[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-warning-letter-xo-biologix-llc-697717-12122024":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":15,"marcs_cms_no":16,"product_type":17,"delivery_method":18,"recipient_name":19,"recipient_title":8,"body_html":20,"body_text":21,"body_fetched_at":22,"medical_device_id":8,"raw":23,"created_at":29,"updated_at":30},1103,"xo-biologix-llc-697717-12122024","Warning Letter","XO Biologix, LLC",null,"Center for Biologics Evaluation and Research (CBER)","Unapproved New Drugs\u002FAdulterated","2025-01-07","2024-12-12","Issued","https:\u002F\u002Fwww.fda.gov\u002Finspections-compliance-enforcement-and-criminal-investigations\u002Fwarning-letters\u002Fxo-biologix-llc-697717-12122024","CBER 25-697717","697717","Biologics","VIA UPS and Electronic Mail","David P. Janice","\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 UPS and Electronic Mail\n                                                                                                                                                                                                                                                                                                                                                                                                                              \u003C\u002Fdd>\n      \n              \u003Cdt class=\"cell-1_2\">Reference #:\u003C\u002Fdt> \n        \u003Cdd class=\"cell-2_2\">CBER 25-697717\u003C\u002Fdd>\n      \n              \u003Cdt class=\"cell-1_3\">Product:\u003C\u002Fdt> \n        \u003Cdd class=\"cell-2_3\">Biologics                          \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\">David P. Janice\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\">Chief Executive Officer and Owner\u003C\u002Fdiv>\n          \u003C\u002Fdiv>\n\u003C\u002Fdd>\n          \n            \u003Cdd>XO Biologix, LLC\u003C\u002Fdd>\n\n          \n                      \u003Cdd>\u003Cp class=\"address\" translate=\"no\">\u003Cspan class=\"address-line1\">609 Castle Ridge Rd, Suite 400\u003C\u002Fspan>\u003Cbr>\n\u003Cspan class=\"locality\">Austin\u003C\u002Fspan>, \u003Cspan class=\"administrative-area\">TX\u003C\u002Fspan> \u003Cspan class=\"postal-code\">78746\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 Biologics Evaluation and Research (CBER)\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>\u003Cu>WARNING LETTER\u003C\u002Fu>\u003C\u002Fstrong>\u003C\u002Fp>\u003Cp class=\"text-align-center\">CBER 25-697717\u003C\u002Fp>\u003Cp>December 12, 2024\u003C\u002Fp>\u003Cp>Dear Mr. Janice:\u003C\u002Fp>\u003Cp>The United States Food and Drug Administration (FDA) inspected your facility located at the above address between January 3, 2024, and January 5, 2024. During the inspection, FDA documented that your company markets and distributes a product derived from amniotic fluid, MaviX™, pursuant to a contract with \u003Cstrong>(b)(4)\u003C\u002Fstrong> (hereinafter, “MaviX™” or “your product”). \u003C\u002Fp>\u003Cp>This letter is to advise you that your product is an unapproved new drug in violation of section 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. § 355(a). Your introduction or delivery for introduction of your product into interstate commerce is prohibited under section 301(d) of the FD&C Act, 21 U.S.C. § 331(d). Your product is also an unlicensed biological product in violation of section 351(a)(1) of the Public Health Service Act (PHS Act), 42 U.S.C. § 262(a)(1)(A). \u003C\u002Fp>\u003Cp>This Warning Letter also notifies you that your products are adulterated due to significant violations of current good manufacturing practice (CGMP) requirements identified at \u003Cstrong>(b)(4)\u003C\u002Fstrong>, including violations of section 501(a)(2)(B) of the FD&C Act, 21 U.S.C. § 351(a)(2)(B), and 21 CFR parts 210 and 211 (See Warning Letter number CBER 25-679023). Your firm is responsible for ensuring that all phases of the production of your product comply with CGMP requirements regardless of who manufactures, processes, packs, or holds it. Because the methods, facilities, or controls for manufacturing, processing, packing, or holding drugs do not conform to CGMP, your product is adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act, 21 U.S.C. § 351(a)(2)(B). Furthermore, MaviX™ is also misbranded under sections 502(a) of the FD&C Act, 21 U.S.C. § 352(a). \u003C\u002Fp>\u003Cp>Your introduction or delivery for introduction of MaviX™, an adulterated and misbranded drug, into interstate commerce is a prohibited act under section 301(a) of the FD&C Act, 21 U.S.C. § 331(a).