[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-warning-letter-ogle-cattle-company-inc-713311-09052025":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},559,"ogle-cattle-company-inc-713311-09052025","Warning Letter","Ogle Cattle Company, Inc.",null,"Center for Veterinary Medicine","New Animal Drug\u002FAdulterated","2025-09-30","2025-09-05","Issued","https:\u002F\u002Fwww.fda.gov\u002Finspections-compliance-enforcement-and-criminal-investigations\u002Fwarning-letters\u002Fogle-cattle-company-inc-713311-09052025","713311","Animal & VeterinaryDrugs","VIA EMAIL WITH READ RECEIPT: NO HARD COPY TO FOLLOW","James C. Ogle, Co-owner","\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 WITH READ RECEIPT: NO HARD COPY TO FOLLOW\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\">James C. Ogle, Co-owner\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\">Julie D. Cook, Co-owner \u003C\u002Fdiv>\n          \u003C\u002Fdiv>\n\u003C\u002Fdd>\n          \n            \u003Cdd>Ogle Cattle Company, Inc. \u003C\u002Fdd>\n\n          \n                      \u003Cdd>\u003Cp class=\"address\" translate=\"no\">\u003Cspan class=\"address-line1\">312 Cattle Pen Road\u003C\u002Fspan>\u003Cbr>\n\u003Cspan class=\"locality\">Bowie\u003C\u002Fspan>, \u003Cspan class=\"administrative-area\">TX\u003C\u002Fspan> \u003Cspan class=\"postal-code\">76230-1166\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    \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>\u003Cbr>\u003Cstrong>CMS # 713311\u003C\u002Fstrong>\u003C\u002Fp>\u003Cp>September 05, 2025\u003C\u002Fp>\u003Cp>Dear Mr. James Ogle and Mrs. Julie Cook,\u003C\u002Fp>\u003Cp>An inspection of your cattle feedlot operation, Ogle Cattle Company, Inc. located at 312 Cattle Pen Road, Bowie, Texas 76230-1166, was conducted by a representative of the U.S. Food and Drug Administration (FDA) on April 17, April 18, May 6, and June 10, 2025. This letter notifies you of the violations of the Federal Food, Drug, and Cosmetic Act (FD&C Act) that we found during our inspection of your operation. You can find the FD&C Act and its associated regulations on the internet through links on FDA’s web page at www.fda.gov.\u003C\u002Fp>\u003Cp>At the close of the inspection, you were issued a Form FDA 483, Inspectional Observations (FDA 483). We have not received a response to the FDA 483 as of the date of this letter.\u003C\u002Fp>\u003Cp>\u003Cstrong>\u003Cu>Adulteration of Animals Offered for Human Consumption\u003C\u002Fu>\u003C\u002Fstrong>\u003C\u002Fp>\u003Cp>Our inspection found you offered for sale animals for slaughter as food that were adulterated. Specifically, you sold the following animals at auction for slaughter as food:\u003C\u002Fp>\u003Cul>\u003Cli>You sold a steer identified with backtag \u003Cstrong>(b)(4)\u003C\u002Fstrong> at auction on or about \u003Cstrong>(b)(4)\u003C\u002Fstrong>. The animal was slaughtered on or about \u003Cstrong>(b)(4)\u003C\u002Fstrong>, at \u003Cstrong>(b)(4)\u003C\u002Fstrong>. The United States Department of Agriculture\u002FFood Safety and Inspection Service (USDA\u002FFSIS) analysis of tissue samples collected from the animal identified the presence of desfuroylceftiofur at 9.44 parts per million (ppm) in kidney tissue.\u003C\u002Fli>\u003Cli>You sold a heifer identified with backtag \u003Cstrong>(b)(4)\u003C\u002Fstrong> at auction on or about \u003Cstrong>(b)(4)\u003C\u002Fstrong>. The animal was slaughtered on or about \u003Cstrong>(b)(4)\u003C\u002Fstrong>, at \u003Cstrong>(b)(4)\u003C\u002Fstrong>. USDA\u002FFSIS analysis of tissue samples collected from the animal identified the presence of desfuroylceftiofur at 0.846 ppm in kidney tissue.