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WARNING LETTER

OOO “Elanders” MARCS-CMS 643068 —

Delivery Method:
Via Express Delivery
Product:
Food & Beverages
Recipient:
Recipient Name
Mr. Genrih Pokotinsky
Recipient Title
CEO and Commercial Director
OOO “Elanders”

Jaunciema Gatve 320
Riga, Rigas rajons, LV-1015
Latvia

Issuing Office:
Center for Food Safety and Applied Nutrition

United States

January 20, 2023

WARNING LETTER


Reference #643068

Dear Mr. Pokotinsky:

The United States Food and Drug Administration (FDA) conducted an inspection of your seafood processing facility, OOO “Elanders”, located at Jaunciema Gatve 320, Riga, Rigas rajons, Latvia 1015 on July 11 - 12, 2022. During the inspection, we found that you had serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations (21 CFR Part 123). At the conclusion of the inspection, the FDA investigator issued an FDA-483, Inspectional Observations, listing the deviations found at your facility. We received your response via email on August 15, 2022. Your response included two revised HACCP plans for ready-to-eat (RTE) refrigerated vacuum-packed cold smoked mackerel and RTE refrigerated salted herring fillets packed in marinade solution. However, our evaluation of the documents revealed that you continue to have serious concerns with your HACCP program as further described in this letter.

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 RTE fish fillet products including vacuum-packed cold smoked mackerel and refrigerated salted herring fillets packed in marinade solution 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 the 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.

Your significant deviations are as follows:

1. 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." However, your firm’s revised HACCP plans for RTE refrigerated vacuum-packed cold smoked mackerel and RTE refrigerated salted herring fillets packed in marinade solution do not identify the food safety hazards of pathogen growth and toxin formation and allergens. Your plans correctly identify the hazards of histamine and Clostridium botulinum, however, since your products are intended to be consumed without further cooking, the growth of aerobic pathogens, including Staphylococcus aureus growth and toxin formation must also be prevented during processing activities. In addition, finfish are identified as a major food allergen. Controls must be included in your HACCP plan to assure that all allergenic ingredients are declared on product labels.

2. 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 critical control points, to comply with 21 CFR 123.6(a) and (c)(2). A critical control point is defined in 21 CFR 123.3(b) as a "point, step, or procedure in a food process at which control can be applied and a food safety hazard can as a result be prevented, eliminated, or reduced to acceptable levels." However, your firm’s revised HACCP plan for RTE refrigerated vacuum-packed cold smoked mackerel does not identify a critical control point for (b)(4) to control the food safety hazard of Clostridium botulinum growth and toxin formation. During (b)(4), it is critical that processors control the (b)(4) temperature to ensure temperatures do not exceed 32.2°C (90°F) to prevent the elimination of competing bacteria which can inhibit the growth of Clostridium botulinum.

3. You must have a HACCP plan that at minimum lists the critical limits that must be met, to comply with 21 CFR 123.6(c)(3). A critical limit is defined in 21 CFR 123.3(c) as the “the maximum or minimum value to which a physical, biological, or chemical parameter must be controlled at a critical control point to prevent, eliminate, or reduce to an acceptable level the occurrence of the identified food safety hazard.” However, your firm’s revised HACCP plans for RTE refrigerated vacuum-packed cold smoked mackerel and RTE refrigerated salted herring fillets packed in marinade solution do not list adequate critical limits to control the food safety hazards of C. botulinum growth and toxin formation and scombrotoxin (histamine) formation at the (b)(4) critical control points. Specifically,

a. Your (b)(4) step lists a critical limit of “(b)(4)” and “(b)(4)” that are inadequate to control histamine formation. FDA recommends monitoring ambient temperatures surrounding the fish to control histamine formation. When previously frozen fish are exposed to temperatures between 21°C and 25°C, safe exposure times should not exceed 12 hours. That limitation has not been included as a critical limit at this critical control point.

AND

b. Your Pickup warehouse and Storage critical control points list critical limits of “(b)(4)” and “(b)(4)”, respectively, which are inadequate to control the food safety hazard of scombrotoxin (histamine) formation. Your listed critical limits allow products to be held at up to (b)(4)°C ((b)(4)°F). FDA recommends that the finished product be held at a cooler temperature of 40°F (4.4°C) or below.

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 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 products are not in violation of the Act, include your reasoning and any supporting information for our consideration.

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.accessdata.fda.gov/cms_ia/importalert_25.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 and all applicable regulations, including the seafood HACCP regulation (21 CFR Part 123) and the Current Good Manufacturing Practice regulation (21 CFR Part 117, Subpart B). 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: Giselle Jordan, Compliance Officer, Office of Compliance, Division of Enforcement, Food Adulteration and Assessment Branch (HFS-607), 5001 Campus Drive, College Park, MD 20740 U.S.A. If you have any questions regarding this letter, you may contact Giselle Jordan via email at: giselle.jordan@fda.hhs.gov. Please include reference #643068 on any submissions and within the subject line of any email correspondence to the agency.

Sincerely,
/S/

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

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