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WARNING LETTER

Neptunus Seafood B.V. MARCS-CMS 599076 —


Delivery Method:
Via Express Delivery
Product:
Food & Beverages

Recipient:
Recipient Name
Mr. Martin Haasnoot
Recipient Title
Director
Neptunus Seafood B.V.

Rijnlandkade 1
2222 AE Katwijk
Netherlands

Issuing Office:
Center for Food Safety and Applied Nutrition

United States


JAN 22, 2020

WARNING LETTER

Reference # 599076

Dear Mr. Haasnoot:

The United States Food and Drug Administration (FDA) conducted an inspection of your seafood processing facility, Neptunus Seafood B.V., located at ljzersteden 7, Enschede, Overijssel, 7547 TB, Netherlands on October 22-23, 2019. During that 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 123). At the conclusion of the inspection, the FDA investigator issued an FDA 483, lnspectional Observations, listing the observations made at your firm. We acknowledge receipt of your responses sent via email on November 5 and 11, 2019. Your responses included a revised HACCP plan for your refrigerated pickled herring products, dated November 11, 2019, and other HACCP related documents. However, our evaluation of your response revealed it was not adequate, 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 ready-to-eat (RTE) refrigerated pickled herring 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. 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, dated November 11, 2019, for your refrigerated pickled herring products, list critical limits that are not adequate to control the identified food safety hazards. Specifically,

a. Your critical limits of "(b)(4)," "(b)(4)" critical control point to control scombrotoxin (histamine) formation and pathogen growth and toxin formation are not adequate. FDA recommends:

i. To control scombrotoxin (histamine) formation during processing (e.g., thawing, brining, curing, packaging, and labeling) of scombrotoxin-forming fish or fishery products that have been previously frozen such as the frozen herring fillets you process into various pickled herring products:

• The fish are not exposed to ambient temperatures above 40°F (4.4°C) for more than 12 hours, cumulatively, if any portion of that time is at temperatures above 70°F (21.1°C);
or
• The fish are not exposed to ambient temperatures above 40°F (4.4°() for more than 24 hours, cumulatively, as long as no portion of that time is at temperatures above 70°F (21.1°C).

ii. To control pathogen growth and toxin formation during unrefrigerated processing of raw, RTE products:

• If at any time the product is held at internal temperatures above 70°F (21.1°C), exposure time (i.e., time at internal temperatures above 50°F (10°C) but below 135°F (57.2°C)) should be limited to 2 hours (3 hours if S. aureus is the only pathogen of concern); or

• Alternatively, exposure time (i.e., time at internal temperatures above 50°F (10°C) but below 135°F (57.2°C)) should be limited to 4 hours, as long as no more than 2 of those hours are between 70°F (21.l°C) and 135°F (57.2°C); or

• If at any time the product is held at internal temperatures above 50°F (10°() but never above 70°F (21.1 °C), exposure time at internal temperatures above 50°F (10°C) should be limited to 5 hours (12 hours if S. aureus is the only pathogen of concern); or

• The product is held at internal temperatures below 50°F (10°C) throughout processing;
or
• Alternatively, the product is held at ambient air temperatures below 50°F (10°C) throughout processing.

b. Your critical limit of "(b)(4)" is not adequate to control Clostridium botulinum (C. botulinum) toxin formation. FDA does not recommend that processors rely on monthly finished product testing to control C. botulinum toxin formation. FDA recommends processing controls such as the following:

i. To control C. botulinum toxin formation during thawing of vacuum packaged fish, the product be thawed at a cooler temperature of 38°F (3 .3°C) or below, immediately before use.

ii. To control C. botulinum toxin formation in refrigerated reduced oxygen packaged finished product, the minimum or maximum values for the critical factors of the brining, pickling, or formulation process should be established by a scientific study. The critical factors are those that are necessary to ensure that the finished product has:

• A water phase salt level of at least 5%; or
• A pH of 5.0 or below; or
• A water activity of below 0.97; or
• A combination of water phase salt, pH, and/or water activity that, when combined, have been demonstrated to prevent the growth of C. botulinum type E and non-proteolytic types B and F.

2. 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, dated November 11, 2019, for your refrigerated pickled herring products, lists a monitoring procedure at the "(b)(4)" critical control points that is not adequate to control C. botulinum toxin formation and scombrotoxin (histamine) formation. Specifically, the monitoring procedures of "(b)(4)" and "(b)(4)" is inadequate. FDA recommends that firms monitor the temperature of the cooler using a continuous temperature-recording device (e.g., a recording thermometer) and a visual check of the recorded data at least once per day.

3. Because you chose to include a corrective action plan in your HACCP plan, your described corrective action must be appropriate, to comply with 21 CFR 123.7(b). However, your corrective action plans for your refrigerated pickled herring products at the "(b)(4)" critical control points to control C. botulinum toxin formation and scombrotoxin (histamine) formation are not appropriate. According to your corrective action plans, when a deviation from the critical limit occurs, you will "(b)(4)." However, it is not clear from this description if your firm will ensure that violative product will not enter into commerce. In addition, your corrective action must ensure the cause of the deviation is corrected.

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, process flow diagrams, hazard analysis, 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 117 Subpart B). You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations.

Additionally, Section 743 of the Act (21 U.S.C. 379j-31) authorizes FDA to assess and collect fees to cover FDA's costs for certain activities, including re-inspection-related costs. A re-inspection is one or more inspections conducted subsequent to an inspection that identified noncompliance materially related to a food safety requirement of the Act, specifically to determine whether compliance has been achieved. Re-inspection-related costs means all expenses, including administrative expenses, incurred in connection with FDA's arranging, conducting, and evaluating the results of the re-inspection and assessing and collecting re-inspection fees (21 U.S.C. 379j-31(a)(2)(B)). The inspection noted in this letter identified noncompliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any re-inspection-related costs.

You should direct your written reply to Sheena Crutchfield, 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 Ms. Crutchfield via email at Sheena.Crutchfield@fda.hhs.gov. Please reference# 599076 on any submissions and on the subject line of any emails to us.


Sincerely,
/S/
William A. Correll
Director
Office of Compliance
Center for Food Safety
     and Applied Nutrition