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  5. Agustson A/S - 684572 - 08/13/2024
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WARNING LETTER

Agustson A/S MARCS-CMS 684572 —

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

Lundahl Nielsens Vej 2
7100 Syddanmark
Denmark

Issuing Office:
Center for Food Safety and Applied Nutrition

United States

August 13, 2024

WARNING LETTER


Reference No. 684572

Dear Mr. Anderson:

The United States Food and Drug Administration (FDA) inspected your acidified food (AF) facility located at Lundahl Nielsens Vej 2, Vejle, Syddanmark, Denmark 7100 on March 4 through March 5, 2024. During that inspection we found that your firm had serious deviations from 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). At the conclusion of the inspection, the FDA investigator issued an FDA-483, Inspectional Observations that lists the serious deviations found at your firm. We received your written response dated March 25, 2024. Our evaluation found your response was not adequate, as further described in this letter.

As a manufacturer of acidified foods intended for export to the United States, you are required to comply with the Federal Food Drug and Cosmetic Act (the Act) and the Federal regulations relating to the processing of acidified food products packaged in hermetically sealed containers. The Emergency Permit Control regulations were issued, in part, pursuant to section 404 of the Act, Emergency Permit Control, 21 U.S.C. § 344. A temporary emergency permit may be required for thermally processed low-acid foods packaged in hermetically sealed containers whenever a processor has failed to fulfill the requirements of 21 CFR 108.25, including registration, and filing of process information, and the mandatory requirements in 21 CFR Parts 114. Regulations specific to the processing of acidified foods are described in 21 CFR 108 and 21 CFR 114.

As outlined in these regulations, a commercial processor that does not adhere to all of the mandatory requirements of 21 CFR 108.25 and 21 CFR 114 could be subjected to an immediate application of the emergency permit control provisions of section 404 of the Act (21 U.S.C. 344). As stated in 21 CFR 108.25(j) for imported products, in lieu of issuing an order of determination that a permit is required before products from a commercial processor can be introduced into interstate commerce, FDA may take steps to refuse admission of the commercial processor's products under section 801 of the Act (21 U.S.C. 381) when offered for entry into the United States. Violation of the mandatory requirements set forth in 21 CFR 108.25 and 21 CFR 114 renders your acidified food products adulterated within the meaning of section 402(a)(4) of the Act, 21 U.S.C. 342(a)(4). You can find the Act and LACF regulations through links in FDA’s home page at www.fda.gov.

Your significant violations are as follows:

1. As a commercial processor engaged in the processing of acidified foods you must process each food in conformity with at least the filed scheduled process, as required by 21 CFR 108.25(c)(3)(i).

Specifically, your filed scheduled processes for acidified Seaweed Cavi-art Black packed in (b)(4)g (b)(4) glass jars I and Seaweed Cavi-art Black packed in (b)(4)g (b)(4) glass jars on July 9, 2023, and July 10, 2023, respectively, identify the following critical factors: pH and cold processing parameters (initial temperature, process temperature, and process time). Since July 2023, you have exported Seaweed Cavi-art Black to the United States approximately three (3) times and at least one lot produced did not adhere to the filed scheduled processes. You told the FDA investigator that the Seaweed Cavi-art Black (Lot (b)(4)) exported to the United States was manufactured on August 29, 2022, prior to the filing the scheduled processes for Seaweed Cavi-art Black in July 2023. According to the batch record for Lot (b)(4), you did not monitor pH nor the cold hold process parameters. Production records do not indicate pH values and the parameters of the cold fill process. Furthermore, as a commercial processor engaged in the processing of acidified foods, you must file scheduled processes before packing any new product including, as necessary, conditions for heat processing and control of pH, salt, sugar, and preservative levels and source and date of the establishment of the process, for each acidified food in each container size, as required by 21 CFR 108.25(c)(2).