\u003C\u002Fli>\u003Cli>You sold a heifer identified with backtag \u003Cstrong>(b)(4)\u003C\u002Fstrong> at auction on or about \u003Cstrong>(b)(4)\u003C\u002Fstrong>. The animal was slaughtered on or about \u003Cstrong>(b)(4)\u003C\u002Fstrong>, at \u003Cstrong>(b)(4)\u003C\u002Fstrong>. USDA\u002FFSIS analysis of tissue samples collected from the animal identified the presence of desfuroylceftiofur at 2.04 ppm in kidney tissue.\u003C\u002Fli>\u003Cli>You sold a steer identified with backtag \u003Cstrong>(b)(4)\u003C\u002Fstrong> at auction on or about \u003Cstrong>(b)(4)\u003C\u002Fstrong>. The animal was slaughtered on or about \u003Cstrong>(b)(4)\u003C\u002Fstrong>, at \u003Cstrong>(b)(4)\u003C\u002Fstrong>. USDA\u002FFSIS analysis of tissue samples collected from the animal identified the presence of desfuroylceftiofur at 0.520 ppm in kidney tissue.\u003C\u002Fli>\u003C\u002Ful>\u003Cp>FDA has established a tolerance of 0.4 ppm of desfuroylceftiofur, a marker residue of ceftiofur drugs, in the kidney tissue of cattle.\u003Cem>\u003Cstrong>\u003Csup>1\u003C\u002Fsup>\u003C\u002Fstrong>\u003C\u002Fem>\u003C\u002Fp>\u003Cp>The presence of this drug in the edible tissues of these animals at these levels cause the food to be adulterated. A food is deemed to be adulterated if it bears or contains a new animal drug that is unsafe.\u003Cem>\u003Cstrong>\u003Csup>2\u003C\u002Fsup>\u003C\u002Fstrong>\u003C\u002Fem> A drug is unsafe if it results in any residues that exceed any established safe levels.\u003Cem>\u003Cstrong>\u003Csup>3\u003C\u002Fsup>\u003C\u002Fstrong>\u003C\u002Fem> The introduction or delivery for introduction into interstate commerce of any food that is adulterated is a prohibited act.\u003Cem>\u003Cstrong>\u003Csup>4\u003C\u002Fsup>\u003C\u002Fstrong>\u003C\u002Fem>\u003C\u002Fp>\u003Cp>Additionally, our inspection found that you hold animals under conditions that are inadequate such that medicated animals bearing potentially harmful drug residues are likely to enter the food supply. Specifically, you failed to keep identity records or record existing identification of animals you purchased and\u002For delivered for sale, you did not maintain treatment records for drugs administered to cattle on your farm, nor did you identify or segregate animals you treated with drugs. Food held under conditions whereby it may have been rendered injurious to health is adulterated.\u003Cem>\u003Cstrong>\u003Csup>5\u003C\u002Fsup>\u003C\u002Fstrong>\u003C\u002Fem>\u003C\u002Fp>\u003Cp>\u003Cstrong>\u003Cu>Adulteration of a New Animal Drug\u003C\u002Fu>\u003C\u002Fstrong>\u003C\u002Fp>\u003Cp>Our inspection found you did not use \u003Cstrong>(b)(4)\u003C\u002Fstrong> as directed by its approved labeling. Use of a drug in a manner that is not consistent with its labeling is extralabel use.\u003Cem>\u003Cstrong>\u003Csup>6\u003C\u002Fsup>\u003C\u002Fstrong>\u003C\u002Fem>\u003C\u002Fp>\u003Cp>Our inspection found that you administered \u003Cstrong>(b)(4)\u003C\u002Fstrong> to cattle without following the approved route of administration. During the inspection, you stated that you administer all medications as a subcutaneous injection in the neck area or over the ribs of animals receiving medical treatment. This drug is labeled for administering to cattle as \u003Cstrong>(b)(4)\u003C\u002Fstrong>. \u003Cstrong>(b)(4)\u003C\u002Fstrong>, a ceftiofur class drug, is prohibited from extralabel use at unapproved routes of administration in food-producing animals.\u003Cem>\u003Cstrong>\u003Csup>7\u003C\u002Fsup>\u003C\u002Fstrong>\u003C\u002Fem> The extralabel use of this drug is only allowed if it complies with the FD&C Act and 21 CFR Part 530 including that such use must be by or on the lawful order of a licensed veterinarian within the context of a valid veterinarian-client-patient relationship.