[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-warning-letter-cavevi-naturals-llc-666694-11082023":3,"fda-latest-sync-dates":30},{"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":28,"updated_at":29},1646,"cavevi-naturals-llc-666694-11082023","Warning Letter","Cavevi Naturals LLC",null,"Division of Southwest Imports","Foreign Supplier Verification Program (FSVP)","2024-01-30","2023-11-08","Issued","https:\u002F\u002Fwww.fda.gov\u002Finspections-compliance-enforcement-and-criminal-investigations\u002Fwarning-letters\u002Fcavevi-naturals-llc-666694-11082023","666694","Food & Beverages","Via Express Delivery","Maria Cantu","\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\">Maria Cantu\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\">Owner\u003C\u002Fdiv>\n          \u003C\u002Fdiv>\n\u003C\u002Fdd>\n          \n            \u003Cdd>Cavevi Naturals LLC\u003C\u002Fdd>\n\n          \n                      \u003Cdd>\u003Cp class=\"address\" translate=\"no\">\u003Cspan class=\"address-line1\">13602 Paxton Blvd\u003C\u002Fspan>\u003Cbr>\n\u003Cspan class=\"locality\">St. Hedwig\u003C\u002Fspan>, \u003Cspan class=\"administrative-area\">TX\u003C\u002Fspan> \u003Cspan class=\"postal-code\">78152\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> Division of Southwest 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  \u003Cdiv class=\"field field--name-field-issuing-office-paragraph field--type-entity-reference-revisions field--label-above\">\n    \u003Cdiv class=\"field--label\">Secondary Issuing Offices\u003C\u002Fdiv>\n          \u003Cdiv class=\"field--items\">\n              \u003Cdiv class=\"field--item\">    \u003Cbr>\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\u003C\u002Fdiv>\n              \u003C\u002Fdiv>\n      \u003C\u002Fdiv>\n\n    \u003C\u002Fdl>\n  \u003C\u002Fdiv>  \n      \n\u003C\u002Fdiv>\n\n \n\n \n\n\u003Chr>\n\n\u003Cp>November 08, 2023\u003C\u002Fp>\n\n\u003Cp class=\"text-align-center\">\u003Cstrong>WARNING LETTER\u003C\u002Fstrong>\u003C\u002Fp>\n\n\u003Cp class=\"text-align-center\">Re: CMS # 666694\u003C\u002Fp>\n\n\u003Cp>Dear Ms. Cantu,\u003C\u002Fp>\n\n\u003Cp>On August 4, 2023 through August 9, 2023, the Food and Drug Administration (FDA) conducted a Foreign Supplier Verification Program (FSVP) inspection of Cavevi Naturals LLC., located at 25104 Brushline Rd., Edinburg, TX 78542-3451. We also conducted an inspection on December 16, 2020. 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>\n\n\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-foreignsupplier-verification-programs-fsvp-importers-food-humans-and-animals\u003C\u002Fp>\n\n\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 foods you import. Because of these significant violations, you are not in compliance with section 805 of the FD&C Act. At the conclusion of the inspection, our investigator provided you with Form FDA 483a, FSVP Observations.\u003C\u002Fp>\n\n\u003Cp>We acknowledge receipt of your written response dated August 31, 2023. In your response, you stated you are looking to hire a consultant to develop your FSVP which would take four months to complete. We are unable to evaluate the adequacy of your response because you have not provided any supporting documentation regarding your implementation of an FSVP or copies of your FSVPs.\u003C\u002Fp>\n\n\u003Cp>Your significant violations of the FSVP regulation are as follows:\u003C\u002Fp>\n\n\u003Cp>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 any of the foods you import, including:\u003C\u002Fp>\n\n\u003Cul>\n\t\u003Cli>\u003Cstrong>(b)(4)\u003C\u002Fstrong> candy imported from \u003Cstrong>(b)(4)\u003C\u002Fstrong>, located in \u003Cstrong>(b)(4)\u003C\u002Fstrong>\u003C\u002Fli>\n\t\u003Cli>\u003Cstrong>(b)(4)\u003C\u002Fstrong> candy imported from \u003Cstrong>(b)(4)\u003C\u002Fstrong>, located in \u003Cstrong>(b)(4)\u003C\u002Fstrong>\u003C\u002Fli>\n\t\u003Cli>Cheetos Nacho chips imported from \u003Cstrong>(b)(4)\u003C\u002Fstrong>, located in \u003Cstrong>(b)(4)\u003C\u002Fstrong>\u003C\u002Fli>\n\u003C\u002Ful>\n\n\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>\n\n\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>\n\n\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>\n\n\u003Cp>Please send your reply to the Food and Drug Administration, Attention: Ernesto Barba, Compliance Officer, Division of Southwest Imports, 9725 Via de la Amistad, Ste 200, San Diego, CA 92154. If you have any questions regarding this letter, you may contact Compliance Officer Ernesto Barba via email at Ernesto.Barba@fda.hhs.gov. Please reference CMS # 666694 on any documents or records you provide to us and\u002F or within the subject line of any email correspondence you send to us.