[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-warning-letter-samuel-rodriguez-dba-kilokennelzz-674082-12202023":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},1654,"samuel-rodriguez-dba-kilokennelzz-674082-12202023","Warning Letter","Samuel Rodriguez dba KiloKennelzz",null,"Center for Veterinary Medicine","Unapproved New Animal Drug\u002FAdulterated","2024-01-16","2023-12-20","Issued","https:\u002F\u002Fwww.fda.gov\u002Finspections-compliance-enforcement-and-criminal-investigations\u002Fwarning-letters\u002Fsamuel-rodriguez-dba-kilokennelzz-674082-12202023","674082","Animal & Veterinary","Via Email","Samuel Rodriguez","\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 Email\n                                                                                                                                                                                                                                                                                                                                                                                                                              \u003C\u002Fdd>\n      \n      \n              \u003Cdt class=\"cell-1_3\">Product:\u003C\u002Fdt> \n        \u003Cdd class=\"cell-2_3\">Animal & Veterinary                          \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\">Samuel Rodriguez\u003C\u002Fdiv>\n          \u003C\u002Fdiv>\n\u003C\u002Fdd>\n                    \n            \u003Cdd>Samuel Rodriguez dba KiloKennelzz\u003C\u002Fdd>\n\n          \n                      \u003Cdd>\u003Cp class=\"address\" translate=\"no\">\u003Cspan class=\"address-line1\">(b)(6)\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:(b)(6)\"> (b)(6)\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>Center for Veterinary Medicine\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  \u003Cdiv class=\"field field--name-field-issuing-office-paragraph field--type-entity-reference-revisions field--label-above\">\n    \u003Cdiv class=\"field--label\">Secondary Issuing Offices\u003C\u002Fdiv>\n          \u003Cdiv class=\"field--items\">\n              \u003Cdiv class=\"field--item\">    \u003Cbr>\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\u003C\u002Fdiv>\n              \u003C\u002Fdiv>\n      \u003C\u002Fdiv>\n\n    \u003C\u002Fdl>\n  \u003C\u002Fdiv>  \n      \n\u003C\u002Fdiv>\n\n \n\n \n\n\u003Chr>\n\n\u003Cp class=\"text-align-center\">\u003Cstrong>WARNING LETTER\u003C\u002Fstrong>\u003C\u002Fp>\n\n\u003Cp>December 20, 2023\u003C\u002Fp>\n\n\u003Cp class=\"text-align-center\">Re: 674082\u003C\u002Fp>\n\n\u003Cp>Dear Samuel Rodriguez:\u003C\u002Fp>\n\n\u003Cp>This letter concerns your firm’s marketing of an unapproved new animal drug product, Green Monster also known as Green Juice, for the treatment of diseases in animals. The United States Food and Drug Administration (FDA) has reviewed your website at the internet address https:\u002F\u002Fkilokennelzz.com\u002F in October, November, and December 2023 and has determined that you offer this product for sale there.\u003C\u002Fp>\n\n\u003Cp>Based on our review of your website at the internet address https:\u002F\u002Fkilokennelzz.com\u002F, your Green Monster product is a drug under section 201(g)(1) of the Federal Food Drug and Cosmetic Act (FD&C Act) [21 U.S.C. 321(g)(1)], because this product is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in animals and\u002For intended to affect the structure or any function of the body of an animal. This product is an unapproved new animal drug and introducing or delivering this product for introduction into interstate commerce is prohibited under section 301(a) of the FD&C Act [21 U.S.C. § 331(a)].\u003C\u002Fp>\n\n\u003Cp>You can find the FD&C Act and FDA regulations through links on FDA’s homepage at www.fda.gov.\u003C\u002Fp>\n\n\u003Cp>Examples of claims FDA observed on your website and product labeling that show the intended use of your product include the following:\u003C\u002Fp>\n\n\u003Cp>From your home website titled “Green Juice” at the URL https:\u002F\u002Fkilokennelzz.com\u002Fproducts\u002Fgreen-juice:\u003C\u002Fp>\n\n\u003Cul>\n\t\u003Cli>“GREEN MONSTER HELP COMBAT:\u003C\u002Fli>\n\u003C\u002Ful>\n\n\u003Cp>    o PARVO\u003Cbr>\n    o COCCIDIA\u003Cbr>\n    o GIARDIA\u003Cbr>\n    o DISTEMPER\u003Cbr>\n    o KENNEL COUGH\u003Cbr>\n    o PNEUMONIA\u003Cbr>\n    o PYOMETRA\u003Cbr>\n    o MASTITIS\u003Cbr>\n    o PRE BREEDING TREATMENT AS WELL”\u003C\u002Fp>\n\n\u003Cul>\n\t\u003Cli>“Each bottle contains 6ML [sic] and is enough for a single dog.”