[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-warning-letter-star-ocean-wholesale-foods-inc-736562-09012026":3,"fda-latest-sync-dates":29},{"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":8,"case_status":13,"letter_url":14,"reference_number":8,"marcs_cms_no":15,"product_type":16,"delivery_method":17,"recipient_name":18,"recipient_title":8,"body_html":19,"body_text":20,"body_fetched_at":21,"medical_device_id":8,"raw":22,"created_at":27,"updated_at":28},21699,"star-ocean-wholesale-foods-inc-736562-09012026","Warning Letter","Star Ocean Wholesale Foods, Inc.",null,"Office of Inspections and Investigations","Seafood HACCP\u002FCGMP for Foods\u002FAdulterated\u002FInsanitary Conditions","2026-10-06","2026-09-01","Issued","https:\u002F\u002Fwww.fda.gov\u002Finspections-compliance-enforcement-and-criminal-investigations\u002Fwarning-letters\u002Fstar-ocean-wholesale-foods-inc-736562-09012026","736562","Food & Beverages","Via Express Delivery","Mr. Che Ku","\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\">Mr. Che Ku\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\">President\u003C\u002Fdiv>\n          \u003C\u002Fdiv>\n\u003C\u002Fdd>\n          \n            \u003Cdd>Star Ocean Wholesale Foods, Inc.\u003C\u002Fdd>\n\n          \n                      \u003Cdd>\u003Cp class=\"address\" translate=\"no\">\u003Cspan class=\"address-line1\">1211 Pierce Butler Rte.\u003C\u002Fspan>\u003Cbr>\n\u003Cspan class=\"locality\">Saint Paul\u003C\u002Fspan>, \u003Cspan class=\"administrative-area\">MN\u003C\u002Fspan> \u003Cspan class=\"postal-code\">55104-1451\u003C\u002Fspan>\u003Cbr>\n\u003Cspan class=\"country\">United States\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>Office of Inspections and Investigations\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>September 1, 2026\u003C\u002Fp>\u003Cp class=\"text-align-center\">\u003Cstrong>WARNING LETTER\u003C\u002Fstrong>\u003C\u002Fp>\u003Cp class=\"text-align-center\">CMS Case #: 736562\u003C\u002Fp>\u003Cp>Dear Mr. Ku:\u003C\u002Fp>\u003Cp>On August 4th – 6th, 2026 the Food and Drug Administration (FDA) conducted a Seafood Hazard Analysis and Critical Control Point (HACCP) inspection of Star Ocean Wholesale Foods, Inc., located at 1211 Pierce Butler Rte., Saint Paul, MN 55104-1451. We found that you have 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). The specific requirements for imported fish and fishery products are set out in 21 CFR 123.12. As an importer of fish or fishery products, you must operate in accordance with the requirements of Part 123. In accordance with 21 CFR 123.12(d), there must be evidence that all fish and fishery products offered for entry into the United States have been processed under conditions that comply with 21 CFR Part 123. If assurances do not exist that the imported fish or fishery product has been processed under conditions that are equivalent to those required of domestic processors under 21 CFR Part 123, the fish or fishery products will appear to be adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 342(a)(4) and will be denied entry. Because our inspection identified serious violations for 21 CFR Part 123, your Fermented Fish Sauce, manufactured by \u003Cstrong>(b)(4)\u003C\u002Fstrong>, is adulterated under Section 402(a)(4)of the Act (21 U.S.C. § 342(a)(4)), in that it has been prepared, packed, or held under insanitary conditions whereby it may have been rendered injurious to health. You may find the Act, the seafood HACCP regulation and the Fish and Fisheries Products Hazards & Controls Guidance through links in FDA's home page at www.fda.gov.\u003C\u002Fp>\u003Cp>Your significant violations were as follows:\u003C\u002Fp>\u003Cp>You do not have or have not implemented written verification procedures, product specifications and an affirmative step for ensuring that fishery products you import are processed in compliance with the Seafood HACCP regulation.\u003C\u002Fp>\u003Cp>Specifically,\u003C\u002Fp>\u003Cp>You did not implement written verification procedures, product specifications, and an affirmative step for the following fishery products you imported:\u003C\u002Fp>\u003Cp>Fermented Fish Sauce, manufactured by \u003Cstrong>(b)(4)\u003C\u002Fstrong>\u003C\u002Fp>\u003Cp>This is a repeat observation from the previous inspection(s) conducted on 08\u002F14\u002F2024.\u003C\u002Fp>\u003Cp>We may take further action if you do not promptly correct these violations. 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,\" seize your product(s) and\u002For enjoin your firm from further violating the Act.\u003C\u002Fp>\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 doing to correct these violations. You should include in your response documentation, such as HACCP and importer verification records and records that document the performance and results of your firm’s affirmative steps, or other useful information that would assist us in evaluating your corrections. If you cannot complete all corrections before you respond, you should explain the reason for your delay and state when you will correct any remaining violations.\u003C\u002Fp>\u003Cp>This letter may not list all the violations at your facility. You are responsible for ensuring that your seafood importer establishment operates in compliance with the Act and the seafood HACCP regulation (21 CFR Part 123). You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations for the fish or fishery products that you import into the United States.