[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-warning-letter-golden-shrimp-seafood-joint-stock-company-682535-05132024":3,"fda-latest-sync-dates":31},{"id":4,"letter_id":5,"action_type":6,"firm_name":7,"fei_number":8,"issuing_office":9,"subject":10,"posted_date":11,"action_taken_date":12,"response_letter_date":8,"closeout_date":13,"case_status":14,"letter_url":15,"reference_number":8,"marcs_cms_no":16,"product_type":17,"delivery_method":18,"recipient_name":19,"recipient_title":8,"body_html":20,"body_text":21,"body_fetched_at":22,"medical_device_id":8,"raw":23,"created_at":29,"updated_at":30},1168,"golden-shrimp-seafood-joint-stock-company-682535-05132024","Warning Letter","Golden Shrimp Seafood Joint Stock Company",null,"Center for Food Safety and Applied Nutrition","Seafood HACCP\u002FCGMP for Foods\u002FAdulterated\u002FInsanitary Conditions","2024-11-19","2024-05-13","2024-11-22","Closed Out","https:\u002F\u002Fwww.fda.gov\u002Finspections-compliance-enforcement-and-criminal-investigations\u002Fwarning-letters\u002Fgolden-shrimp-seafood-joint-stock-company-682535-05132024","682535","Food & Beverages","Via Express Delivery","Phuc T. Vo","\n\n                            \n                            \n                            \n                            \n                                              \n  \n \n\n                 \n\n  \u003Chr>\n \n\n\u003Cdiv class=\"inset-column\">\n  \u003Cdl class=\"lcds-description-list--grid\">\n\n              \u003Cdt class=\"cell-1_1\">Delivery Method:\u003C\u002Fdt> \n        \u003Cdd class=\"cell-2_1\">Via Express Delivery\n                                                                                                                                                                                                                                                                                                                                                                                                                              \u003C\u002Fdd>\n      \n      \n              \u003Cdt class=\"cell-1_3\">Product:\u003C\u002Fdt> \n        \u003Cdd class=\"cell-2_3\">Food & Beverages                          \n            \n            \n            \n            \n            \n            \n            \n             \n            \n            \n            \n              \n            \n            \n            \u003C\u002Fdd>\n      \n          \u003C\u002Fdl>\n  \u003C\u002Fdiv>            \n\n\n\u003Chr>\n\n\u003Cdiv class=\"row inset-column\">\n  \u003Cdiv class=\"col-xs-12 col-md-6\">\n    \u003Cdl class=\"\">\n\n        \u003Cdt>Recipient:\u003C\u002Fdt>\n\n                      \u003Cdd>\n  \u003Cdiv class=\"field field--name-field-recipient-name field--type-string field--label-above\">\n    \u003Cdiv class=\"field--label\">Recipient Name\u003C\u002Fdiv>\n              \u003Cdiv class=\"field--item\">Phuc T. Vo\u003C\u002Fdiv>\n          \u003C\u002Fdiv>\n\u003C\u002Fdd>\n                                \u003Cdd>\n  \u003Cdiv class=\"field field--name-field-recipient-title field--type-string field--label-above\">\n    \u003Cdiv class=\"field--label\">Recipient Title\u003C\u002Fdiv>\n              \u003Cdiv class=\"field--item\">Company Director\u003C\u002Fdiv>\n          \u003C\u002Fdiv>\n\u003C\u002Fdd>\n          \n            \u003Cdd>Golden Shrimp Seafood Joint Stock Company\u003C\u002Fdd>\n\n          \n                      \u003Cdd>\u003Cp class=\"address\" translate=\"no\">\u003Cspan class=\"address-line1\">Hoa Phau Hamlet, Thuan Yen Village\u003C\u002Fspan>\u003Cbr>\n\u003Cspan class=\"address-line2\">03, National Road 80th, Group\u003C\u002Fspan>\u003Cbr>\n\u003Cspan class=\"locality\">Ha Tien Town\u003C\u002Fspan>\u003Cbr>\n\u003Cspan class=\"administrative-area\">Kien