WARNING LETTER

PESCAMOZ LDA MARCS-CMS 669470 — November 03, 2023

Delivery Method:: Via Express Delivery
Product:: Food & Beverages

Recipient:: Recipient Name

Mr. Filipe Lobo; Recipient Title

Managing Director; PESCAMOZ LDA; Largo Dos Cfm Centro
Cais No 1 Cidade
2100 BeiraSofala
Mozambique

Issuing Office:: Center for Food Safety and Applied Nutrition; United States

November 03, 2023

Warning Letter

Reference 669470

Dear Mr. Lobo:

The United States Food and Drug Administration (FDA) conducted an inspection of your seafood processing facility, PESCAMOZ LDA, located at Largo Dos Cfm Centro, Cais No 1 Cidade, Beira, Sofala, Mozambique 2100 on June 22 – 23, 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 (FDA-483), Inspectional Observations, listing the deviations found at your firm at the conclusion of the inspection. We acknowledge receipt of your responses received via email on July 4, 2023, August 5 and 25, 2023, which included a Corrective Action and Preventive Action Report and Meeting Attendance Register, dated July 05, 2023; a document in Portuguese titled Procedimento de limpieza, hygiene e saneamento, dated 2019/03/01; a Corrective Action and Preventive Action Report, dated July 22, 2023, for a consumer complaint in July 2021 involving scombrotoxin poisoning from yellowfin tuna loins; a copy of a label for Vacuum Packed Frozen Tuna Loins (20 Kgs); and other supporting documents. However, our evaluation of the documents revealed that you continue to have serious concerns with your HACCP program 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 tuna and swordfish 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 you a 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. Tuna and swordfish steaks, loins, and whole fish, to control the food safety hazards of scombrotoxin formation and pathogenic bacterial growth and toxin formation due to time and temperature abuse.

b. Individually frozen, vacuum-packaged fish, to control the food safety hazard of Clostridium botulinum growth and toxin formation.

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.

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.

Additionally, we offer the following comment:

Your firm provided our investigator with a hazard analysis for your “Postas/Blocos de Atum Congelado – Analise de Perigos e Pontos de Controlo Criticos no Floxo do Processo” dated January 2022 which identified multiple food safety hazards as reasonably likely to occur (i.e., pathogens, histamine/decomposition, and metals); 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, primary processors of seafood products must have and implement a written HACCP plan to control the food safety hazards identified.

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 Hazard Analysis and HACCP plans for each kind of fish and fishery 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.

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 #669470 on any submissions and within the subject line of any email correspondence to the agency.

Sincerely,
/S/

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