[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-warning-letter-chula-vista-imports-ltd-614758-09082021":3,"fda-latest-sync-dates":32},{"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":13,"case_status":14,"letter_url":15,"reference_number":8,"marcs_cms_no":16,"product_type":17,"delivery_method":18,"recipient_name":19,"recipient_title":8,"body_html":20,"body_text":21,"body_fetched_at":22,"medical_device_id":8,"raw":23,"created_at":30,"updated_at":31},3139,"chula-vista-imports-ltd-614758-09082021","Warning Letter","Chula Vista Imports Ltd.",null,"Division of Northern Border Imports","Foreign Supplier Verification Program (FSVP)","2021-09-14","2021-09-08","2023-02-24","Closed Out","https:\u002F\u002Fwww.fda.gov\u002Finspections-compliance-enforcement-and-criminal-investigations\u002Fwarning-letters\u002Fchula-vista-imports-ltd-614758-09082021","614758","Food & Beverages","Via Express Delivery","J. Trinidad Sandoval","\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\">J. Trinidad Sandoval\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>Chula Vista Imports Ltd.\u003C\u002Fdd>\n\n          \n                      \u003Cdd>\u003Cp class=\"address\" translate=\"no\">\u003Cspan class=\"address-line1\">2541 S. Damen Ave Unit A\u003C\u002Fspan>\u003Cbr>\n\u003Cspan class=\"locality\">Chicago\u003C\u002Fspan>, \u003Cspan class=\"administrative-area\">IL\u003C\u002Fspan> \u003Cspan class=\"postal-code\">60608-5206\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 Northern Border 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>September 8, 2021\u003C\u002Fp>\n\n\u003Cp class=\"text-align-center\">\u003Cstrong>WARNING LETTER\u003C\u002Fstrong>\u003C\u002Fp>\n\n\u003Cp class=\"text-align-center\">\u003Cbr>\nRe: CMS # 614758\u003C\u002Fp>\n\n\u003Cp>Dear Mr. Sandoval:\u003C\u002Fp>\n\n\u003Cp>On April 15, 2021 through April 22, 2021 the United States Food and Drug Administration (FDA) conducted a Foreign Supplier Verification Program (FSVP) inspection of Chula Vista Imports Ltd. located at 2541 S. Damen Ave, Unit A, Chicago, IL 60608-5206. We also conducted an inspection on July 11, 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 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 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. We have not received your response to the Form FDA 483a issued on April 22, 2021.\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 1.502(a). Specifically, you did not develop an FSVP for any of the foods you import, including the following foods:\u003C\u002Fp>\n\n\u003Cp>• Frozen Strawberries imported from Productores Agricolas de Jacona, Located in Mexico\u003Cbr>\n• Frozen Mango cube imported from \u003Cstrong>(b)(4)\u003C\u002Fstrong>\u003Cbr>\n• Chocolate Flavored coating imported from \u003Cstrong>(b)(4)\u003C\u002Fstrong>\u003C\u002Fp>\n\n\u003Cp>The above violation(s) 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 products. You can find DWPE information relating to FSVP in Import Alert # 99-41, at \u003Ca href=\"https:\u002F\u002Fwww.accessdata.fda.gov\u002Fcms_ia\u002Fialist.html\">https:\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 (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 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 email your reply to Food and Drug Administration, Attention: Julie Scoma, Compliance Officer, Division of Northern Border Imports, at Julie.Scoma@fda.hhs.gov. Please reference CMS #614758 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>Keith J. Jasukaitis\u003Cbr>\nProgram Division Director\u003Cbr>\nDivision of Northern Border 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\nJ. Trinidad Sandoval\n\nRecipient Title\n\nOwner\n\nChula Vista Imports Ltd.\n\n2541 S. Damen Ave Unit A\n\nChicago, IL 60608-5206\n\nUnited States\n\nIssuing Office:\n\nDivision of Northern Border Imports\n\nUnited States\n\nSeptember 8, 2021\n\nWARNING LETTER\n\nRe: CMS # 614758\n\nDear Mr. Sandoval:\n\nOn April 15, 2021 through April 22, 2021 the United States Food and Drug Administration (FDA) conducted a Foreign Supplier Verification Program (FSVP) inspection of Chula Vista Imports Ltd. located at 2541 S. Damen Ave, Unit A, Chicago, IL 60608-5206. We also conducted an inspection on July 11, 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 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 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. We have not received your response to the Form FDA 483a issued on April 22, 2021.\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 1.502(a). Specifically, you did not develop an FSVP for any of the foods you import, including the following foods:\n\n• Frozen Strawberries imported from Productores Agricolas de Jacona, Located in Mexico\n\n• Frozen Mango cube imported from (b)(4)\n\n• Chocolate Flavored coating imported from (b)(4)\n\nThe above violation(s) 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 products. You can find DWPE information relating to FSVP in Import Alert # 99-41, at https:\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 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 email your reply to Food and Drug Administration, Attention: Julie Scoma, Compliance Officer, Division of Northern Border Imports, at Julie.Scoma@fda.hhs.gov. Please reference CMS #614758 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\nKeith J. Jasukaitis\n\nProgram Division Director\n\nDivision of Northern Border Imports","2026-08-20T02:36:04.566+00:00",[24,25,26,9,27,28,29,28],"\u003Ctime datetime=\"2021-09-14T13:20:00Z\">09\u002F14\u002F2021\u003C\u002Ftime>\n","\u003Ctime datetime=\"2021-09-08T04:00:00Z\">09\u002F08\u002F2021\u003C\u002Ftime>\n","\u003Ca href=\"\u002Finspections-compliance-enforcement-and-criminal-investigations\u002Fwarning-letters\u002Fchula-vista-imports-ltd-614758-09082021\">Chula Vista Imports Ltd.\u003C\u002Fa>","Foreign Supplier Verification Program (FSVP)\u003Cbr \u002F>\r\n","","\u003Ca href=\"\u002Finspections-compliance-enforcement-and-criminal-investigations\u002Fwarning-letters\u002Fchula-vista-imports-ltd-614758-02142023\">\u003Ctime datetime=\"2023-02-24T05:00:00Z\">02\u002F24\u002F2023\u003C\u002Ftime>\n\u003C\u002Fa>","2026-08-18T06:42:29.386127+00:00","2026-08-20T02:36:06.709807+00:00",{"510k":33,"classification":34,"enforcement":35,"event":36,"pma":37,"warning_letter":38},"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"]