[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-warning-letter-lempira-distribution-llc-616514-11032021":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},2667,"lempira-distribution-llc-616514-11032021","Warning Letter","Lempira Distribution LLC",null,"Division of Southeast Imports","Foreign Supplier Verification Program (FSVP)","2022-05-17","2021-11-03","Issued","https:\u002F\u002Fwww.fda.gov\u002Finspections-compliance-enforcement-and-criminal-investigations\u002Fwarning-letters\u002Flempira-distribution-llc-616514-11032021","616514","Food & Beverages","Via Express Delivery","Mr. Carlos Vigil-Arrieta","\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. Carlos Vigil-Arrieta\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>Lempira Distribution LLC\u003C\u002Fdd>\n\n          \n                      \u003Cdd>\u003Cp class=\"address\" translate=\"no\">\u003Cspan class=\"address-line1\">8519 NW 72nd St.\u003C\u002Fspan>\u003Cbr>\n\u003Cspan class=\"locality\">Miami\u003C\u002Fspan>, \u003Cspan class=\"administrative-area\">FL\u003C\u002Fspan> \u003Cspan class=\"postal-code\">33166-2349\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 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>November 3, 2021\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 # 616514\u003C\u002Fp>\n\n\u003Cp>Dear Mr. Vigil-Arrieta:\u003C\u002Fp>\n\n\u003Cp>From June 9, 2021 through July 16, 2021, the Food and Drug Administration (FDA) conducted a Foreign Supplier Verification Program (FSVP) inspection of Lempira Distribution LLC, located at 8519 NW 72nd St. Miami, FL 33166. We also conducted an inspection from December 15 through December 18, 2017. 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 \u003Ca href=\"https:\u002F\u002Fwww.fda.gov\u002Ffood\u002Ffood-safety-modernization-act-fsma\u002Ffsma-final-rule-foreign-supplier-verification-programs-fsvp-importers-food-humans-and-animals\">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\u002Fa>.\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.\u003C\u002Fp>\n\n\u003Cp>At the conclusion of the inspection on July 16, 2021, our investigator provided you with a Form FDA 483a, FSVP Observations. We acknowledge receipt of your response dated July 26, 2021, and we address your response below.\u003C\u002Fp>\n\n\u003Cp>Your response stated that you are working on a food safety plan for each of your products and working with \u003Cstrong>(b)(4) \u003C\u002Fstrong>to create your FSVPs. You stated that you hoped to have a completed FSVP per product in the next few weeks. We are unable to evaluate the adequacy of your response because you did not provide further details or documentation regarding implementation of an FSVP program, and we have not received copies of your FSVPs to date.\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 implement an FSVP as required by section 805 of the FD&C Act and 21 CFR 1.502(a). Specifically, you did not develop FSVPs for the food products that you import, including, but not limited to:\u003C\u002Fp>\n\n\u003Cul>\n\t\u003Cli>Banana Soft Drink, imported from \u003Cstrong>(b)(4)\u003C\u002Fstrong>, located in \u003Cstrong>(b)(4)\u003C\u002Fstrong>.\u003C\u002Fli>\n\t\u003Cli>Sweet Bread, imported from \u003Cstrong>(b)(4)\u003C\u002Fstrong>, located in \u003Cstrong>(b)(4)\u003C\u002Fstrong>.\u003C\u002Fli>\n\t\u003Cli>\u003Cstrong>(b)(4)\u003C\u002Fstrong> Plantain Chips, imported from \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>\u003Cstrong>(b)(3)(A)\u003C\u002Fstrong>\u003C\u002Fp>\n\n\u003Cp>As a responsible official of a facility that manufactures\u002Fprocesses, packs, or holds food for human or animal consumption in the United States, you are responsible for ensuring that your overall operation and the products you distribute are in compliance with the law.\u003C\u002Fp>\n\n\u003Cp>\u003Cstrong>(b)(3)(A)\u003C\u002Fstrong>\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 \u003Ca href=\"http:\u002F\u002Fwww.accessdata.fda.gov\u002Fcms_ia\u002Fialist.html\">http:\u002F\u002Fwww.accessdata.fda.gov\u002Fcms_ia\u002Fialist.html\u003C\u002Fa>. 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.