Delivery Method:VIA ELECTRONIC MAIL READ/DELIVERY RECEIPT REQUESTEDProduct:DrugsRecipient:Pure Arylcyclohexylamine Store / www.arylcyclohexylamine.comUnited Statesadmin@arylcyclohexylamine.comarylcyclohexylaminesales@gmail.comIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesJune 23, 2026WARNING LETTERReference Number: MARCS-CMS 725151To PURE ARYLCYCLOHEXYLAMINE STORE:This warning letter advises you of significant violations identified during a U.S. Food and Drug Administration (FDA) review of your website www.arylcyclohexylamine.com. Promptly address the violations described herein without delay, including ensuring that appropriate resources are allocated to fully address the violations and prevent their recurrence. This is not intended to be an all-inclusive list of the violations that may exist in connection with your products or operations. It is your responsibility to ensure that you comply with all requirements of federal law, including FDA regulations. Failure to adequately address violations may result in regulatory or legal action without further notice including, without limitation, seizure and injunction.As discussed below, FDA has observed that www.arylcyclohexylamine.com introduces into interstate commerce unapproved and misbranded ketamine drug products, including certain drugs for which the FDA-approved version is an injectable or subject to a Risk Evaluation and Mitigation Strategy (REMS).1 FDA has identified significant risks associated with unapproved ketamine products, especially in the absence of appropriate medical supervision. Given the increased interest in the use of ketamine products, the easy availability of unapproved and misbranded ketamine products via the internet puts U.S. consumers at risk for serious adverse events. Furthermore, injectable drug products can pose a serious risk of harm to users because they bypass many of the body's natural defenses against toxic ingredients, toxins, or dangerous organisms that can lead to serious and life-threatening conditions such as septicemia or sepsis.There are also inherent risks to consumers who purchase unapproved new drugs and misbranded drugs. Unapproved new drugs do not carry the same assurances of safety and effectiveness as those drugs subject to FDA oversight. Drugs that have circumvented regulatory safeguards may be contaminated, counterfeit, contain varying amounts of active ingredients, or contain different ingredients altogether.Accordingly, FDA requests that www.arylcyclohexylamine.com cease offering any unapproved and misbranded drugs for sale to U.S. consumers. This is critical to shielding the American public from harm.FDA ReviewViolations were identified and documented during a review of your website www.arylcyclohexylamine.com, FDA Establishment Identifier (FEI) 3043543962, on February 27, 2026.Violations of the Federal Food, Drug, and Cosmetic ActOn your website at internet address www.arylcyclohexylamine.com, you introduce into interstate commerce misbranded and unapproved new drugs in violation of sections 301(a), 301(d), 502(f)(1), 503(b)(1), and 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 331(a), 331(d), 352(f)(1), 353(b)(1), and 355(a)).The following are violations identified during our review. As a reminder, this is not an all-inclusive list of violations that may exist in connection with your products or operations.Unapproved New Drug ViolationsCertain products offered for sale by www.arylcyclohexylamine.com are drugs within the meaning of section 201(g) of the FD&C Act (21 U.S.C. 321(g)) because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or because they are intended to affect the structure or function of the body. These drugs are also new drugs as defined by section 201(p) of the FD&C Act (21 U.S.C. 321(p)), because they are not generally recognized as safe and effective for their labeled uses. With certain exceptions not applicable here, new drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from FDA, as described in section 505(a) of the FD&C Act.You failed to obtain approved applications pursuant to section 505 of the FD&C Act (21 U.S.C. 355) for these products that you have introduced into interstate commerce. Accordingly, their introduction or delivery for introduction into interstate commerce violates sections 301(d) and 505(a) of the FD&C Act.An example of an unapproved ketamine drug product you offer for sale on www.arylcyclohexylamine.com is ketamine marketed as "KETAMINE 100ML (50MG/ML)." Evidence obtained from your website establishing that this product is a drug intended for human use (as defined in 21 Code of Federal Regulations (CFR) 201.128) includes the claim under "WHAT IS KETAMINE? – KETAMINE 100ML (50MG/ML)," "Ketamine ((RS)-2-(2-chlorophenyl)-2-(methylamino)cyclohexanone) is a powerful psychoactive drug with the unique ability to decouple one’s conscious experience from the body."A second example of an unapproved ketamine drug product you offer for sale on www.arylcyclohexylamine.com is ketamine marketed as "KETAMINE TROCHES." Evidence obtained from your website establishing that this product is a drug intended for human use (as defined in 21 CFR 201.128) includes the claim "Ketamine troches are slow-dissolving ketamine tablets that deliver a steady, sublingual ketamine dosage of the dissociative drug ketamine."While there are FDA-approved versions of ketamine drug products on the market in the United States, there are no approved drug applications pursuant to section 505 of the FD&C Act in effect for "KETAMINE 100ML (50MG/ML)" and "KETAMINE TROCHES" offered by www.arylcyclohexylamine.com.FDA-approved ketamine, including products marketed under the brand name KETALAR, is a Schedule III controlled substance. It is an intravenous or intramuscular injection indicated as a general anesthetic, including as a sole agent or as an adjunct to other anesthetic agents, for the induction of anesthesia and for diagnostic and surgical procedures. Ketamine is a racemic mixture consisting of two mirror image molecules, R- and S-ketamine (arketamine and esketamine, respectively). This product is only available pursuant to a prescription from a licensed practitioner. Ketamine is not FDA-approved for the treatment of any psychiatric disorder.FDA-approved esketamine, a ketamine derivative, is a Schedule III controlled substance marketed under the brand name SPRAVATO. It is a nasal spray indicated for treatment-resistant depression in adults and depressive symptoms in adults with major depressive disorder with acute suicidal ideation or behavior in conjunction with an oral antidepressant. Furthermore, FDA-approved SPRAVATO bears a boxed warning, commonly referred to as a "black box warning," which is the strongest warning FDA requires, indicating that the drug carries a significant risk of serious or even life-threatening adverse effects. The boxed warning addresses the risk for sedation, dissociation, and respiratory depression after administration; the potential for abuse and misuse; the increased risk of suicidal thoughts and behaviors in pediatric and young adult patients taking antidepressants; and the requirement that SPRAVATO be available only through a restricted program, the SPRAVATO REMS, because of the risks of serious adverse outcomes from sedation, dissociation, respiratory depression, abuse, and misuse. The SPRAVATO REMS requires SPRAVATO to be dispensed and administered in medically supervised health care settings that are certified in the REMS and monitor patients for a minimum of two hours following administration. In addition, pharmacies must be certified in the REMS and must only dispense SPRAVATO to health care settings that are certified in the program.Misbranded Drug ViolationsA drug is misbranded under section 502(f)(1) of the FD&C Act if its labeling fails to bear adequate directions for use. "Adequate directions for use" means directions under which a layperson can use a drug safely and for the purposes for which it is intended (see 21 CFR 201.5). Prescription drugs, as defined in section 503(b)(1) of the FD&C Act include those that, because of their toxicity or other potentiality for harmful effect, or the method of their use, or the collateral measures necessary for their use, are not safe for use except under supervision of a practitioner licensed by law to administer them. Prescription drugs, as defined in section 503(b)(1)(A) of the FD&C Act (21 U.S.C. 353(b)(1)(A)), can be used safely only at the direction, and under the supervision, of a licensed practitioner.You failed to bear adequate directions for use on the labeling for these drug products that you have introduced into interstate commerce. Because the aforementioned drugs are prescription drugs intended for conditions that are not amenable to self-diagnosis and treatment by a layperson, adequate directions cannot be written such that a layperson can use the products safely for their intended use. Consequently, the labeling for these drug products fails to bear adequate directions for use, causing them to be misbranded under section 502(f)(1) of the FD&C Act. Because these drugs are not approved in the United States, they are also not exempt under 21 CFR 201.115(a) from the requirements of section 502(f)(1) of the FD&C Act. By offering these drugs for sale to U.S. consumers, www.arylcyclohexylamine.com is causing the introduction of misbranded drugs into interstate commerce in violation of section 301(a) of the FD&C Act.ConclusionAs previously stated, you are responsible for investigating and determining the root causes of any violations and implementing corrective and preventative measures to ensure future and sustained compliance so that these violations and any others do not occur.Send your written response to FDAInternetPharmacyTaskForce-CDER@fda.hhs.gov within 15 business days of receipt of this letter. Include the specific steps you have taken to correct any violations, an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. Identify your written response with reference number “MARCS-CMS 725151” in the subject line of the email.If you have information that you believe demonstrates that your products are not in violation of the FD&C Act and FDA regulations, include that information for our consideration.If you are not located in the United States, please note that products that appear to be misbranded or unapproved new drugs may be detained or refused admission. We may advise the appropriate regulatory officials in the country from which you operate that your products referenced above appear to be unapproved and misbranded products that cannot be legally sold to consumers in the United States.Please note FDA posts warning letters on www.fda.gov.Sincerely,/S/Sangeeta Vaswani Chatterjee, PharmDDirectorOffice of Drug Security, Integrity, and ResponseOffice of ComplianceCenter for Drug Evaluation and ResearchU.S. Food and Drug Administration_____________________1 REMS refers to a drug safety program that FDA can require for certain medications with serious safety concerns to help ensure the benefits of the medication outweigh its risks. See the Risk Evaluation and Mitigation Strategies website at https://www.fda.gov/drugs/drug-safety-and-availability/risk-evaluation-and-mitigation-strategies-rems.

Delivery Method:VIA ELECTRONIC MAIL READ/DELIVERY RECEIPT REQUESTEDProduct:DrugsRecipient:Extra Medication / www.extramedication.comUnited Statessupport@extramedication.comIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesJune 23, 2026WARNING LETTERReference Number: MARCS-CMS 725152To Extra Medication:This warning letter advises you of significant violations identified during a U.S. Food and Drug Administration (FDA) review of your website www.extramedication.com. Promptly address the violations described herein without delay, including ensuring that appropriate resources are allocated to fully address the violations and prevent their recurrence. This is not intended to be an all-inclusive list of the violations that may exist in connection with your products or operations. It is your responsibility to ensure that you comply with all requirements of federal law, including FDA regulations. Failure to adequately address violations may result in regulatory or legal action without further notice including, without limitation, seizure and injunction.As discussed below, FDA has observed that www.extramedication.com introduces into interstate commerce unapproved and misbranded ketamine drug products, including certain drugs for which the FDA-approved version is an injectable or subject to a Risk Evaluation and Mitigation Strategy (REMS).1 FDA has identified significant risks associated with unapproved ketamine products, especially in the absence of appropriate medical supervision. Given the increased interest in the use of ketamine products, the easy availability of unapproved and misbranded ketamine products via the internet puts U.S. consumers at risk for serious adverse events. Furthermore, injectable drug products can pose a serious risk of harm to users because they bypass many of the body's natural defenses against toxic ingredients, toxins, or dangerous organisms that can lead to serious and life-threatening conditions such as septicemia or sepsis.There are also inherent risks to consumers who purchase unapproved new drugs and misbranded drugs. Unapproved new drugs do not carry the same assurances of safety and effectiveness as those drugs subject to FDA oversight. Drugs that have circumvented regulatory safeguards may be contaminated, counterfeit, contain varying amounts of active ingredients, or contain different ingredients altogether.Accordingly, FDA requests that www.extramedication.com cease offering any unapproved and misbranded drugs for sale to U.S. consumers. This is critical to shielding the American public from harm.FDA ReviewViolations were identified and documented during a review of your website www.extramedication.com, FDA Establishment Identifier (FEI) 3043544171, on March 2, 2026.Violations of the Federal Food, Drug, and Cosmetic ActOn your website at internet address www.extramedication.com, you introduce into interstate commerce misbranded and unapproved new drugs in violation of sections 301(a), 301(d), 301(k), 502(f)(1), 503(b)(1), and 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 331(a), 331(d), 331(k), 352(f)(1), 353(b)(1), and 355(a)).The following are violations identified during our review. As a reminder, this is not an all-inclusive list of violations that may exist in connection with your products or operations.Unapproved New Drug ViolationsCertain products offered for sale by www.extramedication.com are drugs within the meaning of section 201(g) of the FD&C Act (21 U.S.C. 321(g)) because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or because they are intended to affect the structure or function of the body. These drugs are also new drugs as defined by section 201(p) of the FD&C Act (21 U.S.C. 321(p)), because they are not generally recognized as safe and effective for their labeled uses. With certain exceptions not applicable here, new drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from FDA, as described in section 505(a) of the FD&C Act.You failed to obtain approved applications pursuant to section 505 of the FD&C Act (21 U.S.C. 355) for these products that you have introduced into interstate commerce. Accordingly, their introduction or delivery for introduction into interstate commerce violates sections 301(d) and 505(a) of the FD&C Act.An example of an unapproved ketamine drug product you offer for sale on www.extramedication.com is ketamine marketed as "Calypsol." Evidence obtained from your website establishing that this product is a drug intended for human use (as defined in 21 Code of Federal Regulations (CFR) 201.128) includes the claim "Calypsol is commonly used for inducing anesthesia (lack of sensation or feeling) before surgery or certain procedures that do not require skeletal muscle relaxation."A second example of an unapproved ketamine drug product you offer for sale on www.extramedication.com is ketamine marketed as "ketanest." Evidence obtained from your website establishing that this product is a drug intended for human use (as defined in 21 CFR 201.128) includes the claim "Ketanest is used to put you to sleep for surgery and to prevent pain and discomfort during certain medical tests or procedures."While there are FDA-approved versions of ketamine drug products on the market in the United States, there are no approved drug applications pursuant to section 505 of the FD&C Act in effect for "Calypsol" and "ketanest" offered by www.extramedication.com.FDA-approved ketamine, including products marketed under the brand name KETALAR, is a Schedule III controlled substance. It is an intravenous or intramuscular injection indicated as a general anesthetic, including as a sole agent or as an adjunct to other anesthetic agents, for the induction of anesthesia and for diagnostic and surgical procedures. Ketamine is a racemic mixture consisting of two mirror image molecules, R- and S-ketamine (arketamine and esketamine, respectively). This product is only available pursuant to a prescription from a licensed practitioner. Ketamine is not FDA-approved for the treatment of any psychiatric disorder.FDA-approved esketamine, a ketamine derivative, is a Schedule III controlled substance marketed under the brand name SPRAVATO. It is a nasal spray indicated for treatment-resistant depression in adults and depressive symptoms in adults with major depressive disorder with acute suicidal ideation or behavior in conjunction with an oral antidepressant. Furthermore, FDA-approved SPRAVATO bears a boxed warning, commonly referred to as a "black box warning," which is the strongest warning FDA requires, indicating that the drug carries a significant risk of serious or even life-threatening adverse effects. The boxed warning addresses the risk for sedation, dissociation, and respiratory depression after administration; the potential for abuse and misuse; the increased risk of suicidal thoughts and behaviors in pediatric and young adult patients taking antidepressants; and the requirement that SPRAVATO be available only through a restricted program, the SPRAVATO REMS, because of the risks of serious adverse outcomes from sedation, dissociation, respiratory depression, abuse, and misuse. The SPRAVATO REMS requires SPRAVATO to be dispensed and administered in medically supervised health care settings that are certified in the REMS and monitor patients for a minimum of two hours following administration. In addition, pharmacies must be certified in the REMS and must only dispense SPRAVATO to health care settings that are certified in the program.Misbranded Drug ViolationsA drug is misbranded under section 502(f)(1) of the FD&C Act if its labeling fails to bear adequate directions for use. "Adequate directions for use" means directions under which a layperson can use a drug safely and for the purposes for which it is intended (see 21 CFR 201.5). Prescription drugs, as defined in section 503(b)(1) of the FD&C Act include those that, because of their toxicity or other potentiality for harmful effect, or the method of their use, or the collateral measures necessary for their use, are not safe for use except under supervision of a practitioner licensed by law to administer them. Prescription drugs, as defined in section 503(b)(1)(A) of the FD&C Act (21 U.S.C. 353(b)(1)(A)), can be used safely only at the direction, and under the supervision, of a licensed practitioner.You failed to bear adequate directions for use on the labeling for these drug products that you have introduced into interstate commerce. Because the aforementioned drugs are prescription drugs intended for conditions that are not amenable to self-diagnosis and treatment by a layperson, adequate directions cannot be written such that a layperson can use the products safely for their intended use. Consequently, the labeling for these drug products fails to bear adequate directions for use, causing them to be misbranded under section 502(f)(1) of the FD&C Act. Because these drugs are not approved in the United States, they are also not exempt under 21 CFR 201.115(a) from the requirements of section 502(f)(1) of the FD&C Act. By offering these drugs for sale to U.S. consumers, www.extramedication.com is causing the introduction of misbranded drugs into interstate commerce in violation of section 301(a) of the FD&C Act.Furthermore, under U.S. law, prescription drugs can be dispensed only pursuant to a prescription from a health care practitioner licensed by law to administer prescription drugs. By offering the aforementioned drug products without requiring a prescription, www.extramedication.com jeopardizes patient safety and misbrands the drug products under section 503(b)(1) of the FD&C Act. Dispensing a prescription drug without a prescription is an act which results in the drug being misbranded while held for sale, in violation of section 301(k) of the FD&C Act.ConclusionAs previously stated, you are responsible for investigating and determining the root causes of any violations and implementing corrective and preventative measures to ensure future and sustained compliance so that these violations and any others do not occur.Send your written response to FDAInternetPharmacyTaskForce-CDER@fda.hhs.gov within 15 business days of receipt of this letter. Include the specific steps you have taken to correct any violations, an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. Identify your written response with reference number “MARCS-CMS 725152” in the subject line of the email.If you have information that you believe demonstrates that your products are not in violation of the FD&C Act and FDA regulations, include that information for our consideration.If you are not located in the United States, please note that products that appear to be misbranded or unapproved new drugs may be detained or refused admission. We may advise the appropriate regulatory officials in the country from which you operate that your products referenced above appear to be unapproved and misbranded products that cannot be legally sold to consumers in the United States.Please note FDA posts warning letters on www.fda.gov.Sincerely,/S/Sangeeta Vaswani Chatterjee, PharmDDirectorOffice of Drug Security, Integrity, and ResponseOffice of ComplianceCenter for Drug Evaluation and ResearchU.S. Food and Drug Administration____________________1 REMS refers to a drug safety program that FDA can require for certain medications with serious safety concerns to help ensure the benefits of the medication outweigh its risks. See the Risk Evaluation and Mitigation Strategies website at https://www.fda.gov/drugs/drug-safety-and-availability/risk-evaluation-and-mitigation-strategies-rems.

