根据《医疗器械监督管理条例》《互联网信息服务管理办法》及《医疗器械网络销售监督管理办法》等相关规定，现依申请注销银川医朵云互联网医院有限公司《医疗器械网络交易服务第三方平台备案凭证》。特此通告。附件：注销医疗器械网络交易服务第三方平台备案具体信息列表.wps宁夏回族自治区药品监督管理局2026年8月18日

8月19日，根据《国家药监局关于〈已使用化妆品原料目录〉管理有关事项的公告》，国家药监局对《已使用化妆品原料目录》进行第五次动态调整。　　壬二酸单酰胺丙基二甲胺、鲸蜡基二甘油三（三甲基硅氧基）硅乙基聚二甲基硅氧烷、β-烟酰胺单核苷酸、补骨脂酚等4个化妆品新原料安全监测期已满3年，经评估符合《化妆品监督管理条例》等相关规定，纳入《已使用化妆品原料目录》Ⅱ。

为加强药品质量监管，保障公众用药安全，根据广东省药品抽检计划,广东省药品监督管理局组织对全省药品生产、经营、使用环节进行药品质量抽查检验，现将药品质量抽查检验结果予以通告（见附件1）。对抽查检验不符合规定药品，药品监督管理部门已要求相关企业和单位采取暂停销售使用、召回等风险控制措施，对不符合规定原因开展调查并切实进行整改。广东省药品监督管理局要求相关地市药品监督管理部门依据《中华人民共和国药品管理法》，组织对相关企业和单位存在的涉嫌违法行为立案调查，并按规定公开查处结果。附件：1.药品质量抽查检验结果（2026年第4期） 2.相关概念和名词解释广东省药品监督管理局2026年8月18日

为加强化妆品监管，保障公众用妆安全，根据2026年广东省化妆品抽检计划，广东省药品监督管理局组织对全省化妆品生产经营环节进行化妆品抽样检验，现将化妆品抽样检验信息予以通告（见附件）。对抽检不符合规定化妆品，广东省药品监督管理局已要求相关企业和单位采取暂停销售、召回等风险控制措施，对不符合规定原因开展调查并切实进行整改。广东省药品监督管理局要求相关地市药品监督管理部门依据《化妆品监督管理条例》《化妆品生产经营监督管理办法》等法规，组织对相关企业和单位存在的涉嫌违法行为立案调查，严厉打击提供虚假信息或者隐瞒真实情况否认生产的违法行为，并按规定公开查处结果。附件：广东省化妆品抽样检验信息（2026年第4期）广东省药品监督管理局2026年8月18日

安徽百岁堂中药饮片有限公司：本局于2026年7月17日发布《安徽省药品监督管理局暂停生产销售通知书》（皖药监药暂停〔2026〕中化-4号），通知你单位暂停生产、销售中药饮片。依据《药品生产监督管理办法》第五十九条第三款的规定，鉴于你单位安全隐患已依法处理，现决定解除相关产品的暂停生产、销售措施。具体产品为：中药饮片。 安徽省药品监督管理局2026年8月18日

根据《中华人民共和国行政许可法》《中华人民共和国药品管理法》《药品经营和使用质量监督管理办法》等规定，现决定依法注销江西天豪仪器设备有限公司、江西鑫润医药有限公司、赣州市可为临检医疗用品经营部、江西佳乐医药有限公司、江西欧氏医药股份有限公司、江西易舒心连锁大药房有限公司等6家公司的《药品经营许可证》（详见列表）。序号企业名称许可证编号经营方式注册地址注销原因1江西天豪仪器设备有限公司赣T791017批发南昌市中山路185号太平洋商务大厦D711室主动申请注销2江西鑫润医药有限公司赣AA7960641批发江西省吉安市新干县河西机电产业园26栋1单元主动申请注销3赣州市可为临检医疗用品经营部赣T797025批发江西省赣州市章贡区文明大道92-3、92-4、92-6号一层；主动申请注销4江西佳乐医药有限公司赣AA796000605批发江西省吉安市新干县河西机电产业园7栋西侧1层主动申请注销5江西欧氏医药股份有限公司赣AA7900455批发江西省新余市渝水区世纪大道18号健康产业园1栋101主动申请注销6江西易舒心连锁大药房有限公司赣BA796000304零售（连锁总部）江西省吉安市井开区君山大道152号宿舍楼3-201室主动申请注销特此公告。江西省药品监督管理局2026年8月18日

根据《互联网药品信息服务管理办法》《互联网药品医疗器械信息服务备案管理规定》有关规定，鉴于江西太极大药房连锁有限公司等415家企业所持《互联网药品信息服务资格证书》或互联网药品信息服务备案对应服务网址长期无法正常访问，江西观颐阁医药有限公司等369家企业所持《互联网药品信息服务资格证书》或互联网药品信息服务备案超过有效期，已不具备互联网药品信息服务开展条件，我局拟依法对上述企业的互联网药品信息服务资格许可或备案予以注销，公示时间：2026年8月18日至2026年9月1日。公示期内，相关企业如对本次拟注销事项存在异议，可携带有效佐证材料向我局提交书面异议申请，逾期未提出异议的，我局将视为无异议，依法依规办理注销手续。联系人：张友利电话：0791-88178551联系地址：南昌市北京东路1566号特此公告。附件：1.网站无法正常访问互联网药品信息服务资格证书或备案的企业名单； 2.互联网药品信息服务资格证书或备案超过有效期的企业名单。江西省药品监督管理局2026年8月18日

依据《中华人民共和国行政许可法》第七十条、《药品经营和使用质量监督管理办法》第二十七条规定，我局决定依法注销通辽市弘扬医药连锁有限责任公司等4家公司《药品经营许可证》。现予通告。附件：《药品生产许可证》注销企业名单内蒙古自治区药品监督管理局2026年8月17日附件《药品经营许可证》注销情况序号企业名称许可证编号注销原因1通辽市弘扬医药连锁有限责任公司蒙BA4750580《药品经营许可证》有效期届满未申请重新审查发证2国药控股兴安盟有限公司蒙AA482000089《药品经营许可证》有效期届满未申请重新审查发证3内蒙古好药师佰汇大药房连锁有限公司蒙BA479000001《药品经营许可证》有效期届满未申请重新审查发证4兴安盟金岛医药有限公司蒙BA4820541主动申请注销《药品经营许可证》

Delivery Method:Via UPS and EMAILReference #:CBER 26-726330Product:BiologicsRecipient:David L. Greene, M.D.Chief Executive OfficerR3 Medical Companies10045 E. Dynamite Blvd., Suite 260Scottsdale, AZ 85262United Statesdgreene@bello.biodgreene@regensuppliers.comIssuing Office:Center for Biologics Evaluation and Research (CBER)United StatesWARNING LETTERAugust 14, 2026CBER 26-726330Dear Dr. Greene:The United States Food and Drug Administration (FDA) inspected your facilities, Bello Bio, LLC (herein referred to as “Bello”) and Regen Suppliers, LLC (herein referred to as “Regen”) co-located at 10045 E. Dynamite Blvd., Suite 260, Scottsdale, AZ 85262, between November 17, 2025, and December 16, 2025.1,2 During the inspections, FDA documented that Bello contract manufactures and labels umbilical cord derived products, ReBellaWJ, ReBellaXO, and ReBellaXOL, for private label distribution by Regen.3,4 Regen approves, labels, stores, and distributes the aforementioned products as well as an umbilical cord blood derived product, ReBellaCB, contract manufactured under private label by (b)(4) ReBellaWJ, ReBellaXO, and ReBellaXOL will herein be referred to as “your umbilical cord derived products.” These three products, together with ReBellaCB, will be referred to collectively as “your products.”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. Your introduction or delivery for introduction of your products into interstate commerce, or the causing thereof, is prohibited under section 301(d) of the FD&C Act, 21 U.S.C. § 331(d).This warning letter also summarizes significant violations of current good manufacturing practice (CGMP) requirements, 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, in the manufacture of your products. Because your methods, facilities, or controls for manufacturing, processing, packing, or holding drugs do not conform to CGMP, your products are adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act, 21 U.S.C. § 351(a)(2)(B). Your introduction or delivery for introduction of your products into interstate commerce, or the causing thereof, is a prohibited act under section 301(a) of the FD&C Act, 21 U.S.C. § 331(a).Unapproved New Drug and Unlicensed Biological