Your response stated that you do not manufacture the seaweed caviar black bulk product used for the packing of the Seaweed Cavi-art black 50g/100g, as you purchase it “ready for repacking” from your supplier. You stated you receive the bulk product from your supplier with a Certificate of Analysis (COA) that certifies the pH level of the batch (less than 4.6) and TPC level as indicator for microbiological quality. You concluded that your supplier’s COA documenting pH of the received batch was reliable basis for establishing the safety of the incoming bulk material and thus was the control point for accepting bulk ingredient for (re)packing. However, you stated going forward you would verify the values of the pH on the COA internally prior to filling. You also reported you had previously tested microbiological quality of the bulk product regularly upon reception and based on consistent conformity in the result that you significantly reduced sampling frequency. You also stated the stabilization of the bulk product was the responsibility of your supplier. You concluded that any risk of post-contamination is controlled by observing your established SOP (for repacking) and SSOP, provided bulk product received is within specification. Although the health risk is minimal at the product pH, the product is exposed to air during the repacking at your facility. If the opened product were to become contaminated with airborne mold the product pH could shift and provide a suitable environment for Clostridium botulinum to grow underneath the pellicle. Therefore, an additional (b)(4) step is required. The (b)(4) step could be in the form of an additional cold fill and hold or the application of a mild heat treatment to kill vegetative pathogens. In addition, as a processor (re-packer) of acidified foods, you are also required to assure that the finished product equilibrium pH of less than 4.6 is maintained in all finished foods, as required by 21 CFR 114.80(a)(1).

Before processing product for export to the United States in the future, you must file your scheduled processes for Seaweed Cavi-art black 50g/100g established by a qualified person who has expert knowledge acquired through appropriate training and experience in the acidification and processing of acidified foods in accordance with 21 CFR 108.25(c)(2).

2. You did not mark each container or product with an identifying code permanently visible to the naked eye to specify the establishment where the product was packed and the product contained within, as required by 21 CFR 114.80(b). Specifically, your identifying lot code on the metal lid of your Seaweed Cavi-art black 50g/100g product only identifies the best by date and the date the product was repacked.

Your response stated the lot code will be corrected and implemented at next production. We will verify the adequacy of your corrective action during a future inspection.

3. You must have plant personnel involved in thermal processing systems or other critical factors of the operation under the operating supervision of a person who has attended a school approved by FDA to comply with 21 CFR 114.10. Specifically, our inspection revealed no one at your firm has received training in critical factors in the production of LACF products nor aseptic processing.

Your response states your Quality Assurance Manager completed “the Better Process Control School, a course of instruction approved by the Commissioner of the U.S. Food and Drug Administration to meet the requirements of 21 CFR 108.25(f), 21 CFR 108.35(g), 21 CFR 113 and 21 CFR 114” on March 23, 2024, and you provided the certificate of completion.

Within fifteen (15) working days of receipt of this letter, please notify this office in writing of the specific steps you have taken to correct any violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective actions within 15 working days, state the reason for the delay and the time within which you will do so. If you believe that your products are not in violation of the Act, include your reasoning and any supporting information for our consideration. Responding in English will help to assist us in our review of your documentation.

If you do not respond to this letter or if we find your response inadequate, we may take further action. For instance, we may take action to refuse admission of your imported acidified food 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, examples of Import Alerts that convey information specific to foreign firms that are not in compliance with the acidified food regulations (21 CFR 108 and 114) are Import Alert 99-37, Detention without Physical Examination of Low-Acid Canned Foods and Acidified Foods without Filed Scheduled Processes and Import Alert #99-38, Detention without Physical Examination of Low-Acid Canned Foods and Acidified Foods due to Inadequate Process Control. These alerts can be found on FDA’s web site at: www.accessdata.fda.gov/cms_ia/ialist.html.

This letter may not list all the deviations at your facility. You are responsible for ensuring that all processing plants you operate are in compliance with the Act and all applicable FDA regulations, including the seafood HACCP regulation (21 CFR Part 123), Acidified Foods regulation (21 CFR Part 114), and the Current Good Manufacturing Practice regulation (21 CFR Part 117, Subpart B). FDA also conducted an inspection at your seafood processing facility located at Englandsvej 11, Vejle, Syddanmark, 7100 Denmark on March 7 and 8, 2024. During the inspection, we found that you had serious violations of the seafood HACCP regulation. Therefore, you were also issued a Warning Letter on August 13, 2024 for violations of the seafood HACCP regulation at your seafood processing facility located at Englandsvej 11, Vejle, Syddanmark, 7100 Denmark. You have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations. 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: Victoria Wagoner, Compliance Officer, Office of Compliance, Division of Enforcement, Food Assessment and Adulteration Branch (HFS-607), 5001 Campus Drive, College Park, MD 20740 U.S.A. If you have any questions regarding this letter, you may contact Victoria Wagoner via email at Victoria.Wagoner@fda.hhs.gov. Please reference 684572 on any submissions and within the subject line of any emails to us.

Sincerely,
/S/

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

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