[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-warning-letter-ivisitdoc-inc-dba-ivisitdoc-716826-09092025":3,"fda-latest-sync-dates":28},{"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":8,"recipient_title":8,"body_html":18,"body_text":19,"body_fetched_at":20,"medical_device_id":8,"raw":21,"created_at":26,"updated_at":27},602,"ivisitdoc-inc-dba-ivisitdoc-716826-09092025","Warning Letter","iVisitDoc, Inc. dba iVisitDoc",null,"Center for Drug Evaluation and Research (CDER)","Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet (Telehealth)","2025-09-16","2025-09-09","Issued","https:\u002F\u002Fwww.fda.gov\u002Finspections-compliance-enforcement-and-criminal-investigations\u002Fwarning-letters\u002Fivisitdoc-inc-dba-ivisitdoc-716826-09092025","716826","Drugs","VIA ELECTRONIC MAIL READ\u002FDELIVERY RECEIPT REQUESTED","\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 ELECTRONIC MAIL READ\u002FDELIVERY RECEIPT REQUESTED\n                                                                                                                                                                                                                                                                                                                                                                                                                              \u003C\u002Fdd>\n      \n      \n              \u003Cdt class=\"cell-1_3\">Product:\u003C\u002Fdt> \n        \u003Cdd class=\"cell-2_3\">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>\u003C\u002Fdd>\n                    \n            \u003Cdd>iVisitDoc, Inc. dba iVisitDoc\u003C\u002Fdd>\n\n          \n                      \u003Cdd>\u003Cp class=\"address\" translate=\"no\">\u003Cspan class=\"address-line1\">7345 Woodland Drive, Suite I\u003C\u002Fspan>\u003Cbr>\n\u003Cspan class=\"locality\">Indianapolis\u003C\u002Fspan>, \u003Cspan class=\"administrative-area\">IN\u003C\u002Fspan> \u003Cspan class=\"postal-code\">46278\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:info@ivisitdoc.com\"> info@ivisitdoc.com\u003C\u002Fa>\u003C\u002Fdd>\n\n          \n    \u003C\u002Fdl>\n  \u003C\u002Fdiv>            \n\n       \u003Cdiv class=\"col-xs-12 col-md-6\">\n    \u003Cdl class=\"\">\n          \n          \u003Cdt>Issuing Office:\u003C\u002Fdt>\n        \n         \n          \u003Cdd>Center for Drug Evaluation and Research (CDER)\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\u003C\u002Fstrong>\u003C\u002Fp>\u003Cp>September 9, 2025\u003C\u002Fp>\u003Cp>iVisitDoc:\u003C\u002Fp>\u003Cp>This letter is to advise you that the United States Food and Drug Administration (FDA) reviewed your website content at the internet address https:\u002F\u002Fivisitdoc.com in August 2025 and has observed that your website offers various compounded semaglutide drug products.1 As described below, your claims concerning compounded semaglutide products are false or misleading under sections 502(a) and 502(bb) of the Federal Food, Drug, and Cosmetic Act (FDCA) [21 U.S.C. §§ 352(a) and 352(bb)], resulting in products being introduced or delivered for introduction into interstate commerce in violation of section 301(a) of the FDCA [21 U.S.C. § 331(a)].\u003C\u002Fp>\u003Cp>Under section 502(a) of the FDCA [21 U.S.C. § 352(a)] a drug is misbranded if its labeling is false or misleading in any particular. Furthermore, under section 502(bb) of the FDCA [21 U.S.C. § 352(bb)], a compounded drug is misbranded if its advertising or promotion is false or misleading in any particular.\u003C\u002Fp>\u003Cp>The following claims concerning compounded semaglutide products appear on your website:\u003Cbr>• “Compounded semaglutide from iVisitDoc has the same active ingredients as Wegovy and Ozempic, but doesn’t come in a preloaded pen.”\u003Cbr>• “Clinically Validated Ingredients”\u003C\u002Fp>\u003Cp>Compounded drug products are not FDA-approved. Your claims imply that your products are the same as an FDA-approved product when they are not. As a result, these claims are false or misleading and your products are therefore misbranded under sections 502(a) and 502(bb) of the FDCA [21 U.S.C. §§ 352(a) and (bb)].