WARNING LETTER

Salazones Garre, S.L. MARCS-CMS 567147 — December 18, 2018

Delivery Method:: Via Express Delivery
Product:: Food & Beverages

Recipient:: Recipient Name

Ms. Ana M. Garre; Recipient Title

CEO/Quality Manager; Salazones Garre, S.L.; Avda. Doctor Artero Guirao 254
30740 San Pedro del Pinatar Murcia
Spain

Issuing Office:: Center for Food Safety and Applied Nutrition (CFSAN); 5001 Campus Drive
College Park, MD 20740
United States

WARNING LETTER

Reference No.# 567147

Dear Ms. Garre:

The U.S. Food and Drug Administration (FDA) conducted an inspection of your seafood processing facility, Salazones Garre, S.L., located at A venida Dr Artero Guirao 245, San Pedro del Pinatar, Murcia, Spain on July 6 and July 9, 2018. That inspection revealed 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, at the conclusion of the inspection, of an FDA-483, Inspectional Observations, listing the deviations found at your firm. We acknowledge receipt of your response received via email on July 21 , 2018, which included a cover letter outlining your corrective actions, a revised HACCP plan entitled "Mojama of Tuna" that covers your refrigerated, ready-to-eat dry cured vacuum-packaged tuna chunk products, a critical control point (CCP) monitoring table, and a Daily sanitation monitoring table. However, our evaluation of the documentation revealed that your response is not adequate, as further described in this letter.

In accordance with 21 CFR 123.6(g), failure of a seafood processing facility 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, ready-to-eat dry cured vacuum-packaged tuna chunk products (i.e., "Mojama of Tuna") 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. 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

We found the following significant deviations:

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 revised HACCP plan, dated July 10, 2018, entitled "Mojama of Tuna" that covers your refrigerated, ready-to-eat dry cured vacuum-packaged tuna chunk products does not list critical limits, or lists critical limits that are not adequate at the following critical control points:

a. As a primary processor receiving the fish directly from the harvest vessels, your "(b)(4)" critical control point does not list critical limits to control scombrotoxin (histamine) formation that is reasonably likely to occur in tuna while held onboard the harvest vessels. Specifically, your revised HACCP plan does not list any maximum or minimum values for the identified parameters ((b)(4)") used to control scombrotoxin (histamine) formation. FDA recommends:

• Analysis of a representative sample of scombrotoxin (histamine) forming fish shows less than 50 ppm histamine in all fish in the sample;
AND
• Sensory examination of a representative sample of scombrotoxin (histamine) forming fish showing 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.

b. Your "(b)(4)" "(b)(4)", "(b)(4)", "(b)(4)", "(b)(4)" and "(b)(4)" critical control points do no list critical limits, or lists critical limits that are not adequate to control scombrotoxin (histamine) formation that is reasonably likely to occur during unrefrigerated processing. Time and temperature controls are necessary to control this hazard during unrefrigerated processing, at least until the product achieves a water phase salt level of at least (b)(4)%, a pH of (b)(4) or below, or a water activity of (b)(4) or below. To control scombrotoxin (histamine) formation during unrefrigerated processing of previously frozen scombrotoxin (histamine) forming fish or fishery products, FDA recommends that:

• The fish are not exposed to ambient temperatures above 40°F (4.4°C) for more than 12 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 24 hours, cumulatively, as long as no portion of that time is at temperatures above 70°F (21.1°C).

In addition, your revised HACCP plan does not list critical limits, or lists critical limits that are not adequate, at the "(b)(4)," "(b)(4)", "(b)(4)", "(b)(4)" and "(b)(4)" critical control points to control pathogen growth and toxin formation that is reasonably likely to occur during unrefrigerated processing. Time and temperature controls are necessary to control this hazard during unrefrigerated processing, at least until the product achieves a water phase salt level of at least (b)(4)%, a pH of (b)(4) or below, or a water activity of (b)(4) or below. To control pathogen growth and toxin formation during unrefrigerated processing, FDA recommends that:

• If at any time the product is held at ambient temperatures above 70°F (21.1°C), exposure time (i.e., time at ambient temperatures above 50°F (10°C) but below 135°F (57.2°C)) should be limited to 2 hours (3 hours if Staphylococcus aureus is the only pathogen of concern),
OR
• Alternatively, exposure time (i.e., time at ambient 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
• If at any time the product is held at ambient temperatures above 50°F (10°C) but never above 70°F (21.1°C), exposure time at ambient temperatures above 50°F (10°C) should be limited to 5 hours (12 hours if Staphylococcus aureus is the only pathogen of concern);
OR
• Alternatively, the product is held at ambient air temperatures below 50°F (10°C) throughout processing.

c. Your "(b)(4)" critical control point lists a critical limit, "(b)(4)", that is not adequate to control scombrotoxin (histamine) formation in a finished product with a water phase salt of "(b)(4)%." FDA recommends that the products be held at a cooler temperature of 40° F (4.4°C) or below. Refrigerated storage at or below 4.4° C is important because our investigators noted that your finished products may not routinely have water activity at (b)(4) or below.

2. 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 revised HACCP plan, dated July 10, 2018, entitled "Mojama of Tuna" lists monitoring procedures at the "(b)(4)" critical control point that are not adequate to control Clostridium botulinum growth and toxin formation in the finished product. Specifically, the monitoring procedures do not address the critical limit for (b)(4) time and the monitoring procedure for maximum (b)(4) temperature does not ensure conformance with your listed critical limit. FDA recommends monitoring the (b)(4) time using a clock to observe the beginning and end of the salting process for each batch. FDA recommends monitoring the (b)(4) (ambient) temperature by using a temperature-indicating device (e.g., a thermometer) at the start of each (b)(4) process and at least every 2 hours or by using a continuous temperature-recording device (e.g., a recording thermometer) with continuous monitoring by the device itself and visual check of the recorded data at least once a day.

3. 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 plan listed in your "Mojama of Tuna" HACCP plan includes inappropriate corrective actions at the following critical control points:

• At the "(b)(4)" and "(b)(4)" critical control points, your corrective actions do not ensure that no adulterated product enters commerce or that the causes of the deviations are corrected as a result of a deviation from the critical limits to control pathogen growth and toxin formation, including Clostridium botulinum growth and toxin formation in the finished product.
• At the "(b)(4)" critical control point, your corrective action does not ensure that the causes of the deviations are corrected as a result of a deviation from the critical limits to control Clostridium botulinum growth and toxin formation.

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 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 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 FD A'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 detennine 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 the Food and Drug Administration, Attention: Renu Kapoor, 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 Renu Kapoor via email at Renu.Kapoor@FDA.HHS.GOV. Please reference #CMS 567147 on any submissions and within the subject line of any emails to us.

Sincerely,

/S/

William A. Correll, Jr.
Director
Office of Compliance
Center for Food Safety
and Applied Nutrition