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WARNING LETTER

Maldives Industrial Fisheries Company Limited MARCS-CMS 607230 —

Delivery Method:
Via Express Delivery
Product:
Food & Beverages
Recipient:
Recipient Name
Mr. Mohamed Ibrahim
Recipient Title
Regional Manager
Maldives Industrial Fisheries Company Limited

Felivaru Fisheries Complex
Hilaalee Magu
Male 20389
Maldives

Issuing Office:
Center for Food Safety and Applied Nutrition (CFSAN)

United States

May 01, 2020

WARNING LETTER

Reference # 607230

Dear Mr. Ibrahim:

The United States Food and Drug Administration (FDA) conducted an inspection of your seafood processing facility, located at Felivaru Fisheries Complex, Lhaviyani Atoll, Felivaru, Lhaviyani, 07100, on January 7, 2019 through January 9, 2019. During that 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). At the conclusion of the inspection, the FDA investigator issued an FDA 483, Inspectional Observations, listing the observations made at your firm. We acknowledge receipt of your response sent via email on January 29, 2020. Your response included a revised HACCP plan, entitled “HACCP on Pouch,” dated January 26, 2020, and associated corrective action documentation. However, our evaluation of your response revealed it 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 cooked ready-to-eat (RTE) tuna products in (b)(4) sealed pouches 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 4th 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 a hazard analysis 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 critical control points, to comply with 21 CFR 123.6(a) and (c)(2). A critical control point is defined in 21 CFR 123.3(b) as a "point, step, or procedure in a food process at which control can be applied and a food safety hazard can as a result be prevented, eliminated, or reduced to acceptable levels." However, your firm’s revised HACCP plan, entitled “HACCP on Pouch,” for your RTE tuna products does not list critical control points for the following:

a. Flaking, Meat Cutting, Meat Filling, Vacuum Sealing, Pressing, Tray and Retort trolley filling for controlling the food safety hazard of Staphylococcus aureus (S. aureus) growth and toxin formation. Specifically, it is reasonably likely that S. aureus will be introduced into the precooked tuna when employees manually de-head, deskin and debone the precooked tuna at the “(b)(4)” step. Once introduced, S. aureus is likely to continue to grow and produce toxin in the precooked tuna until the onset of retorting at the “(b)(4)” step. Although your revised HACCP plan now lists the hazard of S. aureus toxin at the “(b)(4)” critical control point with a critical limit of “(b)(4)” between “(b)(4)”, this is inadequate to prevent S. aureus from growing and producing toxin in the precooked tuna during the processing steps prior to retorting (i.e., Flaking, Meat Cutting, Meat Filling, Vacuum Sealing, Pressing, and Tray and Retort trolley filling). In addition to the “(b)(4)” critical control point, FDA recommends also listing the “Flaking”, “Meat Cutting”, “Meat Filling”, “Vacuum Sealing”, “Pressing”, and “Tray and Retort trolley filling” steps as critical control points to control the hazard of S. aureus growth and toxin production.

b. Thawing for controlling the food safety hazard of scombrotoxin (histamine) formation. Specifically, scombrotoxin (histamine) may form in frozen tuna that undergoes a (b)(4) prior to butchering. During the inspection, your firm indicated (b)(4). During thawing of previously frozen tuna, FDA recommends:
    i. that the fish are not exposed to ambient temperatures above 40°F (4.4°C) for more than 12 hours, cumulatively, if any portion of that time is at temperatures above 70°F (21.1°C); OR,
    ii. that the fish are not exposed to ambient temperatures above 40°F (4.4°C) for more than 24 hours, cumulatively, as long as no portion of that time is at temperatures above 70°F (21.1°C).

2. You must have a HACCP plan that, at a minimum, lists the critical limits that must be met, to comply with 21 CFR 123.6(c)(3). A critical limit is defined in 21 CFR 123.3(c) as "the maximum or minimum value to which a physical, biological, or chemical parameter must be controlled at a critical control point to prevent, eliminate, or reduce to an acceptable level the occurrence of the identified food safety hazard." However,

a. Your firm’s revised HACCP plan, entitled “HACCP on Pouch,” for your RTE pouched tuna products lists a critical limit that is not adequate. Specifically, your firm’s listed critical limit of “(b)(4)” at the “(b)(4)” critical control point is not adequate to control scombrotoxin (histamine) formation because it does not ensure fish were properly handled onboard the harvest vessel. FDA recommends a critical limit of sensory examination of a representative sample of scombrotoxin-forming fish shows decomposition (persistent and readily perceptible) in less than 2.5% of the fish in the sample. For example, no more than (b)(4) fish in a sample of (b)(4) fish may show signs of decomposition.