Product ViolationsBased on information and records reviewed by FDA, including, but not limited to, your YouTube channel, @R3StemCell www.youtube.com/@R3StemCell, TikTok @R3StemCell www.tiktok.com/@r3stemcell, Instagram @R3stemcellofficial, www.instagram.com/r3stemcellofficial, Facebook page R3 Stem Cell www.facebook.com/r3stemcelltherapyofficial, and websites, www.r3stemcell.com, www.bello.bio, and www.regensuppliers.com5, (last visited August 2026), your products are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease or conditions in humans, and/or are intended to affect the structure or function of the body. For example:ReBellaWJ:o R3 Stem Cell, LLC website (www.r3stemcell.com/): In a November 15, 2020, blog post entitled “What is Umbilical Cord Wharton’s Jelly?” (https://r3stemcell.com/what-is-umbilical-cord-whartons-jelly/):• “One of the major effects is the reduction of inflammation. Chronic inflammation has been shown to be present in the body and is a known precursor to many medical conditions including organ failure, arthritis, several types of cancer and more. The biologic’s cells are able to systemically reduce this inflammation…”• “…The top wharton’s jelly stem cell product being offered is ReBellaWJ…To find out more information and to place an order, visit and call Regen Suppliers at (888) 568-6909.” Under a title of “What conditions benefit from their use?” on Umbilical Cord Stem Cell Therapy tab: “In the research literature and from our provider’s experience, there are benefits being shown for: Neurologic Conditions…Heart/Kidney/Lung Failure (e.g. Cardiomyopathy, COPD)…Autism…Cerebral Palsy…Diabetes…Lyme Disease...SI Joint Pain...Erectile Dysfunction..”o R3 Anti-Aging website (https://r3antiaging.com): Under the “Umbilical Cord Allograft” tab within your “Regenerative Therapies” page: “R3 Anti-Aging and Medspa in Scottsdale and Nashville offers umbilical cord allograft therapy for patients who have joint or soft tissue pain...In addition, the umbilical cord tissue contains a significant amount of growth factors, exosomes, mesenchymal stem cells and cytokines as well. These facilitate one's body to amp up the repair and regeneration activities to reduce pain from joint degeneration, tendonitis, bursitis...and neuropathy.”ReBellaXO and ReBellaXOL:o Regen website (https://www.regensuppliers.com): Until recently, within the “ReBellaXO 1.0mL - B” product page: “ReBellaXO an exosome allograft derived from Wharton's Jelly MSCs... For your procedures involving IV's, joints, soft tissue, hair, facial or sexual rejuvenation, ReBellaXO represents your most cost effective and safe option for fitting regenerative biologics into your patient care!” Until recently, under the “About” tab: “ReBellaXOL Lyophilized Exosomes… produces collagenesis, anti-scar, pro-angiogenesis, & anti-apoptosis. BelloXO intensely stimulates regeneration…”o R3 Stem Cell, LLC website (www.r3stemcell.com/): Under the Exosome Therapy tab: “Can exosomes help with neurodegenerative conditions? Research has shown that exosomes can penetrate the blood-brain barrier and stimulate neuronal differentiation, growth of neurons, and reduce inflammatory processes within the brain tissue. This may result in future benefit to neurodegenerative conditions such as Alzheimer’s, Parkinson’s, Post Stroke and other issues.”o R3 Anti-Aging website (https://r3antiaging.com): The "Exosome therapy" page within your "Treatments" tab under "Regenerative Therapies,"• “Exosome Therapy for Joint Pain… Exosome therapy is getting great results for joint pain relief:… Rebuilding cartilage: Exosomes help fix damaged cartilage… Reducing inflammation: They calm the swelling in your joints.”• Listing “Wound Healing” and “Anti-Inflammation” in a chart titled “Benefits of Exosome Therapy”ReBellaCB:o Until recently, the product page for ReBellaCB on your Regen website, (www.regensuppliers.com), states, “REBELLACB is an Umbilical Cord Blood Stem Cell Allograft” and links to an R3 Stem Cell YouTube video, https://www.youtube.com/watch?v=sZeux0WXsUU&feature=youtu.be, titled “Is Umbilical Cord Blood Safe for Regenerative Procedures?” with the video description stating, “For years now, umbilical cord blood has been used increasingly for non-malignant conditions such as arthritis, neurological conditions, autism, diabetes, liver/kidney failure and much more. Umbilical cord tissue has a ton of hematopoietic and mesenchymal stem cells along with cytokines, growth factors, and exosomes. All of this makes it very effective for these conditions.”ReBellaCB and ReBellaXO:o In a video posted on your R3 Stem Cell YouTube Channel on March 5, 2026 (https://www.youtube.com/watch?v=L0QlPvhdjds) titled “Elite Football Player Talks to His Stem Cells (844) GET-STEM,” an employee is seen showing vials of ReBellaCB and ReBellaXO to a patient and states: “These are your stem cells. There’s 30 million in each vial... This is ReBellaXO. These are your exosomes… Those are very anti-inflammatory...” [0.00-0.24] so should help a lot…” The video description states, “When receiving stem cell therapy to help with injuries, athletes should talk to their cells.”