[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-warning-letter-innate-healthcare-institute-695592-08152025":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},697,"innate-healthcare-institute-695592-08152025","Warning Letter","Innate Healthcare Institute",null,"Center for Biologics Evaluation and Research (CBER)","Deviations\u002FCFR\u002FRegulations for Human Cells, Tissues & Cellular Products (HCT\u002FPs)","2025-08-26","2025-08-15","Issued","https:\u002F\u002Fwww.fda.gov\u002Finspections-compliance-enforcement-and-criminal-investigations\u002Fwarning-letters\u002Finnate-healthcare-institute-695592-08152025","CBER 25-695592","695592","Biologics","VIA UPS and Electronic Mail","Travis Whitney, NMD, DAASCP, MSc, MSAc","\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 25-695592\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\">Travis Whitney, NMD, DAASCP, MSc, MSAc \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\">Founder and Chief Medical Officer\u003C\u002Fdiv>\n          \u003C\u002Fdiv>\n\u003C\u002Fdd>\n          \n            \u003Cdd>Innate Healthcare Institute\u003C\u002Fdd>\n\n          \n                      \u003Cdd>\u003Cp class=\"address\" translate=\"no\">\u003Cspan class=\"address-line1\">4835 East Cactus Road, Suite 140\u003C\u002Fspan>\u003Cbr>\n\u003Cspan class=\"locality\">Scottsdale\u003C\u002Fspan>, \u003Cspan class=\"administrative-area\">AZ\u003C\u002Fspan> \u003Cspan class=\"postal-code\">85254\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@innatehealthcare.org \"> info@innatehealthcare.org \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>WARNING LETTER\u003C\u002Fstrong>\u003C\u002Fp>\u003Cp>August 15, 202\u003C\u002Fp>\u003Cp class=\"text-align-center\">CBER 25-695592\u003C\u002Fp>\u003Cp>Dear Dr. Whitney: \u003C\u002Fp>\u003Cp>The United States Food and Drug Administration (FDA) reviewed your company’s website at https:\u002F\u002Finnatehealthcare.org (last visited August 2025), through which your company markets “umbilical cord mesenchymal stem cells (UC-MSCs),” which you also describe as “UC-MSC therapy” (hereinafter, “your product”) for allogeneic use. This letter is to advise you that your misbranding of your product while held for sale after shipment in interstate commerce violates section 301(k) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. § 331(k). \u003C\u002Fp>\u003Cp>\u003Cstrong>Violations \u003C\u002Fstrong>\u003C\u002Fp>\u003Cp>Based on information and records reviewed by FDA, https:\u002F\u002Finnatehealthcare.org (last visited August 2025), your product is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease or conditions in humans and\u002For are intended to affect the structure or function of the body. For example, \u003C\u002Fp>\u003Cp>On your website, https:\u002F\u002Finnatehealthcare.org, you provide the following statements:\u003C\u002Fp>\u003Cul>\u003Cli>“At Innate Healthcare Institute, we combine an effective blend of integrative medicine and regenerative stem cell medicine, treating Autism at its root.”\u003C\u002Fli>\u003Cli>“Stem cell therapy has really helped our son with his autism”\u003C\u002Fli>\u003Cli>“Stem cell therapy with human umbilical cord tissue derived mesenchymal stem cells (UC-MSCs) corrects the inflammatory process by modulating the immune system from a pro-inflammatory attacking state to an anti-inflammatory healthy state. They also have the ability to regenerate damage done from the autoimmune attack. Stem cells do this by secreting healing activators such as growth factors, cytokines, and exosomes to the surrounding environment.”\u003C\u002Fli>\u003Cli>“Stem cell therapy for autism can lead to improvement in cognitive ability, behaviors, and sociability.”\u003C\u002Fli>\u003Cli>“Regenerative cell medicine has the potential to help with many conditions such as pain due to osteoarthritis, tendinopathy\u002Ftendonitis, degenerative disc disease, herniated discs, neuropathy, fractures, muscle injuries, ligament and tendon injuries, COPD, peripheral neuropathy, sexual dysfunction, autoimmune conditions, heart disease, and many more.”