[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-warning-letter-midland-vet-services-667614-11302023":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},1698,"midland-vet-services-667614-11302023","Warning Letter","Midland Vet Services",null,"Center for Veterinary Medicine","Unapproved Medically Important Antimicrobials Marketed for Use in Non-food Minor Species","2023-12-14","2023-11-30","Issued","https:\u002F\u002Fwww.fda.gov\u002Finspections-compliance-enforcement-and-criminal-investigations\u002Fwarning-letters\u002Fmidland-vet-services-667614-11302023","667614","Animal & VeterinaryDrugs","Via Email","Jeffrey Kenkel","\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\">Jeffrey Kenkel\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\u002FPresident\u003C\u002Fdiv>\n          \u003C\u002Fdiv>\n\u003C\u002Fdd>\n          \n            \u003Cdd>Midland Vet Services\u003C\u002Fdd>\n\n          \n                      \u003Cdd>\u003Cp class=\"address\" translate=\"no\">\u003Cspan class=\"address-line1\">11722 Stonegate Cir.\u003C\u002Fspan>\u003Cbr>\n\u003Cspan class=\"locality\">Omaha\u003C\u002Fspan>, \u003Cspan class=\"administrative-area\">NE\u003C\u002Fspan> \u003Cspan class=\"postal-code\">68164\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>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>November 30, 2023\u003C\u002Fp>\n\n\u003Cp class=\"text-align-center\">Re: 667614\u003C\u002Fp>\n\n\u003Cp>Dear Jeffrey Kenkel:\u003C\u002Fp>\n\n\u003Cp>This letter concerns your firm's manufacture and distribution of veterinary products for use in aquarium fish and birds.\u003C\u002Fp>\n\n\u003Cp>In November 2023, the U.S. Food and Drug Administration (FDA) reviewed the websites https:\u002F\u002Fwww.chewy.com\u002F, https:\u002F\u002Fwww.fishick.com\u002F, https:\u002F\u002Fwww.heartlandvetsupply.com\u002F, and https:\u002F\u002Fwww.jefferspet.com\u002F, where these distributors take orders for the following products you manufacture: Aqua-Mox, Aqua-Mox Forte, Aqua-Ceph, Aqua-Ceph Forte, Aqua-Cipro, Aqua-Cipro Forte, Aqua-Doxy, Aqua-Zole, Aqua-Zole Forte, and Aqua-Zithro Birds. The labels of your products can be seen on these websites. The claims on your labels establish that these products are intended for use in the cure, mitigation, treatment, or prevention of diseases in animals, which makes them drugs under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) [21 U.S.C. § 321(g)(1)(B)]. In addition, these animal drugs are misbranded under section 502(o) of the FD&C Act [21 U.S.C. § 352(o)] because they have not been drug listed with FDA, nor have they been manufactured in a facility that is registered with FDA, in accordance with sections 510(b) and (j) of the FD&C Act [21 U.S.C. § 360(b), (j)]. As discussed below, introducing or delivering these unapproved and misbranded new animal drugs for introduction into interstate commerce violates section 301(a) of the FD&C Act [21 U.S.C. § 331(a)].\u003C\u002Fp>\n\n\u003Cp>\u003Cu>\u003Cstrong>UNAPPROVED NEW ANIMAL DRUGS\u003C\u002Fstrong>\u003C\u002Fu>\u003Cbr>\nExamples of product label claims observable on the websites (https:\u002F\u002Fwww.chewy.com\u002F, https:\u002F\u002Fwww.fishick.com\u002F, https:\u002F\u002Fwww.heartlandvetsupply.com\u002F, and https:\u002F\u002Fwww.jefferspet.com\u002F) that establish the intended use of your products as drugs include, but may not be limited to, the following:\u003C\u002Fp>\n\n\u003Cp>\u003Cu>\u003Cstrong>Fish\u003C\u002Fstrong>\u003C\u002Fu>\u003C\u002Fp>\n\n\u003Cul>\n\t\u003Cli>\u003Cstrong>Aqua-Mox\u003C\u002Fstrong>, Amoxicillin, 250 mg, capsules, “Controls common bacterial infections in fish. This product exerts a bactericidal action on gram positive and some gram negative bacteria. It is useful for the control of bacterial diseases of fish, which include Aeromonas and Pseudomonas Genera and Mysobacterial Group (Gill Diseases, Chondrococus)”\u003C\u002Fli>\n\t\u003Cli>\u003Cstrong>Aqua-Mox Forte\u003C\u002Fstrong>, Amoxicillin, 500 mg, capsules, “Controls common bacterial infections in fish. This product is an antibacterial medication. Uses Infected eyes, fin or tail rot, skin ulcerations, pop-eye, columnaris disease and gill disease”.