Giang Province\u003C\u002Fspan> \u003Cspan class=\"postal-code\">920000\u003C\u002Fspan>\u003Cbr>\n\u003Cspan class=\"country\">Vietnam\u003C\u002Fspan>\u003C\u002Fp>\u003C\u002Fdd>\n          \n          \n          \n    \u003C\u002Fdl>\n  \u003C\u002Fdiv>            \n\n       \u003Cdiv class=\"col-xs-12 col-md-6\">\n    \u003Cdl class=\"\">\n          \n          \u003Cdt>Issuing Office:\u003C\u002Fdt>\n        \n         \n          \u003Cdd>Center for Food Safety and Applied Nutrition\u003C\u002Fdd>\n        \n         \n          \u003Cdd>\u003Cp class=\"address\" translate=\"no\">\u003Cspan class=\"country\">United States\u003C\u002Fspan>\u003C\u002Fp>\u003C\u002Fdd>\n        \n        \n        \n        \n        \n    \u003C\u002Fdl>\n    \u003Cdl class=\"\"> \n      \n    \u003C\u002Fdl>\n  \u003C\u002Fdiv>  \n      \n\u003C\u002Fdiv>\n\n \n\n \n\n\u003Chr>\n\n\u003Cp>May 13, 2024\u003C\u002Fp>\n\n\u003Cp class=\"text-align-center\">\u003Cstrong>WARNING LETTER\u003C\u002Fstrong>\u003C\u002Fp>\n\n\u003Cp class=\"text-align-center\">Reference #: CMS 628535\u003C\u002Fp>\n\n\u003Cp>Dear Mr. Vo,\u003C\u002Fp>\n\n\u003Cp>The United States Food and Drug Administration (FDA) conducted an inspection of your seafood processing facility, located at Lot A13 An Phu Industrial Zone, Tuy Hoa, Phu Yen, Vietnam 560000, on December 11 and 12, 2023. This inspection was conducted as a follow-up to a consumer complaint, which involved histamine poisoning from a saku, cubed, and ground yellowfin tuna product. During the 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 a Form FDA-483, Inspectional Observations, listing the deviations found at your firm. We received your responses on December 22, 26, and 27, 2023, which included corrective actions, product testing, and updated raw ingredient sampling procedures for histamine. However, our evaluation of the documentation provided in your responses revealed that your response was not adequate, as further described in this letter.\u003C\u002Fp>\n\n\u003Cp>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 histamine-forming seafood yellowfin tuna (Thunnus albacares) products 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 Fishery Products Hazards and Controls Guidance (the Hazards Guide) through links in FDA's home page at www.fda.gov.\u003C\u002Fp>\n\n\u003Cp>Your significant violations are as follows:\u003C\u002Fp>\n\n\u003Cp>1. 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 “Frozen Yellowfin Tuna CO\u002FTS Treated, Cut into Loin, Saku, Cube, Steak, Strip, Crazy, Portions”, dated 25\u002F09\u002F2022, does not list adequate critical limits at the “\u003Cstrong>(b)(4)\u003C\u002Fstrong>” critical control point to control the food safety hazard of scombrotoxin (histamine) formation. Specifically:\u003C\u002Fp>\n\n\u003Cp>a. You list a critical limit of “\u003Cstrong>(b)(4)\u003C\u002Fstrong>”. However, this critical limit does not provide adequate assurance that your procedures for sampling are representative of all fish in the sample.\u003C\u002Fp>\n\n\u003Cp>b. You do not list a critical limit for when the fish are offloaded from the harvest vessels. For guidance and control strategies, you may reference the Fish and Fishery Products Hazards & Controls Guidance - June 2022 4th Edition at https:\u002F\u002Fwww.fda.gov\u002Fmedia\u002F80648\u002Fdownload, Chapter 17 for \u003Cem>Scrombrotoxin (Histamine) Formation\u003C\u002Fem>.