[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-warning-letter-del-valle-import-export-3-inc-dba-el-progreso-imports-657322-07182023":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},1863,"del-valle-import-export-3-inc-dba-el-progreso-imports-657322-07182023","Warning Letter","Del Valle Import & Export 3, Inc. DBA El Progreso Imports",null,"Division of West Coast Imports","Foreign Supplier Verification Program (FSVP)","2023-09-12","2023-07-18","Issued","https:\u002F\u002Fwww.fda.gov\u002Finspections-compliance-enforcement-and-criminal-investigations\u002Fwarning-letters\u002Fdel-valle-import-export-3-inc-dba-el-progreso-imports-657322-07182023","657322","Food & Beverages","United Parcel Service","Ms. Nely Olivera Garcia","\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\">United Parcel Service\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\">Ms. Nely Olivera Garcia\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\u002FChief Executive Officer\u003C\u002Fdiv>\n          \u003C\u002Fdiv>\n\u003C\u002Fdd>\n          \n            \u003Cdd>Del Valle Import & Export 3, Inc. DBA El Progreso Imports\u003C\u002Fdd>\n\n          \n                      \u003Cdd>\u003Cp class=\"address\" translate=\"no\">\u003Cspan class=\"address-line1\">2824 E 54th St\u003C\u002Fspan>\u003Cbr>\n\u003Cspan class=\"locality\">Vernon\u003C\u002Fspan>, \u003Cspan class=\"administrative-area\">CA\u003C\u002Fspan> \u003Cspan class=\"postal-code\">90058-3632\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 West Coast 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>July 18, 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 #657322\u003C\u002Fp>\n\n\u003Cp>Dear Ms. Nely Olivera Garcia:\u003C\u002Fp>\n\n\u003Cp>From February 22, 2023 through February 28, 2023, the Food and Drug Administration (FDA) conducted a Foreign Supplier Verification Program (FSVP) inspection at Del Valle Import & Export 3, Inc. dba El Progreso Imports located at 2824 E 54th St, Vernon, CA 90058-3632. We also conducted inspections from September 7 through September 13, 2022; February 4 through March 5, 2021; and February 6 through February 12, 2019. 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 FSVP implementing 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\u002FGuidanceRegulation\u002FFSMA\u002Fucm361902.htm\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 from the foreign suppliers indicated in the list provided during the inspection. 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 a Form FDA 483a, FSVP Observations.\u003C\u002Fp>\n\n\u003Cp>Your significant violations of the FSVP regulation are as follows:\u003C\u002Fp>\n\n\u003Cp>1. You did not develop, maintain, and follow an FSVP, as required by section 805 of the FD&C Act and 21 CFR 1.502(a). Specifically, you did not develop an FSVP for the foods from the foreign suppliers indicated in the list provided during the inspection.\u003C\u002Fp>\n\n\u003Cp>Your written response dated March 20, 2023, provided FSVP records from your current consultant for your Corn Chip Snacks, imported from \u003Cstrong>(b)(4)\u003C\u002Fstrong>. You also provided FSVP records from 2020 and 2021 from your previous consultant for your Plantain Chips imported from \u003Cstrong>(b)(4)\u003C\u002Fstrong> and Banana Soft Drink imported from \u003Cstrong>(b)(4)\u003C\u002Fstrong>. However, your written response did not provide records for any other products you import. Your written response also stated that you were taking a number of actions to show that you are in the process of \u003Cstrong>(b)(4)\u003C\u002Fstrong>. However, we cannot evaluate the adequacy of these corrective actions because your written response does not indicate that you have completed any of these actions or provided a timeframe for doing so. We will evaluate the adequacy of any corrective actions at the next FSVP inspection.