DUONG HA PROCESSING TRADING SEAFOOD COMPANY LIMITED

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. 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. fda. gov. The June 2022 Edition of the Hazards Guide can be found on our web site at:

1. 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. 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. 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 “” critical control point to control histamine formation. According to your “,” which states “,” you are receiving fish directly from the fishing vessels. You list a critical limit of “” at the “” 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”). Your monitoring procedure of “” with “” in “” at the “” 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. The fish collected for analysis may be composited if the critical limit is reduced accordingly. 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. Furthermore, your updated “” 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 “” 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. 7(b). 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. e. 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. § 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. ” 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. If you have any questions regarding any issues in this letter, please contact Sheena Phillips via email at: Sheena. hhs. Please include reference CMS #695096 on any submissions and within the subject line of any email correspondence to the agency