\u003C\u002Fp>\u003Cp>\u003Cstrong>Unapproved New Drug and Unlicensed Biological Product Violations\u003C\u002Fstrong>\u003C\u002Fp>\u003Cp>Based on information and records gathered prior to, during, and after the inspection and other information available to FDA, including your website (https:\u002F\u002Fxobiologix.co\u002F), your product is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease or conditions in humans and\u002For is intended to affect the structure or function of the body. For example, MaviX™ promotional material obtained during your inspection states the following: “Patient Benefits: Helps reduce pain, inflammation, and regenerate tissue”. Further, your website indicates that “MaviX™ is a heterogeneous, complex mixture of cell and tissue building blocks, which play a key role in repair and regeneration” and describes MaviX™ as “Anti-Inflammatory” and “Anti-Fibrotic.” Your product is therefore a drug as defined in section 201(g)(1) of the FD&C Act, 21 U.S.C. § 321(g)(1). Additionally, your product is a biological product as defined in section 351(i) of the PHS Act, 42 U.S.C. § 262(i).\u003Cem>\u003Cstrong>\u003Csup>1\u003C\u002Fsup>\u003C\u002Fstrong>\u003C\u002Fem>\u003C\u002Fp>\u003Cp>Subject to certain exceptions not applicable here, to lawfully introduce or deliver for introduction into interstate commerce a drug that is a biological product, a valid biologics license application (BLA) must be in effect under section 351(a)(1) of the PHS Act, 42 U.S.C. § 262(a)(1). Such licenses are issued only after showing that the products are safe, pure, and potent. Your product is not the subject of an approved BLA.\u003C\u002Fp>\u003Cp>\u003Cstrong>Current Good Manufacturing Practice Violations\u003C\u002Fstrong>\u003C\u002Fp>\u003Cp>Refer to Warning Letter number CBER 25-679023 for discussion of CGMP violations.\u003C\u002Fp>\u003Cp>\u003Cstrong>Misbranding Violation\u003C\u002Fstrong>\u003C\u002Fp>\u003Cp>Your product is also misbranded under section 502(a) of the FD&C Act, 21 U.S.C. § 352(a), because your labeling is false or misleading. Specifically, the instructions for use (IFU) for your product indicates that “the tissue is processed and may be cut into predetermined size patches using sterile cutting tools.” This description implies that your product is provided as sheets when it is actually a liquid solution. Further, your certificate of analysis for your product states that the expiry period is five (5) years, while your IFU states that your product has a “3-year shelf life.” Neither of these statements about the stability of your product are supported with stability data. These false or misleading representations about your product on your labeling cause this product to be misbranded under section 502(a) of the FD&C Act, 21 U.S.C. § 352(a).\u003C\u002Fp>\u003Cp>\u003Cstrong>Conclusion\u003C\u002Fstrong>\u003C\u002Fp>\u003Cp>Neither this letter nor the observations noted on the Form FDA-483, List of Inspectional Observations that was issued to \u003Cstrong>(b)(4)\u003C\u002Fstrong>, are intended to be an all-inclusive list of deficiencies that may exist. It is your responsibility to ensure full compliance with the FD&C Act, PHS Act, and all applicable regulations.\u003C\u002Fp>\u003Cp>This letter notifies you of our findings and provides you an opportunity to address them. Failure to adequately address these matters may result in regulatory action without further notice. Such actions may include seizure and\u002For injunction.\u003C\u002Fp>\u003Cp>We request that you respond in writing within fifteen (15) working days from your receipt of this letter, outlining the specific steps you have taken or plan to take to address any violations and prevent their recurrence. Include any documentation necessary to show that the matters have been addressed. If you cannot address these matters within fifteen (15) working days, please explain the reason for your delay and the timeframe for completion. If you do not believe your products are in violation of the FD&C Act, PHS Act, or applicable regulations, include your reasoning and any supporting information for our consideration.