WARNING LETTER
Bacalao Giraldo, S.L.U.
MARCS-CMS 692321 —
September 30, 2024
Delivery Method:
Via Express Delivery and Electronic Mail
Product:
Food & Beverages
Recipient:
Recipient Name
Mr. Roberto Urrutia Beaskoa
Recipient Title
CEO, Managing Director
Bacalao Giraldo, S.L.U.
Pol. Ind. Goiain
San Blas No. 7 Int, Goiain
01170
Legutiano
Álava
Spain
Roberto.Urrutia@giraldofoodgroup.com
Issuing Office:
Center for Food Safety and Applied Nutrition
United States
WARNING LETTER
Reference #692321
Dear Mr. Roberto Urrutia Beaskoa:
The United States Food and Drug Administration (FDA) conducted an inspection of your seafood processing facility, Bacalao Giraldo S.L.A., located at Pol. Ind. Goiain, San Blas No. 7 Int, Goiain, Legutiano, Alava, Spain on May 20 and 21, 2024. During the inspection, we found that you had serious violations of the seafood HACCP regulation (21 CFR 123). At the conclusion of the inspection, the FDA investigator issued an FDA-483, Inspectional Observations that lists the observations made at your firm. We acknowledge receipt of your responses via email on June 10 and 11, 2024, July 18, 2024, and August 26, 2024. Your responses included HACCP related documents and product labels. Our evaluation of your responses revealed they 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 refrigerated and frozen desalted cod in modified atmosphere packaging 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 June 2022 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 have a HACCP plan that at 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 “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 refrigerated and frozen desalted cod in reduced oxygen packaging (ROP) lists a critical limit of
(b)(4)
% for the amount of oxygen in the modified atmospheric packaging (MAP) at your packaging critical control point (CCP) which is not adequate to control
Clostridium botulinum
growth and toxin formation during distribution.
MAP is considered to be ROP because the packaging is
(b)(4)
sealed, and the normal exchange of oxygen is prevented. By reducing or preventing the exchange of normal ambient oxygen with the environment in the package, a processor introduces the food safety hazard of
C. botulinum
. Refrigerated seafood including desalted cod packed in plastic films that prevents the entry of oxygen into the packaging are considered to be ROP and have the hazard of
C. botulinum
germination growth and toxin formation. Any oxygen in
(b)(4)
packaged product, including MAP with at least
(b)(4)
% oxygen present at the time of packing, may be rapidly depleted by activity of spoilage bacteria resulting in a low oxygen environment, which is favorable for
C. botulinum
germination, growth, and toxin formation.
Non-proteolytic
C. botulinum
has a minimum growth temperature of
(b)(4)
°C (
(b)(4)
°F) which is below normal refrigerated distribution and thawing temperatures. Thus, temperature control such as refrigeration and freezing by itself is not adequate to prevent non-proteolytic
C. botulinum
growth and toxin formation once the product leaves your control and enters distribution. Refrigerated product should have a time temperature indicator (TTI) attached to each individual product in ROP. The TTI should be designed to have a visual alert that indicates when product has been exposed to times and temperatures that may allow
C. botulinum
growth and toxin formation. Your HACCP plan should list additional CCPs for the use and attachment of TTIs per the manufacturer’s specifications in addition to a finished product storage CCP with a critical limit of below
(b)(4)
°C (
(b)(4)
°F) for the ambient cooler temperature. Alternatively, instead of using TTIs you could ensure that your finished product is formulated to control non-proteolytic
C. botulinum
such as a minimum water phase salt of
(b)(4)
% or maximum water activity of
(b)(4)
by listing a formulation CCP in your HACCP plan. Your frozen product should be frozen immediately after packaging and your HACCP plan should at the label CCP list a critical limit to ensure each individual ROP package is labeled with instructions to keep the product frozen and for proper thawing such as thaw under refrigeration immediately before use or removing product from packaging before thawing.
