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  5. Myllan-ORA ehf - 637443 - 08/30/2022
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WARNING LETTER

Myllan-ORA ehf MARCS-CMS 637443 —

Delivery Method:
Via Express Delivery
Product:
Food & Beverages
Recipient:
Recipient Name
Mr. Hermann Stefansson
Recipient Title
CEO
Myllan-ORA ehf

Vesturvor 12
200 Kopavogur
Iceland

Issuing Office:
Center for Food Safety and Applied Nutrition (CFSAN)

United States

August 30, 2022

WARNING LETTER

Reference # 637443

Dear Mr. Hermann Stefansson:

The United States Food and Drug Administration (FDA) conducted an inspection of your seafood processing facility, located at Vesturvor 12, Kopavogur, 200 Iceland, on May 24 & 25, 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). That inspection resulted in FDA’s issuance of an FDA-483, Inspectional Observations, listing the deviations found at your firm at the conclusion of the inspection. To date, your firm has not responded to the observations.

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 ready-to-eat (RTE) herring and RTE refrigerated lumpfish caviar 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 the 4th 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. Your HACCP plan does not list one or more critical control points (CCPs) that are necessary for each of the identified food safety hazards as required by 21 CFR 123.6(c)(2). Specifically, your HACCP Plan for Bemka brand RTE refrigerated lumpfish caviar in glass jars, does not identify the following CCPs:

a. Receiving of refrigerated salted caviar in barrels, to control the hazard of toxin formation by Clostridium botulinum and Staphylococcus aureus. Your HACCP plan should list a CCP for the receiving with a critical limit that ensures these barrels of caviar were maintained at 40°F (4.4°C) or less throughout transit. This CCP is needed because the barrels are received refrigerated and you check the brine concentration and add brine if the salt content is lower than 18% indicating that this product may not consistently be shelf-stable, and refrigeration could be needed for food safety. Although your firm subsequently pasteurizes this product, your HACCP plan still needs to control for the formation of heat-stable toxins that will not be eliminated by your (b)(4) step that is listed to control Listeria monocytogenes.

Additionally, your firm is evaluating the salt concentration of the product which is not adequate. You should evaluate the water phase salt (WPS) content of the product which is calculated by multiplying the % salt by 100 and dividing by the sum of the % salt plus the % moisture. As an alternative to WPS, you can measure the water activity of the product. Water activity and WPS are correlated, and these analyses provide a better measurement of the available moisture in the product for pathogen growth and toxin formation than % salt by itself. A seafood product should consistently have a verified minimum WPS of 20% or a maximum water activity of 0.85 to be considered shelf-stable and not need this CCP for refrigerated receiving.

b. Refrigerated storage of the salted caviar in barrels after receiving to control the hazard of toxin formation by C. botulinum and S. aureus. Your HACCP plan should list a CCP for your refrigerated (b)(4) step of the barrels of caviar with a critical limit of 40°F (4.4°C) for the ambient temperature of the cooler and continuous temperature monitoring with a visual check of the recorded data at least daily. This CCP is needed because you were not able to provide documentation to demonstrate that the product you receive is shelf-stable, meaning it was processed in a manner that does not require refrigeration for food safety. Alternatively, this CCP would not be needed if you had a receiving CCP for adjusting the brine to a minimum WPS of 20% or a maximum water activity of 0.85.

c. Addition of water and other ingredients to the salted caviar to lower the salt content to 6.5% before filling in hermetically sealed glass jars to control the hazard of nonproteolytic C. botulinum growth and toxin formation in your finished product. Your HACCP plan should list a CCP for this (b)(4) step with a critical limit that ensures the refrigerated finished product has a minimum WPS of 5% or a water activity below 0.97 with monitoring of each batch by collecting samples to be representative of the entire batch. Although, these jars are subsequently pasteurized your HACCP plan indicates that the target pathogen is L. monocytogenes which does not provide sufficient thermal destruction to control C. botulinum growth and toxin formation.

d. Finished product storage to control the hazard of proteolytic C. botulinum growth and toxin formation. Your HACCP plan should list a CCP for your refrigerated (b)(4) step of the glass jars of caviar with a critical limit of 40°F (4.4°C) for the ambient temperature of the cooler and continuous temperature monitoring with a visual check of the recorded data at least daily.