\u003C\u002Fp>\u003Cp>The introduction or delivery for introduction into interstate commerce of these misbranded products is a prohibited act under section 301(a) of the FDCA [21 U.S.C. § 331(a)]. The claims identified in this letter put you on notice of our concerns but do not represent an exhaustive list of misbranding violations.2\u003C\u002Fp>\u003Cp>For the reasons discussed above, your compounded semaglutide products are misbranded drugs under sections 502(a) and 502(bb) of the FDCA [21 U.S.C. §§ 352(a) and 352(bb)], introduced or delivered for introduction into interstate commerce in violation of section 301(a) of the FDCA [21 U.S.C. § 331(a)]. Please be advised, the receipt in interstate commerce of misbranded drugs, and the delivery or proffered delivery thereof, is also a violation of section 301(c) of the FDCA [21 U.S.C. § 331(c)].\u003C\u002Fp>\u003Cp>As previously stated, the violations cited in this letter are not intended to be an all-inclusive statement of violations that may exist in connection with your products. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your operations comply with all requirements of federal law, including FDA regulations.\u003C\u002Fp>\u003Cp>You should take immediate action to address any violations (including, for example, ceasing and desisting from using the language cited above that misbrands the product). Failure to adequately address any violations may result in legal action without further notice, including, without limitation, seizure and injunction.\u003C\u002Fp>\u003Cp>Within fifteen (15) working days of receipt of this letter, please provide a written response to the Office of Compounding Quality and Compliance (OCQC) within the Center for Drug Evaluation and Research (CDER)’s Office of Compliance describing the specific steps you have taken to address any violations. Please include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. This letter notifies you of our concerns and provides you an opportunity to address them. If you believe your products are not in violation of the FDCA, include your reasoning and any supporting information for our consideration. If you cannot completely address this matter within fifteen (15) working days, state the reason for the delay and the time within which you will do so.\u003C\u002Fp>\u003Cp>If you are not located in the U.S., please note that products that appear to be misbranded may be detained or refused admission. We may advise the appropriate regulatory officials in the country from which you operate that your products referenced above appear to be misbranded drugs that cannot be legally sold to consumers in the U.S.\u003C\u002Fp>\u003Cp>All correspondence should include a subject line that clearly identifies the submission as a Response to Warning Letter. If you have questions regarding the contents of this letter, please contact compoundinginspections@fda.hhs.gov.\u003C\u002Fp>\u003Cp>\u003Cbr>Sincerely,\u003Cbr>\u002FS\u002F\u003Cbr>George Tidmarsh, M.D., Ph.D.\u003Cbr>Director\u003Cbr>Center for Drug Evaluation and Research\u003Cbr>U.S. Food and Drug Administration\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 ELECTRONIC MAIL READ\u002FDELIVERY RECEIPT REQUESTED\n\nProduct:\n\nDrugs\n\nRecipient:\n\niVisitDoc, Inc. dba iVisitDoc\n\n7345 Woodland Drive, Suite I\n\nIndianapolis, IN 46278\n\nUnited States\n\ninfo@ivisitdoc.com\n\nIssuing Office:\n\nCenter for Drug Evaluation and Research (CDER)\n\nUnited States\n\nSecondary Issuing Offices\n\nUnited States\n\nWARNING LETTER\nSeptember 9, 2025\niVisitDoc:\nThis letter is to advise you that the United States Food and Drug Administration (FDA) reviewed your website content at the internet address https:\u002F\u002Fivisitdoc.com in August 2025 and has observed that your website offers various compounded semaglutide drug products.1 As described below, your claims concerning compounded semaglutide products are false or misleading under sections 502(a) and 502(bb) of the Federal Food, Drug, and Cosmetic Act (FDCA) [21 U.S.C. §§ 352(a) and 352(bb)], resulting in products being introduced or delivered for introduction into interstate commerce in violation of section 301(a) of the FDCA [21 U.S.C. § 331(a)].\nUnder section 502(a) of the FDCA [21 U.S.C. § 352(a)] a drug is misbranded if its labeling is false or misleading in any particular. Furthermore, under section 502(bb) of the FDCA [21 U.S.C. § 352(bb)], a compounded drug is misbranded if its advertising or promotion is false or misleading in any particular.