\u003C\u002Fp>\n\n\u003Cp>During the inspection, you informed our investigator that you sample your fish from three portions, including along a one-inch plate at the back of the fin, in the front of the fin, and in front of the fish’s tail. In large scombrotoxin-forming fish, FDA recommends sampling from the lower, anterior (forward) portion of the fish loin (not the belly flap) to provide the best information about the histamine content of the fish. Although you provided corrective actions including updated raw ingredient sampling procedures for histamine, with supporting photographs identifying sampling locations in your response; you did not provide an updated HACCP plan, or any supporting documentation showing the incorporation and implementation of your updated sampling procedures into your HACCP program for our review. Therefore, regarding your updated sampling practices, we cannot evaluate the adequacy of your corrective actions.\u003C\u002Fp>\n\n\u003Cp>This letter may not list all the violations at your facility. You are responsible for ensuring that your processing plant operates in compliance with the Act, the seafood HACCP regulation (21 CFR Part 123), 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.\u003C\u002Fp>\n\n\u003Cp>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. In addition to your current placement on the “Red List” of Import Alert #16-105, \"Detention Without Physical Examination of Fish and Fishery Products from Specific Manufacturers\u002F Shippers Due to Decomposition and\u002For Histamine, and\u002For Indole\", as published 12\u002F19\u002F2022, 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, “Detention Without Physical Examination of Fish\u002FFishery Products from Foreign Processors (Mfrs.) Not in Compliance with Seafood HACCP\". You may view this alert at: http:\u002F\u002Fwww.accessdata.fda.gov\u002Fcms_ia\u002Fialist.html.\u003C\u002Fp>\n\n\u003Cp>Additionally, we offer the following comments:\u003C\u002Fp>\n\n\u003Cul>\n\t\u003Cli>Although you provided an updated CCP monitoring record entitled “\u003Cstrong>(b)(4)\u003C\u002Fstrong>” in your response, it does not appear adequate to document compliance with receiving critical limits because it does not allow for the recording of individual monitoring observations. For example, the record has 3 separate rows for recording “\u003Cstrong>(b)(4)\u003C\u002Fstrong>.”; however, the subsequent columns labeled “\u003Cstrong>(b)(4)\u003C\u002Fstrong>,” do not allow for the documentation of each individual observation on the line(s).\u003C\u002Fli>\n\t\u003Cli>Your HACCP plan for “Frozen Yellowfin Tuna CO\u002FTS Treated, Cut into Loin, Saku, Cube, Steak, Strip, Crazy, Portions” dated 25\u002F09\u002F2022, lists a monitoring procedure to make “\u003Cstrong>(b)(4)\u003C\u002Fstrong>” for “\u003Cstrong>(b)(4)\u003C\u002Fstrong>” for the critical limit of “\u003Cstrong>(b)(4)\u003C\u002Fstrong>” critical control point. This monitoring procedure does not include actual values and\u002For observations to adequately assure that the critical limit is met.\u003C\u002Fli>\n\u003C\u002Ful>\n\n\u003Cp>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 taking to correct these violations. More specifically, your response should include documentation such as your revised HACCP plan, 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 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 the foods you import are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration.\u003C\u002Fp>\n\n\u003Cp>Please send your reply to the Food and Drug Administration, Attention: Amy R. Glynn, Compliance Officer, Food Adulteration Assessment Branch, Office of Compliance, Division of Enforcement, 5001 Campus Drive, College Park, MD 20740 U.S.A., or send via email at amy.glynn@fda.hhs.gov. Please reference CMS # 628535 on any submissions and within the subject line of any emails to us.\u003C\u002Fp>\n\n\u003Cp>Sincerely,\u003Cbr>\n\u002FS\u002F\u003C\u002Fp>\n\n\u003Cp>Ann Oxenham, J.D.\u003Cbr>\nDirector\u003Cbr>\nOffice of Compliance\u003Cbr>\nCenter for Food Safety\u003Cbr>\n    and Applied Nutrition\u003C\u002Fp>\n\n\n\u003C!