\u003C\u002Fli>\u003C\u002Ful>\u003Cp>Therefore, your product is a drug as defined in section 201(g)(1) of the FD&C Act, 21 U.S.C. § 321(g)(1), and a biological product as defined in section 351(i) of the Public Health Service Act (PHS Act), 42 U.S.C. § 262(i). \u003C\u002Fp>\u003Cp>Your UC-MSCs product is also a human cell, tissue, or cellular or tissue-based product (HCT\u002FP) as defined in 21 CFR 1271.3(d) and is subject to regulation under 21 CFR part 1271, issued under the authority of section 361 of the PHS Act, 42 U.S.C. § 264. HCT\u002FPs that do not meet all the criteria in 21 CFR 1271.10(a) are not regulated solely under section 361 of the PHS Act and the regulations in 21 CFR part 1271. Unless an exception in 21 CFR 1271.15 applies, such products are regulated as drugs, devices, and\u002For biological products under the FD&C Act and\u002For the PHS Act and are subject to additional regulation, including applicable premarket review. Based on a review of relevant materials, Innate Healthcare Institute does not qualify for any exception in 21 CFR 1271.15, and your product fails to meet all criteria in 21 CFR 1271.10(a). \u003C\u002Fp>\u003Cp>For example, your UC-MSCs product fails to meet the minimal manipulation criterion set forth in 21 CFR 1271.10(a)(1) and defined for structural tissue in 21 CFR 1271.3(f)(1), because your processing alters the original relevant characteristics of the umbilical cord related to its utility for reconstruction, repair, or replacement. The processing of the umbilical cord from the form of a conduit into an injectable form, significantly alters the physical state of the HCT\u002FP. The umbilical cord is more than minimally manipulated because such processing alters the original relevant characteristics of the HCT\u002FP relating to its utility to serve as a conduit by effectively altering or eliminating its physical integrity and tubular form. \u003C\u002Fp>\u003Cp>In addition, your UC-MSCs product fails to meet the criterion that the HCT\u002FPs be “intended for homologous use only,” which means that the “labeling, advertising, or other indications of the manufacturer’s objective intent” demonstrate that the HCT\u002FP is intended to perform “the same basic function or functions in the recipient as in the donor.” 21 CFR 1271.3(c) and 1271.10(a)(2). Your product is not intended solely to perform the same basic function or functions of the HCT\u002FP in the recipient as in the donor (e.g., serving as a conduit). Rather, your product is intended for use in the treatment of autism as well as other diseases or conditions, which is not a basic function of the umbilical cord in the donor.\u003C\u002Fp>\u003Cp>Therefore, this HCT\u002FP is not regulated solely under section 361 of the PHS Act, 42 U.S.C. § 264, and the regulations in 21 CFR part 1271.\u003Cem>\u003Cstrong>\u003Csup>1\u003C\u002Fsup>\u003C\u002Fstrong>\u003C\u002Fem> See 21 CFR 1271.20. In addition to being regulated under section 361 of the PHS Act and 21 CFR part 1271, your product is regulated as a drug as defined in section 201(g)(1) of the FD&C Act, 21 U.S.C. § 321(g)(1), and a biological product as defined in section 351(i) of the PHS Act, 42 U.S.C. § 262(i), as stated above.\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 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 product is safe, pure, and potent. Your product is not the subject of an approved BLA.\u003C\u002Fp>\u003Cp>Furthermore, your product is a misbranded drug under section 502(f)(1) of the FD&C Act, 21 U.S.C. § 352(f)(1). A drug is misbranded under section 502(f)(1) if the drug fails to bear adequate directions for its intended use(s). “Adequate directions for use” means directions under which a layperson can use a drug safely and for the purposes for which it is intended. 21 CFR 201.5. Prescription drugs, as defined in section 503(b)(1)(A) of the FD&C Act, 21 U.S.C. § 353(b)(1)(A), can only be used safely at the direction, and under the supervision, of a licensed practitioner.