\u003Cem>\u003Cstrong>\u003Csup>8, 9\u003C\u002Fsup>\u003C\u002Fstrong>\u003C\u002Fem>\u003C\u002Fp>\u003Cp>Because your use of this drug was not in conformance with its approved labeling and did not comply with 21 CFR Part 530, you caused the drug to be unsafe and adulterated.\u003Cem>\u003Cstrong>\u003Csup>10\u003C\u002Fsup>\u003C\u002Fstrong>\u003C\u002Fem> The introduction or delivery for introduction into interstate commerce of any drug that is adulterated is a prohibited act.\u003Cem>\u003Cstrong>\u003Csup>11\u003C\u002Fsup>\u003C\u002Fstrong>\u003C\u002Fem>\u003C\u002Fp>\u003Cp>\u003Cstrong>\u003Cu>Conclusion\u003C\u002Fu>\u003C\u002Fstrong>\u003C\u002Fp>\u003Cp>This letter is not intended to be an all-inclusive statement of violations that may exist at your facility. 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 you comply with all requirements of federal law and FDA regulations.\u003C\u002Fp>\u003Cp>This letter notifies you of our concerns and provides you an opportunity to address them. You should take prompt action to correct any violations. Failure to adequately address this matter may lead to legal action, including without limitation, seizure, and injunction.\u003C\u002Fp>\u003Cp>We would like to note that your use of \u003Cstrong>(b)(4)\u003C\u002Fstrong> (enrofloxacin), without maintaining treatment records and\u002For segregating or identifying medicated animals, resulted in the detection of ciprofloxacin, a marker residue of enrofloxacin, in the cattle listed above by USDA\u002FFSIS. Ciprofloxacin has a tolerance of 0.1 ppm in the liver of cattle.\u003Cem>\u003Cstrong>\u003Csup>12\u003C\u002Fsup>\u003C\u002Fstrong>\u003C\u002Fem> Care should be taken to ensure \u003Cstrong>(b)(4)\u003C\u002Fstrong> is administered according to its label and that the appropriate withdrawal time is followed. Use of \u003Cstrong>(b)(4)\u003C\u002Fstrong>, a fluoroquinolone drug, is prohibited from extralabel use.\u003Cem>\u003Cstrong>\u003Csup>13\u003C\u002Fsup>\u003C\u002Fstrong>\u003C\u002Fem>\u003C\u002Fp>\u003Cp>Within fifteen (15) working days of receipt of 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 you have complied with the FD&C Act and FDA regulations, include your reasoning and any supporting information for our consideration.\u003C\u002Fp>\u003Cp>The Food & Drug Administration, Center for Veterinary Medicine, Office of Surveillance and Compliance is encouraging electronic submission of any response you choose to submit to this letter. We encourage you to submit files up to 100 megabytes in a single email, and to divide files greater than 100 megabytes so they may be submitted as smaller files in separate emails. If you submit electronic correspondence, please ensure that your facility’s name, the CMS number at the top of this letter, and the inspection location are included in your correspondence. We intend to issue an electronic acknowledgement upon receipt of your email.\u003C\u002Fp>\u003Cp>Please direct your electronic correspondence to Compliance Officer Dylan C. Grippi at dylan.grippi@fda.hhs.gov. If you are unable to submit your correspondence electronically, please direct it to the attention of Dylan C. Grippi, Compliance Officer, at the following address:\u003C\u002Fp>\u003Cp>U.S. Food and Drug Administration\u003Cbr>Center for Veterinary Medicine\u003Cbr>CPK1, 5001 Campus Drive\u003Cbr>College Park, MD 20740-3835\u003C\u002Fp>\u003Cp>If you have questions regarding this letter, please contact Compliance Officer Dylan C. Grippi by telephone at (301) 452-1608, or by email at dylan.grippi@fda.hhs.gov.