--BEGIN QUALTRICS WEBSITE FEEDBACK SNIPPET-->\n\u003C!--BEGIN QUALTRICS WEBSITE FEEDBACK SNIPPET-->\n\n\n\n              \n                                            \n              \n            ","Delivery Method:\n\nVia Express Delivery\n\nProduct:\n\nFood & Beverages\n\nRecipient:\n\nRecipient Name\n\nPhuc T. Vo\n\nRecipient Title\n\nCompany Director\n\nGolden Shrimp Seafood Joint Stock Company\n\nHoa Phau Hamlet, Thuan Yen Village\n\n03, National Road 80th, Group\n\nHa Tien Town\n\nKien Giang Province 920000\n\nVietnam\n\nIssuing Office:\n\nCenter for Food Safety and Applied Nutrition\n\nUnited States\n\nMay 13, 2024\n\nWARNING LETTER\n\nReference #: CMS 628535\n\nDear Mr. Vo,\n\nThe United States Food and Drug Administration (FDA) conducted an inspection of your seafood processing facility, located at Lot A13 An Phu Industrial Zone, Tuy Hoa, Phu Yen, Vietnam 560000, on December 11 and 12, 2023. This inspection was conducted as a follow-up to a consumer complaint, which involved histamine poisoning from a saku, cubed, and ground yellowfin tuna product. During the 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 a Form FDA-483, Inspectional Observations, listing the deviations found at your firm. We received your responses on December 22, 26, and 27, 2023, which included corrective actions, product testing, and updated raw ingredient sampling procedures for histamine. However, our evaluation of the documentation provided in your responses revealed that your response was not adequate, as further described in this letter.\n\nIn 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 histamine-forming seafood yellowfin tuna (Thunnus albacares) products 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 Fishery Products Hazards and Controls Guidance (the Hazards Guide) through links in FDA's home page at www.fda.gov.\n\nYour significant violations are as follows:\n\n1. 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 “Frozen Yellowfin Tuna CO\u002FTS Treated, Cut into Loin, Saku, Cube, Steak, Strip, Crazy, Portions”, dated 25\u002F09\u002F2022, does not list adequate critical limits at the “(b)(4)” critical control point to control the food safety hazard of scombrotoxin (histamine) formation. Specifically:\n\na. You list a critical limit of “(b)(4)”. However, this critical limit does not provide adequate assurance that your procedures for sampling are representative of all fish in the sample.\n\nb. You do not list a critical limit for when the fish are offloaded from the harvest vessels. For guidance and control strategies, you may reference the Fish and Fishery Products Hazards & Controls Guidance - June 2022 4th Edition at https:\u002F\u002Fwww.fda.gov\u002Fmedia\u002F80648\u002Fdownload, Chapter 17 for Scrombrotoxin (Histamine) Formation.\n\nDuring the inspection, you informed our investigator that you sample your fish from three portions, including along a one-inch plate at the back of the fin, in the front of the fin, and in front of the fish’s tail. In large scombrotoxin-forming fish, FDA recommends sampling from the lower, anterior (forward) portion of the fish loin (not the belly flap) to provide the best information about the histamine content of the fish. Although you provided corrective actions including updated raw ingredient sampling procedures for histamine, with supporting photographs identifying sampling locations in your response; you did not provide an updated HACCP plan, or any supporting documentation showing the incorporation and implementation of your updated sampling procedures into your HACCP program for our review. Therefore, regarding your updated sampling practices, we cannot evaluate the adequacy of your corrective actions.