\u003C\u002Fp>\u003Cp>Your product is intended for use in the treatment of one or more diseases that are not amenable to self-diagnosis or treatment without the supervision of a licensed practitioner. Therefore, it is impossible to write adequate directions for a layperson to use your product safely for its intended purposes. Accordingly, your product fails to bear adequate directions for its intended uses and, therefore, is misbranded under section 502(f)(1) of the FD&C Act, 21 U.S.C. § 352(f)(1). Misbranding your product while it is held for sale after shipment of the drug or one or more of its components in interstate commerce is prohibited under section 301(k) of the FD&C Act, 21 U.S.C. § 331(k).\u003C\u002Fp>\u003Cp>\u003Cstrong>Additional Concerns\u003C\u002Fstrong>\u003C\u002Fp>\u003Cp>FDA’s review of your website also found that you market exosomes. As a general matter, exosomes intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease or conditions in humans and\u002For are intended to affect the structure or function of the body are regulated as drugs as defined in section 201(g)(1) of the FD&C Act and biological products under section 351 of the PHS Act and and are subject to premarket review and approval requirements. We also direct your attention to FDA’s Public Safety Notification on Exosome Products, available at https:\u002F\u002Fwww.fda.gov\u002Fvaccines-blood-biologics\u002Fsafety-availability-biologics\u002Fpublic-safety-notification-exosome-products. FDA issued this public safety notification following multiple reports of serious adverse events experienced by patients who were treated with exosome products.\u003C\u002Fp>\u003Cp>\u003Cstrong>Conclusion\u003C\u002Fstrong>\u003C\u002Fp>\u003Cp>This letter is not intended to be an all-inclusive list of deficiencies that may exist in connection with your product. 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 full compliance with all applicable requirements in the FD&C Act, PHS Act, and all applicable regulations.\u003C\u002Fp>\u003Cp>This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address these matters may result in action without further notice including, without limitation, seizure and\u002For injunction.\u003C\u002Fp>\u003Cp>Please submit your response 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 product is 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 CBERDCMRecommendations@fda.hhs.gov.\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:\u003C\u002Fp>\u003Cp>Innate Healthcare, LLC\u003Cbr>4840 East Indian School Road\u003Cbr>Suite 104\u003Cbr>Phoenix, AZ 85018\u003C\u002Fp>\u003Cp>____________________\u003C\u002Fp>\u003Cp>\u003Cem>\u003Cstrong>1\u003C\u002Fstrong>\u003C\u002Fem> Because your product fails to meet at least one criterion in 21 CFR 1271.10(a), this letter does not evaluate all other criteria in 21 CFR 1271.10(a).\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 25-695592\n\nProduct:\n\nBiologics\n\nRecipient:\n\nRecipient Name\n\nTravis Whitney, NMD, DAASCP, MSc, MSAc\n\nRecipient Title\n\nFounder and Chief Medical Officer\n\nInnate Healthcare Institute\n\n4835 East Cactus Road, Suite 140\n\nScottsdale, AZ 85254\n\nUnited States\n\ninfo@innatehealthcare.org\n\nIssuing Office:\n\nCenter for Biologics Evaluation and Research (CBER)\n\nUnited States\n\nWARNING LETTER\nAugust 15, 202\nCBER 25-695592\nDear Dr. Whitney:\nThe United States Food and Drug Administration (FDA) reviewed your company’s website at https:\u002F\u002Finnatehealthcare.org (last visited August 2025), through which your company markets “umbilical cord mesenchymal stem cells (UC-MSCs),” which you also describe as “UC-MSC therapy” (hereinafter, “your product”) for allogeneic use. This letter is to advise you that your misbranding of your product while held for sale after shipment in interstate commerce violates section 301(k) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. § 331(k).\nViolations\nBased on information and records reviewed by FDA, https:\u002F\u002Finnatehealthcare.org (last visited August 2025), your product is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease or conditions in humans and\u002For are intended to affect the structure or function of the body. For example,\nOn your website, https:\u002F\u002Finnatehealthcare.org, you provide the following statements:\n“At Innate Healthcare Institute, we combine an effective blend of integrative medicine and regenerative stem cell medicine, treating Autism at its root.”