[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-warning-letter-linessa-farms-llc-684424-05162024":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},1428,"linessa-farms-llc-684424-05162024","Warning Letter","Linessa Farms, LLC",null,"Center for Veterinary Medicine","Unapproved New Animal Drug\u002FAdulterated","2024-06-11","2024-05-16","Issued","https:\u002F\u002Fwww.fda.gov\u002Finspections-compliance-enforcement-and-criminal-investigations\u002Fwarning-letters\u002Flinessa-farms-llc-684424-05162024","684424","Animal & VeterinaryDrugs","Via Email","Timothy John Ventrello","\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\u003Cbr>Drugs                          \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\">Timothy John Ventrello\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\">CEO\u003C\u002Fdiv>\n          \u003C\u002Fdiv>\n\u003C\u002Fdd>\n          \n            \u003Cdd>Linessa Farms, LLC\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:customerservice@linessafarms.com\"> customerservice@linessafarms.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>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    \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>May 16, 2024\u003C\u002Fp>\n\n\u003Cp class=\"text-align-center\">\u003Cstrong>Ref: 684424\u003C\u002Fstrong>\u003C\u002Fp>\n\n\u003Cp>Dear Timothy John Ventrello:\u003C\u002Fp>\n\n\u003Cp>This letter concerns your firm’s marketing of unapproved new animal drugs, Blackout Five Pure Toltrazuril Powder and Blackout Five 5% Toltrazuril Solution, for the treatment of coccidiosis in animals in violation of the Federal Food Drug and Cosmetic Act (FD&C Act). The United States Food and Drug Administration (FDA) has reviewed your website, https:\u002F\u002Flinessafarms.com\u002F, from December 2023 through May 2024, and has determined that you offer these products for sale there.\u003C\u002Fp>\n\n\u003Cp>Based on our review of your website, your products are drugs under section 201(g)(1) of the Federal Food Drug and Cosmetic Act (FD&C Act) [21 U.S.C. 321(g)(1)], because they are 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. For the reasons described below, these products are unapproved new animal drugs and introducing or delivering these products 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 products include the following:\u003C\u002Fp>\n\n\u003Cp>From your webpage titled, “\u003Cstrong>Blackout Five Pure Toltrazuril Powder\u003C\u002Fstrong>” at the URL https:\u002F\u002Flinessafarms.com\u002Fproduct\u002Fblackout-five-pure-toltrazuril-powder\u002F?attribute_amount=10+Gram:\u003Cbr>\n• “…Blackout Five Pure Toltrazuril Powder… to help treat and prevent coccidia in many animals…”\u003C\u002Fp>\n\n\u003Cp>From your webpage titled “Blackout Five 5% Toltrazuril Solution” at the URL https:\u002F\u002Flinessafarms.com\u002Fproduct\u002Fblackout-five-5-toltrazuril-solution-400ml\u002F?attribute_size=200ml:\u003Cbr>\n• “…can be easily administered via oral drench and can be stored at room temperature…”\u003Cbr>\n• “…to help treat and prevent coccidia in many animals…”\u003C\u002Fp>\n\n\u003Cp>From your webpage titled “Coccidia Prevention Medications - Linessa Farms, LLC” at the URL https:\u002F\u002Flinessafarms.com\u002Fcoccidia-prevention-medications\u002F:\u003Cbr>\n• “Toltrazuril is a coccidiostat used in sheep and goats to prevent coccidiosis.”\u003Cbr>\n• Image: “Blackout Five […] XXXXX […] Leading Toltrazuril Medication”\u003C\u002Fp>\n\n\u003Cp>From your webpage titled “10 Pound Pack Bovatec 3 – Linessa Farms, LLC” at the URL https:\u002F\u002Flinessafarms.com\u002Fproduct\u002F10-pound-pack-bovatec-3\u002F:\u003Cbr>\n• “…For coccidiosis treatment, try Foundation Feed’s Blackout Five 5% Toltrazuril.”\u003C\u002Fp>\n\n\u003Cp>On your social media webpage at the URL https:\u002F\u002Fwww.facebook.com\u002FLinessaFarmsLLC\u002Fphotos\u002Fpb.100064833035387.-2207520000\u002F1530545100703262\u002F?type=3:\u003Cbr>\n• On your January 13, 2023, Facebook post: “…Don’t let coccidia hurt your gains this season! Read more about toltrazuril and Blackout Five 5% toltrazuril suspension!…”\u003C\u002Fp>\n\n\u003Cp>Your products above are new animal drugs under section 201(v) of the FD&C Act, [21 U.S.C. 321(v)], because they are 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. 