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  5. Manabi Export Panama S.A. - 687475 - 08/14/2024
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WARNING LETTER

Manabi Export Panama S.A. MARCS-CMS 687475 —

Delivery Method:
Via Express Delivery
Product:
Food & Beverages
Recipient:
Recipient Name
Mr. Jose Rodriguez
Recipient Title
Owner
Manabi Export Panama S.A.

5017 Corrado Ave
Ave Maria, FL 34142
United States

rojoworldwide@gmail.com
Issuing Office:
Center for Food Safety and Applied Nutrition

United States

August 14, 2024

WARNING LETTER

Reference #687475

Dear Mr. Jose Rodriguez:

The United States Food and Drug Administration (FDA) conducted an inspection of your seafood processing facility, Manabi Export Panama S.A., located at Barriada Santa Isabel, Edificio Rosado Con Porton Negro, Chepo, Panama, 0804, on April 24 and 25, 2024. During the inspection, we found that you had serious violations of the seafood HACCP regulation (21 CFR 123). At the conclusion of the inspection, the FDA investigator issued an FDA-483, Inspectional Observations that lists the observations made at your firm. We acknowledge receipt of your response via email on May 08, 2024, which included a receipt to attend a HACCP course for yourself. Your response was not adequate, as further described in this letter.

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 ready-to-eat (RTE) cooked clam meat in reduced oxygen packaging (ROP) product is 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 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.

Your significant deviations are as follows:

1. You must conduct or have conducted a hazard analysis for your ready-to-eat (RTE) clam meat in reduced oxygen packaging (ROP) 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 hazard analysis, nor a written HACCP plan to control the following hazards:

a. Natural Toxins and Environmental Chemicals hazards should be controlled at a Receiving critical control point (CCP).
b. Pathogenic bacteria survival through cooking should be controlled at a Cooking CCP.
c. Clostridium botulinum toxin formation hazard should be controlled at a Labeling CCP.
d. Pathogen growth and toxin formation is a reasonably likely hazard during the (b)(4) steps after cooking. The (b)(4) steps should be identified as critical control points.

2. You must maintain adequate sanitation control records that, at a minimum, document monitoring and corrections set out in 21 CFR 123.11(b), to comply with 21 CFR 123.11(c). Specifically, your firm does not have written sanitation procedures and does not maintain sanitation control records that document monitoring for condition and cleanliness of food contact surfaces, prevention of cross-contamination from insanitary objects, maintenance of hand washing, hand sanitizing, and toilet facilities, protection of food, food packaging material, and food contact surfaces from adulteration, proper labeling, storage and use of toxic chemicals, control of employee health conditions and exclusion of pests.

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 13 for Clostridium botulinum Toxin Formation, and Chapter 16 for Pathogenic Bacteria Survival Through Cooking.

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 Hazard Analysis and HACCP plan for your ready-to-eat (RTE) clam meat in reduced oxygen packaging (ROP) product, 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 #687475 on any submissions and within the subject line of any email correspondence to the agency.

Sincerely,
/S/

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

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