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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Hijos De Carlos Albo S.L. 6/5/12


Department of Health and Human Services' logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration

5100 Paint Branch Parkway
College Park, MD 20740

JUN 5, 2012



Mr. Ignacio Albo Quiroga, General Director
Hijos De Carlos Albo S.L.
Calle Jacinto Ben vente 41,
36208, Vigo, Spain

Reference No. 292957

Dear Mr. Albo:

The U.S. Food and Drug Administration (FDA) conducted an inspection of your seafood manufacturing facility, Hijos De Carlos Albo S.L., located at Calle Jacinto Benvente 41, 36208, Vigo, Spain on December 1 - 2, 2011. We found that you had serious deviations from the Seafood Hazard Analysis and Critical Control Point (HACCP) Regulation, Title 21, Code of Federal Regulations, Part 123 (21 CFR 123). At the conclusion of the inspection, the FDA investigator issued an FDA-483, Inspectional Observations, listing the deviations found at your firm. We acknowledge receipt of your initial response dated December 13, 2011, where you provided a written response, sterilization records, and a revised HACCP plan in Spanish. In response to our April 2, 2012, request, on April 4, 2012, your firm provided a HACCP plan for your canned tuna product translated into English to help with our assessment. Although your response satisfactorily addressed the deviations in the FDA-483, our further evaluation of your HACCP system and operations revealed that your firm is not adequately implementing the Seafood HACCP regulation as described below.

Failure of a processor to have and implement a HACCP plan that complies with 21 CFR 123.6(g), or otherwise operate in accordance with the requirements of 21 CFR part 123, renders the 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 firm's canned tuna products appear to be adulterated, 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.

Our further review of your HACCP plan identified the following significant violation:

You must 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(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." However, your firm's HACCP plan for various fresh whole fish, including scombrotoxin-forming species that you process into canned food, does not list the food safety hazards of scombrotoxin formation and Staphylococcus aureus toxin formation.

Your firm conducts steps such as thawing, storage, heading, cutting and cooling. All steps are conducted prior to the start of the retort operation, and can lead to excessive histamine development when not controlled. Your firm also conducts manual cleaning of fish prior to canning which can lead to Staphylococcus aureus contamination followed by growth and toxin formation when not properly controlled. Therefore, your HACCP plan for canned scombrotoxin-forming fish species should include the hazards of histamine formation and Staphylococcus aureus growth and toxin formation and the necessary critical controls.

For additional information related to scombrotoxin (histamine) formation controls as a primary processor, please see Chapter 7 and for information related to pathogenic bacteria growth and toxin formation, please see Chapter 12 of the 4th Edition of FDA's Fish and Fisheries Products Hazards and Controls Guidance. You can access this guidance at: http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/Seafood/FishandFisheriesProductsHazardsandControlsGuide/default.htm

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 possible, please provide an English translation of any documents you submit to assist our assessment.

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 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/ForIndustry/ImportProgram/ImportAlerts/default.htm

Please send your reply to the Food and Drug Administration, Attention: Carol D'lima, CFSAN Office of Compliance, Division of Enforcement, Food Adulteration Assessment Branch, HFS-607, 5100 Paint Branch Parkway, College Park, MD 20740 U.S.A. You may submit documentation accompanying your reply to Carol.Dlima@fda.hhs.gov. You may also contact Carol D'lima at (240) 402-2033 or email if you have any questions about this letter.



Michael W. Roosevelt
Acting Director
Office of Compliance
Center for Food Safety
and Applied Nutrition