[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-warning-letter-platinum-biologics-llc-705090-08152025":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},696,"platinum-biologics-llc-705090-08152025","Warning Letter","Platinum Biologics LLC",null,"Center for Biologics Evaluation and Research","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\u002Fplatinum-biologics-llc-705090-08152025","CBER 25-705090","705090","Biologics","Via UPS and EMAIL","Beeben Russell","\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 EMAIL\n                                                                                                                                                                                                                                                                                                                                                                                                                              \u003C\u002Fdd>\n      \n              \u003Cdt class=\"cell-1_2\">Reference #:\u003C\u002Fdt> \n        \u003Cdd class=\"cell-2_2\">CBER 25-705090\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\">Beeben Russell\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\">Chairman of the Board \u003C\u002Fdiv>\n          \u003C\u002Fdiv>\n\u003C\u002Fdd>\n          \n            \u003Cdd>Platinum Biologics LLC\u003C\u002Fdd>\n\n          \n                      \u003Cdd>\u003Cp class=\"address\" translate=\"no\">\u003Cspan class=\"address-line1\">1510 E Colonial Drive, Suite 103\u003C\u002Fspan>\u003Cbr>\n\u003Cspan class=\"locality\">Orlando\u003C\u002Fspan>, \u003Cspan class=\"administrative-area\">FL\u003C\u002Fspan> \u003Cspan class=\"postal-code\">32803\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:support@platinumbiologics.com\"> support@platinumbiologics.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 Biologics Evaluation and Research\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, 2025\u003C\u002Fp>\u003Cp class=\"text-align-center\">CBER 25-705090\u003C\u002Fp>\u003Cp>Dear Mr. Russell: \u003C\u002Fp>\u003Cp>The United States Food and Drug Administration (FDA) reviewed your company’s website at www.platinumbiologics.com\u002F (last visited August 2025), through which your company sells two umbilical cord derived products, Nano PRP Jelly and Nano Flex, and two exosome products, NanoEx and Nano Xsomes, for allogeneic use (collectively, “your products”).\u003Cem>\u003Cstrong>\u003Csup>1\u003C\u002Fsup>\u003C\u002Fstrong>\u003C\u002Fem> This letter is to advise you that your products are unapproved new drugs in violation of section 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. § 355(a). Your products are also unlicensed biological products in violation of section 351(a)(1) of the Public Health Service Act (PHS Act), 42 U.S.C. § 262(a)(1). A biological product for which a biologics license application (BLA) has been approved under section 351(a) of the PHS Act is not required to have an approved application under section 505 of the FD&C Act, 21 U.S.C. § 355; 42 U.S.C. § 262(j). Otherwise, with certain exceptions not applicable here, a new drug may not be introduced or delivered for introduction into interstate commerce without an approved application from FDA in effect, as described in section 505(a) of the FD&C Act. The introduction or delivery for introduction of your products into interstate commerce, or the causing thereof, is prohibited under sections 301(d) of the FD&C Act, 21 U.S.C. § 331(d). \u003C\u002Fp>\u003Cp>Based on information and records reviewed by FDA, including your website, www.platinumbiologics.com\u002F (last visited August 2025), your products are 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, your products are intended for use in the treatment of autoimmune disease, pain, depression, and the repair of age-related and trauma-related defects in connective tissue. \u003C\u002Fp>\u003Cp>Therefore, your products are drugs as defined in section 201(g)(1) of the FD&C Act, 21 U.S.C. § 321(g)(1), and biological products as defined in section 351(i) of the PHS Act, 42 U.S.C. § 262(i). \u003C\u002Fp>\u003Cp>Your Nano PRP Jelly and Nano Flex products are also human cells, tissues, or cellular or tissue-based products (HCT\u002FPs) as defined in 21 CFR 1271.3(d) and are 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, your establishment does not qualify for any exception in 21 CFR 1271.15, and your products fail to meet all criteria in 21 CFR 1271.10(a). \u003C\u002Fp>\u003Cp>Specifically, your Nano PRP Jelly and Nano Flex products fail 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 and flowable 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 Nano PRP Jelly and Nano Flex products fail 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 products are 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 for umbilical cord). Rather, your products are intended for healing, the repair of age-related and trauma related defects in connective tissue, shoulder injuries, and heart failure, which are not basic functions of umbilical cord tissue in the donor.\u003C\u002Fp>\u003Cp>Therefore, these HCT\u002FPs are 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>2\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 products are regulated as drugs as defined in section 201(g)(1) of the FD&C Act, 21 U.S.C. § 321(g)(1), and biological products as defined in section 351(i) of the PHS Act, 42 U.S.C. § 262(i), as stated above. \u003C\u002Fp>\u003Cp>Your exosome products, NanoEx and Nano Xsomes are also drugs, as defined in section 201(g)(1) of the FD&C Act, 21 U.S.C. § 321(g)(1), and biological products as defined in section 351(i) of the PHS Act, 42 U.S.C. § 262(i), as discussed above, and are subject to premarket review and approval requirements. We direct your attention to FDA’s public safety Notification on Exosome Products, 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>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 products are not the subject of an approved BLA. \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 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 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 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 and any questions regarding this letter to 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>Stephen Mesa\u003Cbr>Co-Founder\u003Cbr>Platinum Biologics, LLC\u003Cbr>1510 E. Colonial Drive, Suite 100\u003Cbr>Orlando, FL 32803\u003C\u002Fp>\u003Cp>__________________\u003C\u002Fp>\u003Cp>\u003Cem>\u003Cstrong>1\u003C\u002Fstrong>\u003C\u002Fem> We note that you also market an umbilical cord derived product, Nano Flow, on your Facebook page, www.facebook.com\u002Fbeeben.russell\u002F. Umbilical cord derived products used to treat diseases and conditions in humans generally are regulated as drugs and biological products under the FD&C Act and the PHS Act, and as such, would be subject to all applicable requirements, including premarket review and current good manufacturing practice requirements. 