[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-warning-letter-la-ilusion-fresh-guava-inc-631141-05122022":3,"fda-latest-sync-dates":31},{"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":29,"updated_at":30},2591,"la-ilusion-fresh-guava-inc-631141-05122022","Warning Letter","La Ilusion Fresh Guava Inc.",null,"Division of Northern Border Imports","Foreign Supplier Verification Program (FSVP)","2022-07-05","2022-05-12","2023-03-14","Closed Out","https:\u002F\u002Fwww.fda.gov\u002Finspections-compliance-enforcement-and-criminal-investigations\u002Fwarning-letters\u002Fla-ilusion-fresh-guava-inc-631141-05122022","631141","Food & Beverages","Via Express Delivery","Mr. Javier Serna Flores","\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. Javier Serna Flores\u003C\u002Fdiv>\n          \u003C\u002Fdiv>\n\u003C\u002Fdd>\n                    \n            \u003Cdd>La Ilusion Fresh Guava Inc.\u003C\u002Fdd>\n\n          \n                      \u003Cdd>\u003Cp class=\"address\" translate=\"no\">\u003Cspan class=\"address-line1\">5100 Tomcin Trl.\u003C\u002Fspan>\u003Cbr>\n\u003Cspan class=\"locality\">Oak Lawn\u003C\u002Fspan>, \u003Cspan class=\"administrative-area\">IL\u003C\u002Fspan> \u003Cspan class=\"postal-code\">60453-5056\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>May 12, 2022\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 # 631141\u003C\u002Fp>\n\n\u003Cp>Dear Mr. Javier Serna Flores:\u003C\u002Fp>\n\n\u003Cp>On March 4, 2022, the Food and Drug Administration (FDA) conducted a Foreign Supplier Verification Program (FSVP) inspection of La Ilusion Fresh Guava Inc. located at 5100 Tomcin Trl, Oak Lawn, IL 60453-5056. We also conducted an inspection that concluded on April 22, 2021. 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\">FSMA Final Rule on Foreign Supplier Verification Programs (FSVP) for Importers of Food for Humans and Animals | FDA\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, our investigator provided you with a Form FDA 483a FSVP Observations. We have not received your response to the Form FDA 483a issued on March 4, 2022.\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>1) Fresh Guava imported from \u003Cstrong>(b)(4)\u003C\u002Fstrong>\u003Cbr>\n2) Fresh Guava imported from \u003Cstrong>(b)(4)\u003C\u002Fstrong>\u003Cbr>\n3) Fresh Guava imported from \u003Cstrong>(b)(4)\u003C\u002Fstrong>\u003Cbr>\n4) Fresh Pitaya \u002F Dragon Fruit imported from \u003Cstrong>(b)(4)\u003C\u002Fstrong>\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 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 (21 U.S.C. 331(zz)).\u003C\u002Fp>\n\n\u003Cp>In addition to the violations above, we offer the following comments:\u003C\u002Fp>\n\n\u003Cp>We note that you may meet the definition of a “very small importer” under 21 CFR 1.500. If you meet the definition, you are still required to follow FSVP requirements. If you are a very small importer and you choose to comply with the modified requirements in 21 CFR 1.512, you must document that you meet the definition of very small importer as required per 21 CFR 1.512(b)(1)(i). If this section applies and you choose to comply with the requirements in paragraph (b) of this section, you are required to comply with the requirements in sections 1.502, 1.503, and 1.509. However, you are not required to comply with the requirements in sections 1.504 through 1.508 or 1.510. In addition, for each food you import, you must obtain written assurance, before importing the food and at least every 2 years thereafter, that your foreign supplier is producing the food in compliance with processes and procedures that provide at least the same level of public health protection as those required under section 418 or 419 of the FD&C Act, if either is applicable, and the implementing regulations, and is producing the food in compliance with sections 402 and 403(w) of the FD&C Act (21 CFR 1.512(b)(3)(i)).\u003C\u002Fp>\n\n\u003Cp>Furthermore, we note that under 21 CFR 1.509, for each line entry of food product offered for importation into the United States, the FSVP importer must provide its name, electronic mail (i.e., email) address, and unique facility identifier (UFI) recognized as acceptable by FDA electronically when filing entry with U.S. Customs and Border Protection. The FSVP importer’s Data Universal Numbering System (DUNS) number is the UFI that is initially recognized as acceptable by FDA. DUNS numbers are assigned and managed by Dun & Bradstreet. You can find the Guidance for Industry: Compliance with Providing an Acceptable Unique Facility Identifier for the Foreign Supplier Verification Programs for Food Importers Regulation at \u003Ca href=\"https:\u002F\u002Fwww.fda.gov\u002Fregulatory-information\u002Fsearch-fda-guidance-documents\u002Fguidance-industry-compliance-providing-acceptable-unique-facility-identifier-foreign-supplier\">https:\u002F\u002Fwww.fda.gov\u002Fregulatory-information\u002Fsearch-fda-guidance-documents\u002Fguidance-industry-compliance-providing-acceptable-unique-facility-identifier-foreign-supplier\u003C\u002Fa>.