赣药监联〔2026〕6号各设区市、赣江新区市场监督管理局、工信局、科技局、卫生健康委、医保局,各相关单位,省药监局机关各处室、各直属单位：为深入贯彻党中央、国务院决策部署，落实《江西省人民政府办公厅关于全面深化药品医疗器械化妆品监管改革促进医药产业高质量发展的实施意见》（赣府厅发〔2025〕31号），推进以临床价值为导向的医疗器械源头创新，聚焦医工深度融合，促进更多临床创新成果向医疗器械产品转化，更好服务人民群众日益增长健康需求，根据国家药监局统一部署，省药监局会同省工信厅、省科技厅、省卫生健康委、省医保局制定了《关于开展医疗器械临床成果转化“春雨行动”的通知》。现印发给你们，请遵照执行。联 系 人：省药监局医疗器械注册管理处联系电话：079188158033                                       江西省药品监督管理局 江西省工业和信息化厅                                        江西省科学技术厅 江西省卫生健康委员会                                        江西省医疗保障局                                       2026年7月1日（公开属性：主动公开）关于开展医疗器械临床成果转化“春雨行动”的通知为深入贯彻落实党中央、国务院决策部署，推进以临床价值为导向的医疗器械源头创新，聚焦医工深度融合，促进更多临床创新成果向医疗器械产品转化，根据国家药监局统一部署，决定在全省范围内组织实施为期三年的“春雨行动”。现将有关事项通知如下：一、总体要求深入落实《江西省人民政府办公厅关于全面深化药品医疗器械化妆品监管改革促进医药产业高质量发展的实施意见》(赣府厅发〔2025〕31号)要求，通过广泛挖掘临床创新创意，建立“征集筛选—对接匹配—辅导培育—转化落地”工作机制，构建“临床创意源头供给—医工协同技术攻关—上下联动培育赋能”的创新生态，畅通临床创新成果转化路径，培育一批具有显著临床应用价值的医工融合标志性产品上市，进一步满足临床需求、保障人民群众健康，推动江西省医疗器械产业高质量发展。二、工作任务（一）具有临床价值和创新性的优质项目的征集和筛选。省药监局负责建立项目征集信息化平台并发布平台操作指南，医疗机构可登录省药监局官网的江西省药品监督管理局智慧监管平台-企业端进入，通过平台申报符合要求的临床创新成果转化项目。省药监局将加强对医疗机构申报项目的指导，审核内容信息的完整性、规范性。项目申报至少应当包含项目名称、工作原理/作用机理、适用范围/预期用途、创新的关键点和满足临床需求的情况、研究团队等基本信息(见附件)。省工信厅、省科技厅、省卫生健康委、省医保局等相关单位和企业可通过该平台查阅信息、对接项目。省药监局成立“春雨行动”工作专班，工作专班由省药监局医疗器械审评审批骨干人员组成，不定期召开专班工作会对征集的项目开展审查，筛选出具有临床应用价值和创新性的优质项目，必要时可外邀专家或省直相关部门工作人员参与审查。筛选原则如下：属于按照医疗器械管理的产品，预期具备一定的临床应用价值(如新的诊疗方法或对现有诊疗方法的改进创新),且具备转化的可行性(如应当具有明确的预期用途、基本的性能指标等)。对未通过筛选的项目，“春雨行动”工作专班也将进行指导，按要求做好有关工作。（二）对接匹配医疗器械企业开展注册研究。“春雨行动”工作专班将建立对接机制，针对经筛选符合要求的项目，帮助医疗机构与医疗器械生产企业进行对接，促进医工双向选择，及时跟进项目进展，建立动态管理与退出机制，对停滞超过6个月的项目，经“春雨行动”工作专班评估，认为不具备转化条件的可以予以清退。（三）辅导培育产品从设计开发到产品定型。对于已对接匹配的项目，省药监局将做好属性界定和分类界定指导工作。对属于第一类医疗器械的，“春雨行动”工作专班将指导有关地市做好支持工作；对属于第二类和第三类医疗器械的，“春雨行动”工作专班将加强与医疗机构、生产企业的沟通交流，定期跟踪项目进展，为产品研发全过程提供支持。（四）转化落地为安全有效质量可控的创新产品。1.属于第三类医疗器械的，经“春雨行动”工作专班初步审查认为符合国家药监局器审中心审评前置条件的，将积极向国家药监局推荐，如纳入审评前置服务通道，国家药监局器审中心将会把技术审评重心向产品研发阶段前移，加强与研制机构、生产企业的沟通交流。未纳入审评前置服务通道的产品，省药监局将指导申请人按照《医疗器械监督管理条例》《医疗器械注册与备案管理办法》 《体外诊断试剂注册与备案管理办法》等相关法规要求开展产品研制与注册工作。对于基本符合国家药监局创新/优先申请条件的，省药监局将指导申请人按程序向国家药监局提交申请。2.属于第二类医疗器械的，经“春雨行动”工作专班审核后，如基本符合我省第二类创新/优先医疗器械的，将纳入“春雨行动”工作专班服务，实施一对一指导帮扶，加快推动产品上市。不符合以上条件的，省药监局将指导申请人按照《医疗器械监督管理条例》《医疗器械注册与备案管理办法》《体外诊断试剂注册与备案管理办法》等相关法规要求开展产品研制与注册工作，推进产品转化落地。3.属于第一类医疗器械的，经“春雨行动”工作专班审核后，将把该产品信息推送至有关地市，“春雨行动”工作专班会同当地有关部门推动产品上市。以上转化工作动态情况，省药监局将定期向国家药监局报告，并通报给省直有关部门及相关地方政府。三、责任分工省药监局负责全省“春雨行动”总体推进和统筹协调，做好宣贯工作，加强向国家药监局的沟通汇报工作，并做好信息共享及有关协调工作。省工信厅加大对“春雨行动”有关项目在项目对接、产业培育方面的政策支持，指导具备转化条件的有关项目优先推荐报送“揭榜挂帅”等项目。省科技厅鼓励并指导创新主体把具备条件的项目信息凝练成研发需求，支持开展医疗器械创新技术攻关和科技成果转化。省卫生健康委广泛动员和指导各级医疗机构和广大医务工作者进行项目申报，加强做好临床资源的统筹调配，支持医疗机构开展相关临床研究。省医保局对通过“春雨行动”获批上市的医用耗材，在医保支付目录政策调整过程中按规定予以支持。各设区市相关部门要加强与“春雨行动”工作专班的联系，支持辖区内有关项目的注册申报和转化落地。四、有关要求各相关单位和部门要加强宣贯解读，推进“春雨行动”在我省落地见效。省药监局将及时总结工作中的经验做法，完善工作机制，每半年向国家药监局器审中心报送工作进展。各医疗机构对报送的临床研究转化项目要进行把关，筛选符合条件的项目，由医疗机构相关部门注册账号后，统一在系统中报送。参与“春雨行动”的单位和个人应当自觉树立和践行正确政绩观，严格遵守法律法规、工作纪律，保守国家秘密和相关企业与研制机构的秘密，遵守廉洁自律相关要求。相关科研机构、大专院校如有相关项目，可参照以上程序参与“春雨行动”。附件：江西省“春雨行动”转化项目信息征集表附件“春雨行动”转化项目信息征集表序号项目名称工作原理/作用机理适用范围/预期用途创新的关键点满足临床需求的情况研究团队合作企业(如有)项目进展(简述项目与企业对接情况及产品研发/生产等进展)联系人及联系方式(姓名、电话、邮箱)示例XXX系统该产品通过手术在XXX植入XXX电极，用于XXX。适用于XXX患者XXX该产品采用XXX技术，实现XXX该产品通过XXX,可以XXX,实现XXX,达到XXX效果，提高XXX安全性/灵敏度等XXX医院XXX公司尚未与企业对接/已与企业达成初步合作意向，产品已完成实验室研发/已基本定型/已完成检验等XXX,138XXXXXX,XXX@XXX.com

Delivery Method:VIA ELECTRONIC MAIL READ/DELIVERY RECEIPT REQUESTEDProduct:DrugsRecipient:Ketacyn Pharmaceuticals / www.ketacynpharma.comUnited Statesinfo@ketacynpharma.comIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesJune 23, 2026WARNING LETTERReference Number: MARCS-CMS 725153To Ketacyn Pharmaceuticals:This warning letter advises you of significant violations identified during a U.S. Food and Drug Administration (FDA) review of your website www.ketacynpharma.com. Promptly address the violations described herein without delay, including ensuring that appropriate resources are allocated to fully address the violations and prevent their recurrence. This is not intended to be an all-inclusive list of the violations that may exist in connection with your products or operations. It is your responsibility to ensure that you comply with all requirements of federal law, including FDA regulations. Failure to adequately address violations may result in regulatory or legal action without further notice including, without limitation, seizure and injunction.As discussed below, FDA has observed that www.ketacynpharma.com introduces into interstate commerce unapproved and misbranded ketamine drug products, including certain drugs for which the FDA-approved version is an injectable or subject to a Risk Evaluation and Mitigation Strategy (REMS).1 FDA has identified significant risks associated with unapproved ketamine products, especially in the absence of appropriate medical supervision. Given the increased interest in the use of ketamine products, the easy availability of unapproved and misbranded ketamine products via the internet puts U.S. consumers at risk for serious adverse events. Furthermore, injectable drug products can pose a serious risk of harm to users because they bypass many of the body's natural defenses against toxic ingredients, toxins, or dangerous organisms that can lead to serious and life-threatening conditions such as septicemia or sepsis.There are also inherent risks to consumers who purchase unapproved new drugs and misbranded drugs. Unapproved new drugs do not carry the same assurances of safety and effectiveness as those drugs subject to FDA oversight. Drugs that have circumvented regulatory safeguards may be contaminated, counterfeit, contain varying amounts of active ingredients, or contain different ingredients altogether.Accordingly, FDA requests that www.ketacynpharma.com cease offering any unapproved and misbranded drugs for sale to U.S. consumers. This is critical to shielding the American public from harm.FDA ReviewViolations were identified and documented during a review of your website www.ketacynpharma.com, FDA Establishment Identifier (FEI) 3043544178, on February 26, 2026.Violations of the Federal Food, Drug, and Cosmetic ActOn your website at internet address www.ketacynpharma.com, you introduce into interstate commerce misbranded and unapproved new drugs in violation of sections 301(a), 301(d), 301(k), 502(f)(1), 503(b)(1), and 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 331(a), 331(d), 331(k), 352(f)(1), 353(b)(1), and 355(a)).The following are violations identified during our review. As a reminder, this is not an all-inclusive list of violations that may exist in connection with your products or operations.Unapproved New Drug ViolationsCertain products offered for sale by www.ketacynpharma.com are drugs within the meaning of section 201(g) of the FD&C Act (21 U.S.C. 321(g)) because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or because they are intended to affect the structure or function of the body. These drugs are also new drugs as defined by section 201(p) of the FD&C Act (21 U.S.C. 321(p)), because they are not generally recognized as safe and effective for their labeled uses. With certain exceptions not applicable here, new drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from FDA, as described in section 505(a) of the FD&C Act.You failed to obtain approved applications pursuant to section 505 of the FD&C Act (21 U.S.C. 355) for these products that you have introduced into interstate commerce. Accordingly, their introduction or delivery for introduction into interstate commerce violates sections 301(d) and 505(a) of the FD&C Act.An example of an unapproved ketamine drug product you offer for sale on www.ketacynpharma.com is ketamine marketed as "Ketamine Solution for Injection (500 mg/10 mL)." Evidence obtained from your website establishing that this product is a drug intended for human use (as defined in 21 Code of Federal Regulations (CFR) 201.128) includes the claim "Ketacyn Pharmaceuticals manufactures Ketamine Solution for Injection (500 mg/10 mL, 50 mg/mL), a high-potency anesthetic designed for both intravenous (i.v.) and intramuscular (i.m.) use."A second example of an unapproved ketamine drug product you offer for sale on www.ketacynpharma.com is ketamine marketed as "Ketamine Gummies." Evidence obtained from your website establishing that this product is a drug intended for human use (as defined in 21 CFR 201.128) includes the claim "Discover a modern approach to wellness with Ketamine Gummies, specially formulated to provide fast-acting support for mental clarity, mood enhancement, and relaxation."While there are FDA-approved versions of ketamine drug products on the market in the United States, there are no approved drug applications pursuant to section 505 of the FD&C Act in effect for "Ketamine Solution for Injection (500 mg/10 mL)" and "Ketamine Gummies" offered by www.ketacynpharma.com.FDA-approved ketamine, including products marketed under the brand name KETALAR, is a Schedule III controlled substance. It is an intravenous or intramuscular injection indicated as a general anesthetic, including as a sole agent or as an adjunct to other anesthetic agents, for the induction of anesthesia and for diagnostic and surgical procedures. Ketamine is a racemic mixture consisting of two mirror image molecules, R- and S-ketamine (arketamine and esketamine, respectively). This product is only available pursuant to a prescription from a licensed practitioner. Ketamine is not FDA-approved for the treatment of any psychiatric disorder.FDA-approved esketamine, a ketamine derivative, is a Schedule III controlled substance marketed under the brand name SPRAVATO. It is a nasal spray indicated for treatment-resistant depression in adults and depressive symptoms in adults with major depressive disorder with acute suicidal ideation or behavior in conjunction with an oral antidepressant. Furthermore, FDA-approved SPRAVATO bears a boxed warning, commonly referred to as a "black box warning," which is the strongest warning FDA requires, indicating that the drug carries a significant risk of serious or even life-threatening adverse effects. The boxed warning addresses the risk for sedation, dissociation, and respiratory depression after administration; the potential for abuse and misuse; the increased risk of suicidal thoughts and behaviors in pediatric and young adult patients taking antidepressants; and the requirement that SPRAVATO be available only through a restricted program, the SPRAVATO REMS, because of the risks of serious adverse outcomes from sedation, dissociation, respiratory depression, abuse, and misuse. The SPRAVATO REMS requires SPRAVATO to be dispensed and administered in medically supervised health care settings that are certified in the REMS and monitor patients for a minimum of two hours following administration. In addition, pharmacies must be certified in the REMS and must only dispense SPRAVATO to health care settings that are certified in the program.Misbranded Drug ViolationsA drug is misbranded under section 502(f)(1) of the FD&C Act if its labeling fails to bear adequate directions for use. "Adequate directions for use" means directions under which a layperson can use a drug safely and for the purposes for which it is intended (see 21 CFR 201.5). Prescription drugs, as defined in section 503(b)(1) of the FD&C Act include those that, because of their toxicity or other potentiality for harmful effect, or the method of their use, or the collateral measures necessary for their use, are not safe for use except under supervision of a practitioner licensed by law to administer them. Prescription drugs, as defined in section 503(b)(1)(A) of the FD&C Act (21 U.S.C. 353(b)(1)(A)), can be used safely only at the direction, and under the supervision, of a licensed practitioner.You failed to bear adequate directions for use on the labeling for these drug products that you have introduced into interstate commerce. Because the aforementioned drugs are prescription drugs intended for conditions that are not amenable to self-diagnosis and treatment by a layperson, adequate directions cannot be written such that a layperson can use the products safely for their intended use. Consequently, the labeling for these drug products fails to bear adequate directions for use, causing them to be misbranded under section 502(f)(1) of the FD&C Act. Because these drugs are not approved in the United States, they are also not exempt under 21 CFR 201.115(a) from the requirements of section 502(f)(1) of the FD&C Act. By offering these drugs for sale to U.S. consumers, www.ketacynpharma.com is causing the introduction of misbranded drugs into interstate commerce in violation of section 301(a) of the FD&C Act.Furthermore, under U.S. law, prescription drugs can be dispensed only pursuant to a prescription from a health care practitioner licensed by law to administer prescription drugs. By offering the aforementioned drug products without requiring a prescription, www.ketacynpharma.com jeopardizes patient safety and misbrands the drug products under section 503(b)(1) of the FD&C Act. Dispensing a prescription drug without a prescription is an act which results in the drug being misbranded while held for sale, in violation of section 301(k) of the FD&C Act.ConclusionAs previously stated, you are responsible for investigating and determining the root causes of any violations and implementing corrective and preventative measures to ensure future and sustained compliance so that these violations and any others do not occur.Send your written response to FDAInternetPharmacyTaskForce-CDER@fda.hhs.gov within 15 business days of receipt of this letter. Include the specific steps you have taken to correct any violations, an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. Identify your written response with reference number “MARCS-CMS 725153” in the subject line of the email.If you have information that you believe demonstrates that your products are not in violation of the FD&C Act and FDA regulations, include that information for our consideration.If you are not located in the United States, please note that products that appear to be misbranded or unapproved new drugs may be detained or refused admission. We may advise the appropriate regulatory officials in the country from which you operate that your products referenced above appear to be unapproved and misbranded products that cannot be legally sold to consumers in the United States.Please note FDA posts warning letters on www.fda.gov.Sincerely,/S/Sangeeta Vaswani Chatterjee, PharmDDirectorOffice of Drug Security, Integrity, and ResponseOffice of ComplianceCenter for Drug Evaluation and ResearchU.S. Food and Drug Administration________________________1 REMS refers to a drug safety program that FDA can require for certain medications with serious safety concerns to help ensure the benefits of the medication outweigh its risks. See the Risk Evaluation and Mitigation Strategies website at https://www.fda.gov/drugs/drug-safety-and-availability/risk-evaluation-and-mitigation-strategies-rems.