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).Your ReBellaWJ, ReBellaXO, ReBellaXOL, and ReBellaCB products are also human cells, tissues, or cellular or tissue-based products (HCT/Ps) 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/Ps 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/or biological products under the FD&C Act and/or the PHS Act and are subject to additional regulation, including applicable premarket review. Based on a review of relevant materials, your firm 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).For example, your ReBellaWJ, ReBellaXO, ReBellaXOL and ReBellaCB products fail to meet the criterion that the HCT/Ps be “intended for homologous use only.” Homologous use means that the “labeling, advertising, or other indications of the manufacturer’s objective intent” demonstrate that the HCT/P 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/P in the recipient as in the donor (e.g., serving as a conduit for umbilical cord or forming and replenishing the lymphohematopoietic system for umbilical cord blood). Rather, your products are intended for use in the treatment of various diseases and conditions, such as, but not limited to, arthritis and inflammation, which is not a basic function of umbilical cord or umbilical cord blood in the donor.Moreover, your ReBellaCB product fails to meet the criterion in 21 CFR 1271.10(a)(4) because it is manufactured from allogeneic umbilical cord blood, is dependent on the metabolic activity of living cells for its primary function, and is not for autologous use, allogeneic use in a first-degree or second-degree blood relative, or reproductive use.Therefore, these HCT/Ps are not regulated solely under section 361 of the PHS Act, 42 U.S.C. § 264, and the regulations in 21 CFR part 1271.6 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.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.CGMP ViolationsFDA’s inspections of your Bello and Regen facilities documented evidence of significant CGMP violations. At the conclusion of the inspections, FDA investigators issued a Form FDA-483, List of Inspectional Observations (Form FDA-483), to each of Bello and Regen. FDA also identified additional significant violations upon further review of the evidence collected during the inspection, as set forth below.The CGMP violations applicable to your Bello facility pertaining to your umbilical cord derived products include, but are not limited to, the following:1. Failure to establish and follow appropriate written procedures designed to prevent microbiological contamination of drug products purporting to be sterile, including procedures for validation of all aseptic and sterilization processes, as required by 21 CFR 211.113(b). For example, your firm has not validated the aseptic processes used to manufacture your umbilical cord derived products. Your umbilical cord derived products purport to be sterile and are expected to be sterile.2. Failure to establish written procedures for production and process control designed to assure that the drug products have the identity, strength, quality, and purity that they are purported or represented to possess, as required by 21 CFR 211.100(a). For example, your firm has not validated the manufacturing processes for your umbilical cord derived products with respect to identity, strength, quality, and purity.3. Failure to establish laboratory controls that include scientifically sound and appropriate specifications, standards, and test procedures designed to assure that components, drug product containers, closures, in-process materials, labeling, and drug products conform to appropriate standards of identity, strength, quality, and purity, as required by 21 CFR 211.160(b). For example, samples of your umbilical cord derived products are frozen and thawed prior to sterility testing. Freezing samples has the potential to destroy or compromise any microbial content in the samples before testing, if present; therefore, any contamination that was present prior to freezing may not be reliably detected.4. Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment to produce aseptic conditions, as required by 21 CFR 211.42(c)(10)(v). For example, you have not validated your processes for cleaning and disinfecting the ISO (b)(4) biological safety cabinet (BSC) where your products are exposed to the environment during aseptic processing.5. Failure to establish and follow a written testing program designed to assess the stability characteristics of drug products and to use results of such stability testing to determine appropriate storage conditions and expiration dates, as required by 21 CFR 211.166(a). For example, your firm assigns a 24-month expiration date to your products without supporting stability testing data.The CGMP violations applicable to your Bello and Regen facilities pertaining to your products include, but are not limited to, the following:76. The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed, as required by 21 CFR 211.22(d). For example, at the time of the inspection, written procedures describing the responsibilities of the quality unit had not been established, including but not limited to, procedures for the approval or rejection of drug products (21 CFR 211.22(a)) and the handling of all written and oral complaints regarding a drug product (21 CFR 211.198(a)).Responses to the Form FDA-483We have reviewed your responses to the Form FDA-483s issued to each of your Bello and Regen facilities dated January 08, 2026 and January 06, 2026, as well as your correspondence dated November 20, 2025, in detail. While you represented that you have implemented or plan to implement certain corrective actions, the described corrective actions are not adequate to remedy the violations noted above. For example, your responses do not address your continued distribution of your products or specific plans for disposition of the remaining inventory manufactured under the violative conditions outlined above. We note that certain corrective actions cannot be evaluated because they lack supporting documentation.Further, for your previously distributed products, you do not describe actions you have taken or plan to take that adequately address the impact of the above-noted deficiencies on your distributed products that are still within expiry and were manufactured under the above-described violative conditions.We acknowledge your commitment to temporarily suspend manufacturing operations until you have made corrections to the observations listed on the Form FDA-483 issued to each of your Bello and Regen facilities. However, this does not resolve the violations outlined in this letter because your responses do not adequately address your failure to have an Investigational New Drug (IND) in effect to study your products addressed in this letter or your lack of an approved BLA to lawfully market your products.FDA has previously provided notice to you, David Greene, in a letter dated May 28, 2019, that based on a review of your website for R3 Stem Cell, LLC (www.r3stemcell.com) at that time, your firm appeared to offer “regenerative stem cell therapies” while promoting these stem cell therapies for numerous diseases or conditions, such as amyotrophic lateral sclerosis (ALS), diabetes, kidney failure, Lyme disease, Parkinson’s disease, and stroke. Based on that review, R3 Stem Cell, LLC did not appear to qualify for any exception under 21 CFR 1271.15; the “regenerative stem cell therapies” were intended for nonhomologous uses and thus would be regulated as drugs as defined in section 201(g) of the FD&C Act [21 U.S.C. 321(g)] and biological products as defined in section 351(i) of the PHS Act [42 U.S.C. 262(i)]. However, our review of your current websites and various social media accounts, which are also linked to your websites, indicates umbilical stem cell therapy and exosome therapy continue to be offered by R3 Stem Cell, LLC for treatment of various diseases and conditions, as described above.Additional ConcernsIn addition to the violations described above, we have the following concerns:FDA’s review of information and records collected during the inspections documented Bello also manufactures the following umbilical cord derived8 products: BelloWJ, BelloXO, and BelloXOL. Your response dated January 08, 2026 asserts that Bello is a manufacturer of HCT/Ps and is subject only to current good tissue practice (CGTP) requirements of 21 CFR Part 1271 and is regulated solely under section 361 of the PHS Act); however, review of the evidence collected shows these products do not appear to meet the relevant criteria to be regulated solely under section 361 of the PHS Act, for the reasons discussed above. These products appear to be drugs and/or biological products, which are subject to premarket review and approval requirements.FDA review of Bello’s