\u003C\u002Fp>\u003Cp>Sincerely,\u003Cbr>\u002FS\u002F\u003C\u002Fp>\u003Cp>Isaac K. Carney\u003Cbr>Director of Food Compliance, Office of Surveillance and Compliance\u003Cbr>Center for Veterinary Medicine\u003Cbr>U.S. Food and Drug Administration\u003Cbr>\u003Cbr>CC: \u003C\u002Fp>\u003Cp>\u003Cstrong>(b)(4)\u003C\u002Fstrong>\u003Cbr>\u003Cstrong>(b)(6)\u003C\u002Fstrong>\u003C\u002Fp>\u003Cp>________________________\u003C\u002Fp>\u003Cp>\u003Cem>\u003Cstrong>1\u003C\u002Fstrong>\u003C\u002Fem> See 21 CFR 556.113(b)(1)(i).\u003C\u002Fp>\u003Cp>\u003Cem>\u003Cstrong>2\u003C\u002Fstrong>\u003C\u002Fem> See section 402(a)(2)(C)(ii) of the FD&C Act [21 U.S.C. § 342(a)(2)(C)(ii)].\u003C\u002Fp>\u003Cp>\u003Cem>\u003Cstrong>3\u003C\u002Fstrong>\u003C\u002Fem> See section 512(a)(4)(B) of the FD&C Act [21 U.S.C. § 360b(a)(4)(B)].\u003C\u002Fp>\u003Cp>\u003Cem>\u003Cstrong>4\u003C\u002Fstrong>\u003C\u002Fem> See section 301(a) of the FD&C Act [21 U.S.C. § 331(a)].\u003C\u002Fp>\u003Cp>\u003Cem>\u003Cstrong>5\u003C\u002Fstrong>\u003C\u002Fem> See section 402(a)(4) of the FD&C Act [21 U.S.C. § 342(a)(4)].\u003C\u002Fp>\u003Cp>\u003Cem>\u003Cstrong>6\u003C\u002Fstrong>\u003C\u002Fem> See 21 CFR 530.3(a).\u003C\u002Fp>\u003Cp>\u003Cem>\u003Cstrong>7\u003C\u002Fstrong>\u003C\u002Fem> See 21 CFR 530.41(a)(13)(ii).\u003C\u002Fp>\u003Cp>\u003Cem>\u003Cstrong>8 \u003C\u002Fstrong>\u003C\u002Fem>See section 512(a)(4) and (5) of the FD&C Act [21 U.S.C. § 360b(a)(4) and (5)].\u003C\u002Fp>\u003Cp>\u003Cem>\u003Cstrong>9\u003C\u002Fstrong>\u003C\u002Fem> See 21 CFR 530.3(i)(1).\u003C\u002Fp>\u003Cp>\u003Cem>\u003Cstrong>10\u003C\u002Fstrong>\u003C\u002Fem> Under section 501(a)(5) of the FD&C Act [21 U.S.C. § 351(a)(5)], a new animal drug is deemed adulterated if it is unsafe within the meaning of section 512 of the FD&C Act [21 U.S.C. § 360b].\u003C\u002Fp>\u003Cp>\u003Cem>\u003Cstrong>11\u003C\u002Fstrong>\u003C\u002Fem> See section 301(a) of the FD&C Act [21 U.S.C. § 331(a)].\u003C\u002Fp>\u003Cp>\u003Cem>\u003Cstrong>12\u003C\u002Fstrong>\u003C\u002Fem> See 21 CFR 556.226(b)(1).\u003C\u002Fp>\u003Cp>\u003Cem>\u003Cstrong>13\u003C\u002Fstrong>\u003C\u002Fem> See 21 CFR 530.41(a)(10).\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 EMAIL WITH READ RECEIPT: NO HARD COPY TO FOLLOW\n\nProduct:\n\nAnimal & Veterinary\nDrugs\n\nRecipient:\n\nRecipient Name\n\nJames C. Ogle, Co-owner\n\nRecipient Title\n\nJulie D. Cook, Co-owner\n\nOgle Cattle Company, Inc.\n\n312 Cattle Pen Road\n\nBowie, TX 76230-1166\n\nUnited States\n\n(b)(6)\n\nIssuing Office:\n\nCenter for Veterinary Medicine\n\nUnited States\n\nWARNING LETTER\nCMS # 713311\nSeptember 05, 2025\nDear Mr. James Ogle and Mrs. Julie Cook,\nAn inspection of your cattle feedlot operation, Ogle Cattle Company, Inc. located at 312 Cattle Pen Road, Bowie, Texas 76230-1166, was conducted by a representative of the U.S. Food and Drug Administration (FDA) on April 17, April 18, May 6, and June 10, 2025. This letter notifies you of the violations of the Federal Food, Drug, and Cosmetic Act (FD&C Act) that we found during our inspection of your operation. You can find the FD&C Act and its associated regulations on the internet through links on FDA’s web page at www.fda.gov.\nAt the close of the inspection, you were issued a Form FDA 483, Inspectional Observations (FDA 483). We have not received a response to the FDA 483 as of the date of this letter.\nAdulteration of Animals Offered for Human Consumption\nOur inspection found you offered for sale animals for slaughter as food that were adulterated. Specifically, you sold the following animals at auction for slaughter as food:\nYou sold a steer identified with backtag (b)(4) at auction on or about (b)(4). The animal was slaughtered on or about (b)(4), at (b)(4). The United States Department of Agriculture\u002FFood Safety and Inspection Service (USDA\u002FFSIS) analysis of tissue samples collected from the animal identified the presence of desfuroylceftiofur at 9.44 parts per million (ppm) in kidney tissue.