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WARNING LETTER

Pacific Export Corporation MARCS-CMS 499051 —


Recipient:
Pacific Export Corporation


United States

Issuing Office:
Center for Food Safety and Applied Nutrition

United States


  

Department of Health and Human Services logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
 College Park, MD  20740 

 

WARNING LETTER
JUL 25, 2016 
 
 
VIA EXPRESS DELIVERY
 
Mr. Alexis Tapia, Owner
Pacific Export Corporation
El Puerto
Remedios, Chiriqui, Panama
 
Reference No. #499051
 
 
 
Dear Mr. Tapia:
 
The U.S. Food and Drug Administration (FDA) inspected your seafood processing facility Pacific Export Corporation, located at El Puerto, Remedios, Chiriqui, Panama on March 3 and 4, 2016. 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). The inspection resulted in an issuance of an FDA-483, Inspectional Observations, listing the deviations at your firm at the conclusion of the inspection. We acknowledge receipt of your response sent via email on March 22, 2016. Your response included a timeline of estimated dates by which you plan to implement corrections to the FDA-483 observations; however, your response did not include any documentation to substantiate implementation of any of the corrections, including, for example, a copy of your corrected HACCP plan. Our evaluation of your response revealed that it inadequately addressed the observations noted during the inspection, 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 scombroid species 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 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:
 
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 a minimum, lists the critical control points, to comply with 21 CFR 123.6(a) and (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 Mahi Mahi/Tuna Headed and Gutted Fresh does not list the critical control points of raw material and in-process iced storage and unrefrigerated processing for controlling the food safety hazard of scombrotoxin formation. Discussions during the inspection revealed that your firm holds the fish on ice for (b)(4) prior to conducting unrefrigerated processing steps.  Consequently, FDA recommends that your firm include these steps as critical control points with the following critical limits:
 
a.  For raw material, in-process product, or finished product stored under ice:
  • The product is completely and continuously surrounded by ice throughout the storage time.
b.  During processing (e.g., butchering, cleaning, packing, labeling, and staging) of scombrotoxin-forming fish that have not been previously frozen or heat processed sufficiently to destroy scombrotoxin-forming bacteria:
  • 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
  • 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). 
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 Mahi Mahi/Tuna Headed and Gutted Fresh lists critical limits at the “(b)(4)” critical control point that are not adequate to control the food safety hazard of scombrotoxin formation because they do not include control strategies that ensure the fish were properly handled onboard the harvest vessels. FDA recommends that your HACCP plan list critical limits for sensory (decomposition); harvest vessel records or histamine testing; and internal temperature monitoring of a representative number of the largest fish in the lot at the time of off-loading from the harvest vessel.
 
a.  For sensory (decomposition) examination FDA recommends:
  • Sensory examination of a representative sample of scombrotoxin-forming fish ensuring that there is less than 2.5% decomposition (persistent and readily perceptible) in the sample. For example, there should be no more than 2 fish in a sample of 118 fish showing 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.  For harvest vessel records, FDA recommends that all scombrotoxin-forming fish lots received are accompanied by harvest vessel records that show:
  • 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
  • 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
  • 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
  • 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
  • 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
 
o   The fish were stored completely and continuously surrounded by ice after cooling.
 
c.  For histamine testing, FDA recommends:
  • Analysis of a representative sample of scombrotoxin-forming fish shows less than 50 ppm histamine in all fish in the sample.
d.  For the internal temperature FDA recommends monitoring a representative number of the largest fish in the lot, at the time of off-loading from the harvest vessel and:
  • For fish held iced or refrigerated (not frozen) onboard the vessel 24 or more hours after death:
o   The internal temperature should be 40°F (4.4°C) or below;
 
OR
  • For fish held iced or refrigerated (not frozen) onboard the vessel from 15 to less than 24 hours after death:
o   The internal temperature should be 50°F (10°C) or below;
OR
  • For fish held iced or refrigerated (not frozen) onboard the vessel from 12 to less than 15 hours after death:
o   The internal temperature should be 60°F (15.6°C) or below;
 
OR
  • For fish held iced or refrigerated (not frozen) onboard the vessel less than 12 hours after death:
o   The internal temperature should be sufficiently below water and air temperatures to indicate that appropriate chilling methods were implemented onboard the harvest vessel. Chilling of the fish should begin on the harvest vessel regardless of the time from death until off-loading from the vessel by the processor, unless the environmental conditions (e.g. air and water temperatures) are below 40°F (4.4°C) from the time of death until off-loading from the vessel by the processor;
 
OR
  • For fish held iced or refrigerated (not frozen) onboard the vessel:
o   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.
 
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., records for the production of 5 production date codes of the products) to demonstrate implementation of the plan or 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 applicable laws and regulations. Submission of the information in English will assist in our review.   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 imported fish or fishery products under Section 801(a) or 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 HAACP regulation is Import Alert #16-120. You may view this alert 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 and the Good Manufacturing Practice regulation (21 CFR 110). 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 be 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 the re-inspection fees (21 U.S.C. § 379j-31(a)(2)(B)). For a foreign facility, FDA will assess and collect fees for re-inspection-related costs from the U.S. Agent for the foreign facility. 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. Please consider providing a copy of this letter to your U.S. Agent.
 
Please send your reply to Food and Drug Administration, Attention: April Bowen, Consumer Safety Officer, Office of Compliance, Division of Enforcement, Food Adulteration Assessment Branch (HFS-607), 5001 Campus Drive, College Park, MD 20740 U.S.A. You may send any information related to this case and/or any questions you may have regarding this letter to Ms. Bowen via email at: April.Bowen@fda.hhs.gov. Please reference #499051 on any submissions and within the subject line of any emails to us.
 
 
Sincerely,
/S/ 
William A. Correll, Jr.
Director
Office of Compliance
Center for Food Safety
     and Applied Nutrition