\u003C\u002Fli>\n\t\u003Cli>\u003Cstrong>Aqua-Ceph\u003C\u002Fstrong>, Cephalexin, 250 mg, capsules, “Controls common bacterial infections in fish. This product exerts a bactericidal action and is used in aquariums for the treatment of bacterial activity.”\u003C\u002Fli>\n\t\u003Cli>\u003Cstrong>Aqua-Ceph Forte\u003C\u002Fstrong>, Cephalexin, 500 mg, capsules, “Controls common bacterial infections in fish.”\u003C\u002Fli>\n\t\u003Cli>\u003Cstrong>Aqua-Cipro\u003C\u002Fstrong>, Ciprofloxacin, 250 mg, tablets, “Controls common bacterial infections in fish.”\u003C\u002Fli>\n\t\u003Cli>\u003Cstrong>Aqua-Cipro Forte\u003C\u002Fstrong>, Ciprofloxacin, 500 mg, tablets, “Controls common bacterial infections in fish. This product exerts a bactericidal action on gram positive and some gram negative bacteria. It is useful for the control of bacterial diseases of fish, which includes fin and tail rot and flexibacter infections”.\u003C\u002Fli>\n\t\u003Cli>\u003Cstrong>Aqua-Doxy\u003C\u002Fstrong>, doxycycline, 100 mg, capsules, “Controls common bacterial infections in fish. This product is a broad spectrum antibiotic. It works by stopping the growth of bacteria. Uses Infected eyes, fin or tail rot, skin ulcerations, pop-eye, Columnaris disease, and Gill disease.”\u003C\u002Fli>\n\t\u003Cli>\u003Cstrong>Aqua-Zole\u003C\u002Fstrong>, Metronidazole, 250 mg, tablets, “Controls common bacterial infections in fish. This product exerts a bactericidal action on gram positive and some gram negative bacteria. It is useful for the control of bacterial diseases of fish, which include Aeromonas and Pseudomonas Genera and Mysobacterial Group (Gill Diseases, Chondrococcus.)”\u003C\u002Fli>\n\t\u003Cli>\u003Cstrong>Aqua-Zole Forte\u003C\u002Fstrong>, Metronidazole, 500 mg, tablets, “Controls common bacterial infections in fish. This product exerts a bactericidal action on gram positive and some gram negative bacteria. It is useful for the control of bacterial diseases of fish, which include Aeromonas and Pseudomonas Genera and Mysobacterial Group (Gill Diseases, Chondrococcus.)”\u003C\u002Fli>\n\u003C\u002Ful>\n\n\u003Cp>\u003Cu>\u003Cstrong>Birds\u003C\u002Fstrong>\u003C\u002Fu>\u003C\u002Fp>\n\n\u003Cul>\n\t\u003Cli>\u003Cstrong>Aqua-Zithro Birds\u003C\u002Fstrong>, “Controls common bacterial infections in birds.”\u003C\u002Fli>\n\u003C\u002Ful>\n\n\u003Cp>These products are new animal drugs under section 201(v) of the FD&C Act [21 U.S.C. § 321(v)] because they are for use in nonfood-producing fish and birds, which are minor species as defined by sections 201(nn) and (oo) of the FD&C Act [21 U.S.C. § 321(nn) and (oo)], and are not the subject of a final FDA regulation finding either that the drugs are 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 drug’s labeling, or finding that the exception to the criterion in section 201(v)(1) of the FD&C Act has been met.\u003C\u002Fp>\n\n\u003Cp>To be legally marketed, a new animal drug must be the subject of an approved new animal drug application, a conditionally approved new animal drug application, or a listing on the Index of Legally Marketed Unapproved New Animal Drugs for Minor Species (“index listing”) under section 512, 571, or 572 of the FD&C Act [21 U.S.C. § 360b, 360ccc, and 360ccc-1]. The FDA approval and index listing processes allow FDA to ensure that there is adequate evidence to demonstrate that new animal drugs are safe, properly manufactured, accurately labeled, and meet the relevant effectiveness standard. The animal drugs named above have not been approved, conditionally approved, or index listed.\u003C\u002Fp>\n\n\u003Cp>Animal drugs that lack the required approval or index listing are considered unsafe and adulterated under sections 512(a) and 501(a)(5) of the FD&C Act [21 U.S.C. §§ 360b(a) and 351(a)(5)]. Introduction or delivery for introduction of an adulterated animal drug 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>FDA is particularly concerned about your unapproved animal drugs because they raise public health concerns. Available as over-the-counter drugs, they contain antimicrobials that are considered medically important in the treatment of human disease.