Inspections, Compliance, Enforcement, and Criminal Investigations

Balfego and Balfego, SL 11/14/14

  

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

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

NOV 14, 2014

WARNING LETTER
 
 
VIA EXPRESS DELIVERY
 
Begonya Melich, Director of Technical Services
Balfego and Balfego, S.L.
Poligono Industrial Edificio Balfego
Tarragona Provence
L’ametlla De Mar, Spain 43860 
 
Reference # 442297
 
Dear Ms. Melich:
 
This letter is in response to the documentation that your firm provided to the U.S. Food and Drug Administration (FDA) on September 4, 2014, that included your revised HACCP plan dated August 18, 2014, for your sashimi grade Bluefin tuna. This revised HACCP plan was sent in addition to and following previous information that your firm had provided on April 25, August 8 and August 21, 2014, all in response to violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations, Part 123 (21 CFR 123) noted via an FDA Form 483 that was issued to your firm at the conclusion of an inspection conducted at your processing facility located at Poligono Industrial Edificio Balfego, L’ametlla de Mar, Spain on April 7-8, 2014. Review of the documentation provided by your firm revealed that the responses were not adequate 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 sashimi grade Bluefin tuna is adulterated, in that it has 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 Fishery Products Hazards and Controls Guidance (the Hazards Guide) through links on FDA's home page at www.fda.gov. The Hazards Guide, which provides our recommendations regarding identification and control of food safety hazards reasonably likely to occur for your fish and fishery products, can be found on our web site at: http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/Seafood/ucm2018426.htm.
 
Your significant deviations are as follows:
 
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 firm’s revised HACCP plan dated 18 August 2014 lists critical limits at the “6.-Receiving and unloading” critical control point that are not adequate to control the hazard of histamine formation. Specifically,
  • Your revised plan lists “(b)(4) at hold vessel; temperature at hold vessel (b)(4) at cold room...” which are not adequate because these critical limits do not adequately address handling of the fish onboard the harvest vessels. For primary processors receiving the fish directly from the harvest vessels, when firms are using the harvest vessel record strategy (rather than the histamine testing strategy), FDA recommends that the critical limits for harvest vessel control strategy include three components: harvest vessel records; sensory examination; and internal temperature monitoring at the time of off-loading from the harvest vessel. 
o    For harvest vessel records, the critical limit should be that all scombrotoxin-forming fish lots are accompanied by harvest vessel records
o    For sensory examination, FDA recommends sensory examination of a representative sample of scombrotoxin-forming fish shows decomposition 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.
o    For internal temperature measurements (at the time of off-loading from the harvest vessel) the critical limits should be:
 
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 of 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.
 
With regard to internal temperature monitoring at off-loading, we acknowledge that in your August 21, 2014 response, your firm indicated that the internal temperature of the product can be (b)(4) ambient temperatures at the time of the product reception to your facility and that temperature controls in the vessel’s hold were implemented to ensure that the cooling method is appropriate. We understand that internal temperature of Bluefin tuna can be higher than ambient temperatures at the time of off-loading from the harvest vessel for fish that have been held iced or refrigerated onboard the vessel (b)(4) after death, and we commend your firm for implementing temperature control in the vessel’s hold. However, comparing the internal temperature of the Bluefin tuna at time of off-loading from the harvest vessel to water and air temperatures may not indicate that appropriate chilling methods were implemented onboard the vessel for fish that have been held iced or refrigerated onboard the vessel (b)(4) after death. Consequently, FDA recommends that internal temperature measurements (at time of off-loading from the harvest vessel) as necessary to ensure that appropriate chilling methods were implemented onboard the harvest vessel.
 