\u003C\u002Fp>\u003Cp>Send your electronic response to CBERDCMRecommendations@fda.hhs.gov. If you have questions regarding this letter, contact the Division of Case Management, CBER at (240) 402-9156.\u003C\u002Fp>\u003Cp>Sincerely,\u003Cbr>\u002FS\u002F\u003C\u002Fp>\u003Cp>Melissa J. Mendoza\u003Cbr>Director\u003Cbr>Office of Compliance and Biologics Quality\u003Cbr>Center for Biologics Evaluation and Research\u003C\u002Fp>\u003Cp>Cc:\u003Cbr>\u003Cstrong>(b)(4)\u003C\u002Fstrong>\u003C\u002Fp>\u003Cp>_________________\u003C\u002Fp>\u003Cp>\u003Cem>\u003Cstrong>1\u003C\u002Fstrong>\u003C\u002Fem> FDA does not consider MaviX™, an amniotic fluid-based product, to be a human cell, tissue, or cellular or tissue-based product (HCT\u002FP). HCT\u002FPs, as defined in 21 CFR 1271.3(d), do not include secreted or extracted human products. Accordingly, secreted bodily fluids, such as amniotic fluid, are generally not considered HCT\u002FPs subject to regulation under 21 CFR part 1271.\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 UPS and Electronic Mail\n\nReference #:\n\nCBER 25-697717\n\nProduct:\n\nBiologics\n\nRecipient:\n\nRecipient Name\n\nDavid P. Janice\n\nRecipient Title\n\nChief Executive Officer and Owner\n\nXO Biologix, LLC\n\n609 Castle Ridge Rd, Suite 400\n\nAustin, TX 78746\n\nUnited States\n\n(b)(6)\n\nIssuing Office:\n\nCenter for Biologics Evaluation and Research (CBER)\n\nUnited States\n\nWARNING LETTER\nCBER 25-697717\nDecember 12, 2024\nDear Mr. Janice:\nThe United States Food and Drug Administration (FDA) inspected your facility located at the above address between January 3, 2024, and January 5, 2024. During the inspection, FDA documented that your company markets and distributes a product derived from amniotic fluid, MaviX™, pursuant to a contract with (b)(4) (hereinafter, “MaviX™” or “your product”).\nThis letter is to advise you that your product is an unapproved new drug in violation of section 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. § 355(a). Your introduction or delivery for introduction of your product into interstate commerce is prohibited under section 301(d) of the FD&C Act, 21 U.S.C. § 331(d). Your product is also an unlicensed biological product in violation of section 351(a)(1) of the Public Health Service Act (PHS Act), 42 U.S.C. § 262(a)(1)(A).\nThis Warning Letter also notifies you that your products are adulterated due to significant violations of current good manufacturing practice (CGMP) requirements identified at (b)(4), including violations of section 501(a)(2)(B) of the FD&C Act, 21 U.S.C. § 351(a)(2)(B), and 21 CFR parts 210 and 211 (See Warning Letter number CBER 25-679023). Your firm is responsible for ensuring that all phases of the production of your product comply with CGMP requirements regardless of who manufactures, processes, packs, or holds it. Because the methods, facilities, or controls for manufacturing, processing, packing, or holding drugs do not conform to CGMP, your product is adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act, 21 U.S.C. § 351(a)(2)(B). Furthermore, MaviX™ is also misbranded under sections 502(a) of the FD&C Act, 21 U.S.C. § 352(a).\nYour introduction or delivery for introduction of MaviX™, an adulterated and misbranded drug, into interstate commerce is a prohibited act under section 301(a) of the FD&C Act, 21 U.S.C. § 331(a).\nUnapproved New Drug and Unlicensed Biological Product Violations\nBased on information and records gathered prior to, during, and after the inspection and other information available to FDA, including your website (https:\u002F\u002Fxobiologix.co\u002F), your product is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease or conditions in humans and\u002For is intended to affect the structure or function of the body. For example, MaviX™ promotional material obtained during your inspection states the following: “Patient Benefits: Helps reduce pain, inflammation, and regenerate tissue”. Further, your website indicates that “MaviX™ is a heterogeneous, complex mixture of cell and tissue building blocks, which play a key