21 CFR 1271.20.\u003C\u002Fp>\u003Cp>\u003Cem>\u003Cstrong>2\u003C\u002Fstrong>\u003C\u002Fem> Because your Nano PRP Jelly and Nano Flex products fail 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 EMAIL\n\nReference #:\n\nCBER 25-705090\n\nProduct:\n\nBiologics\n\nRecipient:\n\nRecipient Name\n\nBeeben Russell\n\nRecipient Title\n\nChairman of the Board\n\nPlatinum Biologics LLC\n\n1510 E Colonial Drive, Suite 103\n\nOrlando, FL 32803\n\nUnited States\n\nsupport@platinumbiologics.com\n\nIssuing Office:\n\nCenter for Biologics Evaluation and Research\n\nUnited States\n\nWARNING LETTER\nAugust 15, 2025\nCBER 25-705090\nDear Mr. Russell:\nThe United States Food and Drug Administration (FDA) reviewed your company’s website at www.platinumbiologics.com\u002F (last visited August 2025), through which your company sells two umbilical cord derived products, Nano PRP Jelly and Nano Flex, and two exosome products, NanoEx and Nano Xsomes, for allogeneic use (collectively, “your products”).1 This letter is to advise you that your products are unapproved new drugs in violation of section 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. § 355(a). Your products are also unlicensed biological products in violation of section 351(a)(1) of the Public Health Service Act (PHS Act), 42 U.S.C. § 262(a)(1). A biological product for which a biologics license application (BLA) has been approved under section 351(a) of the PHS Act is not required to have an approved application under section 505 of the FD&C Act, 21 U.S.C. § 355; 42 U.S.C. § 262(j). Otherwise, with certain exceptions not applicable here, a new drug may not be introduced or delivered for introduction into interstate commerce without an approved application from FDA in effect, as described in section 505(a) of the FD&C Act. The introduction or delivery for introduction of your products into interstate commerce, or the causing thereof, is prohibited under sections 301(d) of the FD&C Act, 21 U.S.C. § 331(d).\nBased on information and records reviewed by FDA, including your website, www.platinumbiologics.com\u002F (last visited August 2025), your products are 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, your products are intended for use in the treatment of autoimmune disease, pain, depression, and the repair of age-related and trauma-related defects in connective tissue.\nTherefore, your products are drugs as defined in section 201(g)(1) of the FD&C Act, 21 U.S.C. § 321(g)(1), and biological products as defined in section 351(i) of the PHS Act, 42 U.S.C. § 262(i).\nYour Nano PRP Jelly and Nano Flex products are also human cells, tissues, or cellular or tissue-based products (HCT\u002FPs) as defined in 21 CFR 1271.3(d) and are 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, your establishment does not qualify for any exception in 21 CFR 1271.15, and your products fail to meet all criteria in 21 CFR 1271.10(a).\nSpecifically, your Nano PRP Jelly and Nano Flex products fail 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 and flowable 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 Nano PRP Jelly and Nano Flex products fail 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 products are 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 for umbilical cord). Rather, your products are intended for healing, the repair of age-related and trauma related defects in connective tissue, shoulder injuries, and heart failure, which are not basic functions of umbilical cord tissue in the donor.\nTherefore, these HCT\u002FPs are not regulated solely under section 361 of the PHS Act, 42 U.S.C. § 264, and the regulations in 21 CFR part 1271.2 See 21 CFR 1271.20. In addition to being regulated under section 361 of the PHS Act and 21 CFR part 1271, your products are regulated as drugs as defined in section 201(g)(1) of the FD&C Act, 21 U.S.C. § 321(g)(1), and biological products as defined in section 351(i) of the PHS Act, 42 U.S.C. § 262(i), as stated above.\nYour exosome products, NanoEx and Nano Xsomes are also drugs, as defined in section 201(g)(1) of the FD&C Act, 21 U.S.C. § 321(g)(1), and biological products as defined in section 351(i) of the PHS Act, 42 U.S.C. § 262(i), as discussed above, and are subject to premarket review and approval requirements. We direct your attention to FDA’s public safety Notification on Exosome Products, 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.\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 products are not the subject of an approved BLA.\nConclusion\nThis letter is not intended to be an all-inclusive list of deficiencies 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 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 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 and any questions regarding this letter to 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:\nStephen Mesa\nCo-Founder\nPlatinum Biologics, LLC\n1510 E. Colonial Drive, Suite 100\nOrlando, FL 32803\n__________________\n1 We note that you also market an umbilical cord derived product, Nano Flow, on your Facebook page, www.facebook.com\u002Fbeeben.russell\u002F. Umbilical cord derived products used to treat diseases and conditions in humans generally are regulated as drugs and biological products under the FD&C Act and the PHS Act, and as such, would be subject to all applicable requirements, including premarket review and current good manufacturing practice requirements. 21 CFR 1271.20.\n2 Because your Nano PRP Jelly and Nano Flex products fail 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).","2026-08-19T16:29:05.979+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\u002Fplatinum-biologics-llc-705090-08152025\">Platinum Biologics LLC\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"]