[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-warning-letter-rio-verde-food-service-inc-719149-02272026":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},273,"rio-verde-food-service-inc-719149-02272026","Warning Letter","Rio Verde Food Service Inc.",null,"Human Foods Program","Seafood HACCP\u002FCGMP for Foods\u002FAdulterated\u002FInsanitary Conditions","2026-03-10","2026-02-27","Issued","https:\u002F\u002Fwww.fda.gov\u002Finspections-compliance-enforcement-and-criminal-investigations\u002Fwarning-letters\u002Frio-verde-food-service-inc-719149-02272026","719149","Food & Beverages","VIA ELECTRONIC DELIVERY","Ruben Acosta Galicia","\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 ELECTRONIC 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\">Ruben Acosta Galicia\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\u002FOwner \u003C\u002Fdiv>\n          \u003C\u002Fdiv>\n\u003C\u002Fdd>\n          \n            \u003Cdd>Rio Verde Food Service Inc.\u003C\u002Fdd>\n\n          \n                      \u003Cdd>\u003Cp class=\"address\" translate=\"no\">\u003Cspan class=\"address-line1\">1800 Dixon Street, Suite H\u003C\u002Fspan>\u003Cbr>\n\u003Cspan class=\"locality\">Des Moines\u003C\u002Fspan>, \u003Cspan class=\"administrative-area\">IA\u003C\u002Fspan> \u003Cspan class=\"postal-code\">50316-2172\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:ra@rioverdefoodservice.com \"> ra@rioverdefoodservice.com \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>Human Foods Program\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>February 27, 2026\u003C\u002Fp>\u003Cp class=\"text-align-center\">\u003Cstrong>WARNING LETTER\u003C\u002Fstrong>\u003C\u002Fp>\u003Cp class=\"text-align-center\">Re: CMS #719149\u003C\u002Fp>\u003Cp>Dear Mr. Galicia:\u003C\u002Fp>\u003Cp>The United States Food and Drug Administration (FDA) conducted an inspection of your seafood processing facility, located at 1800 Dixon Street, Suite H, Des Moines, IA 50316, from July 22, 2025, to July 25, 2025. During our inspection, 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 your facility a Form FDA 483 (FDA-483), Inspectional Observations, listing the deviations found at your firm. You provided a response to the FDA-483 on September 19, 2025, including your revised HACCP plan for “HACCP Plan – Live Oysters”, approved August 9, 2025. Your written response did not include any supporting HACCP documentation. After reviewing your response, we continue to have concerns with your HACCP program for Live Oysters, as further described in this letter.\u003C\u002Fp>\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 Live Oysters 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 4th Edition of the Fish and Fisheries Products Hazards & Controls Guidance (the Hazards Guide) through links in FDA’s home page at www.fda.gov.\u003C\u002Fp>\u003Cp>Your significant violations of the seafood HACCP regulation are as follows:\u003C\u002Fp>\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:\u003C\u002Fp>\u003Cp>a. Your revised HACCP plan for “Live Oysters” submitted with your September 19, 2025, response lists a critical limit in the plan for receiving refrigerated product that does not control the pathogen hazard. Processors of seafood intended to be eaten raw must ensure the temperature of the product was held at or below an ambient temperature of 40°F (4.4°C) throughout transit. Your plan lists “\u003Cstrong>(b)(4)\u003C\u002Fstrong>” as the critical limit at the “\u003Cstrong>(b)(4)\u003C\u002Fstrong>” critical control point.\u003C\u002Fp>\u003Cp>b. Your revised HACCP plan for “Live Oysters submitted with your September 19, 2025, response lists a critical limit in the plan for storage of live oysters that does not control the pathogen hazard. Processors of live oysters to be eaten raw should ensure the oysters are continuously held at or below 40°F during storage.\u003C\u002Fp>\u003Cp>2. Because you chose to include corrective action plans in your HACCP, your described corrective actions must be appropriate, to comply with 21 CFR 123.7(b). However, your corrective action plan listed in your HACCP plan for “Live Oysters” does not ensure that affected product does not enter into commerce.\u003C\u002Fp>\u003Cp>This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address this matter may result in legal action including, without limitation, seizure, injunction, or administrative action for suspension of food facility registration if criteria and conditions warrant.\u003C\u002Fp>\u003Cp>Please notify FDA in writing within fifteen (15) working days of receipt of this letter, of the specific steps you have taken to address any violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective actions within fifteen (15) working days, state the reason for the delay and the time within which you will do so. If you believe that your products are not in violation of the Act, include your reasoning and any supporting information for our consideration.