\u003Csup>\u003Cem>\u003Cstrong>1\u003C\u002Fstrong>\u003C\u002Fem>\u003C\u002Fsup> Concern about the development of resistance to antimicrobials important in human medicine has led FDA to promote more judicious use of animal drugs containing medically important antimicrobials, including working toward ensuring that these drugs can be used in animals only under the supervision of a licensed veterinarian.\u003C\u002Fp>\n\n\u003Cp>\u003Cu>\u003Cstrong>MISBRANDED NEW ANIMAL DRUGS\u003C\u002Fstrong>\u003C\u002Fu>\u003Cbr>\nSections 510(b)(1) and (j)(1) of the FD&C Act [21 U.S.C. § 360(b), (j)] require that manufacturers (which includes repackers and relabelers) of drugs, including animal drugs, register their manufacturing establishments with FDA and provide the agency with a list of all the drug products they manufacture. Drugs that are manufactured in unregistered establishments or that have not been listed with FDA are misbranded under section 502(o) of the FD&C Act. None of the animal drugs in this letter are drug listed with FDA, nor have they been manufactured in a facility that is registered with FDA. Accordingly, these animal drugs are misbranded. Introduction or delivery for introduction of a misbranded animal drug into interstate commerce is prohibited under section 301(a) of the FD&C Act.\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(s). 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 requirements of federal law and FDA regulations.\u003C\u002Fp>\n\n\u003Cp>This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address this matter may lead to legal or regulatory action, including without limitation, seizure and\u002For injunction.\u003C\u002Fp>\n\n\u003Cp>You should be aware that if we take enforcement action against any of the drugs named above or other unapproved\u002Funindexed products you market that contain medically important antimicrobials, we may take action against all of your products that violate the FD&C Act at the same time, including but not limited to enjoining the manufacturing and distribution of any unapproved\u002Funindexed products.\u003C\u002Fp>\n\n\u003Cp>We have the following comments:\u003C\u002Fp>\n\n\u003Cp>1. You can legally market the products named above if you obtain an index listing, approval, or conditional approval. Information about the processes and requirements for obtaining an index listing and various types of animal drug approval is available on the FDA website at\u003C\u002Fp>\n\n\u003Cul>\n\t\u003Cli>https:\u002F\u002Fwww.fda.gov\u002Fanimal-veterinary\u002Fdevelopment-approval-process\u002Fminor-useminor-species and\u003C\u002Fli>\n\t\u003Cli>https:\u002F\u002Fwww.fda.gov\u002Fanimal-veterinary\u002Fdevelopment-approval-process\u002Fnew-animal-drug-applications\u003C\u002Fli>\n\u003C\u002Ful>\n\n\u003Cp>The index listing process was added to the FD&C Act in 2004 as a streamlined alternative process that addresses the challenges of obtaining FDA approval for drugs for minor species (which are any animal species other than horses, cattle, pigs, dogs, cats, chickens, and turkeys). Drugs intended for use in minor species not used for human or animal food are eligible for index listing. Because the above-named products are intended for use in nonfood-producing fish and birds, you may wish to explore the index listing process. The approval process can also be used for drugs for use in these species.\u003C\u002Fp>\n\n\u003Cp>2. Information on establishment registration and drug listing is available on the FDA website at:\u003C\u002Fp>\n\n\u003Cul>\n\t\u003Cli>https:\u002F\u002Fwww.fda.gov\u002Findustry\u002Ffda-basics-industry\u002Fregistration-and-listing\u003C\u002Fli>\n\u003C\u002Ful>\n\n\u003Cp>Within fifteen (15) working days of receiving this letter, please notify this office in writing of the specific steps that you have taken to correct 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 actions 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 products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration.\u003C\u002Fp>\n\n\u003Cp>Your written response should be sent to Dr. Vic Boddie, United States Food and Drug Administration, Center for Veterinary Medicine, Office of Surveillance and Compliance, Division of Drug Compliance, by emailing CVMUnapprovedDrugs@fda.hhs.gov.\u003C\u002Fp>\n\n\u003Cp>Sincerely,\u003Cbr>\n\u002FS\u002F\u003C\u002Fp>\n\n\u003Cp>Neal Bataller, ME, DVM\u003Cbr>\nDirector Division of Drug Compliance\u003Cbr>\nOffice of Surveillance and Compliance\u003Cbr>\nCenter for Veterinary Medicine\u003C\u002Fp>\n\n\u003Cp>________________\u003C\u002Fp>\n\n\u003Cp>\u003Cem>\u003Cstrong>1\u003C\u002Fstrong>\u003C\u002Fem> A list of medically important drug classes of antimicrobials can be found in Guidance for Industry (GFI) # 152, “Evaluating the Safety of Antimicrobial New Animal Drugs with Regard to Their Microbiological Effects on Bacteria of Human Health Concern,” available at https:\u002F\u002Fwww.fda.gov\u002Fdownloads\u002FAnimalVeterinary\u002FGuidanceComplianceEnforcement\u002FGuidanceforIndustry\u002FUCM052519.pdf\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\nJeffrey Kenkel\n\nRecipient Title\n\nCEO\u002FPresident\n\nMidland Vet Services\n\n11722 Stonegate Cir.\n\nOmaha, NE 68164\n\nUnited States\n\nIssuing Office:\n\nCenter for Veterinary Medicine\n\nUnited States\n\nWARNING LETTER\n\nNovember 30, 2023\n\nRe: 667614\n\nDear Jeffrey Kenkel:\n\nThis letter concerns your firm's manufacture and distribution of veterinary products for use in aquarium fish and birds.\n\nIn November 2023, the U.S. Food and Drug Administration (FDA) reviewed the websites https:\u002F\u002Fwww.chewy.com\u002F, https:\u002F\u002Fwww.fishick.com\u002F, https:\u002F\u002Fwww.heartlandvetsupply.com\u002F, and https:\u002F\u002Fwww.jefferspet.com\u002F, where these distributors take orders for the following products you manufacture: Aqua-Mox, Aqua-Mox Forte, Aqua-Ceph, Aqua-Ceph Forte, Aqua-Cipro, Aqua-Cipro Forte, Aqua-Doxy, Aqua-Zole, Aqua-Zole Forte, and Aqua-Zithro Birds. The labels of your products can be seen on these websites. The claims on your labels establish that these products are intended for use in the cure, mitigation, treatment, or prevention of diseases in animals, which makes them drugs under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) [21 U.S.C. § 321(g)(1)(B)]. In addition, these animal drugs are misbranded under section 502(o) of the FD&C Act [21 U.S.C. § 352(o)] because they have not been drug listed with FDA, nor have they been manufactured in a facility that is registered with FDA, in accordance with sections 510(b) and (j) of the FD&C Act [21 U.S.C. § 360(b), (j)]. As discussed below, introducing or delivering these unapproved and misbranded new animal drugs for introduction into interstate commerce violates section 301(a) of the FD&C Act [21 U.S.C. § 331(a)].\n\nUNAPPROVED NEW ANIMAL DRUGS\n\nExamples of product label claims observable on the websites (https:\u002F\u002Fwww.chewy.com\u002F, https:\u002F\u002Fwww.fishick.com\u002F, https:\u002F\u002Fwww.heartlandvetsupply.com\u002F, and https:\u002F\u002Fwww.jefferspet.com\u002F) that establish the intended use of your products as drugs include, but may not be limited to, the following:\n\nFish\n\nAqua-Mox, Amoxicillin, 250 mg, capsules, “Controls common bacterial infections in fish. This product exerts a bactericidal action on gram positive and some gram negative bacteria. It is useful for the control of bacterial diseases of fish, which include Aeromonas and Pseudomonas Genera and Mysobacterial Group (Gill Diseases, Chondrococus)”\n\nAqua-Mox Forte, Amoxicillin, 500 mg, capsules, “Controls common bacterial infections in fish. This product is an antibacterial medication. Uses Infected eyes, fin or tail rot, skin ulcerations, pop-eye, columnaris disease and gill disease”.\n\nAqua-Ceph, Cephalexin, 250 mg, capsules, “Controls common bacterial infections in fish. This product exerts a bactericidal action and is used in aquariums for the treatment of bacterial activity.”\n\nAqua-Ceph Forte, Cephalexin, 500 mg, capsules, “Controls common bacterial infections in fish.”\n\nAqua-Cipro, Ciprofloxacin, 250 mg, tablets, “Controls common bacterial infections in fish.”