WARNING LETTER
Trang Thuy Seafood Co., LTD
MARCS-CMS 66434 —
November 03, 2023
Delivery Method:
Via Express Delivery
Product:
Food & Beverages
Recipient:
Recipient Name
Mr. Trang Nguyen
Recipient Title
Owner and Director
Trang Thuy Seafood Co., LTD
Lot A 12 An Phu Industrial Zone
Tuy Hoa
Phu Yen Province
Vietnam
Issuing Office:
Center for Food Safety and Applied Nutrition (CFSAN)
United States
Secondary Issuing Offices
United States
November 3, 2023
WARNING LETTER
Reference # 668434
Dear Mr. Nguyen:
The United States Food and Drug Administration (FDA) conducted a Foreign Remote Regulatory Assessment of your seafood processing facility, Trang Thuy Seafood Co., LTD, located at 3 Chome 14-1 C, Nagahama, Chuo, Fukuoka, Fukuoka Japan on April 9-13, 2023. This assessment was requested due to a consumer complaint which involved histamine poisoning from yellowfin tuna loins, resulting in a voluntary recall. During the remote assessment, 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). At the conclusion of the assessment, the FDA investigator discussed items of concern. We acknowledge receipt of your responses, received via email on August 16, 2023, which included an updated HACCP plan, records of training, Sanitation Standard Operating Procedures, and other supporting documents. However, our evaluation of your responses 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 frozen, vacuum packed, yellowfin 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 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 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 for “Frozen Tuna Treated by CO”, dated April 25, 2023, does not list a critical control point to control scombrotoxin (histamine) formation during transport of fresh tuna from the harvest vessel to the processing facility. For tuna delivered refrigerated or on ice from the harvest vessel, FDA recommends a critical control point at receiving to ensure the fish were held at or below 40°F (4.4°C), or completely surrounded by ice, throughout transit.
2. 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 “Frozen Tuna Treated by CO”, dated April 25, 2023, list monitoring procedures that are not adequate to control scombrotoxin (histamine) formation.
a. Your monitoring procedure of “
(b)(4)
” at a frequency of “
(b)(4)
” at the “
(b)(4)
” critical control point is not adequate. You should use a continuous temperature- recording device (e.g., a recording thermometer) to continuously monitor the temperature and perform a visual check of the recorded data at least once per day.
b. Your monitoring procedure of “
(b)(4)
” at a frequency of “
(b)(4)
” at the “
(b)(4)
” critical control point is not adequate. You should use a continuous temperature-recording device (e.g., a recording thermometer) to continuously monitor the temperature and perform a visual check of the recorded data at least once per day.
3. Because you chose to include a corrective action plan in your HACCP plan, your described corrective action must be appropriate, to comply with 21 CFR 123.7(b). However, your corrective action plan for “Frozen Tuna Treated by CO”, dated April 25, 2023, does not ensure the cause of deviation is corrected at your critical control points.
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.
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.
Additionally, we offer the following comments:
The critical limit of “Fish are removed the viscera before chilled in ice and it are chilled in ice at ≤4°C as soon as possible after harvest but is not exceed 12 hour after fish die. Fish were cover by ice above, under,
(b)(4)
” listed in your HACCP plan for “Frozen Tuna Treated by CO”, dated April 25, 2023, at the “
(b)(4)
” critical control point to control histamine formation is a parameter associated with onboard handling. However, the critical limit does not state that you are collecting records that document this information. We acknowledge that your listed monitoring procedures indicate that you obtain this information from the harvest vessel and that you are checking the records received from the harvest vessel. To ensure that incoming fish are properly handled onboard the harvest vessel, FDA recommends that your critical limit include that all lots received are accompanied by harvest records.
The critical limit of “
(b)(4)
” listed in your HACCP plan for “Frozen Tuna Treated by CO”, dated April 25, 2023, at the “
(b)(4)
” critical control point does not identify where this temperature is obtained. We acknowledge that your monitoring procedure states that the “
(b)(4)
” is monitored, however, FDA recommends that your critical limit include that the internal fish temperatures at the time they are offloaded from the vessel are ≤4°C.
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.
Please send your reply to the U.S. Food and Drug Administration, Attention: Sheena Phillips, Compliance Officer, Office of Compliance, Division of Enforcement, Food Adulteration and Assessment Branch (HFS-607), 5001 Campus Drive, College Park, Maryland 20740 U.S.A. If you have any questions regarding this letter, you may contact Ms. Phillips via email at Sheena.Phillips@fda.hhs.gov. Please reference CMS # 668434 on any documents or records you provide to us and/or within the subject line of any email correspondence you send to us.
Sincerely,
/S/
Ann M. Oxenham, J.D.
Director
Office of Compliance
Center for Food Safety and Applied Nutrition
Content current as of:
03/05/2024
Regulated Product(s)
Food & Beverages