WARNING LETTER
Burren Smokehouse Ltd.
MARCS-CMS 584335 —
July 30, 2019
Delivery Method:
Via Express Delivery
Product:
Food & Beverages
Recipient:
Recipient Name
Ms. Birgitta Hedin Curin
Recipient Title
Managing Director
Burren Smokehouse Ltd.
Kincora Road
Lisdoonvarna
Co. Clare
V95 HD70
Ireland
Issuing Office:
Center for Food Safety and Applied Nutrition
5001 Campus Drive
College Park
,
MD
20740-3835
United States
WARNING LETTER
JUL 30, 2019
Reference # 584335
Dear Ms. Burgitta Hedin Curin:
The United States Food and Drug Administration (FDA) conducted an inspection of your seafood processing facility, Burren Smokehouse Ltd. Kincora Road Lisdoonvarna, Co. Clare, V95 HD70, Ireland on March 7 and 8, 2019.  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).  At the conclusion of the inspection, the FDA investigator issued an FDA-483, Inspectional Observations, listing the observations made at your firm.  We acknowledge receipt of your responses to the FDA-483 received via email on March 21, April 2 and 29, 2019, which included revised HACCP plans for your refrigerated, vacuum-packaged hot and cold smoked fish products, flow charts, and an SOP for cleaning the vacuum packaging machine.
However, our evaluation of your response revealed it was 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 hot and cold smoked salmon, trout, and mackerel products 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 Fishery Products Hazards and Controls Guidance (the Hazards Guide) through links on FDA's home page at www.fda.gov.
Your significant deviations are as follows:
You must have a HACCP plan that, at a minimum, lists the critical control points, to comply with 21 CFR 123.6(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 plans provided with your responses do not list one or more critical control points to control the food safety hazard of pathogen growth and toxin formation. Specifically, for your
HACCP plan entitled “
Process Hazard Analysis Cold Smoked Farmed Salmon Plain or with added ingredients
”
The
(b)(4)
step, “
(b)(4)
,” which is referenced in your HACCP plan but which is not included as a critical control point needs to be listed as an actual critical control point to control the hazard of
C. botulinum
growth and toxin formation in the vacuum-packaged finished product and pathogen growth and toxin formation during salting.  FDA recommends a critical control point with a critical limit that lists the critical factors for salting as established by a scientific study that are necessary to ensure that the finished product has a water phase salt level of 3.5% or more.  As an alternative to measuring the critical factors, the water phase salt level of the finished product for each batch can be analyzed and recorded.  Additionally, since the fish is refrigerated during the four-hour salting step, the critical limit should also list that the ambient temperature is to be 40°F (4.4°C) or less.
The
(b)(4)
step, “
(b)(4)
,” which again is not listed as an actual critical control point needs to be listed as a critical control point to control the hazard of pathogen growth and toxin formation.  The listed GMP limits of drying for
(b)(4)
hours at
(b)(4)
°C (
(b)(4)
°F) exceed the FDA recommended cumulative time and temperate exposures limits for unrefrigerated processing of 2 hours when temperatures are above 70°F (21.1°C) and less than 135°F (57.2°C).   FDA recommends drying be listed as a critical control point with a critical limit that lists 2 hours or less at an ambient temperature of 86.0-89.6°F (30-32°C) to prevent
Staphylococcus aureus
toxin formation.
The
(b)(4)
step, “
(b)(4)
,” which again is not listed as an actual critical control point needs to be listed as a critical control point to control the hazard of
C. botulinum
growth and toxin formation in the finished product.  FDA recommends a critical control point with a critical limit that lists smoker temperature must not exceed 90°F (32.2°C).
