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WARNING LETTER

Antonio Mineiro e Andrade MARCS-CMS 497017 —


Recipient:
Antonio Mineiro e Andrade


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
 JUN 28, 2016
 
VIA EXPRESS DELIVERY
 
 
Mr. Bdegardo M. Moniz, Plant Manager
Antonio Mineiro e Andrade
Canada das Yinhas, s/n Rabo de Peixe
Ribeira Grande, Regiao Autonoma dos Acores, 9600 Portugal
 
Reference # 497017 
 
Dear Mr. Moniz,
 
The U.S. Food and Drug Administration inspected your seafood processing facility, Antonio Mineiro e Andrade, located at Canada das Vinhas, s/n Rabo de Peixe, Ribeira Grande, Regiao Autonoma dos Acores, Portugal on February 11-12, 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). That inspection resulted in FDA’s issuance of an FDA-483, lnspectional Observations, listing the deviations found at your firm and presented to your firm at the conclusion of the inspection. We have not, as of this time, received any response from your firm to that FDA-483.
 
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 tuna, bonito, mackerel, jack and sardines 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 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 HACCP plan for Fresh Fish does not list the critical control points of refrigerated storage and unrefrigerated processing for controlling the food safety hazard of scombrotoxin formation. FDA recommends that the following critical limits be established at these critical control points:
 
a.  For refrigerated storage, FDA recommends the product is held at a cooler temperature of 40°F (4.4°C) or below.
b.  During processing (e.g., butchering, cleaning, packing, labeling, and staging) of scombrotoxin-forming fish that have not been previously frozen:
  • 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 HACCP plan for Fresh Fish lists a critical limit, “> (b)(4)”, at the “Reception of whole fresh fish” critical control point that alone is not adequate to control the food safety hazard of scombrotoxin formation that is reasonably likely to occur onboard the harvest vessel. Moreover, because your firm is not located at the wharf where the fish are unloaded from the harvest vessels, your firm needs to include adequate temperature controls during transit from the harvest vessel to your facility.  
 
a.  As a primary processor receiving the fish directly from the harvest vessels, your firm needs to ensure that appropriate harvesting and onboard practices were used onboard the harvest vessel. Consequently, your HACCP plan needs to include adequate critical limits associated with your histamine testing strategy. In addition your plan needs to include sensory examination, and internal temperature monitoring of the fish  as part of your receiving critical control point. FDA recommends that:
  • For histamine testing:
o   Analysis of a representative sample of scombrotoxin-forming fish shows less than (b)(4) ppm histamine in all fish in the sample. In addition, we recommend that firm’s monitor the histamine content in the scombrotoxin-forming fish flesh by testing  a minimum of 18 fish, collected representatively throughout each lot (or the entire lot when there are fewer than 18 fish in the lot.) 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.
AND
  • For Sensory examination:
o   Sensory examination of a representative sample of scombrotoxin-forming fish shows decomposition (persistent and readily perceptible) in less than 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.
AND
  • For Internal temperature measurements:
o   For fish held iced or refrigerated (not frozen) onboard the vessel 24 or more hours after death:
-  The internal temperature should be 40°F (4.4°C) or below;
OR
 
o   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
 
o   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
 
o   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. 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
o   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.
 
b.      And because your facility is not located at the wharf where the fish are unloaded from the harvest vessels your firm needs to ensure that appropriate transportation-handling practices were used throughout transit from the harvest vessel to your facility (including the time the product is at the auction), FDA recommends that:
  • For fish delivered refrigerated (not frozen):
o   All lots received are accompanied by transportation records that show that the fish were held at or below an ambient or internal temperature of 40°F (4.4°C) throughout transit. Note that allowance for routine refrigeration defrost cycles may be necessary;
OR
  • For fish delivered under ice:
o   Fish are completely surrounded by ice at the time of delivery;
OR
  • For fish delivered under ice on an open-bed truck:
o   Fish are stored completely surrounded by ice;
AND
o   The internal temperature of the fish at the time of delivery is 40°F (4.4°C) or below;
OR
  • For fish delivered under chemical cooling media such as gel packs:
o   There is an adequate quantity of cooling media that remain frozen to have maintained product at an internal temperature of 40°F (4.4°C) or below throughout transit;
AND
o   The internal temperature of the fish at the time of delivery is 40°F (4.4°C) or below;
OR
  • For fish delivered refrigerated (not frozen) with a transit time (including all time outside a controlled temperature environment) of 4 hours or less (optional control strategy):
o   Time of transit does not exceed 4 hours; ˚
AND
o   Internal temperature of the fish at the time of delivery does not exceed 40°F (4.4°C).
 
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, 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 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.
 
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 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.
 
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.
 
Please send your reply to Food and Drug Administration, Attention: Philip Bermel, Compliance Officer, Food Adulteration Assessment Branch (HFS-607), Division of Enforcement, Office of Compliance, 5001 Campus Drive, College Park, MD 20740 U.S.A. If you have any questions regarding this letter, you may contact Mr. Bermel via email at Philip.Bermel@fda.hhs.gov.
 
 
 
 
Sincerely,
/S/ 
Michael Roosevelt
Acting Director
Office of Compliance
Center for Food Safety   
     and Applied Nutrition