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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Empacadora Diamante S.A. 11/26/13


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

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

NOV 26, 2013 

Ms. Victoria Ross, General Manager
Empacadora Diamante S.A.
Km 2 via Atacames
Esmeraldas, Ecuador
Reference No. 411405
Dear Ms. Ross:
We inspected your seafood processing facility, Empacadora Diamante S.A., located at Km. 2 Via Atacames, Esmeraldas, Ecuador, on April 3-4, 2013. 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, Part 123 (21 CFR 123). At the conclusion of the inspection, FDA issued a FDA-483, Inspectional Observations, listing the deviations found at your firm. We acknowledge receipt of your response via email dated May 13, 2013, that included written corrective action; a revised HACCP plan for Mahi mahi, Tuna, Wahoo, Escolar, Amberjack and Marlin; and blank and completed monitoring records. We have assessed the response and have continuing concerns as further described in this letter.
In accordance with 21 CFR 123.6(g), failure of a processor of fish and 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 histamine-forming 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 and Control Guidance (the Hazard Guide) through links in FDA’s homepage at www.fda.gov. The Hazards Guide can be found on our web site at: http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/Seafood/FishandFisheriesProductsHazardsandControlsGuide/default.htm.
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 revised HACCP plan for scombrotoxin (histamine)-forming fish does not list critical control points for storage and for processing to control histamine formation. 
Your firm’s HACCP plan does not list a critical control point for the storage step that occurs after processing. Your firm’s flow diagram includes two storage steps, but your HACCP plan only includes a critical control point for the storage step that occurs prior to processing. Your firm needs to add a critical control point for the storage step following processing to ensure adequate monitoring of the (b)(4)
FDA recommends a critical control point for processing (to include eviscerating, cutting, cleaning, and classifying) to ensure the fish are not exposed to unrefrigerated temperatures for extended time periods during these processing steps to control histamine formation.
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 revised HACCP plan for scombrotoxin (histamine)-forming fish lists critical limits at the receiving critical control point that are not adequate to control histamine. 
a.    Your firm’s plan lists a critical limit of decomposition in (b)(4) in a 118 fish sample. FDA recommends that no more than 2 fish in a sample of 118 fish may show signs of decomposition.
b.    Your firm’s plan lists a critical limit for internal temperature of fish delivered at or (b)(4) if delivery is (b)(4) or more hours after death. Our investigator observed that fish are potentially held aboard the vessel for (b)(4). FDA recommends that for fish held iced onboard the vessel 24 hours or more hours after death, the internal temperature should be 40°F (4.4°C) or below.
3.    You must have a HACCP plan that, at a minimum, lists monitoring procedures and their frequency for each for each critical control point, to comply with 21 CFR 123.6(c)(4). However, your firm’s revised HACCP plan for scombrotoxin (histamine)-forming fish does not list a monitoring procedure/frequency at the “(b)(4)” critical control point to control histamine. 
The critical limit lists “(b)(4),” but your plan does not list any corresponding monitoring procedures or any frequency of monitoring for this part of the critical control point. Your firm also lists monitoring of the (b)(4) at this same critical control point.  FDA recommends you either monitor presence or adequacy of ice; or ambient temperature of ice water.
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 plans for your scombrotoxin (histamine)-forming fish are not appropriate. 
a.    At the receiving critical control point, your plan states, “(b)(4)” in association with your histamine testing strategy. FDA does not recommend sorting and retesting when the histamine critical limits have been exceeded.
b.    At the receiving critical control point, your plan does not list actions to regain control of your process such as discontinue use of the supplier until evidence is obtained that the identified harvesting and onboard practices have been improved.
c.    Your corrective action plan for histamine-forming fish at the “(b)(4)” critical control point does not list actions to regain control over the operation and address the root cause.
You should respond in writing within 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) 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 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 been 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: Standra Purnell, Consumer Safety Officer, Office of Compliance, Division of Enforcement, Food Adulteration Assessment Branch (HFS-607), 5100 Paint Branch Parkway, College Park, MD 20740 U.S.A. If you have any questions regarding this letter, you may contact Ms. Purnell via email at standra.purnell@fda.hhs.gov.
William A. Correll, Jr.  
Acting Director
Office of Compliance
Center for Food Safety
       and Applied Nutrition