role in repair and regeneration” and describes MaviX™ as “Anti-Inflammatory” and “Anti-Fibrotic.” Your product is therefore a drug as defined in section 201(g)(1) of the FD&C Act, 21 U.S.C. § 321(g)(1). Additionally, your product is a biological product as defined in section 351(i) of the PHS Act, 42 U.S.C. § 262(i).1\nSubject to certain exceptions not applicable here, to lawfully introduce or deliver for introduction into interstate commerce a drug that is a biological product, a valid biologics license application (BLA) must be in effect under section 351(a)(1) of the PHS Act, 42 U.S.C. § 262(a)(1). Such licenses are issued only after showing that the products are safe, pure, and potent. Your product is not the subject of an approved BLA.\nCurrent Good Manufacturing Practice Violations\nRefer to Warning Letter number CBER 25-679023 for discussion of CGMP violations.\nMisbranding Violation\nYour product is also misbranded under section 502(a) of the FD&C Act, 21 U.S.C. § 352(a), because your labeling is false or misleading. Specifically, the instructions for use (IFU) for your product indicates that “the tissue is processed and may be cut into predetermined size patches using sterile cutting tools.” This description implies that your product is provided as sheets when it is actually a liquid solution. Further, your certificate of analysis for your product states that the expiry period is five (5) years, while your IFU states that your product has a “3-year shelf life.” Neither of these statements about the stability of your product are supported with stability data. These false or misleading representations about your product on your labeling cause this product to be misbranded under section 502(a) of the FD&C Act, 21 U.S.C. § 352(a).\nConclusion\nNeither this letter nor the observations noted on the Form FDA-483, List of Inspectional Observations that was issued to (b)(4), are intended to be an all-inclusive list of deficiencies that may exist. It is your responsibility to ensure full compliance with the FD&C Act, PHS Act, and all applicable regulations.\nThis letter notifies you of our findings and provides you an opportunity to address them. Failure to adequately address these matters may result in regulatory action without further notice. Such actions may include seizure and\u002For injunction.\nWe request that you respond in writing within fifteen (15) working days from your receipt of this letter, outlining the specific steps you have taken or plan to take to address any violations and prevent their recurrence. Include any documentation necessary to show that the matters have been addressed. If you cannot address these matters within fifteen (15) working days, please explain the reason for your delay and the timeframe for completion. If you do not believe your products are in violation of the FD&C Act, PHS Act, or applicable regulations, include your reasoning and any supporting information for our consideration.\nSend your electronic response to CBERDCMRecommendations@fda.hhs.gov. If you have questions regarding this letter, contact the Division of Case Management, CBER at (240) 402-9156.\nSincerely,\n\u002FS\u002F\nMelissa J. Mendoza\nDirector\nOffice of Compliance and Biologics Quality\nCenter for Biologics Evaluation and Research\nCc:\n(b)(4)\n_________________\n1 FDA does not consider MaviX™, an amniotic fluid-based product, to be a human cell, tissue, or cellular or tissue-based product (HCT\u002FP). HCT\u002FPs, as defined in 21 CFR 1271.3(d), do not include secreted or extracted human products. Accordingly, secreted bodily fluids, such as amniotic fluid, are generally not considered HCT\u002FPs subject to regulation under 21 CFR part 1271.","2026-08-19T17:06:11.643+00:00",[24,25,26,9,27,28,28,28],"\u003Ctime datetime=\"2025-01-07T14:20:00Z\">01\u002F07\u002F2025\u003C\u002Ftime>\n","\u003Ctime datetime=\"2024-12-12T05:00:00Z\">12\u002F12\u002F2024\u003C\u002Ftime>\n","\u003Ca href=\"\u002Finspections-compliance-enforcement-and-criminal-investigations\u002Fwarning-letters\u002Fxo-biologix-llc-697717-12122024\">XO Biologix, LLC\u003C\u002Fa>","Unapproved New Drugs\u002FAdulterated\u003Cbr \u002F>\r\n","","2026-08-18T06:42:28.856152+00:00","2026-08-20T02:24:56.037289+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"]