manufacturing records revealed that (b)(4) is a component of the (b)(4) used during Bello’s manufacturing process of products derived from umbilical cord tissue; however, there did not appear to be evidence that testing for (b)(4) had been performed prior to the release of these products, as required by (b)(4).Bello determines donor eligibility upon review of relevant medical records per your contract agreement with (b)(4). The “Donor Eligibility Criteria” documents (effective date 08/15/2023) submitted with your January 8, 2026, response and also collected during the inspection do not include “qualifiers/comments” for Transmissible Spongiform Encephalopathy (TSE). In accordance with 21 CFR 1271.75(a)(1)(iv), all donors of cells or tissues, except as provided under 1271.90, must be screened by reviewing the donor’s relevant medical records for risk factors for, and clinical evidence of, relevant communicable disease agents and diseases, including human transmissible spongiform encephalopathy, including Creutzfeldt-Jakob disease. Additionally, FDA Guidance for Industry: Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (August 2007)9 recommends screening donors for TSE, including Creutzfeldt-Jakob disease (CJD) and variant CJD (vCJD), by asking if donors have been diagnosed with dementia or any degenerative or demyelinating diseases of the central nervous system or other neurological disease of unknown etiology. For additional information and recommendations intended to assist establishments with complying with all requirements in 21 CFR part 1271, subpart C, please refer to the guidance.ConclusionNeither this letter nor the observations noted on the Form FDA-483s for both Bello and Regen, which were discussed with you at the conclusion of the inspections, are intended to be all-inclusive lists 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 the FD&C Act, PHS Act, and all applicable regulations.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/or injunction.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.Send your electronic response and any questions regarding this letter to CBER’s Office of Compliance and Biologics Quality, Division of Case Management at CBERDCMRecommendations@fda.hhs.gov.Sincerely,/S/Vincent AmatrudoActing DirectorOffice of Compliance and Biologics QualityCenter for Biologics Evaluation and ResearchCc: (b)(4)________________________1 During the inspections, you informed FDA that R3 Medical Companies is the parent company of these companies co-located at the same business address: Bello, Regen, R3 Stem Cell, LLC and R3 Anti-Aging Scottsdale LLC. You bear primary responsibility for the business operations at each of the aforementioned entities.2 Greene Technologies, LLC, for which you are the co-owner and majority holder, along with Ms. Deborah Greene, invests in the referenced entities and other R3 Anti-Aging LLC clinics located at 5020 Thoroughbred Lane, Brentwood, TN 37027 and 9301 Wilshire Boulevard Penthouse, Beverly Hills, CA 90210. The referenced entities function together with Bello as the manufacturer and Regen as the private label distributor to the three R3 Anti-Aging clinics, healthcare professionals, and other clinics as direct-to-customers and through R3 Stem Cell’s partnership program, R3 Alliance Partner. We note you are also the current Chief Executive Officer (CEO) of R3 Anti-Aging & MedSpa Nashville, LLC (located at 5020 Thoroughbred Lane, Brentwood, TN 37027) and R3 Anti-Aging Beverly Hills, LLC (located at 9301 Wilshire Boulevard Penthouse, Beverly Hills, CA 90210).3 Regen markets ReBellaXO and ReBellaXOL as exosome products; however, products manufactured by Bello use the same starting material and manufacturing process (with the exception of an added lyophilization step for ReBellaXOL), which does not appear would isolate exosomes.4 ReBellaXOL was also labeled as ReBellaGF by Bello at the time of the inspections.5 As of August 14, 2026, it appears that the Regen Suppliers website www.regensuppliers.com is no longer accessible with a “404, Not Found.” message displayed.6 Because your 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) for each product.7 Although products are contract manufactured for Regen, Regen’s activities, as described above, constitute manufacturing under 21 CFR 210.3(b)(12). Regen is therefore subject to CGMP requirements.8 Bello markets BelloXO and BelloXOL as exosome products; however, it does not appear that the manufacturing process would isolate exosomes.9 See https://www.fda.gov/regulatory-information/search-fda-guidance-documents/eligibility-determination-donors-human-cells-tissues-and-cellular-and-tissue-based-products.

