[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-warning-letter-ocho-rios-atlanta-inc-718580-10242025":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},476,"ocho-rios-atlanta-inc-718580-10242025","Warning Letter","Ocho Rios Atlanta Inc.",null,"Division of Southeast Imports","Foreign Supplier Verification Program (FSVP)","2025-11-18","2025-10-24","Issued","https:\u002F\u002Fwww.fda.gov\u002Finspections-compliance-enforcement-and-criminal-investigations\u002Fwarning-letters\u002Focho-rios-atlanta-inc-718580-10242025","718580","Food & Beverages","Via Email","Aston Lue","\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 Email\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\">Aston Lue\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 and Owner\u003C\u002Fdiv>\n          \u003C\u002Fdiv>\n\u003C\u002Fdd>\n          \n            \u003Cdd>Ocho Rios Atlanta Inc.\u003C\u002Fdd>\n\n          \n                      \u003Cdd>\u003Cp class=\"address\" translate=\"no\">\u003Cspan class=\"address-line1\">1989 Tucker Industrial Rd.\u003C\u002Fspan>\u003Cbr>\n\u003Cspan class=\"locality\">Tucker\u003C\u002Fspan>, \u003Cspan class=\"administrative-area\">GA\u003C\u002Fspan> \u003Cspan class=\"postal-code\">30084-6640\u003C\u002Fspan>\u003Cbr>\n\u003Cspan class=\"country\">United States\u003C\u002Fspan>\u003C\u002Fp>\u003C\u002Fdd>\n          \n          \n            \n            \u003Cdd>\u003C!-- Loop this field. For FDA Office content type. Display the Other contact channel is a dd span with an icon-->\n\n    \u003C\u002Fdd>\u003Cdd>\u003Cspan class=\"fa fa-envelope\" aria-hidden=\"true\">\u003C\u002Fspan>\u003Ca href=\"mailto:(b)(6), (b)(7)(C)\"> (b)(6), (b)(7)(C)\u003C\u002Fa>\u003C\u002Fdd>\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>Division of Southeast Imports\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>October 24, 2025\u003C\u002Fp>\u003Cp class=\"text-align-center\">\u003Cstrong>WARNING LETTER\u003C\u002Fstrong>\u003C\u002Fp>\u003Cp class=\"text-align-center\">RE: CMS# 718580\u003C\u002Fp>\u003Cp>Dear Mr. Aston Lue:\u003C\u002Fp>\u003Cp>From September 18th to 30th, 2025, the Food and Drug Administration (FDA) conducted a Foreign Supplier Verification Program (FSVP) inspection of Ocho Rios Atlanta Inc., located at 1989 Tucker Industrial Rd., Tucker, GA 30084-6640. We also conducted inspections on August 27th, 2018; November 1st, 2019; July 7th through September 17th, 2021; June 14th through 27th, 2023; and January 31st through February 6th, 2024. These inspections were conducted to determine compliance with the requirements of section 805 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 384a) and the implementing FSVP regulation in 21 CFR part 1, subpart L.\u003C\u002Fp>\u003Cp>The FSVP regulation requires that importers perform certain risk-based activities to verify that human and\u002For animal food they import into the United States has been produced in a manner that meets applicable U.S. food safety standards. You may find information relating to the FSVP regulation and your responsibilities to comply with the regulation through links in FDA’s FSVP web page at https:\u002F\u002Fwww.fda.gov\u002Ffood\u002Ffood-safety-modernization-act-fsma\u002Ffsma-final-rule-foreign-supplier-verification-programs-fsvp-importers-food-humans-and-animals.\u003C\u002Fp>\u003Cp>During the most recent inspection, we found that you are not in compliance with the requirements of 21 CFR part 1, subpart L for the following foods you import: Mixed spices and seasonings \u003Cstrong>(b)(4)\u003C\u002Fstrong> in \u003Cstrong>(b)(4)\u003C\u002Fstrong>; Brown sauce from \u003Cstrong>(b)(4)\u003C\u002Fstrong> in \u003Cstrong>(b)(4)\u003C\u002Fstrong>; Juice drinks from \u003Cstrong>(b)(4)\u003C\u002Fstrong> in \u003Cstrong>(b)(4)\u003C\u002Fstrong>; and Tea from \u003Cstrong>(b)(4)\u003C\u002Fstrong> in \u003Cstrong>(b)(4)\u003C\u002Fstrong>. Because of these significant violations, you are not in compliance with section 805 of the FD&C Act.\u003C\u002Fp>\u003Cp>At the conclusion of the inspection, our investigator provided you with a Form FDA 483a FSVP Observations.\u003C\u002Fp>\u003Cp>We acknowledge receipt of your response, dated October 2, 2025, in which you stated your Qualified Individual will develop and implement FSVP plans for all the imported foods that your firm identified as not having an FSVP in place. No timeframes were provided. We are unable to evaluate the adequacy of your response because you have not provided any supporting documentation demonstrating your corrective actions for all the imported foods that your firm identified as not having an FSVP in place. To date, no additional FSVP documents have been received by FDA.