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Kemal Balikcilik Ihracat MARCS-CMS 618729 —

Delivery Method:
Via Express Delivery
Food & Beverages

Recipient Name
Mr. Ahmet Tuncay Sagun
Recipient Title
Kemal Balikcilik Ihracat

Icmeler Mahallesi
Cesme Urla Izmir Asfalti Caddes No. 329
35430 Urla/İzmir

Issuing Office:
Center for Food Safety and Applied Nutrition (CFSAN)

United States

January 12, 2022


Reference # 618729

Dear Mr. Ahmet Tuncay Sagun:

The United States Food and Drug Administration (FDA) conducted a Foreign Remote Regulatory Assessment (FRRA) of your seafood processing facility, located at Icmeler Mahallesi Cesme Urla Izmir Asfalti Caddes No. 329, Urla, Izmir, 35430, Turkey, on September 7, 2021 through September 14, 2021. An on-site inspection was not possible due to travel restrictions during the COVID-19 pandemic. During the remote assessment, we found that you had serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations (21 CFR Part 123). At the conclusion of the assessment, the FDA investigator discussed items of concern. To date, your firm has not responded to the discussion items identified during the FFRA.

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, Seabass, Seabream, Salmon, Trout and Anchovy 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 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:

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 plans for aquaculture seabass, seabream, salmon, trout, and anchovy products, do not list the critical control point of receiving to control the food safety hazard of aquaculture drugs. Your HACCP plans identified the food safety hazard, but you did not consider the hazard critical or include adequate controls. FDA recommends you include a critical control point of receiving and include the critical limits described in Chapter 11 of the Hazards Guide.

In addition, your firm’s HACCP plans for tuna and anchovy products do not list critical control points of receiving, processing, and refrigerated storage to control the food safety hazard of scombrotoxin (histamine) formation. Your HACCP plans identified the food safety hazard but did not consider the hazard critical or include adequate controls. For example, your current “(b)(4)” processing step lists a processing limit of “(b)(4)” that does not ensure that the presence of histamine is no more than (b)(4) ppm in the edible portion of the fish for each lot of scombrotoxin-forming fish received. Please refer to Chapter 7 of the Hazards Guide for additional information regarding critical control points and critical limits.

You should respond in writing within fifteen (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 or 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 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 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. You may view this alert at: http://www.accessdata.fda.gov/cms_ia/ialist.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 and the Current Good Manufacturing Practice regulation (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.

In addition to the deviations listed above, we have the following comment:

We note that your specific HACCP plans above identify “(b)(4)” for the list of fish which potentially include tuna. Your firm has identified and submitted (b)(4) individual HACCP plans specific to tuna. It is unclear whether the fish identified in these Tuna HACCP plans are wild, aquacultured, or both. The HACCP plans do not identify aquaculture drugs. Tuna should either be listed on the above-mentioned HACCP plans since it appears to be a major commodity produced or the Tuna HACCP plans should further identify aquaculture drugs as potential hazard. Finally, although allergens are identified as a hazard in some of the HACCP plans as annual (b)(4) step, you did not identify the hazard pertaining to undeclared allergens for the labeling Critical Control Points (CCPs) in each HACCP plan to ensure the appropriate allergen is listed on the label and the label is placed on the correct product. We recommend that you review each of your HACCP plans and ensure your specific seafood products are identified in the appropriate plan.

You should direct your written reply to Rosemary Sexton, Food and Drug Administration, Center for Food Safety and Applied Nutrition, 5001 Campus Drive, Office of Compliance (HFS-608), Division of Enforcement, College Park, Maryland 20740-3835. If you have any questions regarding this letter, you may contact Rosemary Sexton via email at Rosemary.Sexton@fda.hhs.gov. Please reference CMS #618729 on any submissions and on the subject line of any emails to us.


Ann M. Oxenham
Acting Director
Office of Compliance
Center for Food Safety and Applied Nutrition

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