Delivery Method:Via Electronic Mail - Return Receipt RequestedReference #:320-26-114Product:DrugsOver-the-Counter DrugsRecipient:Mr. Travis BradyPresidentSuretec Innovations, LLC7055 South Lindell RoadLas Vegas, NV 89118United StatesIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesWarning Letter320-26-114August 13, 2026Dear Mr. Brady:The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, Suretec Innovations, LLC, FEI 3030456591, at 190 South McQueen Road, Suite 102, Gilbert, Arizona, from March 2 to 5, 2026.This warning letter summarizes significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals. See Title 21 Code of Federal Regulations (CFR), parts 210 and 211 (21 CFR parts 210 and 211).Because your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your drug product is adulterated within the meaning of section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 351(a)(2)(B).In addition, violations were identified and documented during a review of your firm’s drug listing submissions in FDA’s electronic Drug Registration and Listing System (eDRLS). Based on our review, you failed to provide drug listing information for KleenLine Alcohol-Free Sanitizing Wipes, a drug you are manufacturing on behalf of a private label distributor (PLD). Failure to provide listing information for a drug in accordance with 510(j) of the FD&C Act, 21 U.S.C. 360(j), is prohibited under section 301(p) of the FD&C Act, 21 U.S.C. 331(p). Therefore, this drug is misbranded under section 502(o) of the FD&C Act, 21 U.S.C. 352(o). Introducing or delivering for introduction into interstate commerce, or the causing thereof, of this drug is prohibited under section 301(a) of the FD&C Act, 21 U.S.C. 331(a). These violations are described in more detail below.We reviewed your March 25, 2026, response to our Form FDA 483 in detail and acknowledge receipt of your subsequent correspondence.During our inspection, our investigator observed specific violations including, but not limited to, the following.CGMP Violations1. Your firm failed to test samples of each component for identity and conformity with all appropriate written specifications for purity, strength, and quality. Your firm also failed to validate and establish the reliability of your component supplier’s test analyses at appropriate intervals (21 CFR 211.84(d)(1) and 211.84(d)(2)).Your firm contract manufactures over-the-counter (OTC) (b)(4) containing the active pharmaceutical ingredient (API) (b)(4). You failed to conduct adequate identity testing of incoming components, including the API, used in the manufacturing of your drug product. Additionally, you relied on your suppliers’ certificates of analyses (COA) without establishing the reliability of each of your component suppliers’ analyses at appropriate intervals.Your response is inadequate. You state that you initiated supplier qualification activities on March 23, 2026, and you provided your Supplier Qualification and Approval Program procedure. You also provided references to supplier qualification activities. However, your response lacks sufficient details to demonstrate adequate corrective action. Specifically, your response failed to include documentation establishing component-specific acceptance criteria, defined identity testing specifications and methods for (b)(4) or other incoming components, or results of any retrospective confirmatory testing.Without adequate testing and confirmation of reliability of supplier test results, you lack scientific evidence that the components conform to appropriate specifications prior to use in the drugs products you manufacture.In response to this letter, provide:A comprehensive, independent review of your material system, including but not limited to:o Evaluating all suppliers of materials (components, containers, and closures) to determine if they are reliable and appropriately qualified;o An assessment of all materials to determine whether they are consistently of acceptable quality;o A review to ensure assigned expiration or retest dates are appropriate (supported by data)o Adequacy of the supplier qualification program, and its selection, qualification, and disqualification provisions.Based on a thorough review, provide a summary of your systems corrective actions and preventive actions (CAPA) to remediate the vendor qualification program and prevent use of unsuitable components, containers and closures.The chemical and microbiological quality control specifications you use to test and release each incoming lot of component for use in manufacturing.A description of how you will test each component lot for conformity with all appropriate specifications for identity, strength, quality, and purity. If you intend to accept any results from your supplier’s COA instead of testing each component lot for strength, quality, and purity, specify how you will robustly establish the reliability of your supplier’s results through initial validation as well as periodic re-validation. In addition,include a commitment to always conduct at least one specific identity test for each incoming component lot.A summary of results obtained from testing all components to evaluate the reliability of the COA from each component manufacturer. Include your standard operating procedure that describes this COA validation program.A summary of your program for qualifying and overseeing contract facilities that test your components and the finished drug products you manufacture.2. Your firm failed to conduct appropriate laboratory testing, as