[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-warning-letter-life-food-inc-731887-06152026":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},69,"life-food-inc-731887-06152026","Warning Letter","Life & Food Inc.",null,"Office of Inspections and Investigations","Foreign Supplier Verification Program (FSVP)","2026-06-30","2026-06-15","Issued","https:\u002F\u002Fwww.fda.gov\u002Finspections-compliance-enforcement-and-criminal-investigations\u002Fwarning-letters\u002Flife-food-inc-731887-06152026","731887","Food & Beverages","Via Express Delivery","Duncan Zheng","\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\">Duncan Zheng\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\u002FDirector   \u003C\u002Fdiv>\n          \u003C\u002Fdiv>\n\u003C\u002Fdd>\n          \n            \u003Cdd>Life & Food Inc.\u003C\u002Fdd>\n\n          \n                      \u003Cdd>\u003Cp class=\"address\" translate=\"no\">\u003Cspan class=\"address-line1\">1050 E Flamingo Road, #S107 #2094\u003C\u002Fspan>\u003Cbr>\n\u003Cspan class=\"locality\">Las Vegas\u003C\u002Fspan>, \u003Cspan class=\"administrative-area\">NV\u003C\u002Fspan> \u003Cspan class=\"postal-code\">89119-7427\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:sales@lifefoodpro.com  \"> sales@lifefoodpro.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>Office of Inspections and Investigations\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>June 15, 2026\u003C\u002Fp>\u003Cp class=\"text-align-center\">\u003Cstrong>WARNING LETTER\u003C\u002Fstrong>\u003C\u002Fp>\u003Cp class=\"text-align-center\">Re: CMS # 731887\u003C\u002Fp>\u003Cp>Dear Mr. Zheng:\u003C\u002Fp>\u003Cp>From May 4, 2026, through May 7, 2026, the Food and Drug Administration (FDA) conducted a Foreign Supplier Verification Program (FSVP) inspection of Life & Food Inc., located at 1050 E Flamingo Road, #S107 #2094, Las Vegas, NV 89119-7427. This inspection was 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>\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 United States 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.\u003C\u002Fp>\u003Cp>During the 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. At the conclusion of the inspection, our investigator provided you with a Form FDA 483a FSVP Observations.\u003C\u002Fp>\u003Cp>We acknowledge receipt of your response, dated May 14, 2026, in which you stated that Life & Food Inc. operates as a Very Small Importer (VSI) and follows modified requirements. You also provided VSI Eligibility Declarations for \u003Cstrong>(b)(4)\u003C\u002Fstrong>, and written assurances for your foreign suppliers, \u003Cstrong>(b)(4)\u003C\u002Fstrong>, and \u003Cstrong>(b)(4)\u003C\u002Fstrong>. We are unable to evaluate the adequacy of your response because you have not provided supporting documentation demonstrating your corrective actions. Specifically, you did not provide documentation such as tax forms or income statements to substantiate your VSI eligibility. Additionally, the written assurances you submitted appear to be templates prepared by your firm rather than independent documents provided by your foreign suppliers. Furthermore, even if you meet the definition of a VSI, you are still required to develop and maintain a written FSVP, which you have not provided. To date, no additional FSVP documents have been received by FDA.\u003C\u002Fp>\u003Cp>Your significant violations of the FSVP regulation are as follows:\u003C\u002Fp>\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 each of the following foods:\u003C\u002Fp>\u003Cul>\u003Cli>Midori Spring Gold Organic Ceremonial Matcha, imported from \u003Cstrong>(b)(4)\u003C\u002Fstrong>, located in \u003Cstrong>(b)(4)\u003C\u002Fstrong>.\u003C\u002Fli>\u003Cli>Green Tea, imported from \u003Cstrong>(b)(4)\u003C\u002Fstrong>, located in \u003Cstrong>(b)(4)\u003C\u002Fstrong>.\u003C\u002Fli>\u003Cli>Matcha Green Tea, imported from \u003Cstrong>(b)(4)\u003C\u002Fstrong>, located in \u003Cstrong>(b)(4)\u003C\u002Fstrong>.\u003C\u002Fli>\u003C\u002Ful>\u003Cp>During our inspection, you indicated you choose to comply with the requirements for very small importers and may meet the definition of a “very small importer” under 21 CFR 1.500. If you choose to comply with the modified requirements in 21 CFR 1.512, you must document that you meet the definition of a very small importer as required by 21 CFR 1.512(b)(1)(i). You are also still 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) (if applicable) of the FD&C Act (21 CFR 1.512(b)(3)(i)).