firm conduct a study to verify that the cooker temperature(s) and corresponding cook time(s) used by your firm consistently achieve an adequate cook process for every shrimp. The study should be performed using the largest raw shrimp that your firm receives, beginning the cook study at the lowest initial temperature (i.e., 0 C). In addition, temperature monitoring should occur at the coldest spot in the cooker as determined by a heat distribution study.

Your firm lists “check product” in the monitoring “How” section of your plan, implying that you intend to measure internal temperature. Although measuring internal temperature is necessary in performing the cook study, it is not the best choice as a routine monitoring procedure due to the variability between shrimp. Monitoring cooker temperature by probe (in the coldest part of the cooker) and cook time (stop watch, RPM, or tachometer) are recommended methods for monitoring the cook.

In addition, we recommend that you identify the significant hazard as “pathogen survival through cooking,” rather than “Bacteria” as currently listed at this critical control point.

o At the “Cooling” critical control point the plan does not list adequate critical limits to control “Bacteria.” Your hazard analysis indicates that cooling is performed by ice water bath; however, your HACCP plan does not list a critical limit for monitoring residual chlorine (or other) water sanitizer to control pathogen introduction into cooked product. We recommend that you include this control measure to better ensure the cooling water is pathogen free, in order to reduce the likelihood for post-cook contamination.

In addition, we recommend that your firm perform a cooling rate study to demonstrate the critical limit for temperature (b)(4) is adequate to meet FDA’s recommended cooling rates (i.e., cooling product from (b)(4) to (b)(4) or below within (b)(4); and cooling to (b)(4) or below within an additional (b)(4) Important factors in the study should include dimensions of bath, cooling water temperature, weight or number of shrimp, initial product temperature, and required cooling time(s). Measuring internal product temperature is best when used while conducting the cooling rate study, but is not recommended for routine monitoring of the cooling step due to unit to unit product variation.

In addition, we recommend that you identify the significant hazard as “pathogen introduction,” rather than “Bacteria” as is currently listed at this critical control point.

For more information related to the hazards of pathogen survival through cooking and pathogen introduction (i.e., post-processing contamination), please refer to Chapters 16 and 18 in the Fish and Fisheries Products Hazards and Controls Guidance, Third Edition, found at: www.cfsan.fda.gov/~comm/haccp4.html.

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 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 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 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

Sincerely,

/S/

Roberta Wagner

Director

Office of Compliance

Center for Food Safety and Applied Nutrition

Enclosure – HACCP plan

cc:

Crystal Cove Seafood Corporation

109 south Tyson Avenue

Floral Park, New York, 11001-1822

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