\n“Stem cell therapy has really helped our son with his autism”\n“Stem cell therapy with human umbilical cord tissue derived mesenchymal stem cells (UC-MSCs) corrects the inflammatory process by modulating the immune system from a pro-inflammatory attacking state to an anti-inflammatory healthy state. They also have the ability to regenerate damage done from the autoimmune attack. Stem cells do this by secreting healing activators such as growth factors, cytokines, and exosomes to the surrounding environment.”\n“Stem cell therapy for autism can lead to improvement in cognitive ability, behaviors, and sociability.”\n“Regenerative cell medicine has the potential to help with many conditions such as pain due to osteoarthritis, tendinopathy\u002Ftendonitis, degenerative disc disease, herniated discs, neuropathy, fractures, muscle injuries, ligament and tendon injuries, COPD, peripheral neuropathy, sexual dysfunction, autoimmune conditions, heart disease, and many more.”\nTherefore, your product is a drug as defined in section 201(g)(1) of the FD&C Act, 21 U.S.C. § 321(g)(1), and a biological product as defined in section 351(i) of the Public Health Service Act (PHS Act), 42 U.S.C. § 262(i).\nYour UC-MSCs product is also a human cell, tissue, or cellular or tissue-based product (HCT\u002FP) as defined in 21 CFR 1271.3(d) and is subject to regulation under 21 CFR part 1271, issued under the authority of section 361 of the PHS Act, 42 U.S.C. § 264. HCT\u002FPs that do not meet all the criteria in 21 CFR 1271.10(a) are not regulated solely under section 361 of the PHS Act and the regulations in 21 CFR part 1271. Unless an exception in 21 CFR 1271.15 applies, such products are regulated as drugs, devices, and\u002For biological products under the FD&C Act and\u002For the PHS Act and are subject to additional regulation, including applicable premarket review. Based on a review of relevant materials, Innate Healthcare Institute does not qualify for any exception in 21 CFR 1271.15, and your product fails to meet all criteria in 21 CFR 1271.10(a).\nFor example, your UC-MSCs product fails to meet the minimal manipulation criterion set forth in 21 CFR 1271.10(a)(1) and defined for structural tissue in 21 CFR 1271.3(f)(1), because your processing alters the original relevant characteristics of the umbilical cord related to its utility for reconstruction, repair, or replacement. The processing of the umbilical cord from the form of a conduit into an injectable form, significantly alters the physical state of the HCT\u002FP. The umbilical cord is more than minimally manipulated because such processing alters the original relevant characteristics of the HCT\u002FP relating to its utility to serve as a conduit by effectively altering or eliminating its physical integrity and tubular form.\nIn addition, your UC-MSCs product fails to meet the criterion that the HCT\u002FPs be “intended for homologous use only,” which means that the “labeling, advertising, or other indications of the manufacturer’s objective intent” demonstrate that the HCT\u002FP is intended to perform “the same basic function or functions in the recipient as in the donor.” 21 CFR 1271.3(c) and 1271.10(a)(2). Your product is not intended solely to perform the same basic function or functions of the HCT\u002FP in the recipient as in the donor (e.g., serving as a conduit). Rather, your product is intended for use in the treatment of autism as well as other diseases or conditions, which is not a basic function of the umbilical cord in the donor.\nTherefore, this HCT\u002FP is not regulated solely under section 361 of the PHS Act, 42 U.S.C. § 264, and the regulations in 21 CFR part 1271.1 See 21 CFR 1271.20. In addition to being regulated under section 361 of the PHS Act and 21 CFR part 1271, your product is regulated as a drug as defined in section 201(g)(1) of the FD&C Act, 21 U.S.C. § 321(g)(1), and a biological product as defined in section 351(i) of the PHS Act, 42 U.S.C. § 262(i), as stated above.