[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-warning-letter-mike-millenkamp-dairy-cattle-640782-11282022":3,"fda-latest-sync-dates":31},{"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":29,"updated_at":30},2274,"mike-millenkamp-dairy-cattle-640782-11282022","Warning Letter","Mike Millenkamp Dairy Cattle",null,"Division of Human and Animal Food Operations West II","New Animal Drug\u002FAdulterated","2022-12-27","2022-11-28","Issued","https:\u002F\u002Fwww.fda.gov\u002Finspections-compliance-enforcement-and-criminal-investigations\u002Fwarning-letters\u002Fmike-millenkamp-dairy-cattle-640782-11282022","640782","Animal & VeterinaryDrugs","Certified Mail","Michael T. Millenkamp","\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\">Certified Mail\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\">Michael T. Millenkamp\u003C\u002Fdiv>\n          \u003C\u002Fdiv>\n\u003C\u002Fdd>\n                                \u003Cdd>\n  \u003Cdiv class=\"field field--name-field-recipient-title field--type-string field--label-above\">\n    \u003Cdiv class=\"field--label\">Recipient Title\u003C\u002Fdiv>\n              \u003Cdiv class=\"field--item\">Owner\u003C\u002Fdiv>\n          \u003C\u002Fdiv>\n\u003C\u002Fdd>\n          \n            \u003Cdd>Mike Millenkamp Dairy Cattle\u003C\u002Fdd>\n\n          \n                      \u003Cdd>\u003Cp class=\"address\" translate=\"no\">\u003Cspan class=\"address-line1\">2065 137th Street\u003C\u002Fspan>\u003Cbr>\n\u003Cspan class=\"locality\">Earlville\u003C\u002Fspan>, \u003Cspan class=\"administrative-area\">IA\u003C\u002Fspan> \u003Cspan class=\"postal-code\">52041\u003C\u002Fspan>\u003Cbr>\n\u003Cspan class=\"country\">United States\u003C\u002Fspan>\u003C\u002Fp>\u003C\u002Fdd>\n          \n          \n          \n    \u003C\u002Fdl>\n  \u003C\u002Fdiv>            \n\n       \u003Cdiv class=\"col-xs-12 col-md-6\">\n    \u003Cdl class=\"\">\n          \n          \u003Cdt>Issuing Office:\u003C\u002Fdt>\n        \n         \n          \u003Cdd> Division of Human and Animal Food Operations West II \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>November 28, 2022\u003C\u002Fp>\n\n\u003Cp>RE: CMS CASE 640782\u003C\u002Fp>\n\n\u003Cp class=\"text-align-center\">\u003Cstrong>WARNING LETTER\u003C\u002Fstrong>\u003C\u002Fp>\n\n\u003Cp>Dear Mr. Millenkamp:\u003C\u002Fp>\n\n\u003Cp>An inspection of your beef cattle growing operation Mike Millenkamp Dairy Cattle located at 2065 137th Street, Earlville, Iowa, was conducted by representatives of the U.S. Food and Drug Administration (FDA) on August 2 and 5, 2022. This letter notifies you of violations of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) that were revealed during our investigation of your operation. You can find the Act and its associated regulations on the Internet through links on the FDA’s web page at \u003Ca href=\"\u002F\u002Fwww.fda.gov.\">www.fda.gov.\u003C\u002Fa>\u003C\u002Fp>\n\n\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 on this letter.\u003C\u002Fp>\n\n\u003Cp>\u003Cstrong>Adulteration of a New Animal Drug\u003C\u002Fstrong>\u003C\u002Fp>\n\n\u003Cp>Our investigation found that you adulterated the new animal drug enrofloxacin \u003Cstrong>(b)(4)\u003C\u002Fstrong> by administering it to a beef steer, identified with ear tag \u003Cstrong>(b)(4)\u003C\u002Fstrong>, without following the duration of use for the treatment as stated in the approved label. Specifically, you administered enrofloxacin 10 times during a thirty-day period starting on or about December 21, 2021 to treat a beef steer (ear tag \u003Cstrong>(b)(4)\u003C\u002Fstrong>) for \u003Cem>Mycoplasma bovis\u003C\u002Fem>. No approved drug containing enrofloxacin is labeled for multiple uses for the treatment of \u003Cem>Mycoplasma bovis\u003C\u002Fem> in cattle. Use of this drug in this manner is an extralabel use, as defined by Title 21, \u003Cstrong>Code of Federal Regulations\u003C\u002Fstrong> § 530.3(a) [21 CFR § 530.3(a)]. The only labeled use of enrofloxacin, for the treatment of \u003Cem>Mycoplasma bovis\u003C\u002Fem> in cattle, is a single subcutaneous dose followed by 28 days of withdrawal time.\u003C\u002Fp>\n\n\u003Cp>Under 21 CFR § 530.41(a)(10), fluoroquinolones, which include enrofloxacin, are prohibited from extralabel use. Because your use of this drug was not in conformance with the approved label and labeling, you caused the drug to be unsafe under section 512(a) of the FD&C Act, 21 U.S.C. § 360(b)(a), and adulterated within the meaning of section 501(a)(5) of the FD&C Act, 21 U.S.C. § 351(a)(5). The doing of any act to a drug after shipment of the drug and or\u002Fits components in interstate commerce while the drug is held for sale (whether or not the first sale) that results in the drug being adulterated or misbranded is a prohibited act under section 301(k) of the FD&C Act [21 U.S.C § 331(k)].\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 at your facility. You are responsible for investigating and determining the cause 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 without further notice, including without limitation, seizure and 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 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 you have complied with the FD&C Act and FDA regulations, include your reasoning and any supporting information for our consideration.