\n\nAqua-Cipro Forte, Ciprofloxacin, 500 mg, tablets, “Controls common bacterial infections in fish. This product exerts a bactericidal action on gram positive and some gram negative bacteria. It is useful for the control of bacterial diseases of fish, which includes fin and tail rot and flexibacter infections”.\n\nAqua-Doxy, doxycycline, 100 mg, capsules, “Controls common bacterial infections in fish. This product is a broad spectrum antibiotic. It works by stopping the growth of bacteria. Uses Infected eyes, fin or tail rot, skin ulcerations, pop-eye, Columnaris disease, and Gill disease.”\n\nAqua-Zole, Metronidazole, 250 mg, tablets, “Controls common bacterial infections in fish. This product exerts a bactericidal action on gram positive and some gram negative bacteria. It is useful for the control of bacterial diseases of fish, which include Aeromonas and Pseudomonas Genera and Mysobacterial Group (Gill Diseases, Chondrococcus.)”\n\nAqua-Zole Forte, Metronidazole, 500 mg, tablets, “Controls common bacterial infections in fish. This product exerts a bactericidal action on gram positive and some gram negative bacteria. It is useful for the control of bacterial diseases of fish, which include Aeromonas and Pseudomonas Genera and Mysobacterial Group (Gill Diseases, Chondrococcus.)”\n\nBirds\n\nAqua-Zithro Birds, “Controls common bacterial infections in birds.”\n\nThese products are new animal drugs under section 201(v) of the FD&C Act [21 U.S.C. § 321(v)] because they are for use in nonfood-producing fish and birds, which are minor species as defined by sections 201(nn) and (oo) of the FD&C Act [21 U.S.C. § 321(nn) and (oo)], and are not the subject of a final FDA regulation finding either that the drugs are 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 drug’s labeling, or finding that the exception to the criterion in section 201(v)(1) of the FD&C Act has been met.\n\nTo be legally marketed, a new animal drug must be the subject of an approved new animal drug application, a conditionally approved new animal drug application, or a listing on the Index of Legally Marketed Unapproved New Animal Drugs for Minor Species (“index listing”) under section 512, 571, or 572 of the FD&C Act [21 U.S.C. § 360b, 360ccc, and 360ccc-1]. The FDA approval and index listing processes allow FDA to ensure that there is adequate evidence to demonstrate that new animal drugs are safe, properly manufactured, accurately labeled, and meet the relevant effectiveness standard. The animal drugs named above have not been approved, conditionally approved, or index listed.\n\nAnimal drugs that lack the required approval or index listing are considered unsafe and adulterated under sections 512(a) and 501(a)(5) of the FD&C Act [21 U.S.C. §§ 360b(a) and 351(a)(5)]. Introduction or delivery for introduction of an adulterated animal drug into interstate commerce is prohibited under section 301(a) of the FD&C Act [21 U.S.C. § 331(a)].\n\nFDA is particularly concerned about your unapproved animal drugs because they raise public health concerns. Available as over-the-counter drugs, they contain antimicrobials that are considered medically important in the treatment of human disease.1 Concern about the development of resistance to antimicrobials important in human medicine has led FDA to promote more judicious use of animal drugs containing medically important antimicrobials, including working toward ensuring that these drugs can be used in animals only under the supervision of a licensed veterinarian.\n\nMISBRANDED NEW ANIMAL DRUGS\n\nSections 510(b)(1) and (j)(1) of the FD&C Act [21 U.S.C. § 360(b), (j)] require that manufacturers (which includes repackers and relabelers) of drugs, including animal drugs, register their manufacturing establishments with FDA and provide the agency with a list of all the drug products they manufacture. Drugs that are manufactured in unregistered establishments or that have not been listed with FDA are misbranded under section 502(o) of the FD&C Act. None of the animal drugs in this letter are drug listed with FDA, nor have they been manufactured in a facility that is registered with FDA. Accordingly, these animal drugs are misbranded. Introduction or delivery for introduction of a misbranded animal drug into interstate commerce is prohibited under section 301(a) of the FD&C Act.