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  1. Warning Letters

WARNING LETTER

Independent Seafoods Panama, S.A. dba Panama Artisanal Seafoods FQ MARCS-CMS 665705 —

Delivery Method:
Via Express Delivery
Product:
Food & Beverages
Recipient:
Recipient Name
Mr. Miguel Molina
Recipient Title
Owner
Independent Seafoods Panama, S.A. dba Panama Artisanal Seafoods FQ

Juan Diaz, Avenida 1b Sur
Calle San Francisco, San Felipe
Panama City
Panama
Panama

(b)(6)@yahoo.com
(b)(6)@hotmail.com
Issuing Office:
Center for Food Safety and Applied Nutrition

United States

November 3, 2023

WARNING LETTER

Reference #665705

Dear Mr. Miguel Molina:

The United States Food and Drug Administration (FDA) conducted an inspection of your seafood processing facility, Independent Seafoods Panama, S.A. dba Panama Artisanal Seafoods FQ, located at Juan Diaz, Avenida 1b Sur, Calle San Francisco, San Felipe, Panama City, Panama, Panama 0801 on June 12 – 13, 2023. During the inspection, 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). That inspection resulted in FDA’s issuance of an FDA-483, Inspectional Observations, listing the deviations found at your firm at the conclusion of the inspection.

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 artisanal fish and histamine 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 June 2022 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:

You must conduct or have conducted for your hazard analysis for each kind of fish and fishery product that you produce to determine whether there are any food safety hazards that are reasonably likely to occur and you must have and implement a written HACCP plan to control any food safety hazards that are reasonably likely to occur, to comply with 21 CFR 123.6(a) and (b). However, your firm does not have a HACCP plan for the following seafood products:

a. Grouper, snapper, and amberjack which have been associated with the food safety hazard of ciguatera fish poisoning (CFP).
b. Scombrotoxin forming fish like yellowfin tuna, mahimahi, mackerel, and amberjack which are associated with the food safety hazard of histamine toxin formation.
c. Vacuum-packaged mahimahi fillets and stingray wings which are associated with the food safety hazard of Clostridium botulinum.

Additional comments:

Your firm provided our investigator with hazard analyses for your various seafood products, which identified multiple food safety hazards as reasonably likely, i.e. pathogens and chemical residues; however, your firm did not consider any of your processing steps as critical control points. As stated above, when a food safety hazard is reasonably likely to occur, processors of seafood products must have and implement a HACCP plan to control the food safety hazards. Processors cannot rely solely on “preventive measures,” as described in your hazard analysis.

For additional guidance of the identified food safety hazards, you may reference the Fish and Fishery Products Hazards & Controls Guidance - June 2022 Edition at https://www.fda.gov/media/80637/download, Chapter 2 for Conducting a Hazard Analysis and Developing a HACCP Plan, Chapter 6 for Natural Toxins, Chapter 7 for Scombrotoxin (Histamine)
Formation, and Chapter 13 for Clostridium botulinum 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 deviations. More specifically, your response should include documentation reflecting the changes you made, such as a copy of your revised Hazar Analysis and HACCP plans for every type of fish, 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.

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: Giselle Jordan, Compliance Officer, Office of Compliance, Division of Enforcement, Food Adulteration and Assessment Branch (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 Giselle Jordan via email at: giselle.jordan@fda.hhs.gov. Please include reference #665705 on any submissions and within the subject line of any email correspondence to the agency.

Sincerely,
/S/

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

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