\u003C\u002Fp>\u003Cp>Your significant violations of the FSVP regulation are as follows:\u003C\u002Fp>\u003Cp>1. You did not develop, maintain, and follow an FSVP as required by section 805 of the FD&C Act and 21 CFR part 1.502(a). Specifically, you did not develop an FSVP for the following foods you import:\u003C\u002Fp>\u003Cul>\u003Cli>Mixed spices and seasonings \u003Cstrong>(b)(4)\u003C\u002Fstrong> imported from \u003Cstrong>(b)(4)\u003C\u002Fstrong>, located in \u003Cstrong>(b)(4)\u003C\u002Fstrong>\u003C\u002Fli>\u003Cli>Brown sauce imported from \u003Cstrong>(b)(4)\u003C\u002Fstrong>, located in \u003Cstrong>(b)(4)\u003C\u002Fstrong>\u003C\u002Fli>\u003Cli>Juice drinks imported from \u003Cstrong>(b)(4)\u003C\u002Fstrong>, located in \u003Cstrong>(b)(4)\u003C\u002Fstrong>\u003C\u002Fli>\u003Cli>Tea imported from \u003Cstrong>(b)(4)\u003C\u002Fstrong>, located in \u003Cstrong>(b)(4)\u003C\u002Fstrong>\u003C\u002Fli>\u003C\u002Ful>\u003Cp>The above violations are not intended to be an all-inclusive list of violations of the FSVP requirements. It is your responsibility to ensure that you are in compliance with section 805 of the FD&C Act and the implementing regulation in 21 CFR part 1, subpart L.\u003C\u002Fp>\u003Cp>This letter notifies you of our concerns and provides you an opportunity to address them. If you do not adequately address this matter, we may take further action. For instance, we may take action under section 801(a)(3) of the FD&C Act (21 U.S.C. 381(a)(3)) to refuse admission of the food you import for which you appear to be in violation of section 805. We may place the foods you import into the United States on detention without physical examination (DWPE) when you import the foods. You can find DWPE information relating to FSVP in Import Alert # 99-41 at http:\u002F\u002Fwww.accessdata.fda.gov\u002Fcms_ia\u002Fialist.html. In addition, the importation or offering for importation into the United States of an article of food without the importer having an FSVP that meets the requirements of section 805 of the FD&C Act or the FSVP regulation is prohibited under section 301(zz) of the FD&C Act (21 U.S.C. 331(zz)).\u003C\u002Fp>\u003Cp>You should respond in writing within fifteen (15) working days from your receipt of this letter. Your response should address the specific things you are doing to correct any violations. You should include in your response documentation and information that would assist us in evaluating your corrections (e.g., documentation of changes you made, such as a copy of your FSVP, records to demonstrate implementation of your FSVP), and any additional information that you wish to supply relevant to your compliance with the FSVP regulation. If you believe that you are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration. If you cannot complete all corrections within 15 working days, you should explain the reason for your delay and state when you will correct any remaining violations.\u003C\u002Fp>\u003Cp>Please send your reply to Food and Drug Administration, Attention: Allison McGloin, Compliance Officer, Division of Southeast Imports: OIIOIODSEIFirmCorrespondence@fda.hhs.gov. Please also cc (carbon copy) Allison.McGloin@fda.hhs.gov. If you have any questions regarding this letter, you may contact Compliance Officer McGloin via email at Allison.McGloin@fda.hhs.gov. Please reference CMS # 718580 on any documents or records you provide to us and on the subject line of any email correspondence you send to us.\u003C\u002Fp>\u003Cp>Sincerely,\u003Cbr>\u002FS\u002F\u003C\u002Fp>\u003Cp>Christopher Boulmay\u003Cbr>Acting Program Division Director\u003Cbr>Division of Southeast 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 Email\n\nProduct:\n\nFood & Beverages\n\nRecipient:\n\nRecipient Name\n\nAston Lue\n\nRecipient Title\n\nPresident and Owner\n\nOcho Rios Atlanta Inc.\n\n1989 Tucker Industrial Rd.\n\nTucker, GA 30084-6640\n\nUnited States\n\n(b)(6), (b)(7)(C)\n\nIssuing Office:\n\nDivision of Southeast Imports\n\nUnited States\n\nOctober 24, 2025\nWARNING LETTER\nRE: CMS# 718580\nDear Mr. Aston Lue:\nFrom September 18th to 30th, 2025, the Food and Drug Administration (FDA) conducted a Foreign Supplier Verification Program (FSVP) inspection of Ocho Rios Atlanta Inc., located at 1989 Tucker Industrial Rd., Tucker, GA 30084-6640. We also conducted inspections on August 27th, 2018; November 1st, 2019; July 7th through September 17th, 2021; June 14th through 27th, 2023; and January 31st through February 6th, 2024. These inspections were conducted to determine compliance with the requirements of section 805 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 384a) and the implementing FSVP regulation in 21 CFR part 1, subpart L.\nThe FSVP regulation requires that importers perform certain risk-based activities to verify that human and\u002For animal food they import into the United States has been produced in a manner that meets applicable U.S. food safety standards. You may find information relating to the FSVP regulation and your responsibilities to comply with the regulation through links in FDA’s FSVP web page at https:\u002F\u002Fwww.fda.gov\u002Ffood\u002Ffood-safety-modernization-act-fsma\u002Ffsma-final-rule-foreign-supplier-verification-programs-fsvp-importers-food-humans-and-animals.