Inspections, Compliance, Enforcement, and Criminal Investigations

Pesca Fina, S.A. 7/18/17

 

  

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5001 Campus Drive
College Park, MD 20740 

 
 

WARNING LETTER

JUL 18, 2017

VIA EXPRESS DELIVERY

Mr. Constantino Rusodimos, General Manager
Pesca Fina, S.A.
Port of Vacamonte
Vista Alegre, Anaijan, Panama

Reference #524192
 

On April 4, 2017, a representative of the UnHed States Food and Drug Administration (FDA) conducted an inspection of a fish and fishery products importer located in the United States, (b)(4) located in (b)(4), to assess that importer's compliance with the United States Seafood Hazard Analysis and Critical Control Point (HACCP) Regulation, Title 21, Code of Federal Regulations, Part 123 (21 CFR Part 123), refened to as the seafood HACCP regulation. That importer was found to be importing fresh wild caught whole, eviscerated yellowtail tuna (Thunnus Albacares) from your processing facility. During the inspection of that impo11er, we collected a copy of your firm's HACCP plan for fresh wild caught whole, eviscerated yellowtail tuna (Thunnus Albacares). Our evaluation of that HACCP plan (copy attached) revealed that the plan demonstrates serious deviations from the requirements of the seafood HACCP regulation (21 CFR 123).

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 fresh wild caught whole, eviscerated scombrotoxin (histamine) forming fish, including your Mahi Mahi (i.e., Dorado) and Yellowtail tuna (Thunnus Albacares) 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 FD A's 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. The 4th Edition of the Hazards Guide can be found on our web site at http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatorylnformation/Seafood/ucm2018426.htm

We found the following significant deviations:

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 HACCP plan entitled "HACCP plan for Whole, Eviscerated Fish, Histamine Producers" lists critical limits at the "Receiving fresh histamine producing fish in ice or refrigerated from harvest vessel" critical control point which are not adequate to control the food safety hazard of scombrotoxin (histamine) fonnation. Specifically, your critical limit, "Records of vessel performance in relation to method of capture, time to cooling and cool storage on-bard vessel" is not adequate because it does not specify the parameters in the harvest vessel records that must be met to control the hazard of scombrotoxin (histamine) formation. When relying on harvest vessel records, your critical limit must ensure that all lots of scombrotoxin (histamine) forming fish are accompanied by harvest vessel records that show:

o  Fish exposed to air or water temperatures above 83 °F (28.3 °C) were placed in ice, or in refrigerated seawater, ice slurry, or brine of 40°F (4.4°C) or less, as soon as possible after harvest, but not longer than 6 hours from the time of death;
OR
o  Fish exposed to air and water temperatures of 83 °F (28.3 °C) or less were placed in ice, or in refrigerated seawater, ice slurry, or brine of 40°F ( 4.4°C) or less, as soon as possible after harvest, but not longer than 9 hours from the time of death;
OR
o  Fish that were gilled and gutted before chilling were placed in ice, or in refrigerated seawater, ice slurry, or brine of 40°F (4.4°C) or less, as soon as possible after harvest, but not longer than 12 hours from the time of death;
OR
o  Fish that were harvested under conditions that expose dead fish to harvest waters of 65°F (18.3 °C) or less for 24 hours or less were placed in ice, or in refrigerated seawater, ice slurry, or brine of 40°F (4.4°C) or less, as soon as possible after harvest, but not more than the time limits listed above, with the time period starting when the fish left the 65°F (18.3°) or less environment;
OR
o  Other critical limits for onboard handling (e.g., maximum refrigerated brine or seawater temperature, maximum fish size, maximum fish to brine/seawater/ice ratio, maximum initial temperature of the fish) necessary to achieve a cooling rate that will prevent development of an unsafe level of histamine in the specific species, as established through a scientific study.

AND

• For fish held refrigerated (not frozen) onboard the vessel:
o  The fish were stored at or below 40°F (4.4°C) after cooling;
OR
The fish were stored completely and continuously surrounded by ice after cooling.

