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March 21, 2024

WARNING LETTER
Reference # 677664

Dear Mr. Mejias:

The United States Food and Drug Administration (FDA) conducted a Foreign Regulatory Assessment (FRRA) of your seafood processing facility, located at Autovia Sevilla - Huelva Km 22.5, Huevar De Aljarafe, Sevilla, Spain on October 2 through October 11, 2023. During that assessment, we found that you have serious violations of 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 assessment, the FDA investigator issued you a listing of the observations made during the assessment. You provided responses to the observations, describing corrective actions taken by your firm. After reviewing the remote regulatory assessment findings and the responses that your firm provided, we are issuing this letter to advise you of FDA’s concerns and to provide detailed information describing the findings at your facility. We also address your responses below.

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). Furthermore, Accordingly, your ready-to-eat (RTE) cold smoked salmon products are adulterated, in that they have been prepared, packed, or held under conditions whereby they may have been rendered injurious to health. You may find the Act, the seafood HACCP regulation and FDA’s 4th Edition of the Fish and Fisheries Products Hazards & Controls Guidance (the Hazards Guide) through links in FDA's home page at www.fda.gov. The 4th Edition of the Hazards Guide can be found on our web site at: https://www.fda.gov/food/guidanceregulation/guidancedocumentsregulatoryinformation/seafood/ucm2018426.htm

Your significant violations are as follows:

1. You must conduct a hazard analysis 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). 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 green olives stuffed with anchovy or tuna does not list the food safety hazard of scombrotoxin (histamine) formation, Staphylococcus aureus (S. aureus) growth and toxin formation, and allergens associated with the tuna and anchovies; and the food safety hazard of S. aureus growth and toxin formation associated with the olives cooked and fermented at your facility.

a. Your HACCP plan does not list the hazards of histamine formation and S. aureus growth and toxin formation associated with the salted anchovies, tuna in oil and natural tuna. Your firm introduces these hazards when you make your filling pastes with the addition of water. The addition of water to the anchovies may affect the water activity of the fermented anchovies allowing histamine formation and S. aureus growth and toxin formation in the absence of time/temperature controls. The manipulation of the shelf stable tuna products can have a similar effect in that the hazard of histamine formation is reintroduced by the grinding and mixing of the tuna and the manipulation also allows the re-introduction of S. aureus into the paste. Neither hazard is eliminated by the subsequent thermal process. Time and temperature controls, including refrigeration, must be in place to prevent the formation of scombrotoxin and S. aureus toxin when the products have not achieved a pH, water activity, or water phase salt level sufficient to prevent toxin formation in the absence of refrigeration or time/temperature controls.

In addition, we note that your product specifications allow for a histamine content of (b)(4) ppm and that your internal histamine specification allows histamine levels of (b)(4) < m:(b)(4), M:(b)(4) ppm. Please be aware that when histamine levels meet or exceed 50 ppm but are below 500 ppm, the fishery products are considered adulterated by FDA under Sec. 402(a)(3) of the Food, Drug, and Cosmetic Act in that they are decomposed. FDA considers scombrotoxin species products decomposed when histamine meets or exceeds 50 ppm and that scombrotoxin species products where histamine content meets or exceeds 500 ppm to contain a “poisonous or deleterious substance.”

b. Your hazard analysis and HACCP plan fail to identify S. aureus growth and toxin formation at the “(b)(4)” step. Pre-formed S. aureus toxin will not be eliminated by the subsequent thermal process. Your firm has (b)(4) underground (b)(4) tanks on site. After olives are cooked, (b)(4). The (b)(4) tanks are buried because the temperature is cooler in the ground than atmospheric temperature. In the absence of controls (temperature, pH, salinity, water activity), S. aureus toxin formation appears reasonably likely. The controls should be listed in the HACCP plan and critical control point(s) identified.

Subsequent processing steps may require time/temperature controls until the thermal process occurs, if a pH or water activity sufficient to prevent S. aureus toxin formation has not been achieved during (b)(4). For example, when temperatures remain between 10°C (50°F) and 21.1°C (70°F), FDA recommends that a pH of <4.0 or water activity of <0.85 be achieved within 12 hrs. to prevent S. aureus toxin formation during the (b)(4) process and subsequent processing steps until the thermal process.

c. Although your hazard analysis considers allergens as a hazard, your HACCP plan does not identify undeclared major food allergens as a food safety hazard that is reasonably likely to occur. Anchovies and tuna are finfish identified by FDA as a major allergen and food safety hazard which requires inclusion of controls for the hazard in the HACCP plan. Your HACCP plan should include a critical control point the ensures the accurate declaration of all food allergens on the finished product labels.

