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  5. Comercializadora Internacional Piscicola New Your S.A - 672013 - 01/08/2024
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WARNING LETTER

Comercializadora Internacional Piscicola New Your S.A MARCS-CMS 672013 —

Delivery Method:
Via Express Delivery
Product:
Food & Beverages
Recipient:
Recipient Name
Mauricio Silva Ruiz
Recipient Title
General Manager
Comercializadora Internacional Piscicola New Your S.A

Km 15 Via Al Sur Vereda
Rio Frio Rivera, HUI, 413008
Colombia

Issuing Office:
Center for Food Safety and Applied Nutrition

United States

January 8, 2024

WARNING LETTER

Reference # 672013

Dear Mr. Ruiz,

The United States Food and Drug Administration (FDA) conducted a Foreign Remote Regulatory Assessment (FRRA) of your seafood processing facility located at Km 15 Via Al Sur Vereda, Rio Frio Rivera Huila 413008 Colombia, on May 23 through May 29, 2023. During that 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, Part 123 (21 CFR 123). At the conclusion of the assessment, the FDA investigator issued a RRA Observations, listing the deviation found at your firm. To date, we have not received a response from your firm.

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 fresh and frozen fish 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 deviation is listed below:

You must conduct or have conducted for you a hazard analysis for each kind of fish and fishery product 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 Fresh and Frozen Whole or Filleted Tilapia does not list the biological food safety hazard, Clostridium bolulinum, as a hazard at the (b)(4) step. Furthermore, there is no label statement referring to “keep frozen: during storage on the individual packages. Additionally, your firm receives live tilapia from farms that may use aquaculture drugs. The HACCP plan does not identify the hazard of aquaculture drugs or environmental contaminates associated with receiving “live” fish.

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.

Please send your reply to the U.S. Food and Drug Administration, Attention: Sheena Phillips, Compliance Officer, Office of Compliance, Division of Enforcement, Food Adulteration and Assessment Branch (HFS-607), 5001 Campus Drive, College Park, Maryland 20740 U.S.A. If you have any questions regarding this letter, you may contact Ms. Kapoor via email at Renu.Kapoor@fda.hhs.gov. Please reference CMS # 672013 on any documents or records you provide to us and/or within the subject line of any email correspondence you send to us.

Sincerely,
/S/

Ann M. Oxenham, J.D.
Director, Office of Compliance
Center for Food Safety and Applied Nutrition

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