Delivery Method:VIA ELECTRONIC MAIL READ/DELIVERY RECEIPT REQUESTEDProduct:DrugsRecipient:LyfeUnit / www.lyfeunit.comUnited Statesinquiries.lyfeunit@proton.meIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesJune 23, 2026WARNING LETTERReference Number: MARCS-CMS 725156To LyfeUnit:This warning letter advises you of significant violations identified during a U.S. Food and Drug Administration (FDA) review of your website www.lyfeunit.com. Promptly address the violations described herein without delay, including ensuring that appropriate resources are allocated to fully address the violations and prevent their recurrence. This is not intended to be an all-inclusive list of the violations that may exist in connection with your products or operations. It is your responsibility to ensure that you comply with all requirements of federal law, including FDA regulations. Failure to adequately address violations may result in regulatory or legal action without further notice including, without limitation, seizure and injunction.As discussed below, FDA has observed that www.lyfeunit.com introduces into interstate commerce unapproved and misbranded ketamine drug products, including certain drugs for which the FDA-approved version is an injectable or subject to a Risk Evaluation and Mitigation Strategy (REMS).1 FDA has identified significant risks associated with unapproved ketamine products, especially in the absence of appropriate medical supervision. Given the increased interest in the use of ketamine products, the easy availability of unapproved and misbranded ketamine products via the internet puts U.S. consumers at risk for serious adverse events. Furthermore, injectable drug products can pose a serious risk of harm to users because they bypass many of the body's natural defenses against toxic ingredients, toxins, or dangerous organisms that can lead to serious and life-threatening conditions such as septicemia or sepsis.There are also inherent risks to consumers who purchase unapproved new drugs and misbranded drugs. Unapproved new drugs do not carry the same assurances of safety and effectiveness as those drugs subject to FDA oversight. Drugs that have circumvented regulatory safeguards may be contaminated, counterfeit, contain varying amounts of active ingredients, or contain different ingredients altogether.Accordingly, FDA requests that www.lyfeunit.com cease offering any unapproved and misbranded drugs for sale to U.S. consumers. This is critical to shielding the American public from harm.FDA ReviewViolations were identified and documented during a review of your website www.lyfeunit.com, FDA Establishment Identifier (FEI) 3043544191, on February 27, 2026.Violations of the Federal Food, Drug, and Cosmetic ActOn your website at internet address www.lyfeunit.com, you introduce into interstate commerce misbranded and unapproved new drugs in violation of sections 301(a), 301(d), 301(k), 502(f)(1), 503(b)(1), and 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 331(a), 331(d), 331(k), 352(f)(1), 353(b)(1), and 355(a)).The following are violations identified during our review. As a reminder, this is not an all-inclusive list of violations that may exist in connection with your products or operations.Unapproved New Drug ViolationsCertain products offered for sale by www.lyfeunit.com are drugs within the meaning of section 201(g) of the FD&C Act (21 U.S.C. 321(g)) because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or because they are intended to affect the structure or function of the body. These drugs are also new drugs as defined by section 201(p) of the FD&C Act (21 U.S.C. 321(p)), because they are not generally recognized as safe and effective for their labeled uses. With certain exceptions not applicable here, new drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from FDA, as described in section 505(a) of the FD&C Act.You failed to obtain approved applications pursuant to section 505 of the FD&C Act (21 U.S.C. 355) for these products that you have introduced into interstate commerce. Accordingly, their introduction or delivery for introduction into interstate commerce violates sections 301(d) and 505(a) of the FD&C Act.An example of an unapproved ketamine drug product you offer for sale on www.lyfeunit.com is ketamine marketed as "Buy Rotexmedica Ketamine 500mg/10ml Vials | Mental Health Treatments." Evidence obtained from your website establishing that this product is a drug intended for human use (as defined in 21 Code of Federal Regulations (CFR) 201.128) includes the claims "Mental Health Treatments" and "Rotexmedica Ketamine 500mg/10ml, serves as a sole anesthetic for short diagnostic and surgical procedures not requiring muscle relaxation, such as those involving the eye, ear, nose, mouth, or dental extractions. Ketamine from Rotexmedica is also indicated for anesthesia induction before other general anesthetics or to supplement weaker agents like nitrous oxide."While there are FDA-approved versions of ketamine drug products on the market in the United States, there is no approved drug application pursuant to section 505 of the FD&C Act in effect for "Buy Rotexmedica Ketamine 500mg/10ml Vials | Mental Health Treatments" offered by www.lyfeunit.com.FDA-approved ketamine, including products marketed under the brand name KETALAR, is a Schedule III controlled substance. It is an intravenous or intramuscular injection indicated as a general anesthetic, including as a sole agent or as an adjunct to other anesthetic agents, for the induction of anesthesia and for diagnostic and surgical procedures. Ketamine is a racemic mixture consisting of two mirror image molecules, R- and S-ketamine (arketamine and esketamine, respectively). This product is only available pursuant to a prescription from a licensed practitioner. Ketamine is not FDA-approved for the treatment of any psychiatric disorder.FDA-approved esketamine, a ketamine derivative, is a Schedule III controlled substance marketed under the brand name SPRAVATO. It is a nasal spray indicated for treatment-resistant depression in adults and depressive symptoms in adults with major depressive disorder with acute suicidal ideation or behavior in conjunction with an oral antidepressant. Furthermore, FDA-approved SPRAVATO bears a boxed warning, commonly referred to as a "black box warning," which is the strongest warning FDA requires, indicating that the drug carries a significant risk of serious or even life-threatening adverse effects. The boxed warning addresses the risk for sedation, dissociation, and respiratory depression after administration; the potential for abuse and misuse; the increased risk of suicidal thoughts and behaviors in pediatric and young adult patients taking antidepressants; and the requirement that SPRAVATO be available only through a restricted program, the SPRAVATO REMS, because of the risks of serious adverse outcomes from sedation, dissociation, respiratory depression, abuse, and misuse. The SPRAVATO REMS requires SPRAVATO to be dispensed and administered in medically supervised health care settings that are certified in the REMS and monitor patients for a minimum of two hours following administration. In addition, pharmacies must be certified in the REMS and must only dispense SPRAVATO to health care settings that are certified in the program.Misbranded Drug ViolationsA drug is misbranded under section 502(f)(1) of the FD&C Act if its labeling fails to bear adequate directions for use. "Adequate directions for use" means directions under which a layperson can use a drug safely and for the purposes for which it is intended (see 21 CFR 201.5). Prescription drugs, as defined in section 503(b)(1) of the FD&C Act include those that, because of their toxicity or other potentiality for harmful effect, or the method of their use, or the collateral measures necessary for their use, are not safe for use except under supervision of a practitioner licensed by law to administer them. Prescription drugs, as defined in section 503(b)(1)(A) of the FD&C Act (21 U.S.C. 353(b)(1)(A)), can be used safely only at the direction, and under the supervision, of a licensed practitioner.You failed to bear adequate directions for use on the labeling for this drug product that you have introduced into interstate commerce. Because the aforementioned drug is a prescription drug intended for conditions that are not amenable to self-diagnosis and treatment by a layperson, adequate directions cannot be written such that a layperson can use this product safely for its intended use. Consequently, the labeling for this drug product fails to bear adequate directions for use, causing it to be misbranded under section 502(f)(1) of the FD&C Act. Because this drug is not approved in the United States, it is also not exempt under 21 CFR 201.115(a) from the requirements of section 502(f)(1) of the FD&C Act. By offering this drug for sale to U.S. consumers, www.lyfeunit.com is causing the introduction of misbranded drugs into interstate commerce in violation of section 301(a) of the FD&C Act.Furthermore, under U.S. law, prescription drugs can be dispensed only pursuant to a prescription from a health care practitioner licensed by law to administer prescription drugs. By offering the aforementioned drug product without requiring a prescription, www.lyfeunit.com jeopardizes patient safety and misbrands the drug product under section 503(b)(1) of the FD&C Act. Dispensing a prescription drug without a prescription is an act which results in the drug being misbranded while held for sale, in violation of section 301(k) of the FD&C Act.ConclusionAs previously stated, you are responsible for investigating and determining the root causes of any violations and implementing corrective and preventative measures to ensure future and sustained compliance so that these violations and any others do not occur.Send your written response to FDAInternetPharmacyTaskForce-CDER@fda.hhs.gov within 15 business days of receipt of this letter. Include the specific steps you have taken to correct any violations, an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. Identify your written response with reference number “MARCS-CMS 725156” in the subject line of the email.If you have information that you believe demonstrates that your products are not in violation of the FD&C Act and FDA regulations, include that information for our consideration.If you are not located in the United States, please note that products that appear to be misbranded or unapproved new drugs may be detained or refused admission. We may advise the appropriate regulatory officials in the country from which you operate that your products referenced above appear to be unapproved and misbranded products that cannot be legally sold to consumers in the United States.Please note FDA posts warning letters on www.fda.gov.Sincerely,/S/Sangeeta Vaswani Chatterjee, PharmDDirectorOffice of Drug Security, Integrity, and ResponseOffice of ComplianceCenter for Drug Evaluation and ResearchU.S. Food and Drug Administration______________________1 REMS refers to a drug safety program that FDA can require for certain medications with serious safety concerns to help ensure the benefits of the medication outweigh its risks. See the Risk Evaluation and Mitigation Strategies website at https://www.fda.gov/drugs/drug-safety-and-availability/risk-evaluation-and-mitigation-strategies-rems.