Additionally, your response of using potassium sorbate, packaging that starts with
(b)(4)
% oxygen and an expiry date based on oxygen depletion and shelf-life studies are not adequate to control non-proteolytic
C. botulinum
because they do not provide an equivalent food safety assurance as the recommended controls listed above. Your measures do not provide adequate controls for time and temperature exposures that allow
C. botulinum
growth and toxin formation that typically occur during distribution. While potassium sorbate can cause cell deformation and lysis as stated in your response, sorbate does not stop germination and outgrowth of non-proteolytic type E
C. botulinum
at elevated temperatures and pH values typical for fish and deformed cells can produce toxin (Seward et al., 1982). The Lund et al., 1987 study referenced in your response was for the use of sorbic acid and one strain of
proteolytic
C. botulinum
, which is not sufficient to demonstrate controlling
non-proteolytic
C. botulinum
in your product. The use of an expiry date based on oxygen depletion and shelf-life is not an adequate control for
C. botulinum
because it does not consider that spoilage organisms will deplete the available oxygen at a rate that will vary depending on temperature exposures and abuse during distribution and the levels of oxygen can vary within the packaging due to low oxygen microenvironments in the packaged product. See Chapter 13 of the Hazards Guide for more information on recommended controls for
C. botulinum
growth and toxin formation.
References
• Lund, B.M., George, S.M. and Franklin, J.G., 1987. Inhibition of type A and type B (proteolytic) Clostridium botulinum by sorbic acid. Applied and Environmental Microbiology, 53(5), pp.935-941.
• Seward, R.A., Deibel, R.H. and Lindsay, R.C., 1982. Effects of potassium sorbate and other antibotulinal agents on germination and outgrowth of Clostridium botulinum type E spores in microcultures. Applied and Environmental Microbiology, 44(5), pp.1212-1221.
2. 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 refrigerated desalted cod in ROP does not list your refrigerated finished product
(b)(4)
step as a CCP to control for
C. botulinum
growth and toxin formation. The critical limit at your finished product storage CCP should be for the ambient temperature of the cooler to be below
(b)(4)
°C (
(b)(4)
°F) with continuous temperature monitoring with at least a daily visual check of the recorded data. Alternatively, if your finished product is formulated to control non-proteolytic
C. botulinum
(e.g., minimum
(b)(4)
% water phase salt or maximum
(b)(4)
water activity) then the critical limit should be for the ambient temperature of the cooler to be
(b)(4)
°C (
(b)(4)
°F) or below.
3. You must conduct or have conducted a hazard analysis for your desalted cod that you produce 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 food safety hazards that are reasonably likely to occur, to comply with 21 CFR 123.6(a) and (c)(1). A food safety hazard is defined in 21 CFR 123.3(f) as "any biological, chemical, or physical property that may cause a food to be unsafe for human consumption." However, your firm’s HACCP plan for desalted cod in ROP does not list the food safety hazard of undeclared allergens. Your HACCP plan should list a CCP that ensures your labels list major food allergens such as fish by market or common name (e.g., cod). See Chapter 19 of the Hazards Guide for recommended controls for the hazard of undeclared major food 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 deviations. More specifically, your response should include documentation reflecting the changes you made, such as a copy of your Hazard Analysis and HACCP plan for your desalted cod in ROP product, 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 that your product is not in violation of the Act, 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. Additionally, your desalted cod in ROP is subject to Import Alert 16-125 and can be detained if HACCP controls for
C. botulinum
growth and toxin formation are not properly implemented. This alert can be found on FDA’s web site at: https://www.accessdata.fda.gov/cms_ia/importalert_28.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 (21 CFR Part 123) 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.
Please send your reply to the Food and Drug Administration, Attention: Rosemary Sexton, Compliance Officer, Human Foods Program – Office of Compliance and Enforcement, Office of Enforcement – Division of Conventional Foods Enforcement (HFS-607), 5001 Campus Drive, College Park, MD 20740 U.S.A. If you have any questions regarding any issues in this letter, please contact Rosemary Sexton via email at: rosemary.sexton@fda.hhs.gov. Please include reference #692321 on any submissions and within the subject line of any email correspondence to the agency.
Sincerely,
/S/
Ann M. Oxenham, J.D.
Director
Office of Compliance
Center for Food Safety and Applied Nutrition
Content current as of:
10/15/2024
Regulated Product(s)
Food & Beverages