[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-warning-letter-martin-farm-konrad-martin-664784-11142023":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},1639,"martin-farm-konrad-martin-664784-11142023","Warning Letter","Martin Farm, Konrad Martin",null,"Division of Human and Animal Food Operations East VI","New Animal Drug\u002FAdulterated","2024-01-30","2023-11-14","Issued","https:\u002F\u002Fwww.fda.gov\u002Finspections-compliance-enforcement-and-criminal-investigations\u002Fwarning-letters\u002Fmartin-farm-konrad-martin-664784-11142023","664784","Animal & VeterinaryFood & Beverages","VIA EMAIL AND UNITED PARCEL SERVICE","Mr. Konrad Martin","\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 AND UNITED PARCEL SERVICE\n                                                                                                                                                                                                                                                                                                                                                                                                                              \u003C\u002Fdd>\n      \n      \n              \u003Cdt class=\"cell-1_3\">Product:\u003C\u002Fdt> \n        \u003Cdd class=\"cell-2_3\">Animal & Veterinary\u003Cbr>Food & Beverages                          \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\">Mr. Konrad Martin\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\">Part Owner\u003C\u002Fdiv>\n          \u003C\u002Fdiv>\n\u003C\u002Fdd>\n          \n            \u003Cdd>Martin Farm, Konrad Martin\u003C\u002Fdd>\n\n          \n                      \u003Cdd>\u003Cp class=\"address\" translate=\"no\">\u003Cspan class=\"address-line1\">68572 Country Road 11\u003C\u002Fspan>\u003Cbr>\n\u003Cspan class=\"locality\">Nappanee\u003C\u002Fspan>, \u003Cspan class=\"administrative-area\">IN\u003C\u002Fspan> \u003Cspan class=\"postal-code\">46550-8946\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)(7)(C)\"> (b)(6), (b)(7)(C)\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> Division of Human and Animal Food Operations East VI\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\u003Cbr>\nCMS 664784\u003C\u002Fstrong>\u003C\u002Fp>\n\n\u003Cp>November 14, 2023\u003Cbr>\n\u003Cbr>\nMailing Address:\u003Cbr>\n\u003Cstrong>(b)(6), (b)(7)(C)\u003C\u002Fstrong>\u003C\u002Fp>\n\n\u003Cp>Dear Mr. Martin:\u003C\u002Fp>\n\n\u003Cp>An inspection of your dairy operation located at 68572 Country Road 46, Nappanee, Indiana, was conducted by representatives of the U.S. Food and Drug Administration (FDA) on May 24, 2023, and June 21, 2023. This letter notifies you of violations of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) that were revealed during our inspection of your operation. You can find the FD&C Act and its associated regulations on the Internet through links on the FDA’s webpage at www.fda.gov.\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 of this letter.\u003C\u002Fp>\n\n\u003Cp>\u003Cu>\u003Cstrong>Adulteration of an Animal Offered for Human Consumption\u003C\u002Fstrong>\u003C\u002Fu>\u003C\u002Fp>\n\n\u003Cp>Our inspection found that you hold animals under conditions that are so inadequate that medicated animals bearing potentially harmful drug residues are likely to enter the food supply. Specifically, you failed to maintain complete and accurate treatment records. For example, you do not maintain any treatment records for drugs administered to calves on your farm, nor do you keep complete treatment records of drugs administered to cattle on your farm as those records lack dose, total days of treatment, route of administration, and person medicating animal and calves.\u003C\u002Fp>\n\n\u003Cp>Food held under such conditions is adulterated.\u003Csup>\u003Cem>\u003Cstrong>1\u003C\u002Fstrong>\u003C\u002Fem>\u003C\u002Fsup>\u003C\u002Fp>\n\n\u003Cp>\u003Cspan style=\"display: none;\"> \u003C\u002Fspan>\u003Cstrong>\u003Cu>Adulteration of a New Animal Drug\u003C\u002Fu>\u003C\u002Fstrong>\u003C\u002Fp>\n\n\u003Cp>We also found that you did not use \u003Cstrong>(b)(4)\u003C\u002Fstrong> (enrofloxacin, \u003Cstrong>(b)(4)\u003C\u002Fstrong>) and \u003Cstrong>(b)(4)\u003C\u002Fstrong> (ceftiofur hydrochloride, \u003Cstrong>(b)(4)\u003C\u002Fstrong>) as directed by their approved labeling and prescription labels. Use of a drugs in a manner that is not consistent with its labeling is an extralabel use.