Delivery Method:VIA ELECTRONIC MAIL READ/DELIVERY RECEIPT REQUESTEDProduct:DrugsRecipient:Ketamine Store / www.ketaminestore.orgUnited Statesorder@ketaminestore.orgIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesJune 23, 2026WARNING LETTERReference Number: MARCS-CMS 725147To Ketamine Store:This warning letter advises you of significant violations identified during a U.S. Food and Drug Administration (FDA) review of your website www.ketaminestore.org. Promptly address the violations described herein without delay, including ensuring that appropriate resources are allocated to fully address the violations and prevent their recurrence. This is not intended to be an all-inclusive list of the violations that may exist in connection with your products or operations. It is your responsibility to ensure that you comply with all requirements of federal law, including FDA regulations. Failure to adequately address violations may result in regulatory or legal action without further notice including, without limitation, seizure and injunction.As discussed below, FDA has observed that www.ketaminestore.org introduces into interstate commerce unapproved and misbranded ketamine drug products, including certain drugs for which the FDA-approved version is an injectable or subject to a Risk Evaluation and Mitigation Strategy (REMS).1 FDA has identified significant risks associated with unapproved ketamine products, especially in the absence of appropriate medical supervision. Given the increased interest in the use of ketamine products, the easy availability of unapproved and misbranded ketamine products via the internet puts U.S. consumers at risk for serious adverse events. Furthermore, injectable drug products can pose a serious risk of harm to users because they bypass many of the body's natural defenses against toxic ingredients, toxins, or dangerous organisms that can lead to serious and life-threatening conditions such as septicemia or sepsis.There are also inherent risks to consumers who purchase unapproved new drugs and misbranded drugs. Unapproved new drugs do not carry the same assurances of safety and effectiveness as those drugs subject to FDA oversight. Drugs that have circumvented regulatory safeguards may be contaminated, counterfeit, contain varying amounts of active ingredients, or contain different ingredients altogether.Accordingly, FDA requests that www.ketaminestore.org cease offering any unapproved and misbranded drugs for sale to U.S. consumers. This is critical to shielding the American public from harm.FDA ReviewViolations were identified and documented during a review of your website www.ketaminestore.org, FDA Establishment Identifier (FEI) 3043544014, on February 26, 2026.Violations of the Federal Food, Drug, and Cosmetic ActOn your website at internet address www.ketaminestore.org, you introduce into interstate commerce misbranded and unapproved new drugs in violation of sections 301(a), 301(d), 301(k), 502(f)(1), 503(b)(1), and 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 331(a), 331(d), 331(k), 352(f)(1), 353(b)(1), and 355(a)).The following are violations identified during our review. As a reminder, this is not an all-inclusive list of violations that may exist in connection with your products or operations.Unapproved New Drug ViolationsDrugs Introduced or Delivered for Introduction into Interstate Commerce Without an Approved Application in Violation of Sections 505(a) and 301(d) of the FD&C ActCertain products offered for sale by www.ketaminestore.org are drugs within the meaning of section 201(g) of the FD&C Act (21 U.S.C. 321(g)) because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or because they are intended to affect the structure or function of the body. These drugs are also new drugs as defined by section 201(p) of the FD&C Act (21 U.S.C. 321(p)), because they are not generally recognized as safe and effective for their labeled uses. With certain exceptions not applicable here, new drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from FDA, as described in section 505(a) of the FD&C Act.You failed to obtain approved applications pursuant to section 505 of the FD&C Act (21 U.S.C. 355) for these products that you have introduced into interstate commerce. Accordingly, their introduction or delivery for introduction into interstate commerce violates sections 301(d) and 505(a) of the FD&C Act.An example of an unapproved ketamine drug product you offer for sale on www.ketaminestore.org is ketamine marketed as "KETAMINE LIQUID." Evidence obtained from your website establishing that this product is a drug intended for human use (as defined in 21 Code of Federal Regulations (CFR) 201.128) includes the claim "Whether used for pain relief, depression treatment, or anxiety management, liquid ketamine provides reliable effects under professional care."While there are FDA-approved versions of ketamine drug products on the market in the United States, there are no approved drug applications pursuant to section 505 of the FD&C Act in effect for "KETAMINE LIQUID" offered by www.ketaminestore.org.FDA-approved ketamine, including products marketed under the brand name KETALAR, is a Schedule III controlled substance. It is an intravenous or intramuscular injection indicated as a general anesthetic, including as a sole agent or as an adjunct to other anesthetic agents, for the induction of anesthesia and for diagnostic and surgical procedures. Ketamine is a racemic mixture consisting of two mirror image molecules, R- and S-ketamine (arketamine and esketamine, respectively). This product is only available pursuant to a prescription from a licensed practitioner. Ketamine is not FDA-approved for the treatment of any psychiatric disorder.FDA-approved esketamine, a ketamine derivative, is a Schedule III controlled substance marketed under the brand name SPRAVATO. It is a nasal spray indicated for treatment-resistant depression in adults and depressive symptoms in adults with major depressive disorder with acute suicidal ideation or behavior in conjunction with an oral antidepressant. Furthermore, FDA-approved SPRAVATO bears a boxed warning, commonly referred to as a "black box warning," which is the strongest warning FDA requires, indicating that the drug carries a significant risk of serious or even life-threatening adverse effects. The boxed warning addresses the risk for sedation, dissociation, and respiratory depression after administration; the potential for abuse and misuse; the increased risk of suicidal thoughts and behaviors in pediatric and young adult patients taking antidepressants; and the requirement that SPRAVATO be available only through a restricted program, the SPRAVATO REMS, because of the risks of serious adverse outcomes from sedation, dissociation, respiratory depression, abuse, and misuse. The SPRAVATO REMS requires SPRAVATO to be dispensed and administered in medically supervised health care settings that are certified in the REMS and monitor patients for a minimum of two hours following administration. In addition, pharmacies must be certified in the REMS and must only dispense SPRAVATO to health care settings that are certified in the program.Compounded Drug Products Not Eligible for the Exemptions Under Sections 503A and 503B of the FD&C Act and Therefore Also in Violation of Sections 505(a) and 301(d) of the FD&C ActSection 503A of the FD&C Act (21 U.S.C. 353a) describes the conditions under which human drug products compounded by a licensed pharmacist in a State-licensed pharmacy or a Federal facility, or a licensed physician, qualify for exemptions from three sections of the FD&C Act: compliance with current good manufacturing practice of section 501(a)(2)(B) (21 U.S.C. 351(a)(2)(B)); labeling with adequate directions for use of section 502(f)(1); and FDA approval prior to marketing of section 505.2Section 503B of the FD&C Act (21 U.S.C. 353b) describes the conditions under which human drug products compounded by or under the direct supervision of a licensed pharmacist in an outsourcing facility qualify for exemptions from three sections of the FD&C Act: labeling with adequate directions for use of section 502(f)(1); FDA approval prior to marketing of section 505; and the Drug Supply Chain Security Act requirements in section 582 (21 U.S.C. 360eee-1).3You failed to meet the conditions of sections 503A and 503B of the FD&C Act.An example of an unapproved compounded ketamine drug product you offer for sale on www.ketaminestore.org is ketamine marketed as "Ketamine Troches." Evidence obtained from your website establishing that this product is a drug intended for human use (as defined in 21 CFR 201.128) includes the claim "Our pharmacy offers high-quality ketamine troches, also known as ketamine lozenges, which are designed for faster relief in the treatment of depression, anxiety . . . ."A second example of an unapproved compounded ketamine drug product you offer for sale on www.ketaminestore.org is esketamine marketed as "KETAMINE NASAL SPRAY." Evidence obtained from your website establishing that this product is a drug intended for human use (as defined in 21 CFR 201.128) includes the claim "Buy ketamine nasal spray, which is one of the most demanded forms of ketamine for the treatment of depression, anxiety . . . ."Your operation permits the purchase of "Ketamine Troches" and "KETAMINE NASAL SPRAY" that have not been compounded pursuant to a prescription. Receipt of prescriptions for individually identified patients for drug products compounded by licensed pharmacists in State-licensed pharmacies and Federal facilities, or by licensed physicians is a condition necessary to qualify for the exemptions under section 503A of the FD&C Act. In addition, your operation is not a registered outsourcing facility, and therefore, any drug products produced by your operation do not qualify for the exemptions under section 503B of the FD&C Act. Further, section 503B of the FD&C Act includes a condition that states a drug compounded by an outsourcing facility "will not be sold or transferred by an entity other than the outsourcing facility that compounded such drug."4 Because your “Ketamine Troches” and "KETAMINE NASAL SPRAY” do not meet the conditions of either section 503A or section 503B of the FD&C Act, they are not eligible for the exemptions of those sections, including FDA approval requirements of section 505 of the FD&C Act.There are no FDA-approved applications in effect for your “Ketamine Troches” and "KETAMINE NASAL SPRAY.” Under sections 505(a) and 301(d) of the FD&C Act a new drug may not be introduced into or delivered for introduction into interstate commerce unless an application approved by FDA under section 505 of the FD&C Act is in effect for the drug. Marketing of these products, or other applicable products, without an approved application violates these provisions of the FD&C Act.Misbranded Drug ViolationsA drug is misbranded under section 502(f)(1) of the FD&C Act if its labeling fails to bear adequate directions for use. "Adequate directions for use" means directions under which a layperson can use a drug safely and for the purposes for which it is intended (see 21 CFR 201.5). Prescription drugs, as defined in section 503(b)(1) of the FD&C Act include those that, because of their toxicity or other potentiality for harmful effect, or the method of their use, or the collateral measures necessary for their use, are not safe for use except under supervision of a practitioner licensed by law to administer them. Prescription drugs, as defined in section 503(b)(1)(A) of the FD&C Act (21 U.S.C. 353(b)(1)(A)), can be used safely only at the direction, and under the supervision, of a licensed practitioner.You failed to bear adequate directions for use on the labeling for these drug products that you have introduced into interstate commerce. Because the aforementioned drugs are prescription drugs intended for conditions that are not amenable to self-diagnosis and treatment by a layperson, adequate directions cannot be written such that a layperson can use the products safely for their intended use. Consequently, the labeling for these drug products fails to bear adequate directions for use, causing them to be misbranded under section 502(f)(1) of the FD&C Act. Because these drugs are not approved in the United States, they are also not exempt under 21 CFR 201.115(a) from the requirements of section 502(f)(1) of the FD&C Act. In addition, because your compounded drug products do not meet the conditions of sections 503A or 503B of the FD&C Act, they are also not exempt from section 502(f)(1) of the FD&C Act. By offering these drugs for sale to U.S. consumers, www.ketaminestore.org is causing the introduction of misbranded drugs into interstate commerce in violation of section 301(a) of the FD&C Act.Furthermore, under U.S. law, prescription drugs can be dispensed only pursuant to a prescription from a health care practitioner licensed by law to administer prescription drugs. By offering the aforementioned drug products without requiring a prescription, www.ketaminestore.org jeopardizes patient safety and misbrands the drug products under section 503(b)(1) of the FD&C Act. Dispensing a prescription drug without a prescription is an act which results in the drug being misbranded while held for sale, in violation of section 301(k) of the FD&C Act.ConclusionAs previously stated, you are responsible for investigating and determining the root causes of any violations and implementing corrective and preventative measures to ensure future and sustained compliance so that these violations and any others do not occur.Send your written response to FDAInternetPharmacyTaskForce-CDER@fda.hhs.gov within 15 business days of receipt of this letter. Include the specific steps you have taken to correct any violations, an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. Identify your written response with reference number “MARCS-CMS 725147” in the subject line of the email.If you have information that you believe demonstrates that your products are not in violation of the FD&C Act and FDA regulations, include that information for our consideration.If you are not located in the United States, please note that products that appear to be misbranded or unapproved new drugs may be detained or refused admission. We may advise the appropriate regulatory officials in the country from which you operate that your products referenced above appear to be unapproved and misbranded products that cannot be legally sold to consumers in the United States.Please note FDA posts warning letters on www.fda.gov.Sincerely,/S/Sangeeta Vaswani Chatterjee, PharmDDirectorOffice of Drug Security, Integrity, and ResponseOffice of ComplianceCenter for Drug Evaluation and ResearchU.S. Food and Drug Administration/S/Matthew J. Lash, JDActing DirectorOffice of Compounding Quality and ComplianceOffice of ComplianceCenter for Drug Evaluation and ResearchU.S. Food and Drug Administration____________________________1 REMS refers to a drug safety program that FDA can require for certain medications with serious safety concerns to help ensure the benefits of the medication outweigh its risks. See the Risk Evaluation and Mitigation Strategies website at https://www.fda.gov/drugs/drug-safety-and-availability/risk-evaluation-and-mitigation-strategies-rems.2 We remind you that there are conditions other than those discussed in this letter that must be satisfied to qualify for the exemptions in section 503A of the FD&C Act.3 We remind you that there are conditions, other than those discussed in this letter, that must be satisfied to qualify for the exemptions in section 503B of the FD&C Act.4 Section 503B(a)(8) of the FD&C Act (21 U.S.C. 353b(a)(8)) does not prohibit administration of the drug in a health care setting or dispensing a drug pursuant to a prescription executed in accordance with section 503(b)(1) of the FD&C Act.

