[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-warning-letter-fella-group-llc-625512-02252022":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},2809,"fella-group-llc-625512-02252022","Warning Letter","Fella Group LLC",null,"Division of West Coast Imports","Foreign Supplier Verification Program (FSVP)","2022-03-15","2022-02-25","Issued","https:\u002F\u002Fwww.fda.gov\u002Finspections-compliance-enforcement-and-criminal-investigations\u002Fwarning-letters\u002Ffella-group-llc-625512-02252022","625512","Food & Beverages","Via Express Delivery","Jesus F. Felix Miranda","\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\">Jesus F. Felix Miranda\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>Fella Group LLC\u003C\u002Fdd>\n\n          \n                      \u003Cdd>\u003Cp class=\"address\" translate=\"no\">\u003Cspan class=\"address-line1\">24 Seedling\u003C\u002Fspan>\u003Cbr>\n\u003Cspan class=\"locality\">Irvine\u003C\u002Fspan>, \u003Cspan class=\"administrative-area\">CA\u003C\u002Fspan> \u003Cspan class=\"postal-code\">92618-8860\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>February 25, 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 # 625512\u003C\u002Fp>\n\n\u003Cp>Dear Mr. Felix:\u003C\u002Fp>\n\n\u003Cp>On December 10, 2021, the Food and Drug Administration conducted a Foreign Supplier Verification Programs (FSVP) inspection at FELLA GROUP LLC, 24 Seedling, Irvine, CA 92618-8860. We also conducted an inspection on July 28, 2020. 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 were 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.\u003C\u002Fp>\n\n\u003Cp>We acknowledge receipt of your response dated January 6, 2022, and we address your response below.\u003C\u002Fp>\n\n\u003Cp>Your response stated that you would develop an FSVP plan for all imported food products imported by Fella Group LLC, and the time required to develop the FSVP plan would be between January 6, 2022 to December 15, 2022. You provided the same response to your initial inspection in which you provided a time frame of August 8, 2020 to July 31, 2021. To date, you have not made adequate corrective actions or provided sufficient FSVP documentation for the foods you import.\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 each of the following foods:\u003C\u002Fp>\n\n\u003Cul>\n\t\u003Cli>Mayocoba Beans imported from \u003Cstrong>(b)(4)\u003C\u002Fstrong>\u003C\u002Fli>\n\t\u003Cli>Chick Peas (Garbanzo Beans) imported from \u003Cstrong>(b)(4)\u003C\u002Fstrong>\u003C\u002Fli>\n\t\u003Cli>Rustic Salad Dressing imported from \u003Cstrong>(b)(4) \u003C\u002Fstrong>and\u003C\u002Fli>\n\t\u003Cli>any other foods you import\u003C\u002Fli>\n\u003C\u002Ful>\n\n\u003Cp>The above violation is 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>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.\u003Cbr>\n\u003Cbr>\nPlease send your reply to Food and Drug Administration, Attention: William Park, Compliance Officer, Division of West Coast Imports, One World Trade Center, Ste 300, Long Beach, CA 90831. If you have any questions regarding this letter, you may contact William Park via email at william.park@fda.hhs.gov. Please reference CMS # 625512 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>Dr. Kathleen Turner\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\nVia Express Delivery\n\nProduct:\n\nFood & Beverages\n\nRecipient:\n\nRecipient Name\n\nJesus F. Felix Miranda\n\nRecipient Title\n\nOwner\n\nFella Group LLC\n\n24 Seedling\n\nIrvine, CA 92618-8860\n\nUnited States\n\nIssuing Office:\n\nDivision of West Coast Imports\n\nUnited States\n\nFebruary 25, 2022\n\nWARNING LETTER\n\nRe: CMS # 625512\n\nDear Mr. Felix:\n\nOn December 10, 2021, the Food and Drug Administration conducted a Foreign Supplier Verification Programs (FSVP) inspection at FELLA GROUP LLC, 24 Seedling, Irvine, CA 92618-8860. We also conducted an inspection on July 28, 2020. 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 were 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.\n\nWe acknowledge receipt of your response dated January 6, 2022, and we address your response below.\n\nYour response stated that you would develop an FSVP plan for all imported food products imported by Fella Group LLC, and the time required to develop the FSVP plan would be between January 6, 2022 to December 15, 2022. You provided the same response to your initial inspection in which you provided a time frame of August 8, 2020 to July 31, 2021. To date, you have not made adequate corrective actions or provided sufficient FSVP documentation for the foods you import.\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 each of the following foods:\n\nMayocoba Beans imported from (b)(4)\n\nChick Peas (Garbanzo Beans) imported from (b)(4)\n\nRustic Salad Dressing imported from (b)(4) and\n\nany other foods you import\n\nThe above violation is 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\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: William Park, Compliance Officer, Division of West Coast Imports, One World Trade Center, Ste 300, Long Beach, CA 90831. If you have any questions regarding this letter, you may contact William Park via email at william.park@fda.hhs.gov. Please reference CMS # 625512 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\nDr. Kathleen Turner\n\nProgram Division Director\n\nDivision of West Coast Imports","2026-08-20T02:06:01.616+00:00",[23,24,25,9,10,26,26,26],"\u003Ctime datetime=\"2022-03-15T13:20:00Z\">03\u002F15\u002F2022\u003C\u002Ftime>\n","\u003Ctime datetime=\"2022-02-25T05:00:00Z\">02\u002F25\u002F2022\u003C\u002Ftime>\n","\u003Ca href=\"\u002Finspections-compliance-enforcement-and-criminal-investigations\u002Fwarning-letters\u002Ffella-group-llc-625512-02252022\">Fella Group LLC\u003C\u002Fa>","","2026-08-18T06:42:29.262718+00:00","2026-08-20T02:24:56.48659+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"]