HACCP plan entitled “Process Hazard Analysis Hot Smoked Farmed Trout”
The
(b)(4)
step, “
(b)(4)
,”
which again is not listed as an actual critical control point needs
to be listed as a critical control point to control the hazard of
C. botulinum
growth and toxin formation in the finished product and pathogen growth and toxin formation during salting.  FDA recommends a critical control point with a critical limit that lists the critical factors for salting as established by a scientific study that are necessary to ensure that the finished product has a water phase salt level of 3.5% or more.  As an alternative to measuring the critical factors, the water phase salt level of the finished product for each batch can be analyzed and recorded.  Additionally, since the fish is refrigerated during the
(b)(4)
-hour
(b)(4)
step, the critical limit should also list that the ambient temperature is to be 40°F (4.4°C) or less.
The
(b)(4)
step, “
(b)(4)
,”
which again is not listed as an actual critical control point needs
to be listed as a critical control point to control the hazard of pathogen growth and toxin formation.  FDA recommends a critical control point with a critical limit that lists 3 hours or less at an ambient temperature of 86.0-89.6°F (30-32°C) to prevent
Staphylococcus aureus
toxin formation.
HACCP plan entitled “
Process Hazard Analysis Hot Smoked Wild Mackerel
”
The
(b)(4)
step, “
(b)(4)
,” which again is not listed as an actual critical control point needs to be listed as a critical control point to control the hazard of
C. botulinum
growth and toxin formation in the finished product and pathogen growth and toxin formation during salting.  FDA recommends a critical control point with a critical limit that lists the critical factors for salting as established by a scientific study that are necessary to ensure that the finished product has a water phase salt level of 3.5% or more.  As an alternative to measuring the critical factors, the water phase salt level of the finished product for each batch can be analyzed and recorded.  Additionally, since the fish is refrigerated during the
(b)(4)
-hour
(b)(4)
step, the critical limit should also list that the ambient temperature is to be
(b)(4)
°F (
(b)(4)
°C) or less.
HACCP plan entitled “Process Hazard Analysis Hot Smoked Farmed Salmon Plain or with added ingredients”
The
(b)(4)
step, “
(b)(4)
,”
which again is not listed as an actual critical control point needs
to be listed as a critical control point to control the hazard of
C. botulinum
growth and toxin formation in the finished product and pathogen growth and toxin formation during salting.  FDA recommends a critical control point with a critical limit that lists the critical factors for salting as established by a scientific study that are necessary to ensure that the finished product has a water phase salt level of 3.5% or more.  As an alternative to measuring the critical factors, the water phase salt level of the finished product for each batch can be analyzed and recorded.  Additionally, since the fish is refrigerated during the
(b)(4)
-hour
(b)(4)
step, the critical limit should also list that the ambient temperature is to be
(b)(4)
°F (
(b)(4)
°C) or less.
The
(b)(4)
step, “
(b)(4)
,”
which again is not listed as an actual critical control point needs
to be listed as a critical control point to control the hazard of pathogen growth and toxin formation.  The listed GMP limits of drying for
(b)(4)
hours at
(b)(4)
°C (
(b)(4)
°F) exceed the FDA recommended cumulative time and temperate exposures limits for unrefrigerated processing of 3 hours when temperatures are above 70°F (21.1°C) and less than 135°F (57.2°C).   FDA recommends drying be listed as a critical control point with a critical limit that lists 3 hours or less at an ambient temperature of 30-32°C (86.0-89.6°F) to control the hazard of
Staphylococcus aureus
toxin formation.
You must have a HACCP plan that, at a minimum, lists monitoring procedures and their frequency for each critical control point, to comply with 21 CFR 123.6(c)(4).  However, your firm’s HACCP plans provided with your responses list monitoring procedures that are inadequate to control pathogen growth and toxin formation.  Specifically, for your
HACCP plan entitled “
Process Hazard Analysis Cold Smoked Farmed Salmon Plain or with added ingredients
”
At the
(b)(4)
critical control point, “CCP1,” the listed monitoring procedures of “
(b)(4)
” is not adequate to control for the hazard of pathogen growth and toxin formation.  FDA recommends when the monitoring the presence of ice, that the procedure list visual observations for the adequacy of ice from a representative number of containers throughout the shipment for every lot received and identify the person responsible for this procedure.  Additionally, periodically the internal temperature of the fish should be measured as a verification procedure to ensure that the amount of ice used is maintaining the fish at 40°F (4.4°C) or less.  In addition, your plan combines storage after
(b)(4)
with CCP1, however, the listed monitoring procedure of “
(b)(4)
” is not adequate to control for the hazard of pathogen growth and toxin formation during storage after
(b)(4)
.  FDA recommends the monitoring procedure list that the ambient air temperature of the cooler will be continuously monitored by a temperature recording device with a visual check of the recorded data at least once a day.  FDA also recommends that the storage of fish after receiving be listed as a separate critical control point.