Delivery Method:VIA ELECTRONIC MAIL READ/DELIVERY RECEIPT REQUESTEDProduct:DrugsRecipient:Keta Med Lab / www.ketamedlab.comUnited Statesinfo@ketamedlab.comIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesJune 23, 2026WARNING LETTERReference Number: MARCS-CMS 725154To Keta Med Lab:This warning letter advises you of significant violations identified during a U.S. Food and Drug Administration (FDA) review of your website www.ketamedlab.com. Promptly address the violations described herein without delay, including ensuring that appropriate resources are allocated to fully address the violations and prevent their recurrence. This is not intended to be an all-inclusive list of the violations that may exist in connection with your products or operations. It is your responsibility to ensure that you comply with all requirements of federal law, including FDA regulations. Failure to adequately address violations may result in regulatory or legal action without further notice including, without limitation, seizure and injunction.As discussed below, FDA has observed that www.ketamedlab.com introduces into interstate commerce unapproved and misbranded ketamine drug products, including certain drugs for which the FDA-approved version is an injectable or subject to a Risk Evaluation and Mitigation Strategy (REMS).1 FDA has identified significant risks associated with unapproved ketamine products, especially in the absence of appropriate medical supervision. Given the increased interest in the use of ketamine products, the easy availability of unapproved and misbranded ketamine products via the internet puts U.S. consumers at risk for serious adverse events. Furthermore, injectable drug products can pose a serious risk of harm to users because they bypass many of the body's natural defenses against toxic ingredients, toxins, or dangerous organisms that can lead to serious and life-threatening conditions such as septicemia or sepsis.There are also inherent risks to consumers who purchase unapproved new drugs and misbranded drugs. Unapproved new drugs do not carry the same assurances of safety and effectiveness as those drugs subject to FDA oversight. Drugs that have circumvented regulatory safeguards may be contaminated, counterfeit, contain varying amounts of active ingredients, or contain different ingredients altogether.Accordingly, FDA requests that www.ketamedlab.com cease offering any unapproved and misbranded drugs for sale to U.S. consumers. This is critical to shielding the American public from harm.FDA ReviewViolations were identified and documented during a review of your website www.ketamedlab.com, FDA Establishment Identifier (FEI) 3043543982, on February 26, 2026.Violations of the Federal Food, Drug, and Cosmetic ActOn your website at internet address www.ketamedlab.com, you introduce into interstate commerce misbranded and unapproved new drugs in violation of sections 301(a), 301(d), 301(k), 502(f)(1), 503(b)(1), and 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 331(a), 331(d), 331(k), 352(f)(1), 353(b)(1), and 355(a)).The following are violations identified during our review. As a reminder, this is not an all-inclusive list of violations that may exist in connection with your products or operations.Unapproved New Drug ViolationsCertain products offered for sale by www.ketamedlab.com are drugs within the meaning of section 201(g) of the FD&C Act (21 U.S.C. 321(g)) because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or because they are intended to affect the structure or function of the body. These drugs are also new drugs as defined by section 201(p) of the FD&C Act (21 U.S.C. 321(p)), because they are not generally recognized as safe and effective for their labeled uses. With certain exceptions not applicable here, new drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from FDA, as described in section 505(a) of the FD&C Act.You failed to obtain approved applications pursuant to section 505 of the FD&C Act (21 U.S.C. 355) for these products that you have introduced into interstate commerce. Accordingly, their introduction or delivery for introduction into interstate commerce violates sections 301(d) and 505(a) of the FD&C Act.An example of an unapproved ketamine drug product you offer for sale on www.ketamedlab.com is ketamine marketed as "Buy Ketamine Liquid Online." Evidence obtained from your website establishing that this product is a drug intended for human use (as defined in 21 Code of Federal Regulations (CFR) 201.128) includes the claim "Ketamine is most often used in veterinary medicine. In humans, it can induce and maintain general anesthesia before, during, and after surgery."A second example of an unapproved ketamine drug product you offer for sale on www.ketamedlab.com is ketamine marketed as "Break Free from Depression with Ketamine Troches." Evidence obtained from your website establishing that this product is a drug intended for human use (as defined in 21 CFR 201.128) includes the claim "Ketamine troches are gaining attention in mental health treatment. They offer a unique approach to managing depression."A third example of an unapproved ketamine drug product you offer for sale on www.ketamedlab.com is esketamine marketed as "Buy ketamine Nasal Spray." Evidence obtained from your website establishing that this product is a drug intended for human use (as defined in 21 CFR 201.128) includes the claims "Ketamine nasal spray is a treatment primarily used for individuals with treatment-resistant depression."While there are FDA-approved versions of ketamine drug products on the market in the United States, there are no approved drug applications pursuant to section 505 of the FD&C Act in effect for "Buy Ketamine Liquid Online," "Break Free from Depression with Ketamine Troches," and "Buy ketamine Nasal Spray" offered by www.ketamedlab.com.FDA-approved ketamine, including products marketed under the brand name KETALAR, is a Schedule III controlled substance. It is an intravenous or intramuscular injection indicated as a general anesthetic, including as a sole agent or as an adjunct to other anesthetic agents, for the induction of anesthesia and for diagnostic and surgical procedures. Ketamine is a racemic mixture consisting of two mirror image molecules, R- and S-ketamine (arketamine and esketamine, respectively). This product is only available pursuant to a prescription from a licensed practitioner. Ketamine is not FDA-approved for the treatment of any psychiatric disorder.FDA-approved esketamine, a ketamine derivative, is a Schedule III controlled substance marketed under the brand name SPRAVATO. It is a nasal spray indicated for treatment-resistant depression in adults and depressive symptoms in adults with major depressive disorder with acute suicidal ideation or behavior in conjunction with an oral antidepressant. Furthermore, FDA-approved SPRAVATO bears a boxed warning, commonly referred to as a "black box warning," which is the strongest warning FDA requires, indicating that the drug carries a significant risk of serious or even life-threatening adverse effects. The boxed warning addresses the risk for sedation, dissociation, and respiratory depression after administration; the potential for abuse and misuse; the increased risk of suicidal thoughts and behaviors in pediatric and young adult patients taking antidepressants; and the requirement that SPRAVATO be available only through a restricted program, the SPRAVATO REMS, because of the risks of serious adverse outcomes from sedation, dissociation, respiratory depression, abuse, and misuse. The SPRAVATO REMS requires SPRAVATO to be dispensed and administered in medically supervised health care settings that are certified in the REMS and monitor patients for a minimum of two hours following administration. In addition, pharmacies must be certified in the REMS and must only dispense SPRAVATO to health care settings that are certified in the program.Misbranded Drug ViolationsA drug is misbranded under section 502(f)(1) of the FD&C Act if its labeling fails to bear adequate directions for use. "Adequate directions for use" means directions under which a layperson can use a drug safely and for the purposes for which it is intended (see 21 CFR 201.5). Prescription drugs, as defined in section 503(b)(1) of the FD&C Act include those that, because of their toxicity or other potentiality for harmful effect, or the method of their use, or the collateral measures necessary for their use, are not safe for use except under supervision of a practitioner licensed by law to administer them. Prescription drugs, as defined in section 503(b)(1)(A) of the FD&C Act (21 U.S.C. 353(b)(1)(A)), can be used safely only at the direction, and under the supervision, of a licensed practitioner.You failed to bear adequate directions for use on the labeling for these drug products that you have introduced into interstate commerce. Because the aforementioned drugs are prescription drugs intended for conditions that are not amenable to self-diagnosis and treatment by a layperson, adequate directions cannot be written such that a layperson can use the products safely for their intended use. Consequently, the labeling for these drug products fails to bear adequate directions for use, causing them to be misbranded under section 502(f)(1) of the FD&C Act. Because these drugs are not approved in the United States, they are also not exempt under 21 CFR 201.115(a) from the requirements of section 502(f)(1) of the FD&C Act. By offering these drugs for sale to U.S. consumers, www.ketamedlab.com is causing the introduction of misbranded drugs into interstate commerce in violation of section 301(a) of the FD&C Act.Furthermore, under U.S. law, prescription drugs can be dispensed only pursuant to a prescription from a health care practitioner licensed by law to administer prescription drugs. By offering the aforementioned drug products without requiring a prescription, www.ketamedlab.com jeopardizes patient safety and misbrands the drug products under section 503(b)(1) of the FD&C Act. Dispensing a prescription drug without a prescription is an act which results in the drug being misbranded while held for sale, in violation of section 301(k) of the FD&C Act.ConclusionAs previously stated, you are responsible for investigating and determining the root causes of any violations and implementing corrective and preventative measures to ensure future and sustained compliance so that these violations and any others do not occur.Send your written response to FDAInternetPharmacyTaskForce-CDER@fda.hhs.gov within 15 business days of receipt of this letter. Include the specific steps you have taken to correct any violations, an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. Identify your written response with reference number “MARCS-CMS 725154” in the subject line of the email.If you have information that you believe demonstrates that your products are not in violation of the FD&C Act and FDA regulations, include that information for our consideration.If you are not located in the United States, please note that products that appear to be misbranded or unapproved new drugs may be detained or refused admission. We may advise the appropriate regulatory officials in the country from which you operate that your products referenced above appear to be unapproved and misbranded products that cannot be legally sold to consumers in the United States.Please note FDA posts warning letters on www.fda.gov.Sincerely,/S/Sangeeta Vaswani Chatterjee, PharmDDirectorOffice of Drug Security, Integrity, and ResponseOffice of ComplianceCenter for Drug Evaluation and ResearchU.S. Food and Drug Administration___________________________1 REMS refers to a drug safety program that FDA can require for certain medications with serious safety concerns to help ensure the benefits of the medication outweigh its risks. See the Risk Evaluation and Mitigation Strategies website at https://www.fda.gov/drugs/drug-safety-and-availability/risk-evaluation-and-mitigation-strategies-rems.

Delivery Method:VIA ELECTRONIC MAIL READ/DELIVERY RECEIPT REQUESTEDProduct:DrugsRecipient:Ket Plug / ketaminelab.org and buyketaminepowderonline.comUnited Statessale@ketaminelab.orgsale@buyketaminepowderonline.comIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesJune 23, 2026WARNING LETTERReference Number: MARCS-CMS 728919To Ket Plug:This warning letter advises you of significant violations observed during a U.S. Food and Drug Administration (FDA) review of your website www.buyketaminepowderonline.com (redirected from www.ketaminelab.org). Promptly address the violations described herein without delay, including ensuring that appropriate resources are allocated to fully address the violations and prevent their recurrence. This is not intended to be an all-inclusive list of the violations that may exist in connection with your products or operations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations. Failure to adequately address violations may result in regulatory or legal action without further notice including, without limitation, seizure and injunction.As discussed below, FDA has observed that www.buyketaminepowderonline.com introduces into interstate commerce an unapproved and misbranded ketamine drug product, which the FDA-approved version is an injectable or subject to a Risk Evaluation and Mitigation Strategy (REMS).1 FDA has identified significant risks associated with unapproved ketamine products, especially in the absence of appropriate medical supervision.2 Given the increased interest in the use of ketamine products, the easy availability of unapproved ketamine products via the internet puts U.S. consumers at risk for serious adverse events. Furthermore, injectable drug products can pose a serious risk of harm to users because they bypass many of the body's natural defenses against toxic ingredients, toxins, or dangerous organisms that can lead to serious and life-threatening conditions such as septicemia or sepsis.3There are also inherent risks to consumers who purchase unapproved new drugs and misbranded drugs. Unapproved new drugs do not carry the same assurances of safety and effectiveness as those drugs subject to FDA oversight. Drugs that have circumvented regulatory safeguards may be contaminated, counterfeit, contain varying amounts of active ingredients, or contain different ingredients altogether.Accordingly, FDA requests that www.buyketaminepowderonline.com cease offering any unapproved and misbranded drugs for sale to U.S. consumers. This is critical to shielding the American public from harm.FDA ReviewViolations were identified and documented during a review of your website www.buyketaminepowderonline.com, FDA Establishment Identifier (FEI) 3044408515, in April 2026. Based on our review, your ketamine powder is an unapproved new drug under section 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(a)). As explained further below, introducing or delivering this product for introduction into interstate commerce violates sections 301(d) (21 U.S.C. 331(d)) and 505(a) of the FD&C Act. Furthermore, your ketamine powder is a misbranded drug under section 502 of the FD&C Act (21 U.S.C. 352), and the introduction or delivering this product for introduction into interstate commerce violates section 301(a) of the FD&C Act (21 U.S.C. 331(a)).Violations of the Federal Food, Drug, and Cosmetic ActThe following are violations identified during our review. As a reminder, this is not an all-inclusive list of violations that may exist in connection with your products or operations.Unapproved New Drug ViolationsBased on a review of your website, your ketamine powder is a drug under section 201(g)(1) of the FD&C Act (21 U.S.C. 321(g)(1)), because it is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease, and/or intended to affect the structure or any function of the body.4 Examples from your website labeling that provide evidence of the intended use (as defined in 21 Code of Federal Regulations (CFR) 201.128) of this product as a drug include, but may not be limited to, the following:On the webpage www.buyketaminepowderonline.com:• “Neuroscience and Brain Function Research . . . Researchers use Ketamine to model dissociative states and altered neural connectivity, helping to explore cognition, perception, and consciousness at a molecular and systems level.”• “Psychiatric and Mood Disorder Research Models . . . Ketamine is frequently studied in preclinical and mechanistic research related to depression and mood regulation, particularly in examining rapid-onset neuroplastic changes.”Your ketamine powder is a “new drug” under section 201(p) of the FD&C Act (21 U.S.C. 321(p)), because it is not generally recognized as safe and effective (GRASE) for use under the conditions prescribed, recommended, or suggested in its labeling. 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. No approved drug applications pursuant to section 505 of the FD&C Act (21 U.S.C. 355), are in effect for this product. Accordingly, this product is an unapproved new drug. The introduction or delivery for introduction into interstate commerce of this unapproved new drug product violates sections 301(d) and 505(a) of the FD&C Act.Misbranded Drug ViolationsYour ketamine powder is also misbranded under section 502(f)(1) of the FD&C Act (21 U.S.C. 352(f)(1)), in that its labeling fails to bear adequate directions for its intended use(s). “Adequate directions for use” means directions under which a layman 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)), include those that, because of their toxicity or other potentiality for harmful effect, or the method of their use, or the collateral measures necessary for their use, are not safe for use except under the supervision of a practitioner licensed by law to administer them. Your ketamine powder is indicated for a condition that is not amenable to self-diagnosis and treatment by a layperson, therefore adequate directions cannot be written such that a layperson can use the product safely for its intended use. In addition, your ketamine powder is also a prescription drug as defined in section 503(b)(1)(A) of the FD&C Act, in light of its toxicity or potential for harmful effects, methods of use, or collateral measures necessary for its use. For these reasons, your ketamine powder is misbranded under section 502(f)(1) of the FD&C Act.The introduction, delivery for introduction, or causing the introduction or delivery for introduction into interstate commerce of this misbranded drug is a prohibited act under section 301(a) of the FD&C Act.ConclusionAs previously stated, you are responsible for investigating and determining the root causes of any violations and implementing corrective and preventative measures to ensure future and sustained compliance so that these violations and any others do not occur.Send your written response to FDAAdvisory@fda.hhs.gov within 15 business days of receipt of this letter. Include the specific steps you have taken to correct any violations, an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. Identify your response with reference number “MARCS-CMS 728919” in the subject line of the email.If you have information that you believe demonstrates that your product is not in violation of the FD&C Act and FDA regulations, include that information for our consideration.If you are not located in the United States, please note that products that appear to be misbranded or unapproved new drugs may be detained or refused admission. We may advise the appropriate regulatory officials in the country from which you operate that your products referenced above appear to be unapproved and misbranded products that cannot be legally sold to consumers in the United States.Please note FDA posts warning letters on www.fda.gov.Sincerely,/S/Tina Smith, MSCaptain, U.S. Public Health ServiceDirectorOffice of Unapproved Drugs and Labeling ComplianceOffice of ComplianceCenter for Drug Evaluation and ResearchU.S. Food and Drug Administration____________________________1 REMS refers to a drug safety program that FDA can require for certain medications with serious safety concerns to help ensure the benefits of the medication outweigh its risks. See the Risk Evaluation and Mitigation Strategies website at https://www.fda.gov/drugs/drug-safety-and-availability/risk-evaluation-and-mitigation-strategies-rems.2 FDA-approved esketamine, a ketamine derivative marketed under the brand name SPRAVATO, bears a boxed warning indicating that the drug carries a significant risk of serious or even life-threatening adverse effects. Additionally, it is required to be available only through a restricted program, the SPRAVATO REMS.3 FDA-approved ketamine, including products marketed under the brand name KETALAR, is an intravenous or intramuscular injection.4 Despite statements on your website labeling marketing your product “for research and scientific use” and “for non-clinical purposes,” evidence obtained from your website labeling establishes that your product is intended to be a drug for human use.

