[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-warning-letter-paso-real-produce-llc-691665-10012024":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},1196,"paso-real-produce-llc-691665-10012024","Warning Letter","Paso Real Produce LLC",null,"Division of Southwest Imports","Foreign Supplier Verification Program (FSVP)","2024-10-29","2024-10-01","Issued","https:\u002F\u002Fwww.fda.gov\u002Finspections-compliance-enforcement-and-criminal-investigations\u002Fwarning-letters\u002Fpaso-real-produce-llc-691665-10012024","691665","Food & Beverages","Via Express Delivery","Mr. Salvador Pulido Novoa","\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. Salvador Pulido Novoa\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\u002FPresident \u003C\u002Fdiv>\n          \u003C\u002Fdiv>\n\u003C\u002Fdd>\n          \n            \u003Cdd>Paso Real Produce LLC\u003C\u002Fdd>\n\n          \n                      \u003Cdd>\u003Cp class=\"address\" translate=\"no\">\u003Cspan class=\"address-line1\">1301 W. Capote Central Ave.\u003C\u002Fspan>\u003Cbr>\n\u003Cspan class=\"locality\">Pharr\u003C\u002Fspan>, \u003Cspan class=\"administrative-area\">TX\u003C\u002Fspan> \u003Cspan class=\"postal-code\">78577\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:salvador@pasorealproduce.com\"> salvador@pasorealproduce.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>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    \u003C\u002Fdl>\n  \u003C\u002Fdiv>  \n      \n\u003C\u002Fdiv>\n\n \n\n \n\n\u003Chr>\n\n\u003Cp>October 1, 2024\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 # 691665\u003C\u002Fp>\n\n\u003Cp>Dear Mr. Pulido,  \u003C\u002Fp>\n\n\u003Cp>On August 9-14, 2024, the Food and Drug Administration (FDA) conducted a Foreign Supplier Verification Program (FSVP) inspection of Paso Real Produce, LLC located at 1301 W. Capote Central Ave., Pharr, TX 78577.  We also conducted inspections on September 10, 2021 and April 4-5, 2023. 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-ruleforeign-supplier-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 this significant violation, you are not in compliance with section 805 of the FD&C Act.  \u003C\u002Fp>\n\n\u003Cp>At the conclusion of the inspection, our investigator provided you with a Form FDA 483a FSVP Observations.\u003C\u002Fp>\n\n\u003Cp>We have not received your response to the Form 483a issued on August 14, 2024.\u003C\u002Fp>\n\n\u003Cp>Your significant violation 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, your firm did not develop an FSVP for any of the foods you import, including each of the following:  \u003C\u002Fp>\n\n\u003Cul>\n\t\u003Cli>Avocados imported from \u003Cstrong>(b)(4)\u003C\u002Fstrong> located in \u003Cstrong>(b)(4)\u003C\u002Fstrong>\u003C\u002Fli>\n\t\u003Cli>Limes imported from \u003Cstrong>(b)(4)\u003C\u002Fstrong> located in \u003Cstrong>(b)(4)\u003C\u002Fstrong>\u003C\u002Fli>\n\t\u003Cli>Limes imported from \u003Cstrong>(b)(4)\u003C\u002Fstrong> located in \u003Cstrong>(b)(4)\u003C\u002Fstrong>\u003C\u002Fli>\n\t\u003Cli>Limes imported from \u003Cstrong>(b)(4)\u003C\u002Fstrong> located in \u003Cstrong>(b)(4)\u003C\u002Fstrong>\u003C\u002Fli>\n\u003C\u002Ful>\n\n\u003Cp>This is a repeat observation from the previous inspections conducted on September 10, 2021 and April 4-5, 2023  \u003C\u002Fp>\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 foods you import which appear to be in violation of section 805. We may place these 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: Rosa Linda Santos, Compliance Officer, Division of Southwest Imports, 1201 Main Street, Suite 7200, Dallas, TX, 75202.  If you have any questions regarding this letter, or wish to provide your response via email, you may contact Rosa Linda Santos at rosa.santos@fda.hhs.gov.   Please reference CMS #691665 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>\n\n\u003Cp>Sincerely,\u003Cbr>\n\u002FS\u002F\u003Cbr>\nTodd Cato\u003Cbr>\nProgram Division Director\u003Cbr>\nDivision of Southwest Imports  \u003Cbr>\n1201 Main Street, Suite 7200\u003Cbr>\nDallas, TX 75202 \u003C\u002Fp>\n\n\u003Cp>Cc: Paso Real Produce LLC        \u003Cbr>\n1301 W. Capote Central Ave.      \u003Cbr>\nPharr, TX 78577\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. Salvador Pulido Novoa\n\nRecipient Title\n\nOwner\u002FPresident\n\nPaso Real Produce LLC\n\n1301 W. Capote Central Ave.\n\nPharr, TX 78577\n\nUnited States\n\nsalvador@pasorealproduce.com\n\nIssuing Office:\n\nDivision of Southwest Imports\n\nUnited States\n\nOctober 1, 2024\n\nWARNING LETTER\n\nRe: CMS # 691665\n\nDear Mr. Pulido,\n\nOn August 9-14, 2024, the Food and Drug Administration (FDA) conducted a Foreign Supplier Verification Program (FSVP) inspection of Paso Real Produce, LLC located at 1301 W. Capote Central Ave., Pharr, TX 78577. We also conducted inspections on September 10, 2021 and April 4-5, 2023. 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-ruleforeign-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 this significant violation, you are not in compliance with section 805 of the FD&C Act.\n\nAt the conclusion of the inspection, our investigator provided you with a Form FDA 483a FSVP Observations.\n\nWe have not received your response to the Form 483a issued on August 14, 2024.\n\nYour significant violation 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, your firm did not develop an FSVP for any of the foods you import, including each of the following:\n\nAvocados imported from (b)(4) located in (b)(4)\n\nLimes imported from (b)(4) located in (b)(4)\n\nLimes imported from (b)(4) located in (b)(4)\n\nLimes imported from (b)(4) located in (b)(4)\n\nThis is a repeat observation from the previous inspections conducted on September 10, 2021 and April 4-5, 2023\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 foods you import which appear to be in violation of section 805. We may place these 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: Rosa Linda Santos, Compliance Officer, Division of Southwest Imports, 1201 Main Street, Suite 7200, Dallas, TX, 75202. If you have any questions regarding this letter, or wish to provide your response via email, you may contact Rosa Linda Santos at rosa.santos@fda.hhs.gov. Please reference CMS #691665 on any documents or records you provide to us and\u002For within the subject line of any email correspondence you send to us.\n\nSincerely,\n\n\u002FS\u002F\n\nTodd Cato\n\nProgram Division Director\n\nDivision of Southwest Imports\n\n1201 Main Street, Suite 7200\n\nDallas, TX 75202\n\nCc: Paso Real Produce LLC\n\n1301 W. Capote Central Ave.\n\nPharr, TX 78577","2026-08-19T21:55:14.304+00:00",[23,24,25,9,10,26,26,26],"\u003Ctime datetime=\"2024-10-29T13:20:00Z\">10\u002F29\u002F2024\u003C\u002Ftime>\n","\u003Ctime datetime=\"2024-10-01T04:00:00Z\">10\u002F01\u002F2024\u003C\u002Ftime>\n","\u003Ca href=\"\u002Finspections-compliance-enforcement-and-criminal-investigations\u002Fwarning-letters\u002Fpaso-real-produce-llc-691665-10012024\">Paso Real Produce LLC\u003C\u002Fa>","","2026-08-18T06:42:28.856152+00:00","2026-08-20T02:24:56.037289+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"]