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June 17, 2022

WARNING LETTER

Reference # 634440

Dear Mr. Santiago Ortiz de Zarate:

The United States Food and Drug Administration (FDA) conducted an inspection of your seafood/lowacid canned food (LACF) processing facility, located at Inaki Deuna, 15, Ondarroa, Bizkaia, 48700 Spain, on February 14 through 16, 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. On March 8, 2022 and April 11, 2022, you responded to the observations issued to your facility on February 16, 2022. Your responses included an updated HACCP plan, HACCP monitoring and verification records, and LACF records which were reviewed and addressed below.

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 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 deviation is as follows:
1. You must conduct a Hazard Analysis to determine whether there are food safety hazards that are reasonably likely to occur and have a HACCP plan that, at minimum, lists the critical control points, to comply with 21 CFR 123.6(c)(2). A critical control point is defined in 21 CFR 123.3(b) as a “point, step, or procedure in a food process at which control can be applied and a food safety hazard can as a result be prevented, eliminated, or reduced to acceptable levels”. However, your firm’s HACCP plan for “CANNED TUNA PRODUCTS” does not list critical control points for the following processing steps:

a. At the “(b)(4)” step after the “(b)(4)” step to control the food safety hazard of scombrotoxin (histamine) formation. During processing of scombrotoxin‐forming fish or fishery products that have been (1) previously frozen or (2) heat processed sufficiently to destroy scombrotoxin‐forming bacteria, FDA recommends:

  i. That 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
  ii. That the fish are not exposed to ambient temperatures above 40°F (4.4°C) for more than 24 hours, cumulatively, so long as no portion of that time is at temperatures above 70°F (21.1°C).

We acknowledge that your firm has established a critical limit of “(b)(4)°C” at the “(b)(4)” step. However, per the cited reference “(b)(4),” this temperature is only sufficient to “pause subsequent histamine formation for 12 to 18 h,” not to eliminate histamine formation.

b. At the “(b)(4)”, “(b)(4)”, “(b)(4)”, “(b)(4)”, “(b)(4)”, “(b)(4)” and “(b)(4)” steps up until the retort comes up temperatures to control the food safety hazard of Staphylococcus aureus growth and toxin formation. For product handling after cooking, FDA recommends the following:

  i. If at any time the product is held at internal temperatures above 80°F (26.7°C), exposure time should be limited to 3 hours.
OR
  ii. If at any time the product is held at internal temperatures above 70°F (21.1°C) but never above 80°F (26.7°C), exposure time should be limited to 3 hours.
OR
  iii. If at any time the product is held at internal temperatures above 50°F (10°C) but never above 70°F (21.1°C), exposure time should be limited to 5 hours.

2. You must have a HACCP Plan that, that at 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 TUNA PRODUCTS” does not list a critical limit at the “Fresh Fish and Frozen Fish reception CCP1 and CCP3” critical control point to control the food safety hazard of scombrotoxin (histamine) formation.

Specifically, your HACCP plan does not list a critical limit for measuring internal fish temperatures at the time the fish are offloaded from the harvest vessel. We acknowledge your HACCP plan does include the critical limit of “(b)(4)°C refrigerated fish (b)(4)°C ((b)(4)°C in case of brine frozen whole round fish).” However, this critical limit appears to apply to the fish temperatures at the time they are received at the processing facility. For primary processors offloading at the dock and then transporting fish to the processing facility, it may be necessary to select more than one control strategy in order to fully control the hazard. In addition to your listed critical limits for sensory exams, histamine analyses, and temperature measurements when the fish arrive at the processing facility, FDA also recommends the following critical limits for fish internal temperatures at the time fish are offloaded from the harvest vessel:

  i. For fish held iced or refrigerated (not frozen) onboard the vessel 24 or more hours after death, the internal temperatures should be 40°F (4.4°C) or below.
OR
  ii. For fish held iced or refrigerated (not frozen) onboard the vessel from 15 to less than 24 hours after death, the internal temperature should be 50°F (10°C) or below.
OR
  iii. For fish held iced or refrigerated (not frozen) onboard the vessel from 12 to less than 15 hours after death, the internal temperature should be 60°F (15.6°C) or below.
OR
  iv. For fish held iced or refrigerated (not frozen) onboard the vessel less than 12 hours after death, the internal temperature should be sufficiently below water and air temperatures to indicate that appropriate chilling methods were implemented onboard the harvest vessel.
OR
  v. For fish held iced or refrigerated (not frozen) onboard the vessel, elapsed time from death and internal temperatures at the time of off‐loading from the vessel by the processor should be consistent with cooling curves that will prevent development of an unsafe level of histamine in the specific species, as established through a scientific study.

