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WARNING LETTER

COFISA - Conservas de Peixe da Figueira, S.A. MARCS-CMS 694446 —

Delivery Method:
Via Express Delivery and Electronic Mail
Product:
Food & Beverages
Recipient:
Recipient Name
Helga C. Augusto
Recipient Title
Quality Manager
COFISA - Conservas de Peixe da Figueira, S.A.

Terrapleno Do Porto De Pesca
3090-735 Figueira Da Foz Sao Pedro
Portugal

helgacaugusto@cofisa.pt
graca.domingues@triunfofoods.co
Issuing Office:
Human Foods Program

United States

December 18, 2024

WARNING LETTER

Reference # 694446

Dear Ms. Helga C. Augusto

The United States Food and Drug Administration (FDA) conducted an inspection of your seafood processing facility, COFISA - Conservas de Peixe da Figueira, S.A., located at Terrapleno Do Porto De Pesca, Figueira Da Foz Sao Pedro, Portugal 3090-735 on April 10 and 12, 2024. 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 (21 CFR Part 123). At the conclusion of the inspection, the FDA investigator issued an FDA-483, Inspectional Observations that lists the observations made at your firm. We received your responses via email on May 3, 2024, July 2, 2024, July 24, 2024, and July 30, 2024. Your responses included undated revised HACCP plans for canned tuna and canned sardine products with monitoring records and a clarification email, dated July 24, 2024, to FDA inquiries, as evidence of your corrective actions. Our evaluation of your responses revealed they were 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 canned tuna and canned sardine 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 & Controls Guidance (the Hazards Guide) through links in FDA's home page at www.fda.gov.

Your significant deviations are as follows:

HACCP PLAN FOR CANNED SARDINES:

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 Canned Sardines does list the food safety hazard of Staphylococcus aureus growth and toxin formation. According to your process description for “Step 8 – (b)(4)”, “(b)(4).” It is reasonably likely for S. aureus to be introduced into the product during this (b)(4) step.

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. However, your firm’s HACCP plan for canned sardines lists critical limits that are not adequate. Specifically:

a. Your listed critical limit of “(b)(4)” at the “Step 1: (b)(4)” critical control point (CCP1) is not adequate for controlling the hazard of histamines. The internal temperatures of all fish are to meet temperature criteria dependent on the time of death of the fish onboard the harvest vessel and are to be measured at the time fish are offloaded from the harvest vessel. However, your firm does not receive harvest vessel records for any shipments of sardines, and your firm is not measuring temperatures at offloading.

b. Your listed critical limit of “(b)(4)” at the “Step 1: (b)(4)” critical control point (CCP1) is not adequate to control the food safety hazard of scombrotoxin (histamine) formation because it allows for acceptance of lots containing decomposition in more than 2.5% of the fish received (3 fish). The critical limit should ensure that no more than two fish in a sample of 118 fish in the sample show evidence of decomposition.

c. Your listed critical limit of “(b)(4)” at the “Steps 5 to 10/Steps 13 to 19: (b)(4) steps” critical control point (CCP1) is not adequate because it lists two (2) different cumulative time limits. The cumulative time for fish not previously frozen should not exceed 4 hours. This includes all unrefrigerated (b)(4) steps.

3. Because you chose to include a corrective action plan in your HACCP plan, your described corrective actions must be appropriate, to comply with 21 CFR 123.7(b). However, your corrective action plan of “(b)(4)” for the listed critical limit of “(b)(4)” at the “Step 1 (b)(4)” critical control point (CCP1) is not appropriate because it does not list target histamine limits. You should reject the lot if any fish is found with histamine greater than or equal to 35 ppm. This lower histamine level is consistent with the current recommendations listed in CPG 540.525, which was updated on November 1, 2024 (see: CPG Sec 540.525 Scombrotoxin (Histamine)-forming Fish and Fishery Products – Decomposition and Histamine (CPG 7108.24) | FDA).

HACCP PLAN FOR CANNED TUNA:

4. Because you chose to include a corrective action plan in your HACCP plan, your described corrective actions must be appropriate, to comply with 21 CFR 123.7(b). However, your corrective action plan of “(b)(4)” for the listed critical limit of “(b)(4)” at the “Step 1: (b)(4)” critical control point (CCP1) is not appropriate because it does not list target histamine limits. You should reject the lot if any fish is found with histamine greater than or equal to 35 ppm. These lower histamine levels are consistent with the current recommendations listed in CPG 540.525, which was updated on November 1, 2024 (see: CPG Sec 540.525 Scombrotoxin (Histamine)-forming Fish and Fishery Products – Decomposition and Histamine (CPG 7108.24) | FDA).

5. You must monitor sanitation conditions and practices during processing with sufficient frequency to ensure, at a minimum, compliance with the current good manufacturing practice requirements in 21 CFR 117, Subpart B (CGMPs) and maintain records of your observations as required by 21 CFR 123.11. Specifically, our investigator observed that your firm does not sanitize your food contact surfaces after washing and rinsing the equipment. Cleaning should include using a detergent for cleaning, scrubbing off organic material, rinsing the surface, then using a sanitizer. We acknowledge that your corrective action plan, submitted by email on May 3, 2024, states (b)(4).

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 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. 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 comments:

1. FDA is in the process of updating the histamine levels in Chapter 7 of the Fish and Fishery Products Hazards and Controls Guidance to change all references to 50-ppm to 35-ppm. FDA recommends you update your HACCP plan to reflect the lower 35-ppm histamine level (11 ppm for composites consisting of 3-fish each). This includes any histamine critical limits and corrective actions.

2. Your Canned Tuna HACCP plan lists the hazard of “(b)(4)” at “Steps 9 and 12 to 17 – (b)(4) steps” (CCP2). The HACCP plan should list the specific pathogen of concern, which is Staphylococcus aureus.

3. Not all the records submitted contain all the necessary information to document that the critical limit was met. Here are two examples associated with your Canned Tuna HACCP plan:

a. Your monitoring procedure at Step 1 states (b)(4)”. However, a review of your submitted records entitled “(b)(4)” and “(b)(4)” found the a monitoring record of the date and time the product was removed from a controlled temperature environment (“Data e Hora de Transporto”), but only a date was recorded for the ”date of arrival” (“Data” only). We observed something written to the left of the word “Data”, but the entry has no label, and it is difficult to determine what the entry represents.

b. Your monitoring procedure at Step 14 states, “(b)(4).” However, your submitted monitoring record entitled, “(b)(4)” contains a series of boxes under the section entitled “(b)(4)”. Several of the boxes contain a letter indicating monitoring was performed, but there is no record of the exact time each monitoring activity occurred.

Please be advised that per 21 CFR 123.6(c)(7), the HACCP plan shall, at minimum provide for a recordkeeping system that documents the monitoring of the critical control points. The records shall contain the actual values and observations obtained during monitoring.

For additional guidance of the identified food safety hazards, you may reference 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-and-fishery-products-hazards-and-controls, CHAPTER 7: Scombrotoxin (Histamine) Formation, Chapter 12 Pathogenic Bacteria Growth and Toxin Formation (Other than Clostridium botulinum) as a Result of Time and Temperature Abuse.

Please send your reply to the Food and Drug Administration, Attention: Tracy Li, Compliance Officer, Office of Compliance & Enforcement, Office of Enforcement, Division of Conventional Foods Enforcement, Conventional Foods Enforcement Branch 1, 5001 Campus Drive, College Park, MD 20740 U.S.A. If you have any questions regarding any issues in this letter, please contact Tracy Li via email at: tracy.li@fda.hhs.gov. Please include reference #694446 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 & Enforcement
Human Foods Program

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