\u003Csup>\u003Cem>\u003Cstrong>2\u003C\u002Fstrong>\u003C\u002Fem>\u003C\u002Fsup>\u003C\u002Fp>\n\n\u003Cp>Our inspection found that you administered \u003Cstrong>(b)(4)\u003C\u002Fstrong> to calves without following the animal class, indications for use, route of administration, and withdrawal time. During the inspection, you stated that you administer \u003Cstrong>(b)(4)\u003C\u002Fstrong> of \u003Cstrong>(b)(4)\u003C\u002Fstrong> to prevent and treat scours and respiratory disease in most calves, either intramuscularly (IM) or orally with milk, and you do not follow meat withdrawal periods. This drug is not approved for use in calves or for disease prevention purposes for scours, and cannot be administered IM or orally or used without a meat withhold period. Extra-label use of \u003Cstrong>(b)(4)\u003C\u002Fstrong> is prohibited.\u003Csup>\u003Cem>\u003Cstrong>3\u003C\u002Fstrong>\u003C\u002Fem>\u003C\u002Fsup>\u003C\u002Fp>\n\n\u003Cp>Our inspection also found that you used \u003Cstrong>(b)(4)\u003C\u002Fstrong> without following the labeled dose. For example, during the inspection you explained that you used \u003Cstrong>(b)(4)\u003C\u002Fstrong> by giving \u003Cstrong>(b)(4)\u003C\u002Fstrong>. This drug is labeled for administering no more than \u003Cstrong>(b)(4)\u003C\u002Fstrong> per injection site. \u003Cstrong>(b)(4)\u003C\u002Fstrong>, a ceftiofur class drug, is prohibited from extra label use.\u003Csup>\u003Cem>\u003Cstrong>4\u003C\u002Fstrong>\u003C\u002Fem>\u003C\u002Fsup>\u003C\u002Fp>\n\n\u003Cp>Because your use of these drugs was not in conformance with their approved labeling and did not comply with 21 CFR Part 530, you caused the drugs to be unsafe and adulterated.\u003Csup>\u003Cem>\u003Cstrong>5\u003C\u002Fstrong>\u003C\u002Fem>\u003C\u002Fsup> The introduction or delivery for introduction into interstate commerce of any drug that is adulterated is a prohibited act.\u003Csup>\u003Cem>\u003Cstrong>6\u003C\u002Fstrong>\u003C\u002Fem>\u003C\u002Fsup>\u003C\u002Fp>\n\n\u003Cp>\u003Cu>\u003Cstrong>Conclusion\u003C\u002Fstrong>\u003C\u002Fu>\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\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 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 Dylan C. Grippi, Compliance Officer, at 300 River Place Drive, Suite 5900, Detroit, MI 48207 or via email (preferred) to Dylan.Grippi@fda.hhs.gov. If you have any questions about this letter, please contact Mr. Grippi at (301)-452-1608, or by e-mail at Dylan.Grippi@fda.hhs.gov.\u003C\u002Fp>\n\n\u003Cp>Sincerely,\u003Cbr>\n\u002FS\u002F\u003C\u002Fp>\n\n\u003Cp>William R. Weissinger, MS\u003Cbr>\nProgram Division Director\u003Cbr>\nOffice of Human and Animal Food Operations East Division 6\u003C\u002Fp>\n\n\u003Cp>CC: \u003Cstrong>(b)(4)\u003C\u002Fstrong>\u003C\u002Fp>\n\n\u003Cp>___________________\u003C\u002Fp>\n\n\u003Cp>\u003Cem>\u003Cstrong>1\u003C\u002Fstrong>\u003C\u002Fem> See section 402(a)(4) of the FD&C Act [21 U.S.C. § 342(a)(4)]\u003C\u002Fp>\n\n\u003Cp>\u003Cem>\u003Cstrong>2\u003C\u002Fstrong>\u003C\u002Fem> See 21 CFR 530.3(a).\u003C\u002Fp>\n\n\u003Cp>\u003Cem>\u003Cstrong>3\u003C\u002Fstrong>\u003C\u002Fem> See 21 CFR 530.41(a)(10).\u003C\u002Fp>\n\n\u003Cp>\u003Cem>\u003Cstrong>4\u003C\u002Fstrong>\u003C\u002Fem> See 21 CFR 530.41(a)(13)(ii).\u003C\u002Fp>\n\n\u003Cp>\u003Cem>\u003Cstrong>5\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>\n\n\u003Cp>\u003Cem>\u003Cstrong>6\u003C\u002Fstrong>\u003C\u002Fem> See section 301(a) of the FD&C Act [21 U.S.C. § 331(a)]\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 AND UNITED PARCEL SERVICE\n\nProduct:\n\nAnimal & Veterinary\nFood & Beverages\n\nRecipient:\n\nRecipient Name\n\nMr. Konrad Martin\n\nRecipient Title\n\nPart Owner\n\nMartin Farm, Konrad Martin\n\n68572 Country Road 11\n\nNappanee, IN 46550-8946\n\nUnited States\n\n(b)(6), (b)(7)(C)\n\nIssuing Office:\n\nDivision of Human and Animal Food Operations East VI\n\nUnited States\n\nSecondary Issuing Offices\n\nUnited States\n\nWARNING LETTER\n\nCMS 664784\n\nNovember 14, 2023\n\nMailing Address:\n\n(b)(6), (b)(7)(C)\n\nDear Mr. Martin:\n\nAn inspection of your dairy operation located at 68572 Country Road 46, Nappanee, Indiana, was conducted by representatives of the U.S. Food and Drug Administration (FDA) on May 24, 2023, and June 21, 2023. This letter notifies you of violations of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) that were revealed during our inspection of your operation. You can find the FD&C Act and its associated regulations on the Internet through links on the FDA’s webpage 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 of this letter.