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WARNING LETTER

Agustson A/S MARCS-CMS 687113 —

Delivery Method:
Via Express Delivery
Product:
Food & Beverages
Recipient:
Recipient Name
Mr. Esben Anderson
Recipient Title
Chief Executive Officer
Agustson A/S

Englandsvej 11 Vejle
7100 Syddanmark
Denmark

Issuing Office:
Center for Food Safety and Applied Nutrition

United States

August 13, 2024

WARNING LETTER

Reference # 687113

Dear Mr. Anderson:

The United States Food and Drug Administration (FDA) conducted an inspection of your seafood processing facility, Agustson A/S, located at Englandsvej 11, Vejle, Syddanmark, Denmark 7100 on March 7 – 8, 2024. 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, Part 123 (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 firm. We acknowledge receipt of your responses, received via email on March 31, April 5, May 8 and 13, and June 6, 2024, which included a written statement of corrective actions, letter from Acme Smoked Fish Corp, product information and data sheet for laminated film used for food packaging, HACCP Plan for frozen hot smoked trout fillets in reduced-oxygen packaging, and other supporting documents. However, our evaluation of your responses 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 frozen, reduced oxygen packed hot smoked trout fillets 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 June 2022 Edition of the Fish and Fisheries Products Hazards and 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 HACCP plan for “Hot Smoked trout Fillets (farm-raised), Reduced-Oxygen Packed, Frozen”, dated June 6, 2024, does not identify the following food safety hazards:

a. You do not identify agriculture drugs as a food safety hazard. Your hazard analysis states that you will control environmental chemicals by “(b)(4)” through “(b)(4).” However, the seafood HACCP regulation requires that food safety hazards that are reasonably likely to occur in the absence of controls be addressed in a HACCP plan.

b. You do not identify Staphylococcus aureus growth and toxin formation as a food safety hazard. The hazard is introduced at the “(b)(4)” step where the fish are first salted and competing bacteria are significantly reduced. The hazard continues to be reasonably likely during the “(b)(4)”, “(b)(4)”, and “(b)(4)” steps in the absence of time and temperature controls.

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 HACCP plan for “Hot Smoked trout Fillets (farm-raised), Reduced-Oxygen Packed, Frozen”, dated June 6, 2024, does not list a critical control point to control pathogenic bacteria growth and toxin formation during refrigerated storage. Pathogenic bacteria can be introduced during processing, even after cooking.

3. You must have a HACCP plan that, at a 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 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 HACCP plan for “Hot Smoked trout Fillets (farm-raised), Reduced-Oxygen Packed, Frozen”, dated June 6, 2024, list the critical limits of “(b)(4)” and “Log 5 reduction” at the “CCP 5: (b)(4)” critical control point that are not adequate to control pathogenic bacteria growth and survival. Your (b)(4) process should achieve at least a 6-log reduction of Listeria monocytogenes. For (b)(4) operations, FDA recommends that the internal temperature of the fish be maintained at or above 145°F (62.8°C) throughout the fish for at least 30 minutes.

4. You must have a HACCP plan that, at a minimum, lists monitoring procedures and their frequencies for each critical control point to comply with 21 CFR 123.6(c)(4). However, your firm’s HACCP plan for “Hot Smoked trout Fillets (farm-raised), Reduced-Oxygen Packed, Frozen”, dated June 6, 2024, lists a critical limit of “Minimum brining time and brining strength as stated in the brining SOP and programmes in EQ section 4.8.4” to control Clostridium botulinum (C. botulinum) growth and toxin formation, however, you do not list monitoring procedures for the minimum brining time.

This letter may not list all the deviations at your facility. You are responsible for ensuring that all of your processing plants operate in compliance with the Act and all applicable regulations, including the seafood HACCP regulation, acidified foods regulations (21 CFR Parts 108 and 114), and the Current Good Manufacturing Practice regulation (21 CFR Part 117, Subpart B). FDA also conducted an inspection at your acidified food facility located at Lundahl Nielsens Vej 2, Vejle, Syddanmark, Denmark 7100 on March 4 through March 5, 2024. During the inspection, we found that your firm had serious violations of the Emergency Permit Control regulation, Title 21, Code of Federal Regulations, Part 108 (21 CFR Part 108) and the Acidified Foods regulation (21 CFR Part 114). Therefore, you were issued a Warning Letter on August 13, 2024 (Reference #684572). You have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations.

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. You may view this alert at: http://www.accessdata.fda.gov/cms_ia/ialist.html.

Additionally, we offer the following comment:

  • Your critical limit at the (b)(4) critical control points lists that that the “(b)(4)” are defined in the “(b)(4) SOP and programmes in (b)(4)” and “(b)(4).” However, you have not provided these documents that are considered part of the HACCP plan. You should provide the documents, or the critical limits should be included in the HACCP plan.

You should respond in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific steps you are taking 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(s), 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.

Please send your reply to the U.S. Food and Drug Administration, Attention: Sheena Phillips, Compliance Officer, Office of Compliance, Division of Enforcement, Food Adulteration and Assessment Branch (HFS-607), 5001 Campus Drive, College Park, Maryland 20740 U.S.A. If you have any questions regarding this letter, you may contact Ms. Phillips via email at Sheena.Phillips@fda.hhs.gov. Please reference CMS # 687113 on any documents or records you provide to us and/or within the subject line of any email correspondence you send to us.

Sincerely,
/S/

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

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