  • Your revised plan lists (b)(4) of histamine; histamine determina-tion by immunosorbent assay; (b)(4)” a critical limit that is not adequate to control the hazard of histamine formation under a histamine testing control strategy. FDA recommends that the critical limits for this control strategy should include three components; histamine testing, sensory examination; and internal temperature measurements (at the time of off-loading from the harvest vessel). For histamine testing the critical limit should be:
o    Analysis of a representative sample of scombrotoxin-forming fish shows less than 50 ppm histamine in all fish in the sample.
 
o    For sensory examination and internal temperature measurements (at the time of off-loading from the harvest vessel) the critical limits should be identical to the critical limits for sensory examination and internal temperature measurements listed under harvest vessel control strategy. 
 
Please be advised that your firm only needs to adopt one of the two strategies, either the harvest vessel record strategy or the histamine testing strategy. 
 
  • Your revised plan dated 18 August 2014 lists critical limits at the “(b)(4)” critical control point that are not adequate to control the hazard of histamine formation during transit from the port to your processing plant because they do not ensure that the fish were maintained at proper temperatures during the entire duration of the transit period. FDA recommends that:
o    For fish delivered refrigerated (not frozen), 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; OR
o    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 (at the processing plant) does not exceed 40°F (4.4°C).
 
  • Your revised plan dated 18 August 2014 lists critical limits of “Maximum manipulation room temperature of (b)(4)” critical control points that are not adequate to control histamine formation and pathogen growth and toxin formation during unrefrigerated processing because these critical limits do not include a maximum cumulative time of exposure. 
o    FDA recommends the following critical limits to control histamine formation during unrefrigerated processing:
o    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
o    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).
 
Please be advised that these exposure times are cumulative and should include all of the unrefrigerated processing steps in your operation.
 
  • FDA recommends the following critical limits to control pathogen growth and toxin formation during unrefrigerated processing of raw ready-to-eat products:
o    If at any time the product is held at internal temperatures above 70°F (21.1°C), exposure time (i.e., time at internal temperatures above 50°F (10°C) but below135°F (57.2°C) should be limited to 2 hours (3 hours if S. aureus is the only pathogen of concern), or
o    Alternatively, exposure time (i.e., time at internal temperatures above 50°F (10°C) but below 135°F (57.2°C) should be limited to 4 hours, as long as no more than 2 of those hours are between 70°F (21.1°C) and 135°F (57.2°C); or
o    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 at internal temperatures above 50°F (10°C) should be limited to 5 hours (12 hours if Staph aureus is the only pathogen of concern); or
o    The product is held at internal temperatures below 50°F (10°C) throughout processing; or
o    Alternatively, the product is held at ambient air temperatures below 50°F (10°C) throughout processing.
 
Please be advised that control of both hazards may be achieved by controlling the amount of time the product is exposed to temperatures above 40°F (4.4°C)
 
2.    You must have a HACCP plan, that at a minimum, lists monitoring procedures and their frequency, to comply with 21 CFR 123.6(c)(4). However, your firm’s revised HACCP plan dated 18 August 2014 lists monitoring procedures and frequencies that are not adequate. Specifically,
 
  • At the “(b)(4)” critical control point, your monitor procedure for histamine testing lists a frequency of “(b)(4)” is not adequate because it does ensure that the sample reflects the condition of the entire lot. FDA recommends that for histamine analysis that test a minimum of 18 fish, collected representatively throughout each lot (or the entire lot when there are fewer than 18 fish in the lot).
  • At the unrefrigerated processing critical control points listed in your plan (b)(4), your monitoring procedures list “(b)(4)” with a frequency of “(b)(4)” which is not an adequate frequency to ensure control of the temperatures in the interim, between the (b)(4). FDA recommends a monitoring frequency for temperature of the manipulation rooms at least every 2 hours.   In your response submitted August 21, 2014 you indicated that the temperature monitor frequency of all manipulation rooms is continuous and that the temperatures from all manipulation rooms are review 2 times a day. However, your revised HACCP plan dated 18 August 2014 was not modified to include this procedure.
  • At the “(b)(4)” critical control points, your monitoring procedures list “(b)(4)”, with a frequency of “(b)(4)” which is not an adequate frequency to ensure control of the temperatures in the interim, between the twice daily checks.  FDA recommends that you continuously monitor the cold room temperature using a continuous temperature-recording device (e.g., a recording thermometer), with a visual check of the recorded data at least once a day.
3.   Because you chose to include a corrective action plan in your revised HACCP plan dated 18 August 2014, your described corrective actions must be appropriate, to comply with 21 CFR 123.7(b). However, your correction action plans are not appropriate. Your corrective actions should ensure that unsafe product does not enter into commerce and correct the cause of the deviation. Specifically,
 