We note, during the inspection, you stated you operate as a primary processor of fresh tuna and as a secondary processor of frozen tuna and you perform histamine testing using the (b)(4) assay on a minimum of (b)(4) samples” on fresh tuna. Although your firm is a primary processor of fresh fish and a secondary processor of frozen fish, you combine receipt of both fresh and frozen fish at the “(b)(4)” critical control point with primary processor critical limits for histamine testing and sensory examinations. A firm’s HACCP plan may group kinds of fish and fishery products together, or group kinds of production methods together, if the food safety hazards, critical control points, critical limits, and procedures required to be identified and performed are identical for all fish and fishery products so grouped or for all production methods so grouped. Based on the current receiving critical limits listed in your HACCP plan for canned tuna, your firm is expected to perform histamine testing and sensory testing when receiving both fresh and frozen fish.

3. You must have a HACCP plan that, at 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 TUNA PRODUCTS” lists the following critical limits that are not adequate:

  a. Your firm’s HACCP plan lists a critical limit of “(b)(4)” at the “(b)(4)” critical control point that is not adequate to control scombrotoxin (histamine) formation. FDA recommends, sensory examination of a representative sample of scombrotoxin‐forming fish shows decomposition (persistent and readily perceptible) in less than 2.5% (<2.5%) of the fish in the sample. For example, no more than 2 fish in a sample of 118 fish may show signs of decomposition. Note that the FFD&C Act prohibits interstate commerce of any decomposed fish whether or not the HACCP critical limit has been exceeded.

  b. Your firm’s HACCP plan lists critical limits of “(b)(4) and “(b)(4)” at the “(b)(4)” critical control point that that are not adequate to control scombrotoxin (histamine) formation. Specifically, this critical control point appears to combine refrigerated storage and refrigerated processing steps with unrefrigerated processing steps. A firm’s HACCP plan may group kinds of fish and fishery products together, or group kinds of production methods together, if the food safety hazards, critical control points, critical limits, and procedures required to be identified and performed are identical for all fish and fishery products so grouped or for all production methods so grouped. However, the critical limits recommended by FDA to control scombrotoxin (histamine) formation during refrigerated storage and refrigerated processing are not identical to the critical limits to control scombrotoxin (histamine) formation during unrefrigerated processing.

For unrefrigerated processing of fresh fish (not frozen) at the “(b)(4)” and “(b)(4)” steps performed before the “(b)(4)” step ((b)(4)), FDA recommends:

  i. The fish are not exposed to ambient temperatures above 40°F (4.4°C) for more than 4 hours, cumulatively, if any portion of that time is at temperatures above 70°F (21.1°C).
OR
  ii. The fish are not exposed to ambient temperatures above 40°F (4.4°C) for more than 8 hours, cumulatively, as long as no portion of that time is at temperatures above 70°F (21.1°C). Note: only one of the two limits above should be selected. They should not be added for a total exposure of 12 hours.

For unrefrigerated processing of frozen fish at the “(b)(4)”, “(b)(4)” and “(b)(4)” steps performed before the “(b)(4)” step ((b)(4)), FDA recommends:

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

For refrigerated (not frozen) storage of fish at the “(b)(4),” “(b)(4) and “(b)(4)” steps, or for the “(b)(4)” step, FDA recommends:
  i. The product is held at a cooler temperature of 40°F (4.4°C) or below throughout storage or throughout the thawing process.

4. You must have a HACCP plan that, at minimum, lists monitoring procedures and their frequency for each critical control point, to comply with 21 CFR 123.6(c)(4). However, your firm’s HACCP plan for “CANNED TUNA PRODUCTS” lists a monitoring frequency at the “(b)(4)” critical control point that is not adequate to control the hazard of undeclared allergens. Specifically, your monitoring procedures state you will perform a visual confirmation of the labels with the frequency “(b)(4).” This frequency does not provide specific information about the how you will identify the “middle” of the labeling step or process. FDA recommends you monitor the labeling critical limit with the following frequency:

  i. At the start of the production lot
AND
  ii. At least every 2 hours
OR
  iii. When new containers of labels are opened or rolls of labels are changed.

5. 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 HACCP plan for “CANNED TUNA PRODUCTS” at the “(b)(4)” critical control point lists corrective actions that are not appropriate to control scombrotoxin (histamine) formation. Specifically:

a. Your listed corrective action of “(b)(4)” does not ensure unsafe product does not reach the consumer. When the histamine critical limit has not been met, FDA recommends you reject the lot or divert the lot to a non‐food use. Conducting additional histamine testing is not appropriate.
b. Your listed corrective action of “(b)(4)” does not ensure unsafe product does not reach the consumer. When the sensory critical limit has not been met, and if histamine did not exceed 35 ppm (mg/kg) in the initial testing, FDA recommends the following:

  i. Chill and hold the affected lot until histamine analysis is performed on a minimum of 60 fish representatively collected from throughout the lot, including all fish in the lot that show evidence of decomposition. Reject the lot if any fish are found with histamine greater than or equal to 35 ppm.
AND
  ii. If any fish in the lot are to proceed into commerce for food use, perform a sensory examination on all fish in the lot to ensure that no decomposed fish proceed.
AND
  iii. Any individual fish found to be decomposed should be destroyed or diverted to a non‐food use.
OR
  iv. Reject the lot.

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 #634440 on any submissions and on the subject line of any emails to us.

Sincerely,
/S/

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