\n\nAdulteration of an Animal Offered for Human Consumption\n\nOur inspection found that you hold animals under conditions that are so inadequate that medicated animals bearing potentially harmful drug residues are likely to enter the food supply. Specifically, you failed to maintain complete and accurate treatment records. For example, you do not maintain any treatment records for drugs administered to calves on your farm, nor do you keep complete treatment records of drugs administered to cattle on your farm as those records lack dose, total days of treatment, route of administration, and person medicating animal and calves.\n\nFood held under such conditions is adulterated.1\n\nAdulteration of a New Animal Drug\n\nWe also found that you did not use (b)(4) (enrofloxacin, (b)(4)) and (b)(4) (ceftiofur hydrochloride, (b)(4)) as directed by their approved labeling and prescription labels. Use of a drugs in a manner that is not consistent with its labeling is an extralabel use.2\n\nOur inspection found that you administered (b)(4) to calves without following the animal class, indications for use, route of administration, and withdrawal time. During the inspection, you stated that you administer (b)(4) of (b)(4) to prevent and treat scours and respiratory disease in most calves, either intramuscularly (IM) or orally with milk, and you do not follow meat withdrawal periods. This drug is not approved for use in calves or for disease prevention purposes for scours, and cannot be administered IM or orally or used without a meat withhold period. Extra-label use of (b)(4) is prohibited.3\n\nOur inspection also found that you used (b)(4) without following the labeled dose. For example, during the inspection you explained that you used (b)(4) by giving (b)(4). This drug is labeled for administering no more than (b)(4) per injection site. (b)(4), a ceftiofur class drug, is prohibited from extra label use.4\n\nBecause your use of these drugs was not in conformance with their approved labeling and did not comply with 21 CFR Part 530, you caused the drugs to be unsafe and adulterated.5 The introduction or delivery for introduction into interstate commerce of any drug that is adulterated is a prohibited act.6\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\u002For 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 Dylan C. Grippi, Compliance Officer, at 300 River Place Drive, Suite 5900, Detroit, MI 48207 or via email (preferred) to Dylan.Grippi@fda.hhs.gov. If you have any questions about this letter, please contact Mr. Grippi at (301)-452-1608, or by e-mail at Dylan.Grippi@fda.hhs.gov.\n\nSincerely,\n\n\u002FS\u002F\n\nWilliam R. Weissinger, MS\n\nProgram Division Director\n\nOffice of Human and Animal Food Operations East Division 6\n\nCC: (b)(4)\n\n___________________\n\n1 See section 402(a)(4) of the FD&C Act [21 U.S.C. § 342(a)(4)]\n\n2 See 21 CFR 530.3(a).\n\n3 See 21 CFR 530.41(a)(10).\n\n4 See 21 CFR 530.41(a)(13)(ii).\n\n5 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].\n\n6 See section 301(a) of the FD&C Act [21 U.S.C. § 331(a)]","2026-08-20T00:21:22.861+00:00",[23,24,25,26,10,27,27,27],"\u003Ctime datetime=\"2024-01-30T14:20:00Z\">01\u002F30\u002F2024\u003C\u002Ftime>\n","\u003Ctime datetime=\"2023-11-14T05:00:00Z\">11\u002F14\u002F2023\u003C\u002Ftime>\n","\u003Ca href=\"\u002Finspections-compliance-enforcement-and-criminal-investigations\u002Fwarning-letters\u002Fmartin-farm-konrad-martin-664784-11142023\">Martin Farm, Konrad Martin\u003C\u002Fa>"," Division of Human and Animal Food Operations East VI","","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"]