Grupo Alimentario Del Atlantico Sa "Gralco Sa" 12/23/09

December 23, 2009

WARNING LETTER

VIA OVERNIGHT MAIL

Hugo D. Marino, President
Grupo Alimentario Del Atlantico S.A.
Calle 1 No. 38-121 Zona Ind’l
Barranquilla
Columbia
South America

Re: MARCS-CMS Case ID #79364

Dear Mr. Marino:

We inspected your seafood processing facility, located at Calle 1 No. 38-121 Zona Ind’l, Barranquilla, Columbia on August 6 – 10, 2009. Upon further review of our investigator's inspection report and findings during the inspection, we determined 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 regulation for foods, Title 21, Code of Federal Regulations, Part 110 (21 CFR 123 & 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 canned and vacuum packaged frozen tuna 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.

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.” Your firm’s HACCP plan for “Frozen tuna loins and canned tuna” does not list the food safety hazard of Staphylococcus aureus toxin development that is reasonably likely to occur after the precook operation, prior to either freezing the tuna loins or conducting the thermal process for the canned tuna. Our investigation revealed several steps conducted following the precook operation that involve handling and holding the fish for up to 10 hours following the precook operation. This time period poses a significant risk for Staphylococcus aureus toxin development.

In addition, this extended time period poses an additional risk for histamine development.

o 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). Your corrective action plan for your tuna at the “Skinning/Cleaning” critical control point is not adequate to address foreign contaminate (i.e., metal fragments). Specifically, holding product that is suspected to contain metal fragments and re-testing the package by rerunning through the detector, as listed in your plan, will not prevent the distribution of potentially adulterated products into the marketplace. Moreover, your corrective actions do not provide any means to determine the source of the metal fragments and does not address the final disposition of the product.

In addition, we have the following comments with regard to your HACCP plan:

o Your receiving critical control point should include a total of (b)(4) subsamples for histamine testing, rather than the (b)(4) subsamples currently listed in your plan (i.e., (b)(4) fish each from top, middle and bottom of the holding tank).

o Your critical limit for histamine at the receiving critical control point should be reduced to (b)(4) ppm because you are forming a composite of (b)(4) fish, rather than (b)(4) ppm for individual samples currently listed in your plan. Your corrective actions should also be amended accordingly.

o Your receiving critical control point should include an organoleptic evaluation for decomposition.

o Your firm should assess, via a hazard analysis, the thawing time for the fish to determine whether there is a need for a “thawing” critical control point to control histamine formation.

Please note that the labels for your vacuum packaged frozen tuna loins should include the following, in order to reduce the likelihood for Clostridium botulinum toxin formation: “Important, keep frozen until used, thaw under refrigeration immediately before use”, or a similar statement that conveys similar information.

For more information on the hazard associated with Staphylococcus aureus toxin development please refer to the Fish and Fisheries Products Hazards and Controls Guidance: Third Edition, Chapter 15. For more information on the hazard of scombrotoxin (histamine) please refer to Chapter 7. The Fish and Fisheries Products Hazards and Controls Guidance: Third Edition may be found on our web site 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 other useful information that would assist us in evaluating your corrections. If you cannot complete all corrections before the 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 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. This procedure is generally based on past history or other information, such as the inspection of a facility or HACCP plan review, indicating that the factory producing the product or the product itself may not be in compliance with FDA’s laws and regulations. DWPE information is conveyed in FDA’s Import Alerts. 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 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 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.

Sincerely,

/s/

Roberta Wagner
Director
Office of Compliance
Center for Food Safety and Applied Nutrition