\n\nThis letter is not intended to be an all-inclusive statement of violations that may exist in connection with your product(s). 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 requirements of federal law and FDA regulations.\n\nThis letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address this matter may lead to legal or regulatory action, including without limitation, seizure and\u002For injunction.\n\nYou should be aware that if we take enforcement action against any of the drugs named above or other unapproved\u002Funindexed products you market that contain medically important antimicrobials, we may take action against all of your products that violate the FD&C Act at the same time, including but not limited to enjoining the manufacturing and distribution of any unapproved\u002Funindexed products.\n\nWe have the following comments:\n\n1. You can legally market the products named above if you obtain an index listing, approval, or conditional approval. Information about the processes and requirements for obtaining an index listing and various types of animal drug approval is available on the FDA website at\n\nhttps:\u002F\u002Fwww.fda.gov\u002Fanimal-veterinary\u002Fdevelopment-approval-process\u002Fminor-useminor-species and\n\nhttps:\u002F\u002Fwww.fda.gov\u002Fanimal-veterinary\u002Fdevelopment-approval-process\u002Fnew-animal-drug-applications\n\nThe index listing process was added to the FD&C Act in 2004 as a streamlined alternative process that addresses the challenges of obtaining FDA approval for drugs for minor species (which are any animal species other than horses, cattle, pigs, dogs, cats, chickens, and turkeys). Drugs intended for use in minor species not used for human or animal food are eligible for index listing. Because the above-named products are intended for use in nonfood-producing fish and birds, you may wish to explore the index listing process. The approval process can also be used for drugs for use in these species.\n\n2. Information on establishment registration and drug listing is available on the FDA website at:\n\nhttps:\u002F\u002Fwww.fda.gov\u002Findustry\u002Ffda-basics-industry\u002Fregistration-and-listing\n\nWithin fifteen (15) working days of receiving this letter, please notify this office in writing of the specific steps that you have taken to correct 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 actions 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 products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration.\n\nYour written response should be sent to Dr. Vic Boddie, United States Food and Drug Administration, Center for Veterinary Medicine, Office of Surveillance and Compliance, Division of Drug Compliance, by emailing CVMUnapprovedDrugs@fda.hhs.gov.\n\nSincerely,\n\n\u002FS\u002F\n\nNeal Bataller, ME, DVM\n\nDirector Division of Drug Compliance\n\nOffice of Surveillance and Compliance\n\nCenter for Veterinary Medicine\n\n________________\n\n1 A list of medically important drug classes of antimicrobials can be found in Guidance for Industry (GFI) # 152, “Evaluating the Safety of Antimicrobial New Animal Drugs with Regard to Their Microbiological Effects on Bacteria of Human Health Concern,” available at https:\u002F\u002Fwww.fda.gov\u002Fdownloads\u002FAnimalVeterinary\u002FGuidanceComplianceEnforcement\u002FGuidanceforIndustry\u002FUCM052519.pdf","2026-08-20T00:26:38.452+00:00",[23,24,25,9,10,26,26,26],"\u003Ctime datetime=\"2023-12-14T13:45:00Z\">12\u002F14\u002F2023\u003C\u002Ftime>\n","\u003Ctime datetime=\"2023-11-30T05:00:00Z\">11\u002F30\u002F2023\u003C\u002Ftime>\n","\u003Ca href=\"\u002Finspections-compliance-enforcement-and-criminal-investigations\u002Fwarning-letters\u002Fmidland-vet-services-667614-11302023\">Midland Vet Services\u003C\u002Fa>","","2026-08-18T06:42:28.994808+00:00","2026-08-20T02:24:56.185295+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"]