\u003C\u002Fp>\u003Cp>Please send your reply to the Food and Drug Administration, Attention: Bruce E. Taylor, 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 Bruce E. Taylor via email at: Bruce.Taylor@fda.hhs.gov. Please include reference #719149 CMS Number on any submissions and within the subject line of any email correspondence to the agency.\u003C\u002Fp>\u003Cp>Sincerely,\u003Cbr>\u002FS\u002F\u003C\u002Fp>\u003Cp>Maria S. Knirk, JD, MBA\u003Cbr>Acting Director\u003Cbr>Division of Conventional Foods Enforcement\u003Cbr>Office of Compliance and Enforcement\u003Cbr>Human Foods Program\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 ELECTRONIC DELIVERY\n\nProduct:\n\nFood & Beverages\n\nRecipient:\n\nRecipient Name\n\nRuben Acosta Galicia\n\nRecipient Title\n\nPresident\u002FOwner\n\nRio Verde Food Service Inc.\n\n1800 Dixon Street, Suite H\n\nDes Moines, IA 50316-2172\n\nUnited States\n\nra@rioverdefoodservice.com\n\nIssuing Office:\n\nHuman Foods Program\n\nUnited States\n\nFebruary 27, 2026\nWARNING LETTER\nRe: CMS #719149\nDear Mr. Galicia:\nThe United States Food and Drug Administration (FDA) conducted an inspection of your seafood processing facility, located at 1800 Dixon Street, Suite H, Des Moines, IA 50316, from July 22, 2025, to July 25, 2025. During our inspection, 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 your facility a Form FDA 483 (FDA-483), Inspectional Observations, listing the deviations found at your firm. You provided a response to the FDA-483 on September 19, 2025, including your revised HACCP plan for “HACCP Plan – Live Oysters”, approved August 9, 2025. Your written response did not include any supporting HACCP documentation. After reviewing your response, we continue to have concerns with your HACCP program for Live Oysters, as further described in this letter.\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 Live Oysters 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 4th Edition of the Fish and Fisheries Products Hazards & Controls Guidance (the Hazards Guide) through links in FDA’s home page at www.fda.gov.\nYour significant violations of the seafood HACCP regulation are as follows:\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:\na. Your revised HACCP plan for “Live Oysters” submitted with your September 19, 2025, response lists a critical limit in the plan for receiving refrigerated product that does not control the pathogen hazard. Processors of seafood intended to be eaten raw must ensure the temperature of the product was held at or below an ambient temperature of 40°F (4.4°C) throughout transit. Your plan lists “(b)(4)” as the critical limit at the “(b)(4)” critical control point.\nb. Your revised HACCP plan for “Live Oysters submitted with your September 19, 2025, response lists a critical limit in the plan for storage of live oysters that does not control the pathogen hazard. Processors of live oysters to be eaten raw should ensure the oysters are continuously held at or below 40°F during storage.\n2. Because you chose to include corrective action plans in your HACCP, your described corrective actions must be appropriate, to comply with 21 CFR 123.7(b). However, your corrective action plan listed in your HACCP plan for “Live Oysters” does not ensure that affected product does not enter into commerce.\nThis letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address this matter may result in legal action including, without limitation, seizure, injunction, or administrative action for suspension of food facility registration if criteria and conditions warrant.\nPlease notify FDA in writing within fifteen (15) working days of receipt of this letter, of the specific steps you have taken to address any violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective actions within fifteen (15) working days, state the reason for the delay and the time within which you will do so. If you believe that your products are not in violation of the Act, include your reasoning and any supporting information for our consideration.\nPlease send your reply to the Food and Drug Administration, Attention: Bruce E. Taylor, 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 Bruce E. Taylor via email at: Bruce.Taylor@fda.hhs.gov. Please include reference #719149 CMS Number on any submissions and within the subject line of any email correspondence to the agency.\nSincerely,\n\u002FS\u002F\nMaria S. Knirk, JD, MBA\nActing Director\nDivision of Conventional Foods Enforcement\nOffice of Compliance and Enforcement\nHuman Foods Program","2026-08-19T04:52:08.534+00:00",[23,24,25,9,10,26,26,26],"\u003Ctime datetime=\"2026-03-10T04:00:00Z\">03\u002F10\u002F2026\u003C\u002Ftime>\n","\u003Ctime datetime=\"2026-02-27T05:00:00Z\">02\u002F27\u002F2026\u003C\u002Ftime>\n","\u003Ca href=\"\u002Finspections-compliance-enforcement-and-criminal-investigations\u002Fwarning-letters\u002Frio-verde-food-service-inc-719149-02272026\">Rio Verde Food Service 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"]