\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 food products you import for which you appear to be in violation of section 805. We may place the foods you import 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 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 revised 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 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: Dennis N. Hoang, Compliance Officer, Division of West Coast Imports, One World Trade Center, Suite 300, Long Beach, CA 90831, with a copy via electronic mail to WCID@fda.hhs.gov. If you have any questions regarding this letter, you may contact Compliance Officer Hoang via email at dennis.hoang@fda.hhs.gov. Please reference CMS #657322 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\u003C\u002Fp>\n\n\u003Cp>Kathleen Turner, DVM\u003Cbr>\nProgram Division Director\u003Cbr>\nDivision of West Coast 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\nUnited Parcel Service\n\nProduct:\n\nFood & Beverages\n\nRecipient:\n\nRecipient Name\n\nMs. Nely Olivera Garcia\n\nRecipient Title\n\nPresident\u002FChief Executive Officer\n\nDel Valle Import & Export 3, Inc. DBA El Progreso Imports\n\n2824 E 54th St\n\nVernon, CA 90058-3632\n\nUnited States\n\nIssuing Office:\n\nDivision of West Coast Imports\n\nUnited States\n\nJuly 18, 2023\n\nWARNING LETTER\n\nRe: CMS #657322\n\nDear Ms. Nely Olivera Garcia:\n\nFrom February 22, 2023 through February 28, 2023, the Food and Drug Administration (FDA) conducted a Foreign Supplier Verification Program (FSVP) inspection at Del Valle Import & Export 3, Inc. dba El Progreso Imports located at 2824 E 54th St, Vernon, CA 90058-3632. We also conducted inspections from September 7 through September 13, 2022; February 4 through March 5, 2021; and February 6 through February 12, 2019. 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 FSVP implementing 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\u002FGuidanceRegulation\u002FFSMA\u002Fucm361902.htm\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 from the foreign suppliers indicated in the list provided during the inspection. 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 a Form FDA 483a, FSVP Observations.\n\nYour significant violations of the FSVP regulation are as follows:\n\n1. You did not develop, maintain, and follow an FSVP, as required by section 805 of the FD&C Act and 21 CFR 1.502(a). Specifically, you did not develop an FSVP for the foods from the foreign suppliers indicated in the list provided during the inspection.\n\nYour written response dated March 20, 2023, provided FSVP records from your current consultant for your Corn Chip Snacks, imported from (b)(4). You also provided FSVP records from 2020 and 2021 from your previous consultant for your Plantain Chips imported from (b)(4) and Banana Soft Drink imported from (b)(4). However, your written response did not provide records for any other products you import. Your written response also stated that you were taking a number of actions to show that you are in the process of (b)(4). However, we cannot evaluate the adequacy of these corrective actions because your written response does not indicate that you have completed any of these actions or provided a timeframe for doing so. We will evaluate the adequacy of any corrective actions at the next FSVP inspection.\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 products you import for which you appear to be in violation of section 805. We may place the foods you import 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 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 revised 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 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: Dennis N. Hoang, Compliance Officer, Division of West Coast Imports, One World Trade Center, Suite 300, Long Beach, CA 90831, with a copy via electronic mail to WCID@fda.hhs.gov. If you have any questions regarding this letter, you may contact Compliance Officer Hoang via email at dennis.hoang@fda.hhs.gov. Please reference CMS #657322 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\nKathleen Turner, DVM\n\nProgram Division Director\n\nDivision of West Coast Imports","2026-08-20T00:41:50.156+00:00",[23,24,25,26,10,27,27,27],"\u003Ctime datetime=\"2023-09-12T13:20:00Z\">09\u002F12\u002F2023\u003C\u002Ftime>\n","\u003Ctime datetime=\"2023-07-18T04:00:00Z\">07\u002F18\u002F2023\u003C\u002Ftime>\n","\u003Ca href=\"\u002Finspections-compliance-enforcement-and-criminal-investigations\u002Fwarning-letters\u002Fdel-valle-import-export-3-inc-dba-el-progreso-imports-657322-07182023\">Del Valle Import & Export 3, Inc. DBA El Progreso Imports\u003C\u002Fa>"," Division of West Coast 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"]