\u003C\u002Fli>\n\t\u003Cli>“Administer medication via IM injection in dogs rear legs. Use .5ML [sic] on each rear leg for 6 days. ONLY REARS!”\u003C\u002Fli>\n\u003C\u002Ful>\n\n\u003Cp>This product is a new animal drug under section 201(v) of the FD&C Act, [21 U.S.C. 321(v)], because it is not generally recognized, among experts qualified by scientific training and experience to evaluate the safety and effectiveness of animal drugs, as safe and effective for use under the conditions prescribed, recommended, or suggested in the labeling.\u003C\u002Fp>\n\n\u003Cp>To be legally marketed, a new animal drug must have an approved new animal drug application, conditionally approved new animal drug application, or index listing under sections 512, 571, and 572 of the FD&C Act [21 U.S.C. § 360b, 360ccc, and 360ccc-1]. This product is not approved or index listed by FDA, and therefore, the product is unsafe within the meaning of section 512(a) of the FD&C Act, [21 U.S.C. § 360b(a)], and adulterated under section 501(a)(5) of the FD&C Act [21 U.S.C. § 351(a)(5)]. The introduction or delivery for introduction into interstate commerce of an adulterated drug is prohibited under section 301(a) of the FD&C Act [21 U.S.C. § 331(a)].\u003C\u002Fp>\n\n\u003Cp>\u003Cstrong>Conclusion\u003C\u002Fstrong>\u003C\u002Fp>\n\n\u003Cp>This letter is not intended to be an all-inclusive statement of violations that may exist in connection with your product. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all the requirements of federal law, including FDA regulations.\u003C\u002Fp>\n\n\u003Cp>This letter notifies you of our concerns and provides you an opportunity to address them. Failure to address this matter may lead to legal action without further notice, including, without limitation, seizure and\u002For injunction.\u003C\u002Fp>\n\n\u003Cp>Within fifteen (15) working days of receipt of this letter, please notify this office in writing of the specific steps you have taken to address any violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective action within fifteen (15) working days, state the reason for the delay and the time within which you will complete the correction. If you believe that your product is not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration.\u003C\u002Fp>\n\n\u003Cp>Please direct your response to U.S. Food and Drug Administration, Center for Veterinary Medicine, Office of Surveillance and Compliance, Division of Drug Compliance by email to CVMUnapprovedDrugs@fda.hhs.gov. Please include “Reference 674082” in the subject line of your email.\u003C\u002Fp>\n\n\u003Cp>Sincerely,\u003Cbr>\n\u002FS\u002F\u003C\u002Fp>\n\n\u003Cp>Neal Bataller, ME, DVM\u003Cbr>\nDirector\u003Cbr>\nDivision of Drug Compliance\u003Cbr>\nOffice of Surveillance and Compliance\u003Cbr>\nCenter for Veterinary Medicine\u003C\u002Fp>\n\n\u003Cp>Cc: \u003Cstrong>(b)(6)\u003C\u002Fstrong>\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 Email\n\nProduct:\n\nAnimal & Veterinary\n\nRecipient:\n\nRecipient Name\n\nSamuel Rodriguez\n\nSamuel Rodriguez dba KiloKennelzz\n\n(b)(6)\n\nUnited States\n\n(b)(6)\n\nIssuing Office:\n\nCenter for Veterinary Medicine\n\nUnited States\n\nSecondary Issuing Offices\n\nUnited States\n\nWARNING LETTER\n\nDecember 20, 2023\n\nRe: 674082\n\nDear Samuel Rodriguez:\n\nThis letter concerns your firm’s marketing of an unapproved new animal drug product, Green Monster also known as Green Juice, for the treatment of diseases in animals. The United States Food and Drug Administration (FDA) has reviewed your website at the internet address https:\u002F\u002Fkilokennelzz.com\u002F in October, November, and December 2023 and has determined that you offer this product for sale there.