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WARNING LETTER

Blue Caribbean Foods Inc. MARCS-CMS 678898 —


Delivery Method:
Via Express Delivery and Electronic Mail
Product:
Food & Beverages

Recipient:
Recipient Name
Mr. Benjamin P. Exeter
Recipient Title
CEO
Blue Caribbean Foods Inc.

Kingstown Fish Market Bay Street
Kingstown, Saint George
Grenada

benjaminexeter@gmail.com
ben@bluecaribbeanfoods.com
Issuing Office:
Center for Food Safety and Applied Nutrition (CFSAN)

United States


WARNING LETTER

April 17, 2024

Reference #678898

Dear Mr. Benjamin P. Exeter:

The United States Food and Drug Administration (FDA) conducted an inspection of your seafood processing facility, Blue Caribbean Foods Inc., located at Kingstown Fish Market, Bay Street, Kingstown, Saint George, St. Vincent & The Grenadines, on November 13 - 14, 2023. 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 via email on December 05, 2023. Your response provided an explanation of the steps your firm is taking to implement corrective actions in the future for each of the noted FDA observations but did not include supporting documents or a date when you estimate providing a revised HACCP plan and supporting documents of your corrective actions. 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 fresh (iced) yellowtail and big eye tuna 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 & 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 HACCP plan titled “Fresh Tuna Processing, Second Edition July 8th, 2022”, does not list the critical control points for:

a. (b)(4) step for verifying transportation conditions from the landing site to the processing facility to prevent scombrotoxin (histamine) formation. Transportation conditions, such as the adequacy of ice surrounding the fish or refrigeration temperature with a continuous recorder, should be monitored during transport to ensure tuna has not been exposed to unsafe temperatures; and evaluated by sensory examination of a minimum of (b)(4) fish or the entire vessel lot if less than (b)(4) fish upon delivery to the processing facility for odors of decomposition.

b. (b)(4) step to ensure that proper time and temperature controls are maintained to control scombrotoxin (histamine) formation. Your firm stores fish in a refrigerated cooler until processing and the HACCP plan does not address cumulative time and temperature exposure starting when the fish was removed from refrigeration to processing.

Labelling critical control point to control the possible hazard of allergens (fish). All fish are considered major food allergens by FDA and must be addressed in your HACCP plan.

2. You did not implement the monitoring and recordkeeping procedures listed in your HACCP plan for fresh (iced) tuna for export to USA, to comply with 21 CFR 123.6(b). Every processor shall have and implement a written HACCP plan whenever a hazard analysis reveals one or more food safety hazards that are reasonably likely to occur, Specifically, you are not following your monitoring and recordkeeping procedures for your identified Landing critical control point (CCP) to control the hazard of scombrotoxin (histamine) formation, which requires your firm to monitor critical limits and maintain records. Specifically,

a. The Landing CCP includes critical limits for internal temperature; harvest vessel records (On-board Fish Harvesting/Storage Record) accompanied the lot; the adequacy of ice, and histamine testing. Your firm was unable to provide harvest vessel records or records for histamine testing results.

b. The Chilling CCP lists a critical limit, “(b)(4)”. The “Tuna Fish Processing Records” you provided require “(b)(4)”; “(b)(4)” and “(b)(4)” to be monitored. However, the records do not include observations showing that the critical limits were monitored.

c. The records you provided during the inspection, “Tuna Fish Processing Record”, showing the monitoring observations for the adequacy of ice listed as critical limits in your HACCP plan did not consistently show that your critical limit, “(b)(4)”, were met. For example,
    i. The record requires monitoring “(b)(4)”, however, the actual observations recorded do not consistently document the presence of ice as required by the critical limit.
    ii. The record dated 22 February 2023, lists the word “(b)(4)” for fish #26, 28, 31-33 and the boxes for the rest of the fish are blank. The record dated 3 July 2023 is blank for fish #1-15 and 17-19, Fish #16 has 1346 recorded in the column without a description or explanation.
    iii. The record dated 31.7.2023 is blank for fish #1-3, 7, and 10-14. For Fish #4-6 indicate NS, BE, NS respectively, and 8-9 indicates BE. No explanation or description indicated.