\nYou sold a heifer identified with backtag (b)(4) at auction on or about (b)(4). The animal was slaughtered on or about (b)(4), at (b)(4). USDA\u002FFSIS analysis of tissue samples collected from the animal identified the presence of desfuroylceftiofur at 0.846 ppm in kidney tissue.\nYou sold a heifer identified with backtag (b)(4) at auction on or about (b)(4). The animal was slaughtered on or about (b)(4), at (b)(4). USDA\u002FFSIS analysis of tissue samples collected from the animal identified the presence of desfuroylceftiofur at 2.04 ppm in kidney tissue.\nYou sold a steer identified with backtag (b)(4) at auction on or about (b)(4). The animal was slaughtered on or about (b)(4), at (b)(4). USDA\u002FFSIS analysis of tissue samples collected from the animal identified the presence of desfuroylceftiofur at 0.520 ppm in kidney tissue.\nFDA has established a tolerance of 0.4 ppm of desfuroylceftiofur, a marker residue of ceftiofur drugs, in the kidney tissue of cattle.1\nThe presence of this drug in the edible tissues of these animals at these levels cause the food to be adulterated. A food is deemed to be adulterated if it bears or contains a new animal drug that is unsafe.2 A drug is unsafe if it results in any residues that exceed any established safe levels.3 The introduction or delivery for introduction into interstate commerce of any food that is adulterated is a prohibited act.4\nAdditionally, our inspection found that you hold animals under conditions that are inadequate such that medicated animals bearing potentially harmful drug residues are likely to enter the food supply. Specifically, you failed to keep identity records or record existing identification of animals you purchased and\u002For delivered for sale, you did not maintain treatment records for drugs administered to cattle on your farm, nor did you identify or segregate animals you treated with drugs. Food held under conditions whereby it may have been rendered injurious to health is adulterated.5\nAdulteration of a New Animal Drug\nOur inspection found you did not use (b)(4) as directed by its approved labeling. Use of a drug in a manner that is not consistent with its labeling is extralabel use.6\nOur inspection found that you administered (b)(4) to cattle without following the approved route of administration. During the inspection, you stated that you administer all medications as a subcutaneous injection in the neck area or over the ribs of animals receiving medical treatment. This drug is labeled for administering to cattle as (b)(4). (b)(4), a ceftiofur class drug, is prohibited from extralabel use at unapproved routes of administration in food-producing animals.7 The extralabel use of this drug is only allowed if it complies with the FD&C Act and 21 CFR Part 530 including that such use must be by or on the lawful order of a licensed veterinarian within the context of a valid veterinarian-client-patient relationship.8, 9\nBecause your use of this drug was not in conformance with its approved labeling and did not comply with 21 CFR Part 530, you caused the drug to be unsafe and adulterated.10 The introduction or delivery for introduction into interstate commerce of any drug that is adulterated is a prohibited act.11\nConclusion\nThis letter is not intended to be an all-inclusive statement of violations that may exist at your facility. 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 you comply with all requirements of federal law and FDA regulations.