\u003C\u002Fp>\n\n\u003Cp>Sincerely,\u003Cbr>\n\u002FS\u002F\u003C\u002Fp>\n\n\u003Cp>Todd Cato\u003Cbr>\nDirector\u003Cbr>\nDivision of Southwest Imports\u003Cbr>\nOne Main Place\u003Cbr>\n1201 Main Street, Suite 7200\u003Cbr>\nDallas, TX 75202\u003C\u002Fp>\n\n\u003Cp>\u003Cbr>\nCc:\u003Cbr>\nCavevi Naturals Llc\u003Cbr>\n13602 Paxton Blvd.\u003Cbr>\nSt. Hedwig, TX 78152\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\nMaria Cantu\n\nRecipient Title\n\nOwner\n\nCavevi Naturals LLC\n\n13602 Paxton Blvd\n\nSt. Hedwig, TX 78152\n\nUnited States\n\nIssuing Office:\n\nDivision of Southwest Imports\n\nUnited States\n\nSecondary Issuing Offices\n\nUnited States\n\nNovember 08, 2023\n\nWARNING LETTER\n\nRe: CMS # 666694\n\nDear Ms. Cantu,\n\nOn August 4, 2023 through August 9, 2023, the Food and Drug Administration (FDA) conducted a Foreign Supplier Verification Program (FSVP) inspection of Cavevi Naturals LLC., located at 25104 Brushline Rd., Edinburg, TX 78542-3451. We also conducted an inspection on December 16, 2020. 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.\n\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-foreignsupplier-verification-programs-fsvp-importers-food-humans-and-animals\n\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 foods you import. Because of these significant violations, you are not in compliance with section 805 of the FD&C Act. At the conclusion of the inspection, our investigator provided you with Form FDA 483a, FSVP Observations.\n\nWe acknowledge receipt of your written response dated August 31, 2023. In your response, you stated you are looking to hire a consultant to develop your FSVP which would take four months to complete. We are unable to evaluate the adequacy of your response because you have not provided any supporting documentation regarding your implementation of an FSVP or copies of your FSVPs.\n\nYour significant violations of the FSVP regulation are as follows:\n\nYou 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 any of the foods you import, including:\n\n(b)(4) candy imported from (b)(4), located in (b)(4)\n\n(b)(4) candy imported from (b)(4), located in (b)(4)\n\nCheetos Nacho chips imported from (b)(4), located in (b)(4)\n\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.\n\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)).\n\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.\n\nPlease send your reply to the Food and Drug Administration, Attention: Ernesto Barba, Compliance Officer, Division of Southwest Imports, 9725 Via de la Amistad, Ste 200, San Diego, CA 92154. If you have any questions regarding this letter, you may contact Compliance Officer Ernesto Barba via email at Ernesto.Barba@fda.hhs.gov. Please reference CMS # 666694 on any documents or records you provide to us and\u002F or within the subject line of any email correspondence you send to us.\n\nSincerely,\n\n\u002FS\u002F\n\nTodd Cato\n\nDirector\n\nDivision of Southwest Imports\n\nOne Main Place\n\n1201 Main Street, Suite 7200\n\nDallas, TX 75202\n\nCc:\n\nCavevi Naturals Llc\n\n13602 Paxton Blvd.\n\nSt. Hedwig, TX 78152","2026-08-20T00:20:59.78+00:00",[23,24,25,26,10,27,27,27],"\u003Ctime datetime=\"2024-01-30T14:20:00Z\">01\u002F30\u002F2024\u003C\u002Ftime>\n","\u003Ctime datetime=\"2023-11-08T05:00:00Z\">11\u002F08\u002F2023\u003C\u002Ftime>\n","\u003Ca href=\"\u002Finspections-compliance-enforcement-and-criminal-investigations\u002Fwarning-letters\u002Fcavevi-naturals-llc-666694-11082023\">Cavevi Naturals LLC\u003C\u002Fa>"," Division of Southwest Imports","","2026-08-18T06:42:28.994808+00:00","2026-08-20T02:24:56.185295+00:00",{"510k":31,"classification":32,"enforcement":33,"event":34,"pma":35,"warning_letter":36},"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"]