necessary, for each batch of drug product required to be free of objectionable microorganisms (21 CFR 211.165(b)).You failed to ensure adequate microbiological testing for each batch of your drug product prior to release. Your non-compendial test method used to determine microbiological attributes (e.g., total count, objectionable microorganisms) for your finished OTC drug product was inadequate. Specifically, you lacked appropriate incubation times, lacked appropriate method suitability, and lacked positive and negative controls. In addition, you did not validate this non-compendial method.Your response is inadequate. You state that a contract laboratory will perform validation of United States Pharmacopeia (USP)Testing is essential to ensure that the drug product you manufacture conform to all predetermined quality attributes appropriate for their intended use. Because you lacked adequate testing of each batch of your drug products, you do not know whether they conform to all appropriate finished-product specifications and are suitable for release to consumers.In response to this letter, provide:A list of chemical and microbial specifications, including test methods, used to analyze each batch of your drug products before a batch disposition decision.An action plan and timelines for conducting full chemical and microbiological testing of retain samples to determine the quality of all batches of drug product distributed to the United States that are within expiry as of the date of this letter.A summary of all results obtained from testing retain samples from each batch. If such testing reveals substandard-quality drug products, take rapid corrective actions, such as notifying customers and product recalls.3. Your firm failed to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, whether or not the batch has already been distributed (21 CFR 211.192).Your quality unit (QU) failed to thoroughly investigate multiple microbial count results that exceeded (b)(4) colony forming units/milliliters from your (b)(4) system. You use (b)(4) from this system as a component to manufacture your drug products. Instead, you continued to use (b)(4) from this system with out-of-limit (OOL) test results to manufacture drug products that were ultimately released, distributing potentially contaminated drug products to market.Your response is inadequate. You provided your (b)(4) System Monitoring Program procedure and CAPA-2026-005 which references enhanced (b)(4) monitoring and investigation procedures. However, neither document addresses specific microbiological alert or action limits, sampling frequencies, or acceptance criteria for (b)(4) used in drug product manufacturing. Furthermore, your response does not demonstrate that your firm has implemented adequate investigation procedures or completed retrospective reviews of the OOL events.Inadequate investigations can lead to unidentified root causes, ineffective CAPAs, and recurring problems that compromise your ability to manufacture safe and effective drug products.In response to this letter, provide:A comprehensive, independent assessment of your overall system for investigating deviations, discrepancies, complaints, OOL results, and failures. Provide a detailed action plan to remediate this system. Your action plan should include, but not be limited to, significant improvements in investigation competencies, scope determination, root cause evaluation, CAPA effectiveness, QU oversight, and written procedures. Address how your firm will ensure that all phases of investigations are appropriately conducted.A detailed risk assessment addressing the potential effects of the observed (b)(4) system failures on the quality of all drug product lots currently in U.S. distribution or within expiry. Specify actions that you will take in response to the risk assessment, such as customer notifications and product recalls.4. Your firm’s quality control unit failed to exercise its responsibility to ensure drug products manufactured are in compliance with CGMP, and meet established specifications for identity, strength, quality, and purity (21 CFR 211.22).Your firm failed to establish an adequate QU with the responsibilities and authority to oversee the manufacturing of drug products. For example, the QU failed to ensure:Establishment of appropriate written procedures for production and process controls, including appropriate qualification of the (b)(4) system (21 CFR 211.100(a)).Establishment of an appropriate written testing program designed to assess the stability characteristics of drug products and to use results of stability testing to determine appropriate storage conditions and expiration dates (21 CFR 211.166(a)).Establishment of adequate written procedures defining QU responsibilities and controls (21 CFR 211.22(d)).An adequate number of qualified personnel to perform and supervise the manufacturing, processing, packing, or holding of each drug product (21 CFR 211.25(c)).Your firm’s quality systems are inadequate. For help implementing quality systems and risk management approaches to meet the requirements of CGMP regulations 21 CFR, parts 210 and 211, see FDA’s guidance documents Quality Systems Approach to Pharmaceutical CGMP Regulations at https://www.fda.gov/media/71023/download, Q9(R1) Quality Risk Management at https://www.fda.gov/media/167721/download, and ICH Q10 Pharmaceutical Quality System at https://www.fda.gov/media/71553/download.In response to this letter, provide:A comprehensive assessment and remediation plan to