\nThis letter notifies you of our concerns and provides you an opportunity to address them. You should take prompt action to correct any violations. Failure to adequately address this matter may lead to legal action, including without limitation, seizure, and injunction.\nWe would like to note that your use of (b)(4) (enrofloxacin), without maintaining treatment records and\u002For segregating or identifying medicated animals, resulted in the detection of ciprofloxacin, a marker residue of enrofloxacin, in the cattle listed above by USDA\u002FFSIS. Ciprofloxacin has a tolerance of 0.1 ppm in the liver of cattle.12 Care should be taken to ensure (b)(4) is administered according to its label and that the appropriate withdrawal time is followed. Use of (b)(4), a fluoroquinolone drug, is prohibited from extralabel use.13\nWithin fifteen (15) working days of receipt of 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 you have complied with the FD&C Act and FDA regulations, include your reasoning and any supporting information for our consideration.\nThe Food & Drug Administration, Center for Veterinary Medicine, Office of Surveillance and Compliance is encouraging electronic submission of any response you choose to submit to this letter. We encourage you to submit files up to 100 megabytes in a single email, and to divide files greater than 100 megabytes so they may be submitted as smaller files in separate emails. If you submit electronic correspondence, please ensure that your facility’s name, the CMS number at the top of this letter, and the inspection location are included in your correspondence. We intend to issue an electronic acknowledgement upon receipt of your email.\nPlease direct your electronic correspondence to Compliance Officer Dylan C. Grippi at dylan.grippi@fda.hhs.gov. If you are unable to submit your correspondence electronically, please direct it to the attention of Dylan C. Grippi, Compliance Officer, at the following address:\nU.S. Food and Drug Administration\nCenter for Veterinary Medicine\nCPK1, 5001 Campus Drive\nCollege Park, MD 20740-3835\nIf you have questions regarding this letter, please contact Compliance Officer Dylan C. Grippi by telephone at (301) 452-1608, or by email at dylan.grippi@fda.hhs.gov.\nSincerely,\n\u002FS\u002F\nIsaac K. Carney\nDirector of Food Compliance, Office of Surveillance and Compliance\nCenter for Veterinary Medicine\nU.S. Food and Drug Administration\n\nCC:\n(b)(4)\n(b)(6)\n________________________\n1 See 21 CFR 556.113(b)(1)(i).\n2 See section 402(a)(2)(C)(ii) of the FD&C Act [21 U.S.C. § 342(a)(2)(C)(ii)].\n3 See section 512(a)(4)(B) of the FD&C Act [21 U.S.C. § 360b(a)(4)(B)].\n4 See section 301(a) of the FD&C Act [21 U.S.C. § 331(a)].\n5 See section 402(a)(4) of the FD&C Act [21 U.S.C. § 342(a)(4)].\n6 See 21 CFR 530.3(a).\n7 See 21 CFR 530.41(a)(13)(ii).\n8 See section 512(a)(4) and (5) of the FD&C Act [21 U.S.C. § 360b(a)(4) and (5)].\n9 See 21 CFR 530.3(i)(1).\n10 Under section 501(a)(5) of the FD&C Act [21 U.S.C. § 351(a)(5)], a new animal drug is deemed adulterated if it is unsafe within the meaning of section 512 of the FD&C Act [21 U.S.C. § 360b].\n11 See section 301(a) of the FD&C Act [21 U.S.C. § 331(a)].\n12 See 21 CFR 556.226(b)(1).\n13 See 21 CFR 530.41(a)(10).","2026-08-19T16:16:31.05+00:00",[23,24,25,9,10,26,26,26],"\u003Ctime datetime=\"2025-09-30T04:00:00Z\">09\u002F30\u002F2025\u003C\u002Ftime>\n","\u003Ctime datetime=\"2025-09-05T04:00:00Z\">09\u002F05\u002F2025\u003C\u002Ftime>\n","\u003Ca href=\"\u002Finspections-compliance-enforcement-and-criminal-investigations\u002Fwarning-letters\u002Fogle-cattle-company-inc-713311-09052025\">Ogle Cattle Company, Inc. \u003C\u002Fa>","","2026-08-18T06:42:28.676509+00:00","2026-08-20T02:24:55.884391+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"]