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]. These products are not approved or index listed by FDA, and therefore, they are 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 products. 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 684424” 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\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\nDrugs\n\nRecipient:\n\nRecipient Name\n\nTimothy John Ventrello\n\nRecipient Title\n\nCEO\n\nLinessa Farms, LLC\n\n(b)(6)\n\nUnited States\n\ncustomerservice@linessafarms.com\n\nIssuing Office:\n\nCenter for Veterinary Medicine\n\nUnited States\n\nWARNING LETTER\n\nMay 16, 2024\n\nRef: 684424\n\nDear Timothy John Ventrello:\n\nThis letter concerns your firm’s marketing of unapproved new animal drugs, Blackout Five Pure Toltrazuril Powder and Blackout Five 5% Toltrazuril Solution, for the treatment of coccidiosis in animals in violation of the Federal Food Drug and Cosmetic Act (FD&C Act). The United States Food and Drug Administration (FDA) has reviewed your website, https:\u002F\u002Flinessafarms.com\u002F, from December 2023 through May 2024, and has determined that you offer these products for sale there.\n\nBased on our review of your website, your products are drugs under section 201(g)(1) of the Federal Food Drug and Cosmetic Act (FD&C Act) [21 U.S.C. 321(g)(1)], because they are 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. For the reasons described below, these products are unapproved new animal drugs and introducing or delivering these products 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 products include the following:\n\nFrom your webpage titled, “Blackout Five Pure Toltrazuril Powder” at the URL https:\u002F\u002Flinessafarms.com\u002Fproduct\u002Fblackout-five-pure-toltrazuril-powder\u002F?attribute_amount=10+Gram:\n\n• “…Blackout Five Pure Toltrazuril Powder… to help treat and prevent coccidia in many animals…”\n\nFrom your webpage titled “Blackout Five 5% Toltrazuril Solution” at the URL https:\u002F\u002Flinessafarms.com\u002Fproduct\u002Fblackout-five-5-toltrazuril-solution-400ml\u002F?attribute_size=200ml:\n\n• “…can be easily administered via oral drench and can be stored at room temperature…”\n\n• “…to help treat and prevent coccidia in many animals…”\n\nFrom your webpage titled “Coccidia Prevention Medications - Linessa Farms, LLC” at the URL https:\u002F\u002Flinessafarms.com\u002Fcoccidia-prevention-medications\u002F:\n\n• “Toltrazuril is a coccidiostat used in sheep and goats to prevent coccidiosis.”\n\n• Image: “Blackout Five […] XXXXX […] Leading Toltrazuril Medication”\n\nFrom your webpage titled “10 Pound Pack Bovatec 3 – Linessa Farms, LLC” at the URL https:\u002F\u002Flinessafarms.com\u002Fproduct\u002F10-pound-pack-bovatec-3\u002F:\n\n• “…For coccidiosis treatment, try Foundation Feed’s Blackout Five 5% Toltrazuril.”\n\nOn your social media webpage at the URL https:\u002F\u002Fwww.facebook.com\u002FLinessaFarmsLLC\u002Fphotos\u002Fpb.100064833035387.-2207520000\u002F1530545100703262\u002F?type=3:\n\n• On your January 13, 2023, Facebook post: “…Don’t let coccidia hurt your gains this season! Read more about toltrazuril and Blackout Five 5% toltrazuril suspension!…”\n\nYour products above are new animal drugs under section 201(v) of the FD&C Act, [21 U.S.C. 321(v)], because they are 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. 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]. These products are not approved or index listed by FDA, and therefore, they are 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 products. 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 684424” 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","2026-08-20T00:03:01.413+00:00",[23,24,25,9,26,27,27,27],"\u003Ctime datetime=\"2024-06-11T13:20:00Z\">06\u002F11\u002F2024\u003C\u002Ftime>\n","\u003Ctime datetime=\"2024-05-16T04:00:00Z\">05\u002F16\u002F2024\u003C\u002Ftime>\n","\u003Ca href=\"\u002Finspections-compliance-enforcement-and-criminal-investigations\u002Fwarning-letters\u002Flinessa-farms-llc-684424-05162024\">Linessa Farms, LLC\u003C\u002Fa>","Unapproved New Animal Drug\u002FAdulterated\u003Cbr \u002F>\r\n","","2026-08-18T06:42:28.856152+00:00","2026-08-20T02:24:56.037289+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"]