\n\nBased on our review of your website at the internet address https:\u002F\u002Fkilokennelzz.com\u002F, your Green Monster product is a drug under section 201(g)(1) of the Federal Food Drug and Cosmetic Act (FD&C Act) [21 U.S.C. 321(g)(1)], because this product is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in animals and\u002For intended to affect the structure or any function of the body of an animal. This product is an unapproved new animal drug and introducing or delivering this product for introduction into interstate commerce is prohibited under section 301(a) of the FD&C Act [21 U.S.C. § 331(a)].\n\nYou can find the FD&C Act and FDA regulations through links on FDA’s homepage at www.fda.gov.\n\nExamples of claims FDA observed on your website and product labeling that show the intended use of your product include the following:\n\nFrom your home website titled “Green Juice” at the URL https:\u002F\u002Fkilokennelzz.com\u002Fproducts\u002Fgreen-juice:\n\n“GREEN MONSTER HELP COMBAT:\n\no PARVO\n\no COCCIDIA\n\no GIARDIA\n\no DISTEMPER\n\no KENNEL COUGH\n\no PNEUMONIA\n\no PYOMETRA\n\no MASTITIS\n\no PRE BREEDING TREATMENT AS WELL”\n\n“Each bottle contains 6ML [sic] and is enough for a single dog.”\n\n“Administer medication via IM injection in dogs rear legs. Use .5ML [sic] on each rear leg for 6 days. ONLY REARS!”\n\nThis product is a new animal drug under section 201(v) of the FD&C Act, [21 U.S.C. 321(v)], because it is not generally recognized, among experts qualified by scientific training and experience to evaluate the safety and effectiveness of animal drugs, as safe and effective for use under the conditions prescribed, recommended, or suggested in the labeling.\n\nTo be legally marketed, a new animal drug must have an approved new animal drug application, conditionally approved new animal drug application, or index listing under sections 512, 571, and 572 of the FD&C Act [21 U.S.C. § 360b, 360ccc, and 360ccc-1]. This product is not approved or index listed by FDA, and therefore, the product is unsafe within the meaning of section 512(a) of the FD&C Act, [21 U.S.C. § 360b(a)], and adulterated under section 501(a)(5) of the FD&C Act [21 U.S.C. § 351(a)(5)]. The introduction or delivery for introduction into interstate commerce of an adulterated drug is prohibited under section 301(a) of the FD&C Act [21 U.S.C. § 331(a)].\n\nConclusion\n\nThis letter is not intended to be an all-inclusive statement of violations that may exist in connection with your product. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all the requirements of federal law, including FDA regulations.\n\nThis letter notifies you of our concerns and provides you an opportunity to address them. Failure to address this matter may lead to legal action without further notice, including, without limitation, seizure and\u002For injunction.\n\nWithin fifteen (15) working days of receipt of this letter, please notify this office in writing of the specific steps you have taken to address any violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective action within fifteen (15) working days, state the reason for the delay and the time within which you will complete the correction. If you believe that your product is not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration.\n\nPlease direct your response to U.S. Food and Drug Administration, Center for Veterinary Medicine, Office of Surveillance and Compliance, Division of Drug Compliance by email to CVMUnapprovedDrugs@fda.hhs.gov. Please include “Reference 674082” in the subject line of your email.\n\nSincerely,\n\n\u002FS\u002F\n\nNeal Bataller, ME, DVM\n\nDirector\n\nDivision of Drug Compliance\n\nOffice of Surveillance and Compliance\n\nCenter for Veterinary Medicine\n\nCc: (b)(6)","2026-08-20T00:22:45.825+00:00",[23,24,25,9,26,27,27,27],"\u003Ctime datetime=\"2024-01-16T14:20:00Z\">01\u002F16\u002F2024\u003C\u002Ftime>\n","\u003Ctime datetime=\"2023-12-20T05:00:00Z\">12\u002F20\u002F2023\u003C\u002Ftime>\n","\u003Ca href=\"\u002Finspections-compliance-enforcement-and-criminal-investigations\u002Fwarning-letters\u002Fsamuel-rodriguez-dba-kilokennelzz-674082-12202023\">Samuel Rodriguez dba KiloKennelzz\u003C\u002Fa>","Unapproved New Animal Drug\u002FAdulterated\u003Cbr \u002F>\r\n","","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"]