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  5. Comercial Mares de Chiloe - 587913 - 08/19/2019
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WARNING LETTER

Comercial Mares de Chiloe MARCS-CMS 587913 —

Delivery Method:
Via Express Delivery
Product:
Food & Beverages
Seafood/Seafood Product
Recipient:
Recipient Name
Rodrigo Becerra
Recipient Title
Director
Comercial Mares de Chiloe

Cardonal Bajo 2
7 Lote 1A
5500000 Puerto Montt
Los Lagos
Chile

Issuing Office:
Center for Food Safety and Applied Nutrition

5001 Campus Drive
College Park, MD 20740
United States

Dear Mr. Becerra:

In response to a request by a representative of the United States Food and Drug Administration (FDA) on June 14, 2019, for a copy of your firm’s HACCP plan for the fish and fishery products your firm exports into the United States, your firm provided a HACCP plan entitled “Quality Assurance Manual Based on HACCP” for your salmon and trout products, which are intended to be consumed raw or cooked, shipped refrigerated or frozen, and may be vacuum packaged.  Our review of the HACCP plan revealed that the plan demonstrates serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations, Part 123 (21 CFR 123). 

In accordance with 21 CFR 123.6(g), failure of a processor to have and implement a HACCP plan that complies with this section, or otherwise operate in accordance with the requirements of 21 CFR part 123, renders the 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 salmon and trout 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 FDA’s 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.  The 4th Edition of the Hazards Guide can be found on our web site at: https://www.fda.gov/food/guidanceregulation/guidancedocumentsregulatoryinformation/seafood/ucm2018426.htm

We found the following significant deviation:

1. 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 HACCP plan entitled “Quality Assurance Manual Based on HACCP” dated June 14, 2019, does not list the food safety hazards of pathogen growth and toxin formation, including Clostridium botulinum (C. botulinum) in vacuum packaged frozen products, and parasites.
     a. According to your HACCP plan, (b)(4) Pathogen growth is reasonably likely to occur in fish and fishery products that are exposed to unrefrigerated temperatures (e.g. temperatures above 4.4°C (40°F) for unsafe periods of time. Therefore, FDA recommends your HACCP plan include controls for pathogens in your ready-to-eat salmon products.

     b. According to your HACCP plan, (b)(4) If mishandled, it is conducive to C. botulinum growth and toxin formation. Therefore, FDA recommends that your HACCP plan include appropriate controls to ensure that each product is appropriately labeled with handling instructions (e.g. , "Important, keep frozen until used, thaw under refrigeration immediately before use").

     c. Therefore, FDA recommends that your HACCP plan include appropriate controls to ensure that each product is appropriately labeled with handling instructions (e.g., "Important, keep frozen until used, thaw under refrigeration immediately before use").

     d. According to your HACCP plan, (b)(4) Therefore, FDA recommends your HACCP plan include controls for parasites in your ready-to-eat refrigerated salmon products.

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 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.

Additional comment:

On July 10, 2019, the FDA placed your firm, Comercial Mares de Chiloe, S.A., on the red list of Import Alert 16-39 “Detention Without Physical Examination of Processed Seafood and Analogue Seafood (Surimi) Products for Listeria Monocytogenes” based on evidence which identified Listeria Monocytogenes in analyzed portions frozen raw salmon intended for raw consumption. Your firm’s response should consider addressing FDA’s application of DWPE per IA 16-39, including information regarding corrections your firm has made to ensure future shipments are not violative.
 
Please send your reply to Food and Drug Administration, Attention:  Elizabeth 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# 587913 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

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