\u003C\u002Fp>\n\n\u003Cp>Your written response should be sent to Danial S. Hutchison, Compliance Officer, U.S. Food and Drug Administration, 8050 Marshall Drive, Suite 205, Lenexa, KS 66214-1524. If you have any questions about this letter, please contact Compliance Officer Hutchison at 913-495-5154, or Danial.Hutchison@fda.hhs.gov.\u003C\u002Fp>\n\n\u003Cp>Sincerely yours,\u003Cbr>\n\u002FS\u002F\u003C\u002Fp>\n\n\u003Cp>LaTonya M. Mitchell, Ph.D.\u003Cbr>\nProgram Division Director\u003Cbr>\nOffice of Human and Animal Food\u003Cbr>\nWest Division II\u003C\u002Fp>\n\n\u003Cp>cc:\u003C\u002Fp>\n\n\u003Cp>Iowa Department of Inspections and Appeals\u003Cbr>\nLarry Johnson, JR, Director\u003Cbr>\n515-281-5457\u003Cbr>\nlarry.johnson@dia.iowa.gov\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\nCertified Mail\n\nProduct:\n\nAnimal & Veterinary\nDrugs\n\nRecipient:\n\nRecipient Name\n\nMichael T. Millenkamp\n\nRecipient Title\n\nOwner\n\nMike Millenkamp Dairy Cattle\n\n2065 137th Street\n\nEarlville, IA 52041\n\nUnited States\n\nIssuing Office:\n\nDivision of Human and Animal Food Operations West II\n\nUnited States\n\nNovember 28, 2022\n\nRE: CMS CASE 640782\n\nWARNING LETTER\n\nDear Mr. Millenkamp:\n\nAn inspection of your beef cattle growing operation Mike Millenkamp Dairy Cattle located at 2065 137th Street, Earlville, Iowa, was conducted by representatives of the U.S. Food and Drug Administration (FDA) on August 2 and 5, 2022. This letter notifies you of violations of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) that were revealed during our investigation of your operation. You can find the Act and its associated regulations on the Internet through links on the FDA’s web page at www.fda.gov.\n\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 on this letter.\n\nAdulteration of a New Animal Drug\n\nOur investigation found that you adulterated the new animal drug enrofloxacin (b)(4) by administering it to a beef steer, identified with ear tag (b)(4), without following the duration of use for the treatment as stated in the approved label. Specifically, you administered enrofloxacin 10 times during a thirty-day period starting on or about December 21, 2021 to treat a beef steer (ear tag (b)(4)) for Mycoplasma bovis. No approved drug containing enrofloxacin is labeled for multiple uses for the treatment of Mycoplasma bovis in cattle. Use of this drug in this manner is an extralabel use, as defined by Title 21, Code of Federal Regulations § 530.3(a) [21 CFR § 530.3(a)]. The only labeled use of enrofloxacin, for the treatment of Mycoplasma bovis in cattle, is a single subcutaneous dose followed by 28 days of withdrawal time.\n\nUnder 21 CFR § 530.41(a)(10), fluoroquinolones, which include enrofloxacin, are prohibited from extralabel use. Because your use of this drug was not in conformance with the approved label and labeling, you caused the drug to be unsafe under section 512(a) of the FD&C Act, 21 U.S.C. § 360(b)(a), and adulterated within the meaning of section 501(a)(5) of the FD&C Act, 21 U.S.C. § 351(a)(5). The doing of any act to a drug after shipment of the drug and or\u002Fits components in interstate commerce while the drug is held for sale (whether or not the first sale) that results in the drug being adulterated or misbranded is a prohibited act under section 301(k) of the FD&C Act [21 U.S.C § 331(k)].\n\nConclusion\n\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 cause 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 without further notice, including without limitation, seizure and injunction.\n\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 that you have complied with the FD&C Act and FDA regulations, include your reasoning and any supporting information for our consideration.\n\nYour written response should be sent to Danial S. Hutchison, Compliance Officer, U.S. Food and Drug Administration, 8050 Marshall Drive, Suite 205, Lenexa, KS 66214-1524. If you have any questions about this letter, please contact Compliance Officer Hutchison at 913-495-5154, or Danial.Hutchison@fda.hhs.gov.\n\nSincerely yours,\n\n\u002FS\u002F\n\nLaTonya M. Mitchell, Ph.D.\n\nProgram Division Director\n\nOffice of Human and Animal Food\n\nWest Division II\n\ncc:\n\nIowa Department of Inspections and Appeals\n\nLarry Johnson, JR, Director\n\n515-281-5457\n\nlarry.johnson@dia.iowa.gov","2026-08-20T01:21:03.951+00:00",[23,24,25,26,27,28,28,28],"\u003Ctime datetime=\"2022-12-27T14:20:00Z\">12\u002F27\u002F2022\u003C\u002Ftime>\n","\u003Ctime datetime=\"2022-11-28T05:00:00Z\">11\u002F28\u002F2022\u003C\u002Ftime>\n","\u003Ca href=\"\u002Finspections-compliance-enforcement-and-criminal-investigations\u002Fwarning-letters\u002Fmike-millenkamp-dairy-cattle-640782-11282022\">Mike Millenkamp Dairy Cattle\u003C\u002Fa>"," Division of Human and Animal Food Operations West II ","New Animal Drug\u002FAdulterated\u003Cbr \u002F>\r\n","","2026-08-18T06:42:29.145918+00:00","2026-08-20T02:24:56.344395+00:00",{"510k":32,"classification":33,"enforcement":34,"event":35,"pma":36,"warning_letter":37},"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"]