\u003C\u002Fp>\u003Cp>Please send your reply to the Food and Drug Administration, Attention: Compliance Officer Christinaé Hudson via email at christinae.hudson@fda.hhs.gov. Please refer to CMS Case #: 736562 on any documents or records you provide to us and\u002For within the subject line of any email correspondence you send to us.\u003C\u002Fp>\u003Cp>Sincerely,\u003Cbr>\u002FS\u002F\u003C\u002Fp>\u003Cp>Keith Jasukaitis\u003Cbr>Program Division Director\u003Cbr>U.S. Food and Drug Administration\u003Cbr>Office of Inspections and Investigations\u003Cbr>Office of Import Operations\u003Cbr>Division of Northern Border Imports\u003C\u002Fp>\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\nMr. Che Ku\n\nRecipient Title\n\nPresident\n\nStar Ocean Wholesale Foods, Inc.\n\n1211 Pierce Butler Rte.\n\nSaint Paul, MN 55104-1451\n\nUnited States\n\nIssuing Office:\n\nOffice of Inspections and Investigations\n\nUnited States\n\nSeptember 1, 2026\nWARNING LETTER\nCMS Case #: 736562\nDear Mr. Ku:\nOn August 4th – 6th, 2026 the Food and Drug Administration (FDA) conducted a Seafood Hazard Analysis and Critical Control Point (HACCP) inspection of Star Ocean Wholesale Foods, Inc., located at 1211 Pierce Butler Rte., Saint Paul, MN 55104-1451. We found that you have 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). The specific requirements for imported fish and fishery products are set out in 21 CFR 123.12. As an importer of fish or fishery products, you must operate in accordance with the requirements of Part 123. In accordance with 21 CFR 123.12(d), there must be evidence that all fish and fishery products offered for entry into the United States have been processed under conditions that comply with 21 CFR Part 123. If assurances do not exist that the imported fish or fishery product has been processed under conditions that are equivalent to those required of domestic processors under 21 CFR Part 123, the fish or fishery products will appear to be adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 342(a)(4) and will be denied entry. Because our inspection identified serious violations for 21 CFR Part 123, your Fermented Fish Sauce, manufactured by (b)(4), is adulterated under Section 402(a)(4)of the Act (21 U.S.C. § 342(a)(4)), in that it has been prepared, packed, or held under insanitary conditions whereby it may have been rendered injurious to health. You may find the Act, the seafood HACCP regulation and the Fish and Fisheries Products Hazards & Controls Guidance through links in FDA's home page at www.fda.gov.\nYour significant violations were as follows:\nYou do not have or have not implemented written verification procedures, product specifications and an affirmative step for ensuring that fishery products you import are processed in compliance with the Seafood HACCP regulation.\nSpecifically,\nYou did not implement written verification procedures, product specifications, and an affirmative step for the following fishery products you imported:\nFermented Fish Sauce, manufactured by (b)(4)\nThis is a repeat observation from the previous inspection(s) conducted on 08\u002F14\u002F2024.\nWe may take further action if you do not promptly correct these violations. 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,\" seize your product(s) and\u002For enjoin your firm from further violating the Act.\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 doing to correct these violations. You should include in your response documentation, such as HACCP and importer verification records and records that document the performance and results of your firm’s affirmative steps, or other useful information that would assist us in evaluating your corrections. If you cannot complete all corrections before you respond, you should explain the reason for your delay and state when you will correct any remaining violations.\nThis letter may not list all the violations at your facility. You are responsible for ensuring that your seafood importer establishment operates in compliance with the Act and the seafood HACCP regulation (21 CFR Part 123). You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations for the fish or fishery products that you import into the United States.\nPlease send your reply to the Food and Drug Administration, Attention: Compliance Officer Christinaé Hudson via email at christinae.hudson@fda.hhs.gov. Please refer to CMS Case #: 736562 on any documents or records you provide to us and\u002For within the subject line of any email correspondence you send to us.\nSincerely,\n\u002FS\u002F\nKeith Jasukaitis\nProgram Division Director\nU.S. Food and Drug Administration\nOffice of Inspections and Investigations\nOffice of Import Operations\nDivision of Northern Border Imports","2026-10-14T12:33:45.005+00:00",[23,24,25,9,10,26,26,26],"\u003Ctime datetime=\"2026-10-06T04:00:00Z\">10\u002F06\u002F2026\u003C\u002Ftime>\n","\u003Ctime datetime=\"2026-09-01T04:00:00Z\">09\u002F01\u002F2026\u003C\u002Ftime>\n","\u003Ca href=\"\u002Finspections-compliance-enforcement-and-criminal-investigations\u002Fwarning-letters\u002Fstar-ocean-wholesale-foods-inc-736562-09012026\">Star Ocean Wholesale Foods, Inc.\u003C\u002Fa>","","2026-10-14T12:31:16.41489+00:00","2026-10-14T14:44:01.489557+00:00",{"510k":30,"classification":31,"enforcement":32,"event":33,"event_backfill":34,"pma":35,"warning_letter":36},"2026-10-12T02:00:50.914+00:00","2026-10-12T02:00:38.521+00:00","2026-10-12T02:00:45.002+00:00","2026-10-14T04:02:53.8+00:00","2026-09-07T05:17:28.839+00:00","2026-10-12T02:00:52.377+00:00","2026-10-14T14:44:02.318+00:00"]