WARNING LETTER

Fanta Seafoods MARCS-CMS 661349 — September 28, 2023

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

Recipient:: Recipient Name

Mr. Duane Faerber; Recipient Title

Managing Director; Fanta Seafoods; Coldingen Industrial Estate
Lot 3, East Coast Demerara
Georgetown
Guyana; duane@guyana-seafoods.com; stephen@guyana-seafoods.com

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

September 28, 2023

WARNING LETTER

Reference # 661349

Dear Mr. Duane Faerber:

The United States Food and Drug Administration (FDA) conducted an inspection of your seafood processing facility, located at Coldingen Industrial Estate, Lot 3, East Coast Demerara, Georgetown, Guyana, on January 26 and 27, 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, Part 123 (21 CFR Part 123 or the seafood HACCP regulation). At the conclusion of the inspection, the FDA investigator issued an FDA-483, Inspectional Observations. We acknowledge that you responded via email on May 28, 2023, indicating you were working on corrective actions. To date, we have not received any written corrective actions for FDA evaluation.

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 21 CFR 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 seafood products, including but not limited to mackerel (Scomberomorus spp.) and shrimp (Nematopalaemon schmitti), are adulterated under section 402(a)(4) of the Act, 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 and 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 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 when your hazard analysis identifies one or more reasonably likely to occur food safety hazards. That HACCP plan shall be specific to each kind of fish and fishery product to comply with 21 CFR 123.6 (b)(2). A plan may group multiple fishery products that have identical food safety hazards, production methods, and HACCP plan controls. Your current plan groups products with different species and process related hazards and different processing procedures. For example, your plan groups scombrotoxin forming species with non-scombrotoxin forming species; products that are ready-to-eat and not ready-to-eat.

2. 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 multiple seafood products (e.g., shrimp, scombroid and non-scombroid toxin-forming fish species) and processes (e.g., hot smoking, salting and drying) does not list the food safety hazards of allergens, sulfites, scombrotoxin (histamine) formation, and pathogen growth and toxin formation, including Clostridium botulinum and Staphylococcus aureus. Specifically,

a. Your firm places your frozen finished products in (b)(4) plastic bags. This introduces the hazard of C. botulinum when controls are not in place for safe handling. Your plan fails to list the hazard of C. botulinum. FDA recommends ensuring that the primary packages are labeled with safe handling instructions, such as “Keep frozen, Thaw under refrigeration immediately prior to use”.
b. Your HACCP plan does not identify the hazard of Staphylococcus aureus toxin that is reasonably likely to occur at the (b)(4) steps in the absence of controls. FDA recommends adequately drying the fish fillets until a water activity (aw) value of 0.85 or below is achieved (shelf-stable dried fish products). The aw value of 0.85 is based on the minimum water activity for growth and toxin formation of S. aureus. In the case of drying scombrotoxin-forming fish species, which introduces the hazard of histamine when time/temperature controls are not in place, FDA recommends keeping the scombrotoxin-forming fish products at proper refrigeration temperatures during the (b)(4) processes, until the water activity value of 0.85 or below is achieved. Although it is not recommended to keep the water activity values above 0.85 (products might have the appearance of fully dried products), distributing partially dried, properly labeled reduced oxygen packaged products frozen could also be used to control the hazards associated with pathogenic bacterial growth and toxin formation throughout distribution.
c. Your plan does not identify hazards of pathogen growth, including but not limited to, Listeria monocytogenes and Salmonella, associated with the ready-to-eat smoked fish you process.
d. Your HACCP plan identifies Spanish mackerel (i.e., Scomberomorus brasiliensis) and King mackerel (i.e., Scomberomorus cavalla) as species covered in your HACCP plan; however, your HACCP plan does not identify the hazard of scombrotoxin (histamine) formation associated with these species of fish. FDA recommends identifying receiving and time/temperature controls in your HACCP plan.
e. Shrimp is included as a product covered under the HACCP plan provided by your firm. Your HACCP plan does not identify sulfites as a food safety hazard.
f. Finfish and shrimp are identified by FDA as major food allergens. Your HACCP plan does not identify this food safety hazard. FDA recommends listing a critical control point to assure that allergen inclusion is accurately declared on finished product labels.

FDA requires listing all significant food safety hazards in your HACCP plan. The implementation of Good Manufacturing Practices or prerequisite programs cannot replace HACCP plan controls. Your HACCP plan covers products with different food safety hazards, production methods, and HACCP controls, making your hazard analysis inadequate. The hazard analyses should be specific to similar products and processes where the hazards and processing steps are all identical.

3. Your HACCP plan for Fillet, Whole gutted, Pan Ready, Steaked seafood includes a corrective action plan that is not in accordance with 21 CFR 123.7(a) to ensure that affected product is not entered into commerce and that the cause of the deviation was corrected. Your plan lists a corrective action procedure at the “(b)(4)” CCP (i.e., Icing Fish or rejects if spoiled) that does not ensure that the affected products are not entered into interstate commerce and that the cause of the deviation is corrected. When you list corrective action procedures in your HACCP plan, those procedures must ensure that whenever a deviation from a critical limit occurs the corrective action prevents potentially unsafe seafood from entering commerce and that the source or cause of the deviation is addressed to prevent a reoccurrence of the deviation.

4. You must monitor sanitation conditions and practices during processing with sufficient frequency to ensure compliance with current good manufacturing practice requirements to comply with 21 CFR 123.11(b). However, your firm did not monitor sanitation conditions with sufficient frequency. Specifically:
a. Condition and cleanliness of food contact surfaces:
i. The band saw used in direct contact with fish during processing (i.e., heading), appeared to have a build-up of organic debris.
b. Exclusion of pests form the plant:
i. A frog was also seen inside a cabinet near the processing area;
ii. Packaging material had dead flies inside the tape wrapped around the packaging bag containing retail bags as well as what appeared to be rodent feces on the outer wrap and inside the bags and containers where the retail packaging was located;
iii. At least two doors were observed to have visible light showing through along the bottom of the doors leading to the exterior of the building; and
iv. Flies were observed in the different processing areas of the plant.
c. Protection of food and food packaging from adulteration:
i. Packaging material was stored directly on the floor and the floor was wet.
d. Condition and cleanliness of toilet facilities:
i. There was a leaky toilet in the women's restroom.

5. You must maintain 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). However, your firm did not maintain sanitation monitoring records for safety of water; proper labeling, storage and use of toxic compounds; control of employee health conditions; and exclusion of pests required for the processing of your various seafood products.

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.

You should direct your written reply to Rosemary Sexton, Food and Drug Administration, Center for Food Safety and Applied Nutrition, 5001 Campus Drive, Office of Compliance (HFS-608), Division of Enforcement, College Park, Maryland 20740-3835. If you have any questions regarding this letter, you may contact Rosemary Sexton via email at Rosemary.Sexton@fda.hhs.gov. Please reference CMS #661349 on any submissions and on the subject line of any emails to us.

Sincerely,
/S/

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