Furthermore, the HACCP plan you provided does not meet the requirements of 21 CFR 123.6(c) in that it does not list critical limits; monitoring procedures; monitoring records; or verification procedures for any of the critical control points identified.

In your response, you stated you re-evaluated your hazard analysis to include the hazards of histamine and S. aureus toxin during (b)(4) which are carried out at room temperature. You also stated you included labeling as a critical control point in your HACCP plan that includes a critical limit, monitoring procedures, verification procedures, and corrective actions procedures to control allergens. You also stated you would include critical control points that include critical limits, monitoring procedures, verification and corrective actions for histamine and allergens. However, you did not provide supporting documentation, (e.g., revised hazard analysis, revised HACCP plan and monitoring records) to demonstrate the adequacy and implementation of these corrective actions. You should at a minimum have a product flow chart, hazard analysis and HACCP plan specific to your seafood (e.g., tuna and anchovy) stuffed olives. You must also ensure your seafood HACCP plans specifically address the seafood products you process and clearly identify the reasonably likely to occur hazards associated with the seafood products as required by 21 CFR 123.6(a) and (b) and meets the requirements of 123.6(c). To assist you with complying with 21 CFR 123.6, we suggest that you use FDA’s Fish and Fishery Products Hazards and Controls Guidance to create your new seafood HACCP plans. As part of your response, you should provide your revised seafood HACCP plans including supporting documentation (e.g., product flow chart and hazard analysis) for all seafood products processed at your facility. In addition, the individual responsible for developing your HACCP plan must complete training under a standardized HACCP curriculum recognized as adequate by the U.S. FDA or have job experience which demonstrates equivalent knowledge to the standardized HACCP curriculum.

Failure to adequately address these violations may lead to regulatory action. For instance, we may, 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. You may view this alert at: http://www.accessdata.fda.gov/cms_ia/ialist.html.

The violations cited in this letter are not intended to be an all-inclusive list of violations that exist at your facility or in connection with your products. You are responsible for investigating and determining the causes of the violations identified above and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations. You should take prompt action to correct or implement corrections to the violations cited in this letter.

In addition to the violations described above, we offer the following comments:
We acknowledge you filed new scheduled processes for your green olive products, including the seafood stuffed green olives, with an updated equilibrium pH of 4.3 in November 2023. You must also process each food in conformity with at least the scheduled processes filed, as required by 21 CFR 108.25(c)(3).

In addition, you must also maintain processing and production records showing adherence to scheduled processes, including records of pH measurements and other critical factors (e.g., initial temperature, processing time, temperature, and conveyor speed) intended to ensure a safe product, as required by 21 CFR 114.100(b). Specifically, with respect to the pH measurement, we recommend you follow the procedures outlined in 21 CFR 114.90, including determining pH on samples (21 CFR 114.90(a)(5)), preparation of samples (21 CFR 114.90(a)(6)), and process pH determination (21 CFR 114.90(a)(7).

Please respond in writing within fifteen (15) working days from your receipt of this letter. Your response to this letter should outline the specific steps you are taking or have taken to correct these deviations. More specifically, your response should include documentation reflecting the changes you made, such as a copy of your revised HACCP plan or plans, five (5) consecutive days of completed monitoring records (i.e., complete sets of monitoring records for the production of 5 production date codes of products) to demonstrate implementation of the plan, and any additional information that you wish to supply that provides assurance of your intent to fully comply now and in the future with the seafood HACCP regulation. If you cannot complete all corrections within 15 days, you should explain the reason for your delay and state when you will correct any remaining violations. If you believe that your product is not in violation of the Act, include your reasoning and any supporting information for our consideration.

You should direct your written response to Victoria Wagoner, Compliance Officer, Food Adulteration Assessment Branch (HFS-607), Division of Enforcement, Office of Compliance, 5001 Campus Drive, College Park, MD 20740 U.S.A. You may submit documentation accompanying your request to Victoria Wagoner via email at: Victoria.Wagoner@fda.hhs.gov. Please include reference # 677664 on any submissions and within the subject line of any emails to us. If you have any questions regarding this letter, you may contact Victoria Wagoner via email.

Sincerely,
/S/

Ann M. Oxenham, J.D.
Director
Office of Compliance
Center for Food Safety and
   Applied Nutrition