3. You must have a HACCP plan that at 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 “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, your firm’s HACCP plan for “Fresh Tuna Processing, Second Edition July 8th, 2022”, critical limits at the Landing CCP are missing or inadequate. Specifically,

a. Landing 6 indicates internal temperatures of fish based on a critical limit of “(b)(4)”. This critical limit cannot be met as the plan does not require “(b)(4)” on harvest vessel records. Employees do not have this information to determine which critical limit should be applied when taking the internal temperature of the fish.

b. Storage 2 CCP the temperature critical limit of “(b)(4)” is inadequate, as this does not ensure the ambient temperature of the chill room is sufficient to control the hazard of histamine. FDA recommends that histamine forming species be held at or below 4.4°C (40°F) and that refrigeration temperatures are monitored with a continuous recording device. Alternatively, fish may be held surrounded in ice and the ice checked with sufficient frequency to assure it continues to surround the fish.

4. 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 HACCP plan for “Fresh Tuna Processing, Second Edition July 8th, 2022”, lists monitoring procedures that are not adequate to control scombrotoxin (histamine) formation. Specifically,

a. At Landing CCP 6, the plan requires monitoring the internal temperature with a frequency that is determined by the vessel lot size. However, the HACCP plan does not require that the vessel lot size be monitored. This means there is no way to determine if an adequate number of samples were evaluated. FDA recommends collecting a minimum of 12 samples from each species the vessel loads. In addition, the internal temperature critical limit is based on the of time from death aboard the vessel and when the fish are off loaded. The HACCP plan does not include monitoring procedures which track and evaluate these times.

b. At Landing CCP 7, the plan requires histamine testing at this CCP. Sample sizes appear to be determined by the “(b)(4)” and the tonnage of fish on the vessel. The monitoring procedures do not require monitoring the size of the fish or the vessel tonnage, so sample sizes cannot be calculated for each vessel. FDA recommends a minimum of 18 fish of the same species be collected and analyzed.

5. Because you chose to include corrective action plans in your HACCP plan, your described corrective actions must be appropriate, to comply with 21 CFR 123.7(b). However, your corrective action plans for your “Fresh Tuna Processing, Second Edition July 8th, 2022”, at the following critical control points are not appropriate. Specifically,

a. Landing CCP 3, lists a corrective action of “(b)(4)”. The purpose of the harvest vessel records is to determine if the fish have been handled safely aboard the vessel. These alternative actions do not provide an equivalent safety assurance. In addition, the listed corrective actions do not address how the absence of records will be addressed with the supplier.

b. Landing CCP 4 and 6, list corrective actions of rejecting lots that are not adequately iced (4) or where the internal temperature critical limits are exceeded (6). In addition to these measures, the processor must also address the cause of the deviation (the supplier) to prevent a re-occurrence of the deviation.

6. You must review critical control point monitoring records within one week after the records are made, to ensure compliance with 21 CFR 123.8(a)(3). Specifically, your "Checklists for Vessel Inspections” dated February 22, 2023, May 22, 2023, and July 31, 2023, are not signed as reviewed by management.

7. You must monitor sanitation conditions and practices during processing with sufficient frequency to ensure, at a minimum, compliance with the current good manufacturing practice requirements to comply with 21 CFR 123.11 (b) and (c). Specifically, you are not maintaining sanitation control records that document for proper labeling, storage and use of toxic chemicals. You explained to our investigator that you are currently using "Clean and White" liquid chlorine bleach which contains 5% hypochlorite (available chlorine) solution for sanitation by diluting one part bleach with 18 parts-water, when conducting sanitation on food contact surfaces. Per your written response, dated 12/5/2023, you confirmed this dilution gave a concentration of 2,777.8 ppm of chlorine, which was used to sanitize food contact surfaces. This concentration exceeds the recommended use of 200 ppm.

For additional guidance you may reference the Fish and Fishery Products Hazards & Controls Guidance - June 2022 4th Edition at https://www.fda.gov/media/80637/download, Chapter 7: Scombrotoxin (Histamine) 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 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. 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 #678898 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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