WARNING LETTER
Duong Ha Processing Trading Seafood Company Limited
MARCS-CMS 695096 —
November 26, 2024
Delivery Method:
Via Express Delivery and Electronic Mail
Product:
Food & Beverages
Recipient:
Recipient Name
An Duong
Recipient Title
Director
Duong Ha Processing Trading Seafood Company Limited
Ward 12, 1705, 30/4 Street
Vung Tau
Ba Ria-Vung Tau Province
78221
Vietnam
anhoang.dh@gmail.com
Issuing Office:
Human Foods Program
United States
November 26, 2024
WARNING LETTER
Re: CMS #695096
Dear Mr. An Duong:
On July 8 through 9, 2024, the United States Food and Drug Administration (FDA) conducted an inspection of your seafood processing facility, located at Ward 12, 1705, 30/4 Street, Vung Tau, Ba Ria-Vung Tau, Vietnam 78221. During our inspection of your facility, the FDA investigators found serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations, Part 123. At the conclusion of the inspection, the FDA investigator issued an Form FDA 483 (FDA-483), Inspectional Observations, listing the deviations found at your firm. We acknowledge receipt of your responses, received via email on July 19, 2024 and September 16, 2024, which included documents for your “Seafish, Frozen fillet” such as processing flow chart, product description, processing steps description, hazard analysis, revised HACCP plan, standard operating procedures, monitoring records, 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, raw, vacuum-packaged, scombrotoxin-forming fish, 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. The June 2022 Edition of the Hazards Guide can be found on our web site at:
https://www.fda.gov/food/seafood-guidance-documents-regulatory-information/fish-andfishery-products-hazards-and-controls.
Your significant violations 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 updated HACCP plan for “Seafish, Frozen Fillet,” received via email on July 19, 2024, does not list the critical control point for unrefrigerated processing to control the food safety hazard of scombrotoxin (histamine) formation.
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, your firm’s HACCP plan for “Seafish Frozen Fillet,” received via email on July 19, 2024, does not list a critical limit to control scombrotoxin (histamine) formation and lists a critical limit that is inadequate to control
Clostridium botulinum
. Specifically:
a. You do not list a critical limit for measuring internal fish temperatures at the time fish are off-loaded from the harvest vessel at the “
(b)(4)
” critical control point to control histamine formation. According to your “
(b)(4)
,” which states “
(b)(4)
,” you are receiving fish directly from the fishing vessels.
• For fish held iced or refrigerated (not frozen) onboard the vessel 24 or more hours after death, the internal temperature should be 40°F (4.4°C) or below;
OR
• For fish held iced or refrigerated (not frozen) onboard the vessel from 15 to less than 24 hours after death, the internal temperature should be 50°F (10°C) or below;
OR
• For fish held iced or refrigerated (not frozen) onboard the vessel from 12 to less than 15 hours after death, the internal temperatures should be 60°F (15.6°C) or below;
OR
• For fish held iced or refrigerated (not frozen) onboard the vessel less than 12 hours after death, the internal temperature should be sufficiently below water and air temperatures to indicate that appropriate chilling methods were implemented onboard the harvest vessel.
b. You list a critical limit of “
(b)(4)
” at the “
(b)(4)
” critical control point that is not adequate to control Clostridium botulinum. FDA recommends all finished products contain a “keep frozen” statement (e.g., “Important, keep frozen until used, thaw under refrigeration immediately before use”). After updating your critical limit, you should update the associated corrective actions in accordance with 21 CFR 123.7.
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 revised HACCP plan for “Seafish, Frozen fillet,” received via email on July 19, 2024, list monitoring procedures that are not adequate to control scombrotoxin (histamine) formation. Specifically:
a. Your monitoring procedure of “
(b)(4)
” with “
(b)(4)
” in “
(b)(4)
” at the “
(b)(4)
” critical control point is not adequate. FDA recommends the fish be collected representatively throughout each lot (or the entire lot when there are fewer than 18 fish in the lot) for histamine testing using a testing method that is validated for use on each species being tested. 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 be done separately on each species. The fish collected for analysis may be composited if the critical limit is reduced accordingly. For example, a sample of 18 fish may be composited into 6 units of 3 fish each, provided the critical limit is reduced from 35 ppm to 11 ppm for each unit. For additional information, please see FDA’s current recommendations listed in CPG 540.525, which was updated on November 1, 2024 (see: CPG Sec 540.525 Scombrotoxin (Histamine)-forming Fish and Fishery Products – Decomposition and Histamine (CPG 7108.24) | FDA).
b. Your monitoring procedure of “
(b)(4)
” at the “
(b)(4)
” critical control point is not adequate. FDA recommends the fish be collected representatively throughout each lot (or the entire lot, for lots smaller than 118 fish). 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 be done separately on each species.
Furthermore, your updated “
(b)(4)
” monitoring record does not comply with 21 CFR 123.6(c)(7), which states that the HACCP plan shall “Provide for a recordkeeping system that documents the monitoring of the critical control points. The records shall contain the actual values and observations obtained during monitoring.” However, your updated “
(b)(4)
” monitoring record does not provide spaces for documenting which units were examined or the individual observations made when monitoring the critical limits for adequacy of ice, histamine testing, or sensory examination.
4. 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 revised HACCP plan for “Seafish, Frozen fillet,” received via email on July 19, 2024, lists corrective action plans that do not ensure that no product enters commerce that is either injurious to health or is otherwise adulterated as a result of the deviation; and that the cause of the deviation is corrected. Specifically:
a. At the “
(b)(4)
” critical control point, your listed corrective action of “
(b)(4)
” for the critical limit of “
(b)(4)
” is not appropriate. FDA recommends you chill and hold the affected lot until histamine analysis is performed on a minimum of 60 fish representatively collected from throughout the lot, including any fish observed to have been exposed to inadequate cooling media (or the entire lot for lots smaller than 60 fish). Reject the lot if any fish is found with histamine greater than or equal to 50 ppm; OR, reject the lot AND discontinue use of the supplier until evidence is obtained that the identified harvesting and onboard practices have been improved.
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 Hazard Analysis and HACCP plan for your frozen, raw, vacuum-packaged, scombrotoxin-forming fish, 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.
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.
Additionally, we offer the following comment:
• At the “
(b)(4)
” critical control point, your corrective action lists “
(b)(4)
” for the critical limit of “
(b)(4)
.” FDA recommends you hold and isolate labeled product since the last acceptable inspection of labels; inspect 100% of affected product and relabel mislabeled products; inspect remaining labels staged for use and remove inaccurate labels from processing area; and discontinue use of label supplier OR modify label procedures, as appropriate.
Please send your reply to the Food and Drug Administration, Attention: Sheena Phillips, Compliance Officer, Human Foods Program – Office of Compliance and Enforcement, Office of Enforcement – Division of Conventional Foods Enforcement (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 Sheena Phillips via email at: Sheena.Phillips@fda.hhs.gov. Please include reference CMS #695096 on any submissions and within the subject line of any email correspondence to the agency.
Sincerely,
/S/
Maria S. Knirk, JD MBA
Acting Director
Office of Enforcement
Office of Compliance and Enforcement
Human Foods Program
Content current as of:
01/21/2025
Regulated Product(s)
Food & Beverages