b. Your firm’s revised HACCP plan, entitled “HACCP on Pouch,” for your RTE pouched tuna products does not list a critical limit at the “(b)(4)” critical control point to control scombrotoxin (histamine) formation. Specifically, your HACCP plan does not list a critical limit for conducting sensory examinations on the frozen fish you receive. FDA recommends a critical limit of sensory examination of a representative sample of scombrotoxin-forming fish showing decomposition (persistent and readily perceptible) in less than 2.5% of the fish in the sample. For example, no more than (b)(4) fish in a sample of (b)(4) fish may show signs of decomposition.

3. You must have a HACCP plan that, at a minimum, lists monitoring procedures and their frequencies for each critical control point to comply with 21 CFR 123.6(c)(4). However, your firm’s revised HACCP plan, entitled “HACCP on Pouch,” for your RTE pouched tuna products lists a monitoring procedure/frequency at the “(b)(4)” critical control point that is not adequate to control scombrotoxin (histamine) formation. Specifically, your revised HACCP plan lists a monitoring frequency of “(b)(4)” for the “(b)(4)” critical limit. For histamine analysis, FDA recommends firms test a minimum of 18 fish, collected representatively from throughout the lot (or the entire lot when there are fewer than 18 fish in the lot). Additional fish should be examined if variability in fish-to-fish histamine content is expected to be high. Lots should consist of only one species of fish; for vessels delivering multiple species, testing should generally be done separately on each species. FDA recommends rejecting the lot if any fish are found with histamine greater than or equal to 50 ppm (≥50 ppm). Additionally, per your “(b)(4)” dated December 12, 2019, you routinely receive mixed lots of fish and do not record the actual number of fish received per lot.

4. Because you chose to include a corrective action plan in your HACCP plan, your described corrective actions must be appropriate, to comply with 21 CFR 123.7(b). However, your corrective action plan for your RTE pouched tuna products at the “(b)(4)” and “(b)(4)” critical control points is not appropriate. An appropriate corrective action procedure must ensure that an unsafe product does not enter commerce and correct the cause of the critical limit deviation. Specifically, your corrective actions do not correct the cause of the deviation.

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, (b)(4) consecutive days of completed monitoring records (i.e., complete sets of monitoring records for the production of (b)(4) 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.

In addition to the deviations listed above, we have the following comment:

Section 201(qq) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321qq] defines “major food allergens” as milk, eggs, fish, crustacean shellfish, tree nuts, peanuts, wheat, and soybeans, as well as any food ingredient that contains protein derived from one of these foods, with the exception of highly refined oils. The Act requires that all foods, if the food is not a raw agricultural commodity and contains a major food allergen, be labeled to clearly identify the name of the food source from which the allergen is derived. During the inspection, our investigator determined that some of your products may contain a soy ingredient. After further review of your revised HACCP plan entitled “HACCP on Pouch,” for your pouched RTE tuna products (packed in brine, broth or oils) you did not appear to address undeclared allergens as a hazard reasonably likely to occur. For more information on controlling the food safety hazard of undeclared allergens, please refer to Chapter 19 of the Hazards Guide referenced in this letter.

Additionally, Section 743 of the Act (21 U.S.C. 379j-31) authorizes FDA to assess and collect fees to cover FDA’s costs for certain activities, including re-inspection-related costs. A re-inspection is one or more inspections conducted subsequent to an inspection that identified noncompliance materially related to a food safety requirement of the Act, specifically to determine whether compliance has been achieved. Re-inspection-related costs means all expenses, including administrative expenses, incurred in connection with FDA’s arranging, conducting, and evaluating the results of the re-inspection and assessing and collecting re-inspection fees (21 U.S.C. 379j-31(a)(2)(B)). The inspection noted in this letter identified noncompliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any re-inspection-related costs.

You should direct your written reply to Lisa Thursam, 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 Lisa Thursam via email at Lisa.Thursam@fda.hhs.gov. Please reference CMS # 607230 on any submissions and on 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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