\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 Food and Drug Administration, Attention: Rachele A. Saisselin, Compliance Officer, Division of Northern Border Imports. If you have any questions regarding this letter, you may contact Compliance Officer Saisselin via email at Rachele.Saisselin@fda.hhs.gov. Please reference CMS #631141 on any documents or records you provide to us and on 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\nMr. Javier Serna Flores\n\nLa Ilusion Fresh Guava Inc.\n\n5100 Tomcin Trl.\n\nOak Lawn, IL 60453-5056\n\nUnited States\n\nIssuing Office:\n\nDivision of Northern Border Imports\n\nUnited States\n\nMay 12, 2022\n\nWARNING LETTER\n\nRe: CMS # 631141\n\nDear Mr. Javier Serna Flores:\n\nOn March 4, 2022, the Food and Drug Administration (FDA) conducted a Foreign Supplier Verification Program (FSVP) inspection of La Ilusion Fresh Guava Inc. located at 5100 Tomcin Trl, Oak Lawn, IL 60453-5056. We also conducted an inspection that concluded on April 22, 2021. 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 FSMA Final Rule on Foreign Supplier Verification Programs (FSVP) for Importers of Food for Humans and Animals | FDA.\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, our investigator provided you with a Form FDA 483a FSVP Observations. We have not received your response to the Form FDA 483a issued on March 4, 2022.\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\n1) Fresh Guava imported from (b)(4)\n\n2) Fresh Guava imported from (b)(4)\n\n3) Fresh Guava imported from (b)(4)\n\n4) Fresh Pitaya \u002F Dragon Fruit 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\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\nIn addition to the violations above, we offer the following comments:\n\nWe note that you may meet the definition of a “very small importer” under 21 CFR 1.500. If you meet the definition, you are still required to follow FSVP requirements. If you are a very small importer and you choose to comply with the modified requirements in 21 CFR 1.512, you must document that you meet the definition of very small importer as required per 21 CFR 1.512(b)(1)(i). If this section applies and you choose to comply with the requirements in paragraph (b) of this section, you are required to comply with the requirements in sections 1.502, 1.503, and 1.509. However, you are not required to comply with the requirements in sections 1.504 through 1.508 or 1.510. In addition, for each food you import, you must obtain written assurance, before importing the food and at least every 2 years thereafter, that your foreign supplier is producing the food in compliance with processes and procedures that provide at least the same level of public health protection as those required under section 418 or 419 of the FD&C Act, if either is applicable, and the implementing regulations, and is producing the food in compliance with sections 402 and 403(w) of the FD&C Act (21 CFR 1.512(b)(3)(i)).\n\nFurthermore, we note that under 21 CFR 1.509, for each line entry of food product offered for importation into the United States, the FSVP importer must provide its name, electronic mail (i.e., email) address, and unique facility identifier (UFI) recognized as acceptable by FDA electronically when filing entry with U.S. Customs and Border Protection. The FSVP importer’s Data Universal Numbering System (DUNS) number is the UFI that is initially recognized as acceptable by FDA. DUNS numbers are assigned and managed by Dun & Bradstreet. You can find the Guidance for Industry: Compliance with Providing an Acceptable Unique Facility Identifier for the Foreign Supplier Verification Programs for Food Importers Regulation at https:\u002F\u002Fwww.fda.gov\u002Fregulatory-information\u002Fsearch-fda-guidance-documents\u002Fguidance-industry-compliance-providing-acceptable-unique-facility-identifier-foreign-supplier.\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 Food and Drug Administration, Attention: Rachele A. Saisselin, Compliance Officer, Division of Northern Border Imports. If you have any questions regarding this letter, you may contact Compliance Officer Saisselin via email at Rachele.Saisselin@fda.hhs.gov. Please reference CMS #631141 on any documents or records you provide to us and on 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","2026-08-20T01:47:56.964+00:00",[24,25,26,9,10,27,28,27],"\u003Ctime datetime=\"2022-07-05T13:20:00Z\">07\u002F05\u002F2022\u003C\u002Ftime>\n","\u003Ctime datetime=\"2022-05-12T04:00:00Z\">05\u002F12\u002F2022\u003C\u002Ftime>\n","\u003Ca href=\"\u002Finspections-compliance-enforcement-and-criminal-investigations\u002Fwarning-letters\u002Fla-ilusion-fresh-guava-inc-631141-05122022\">La Ilusion Fresh Guava Inc.\u003C\u002Fa>","","\u003Ca href=\"\u002Finspections-compliance-enforcement-and-criminal-investigations\u002Fwarning-letters\u002Fla-ilusion-fresh-guava-inc-631141-03082023\">\u003Ctime datetime=\"2023-03-14T04:00:00Z\">03\u002F14\u002F2023\u003C\u002Ftime>\n\u003C\u002Fa>","2026-08-18T06:42:29.262718+00:00","2026-08-20T02:24:56.48659+00:00",{"510k":32,"classification":33,"enforcement":34,"event":35,"pma":36,"warning_letter":37},"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"]