In addition to relying on harvest vessel records and your listed internal fish temperatures monitoring at the receiving step, FDA recommends performing sensory examination of incoming fish to ensure they do not show signs of decomposition. FDA recommends you include a critical limit for sensory examination of a representative sample of scombrotoxin (histamine) fonning fish that demonstrates decomposition (persistent and readily perceptible) in less than 2.5% of the fish in the sample. For example, you should monitor the amount of decomposition in the lot by examining at least 118 fish, collected representatively throughout each lot (or the entire lot, for lots smaller than 118 fish) for every lot of scombrotoxin (histamine) fonning fish received. Additional fish should be examined if variability in fish-to-fish histamine content is expected to be high. Lots should consist of only one species of fish; for vessels delivering multiple species, testing should generally be done separately on each species.

2.    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 plans for your "HACCP plan for Whole, Eviscerated Fish, Histamine Producers" at the following critical control points to control scombrotoxin fonnation are not appropriate:

a.  At the "Receiving fresh histamine producing fish in ice or refrigerated from harvest vessel" critical control point, your corrective action indicates you will "(b)(4)." However, the corrective action does not ensure that adulterated product remains out of commerce. In the absence of harvest vessel records or when one of the harvester-related critical limits has not been met, or when the internal temperature critical limit at receiving has not been met FDA recommends that firms:

o  Chill and hold the affected lot (i.e., fish of common origin) until histamine analysis is performed on a minimum of 60 fish representatively collected from throughout the lot, including any fish measured to have temperatures that exceeded the critical limit (or the entire lot for lots smaller than 60 fish). Reject the lot if any fish are found with histamine greater than or equal to 50 ppm. The fish collected for analysis may be composited for analysis if the action point is reduced accordingly. For example, a sample of 60 fish may be composited into 20 units of 3 fish each, provided the action point is reduced from 50 ppm to 17 ppm for each unit;
OR
o  Reject the lot.

b.  At the "Refrigerated Storage" critical control point, your corrective action fails to ensure the cause of the deviation is corrected. In addition, your corrective actions list "(b)(4)." However, your critical limits at this "Refrigerated Storage" critical
control point list that the products will be completely covered in ice with a monitoring frequency of every 12 hours to check each tote. As a result your finn will be unable to implement your corrective actions because you do not monitor the temperatures and time parameters that are listed in your corrective action plan (i.e., you are not continuously monitoring and recording temperatures in order to assess the cumulative temperatures at 4 and 8 hour intervals). Moreover, your firm does not include a separate critical control point for butchering/packaging, consequently you will be unable to assess the time/temperature exposures during those steps in your process. When the critical limit for adequacy of ice has not been met FDA recommends that firm:

o  Chill and hold product until histamine analysis is perfonned on a minimum of 60 fish throughout each affected lot. Destroy the lot or divert to non-food use if any fish is found with histamine greater than or equal to 50 ppm. The fish collected for analysis may be composited if the action point is reduced accordingly. For example, a sample of 60 fish may be composited into 20 units of 3 fish each, provided the action point is reduced from 50 ppm to 1 7 ppm for each unit.
OR
o  Destroy the product or divert to non-food use.

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, 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 info1mation 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 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 frozen Scombroid Species fish 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

Additional Comment:

According to your "HACCP plan for Whole, Eviscerated Fish, Histamine Producers," your firm records the internal temperature of a sample of (b)(4) from every vessel at the receiving critical control point. However, it isn't clear whether your firm records these temperatures during offloading from the vessel or after the fish have been transported to your processing facility. In response to this letter, please clarify when you take internal temperatures of fish at the receiving step.

Please send your reply to the U.S. Food and Drug Administration, Attention: Kristen Jackson, Compliance Officer, Food Adulteration Assessment Branch, Division of Enforcement, Office of Compliance, Center for Food Safety and Applied Nutrition, HFS-607, 5001 Campus Drive, College Park, MD 20740 U.S.A. You may submit documentation accompanying your reply to: Kristen.Jackson@fda.hhs.gov. Please reference CMS# 524192 on any submissions and within the subject line of any emails to us. You may also contact Kristen Jackson via email if you have any questions about this letter.

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

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