\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 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 product is safe, pure, and potent. Your product is not the subject of an approved BLA.\nFurthermore, your product is a misbranded drug under section 502(f)(1) of the FD&C Act, 21 U.S.C. § 352(f)(1). A drug is misbranded under section 502(f)(1) if the drug fails to bear adequate directions for its intended use(s). “Adequate directions for use” means directions under which a layperson can use a drug safely and for the purposes for which it is intended. 21 CFR 201.5. Prescription drugs, as defined in section 503(b)(1)(A) of the FD&C Act, 21 U.S.C. § 353(b)(1)(A), can only be used safely at the direction, and under the supervision, of a licensed practitioner.\nYour product is intended for use in the treatment of one or more diseases that are not amenable to self-diagnosis or treatment without the supervision of a licensed practitioner. Therefore, it is impossible to write adequate directions for a layperson to use your product safely for its intended purposes. Accordingly, your product fails to bear adequate directions for its intended uses and, therefore, is misbranded under section 502(f)(1) of the FD&C Act, 21 U.S.C. § 352(f)(1). Misbranding your product while it is held for sale after shipment of the drug or one or more of its components in interstate commerce is prohibited under section 301(k) of the FD&C Act, 21 U.S.C. § 331(k).\nAdditional Concerns\nFDA’s review of your website also found that you market exosomes. As a general matter, exosomes intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease or conditions in humans and\u002For are intended to affect the structure or function of the body are regulated as drugs as defined in section 201(g)(1) of the FD&C Act and biological products under section 351 of the PHS Act and and are subject to premarket review and approval requirements. We also direct your attention to FDA’s Public Safety Notification on Exosome Products, available at https:\u002F\u002Fwww.fda.gov\u002Fvaccines-blood-biologics\u002Fsafety-availability-biologics\u002Fpublic-safety-notification-exosome-products. FDA issued this public safety notification following multiple reports of serious adverse events experienced by patients who were treated with exosome products.\nConclusion\nThis letter is not intended to be an all-inclusive list of deficiencies that may exist in connection with your product. 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 full compliance with all applicable requirements in the FD&C Act, PHS Act, and all applicable regulations.\nThis letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address these matters may result in action without further notice including, without limitation, seizure and\u002For injunction.\nPlease submit your response 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 product is 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 CBERDCMRecommendations@fda.hhs.gov.\nSincerely,\n\u002FS\u002F\nMelissa J. Mendoza\nDirector\nOffice of Compliance and Biologics Quality\nCenter for Biologics Evaluation and Research\nCC:\nInnate Healthcare, LLC\n4840 East Indian School Road\nSuite 104\nPhoenix, AZ 85018\n____________________\n1 Because your product fails to meet at least one criterion in 21 CFR 1271.10(a), this letter does not evaluate all other criteria in 21 CFR 1271.10(a).","2026-08-19T16:28:46.246+00:00",[24,25,26,9,27,28,28,28],"\u003Ctime datetime=\"2025-08-26T04:00:00Z\">08\u002F26\u002F2025\u003C\u002Ftime>\n","\u003Ctime datetime=\"2025-08-15T04:00:00Z\">08\u002F15\u002F2025\u003C\u002Ftime>\n","\u003Ca href=\"\u002Finspections-compliance-enforcement-and-criminal-investigations\u002Fwarning-letters\u002Finnate-healthcare-institute-695592-08152025\">Innate Healthcare Institute\u003C\u002Fa>","Deviations\u002FCFR\u002FRegulations for Human Cells, Tissues & Cellular Products (HCT\u002FPs)","","2026-08-18T06:42:28.676509+00:00","2026-08-20T02:24:55.884391+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"]