\u003C\u002Fp>\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>\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 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>\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>\u003Cp>Please send your reply to Food and Drug Administration, Attention: Celena Ngo, Compliance Officer, Division of West Coast Imports, One World Trade Center, Suite 300, Long Beach, CA 90831. If you have any questions regarding this letter, or wish to send your response electronically, you may contact Celena Ngo via email at celena.ngo@fda.hhs.gov. Please reference CMS # 731887 on any documents or records you provide to us and on the subject line of any email correspondence you send to us.\u003C\u002Fp>\u003Cp>Sincerely,\u003Cbr>\u002FS\u002F\u003C\u002Fp>\u003Cp>Dr. Kathleen Turner\u003Cbr>Program Division Director\u003Cbr>Division of West Coast Imports\u003C\u002Fp>\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\nDuncan Zheng\n\nRecipient Title\n\nOwner\u002FDirector\n\nLife & Food Inc.\n\n1050 E Flamingo Road, #S107 #2094\n\nLas Vegas, NV 89119-7427\n\nUnited States\n\nsales@lifefoodpro.com\n\nIssuing Office:\n\nOffice of Inspections and Investigations\n\nUnited States\n\nJune 15, 2026\nWARNING LETTER\nRe: CMS # 731887\nDear Mr. Zheng:\nFrom May 4, 2026, through May 7, 2026, the Food and Drug Administration (FDA) conducted a Foreign Supplier Verification Program (FSVP) inspection of Life & Food Inc., located at 1050 E Flamingo Road, #S107 #2094, Las Vegas, NV 89119-7427. This inspection was 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.\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 United States 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.\nDuring the 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. At the conclusion of the inspection, our investigator provided you with a Form FDA 483a FSVP Observations.\nWe acknowledge receipt of your response, dated May 14, 2026, in which you stated that Life & Food Inc. operates as a Very Small Importer (VSI) and follows modified requirements. You also provided VSI Eligibility Declarations for (b)(4), and written assurances for your foreign suppliers, (b)(4), and (b)(4). We are unable to evaluate the adequacy of your response because you have not provided supporting documentation demonstrating your corrective actions. Specifically, you did not provide documentation such as tax forms or income statements to substantiate your VSI eligibility. Additionally, the written assurances you submitted appear to be templates prepared by your firm rather than independent documents provided by your foreign suppliers. Furthermore, even if you meet the definition of a VSI, you are still required to develop and maintain a written FSVP, which you have not provided. To date, no additional FSVP documents have been received by FDA.\nYour significant violations of the FSVP regulation are as follows:\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 each of the following foods:\nMidori Spring Gold Organic Ceremonial Matcha, imported from (b)(4), located in (b)(4).\nGreen Tea, imported from (b)(4), located in (b)(4).\nMatcha Green Tea, imported from (b)(4), located in (b)(4).\nDuring our inspection, you indicated you choose to comply with the requirements for very small importers and may meet the definition of a “very small importer” under 21 CFR 1.500. If you choose to comply with the modified requirements in 21 CFR 1.512, you must document that you meet the definition of a very small importer as required by 21 CFR 1.512(b)(1)(i). You are also still 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) (if applicable) of the FD&C Act (21 CFR 1.512(b)(3)(i)).\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.\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)).\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.\nPlease send your reply to Food and Drug Administration, Attention: Celena Ngo, Compliance Officer, Division of West Coast Imports, One World Trade Center, Suite 300, Long Beach, CA 90831. If you have any questions regarding this letter, or wish to send your response electronically, you may contact Celena Ngo via email at celena.ngo@fda.hhs.gov. Please reference CMS # 731887 on any documents or records you provide to us and on the subject line of any email correspondence you send to us.\nSincerely,\n\u002FS\u002F\nDr. Kathleen Turner\nProgram Division Director\nDivision of West Coast Imports","2026-08-19T04:32:41.794+00:00",[23,24,25,9,10,26,26,26],"\u003Ctime datetime=\"2026-06-30T04:00:00Z\">06\u002F30\u002F2026\u003C\u002Ftime>\n","\u003Ctime datetime=\"2026-06-15T04:00:00Z\">06\u002F15\u002F2026\u003C\u002Ftime>\n","\u003Ca href=\"\u002Finspections-compliance-enforcement-and-criminal-investigations\u002Fwarning-letters\u002Flife-food-inc-731887-06152026\">Life & Food Inc.\u003C\u002Fa>","","2026-08-18T06:42:28.498414+00:00","2026-08-20T02:24:55.726997+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"]