2. Your HACCP plan does not list one or more critical control points (CCPs) that are necessary for each of the identified food safety hazards as required by 21 CFR 123.6(c)(2). Specifically, your HACCP Plan for Matjes brand RTE refrigerated spiced canned herring in marinade, does not identify the following CCPs:

a. Receiving of marinated, spiced herring fillets in barrels, to control the hazards of histamine formation and pathogen growth and toxin formation including C. botulinum during transit. Your HACCP plan should list a CCP for the receiving with a critical limit that ensures these barrels of RTE herring were maintained at 40°F (4.4°C) or less throughout transit. This CCP is needed because you were not able to provide documentation to demonstrate that the product you receive is shelf-stable.

b. Refrigerated storage of marinated, spiced herring fillets in barrels after receiving, to control the hazards of histamine formation and pathogen growth and toxin formation including C. botulinum. Your HACCP plan should list a CCP for your refrigerated (b)(4) step of the barrels of RTE herring with a critical limit of 40°F (4.4°C) for the ambient temperature of the cooler and continuous temperature monitoring with a visual check of the recorded data at least daily. This CCP is needed because you were not able to provide documentation to demonstrate that the product you receive is shelf-stable.

3. You must implement the monitoring procedures that you have listed in your HACCP plan to comply with 21 CFR 123.6(b). However, your firm did not follow the monitoring procedure of measuring the pH of the product to ensure the pH is ≤4.4 at the pH measurement CCP to control C. botulinum growth and toxin formation in your finished product of RTE refrigerated spiced canned herring in marinade. Your quality assurance employee was observed to take the pH of the marinade and not the product as listed in your HACCP plan. When instructed to take the measurement of a slurry of the fish product and marinade, the pH was found to be higher than that of the marinade alone.

4. Your HACCP plan lists a monitoring frequency that does not ensure compliance with the critical limit as required by 21 CFR 123.6(c)(4). Specifically, your HACCP Plan for Matjes brand RTE refrigerated spiced canned herring in marinade lists a monitoring frequency of taking the pH of the product from one sample per batch which is not adequate to control C. botulinum growth and toxin formation in the finished product. Your monitoring procedure should ensure the collection of a specified number of finished product samples based on the size of the batch to be representative of the entire batch.

5. Your HACCP plan includes a corrective action plan that is not in accordance with 21 CFR 123.7(b) to ensure affected product is not entered into commerce and the cause of the deviation was corrected as required by 21 CFR 123.6(c)(5). Specifically, your HACCP Plan for Matjes brand RTE spiced herring in marinade solution packed in cans, includes a corrective action plan at the pH measurement and labeling CCPs that are not in accordance with 21 CFR 123.7(b) to ensure that the cause of the deviation was corrected.

a. At the pH Measurement CCP, your corrective actions state that "(b)(4)." However, there is no corrective action listed for the process to ensure the cause of the deviation is corrected, such as modifying the pH adjustment procedure.

b. At the Labeling CCP, your corrective actions states "(b)(4)." However, there is no corrective action listed for the process to ensure the cause of the deviation is corrected, such as modifying the labeling procedure or working with label supplier.

6. You are not monitoring the sanitation conditions and practices with sufficient frequency to assure conformance with Current Good Manufacturing Practices including condition and cleanliness of food contact surfaces as required by 21 CFR 123.11(b). Specifically, the sanitizer used for food-contact surfaces, didecyldimethylammonium chloride, which is a form of quaternary ammonium chloride, is not adequate for use. The chemical is supplied as a solution with a concentration of (b)(4) parts per million (ppm). Your firm uses a (b)(4) solution of this chemical (approximately (b)(4) ppm), applied after cleaning with soap, and then rinsed after (b)(4) minutes. Quaternary ammonium compounds are not supposed to be rinsed after these have been applied to the food-contact surfaces so as not to lose its efficacy and 21 CFR 178.1010 states that the effective usage level for this type of quaternary ammonium compound is 150 to 200 ppm.

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 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.

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.

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 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.

You should direct your written reply to Rosemary Sexton, Food and Drug Administration, Center for Food Safety and Applied Nutrition, 5001 Campus Drive, Office of Compliance (HFS-608), Division of Enforcement, College Park, Maryland 20740-3835. If you have any questions regarding this letter, you may contact Rosemary Sexton via email at Rosemary.Sexton@fda.hhs.gov. Please reference CMS #637443 on any submissions and on the subject line of any emails to us.

Sincerely,
/S/

Amy Barringer
Acting Deputy Director
Office of Compliance
Center for Food Safety and Applied Nutrition

 
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