  • At “(b)(4)” lists “(b)(4).” FDA recommends in addition, to rejecting and destroying the product, you also discontinue use of the supplier until evidence is obtained that the identified harvesting and onboard practices and control have been improved. 
  • At the unrefrigerated processing critical control points, such as “(b)(4),” an your firm’s corrective action for a deviation from a time and temperature of exposure critical limit should also include, in addition to “Addition of ice over the product”:
o    Chill and hold the affected product until histamine analysis is performed on a minimum of 60 fish representatively collected from throughout the affected lot. Destroy the lot or divert it to a non-food use if any fish is found with histamine greater than or equal to 50 ppm; or
o    Destroy the product; or
o    Divert the product to a non-food use, to ensure that unsafe product does not reach consumers; and
o    Modify the process as needed to reduce the time and temperature exposure, to correct the cause of the deviation.
  • At the “(b)(4)” critical control points, your firm’s corrective action for a deviation from your cooler temperature critical control limit of “(b)(4).” FDA recommends that your corrective action should include:
o    Chill and hold the product until it can be evaluated based on its total time and temperature exposure, including exposures during prior processing operations or
o    Chill and hold the affected product until histamine analysis is performed on a minimum of 60 fish collected from throughout each affected lot. Destroy the lot or divert it to a non-food use if any fish is found with histamine greater than or equal to 50 ppm; or
o    Destroy the product; or
o    Divert the product to a non-food use, to ensure that unsafe product does not reach consumers; and
o    Make repairs or adjustments to the malfunctioning cooler, to correct the cause of the deviation.
 
Comments:
  • The vessel records that your firm provided appear to be in the form of a database spreadsheet summary. It is not clear how the observations were entered on the record or whether they were entered on the record at the time it was observed. Please provide a description of your harvest vessel recordkeeping practices.
  • It is not clear whether your HACCP plan lists all of the unrefrigerated and/or unrefrigerated critical control points associated with your products. Specifically, page 1 of 2 of your flow diagrams identifies general processes of “(b)(4).” However, your HACCP plan only lists the “(b)(4).”  Please describe the steps associated with the other general processes identified in your flow diagrams and covered by this HACCP plan.
  • In general, when histamine testing is used as part of a control strategy within critical control points other than the receiving critical control point for a primary processor as the method to ensure safe handling onboard the harvest vessels, it is not an essential component of any of the other critical control points, such as transit control, processing control, and storage control. We note that you have listed a critical limit for histamine testing other critical controls we suggest that at these other critical control points, your firm may want to list histamine testing as part of your verification procedures (i.e., rather than as critical limits at the critical control point that then must also include adequate monitoring procedures to ensure compliance with the critical limit.
  • Your firm’s HACCP plan lists parameters as critical limits, (b)(4)” and “(b)(4)” at various critical control points where they would not apply. These parameters do not appear to be consistent with acceptable cooling methods. Specifically, for products stored in a cool room for (b)(4) under proper temperature controls, we would expect the internal temperature of the products to be far (b)(4) before packaging. Consequently, you may want to consider using additional cooling media, such as placing your products in ice, or ice slurry, or completely and continuously surrounding the fish with ice during storage, to ensure that your products are rapidly cooled and maintained cold prior to packing.
 
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: Standra Purnell, Compliance Officer, Food Adulteration Assessment Branch (HFS-607), Division of Enforcement, Office of Compliance, 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.
 
 
 
Sincerely,
/S/ 
William A. Correll, Jr.
Director
Office of Compliance
Center for Food Safety   
   and Applied Nutrition

Page Last Updated: 11/24/2014
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