\nDuring the most recent inspection, we found that you are not in compliance with the requirements of 21 CFR part 1, subpart L for the following foods you import: Mixed spices and seasonings (b)(4) in (b)(4); Brown sauce from (b)(4) in (b)(4); Juice drinks from (b)(4) in (b)(4); and Tea from (b)(4) in (b)(4). Because of these significant violations, you are not in compliance with section 805 of the FD&C Act.\nAt the conclusion of the inspection, our investigator provided you with a Form FDA 483a FSVP Observations.\nWe acknowledge receipt of your response, dated October 2, 2025, in which you stated your Qualified Individual will develop and implement FSVP plans for all the imported foods that your firm identified as not having an FSVP in place. No timeframes were provided. We are unable to evaluate the adequacy of your response because you have not provided any supporting documentation demonstrating your corrective actions for all the imported foods that your firm identified as not having an FSVP in place. To date, no additional FSVP documents have been received by FDA.\nYour significant violations of the FSVP regulation are as follows:\n1. You did not develop, maintain, and follow an FSVP as required by section 805 of the FD&C Act and 21 CFR part 1.502(a). Specifically, you did not develop an FSVP for the following foods you import:\nMixed spices and seasonings (b)(4) imported from (b)(4), located in (b)(4)\nBrown sauce imported from (b)(4), located in (b)(4)\nJuice drinks imported from (b)(4), located in (b)(4)\nTea imported from (b)(4), located in (b)(4)\nThe above violations are not intended to be an all-inclusive list of violations of the FSVP requirements. It is your responsibility to ensure that you are in compliance with section 805 of the FD&C Act and the implementing regulation in 21 CFR part 1, subpart L.\nThis letter notifies you of our concerns and provides you an opportunity to address them. If you do not adequately address this matter, we may take further action. For instance, we may take action under section 801(a)(3) of the FD&C Act (21 U.S.C. 381(a)(3)) to refuse admission of the food you import for which you appear to be in violation of section 805. We may place the foods you import into the United States on detention without physical examination (DWPE) when you import the foods. You can find DWPE information relating to FSVP in Import Alert # 99-41 at http:\u002F\u002Fwww.accessdata.fda.gov\u002Fcms_ia\u002Fialist.html. In addition, the importation or offering for importation into the United States of an article of food without the importer having an FSVP that meets the requirements of section 805 of the FD&C Act or the FSVP regulation is prohibited under section 301(zz) of the FD&C Act (21 U.S.C. 331(zz)).\nYou should respond in writing within fifteen (15) working days from your receipt of this letter. Your response should address the specific things you are doing to correct any violations. You should include in your response documentation and information that would assist us in evaluating your corrections (e.g., documentation of changes you made, such as a copy of your FSVP, records to demonstrate implementation of your FSVP), and any additional information that you wish to supply relevant to your compliance with the FSVP regulation. If you believe that you are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration. If you cannot complete all corrections within 15 working days, you should explain the reason for your delay and state when you will correct any remaining violations.\nPlease send your reply to Food and Drug Administration, Attention: Allison McGloin, Compliance Officer, Division of Southeast Imports: OIIOIODSEIFirmCorrespondence@fda.hhs.gov. Please also cc (carbon copy) Allison.McGloin@fda.hhs.gov. If you have any questions regarding this letter, you may contact Compliance Officer McGloin via email at Allison.McGloin@fda.hhs.gov. Please reference CMS # 718580 on any documents or records you provide to us and on the subject line of any email correspondence you send to us.\nSincerely,\n\u002FS\u002F\nChristopher Boulmay\nActing Program Division Director\nDivision of Southeast Imports","2026-08-19T14:27:33.617+00:00",[23,24,25,9,10,26,26,26],"\u003Ctime datetime=\"2025-11-18T05:00:00Z\">11\u002F18\u002F2025\u003C\u002Ftime>\n","\u003Ctime datetime=\"2025-10-24T04:00:00Z\">10\u002F24\u002F2025\u003C\u002Ftime>\n","\u003Ca href=\"\u002Finspections-compliance-enforcement-and-criminal-investigations\u002Fwarning-letters\u002Focho-rios-atlanta-inc-718580-10242025\">Ocho Rios Atlanta Inc.\u003C\u002Fa>","","2026-08-18T06:42:28.498414+00:00","2026-08-20T02:24:55.726997+00:00",{"510k":30,"classification":31,"enforcement":32,"event":33,"pma":34,"warning_letter":35},"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"]