Product:Medical DevicesRecipient:David MehneyCEOSkytron, LLC5085 Corporate Exchange Blvd SEGrand Rapids, MI 49512United States(b)(6)@Skytron.comIssuing Office:Center for Devices and Radiological HealthUnited StatesWARNING LETTERMay 19, 2026Dear David Mehney,The United States Food and Drug Administration (FDA or agency) has learned that your firm is marketing the 1140 Sentry, 2280 Syndicate, 3200 Max and UV Smart D25 in the United States without marketing clearance or approval, in violation of the Federal Food, Drug, and Cosmetic Act (the Act).Under section 201(h) of the Act, 21 U.S.C. § 321(h), these products are devices because they are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body.FDA has reviewed your firm’s webpages at https://www.skytron.com/infection-prevention-technologies/, https://www.skytron.com/wp-content/uploads/documentation/UVC-Correctional-Disinfection-REV3-WEB.pdf and UV-Smart-D25-Brochure-WEB.pdf and has determined that the 1140 Sentry, 2280 Syndicate, 3200 Max, and UV Smart D25 devices are adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B), because your firm does not have an approved application for premarket approval (PMA) in effect pursuant to section 515(a) of the Act, 21 U.S.C. § 360e(a), or an approved application for an investigational device exemption (IDE) under section 520(g) of the Act, 21 U.S.C. § 360j(g) for the devices as described and marketed. The 1140 Sentry, 2280 Syndicate, 3200 Max, and UV Smart D25 devices are also misbranded under section 502(o) of the Act, 21 U.S.C. § 352(o), because your firm introduced or delivered for introduction into interstate commerce for commercial distribution these devices without submitting a premarket notification to FDA as required by section 510(k) of the Act, 21 U.S.C. § 360(k), and 21 CFR 807.81.The UV Smart D25 device is further misbranded under section 502(a) of the Act, 21 U.S.C. § 352(a) because of your misleading references, identified in the quoted statements below, to your firm’s registration. Your brochure for that device references that product’s FDA registration in the context of “use[] to clean non-invasive medical equipment,” which creates an impression of official FDA approval, clearance, authorization, or endorsement or other evaluation of your products that is misleading and constitutes misbranding. See 21 CFR 807.39. In addition, although there is a 510(k) exemption for medical washer-disinfector devices under 21 CFR 880.6992, which is the regulation (and product code MEC) under which you registered the UV Smart D25 device, the device is not exempt because it is not the type of device that is within the generic category of devices identified under § 880.6992. Generic devices of this type include functional steps that utilize mechanical processes to physically remove contamination from devices followed by a separate disinfection step, which can be either thermal or chemical. However, based on evidence obtained from your website, the UV Smart D25 is described as utilizing UVC to “clean non-invasive medical equipment.” However, we note that the device does not include a mechanical cleaning step, and disinfection is achieved utilizing non-ionizing UV-C radiation, with no mechanical action included. FDA has defined “cleaning” in this context as “the physical removal of soil and contaminants from an item”.1 In addition, FDA does not consider non-ionizing radiation to fall within the scope of “thermal or chemical” disinfection. As a result, the device fails to qualify for 510(k) exemption under 21 CFR 880.6992 because the device’s technology includes neither a mechanical cleaning nor disinfection step, which is different than medical washer-disinfector devices identified in 21 CFR 880.6992 under which you registered the device.For example, we reviewed your website on May 11, 2026 and it includes the following statements:Regarding the 1140 Sentry, 2280 Syndicate, and 3200 Max:“More Effective Disinfections - 5 Log Reduction Rate - Fewer Germs and Bacteria”“Whole-Room Disinfections - Includes shadowed surfaces - Disinfects all room surfaces”“Infection Prevention Technologies has the ideal UVC solution to fill the disinfection needs of any facility and budget. Industries we serve… Hospitals Serviced by Skytron”Regarding the UV Smart D25:“Achieves at least a log-4 reduction in the full spectrum of microorganisms”“FDA registered UVC device, ensures disinfection of non-invasive medical equipment”“Examples of Equipment that can be Disinfected - Infusion Pumps - Thermometers - Stethoscopes - Surveillance Monitoring Equipment - Blood Pressure Pumps - Pulse Oximeters - Telemetry Equipment - Glucose Meters…”“UV Smart, countertop rapid UVC Disinfector keep germs and viruses away from patients.”In addition, your UV Smart D25 Countertop UVC Disinfector brochure, UV-Smart-D25-Brochure-WEB.pdf, includes the following statements:“The UV Smart D25 disinfection system is the first FDA registered UVC device used to clean non-invasive medical equipment. The disinfection efficacy of the UV Smart D25 has been demonstrated and supported by numerous comprehensive studies conducted in clinical settings at academic medical centers and laboratories...”“Achieve ultimate UVC disinfection of your smaller medical belongings in less than 30 seconds. The UV Smart D25 is a simple-to-use solution to disinfect your hard to clean high-touch items like IV pumps, enteral feeding pumps, monitoring equipment, and thermometers...”“Advantages offered by the UV Smart D25• Automated and consistent disinfection cycle in less than 30 seconds saving working time• Validated, certified and supported by clinical research• Acts on full spectrum of resistant infection-causing microbes• Achieves at least a log-4 reduction in the full spectrum of microorganisms• FDA registered UVC device, ensures disinfection of non-invasive medical equipment…”“Examples of Equipment that can be Disinfected• Infusion Pumps• Thermometers• Stethoscopes• Surveillance Monitoring Equipment• Blood Pressure Pumps• Pulse Oximeters• Telemetry Equipment• Glucose Meters• Reflex Hammers• Comedone Expressors…”The brochure includes a table entitled, “UV Smart D25 Microbiological Efficacy Chart,” which purports to compare medically required reduction of particular microorganisms with the reduction accomplished through use of your device.Your firm has provided no evidence to FDA supporting the safety and effectiveness of these devices for use in disinfecting healthcare environments and/or medical device equipment, as applicable, for the protection of patients against infection or infection causing microbes. FDA is currently unaware of any literature that could support your claims regarding your devices’ functionality for these intended uses. The lack of evidence demonstrating the safety and effectiveness of these devices raise concerns related to potential harm to healthcare workers and patients following UV radiation or chemical byproduct exposure, including skin, eye, and respiratory damage, as well as the risk of patient cross-contamination resulting from inadequate microbial reduction due to device failure or insufficient microbicidal performance. Furthermore, there is a risk that UV radiation emitted by the device may compromise the material integrity of other semi-critical or critical devices in the space, potentially affecting their safety and performance.Correspondence with Skytron since February 2022, as described below, reflects ongoing FDA concern about Skytron’s marketing of the above-named devices.We informed you on February 12, 2022, via an It Has Come to Our Attention (IHCTOA) letter that it appeared that you were marketing your 1140 Sentry Single Emitter System, 3200 Max Single Emitter System, 2280 Syndicate Dual Emitter System, and UV Smart Countertop Rapid UVC Disinfector devices, in a manner that potentially violated the Act. You acknowledged receipt of the letter on February 14, 2022, and replied on April 1, 2022 and June 9, 2022, informing FDA of your intention to limit the statements to those relevant to environmental treatment not typically subject to FDA premarket review. A follow-up e-mail was sent to you on February 26, 2024, after a review of your website found statements showing that your devices were indicated for use in improving the terminal cleaning process for healthcare facilities, and pictures of these devices being used in healthcare spaces. You replied on March 4, 2024, informing us of your decision to remove any claims or images related to healthcare use. That email contained the following: “We’ve made the decision to remove any claims or images related to healthcare use of our 1140 Sentry Single Emitter System, 3200 Max Single Emitter System and 2280 Syndicate Dual Emitter System. This process should be finished within six months. I’ll update the group once this task is done. Feel free to reach out if you have any concerns in the meantime.”On July 1, 2024, we informed you that your website continues to include statements indicating that your 1140 Sentry Single Emitter System, 3200 Max Single Emitter System, and 2280 Syndicate Dual Emitter System products are intended for disease mitigation, disease prevention, risk reduction, health improvement and similar or related statements, including text, images and videos showing the use of your device in healthcare-related environments and for the decontamination of medical devices. We requested that you either remove these claims or submit a formal letter via e-mail by July 9, 2024, indicating that you planned to submit a 510(k) premarket notification by no later than July 31, 2024. You responded on July 5, 2024, stating that your website was updated to address FDA concerns. That email stated, “We have updated our website and removed the text, images, and videos as referenced in your email. Please review these changes and let us know of any further concerns.”However, as noted, as of May 11, 2026, your firm’s website, as well as other current marketing materials, include statements inconsistent with your July 5, 2024, statement to FDA regarding addressing the agency’s concerns. Your materials continue to promote your devices for unapproved medical uses in violation of the Act after you responded to the IHCTOA letter and interactive e-mails indicating that you were going to remove the healthcare use claims for these devices from your webpage.For medical devices requiring premarket approval, the notification required by section 510(k) of the Act, 21 U.S.C. § 360(k), is deemed satisfied when a PMA is pending before the agency in accordance with 21 CFR 807.81(b). The kind of information that your firm needs to submit in order to obtain approval or clearance for the device is described on the Internet at https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/default.htm. The FDA will evaluate the information that your firm submits and decide whether the product may be legally marketed.Our office requests that you cease any activities that result in the misbranding or adulteration of the 1140 Sentry, 2280 Syndicate, 3200 Max, and UV Smart D25 devices, such as the commercial distribution of the devices for the uses discussed above.Your firm should take prompt action to address any violations identified in this letter. Failure to promptly and adequately address this matter may result in regulatory action being initiated by the FDA without further notice. These actions include, but are not limited to, seizure, injunction, and civil money penalties.Other federal agencies may take your compliance with the Act and its implementing regulations into account when considering the award of federal contracts.Please notify this office in writing, within fifteen business days from the date you receive this letter, of the specific steps your firm has taken to correct the noted violation, as well as an explanation of how your firm plans to prevent the violation, or similar violation, from occurring again. Include documentation of the corrections and/or corrective actions (which must address systemic problems) your firm has taken. If your firm's planned corrections and/or corrective actions will occur over time, please include a timetable for implementation of those activities. If corrections and/or corrective actions cannot be completed within fifteen business days, state the reason for the delay and the time within which these activities will be completed. Your firm's response should be comprehensive and address all violations included in this Warning Letter. If you believe that your products are not in violation of the Act, please include your reasoning and any supporting information for our consideration as part of your response.Your firm's response should be sent to via email to Christopher Dugard at CDRHEnforcement@fda.hhs.gov. Please include 'CPT2401217’ in the subject line when replying. If you have any questions about the contents of this letter, please contact Stephen Anisko at stephen.anisko@fda.hhs.gov.Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your firm. It is your firm’s responsibility to ensure compliance with the applicable laws and regulations administered by FDA.Sincerely,/S/Anton E. Dmitriev, Ph.D.Acting DirectorOHT4: Office of Surgical and Infection Control DevicesOffice of Product Evaluation and QualityCenter for Devices and Radiological Health_________________1 See FDA Guidance, “Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling, Guidance for Industry and Food and Drug Administration Staff.”

Product:Medical DevicesRecipient:James M. Rynerson, M.D.Owner & PresidentBlephEx, LLC330 Franklin RoadSuite 135A, Box 117Brentwood, TN 37027-5252United States(b)(6)Issuing Office:Center for Devices and Radiological HealthUnited StatesJune 3, 2026WARNING LETTERCMS #725861Dear Dr. Rynerson:During an inspection of your firm located in Brentwood, TN from October 30, 2025, through November 19, 2025, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures the BlephEx Powered Eyelid Cleaning Sponge, the OptiVize Ophthalmic Battery-Powered Electrolysis Unit, and the OptiVize Ophthalmic Forceps. Under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 321(h), these products are devices because they are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body.Unapproved Device ViolationsBased on our review of the evidence collected during the inspection, your firm’s responses dated December 12, 2025, January 30, 2026, February 27, 2026, March 31, 2026, April 30, 2026, and May 29, 2026, and your firm’s website, www.blephex.com, we determined that the following products are adulterated and misbranded. Specifically:The BlephEx Powered Eyelid Cleaning Sponge is adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B), because your firm does not have an approved application for premarket approval (PMA) in effect pursuant to section 515(a) of the Act, 21 U.S.C. § 360e(a), or an approved application for an investigational device exemption (IDE) under section 520(g) of the Act, 21 U.S.C. § 360j(g) for the device as described and marketed. The BlephEx Powered Eyelid Cleaning Sponge is also misbranded under section 502(o) the Act, 21 U.S.C. § 352(o), because your firm introduced or delivered for introduction this device into interstate commerce for commercial distribution, intended for a use different from the intended use of a legally marketed device in the generic type of device described at 21 CFR 878.4820 without submitting a premarket notification to FDA as required by section 510(k) of the Act, 21 U.S.C. § 360(k), and 21 CFR 807.81(a).On July 7, 2017, your firm submitted a request to FDA for information regarding your “Eyelid Cleaning Product” under section 513(g) of the Act. In that request, your firm proposed, in part, that the Eyelid Cleaning Product be regulated under 21 CFR 878.4820 as a class I device exempt from 510(k) notification, specifying an indication for a “battery-operated [eyelid cleaning] device intended to provide power to operate a spinning micro-sponge that cleans the eyelids”. Your firm described the Eyelid Cleaning Product for “eyelid cleaning/hygiene, and not for the cure, treatment or mitigation of any disease or condition. The purpose of the eyelid cleaning product is to maintain hygiene as part of a healthy lifestyle that may help to reduce the risk of blepharitis and dry eye.” Further, your firm stated that the Eyelid Cleaning Product is not intended to be used as a treatment.On September 11, 2017, FDA responded to your firm. Based on the information provided, FDA believed that the Eyelid Cleaning Product falls within 21 CFR 878.4820, Surgical instrument motors and accessories/attachments (product code PYU) as a class I device exempt from premarket notification requirements of the Act, subject to the limitations under 21 CFR 878.9. The “Eyelid Cleaning Product” referenced in your firm’s July 7, 2017, correspondence has since been marketed as the BlephEx Powered Eyelid Cleaning Sponge.However, there is evidence that the BlephEx Powered Eyelid Cleaning Sponge is intended for uses that are different from those of legally marketed devices classified under 21 CFR 878.4820. Generic devices of this type include surgical instrument motors and accessories that are ACpowered, battery-powered, or air-powered devices intended for use during surgical procedures to provide power to operate various accessories or attachments to cut hard tissue or bone and soft tissue. They also include dermabrasion devices that do not cut hard or soft tissues. Devices under product code PYU are used by healthcare professionals to perform in-office cleaning of the eyelid margins and eyelashes.However, your firm is marketing the BlephEx Powered Eyelid Cleaning Sponge for use in treating the symptoms of blepharitis, dry eye disease, and for pre-cataract and pre-LASIK patients. Examples include the following videos from your firm’s website which instruct viewers to “[w]atch the following video to learn more about how the BlephEx® device is used in a professional clinical setting.” https://www.blephex.com/blephex-procedure.The BlephEx news story video describes the BlephEx Powered Eyelid Cleaning Sponge for “treating an irritating eye condition.” Further noting that, “[t]here is relief for people who suffer from blepharitis.” The video includes a testimonial from a patient diagnosed with blepharitis who is shown receiving a new “treatment option called BlephEx.”www.blephex.com/blephex-procedureIn the BlephEx procedure video featuring you in your capacity as President of BlephEx, LLC, you recommend the BlephEx Powered Eyelid Cleaning Sponge for “dry eye and blepharitis patients” (0:20-0:21/18:07), further stating that the device is used for “opening up the meibomian glands, [which means] we have better oils, therefore better vision.” (0:54 to 0:58/18:07). You also explain that BlephEx Powered Eyelid Cleaning Sponge is “[a]lso, for pre-cataract and pre-LASIK patients” (0:48-0:49/18:07).www.blephex.com/blephex-procedureYour firm appears to be marketing the BlephEx Powered Eyelid Cleaning Sponge device for use on specific vulnerable populations, including those with dry eye, blepharitis, pre-cataract, and pre-LASIK patients. Expanding the device's indications to these specific groups introduces significant, unverified safety concerns. Any eyelid procedure, including use of this device, risks inflammation, tissue injury, or abrasion around the eyelids. In patients with surgical wounds, these risks are compounded — potential eyelid injury or infection could provide a pathway for microbes to enter the eye or under a surgical flap, risking severe vision loss and ocular damage. Patients with dry eyes and blepharitis conditions, particularly in severe cases, often have highly inflamed skin and friable (fragile and easily damaged) tissue, making them more susceptible to tissue injury or post treatment reaction. These clinical concerns highlight that using this device on these specific populations carries unique risks that go beyond standard eyelid hygiene. Because there is evidence that the BlephEx Powered Eyelid Cleaning Sponge is intended for uses that are different from those of legally marketed devices classified under 21 CFR 878.4820, it exceeds the limitations described in 21 CFR 878.9(a) and is not exempt from premarket notification.The OptiVize Ophthalmic Battery-Powered Electrolysis Unit is adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B), because your firm does not have an approved application