At the
(b)(4)
critical control point, “CCP3,” for refrigeration before and after vacuum packaging the listed monitoring procedures are not adequate to control pathogen growth and toxin formation.  FDA recommends the monitoring procedure list that the ambient air temperature of the cooler will be continuously monitored by a temperature recording device with a visual check of the recorded data at least once a day.
HACCP plan entitled “Process Hazard Analysis Hot Smoked Farmed Trout”
At the
(b)(4)
critical control point, “CCP2,” the listed monitoring procedure of “
(b)(4)
” is not adequate to control
C. botulinum
growth and toxin formation in the finished product.  FDA recommends monitoring the internal temperature of the thickest portion of three of the largest fish in the smoking chamber using continuous temperature recording devices.
At the
(b)(4)
critical control point, “CCP4,” for refrigeration before and after vacuum packaging the listed monitoring procedures are not adequate to control pathogen growth and toxin formation. FDA recommends the monitoring procedure list that the ambient air temperature of the cooler will be continuously monitored by a temperature recording device with a visual check of the recorded data at least once a day.
HACCP plan entitled “
Process Hazard Analysis Hot Smoked Wild Mackerel
”
At the
(b)(4)
critical control point, “CCP2,” the listed monitoring procedure of “
(b)(4)
” is not adequate to control
C. botulinum
growth and toxin formation in the finished product.  FDA recommends monitoring the internal temperature of the thickest portion of three of the largest fish in the smoking chamber using continuous temperature recording devices.
At the
(b)(4)
critical control point, “CCP4,” for refrigeration before and after vacuum packaging the listed monitoring procedures are not adequate to control pathogen growth and toxin formation. FDA recommends the monitoring procedure list that the ambient air temperature of the cooler will be continuously monitored by a temperature recording device with a visual check of the recorded data at least once a day.
HACCP plan entitled “Process Hazard Analysis Hot Smoked Farmed Salmon Plain or with added ingredients”
At the
(b)(4)
critical control point, “CCP2,” the listed monitoring procedure of “Control time and temperature of smoking process” is not adequate to control
C. botulinum
growth and toxin formation in the finished product.  FDA recommends monitoring the internal temperature of the thickest portion of three of the largest fish in the smoking chamber using continuous temperature recording devices.
At the
(b)(4)
critical control points, “CCP4,” for refrigeration before and after vacuum packaging the listed monitoring procedures are not adequate to control pathogen growth and toxin formation.  FDA recommends the monitoring procedure list that the ambient air temperature of the cooler will be continuously monitored by a temperature recording device with a visual check of the recorded data at least once a day.
In addition, once you have amended your monitoring procedures in all of your HACCP plans, your HACCP plans need to also include the specific procedures and frequencies that will be used to monitor each of the critical control points.  For example, currently your HACCP plans
(b)(4)
.
Because you chose to include a corrective action plan in your HACCP plans, your described corrective actions must be appropriate, to comply with 21 CFR 123.7(b). However, your corrective action plans provided with your responses for the following HACCP plans are not adequate at the referenced critical controls points in each plan.  Specifically, for your
HACCP plan entitled “
Process Hazard Analysis Cold Smoked Farmed Salmon Plain or with added ingredients
”
At the
(b)(4)
critical control point, “CCP1,” the listed corrective actions for storage “
(b)(4)
” is not adequate to control pathogen growth and toxin formation during storage.  FDA recommends the corrective actions address the disposition of the affected product such as listing chilling, holding, and evaluating the affected product for cumulative time and temperate exposures for food safety or destroying the product.  Additionally, the corrective actions should address the cause of the deviation, such as making repairs to the cooler.