\n\nThis letter may not list all the violations at your facility. You are responsible for ensuring that your processing plant operates in compliance with the Act, the seafood HACCP regulation (21 CFR Part 123), 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.\n\nIf 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. In addition to your current placement on the “Red List” of Import Alert #16-105, \"Detention Without Physical Examination of Fish and Fishery Products from Specific Manufacturers\u002F Shippers Due to Decomposition and\u002For Histamine, and\u002For Indole\", as published 12\u002F19\u002F2022, 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, “Detention Without Physical Examination of Fish\u002FFishery Products from Foreign Processors (Mfrs.) Not in Compliance with Seafood HACCP\". You may view this alert at: http:\u002F\u002Fwww.accessdata.fda.gov\u002Fcms_ia\u002Fialist.html.\n\nAdditionally, we offer the following comments:\n\nAlthough you provided an updated CCP monitoring record entitled “(b)(4)” in your response, it does not appear adequate to document compliance with receiving critical limits because it does not allow for the recording of individual monitoring observations. For example, the record has 3 separate rows for recording “(b)(4).”; however, the subsequent columns labeled “(b)(4),” do not allow for the documentation of each individual observation on the line(s).\n\nYour HACCP plan for “Frozen Yellowfin Tuna CO\u002FTS Treated, Cut into Loin, Saku, Cube, Steak, Strip, Crazy, Portions” dated 25\u002F09\u002F2022, lists a monitoring procedure to make “(b)(4)” for “(b)(4)” for the critical limit of “(b)(4)” critical control point. This monitoring procedure does not include actual values and\u002For observations to adequately assure that the critical limit is met.\n\nYou should respond in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific things you are taking to correct these violations. More specifically, your response should include documentation such as your revised HACCP plan, 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 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 the foods you import are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration.\n\nPlease send your reply to the Food and Drug Administration, Attention: Amy R. Glynn, Compliance Officer, Food Adulteration Assessment Branch, Office of Compliance, Division of Enforcement, 5001 Campus Drive, College Park, MD 20740 U.S.A., or send via email at amy.glynn@fda.hhs.gov. Please reference CMS # 628535 on any submissions and within the subject line of any emails to us.\n\nSincerely,\n\n\u002FS\u002F\n\nAnn Oxenham, J.D.\n\nDirector\n\nOffice of Compliance\n\nCenter for Food Safety\n\nand Applied Nutrition","2026-08-19T18:14:13.525+00:00",[24,25,26,9,10,27,28,27],"\u003Ctime datetime=\"2024-11-19T14:20:00Z\">11\u002F19\u002F2024\u003C\u002Ftime>\n","\u003Ctime datetime=\"2024-05-13T04:00:00Z\">05\u002F13\u002F2024\u003C\u002Ftime>\n","\u003Ca href=\"\u002Finspections-compliance-enforcement-and-criminal-investigations\u002Fwarning-letters\u002Fgolden-shrimp-seafood-joint-stock-company-682535-05132024\">Golden Shrimp Seafood Joint Stock Company\u003C\u002Fa>","","\u003Ca href=\"\u002Finspections-compliance-enforcement-and-criminal-investigations\u002Fwarning-letters\u002Fgolden-shrimp-seafood-joint-stock-company-682535-08222024\">\u003Ctime datetime=\"2024-11-22T05:00:00Z\">11\u002F22\u002F2024\u003C\u002Ftime>\n\u003C\u002Fa>","2026-08-18T06:42:28.856152+00:00","2026-08-20T02:24:56.037289+00:00",{"510k":32,"classification":33,"enforcement":34,"event":35,"pma":36,"warning_letter":37},"2026-08-18T06:35:18.347+00:00","2026-08-18T05:52:53.75+00:00","2026-08-18T08:01:54.918+00:00","2026-08-19T02:58:35.995+00:00","2026-08-18T06:36:30.549+00:00","2026-08-20T03:28:02.95+00:00"]