\nThe following claims concerning compounded semaglutide products appear on your website:\n• “Compounded semaglutide from iVisitDoc has the same active ingredients as Wegovy and Ozempic, but doesn’t come in a preloaded pen.”\n• “Clinically Validated Ingredients”\nCompounded drug products are not FDA-approved. Your claims imply that your products are the same as an FDA-approved product when they are not. As a result, these claims are false or misleading and your products are therefore misbranded under sections 502(a) and 502(bb) of the FDCA [21 U.S.C. §§ 352(a) and (bb)].\nThe introduction or delivery for introduction into interstate commerce of these misbranded products is a prohibited act under section 301(a) of the FDCA [21 U.S.C. § 331(a)]. The claims identified in this letter put you on notice of our concerns but do not represent an exhaustive list of misbranding violations.2\nFor the reasons discussed above, your compounded semaglutide products are misbranded drugs under sections 502(a) and 502(bb) of the FDCA [21 U.S.C. §§ 352(a) and 352(bb)], introduced or delivered for introduction into interstate commerce in violation of section 301(a) of the FDCA [21 U.S.C. § 331(a)]. Please be advised, the receipt in interstate commerce of misbranded drugs, and the delivery or proffered delivery thereof, is also a violation of section 301(c) of the FDCA [21 U.S.C. § 331(c)].\nAs previously stated, the violations cited in this letter are not intended to be an all-inclusive statement of violations that may exist in connection with your products. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your operations comply with all requirements of federal law, including FDA regulations.\nYou should take immediate action to address any violations (including, for example, ceasing and desisting from using the language cited above that misbrands the product). Failure to adequately address any violations may result in legal action without further notice, including, without limitation, seizure and injunction.\nWithin fifteen (15) working days of receipt of this letter, please provide a written response to the Office of Compounding Quality and Compliance (OCQC) within the Center for Drug Evaluation and Research (CDER)’s Office of Compliance describing the specific steps you have taken to address any violations. Please include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. This letter notifies you of our concerns and provides you an opportunity to address them. If you believe your products are not in violation of the FDCA, include your reasoning and any supporting information for our consideration. If you cannot completely address this matter within fifteen (15) working days, state the reason for the delay and the time within which you will do so.\nIf you are not located in the U.S., please note that products that appear to be misbranded may be detained or refused admission. We may advise the appropriate regulatory officials in the country from which you operate that your products referenced above appear to be misbranded drugs that cannot be legally sold to consumers in the U.S.\nAll correspondence should include a subject line that clearly identifies the submission as a Response to Warning Letter. If you have questions regarding the contents of this letter, please contact compoundinginspections@fda.hhs.gov.\n\nSincerely,\n\u002FS\u002F\nGeorge Tidmarsh, M.D., Ph.D.\nDirector\nCenter for Drug Evaluation and Research\nU.S. Food and Drug Administration","2026-08-19T16:22:51.541+00:00",[22,23,24,9,10,25,25,25],"\u003Ctime datetime=\"2025-09-16T13:20:00Z\">09\u002F16\u002F2025\u003C\u002Ftime>\n","\u003Ctime datetime=\"2025-09-09T04:00:00Z\">09\u002F09\u002F2025\u003C\u002Ftime>\n","\u003Ca href=\"\u002Finspections-compliance-enforcement-and-criminal-investigations\u002Fwarning-letters\u002Fivisitdoc-inc-dba-ivisitdoc-716826-09092025\">iVisitDoc, Inc. dba iVisitDoc\u003C\u002Fa>","","2026-08-18T06:42:28.676509+00:00","2026-08-20T02:24:55.884391+00:00",{"510k":29,"classification":30,"enforcement":31,"event":32,"pma":33,"warning_letter":34},"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"]