\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 these 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 your products 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 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 Food and Drug Administration, Attention: Ms. Ruth Dixon, Program Division Director, Division of Southeast Imports, 404 BNA Drive, Building 200 - Suite 500 Nashville, TN 37217-2565. If you have any questions regarding this letter, you may contact Ms. Coral del Mar Lopez, Compliance Officer via email at coraldelmar.lopez@fda.hhs.gov. Please reference CMS #616514 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\u003Cbr>\nRuth Dixon\u003Cbr>\nProgram Division Director\u003Cbr>\nDivision of Southeast Imports\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\nMr. Carlos Vigil-Arrieta\n\nRecipient Title\n\nPresident\n\nLempira Distribution LLC\n\n8519 NW 72nd St.\n\nMiami, FL 33166-2349\n\nUnited States\n\nIssuing Office:\n\nDivision of Southeast Imports\n\nUnited States\n\nNovember 3, 2021\n\nWARNING LETTER\n\nRe: CMS # 616514\n\nDear Mr. Vigil-Arrieta:\n\nFrom June 9, 2021 through July 16, 2021, the Food and Drug Administration (FDA) conducted a Foreign Supplier Verification Program (FSVP) inspection of Lempira Distribution LLC, located at 8519 NW 72nd St. Miami, FL 33166. We also conducted an inspection from December 15 through December 18, 2017. 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-foreign-supplier-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.\n\nAt the conclusion of the inspection on July 16, 2021, our investigator provided you with a Form FDA 483a, FSVP Observations. We acknowledge receipt of your response dated July 26, 2021, and we address your response below.\n\nYour response stated that you are working on a food safety plan for each of your products and working with (b)(4) to create your FSVPs. You stated that you hoped to have a completed FSVP per product in the next few weeks. We are unable to evaluate the adequacy of your response because you did not provide further details or documentation regarding implementation of an FSVP program, and we have not received copies of your FSVPs to date.\n\nYour significant violations of the FSVP regulation are as follows:\n\nYou did not develop, maintain, and implement an FSVP as required by section 805 of the FD&C Act and 21 CFR 1.502(a). Specifically, you did not develop FSVPs for the food products that you import, including, but not limited to:\n\nBanana Soft Drink, imported from (b)(4), located in (b)(4).\n\nSweet Bread, imported from (b)(4), located in (b)(4).\n\n(b)(4) Plantain Chips, imported from (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\n(b)(3)(A)\n\nAs a responsible official of a facility that manufactures\u002Fprocesses, packs, or holds food for human or animal consumption in the United States, you are responsible for ensuring that your overall operation and the products you distribute are in compliance with the law.\n\n(b)(3)(A)\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.\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 these 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 your products 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 days, you should explain the reason for your delay and state when you will correct any remaining violations.\n\nPlease send your reply to Food and Drug Administration, Attention: Ms. Ruth Dixon, Program Division Director, Division of Southeast Imports, 404 BNA Drive, Building 200 - Suite 500 Nashville, TN 37217-2565. If you have any questions regarding this letter, you may contact Ms. Coral del Mar Lopez, Compliance Officer via email at coraldelmar.lopez@fda.hhs.gov. Please reference CMS #616514 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\nRuth Dixon\n\nProgram Division Director\n\nDivision of Southeast Imports","2026-08-20T01:54:09.505+00:00",[23,24,25,9,10,26,26,26],"\u003Ctime datetime=\"2022-05-17T13:20:00Z\">05\u002F17\u002F2022\u003C\u002Ftime>\n","\u003Ctime datetime=\"2021-11-03T04:00:00Z\">11\u002F03\u002F2021\u003C\u002Ftime>\n","\u003Ca href=\"\u002Finspections-compliance-enforcement-and-criminal-investigations\u002Fwarning-letters\u002Flempira-distribution-llc-616514-11032021\">Lempira Distribution LLC\u003C\u002Fa>","","2026-08-18T06:42:29.262718+00:00","2026-08-20T02:24:56.48659+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"]