At the
(b)(4)
storage critical control points, “CCP2” and “CCP3,” the listed corrective actions of testing the product before dispatching to the public is not adequate to control for the hazard of pathogen growth and toxin formation.  Testing finished product is not appropriate.  FDA recommends a food safety evaluation of the product based on the cumulative time and temperature exposures.
HACCP plan entitled “Process Hazard Analysis Hot Smoked Farmed Trout” the listed corrective actions
at the
(b)(4)
critical control points, “CCP3” and “CCP 4,” are not appropriate.  Specifically, the listed corrective actions of testing the product before dispatching to the public is not adequate to control for the hazard of pathogen growth and toxin formation.  Testing finished product is not appropriate.  FDA recommends corrective actions address both the disposition of the affected products and address the cause of the deviation and a food safety evaluation of the product based on the cumulative time and temperature exposures.
HACCP plan entitled “
Process Hazard Analysis Hot Smoked Wild Mackerel
”
the listed corrective actions
at the
(b)(4)
critical control points, “CCP3” and “CCP 4,” are not appropriate.  Specifically, the listed corrective actions of testing the product before dispatching to the public is not adequate to control for the hazard of pathogen growth and toxin formation.  Testing finished product is not appropriate.  FDA recommends corrective actions address both the disposition of the affected products and address the cause of the deviation and a food safety evaluation of the product based on the cumulative time and temperature exposures.
HACCP plan entitled
“Process Hazard Analysis Hot Smoked Farmed Salmon Plain or with added ingredients” the listed corrective actions
at the
(b)(4)
critical control points “CCP3” and “CCP 4” are not appropriate.  Specifically, the listed corrective actions of testing the product before dispatching to the public is not adequate to control for the hazard of pathogen growth and toxin formation.  Testing finished product is not appropriate.  FDA recommends corrective actions address both the disposition of the affected products and address the cause of the deviation and a food safety evaluation of the product based on the cumulative time and temperature exposures.
Additional comments:
Upon further review of your revised HACCP plans, we recommend you update your critical limits at refrigerated storage and in-process handling to ensure the products are held at or below
4.4°C (40°F) or less, rather than 5° C.
Additionally, although several of your HACCP plans identify the allergen hazard at the
(b)(4)
step (with the exception of your HACCP plan for hot smoked farmed trout which does not identify the allergen hazard in the plan), this step does not adequately address the hazard of undeclared ingredients in your finished products. Your critical limits need to address finished product labeling.  FDA recommends a critical control point for finished product labeling with a critical limit that lists all finished product labeling must accurately declare all major food allergens that are included in the product formulation. In addition, your HACCP plan for your hot smoked farmed trout does not identify the hazard allergens.
You should respond in writing within fifteen (15) working days from your receipt of this letter.  Your response should outline the specific things you are doing to correct these violations.  More specifically, your response should include documentation and information that would assist us in evaluating your corrections, such as documentation reflecting the changes you made, such as a copy of your revised HACCP plans, 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 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 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 believe you have complied with FDA regulations, include your reasoning and any supporting information for our consideration.
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.  This alert can be found on FDA’s web site 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 and the current Good Manufacturing Practice Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation (CGMP & PC rule), Title 21, Code of Federal Regulations, Part 117 (21 CFR Part 117 Subpart B).  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:  Elizabeth A. DeGiglio Girard, Compliance Officer,
Office of Compliance, Division of Enforcement, 5001 Campus Drive, College Park, MD 20740 U.S.A.
If you have any questions regarding this letter, you may contact Elizabeth Girard via email at
Elizabeth.Girard@fda.hhs.gov
.  Please reference CMS# 584335 on any submissions and within the subject line of any emails to us.
Sincerely,
/S/
William A. Correll
Director
Office of Compliance
Center for Food Safety
and Applied Nutrition
Content current as of:
08/20/2019
Regulated Product(s)
Food & Beverages