for premarket approval (PMA) in effect pursuant to section 515(a) of the Act, 21 U.S.C. § 360e(a), or an approved application for an investigational device exemption (IDE) under section 520(g) of the Act, 21 U.S.C. § 360j(g) for the device as described and marketed. The OptiVize Ophthalmic Battery-Powered Electrolysis Unit is also misbranded under section 502(o) the Act, 21 U.S.C. § 352(o), because your firm introduced or delivered for introduction this device into interstate commerce for commercial distribution, intended for a use different from the intended use of a legally marketed device in the generic type of device described at 21 CFR 886.4250, Ophthalmic electrolysis unit, without submitting a premarket notification to FDA as required by section 510(k) of the Act, 21 U.S.C. § 360(k), and 21 CFR 807.81(a).Devices classified under 21 CFR 886.4250, Ophthalmic electrolysis unit, are exempt from premarket notification unless they exceed the limitations on exemption at 21 CFR 886.9(a). However, there is evidence that the OptiVize Ophthalmic Battery-Powered Electrolysis Unit is intended for uses that are different from those of legally marketed devices classified under 21 CFR 886.4250. Generic devices of this type are intended to destroy ocular hair follicles by applying a galvanic electrical current. However, your firm is marketing the OptiVize Ophthalmic Battery-Powered Electrolysis Unit for a different intended use. Examples include:“…destruction of biofilm within ocular hair follicles” https://www.blephex.com/optivize“…blows biofilm off the inside of the tiny meibomian oil-making sacs, converting it into millions of tiny protein-polysaccharide particles that are then ready for the next step”www.blephex.com/product/optivize?p=LSomq8aij2hbmHFRi“…completely vaporize biofilm lurking in any structure within the eyelid”www.blephex.com/product/optivize?p=LSomq8aij2hbmHFRiIn addition, your firm is marketing the OptiVize Ophthalmic Battery-Powered Electrolysis Unit using different fundamental scientific technology. Examples include:“…delivers a precise harmonic waveform via a painless electric current to completely vaporize biofilm lurking in any structure within the eyelid”www.blephex.com/product/optivize?p=LSomq8aij2hbmHFRi“…utilizes heated expression forceps”www.blephex.com/product/optivize?p=LSomq8aij2hbmHFRiThe claims of “destruction of biofilm within ocular hair follicles” and “blows biofilm off the inside of the tiny meibomian oil-making sacs, converting it into millions of tiny protein-polysaccharide particles that are then ready for the next step” represent a different intended use from that of an Ophthalmic electrolysis unit under 21 CFR 886.4250. In addition, the OptiVize Ophthalmic Battery-Powered Electrolysis Unit uses a fundamental scientific technology different from that of an Ophthalmic electrolysis unit under 21 CFR 886.4250. Specifically, the Ophthalmic electrolysis unit under 21 CFR 886.4250 uses a galvanic electrical current, whereas the OptiVize unit delivers a precise harmonic waveform.Lastly, the OptiVize Ophthalmic Battery-Powered Electrolysis Unit uses a mode of action different from that of the Ophthalmic electrolysis units. The OptiVize Ophthalmic Battery-Powered Electrolysis Units destroy hair follicles by inserting a needle into the meibomian gland and turning on a galvanic current. This passes an electrical current through the lash root to destroy the follicle. The OptiVize Ophthalmic Battery-Powered Electrolysis Unit delivers the harmonic waveform current through a specially designed eyelid shelf conduction plate. Because the OptiVize Ophthalmic Battery-Powered Electrolysis Unit is intended for uses that are different from those of legally marketed devices classified under 21 CFR 886.4250, it exceeds the limitations described in 21 CFR 886.9(a) and 21 CFR 886.9(b) and is not exempt from premarket notification.The OptiVize Ophthalmic Forceps is adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B), because your firm does not have an approved application for premarket approval (PMA) in effect pursuant to section 515(a) of the Act, 21 U.S.C. § 360e(a), or an approved application for an investigational device exemption (IDE) under section 520(g) of the Act, 21 U.S.C. § 360j(g) for the device as described and marketed. The OptiVize Ophthalmic Forceps is also misbranded under section 502(o) the Act, 21 U.S.C. § 352(o), because your firm introduced or delivered for introduction into interstate commerce for commercial distribution this device intended for a use different from the intended use of a legally marketed device in the generic type of device described at 21 CFR 886.4350 - Manual ophthalmic surgical instrument without submitting a premarket notification to FDA as required by section 510(k) of the Act, 21 U.S.C. § 360(k), and 21 CFR 807.81(a).Devices classified under 21 CFR 886.4350 – Manual ophthalmic surgical instrument are exempt from premarket notification unless they exceed the limitations on exemption at 21 CFR 886.9(a).However, there is evidence that the OptiVize Ophthalmic Forceps is intended for uses that are different from those of legally marketed devices classified under 21 CFR 886.4350 - Manual ophthalmic surgical instrument. Generic devices of this type are nonpowered, handheld devices intended to aid or perform ophthalmic surgical procedures. However, your firm is marketing the OptiVize Ophthalmic Forceps for a different intended use, namely, to clear the meibomian glands of sludge and accumulated bacteria and their inflammatory destructive toxins. Example includes:“VIBRATORY EXPRESSION - OptiVize utilizes heated expression forceps unlike anything on the market. Over the years, meibomian oil is acted upon by bacterial toxins and enzymatically converted into a more stable food source for themselves…a thickened obstructive paste or sludge. By adding vibration to the expression procedure, this sludge is now more effectively removed from inside the meibomian glands, along with accumulated bacteria and their inflammatory destructive toxins.”www.blephex.com/product/optivize?p=LSomq8aij2hbmHFRiIn addition, the OptiVize Ophthalmic Forceps use a mode of action different from that of a manual ophthalmic surgical instrument, namely, the OptiVize Ophthalmic Forceps uses heat and vibration for expression. The use of heat and vibration in the OptiVize Ophthalmic Forceps is an intended use different from that for manual ophthalmic surgical instruments under 21 CFR 886.4350; it therefore exceeds the limitations described in 21 CFR 886.9(a) and is not exempt from premarket notification.For a device requiring premarket approval, the notification required by section 510(k) of the Act, 21 U.S.C. § 360(k), is deemed satisfied when a PMA is pending before the agency. 21 CFR 807.81(b). The kind of information that your firm needs to submit in order to obtain approval or clearance for the device is described on the Internet at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/default.htm. The FDA will evaluate the information that your firm submits and decide whether the product may be legally marketed.Our office requests that BlephEx, LLC cease any activities that result in the misbranding or adulteration of the BlephEx Powered Eyelid Cleaning Sponge, OptiVize Ophthalmic Battery-Powered Electrolysis Unit, and OptiVize Ophthalmic Forceps, such as the commercial distribution of the device for the uses discussed above.Corrections and Removals ViolationOur inspection also revealed that your firm’s BlephEx Powered Eyelid Cleaning Sponge devices are misbranded under section 502(t)(2) of the Act, 21 U.S.C. § 352(t)(2), in that your firm failed or refused to furnish material or information respecting the device that is required by or under section 519 of the Act, 21 U.S.C. § 360i, and 21 CFR Part 806 – Medical Devices; Reports of Corrections and Removals. Significant violations include, but are not limited to, the following:Failure to submit a Report required by 21 CFR 806.10 to FDA, within 10 working days of initiating the correction or removal. For example: you discovered that your BlephEx Powered Eyelid Cleaning Sponge handpiece or “Type G” charger in the (b)(4) or (b)(4) emitted smoke or blew up. To reduce the incidence of these problems, in October 2024 your firm sent USB-A chargers to your distributor in (b)(4) with instructions for distribution to their customers to discontinue use of the original Type G charger assemblies. FDA has determined that a handpiece or charger smoking or blowing up presents a risk to health.This action is a medical device correction or removal initiated to reduce a risk to health posed by the BlephEx Powered Eyelid Cleaning Sponge device or to remedy a violation of the Act caused by the device which may present a risk to health, for which you are required to submit a Report of Correction or Removal to FDA. As of November 19, 2025, you did not submit a Medical Device Report of Correction or Removal to FDA for this action.Your firm’s responses to the FDA-483, dated December 12, 2025, January 30, 2026, and February 27, 2026, are not adequate. The responses explain your action and include MDR Reports for those complaints. You have not submitted a Report of Correction or Removal to FDA as of May 8, 2026.Submitting Required Information to GUDIDThe Blephex Powered Eyelid Cleaning Sponge, the OptiVize Ophthalmic Battery-Powered Electrolysis Unit, and the OptiVize Ophthalmic Forceps are misbranded within the meaning of section 502(t)(2) of the Act, 21 U.S.C. § 352(t)(2), in that there was a failure or refusal to furnish any material or information required by or under section 519 of the Act, 21 U.S.C. § 360i, respecting these devices. In particular, 21 CFR 801.20(a) requires, with exceptions not relevant here, that the label and device package of every medical device bear a unique device identifier (UDI) that meets the requirements of 21 CFR Part 801, subpart B, and 21 CFR Part 830. Also, 21 CFR 830.300(a) and 830.320(b) – both of which were promulgated under section 519 of the Act, among other provisions – require that the labeler of a device submit electronically to FDA’s Global Unique Device Identification Database (GUDID) the information required by 21 CFR Part 830, subpart E, for each version or model required to bear a UDI.FDA has determined that BlephEx, LLC is a “labeler” within the meaning of 21 CFR 830.3 and has not submitted to GUDID information required by 21 CFR Part 830, subpart E, respecting these devices. BlephEx, LLC causes labels to be applied to these device with the intent that they will be commercially distributed without any subsequent replacement or modification of the label and/or causes the labels of these devices to be replaced or modified with the intent that the devices will be commercially distributed without any subsequent replacement or modification of the label (except that the addition of the name of, and contact information for, a person who distributes the device, without making any other changes to the label, is not a modification for the purposes of determining whether a person is a labeler).The failure or refusal to furnish any notification or other material or information required by or under section 519 of the Act, 21 U.S.C. § 360i, also constitutes a prohibited act under section 301(q)(1)(B) of the Act, 21 U.S.C. § 331(q)(1)(B).Quality System Regulation ViolationsThis inspection also revealed that these devices are adulterated within the meaning of section 501(h) of the Act, 21 U.S.C. § 351(h), in that the methods used in, or the facilities or controls used for, their manufacture, packing, storage, or installation are not in conformity with the current good manufacturing practice requirements of the Quality System regulation found at Title 21, Code of Federal Regulations (CFR), Part 820. We received responses from Ryan J. Peterson, Vice President, Operations dated December 12, 2025, January 30, 2026, February 27, 2026, March 31, 2026, April 30, 2026, and May 29, 2026, concerning our investigator’s observations noted on the Form FDA 483 (FDA 483), List of Inspectional Observations, that was issued to your firm. We address the responses below, in relation to each of the noted violations. The violations found during the inspection include, but are not limited to, the following:1. Failure to establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit as required by 21 CFR 820.198(a). Specifically, your firm's Complaint Handling Procedure, Complaint RMA Procedure, Revision 01, is inadequate and not fully implemented for the review, evaluation, and investigation of one hundred and seventy-seven plus (177+) complaints received involving the BlephEx Powered Eyelid Cleaning Sponge product. For example:a) Your firm did not ensure complaints are processed in a uniform and timely manner, as required by 21 CFR 820.198(a)(1). Your firm's Complaint Log, used as the primary document to record complaints received by your firm, is an uncontrolled record that isomitted from your firm's complaint handling procedure. The log records 177+ complaints as opened but does not document when the complaints are closed, as required by Section 6.17 of your firm's complaint procedure.b) Your firm does not maintain and make it readily available for review the BlephEx Complaint RMA forms, required by Section 6.2 of your firm's complaint procedure, to capture detailed information for complaints received by your firm [21 CFR 820.198(a)(2)]. During the inspection, your firm’s VP of Operations confirmed that no detailed complaint records existed for each of the 177+ complaints received.c) Your firm's complaint procedure does not require documentation of the rationale and responsible party when investigations are not conducted, as required by 21 CFR 820.198(b). Your firm’s VP of Operations maintains the Complaint Log as the only record of complaints received by your firm. This log lacks evidence of review and evaluation to determine whether investigations are needed. None of the 177+ complaints include justification for decisions not to investigate or identification of responsible individuals.d) None of the 177+ complaints documented in your firm’s Complaint Log are documented as reviewed, evaluated, investigated, or maintained in a separate complaint file for MDR reporting, as required by 21 CFR 820.198(d). Your firm's complaint procedure, Section 6.15, requires all complaints that represent a reportable event under the MDR regulation must be promptly reviewed, evaluated, and investigated by a designated individual and maintained in a separate complaint file. Specific examples that fail to comply with this requirement included:i) Serial Number (b)(4) (9/9/2024): handpiece "blew up" - not evaluated for reportabilityii) Serial Number (b)(4) (2/14/2025): handpiece "blew up" - not evaluated for reportabilityiii) Serial Number (b)(4) (1/21/2025): handpiece "began smoking" - not evaluated for reportabilityThis is a repeat violation cited on the Form FDA 483, issued for the previous March 27–28, 2019 inspection.We reviewed your firm's responses and concluded they are not adequate. Your firm failed to review and evaluate 100% of complaints over a (b)(4) failed to investigate serious device malfunctions, and failed to report potentially life-threatening events to FDA in a timely manner—these concerns have not been adequately addressed through your corrective actions, and you have not demonstrated that your quality system can now reliably identify, investigate, and report device-related safety issues as required by 21 CFR 820.198 and 21 CFR Part 803.Your responses indicate implementation of a new Complaint Handling Procedure (CAPA-102-01) and Medical Device Reporting Procedure (CAPA-103-01) and completion of associated training, yet critical deficiencies remain unaddressed 191 days after the inspection closeout. Your April 30, 2026, fourth update indicated that complaint investigations and complaint file remediation had been completed as of April 30, 2026. Your May 29, 2026, fifth update provides no new information and confirms only that all action items from the fourth update remain in progress. You have not provided documentation of the review results, investigation findings, or remediated complaint files to demonstrate what corrective actions were taken, how many additional reportable events were identified beyond the original three, whether additional MDRs were submitted, or how complaint files were remediated to meet regulatory requirements. CAPAs 26-001 and 26-002 remain in the implementation phase with no details provided regarding root cause findings or specific corrective actions being implemented. You have not provided evidence that your new complaint handling procedures are being implemented in practice for newly received complaints, such as sample complaint records created using the new Complaint Form (CF-111-01), documentation of MDR evaluations being performed, or evidence that investigations are being conducted with appropriate justifications when not required.2. Failure to establish and maintain procedures for implementing corrective and preventive action, as required by 21 CFR 820.100(a), and failure to document corrective and preventive action activities and results, as required by 21 CFR 820.100(b). Specifically, your firm's Corrective and Preventive Action Procedure, CAPA-101-01, has not been implemented for the issuance, logging, tracking, and execution of corrective and preventive actions (CAPAs), as required by the procedure. Your firm failed to analyze 177+ complaints received between (b)(4) involving the BlephEx Powered Eyelid Cleaning Sponge product, as documented in your firm's Complaint Log, which included failures of the "handpiece" that overheated, smoked, or "blew up." During the inspection, your firm's VP of Operations confirmed that no CAPA had been opened since August 2023 and was unaware of any CAPAs that had been opened prior to that date. The VP of Operations acknowledged that your firm did not follow its written CAPA procedure, which requires documentation of investigations per Section 6.5, verification or validation of corrective actions per Section 6.8, and other CAPA activities, and indicated to our investigator an unawareness of your firm's CAPA procedure until the inspection was pre-announced. For example, your firm failed to open a CAPA per your CAPA procedure, Sections 2., 6.1., and 6.1.6., to investigate the root cause, document the corrective action taken, and verify or validate that the corrective action was effective and did not adversely affect the finished device. Your firm replaced (b)(4) Type G power chargers with USB-A chargers in October 2024 in response to handpiece failures; however, your firm did not document this corrective action, did not conduct and document a root cause investigation to determine why the chargers failed, and did not verify or validate that the replacement chargers addressed the underlying problem or were safe and effective before distributing them to customers.We reviewed your firm's responses and concluded they are not adequate. Your firm failed to document any CAPA activities despite serious device malfunctions requiring investigation, corrective action, and verification—these concerns have not been adequately addressed, and you have not demonstrated that your quality system can now reliably identify, investigate, correct, and prevent recurrence of quality problems as required by 21 CFR 820.100.Your responses indicate implementation of a new Corrective and Preventive Action Procedure (CAPA-101-01) on December 11, 2025, and completion of associated training, yet critical deficiencies remain unaddressed 191 days after the inspection closeout. CAPA 26-003, which you committed to open on your December 12, 2025, initial response to investigate the root cause of your failure to document CAPA activities and results, was not opened until February 22, 2026 — 95 days after the inspection closeout. Your April 30, 2026, fourth update indicated CAPA 26-003 had advanced to the effectiveness monitoring phase. Your May 29, 2026, fifth update provides no new information and confirms only that all action items from the fourth update remain in progress, with no update to CAPA 26-003's status, findings, or effectiveness monitoring results provided. You have not provided any retrospective CAPA documentation for the handpiece failures documented in your Complaint Log, where devices