ensure your QU is given the authority and resources to effectively function. The assessment should also include, but not be limited to:o A determination of whether procedures used by your firm are robust and appropriateo Provisions for QU oversight throughout your operations to evaluate adherence to appropriate practiceso A complete and final review of each batch and its related information before the QU disposition decisiono Oversight and approval of investigations and discharging of all other QU duties to ensure identity, strength, quality, and purity of all products.CGMP Consultant RecommendedBased upon the nature of the violations we identified at your firm, you should engage a consultant qualified as set forth in 21 CFR 211.34 to evaluate your operations and to assist your firm in meeting CGMP requirements. The qualified consultant should also perform a comprehensive six-system audit of your entire operation for CGMP compliance and evaluate the completion and efficacy of your CAPA before you pursue resolution of your firm’s compliance status with FDA.Your use of a consultant does not relieve your firm’s obligation to comply with CGMP. Your firm’s executive management remains responsible for resolving all deficiencies and systemic flaws to ensure ongoing CGMP compliance.Drug Listing ViolationsSection 510(j) of the FD&C Act and 21 CFR Part 207 set forth the requirements for the listing of drugs. In addition to listing a drug that you manufacture under your own labeler code, under 21 CFR 207.41(c)(1), you are required to list each drug you manufacture for commercial distribution under the trade name or label of a PLD using an NDC that includes such PLD’s labeler code. Evidence from the most recent inspection of your site and a search of eDRLS confirms that you are manufacturing KleenLine Alcohol-Free Sanitizing Wipes for a PLD, Brady Industries, Inc., but you did not list this drug under the PLD’s trade name and labeler code as required.Therefore, you failed to fulfill your drug listing obligations in accordance with section 510 of the FD&C Act. Failure to provide listing information for a drug in accordance with 510(j) of the FD&C Act is prohibited under section 301(p) of the FD&C Act. Under section 502(o), a drug is misbranded if it is not included in a list required by section 510(j). Under section 301(a), the introduction or delivery for introduction, or the causing thereof, into interstate commerce of any drug that is misbranded is prohibited.Complete, accurate, and up-to-date establishment registration and drug listing information is essential to promote and protect patient safety. FDA relies on establishment registration and drug listing information for several key programs, including drug establishment inspections, supply chain security, and post-market surveillance. Establishment registration and drug listing information is also widely used outside FDA for purposes such as electronic prescribing and electronic health records, insurance reimbursement, and patient education.We note that the labeling provided in your drug listing for Hand Sanitizing Alcohol-Free Wipes, NDC 84111-000, bears the trade name of what appears to be another PLD. Please update your labeling accordingly. It is your responsibility to ensure that all drugs manufactured at your establishment comply with all establishment registration and drug listing requirements under section 510 of the FD&C Act, 21 U.S.C. 360, 21 CFR Part 207, and all other applicable FDA regulations. Registration and listing information and instructions on how to properly register an establishment or submit drug listings can be found at Electronic Drug Registration and Listing Instructions.ConclusionThe violations cited in this letter are not intended to be an all-inclusive list of violations that exist at your facility. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations.Correct any violations promptly. Failure to promptly and adequately address this matter may result in regulatory or legal action without further notice including, without limitation, seizure and injunction. Unresolved violations may also prevent other Federal agencies from awarding contracts.Failure to address violations may also cause FDA to withhold issuance of Export Certificates. FDA may withhold approval of new applications or supplements listing your firm as a drug manufacturer until any violations are completely addressed and we confirm your compliance with CGMP. We may re-inspect to verify that you have completed corrective actions to address any violations.This letter notifies you of our findings and provides you an opportunity to address the above deficiencies. After you receive this letter, respond to this office in writing within 15 working days. Specify what you have done to address any violations and to prevent their recurrence. In response to this letter, you may provide additional information for our consideration as we continue to assess your activities and practices. If you cannot complete corrective actions within 15 working days, state your reasons for delay and your schedule for completion.Send your electronic reply to CDER-OC-OMQ-Communications@fda.hhs.gov. Identify your response with FEI 3030456591 and ATTN: Christopher M. Jenner.Sincerely,/S/Francis GodwinDirectorOffice of Manufacturing QualityOffice of ComplianceCenter for Drug Evaluation and Research/S/Tina SmithCaptain, U.S. Public Health ServiceDirectorOffice of Unapproved Drugs & Labeling ComplianceOffice of ComplianceCenter for Drug Evaluation and Research