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WARNING LETTER

Reunipeche SAS MARCS-CMS 696493 —

Delivery Method:
Via Express Delivery and Electronic Mail
Product:
Food & Beverages
Recipient:
Recipient Name
Hubert Chenede
Recipient Title
General Manager
Reunipeche SAS

9 Rue D'Armagnac
97420 Le Port La Reunion
France

hubert.chenede@reunipeche.com
Issuing Office:
Human Foods Program

United States

December 26, 2024

WARNING LETTER


Ref: Case # 696493

Dear Mr. Hubert Chenede,

On July 3 and 4, 2024, the United States Food and Drug Administration (FDA) conducted an inspection of your seafood processing facility, located at Batiment 20, Le Port, La Reunion, Le Port, France 97420. During our inspection of your facility, the FDA investigators found serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations, Part 123. At the conclusion of the inspection, the FDA investigator issued a Form FDA 483 (FDA-483), Inspectional Observations, listing the deviations found at your firm. We acknowledge receipt of your responses, received via email on July 19, 2024, September 16 and 24, 2024, which included HACCP documents for your whole fresh fish such as a risk analysis, “(b)(4),” procedure for monitoring fish temperature, monitoring records, and other supporting documents. However, our evaluation of your responses revealed that we 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 whole fresh fish, 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. The June 2022 Edition of the Hazards Guide can be found on our web site at: https://www.fda.gov/food/seafood-guidance-documents-regulatory-information/fish-andfishery-products-hazards-and-controls.

Your significant violations 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 plan for “(b)(4), dated 17/07/2024 does not list the food safety hazard of pathogen growth and toxin formation associated with your products intended to be consumed raw.

In addition, although your “(b)(4)” document lists the hazards of Listeria, parasites, histamine, and allergen, these hazards must be identified in your HACCP plan. The HACCP plan must list the food safety hazards to ensure that the processor or importer knows what the hazards are, so that it controls them by design rather than by chance. Failure to list the food safety hazards can result in a failure to establish the required controls necessary to ensure the safety of the product.

2. 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.” Your firm’s revised HACCP plan (i.e., (b)(4)) for “(b)(4), dated 17/07/2024, lists critical limits at the following critical control points that are not adequate to control the identified food safety hazards. Specifically:

a. Your critical limit of “(b)(4)” at the CCP1 “(b)(4)” critical control point is not adequate to control scombrotoxin (histamine) formation. You stated via email on September 16, 2024, that “(b)(4).” However, you do not indicate that you collect and review harvest vessel records to ensure that incoming fish were properly handled onboard the harvest vessel after harvesting, which according to your management can last between (b)(4) days. FDA recommends your critical limit consist of collecting harvest vessel records to ensure that incoming fish were properly handled and adequately iced onboard the harvest vessels. Alternatively, you may choose to conduct histamine testing at receiving instead of collecting harvest vessel records.

b. Your critical limit of “(b)(4)” at the CCP4 “(b)(4)” critical control point is not adequate to control scombrotoxin (histamine) formation during storage of in-process products. FDA recommends ensuring the fish are held at a cooler temperature of 40°F (4.4°C) or below using a continuous temperature-recording device (e.g., a recording thermometer) with a visual check of the recorded data at least once per day.

After updating your critical limits, you should update the associated corrective actions, ensuring that unsafe product does not enter commerce and the cause of the deviations are corrected, in accordance with 21 CFR 123.7.

3. 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 revised HACCP plan (i.e., (b)(4)) for “(b)(4), dated 17/07/2024, lists monitoring procedures that are not adequate at the following critical control points to control the identified food safety hazards. Specifically:

a. Your monitoring of procedure of “(b)(4)” at the “CCP2 (b)(4)” critical control point to control scombrotoxin (histamine) formation is not adequate. FDA recommends examining at least 118 fish, collected representatively throughout each lot (or the entire lot, for lots smaller than 118 fish). Lots should consist of only one species of fish; for vessels delivering multiple species, testing should generally be done separately on each species.

b. Your monitoring procedure of “(b)(4)” at the CCP3 “(b)(4)” critical control point to control scombrotoxin (histamine) formation is not adequate. FDA recommends using a temperature-indicating device (e.g., a thermometer) to measure the internal temperature of a representative number of the largest fish in each lot, concentrating on any that show signs of having been mishandled. Measure a minimum of 12 fish, unless there are fewer than 12 fish in the lot, in which case measure all of the fish.

After updating your monitoring procedures, you should update the associated corrective actions for each identified hazard critical limit, ensuring that unsafe product does not enter commerce and the cause of the deviations are corrected, in accordance with 21 CFR 123.7.

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 Hazard Analysis and HACCP plan for your whole fresh fish, 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 plans, 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. 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 Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation (CGMP & PC rule), Title 21, Code of Federal Regulations, Part 117 (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.

Additionally, we offer the following comment:

  • Your firm’s revised HACCP plan does not identify the “(b)(4)” step as a critical control point to control the food safety hazard of undeclared allergens and ensure all cartons of your processed fish are properly labeled.

Please send your reply to the Food and Drug Administration, Attention: Sheena Phillips, Compliance Officer, Human Foods Program – Office of Compliance and Enforcement, Office of Enforcement – Division of Conventional Foods Enforcement (HFS-607), 5001 Campus Drive, College Park, MD 20740 U.S.A. If you have any questions regarding any issues in this letter, please contact Sheena Phillips via email at: Sheena.Phillips@fda.hhs.gov. Please include reference CMS #696493 on any submissions and within the subject line of any email correspondence to the agency.

Sincerely,
/S/

Maria S. Knirk, JD MBA
Acting Director, Office of Enforcement
Office of Compliance and Enforcement
Human Foods Program

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