overheated, smoked, or "blew up" between (b)(4). Specifically, you have not provided a documented investigation into the root cause of the Type G charger failures that resulted in handpiece malfunctions, nor have you provided verification or validation that the USB charger replacement implemented in October 2024 is effective and safe. Your firm replaced (b)(4) Type G chargers in October 2024, yet as of May 29, 2026 — approximately 19 months after this corrective action and 191 days after the inspection closeout — you have not demonstrated through CAPA documentation that the root cause of the handpiece failures was properly investigated, that your corrective action addresses the root cause, or that the replacement chargers have been verified or validated to ensure they are safe, effective, and do not adversely affect the finished device. You have not provided evidence that your new CAPA procedure is being implemented in practice, such as sample CAPA records demonstrating that quality data from your 177+ documented complaints is being analyzed to identify nonconforming products or quality problems, or that CAPAs are being opened appropriately for ongoing quality issues.3. Failure to establish and maintain procedures to control the design of the device in order to ensure that specified design requirements are met, as required by 21 CFR 820.30(a), and failure to establish and maintain procedures for the identification, documentation, validation or verification, review, and approval of design changes before their implementation, as required by 21 CFR 820.30(i). Specifically, your firm has not established and does not maintain design control procedures, as required by 21 CFR 820.30(a). During the inspection, your firm's VP of Operations confirmed that your firm does not have design control procedures for the BlephEx Powered Eyelid Cleaning Sponge, the OptiVize Ophthalmic Battery-Powered Electrolysis Unit, and the OptiVize Ophthalmic Forceps, to control the design of the devices to ensure that specified design requirements are met.Your firm's VP of Operations also confirmed that your firm does not have design change control procedures to document, verify or validate, review, and approve design changes before implementation, as required by 21 CFR 820.30(i). Your firm changed the power chargers for the BlephEx Powered Eyelid Cleaning Sponge product from Type G plugs to USB-A configuration in October 2024. Your firm did not verify or validate that the change addressed the underlying problem that caused the "handpiece" to overheat, smoke, or "blow up", as documented in the Complaint Log, and did not verify that the design change did not adversely affect the finished device before implementing the change and distributing (b)(4) replacement chargers to customers. Your firm’s VP of Operations acknowledged to our investigator that the change was agreed upon by your firm’s management and your firm's supplier, and that your supplier made the changes to the device but could not produce written documentation of any communications or correspondence regarding this design change.We reviewed your firm's responses and concluded they are not adequate. Your firm's lack of design control procedures and design change control procedures and lack of documented or validated design changes affecting device safety remain unaddressed.Your firm continues to dispute that design control procedures are required for the BlephEx Powered Eyelid Cleaning Sponge, the OptiVize Ophthalmic Battery-Powered Electrolysis Unit, and the OptiVize Ophthalmic Forceps. However, as outlined above, we have determined and provided rationale that the devices are not Class I, 510(k)-exempt devices and therefore are subject to design control requirements under 21 CFR 820.30(a)(1). Your May 29, 2026, fifth update provides no new information and confirms only that all action items from the fourth update remain in progress, with no evidence provided that design control or design change control procedures have been established, that Design History Files have been created, or that website revisions have been documented. Your firm has not established design change control procedures as required by 21 CFR 820.30(i). Your firm made a design change from Type G to USB chargers for the BlephEx Powered Eyelid Cleaning Sponge in October 2024 in response to serious device malfunctions documented in your Complaint Log, yet you did not document this design change, did not verify or validate the change before implementation, and did not establish procedures for the identification, documentation, validation or verification, review, and approval of design changes before their implementation. As of May 29, 2026, 191 days after the inspection closeout and approximately 19 months after implementing the charger design change, you have not provided documentation or validation of this change, leaving unresolved questions about whether the replacement chargers adequately address the root cause of the failures and whether they are safe and effective.4. Failure to adequately establish and maintain the requirements, including quality requirements, that must be met by suppliers, contractors, and consultants, as required by 21 CFR 820.50(a). Specifically, your firm's Supplier Qualification Procedure, RAQA-101-01, has not been implemented. Your firm manufactures, promotes, and distributes the BlephEx Powered Eyelid Cleaning Sponge and bottle(s) of BlephEx Lid Cleanser used exclusively with the BlephEx handpiece and manufactured by your firm's contract manufacturer. Your firm's supplier qualification procedure, Section 6.7.1, requires that to qualify a contract manufacturer, the supplier file must contain, at a minimum, a Quality Agreement. Your firm's VP of Operations stated that your firm had no quality agreement for the manufacturer of the BlephEx Lid Cleanser. The VP of Operations acknowledged that your firm was not following its Supplier Qualification Procedure.We reviewed your firm's responses and concluded they are not adequate. Your firm's lack of defined controls over a product distributed with your medical device remains unresolved, and you have not provided evidence of compliance with 21 CFR 820.50(a)(2) or your own supplier qualification procedures and newly implemented Purchasing and Supplier Management Procedure.Your firm committed to entering into a supplier agreement with the manufacturer of the BlephEx Lid Cleanser by February 28, 2026. Your February 27, 2026, second update indicated this action remained "in progress" one day before the deadline. Your March 31, 2026, third update indicated the supplier agreement remained "in progress," 31 days after the missed deadline. Your April 30, 2026, fourth update indicated the supplier agreement was completed on April 29, 2026, 60 days after your missed deadline and 162 days after the inspection closeout. Your May 29, 2026, fifth update provides no new information and confirms only that all action items from the fourth update remain in progress. You have not provided a copy of the executed supplier agreement or evidence demonstrating how you now ensure that the BlephEx Lid Cleanser is being produced correctly and reproducibly under adequate quality controls, or how you control the responsibilities between your firm and the manufacturer. Your firm implemented a new Purchasing and Supplier Management Procedure (QM-02-010-02) on February 26, 2026, which requires Quality Agreements for high-risk suppliers, including contract manufacturing suppliers performing product realization operations, yet you did not establish a quality agreement with the BlephEx Lid Cleanser manufacturer until 60 days after your committed deadline. Your firm has distributed the BlephEx Lid Cleanser with your devices for more than six months after the inspection without adequate quality controls over a product placed in or near patients' eyes.5. Failure to establish and maintain procedures to ensure that device history records (DHRs) for each batch, lot, or unit are maintained to demonstrate that the device is manufactured in accordance with the device master record (DMR) and the requirements of this part, as required by 21 CFR 820.184. Specifically, your firm has not established and does not maintain DHR procedures and records for BlephEx Powered Eyelid Cleaning Sponge the OptiVize Ophthalmic Battery-Powered Electrolysis Unit, and the OptiVize Ophthalmic Forceps. During the inspection, your firm’s VP of Operations confirmed that your firm did not have DHR procedures or the DHRs for the BlephEx and OptiVize devices manufactured and distributed.We reviewed your firm's responses and concluded they are not adequate. As of March 31, 2026, you have not demonstrated compliance with 21 CFR 820.184 requirements for device history records, have not verified through audits that your contract manufacturers are maintaining adequate DHRs, and have not provided evidence that you can access DHRs when needed for complaint investigations, MDR evaluations, or quality system oversight.Your responses indicate implementation of a new Purchasing and Supplier Management Procedure (QM-02-010-02) on February 26, 2026, and completion of associated training, yet critical deficiencies remain unaddressed 191 days after the inspection closeout. Your April 30, 2026, fourth update confirmed that your firm is no longer using the services of one of your contract manufacturers. Your May 29, 2026, fifth update provides no new information and confirms only that all action items from the fourth update remain in progress. The review and update of the Supplier Quality Agreement with your active contract manufacturer remains "in progress," 90 days after your missed self-imposed deadline of February 28, 2026, and 191 days after the inspection closeout, with no updated agreement provided. CAPA 26-004 remains in the investigation phase with no details provided regarding investigation findings or determination of possible root cause. Your audits of your contract manufacturer remain "in progress," 59 days after the target completion date of March 31, 2026, with no audit reports, findings, or verification that the manufacturers are maintaining adequate Device History Records provided. You have not provided sample DHRs to demonstrate that these records exist and contain the required information specified in 21 CFR 820.184 or are accessible to your firm. Your new Purchasing and Supplier Management Procedure addresses supplier management generally but does not establish your firm's own procedures for ensuring DHRs are maintained and accessible, does not specify what DHR information your firm must obtain and maintain, and does not address how you will verify that devices are manufactured in accordance with specifications, particularly given the serious BlephEx handpiece malfunctions documented in your Complaint Log.6. Failure to establish and maintain procedures for identifying training needs and ensure that all personnel are trained to adequately perform their assigned responsibilities, as required by 21 CFR 820.25(b). Specifically, during the inspection, your firm’s VP of Operations confirmed that your firm did not have a training procedure and did not have training records. The VP of Operations affirmed that prior to the inspection being preannounced, he was unaware of the firm's quality system, including the complaint handling procedure, CAPA procedure, and other quality system requirements, despite being responsible for overseeing the quality system since August 2023.We reviewed your firm's responses and concluded they are not adequate. Your responses have not included competence assessments for personnel performing quality-critical functions, have not verified training effectiveness beyond attendance documentation, and have not demonstrated that trained personnel are now competently performing their assigned quality system responsibilities as required by 21 CFR 820.25(b). While your firm has demonstrated the ability to conduct and document training on procedures created after the inspection, you have not provided evidence of your firm's retroactive review of training to address the 26-month period (August 2023 through October 2025) during which your VP of Operations was responsible for your quality system without receiving any training on quality system requirements.Your April 30, 2026, fourth update indicated CAPA 26-005 had advanced to the effectiveness monitoring phase 68 days after being opened on February 22, 2026. Your May 29, 2026, fifth update provides no new information and confirms only that all action items from the fourth update remain in progress, with no update to CAPA 26-005's effectiveness monitoring results, root cause findings, or corrective actions implemented provided. CAPA 26-005 was not opened until 95 days after the inspection closeout and, despite advancing to effectiveness monitoring, you have not provided determination of the possible root cause of why your VP of Operations, who was responsible for the quality system since August 2023, operated for 26 months without training on quality system requirements, directly contributing to the systemic failures documented across multiple observations. Your firm must provide evidence that personnel responsible for quality system functions possess the necessary competence through appropriate education, training, skills, and experience, and must verify that training provided has resulted in the ability to adequately perform assigned responsibilities.7. Failure to establish procedures for quality audits and conduct such audits to assure that the quality system is in compliance with the established quality system requirements, as required by 21 CFR 820.22. Specifically, during the inspection, your firm's VP of Operations confirmed that your firm does not maintain established quality audit procedures for conducting quality audits. The VP of Operations also confirmed that your firm has not audited your firm's contract manufacturers, and that your firm's quality system has not been audited since your VP of Operations accepted the position with the company in August 2023 (27+ months prior).We reviewed your firm's responses and concluded they are not adequate. Your firm has not conducted quality audits to verify compliance with established quality system requirements or determine the effectiveness of your quality system, as required by 21 CFR 820.22. This critical deficiency remains unresolved. You have not demonstrated that your quality system includes the oversight mechanism required by 21 CFR 820.22, to systematically identify and correct quality system deficiencies before they result in nonconforming products or regulatory violations.Your responses indicate implementation of a Quality Audit Procedure (QM-02-024-01) on January 29, 2026, and completion of associated training, yet critical deficiencies remain unaddressed 191 days after the inspection closeout. Your April 30, 2026, fourth update indicated CAPA 26-006 had advanced to the implementation phase 68 days after being opened on February 22, 2026. Your May 29, 2026, fifth update provides no new information and confirms only that all action items from the fourth update remain in progress, with no audit schedule, audit reports, audit findings, investigation findings, root cause analysis, or specific corrective actions being implemented provided. Your audits of contract manufacturers remain "in progress," 59 days after the target completion date of March 31, 2026, and 191 days after the inspection closeout, with no audit reports, findings, or verification that the manufacturers are maintaining adequate quality systems or device history records provided. You have not conducted any internal audits of your quality management system 120 days after implementing the Quality Audit Procedure. You have not provided an audit schedule, audit reports, audit findings, or evidence that your quality audit procedure is being implemented in practice. Your firm has not verified through audits that your contract manufacturers are maintaining adequate quality systems, device history records, or conducting proper device testing despite the serious charger malfunctions documented in your Complaint Log that occurred in 2024 and 2025. The fundamental requirement of 21 CFR 820.22 to "conduct such audits" remains unmet.Your firm should take prompt action to address any violations identified in this letter. Failure to adequately address this matter may result in regulatory action being initiated by the FDA without further notice. These actions include, but are not limited to, seizure, injunction, and civil money penalties.Other federal agencies may take your compliance with the FD&C Act and its implementing regulations into account when considering the award of federal contracts. Additionally, should FDA determine that you have Quality Management System Regulation violations that are reasonably related to premarket approval applications for Class III devices, such devices will not be approved until the violations have been addressed. Should FDA determine that your devices or facilities do not meet the requirements of the Act, requests for Certificates to Foreign Governments (CFG) may not be granted.Additionally, on February 2, 2024, the FDA issued a final rule amending the device current good manufacturing practice (CGMP) requirements of the Quality System (QS) Regulation under 21 CFR 820 to align more closely with the international consensus standard for Quality Management Systems for medical devices used by many other regulatory authorities around the world. The revised Part 820, referred to as the Quality Management System Regulation (QMSR), became effective on February 2, 2026. Your most recent inspection on October 30, 2025, through November 19, 2025, was conducted pursuant to the QS Regulation, which was in effect at the time of the inspection. However, any corrective actions you propose, or implement must be pursuant to the QMSR requirements in effect as of February 2, 2026. For more information on the QMSR please refer to our frequently asked questions webpage: https://www.fda.gov/medical-devices/quality-system-qs-regulationmedical-device-current-good-manufacturing-practices-cgmp/quality-management-system-regulation-final-rule-amendin-gquality-system-regulation-frequently-asked.Please notify this office in writing within fifteen business days from the date you receive this letter of the specific steps your firm has taken to address the noted violations, as well as an explanation of how your firm plans to prevent these violations, or similar violations, from occurring again. Include documentation of the corrections and/or corrective actions (which must address systemic problems) that your firm has taken. If your firm’s planned corrections and/or corrective actions will occur over time, please include a timetable for implementation of those activities. If corrections and/or corrective actions cannot be completed within fifteen business days, state the reason for the delay and the time within which these activities will be completed. Your firm's response should be comprehensive and address any violations included in this Warning Letter. If you believe that your products are not in violation of the Act, include your reasoning and any supporting information for our consideration as part of your response.Your firm's response should be sent to: Melissa Michurski, Assistant Director, at CDRHEnforcement@fda.hhs.gov. Refer to CMS# 725861 when replying. If you have any questions about the contents of this letter, please contact Salvatore Randazzo, Compliance Officer, at 407-475-4712 or salvatore.randazzo@fda.hhs.gov.Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your firm's facility. It is your firm's responsibility to ensure compliance with applicable laws and regulations administered by FDA. The specific violations noted in this letter and in the Inspectional Observations, FDA 483, issued at the close of the inspection may be symptomatic of serious problems in your firm' s manufacturing and quality management systems. Your firm should investigate and dete1mine the causes of any violations and take prompt actions to address any violations and bring the products into compliance.Sincerely,/S/CDR Cesar A. Perez, PhD, USPHSActing Deputy DirectorOffice of Regulatory ProgramsOffice of Product Evaluation and QualityCenter for Devices and Radiological HealthCC: Ryan J. Peterson, VP of Operations, BlephEx, LLC, (b)(6)