根据《中华人民共和国药品管理法》第九十九条及《药品检查管理办法（试行）》第六十一条、第六十三条规定，河北省药品监督管理局组织对石家庄市藁城区医药药材公司祥泰经营中心（药品经营许可证号：冀AB311F00031）现场检查确认，企业已完成缺陷项目整改，现决定对该企业解除暂停销售药品风险控制措施。特此通告。河北省药品监督管理局2026年9月24日

经核查，执业药师冉晓婷存在《执业药师注册证》“挂证”行为，现依据《执业药师注册管理办法》第三十四条之规定，依法撤销其《执业药师注册证》（原编号：502225380002），资格证号2017026550262014558007006106，注册单位：重庆仁鑫阁朝杨大药房(个人独资)，三年内不予注册，并将其个人不良信息记入全国执业药师注册管理信息系统。特此公告。重庆市药品监督管理局2026年9月23日

为规范辖区医疗机构放射性药品使用管理，破解行业监管难题，近期，自治区药品检查中心立足职能、精准施策，通过深耕标准建设、优化帮扶服务、建强专业队伍三项举措，抓实放射性药品使用许可检查工作，织密辖区放射性药品安全防护网。深耕标准研创，筑牢监管根基结合辖区监管工作实际，自治区药品检查中心系统梳理放射性药品法律法规，对标国际先进检查经验优化工作体系，牵头完成《医疗机构使用放射性制剂现场检查验收标准研究》药品安全监管科研项目，初步构建标准化、规范化放射性制剂现场验收体系，明确检查流程与判定准则，为后续统一监管尺度、规范现场核查工作奠定基础。同步在核心期刊《中国药事》刊发论文《医疗机构配制放射性药品洁净环境监管要求对比研究》，立足放射性药品质量管控与辐射防护双重属性，明晰洁净环境分级检查标准，为完善监管体系提供理论支撑与决策依据。优化服务举措，赋能行业提质自治区药品检查中心优化许可检查工作模式，推行“提前介入、精准帮扶、全程指导”工作机制，主动下沉医疗机构开展一对一上门指导。针对部分机构设施老旧、整改难度大、升级成本高的问题，通过座谈研判难题、定制整改方案、持续跟进指导，助力医疗机构低成本、高效率完成设施合规升级改造工作，累计帮扶8家医疗机构顺利完成改造。选派2名骨干专家在全区核医学专业医疗质量控制专题培训会上现场授课，普及规范使用与风险防控知识，显著提升了辖区医疗机构放射性药品质量安全责任意识。淬炼专业本领，夯实人才支撑聚焦放射性药品监管专业性、技术性强的特点，自治区药品检查中心常态化开展业务能力建设，通过对接国家级培训资源、选派骨干参训研学、开展典型案例研讨、组织模拟实操检查等多种方式，学习前沿监管理念和先进工作方法。同时，邀请行业权威专家专题授课，围绕药品配制、质量管控、辐射防护、隐患处置等重点环节开展实操指导，精准补齐检查员业务短板。目前自治区药品检查中心已培养7名放射性药品专项骨干检查员，为精细化开展放射性药品许可检查和风险防控工作筑牢人才根基。截至目前，自治区药品检查中心已完成12家次医疗机构放射性药品使用许可检查，排查问题全部闭环整改，推动全区放射性药品使用管理水平显著提升。下一步，自治区药品检查中心将持续严把准入关口，常态化开展风险排查，深化监管政策研究与技术创新，持续提升放射性药品监管规范化、精准化、专业化水平，切实守护群众放射性药品使用安全。

按照《医疗器械监督管理条例》有关规定，根据企业申请，国家药品监督管理局注销以下5家企业共11个产品的医疗器械注册证：一、深圳库珀医疗股份有限公司的1个产品：导丝，注册证编号：国械注准20233030018。二、库克澳大利亚有限公司William A.Cook Australia,Pty.Ltd.的7个产品：精子制动液COOK Sydney IVF PVP，注册证编号：国械注进20173185265；精子梯度分离液套装COOK Sydney IVF Sperm Gradient Kit，注册证编号：国械注进20173185262；腹腔镜下肝脏拉钩系统Nathanson Liver Retraction System and Murdoch Mechanical Arm，注册证编号：国械注进20192021932；精子分离原液COOK Sydney IVF Spermient，注册证编号：国械注进20173185263；囊胚玻璃化冷冻液套装COOK Sydney IVF Blastocyst Vitrification Kit，注册证编号：国械注进20173185266；囊胚玻璃化解冻液套装COOK Sydney IVF Blastocyst Warming Kit，注册证编号：国械注进20173185267；精子培养液COOK Sydney IVF Sperm Medium，注册证编号：国械注进20173185264。三、阿登特克有限公司Adentatec GmbH的1个产品：齿科烤瓷合金Dental alloy for porcelain on nickel-chrome base，注册证编号：国械注进20172170142。四、远大凯尼特医疗科技（常州）有限公司的1个产品：紫杉醇释放冠脉球囊扩张导管，注册证编号：国械注准20253032042。五、安徽太康医疗科技有限公司的1个产品：锁定金属接骨螺钉，注册证编号：国械注准20253130386。 特此公告。国家药监局2026年9月21日

为加强药品质量监管，保障公众用药安全，浙江省药品监督管理局组织对全省药品生产、经营、使用环节进行了药品质量监督抽检，现将抽检不符合规定药品予以通告（见附件）。对抽检不符合规定药品，浙江省药品监督管理局已要求各相关市市场监督管理部门依法进行处置。特此通告。附件：浙江省药品质量监督抽检不符合规定药品信息（2026年第1期）浙江省药品监督管理局2026年9月23日

按照《医疗器械监督管理条例》的规定，根据企业申请，海南省药品监督管理局现注销海南麦瑞生物科技有限公司以下2个产品的医疗器械注册证：医用修护溶液敷料，注册证编号：琼械注准20262140015；医用修护贴敷料，注册证编号：琼械注准20262140022。特此公告。海南省药品监督管理局2026年9月23日

根据《麻醉药品和精神药品管理条例》《非药用类麻醉药品和精神药品列管办法》有关规定，公安部、国家卫生健康委员会和国家药品监督管理局决定将奥啡类物质整类列入《非药用类麻醉药品和精神药品目录》。“奥啡类物质”是指化学结构与溴啡（1-{1-[1-(4-溴苯基)乙基]哌啶-4-基}-1,3-二氢-2H-苯并咪唑-2-酮）相比，符合条件（一）、（二）、（三）中一个或多个条件的物质；或与螺溴啡（8-[1-(4-溴苯基)乙基]-1-苯基-1,3,8-三氮杂螺[4.5]癸烷-4-酮）相比，符合条件（四）、（五）、（六）中一个或多个条件的物质：（一）使用含碳原子数不超过5个的基团替代1,3-二氢-2H-苯并咪唑-2-酮基中任意数量的氢原子；（二）使用任意基团（氢原子除外）替代4-溴苯乙基；（三）使用含碳原子数不超过5个的基团替代哌啶环中任意数量的氢原子；（四）使用取代或未取代的芳香基团替代与氮原子相连的苯基；（五）使用任意基团（氢原子除外）替代4-溴苯乙基；（六）使用含碳原子数不超过5个的基团替代1,3,8-三氮杂螺[4.5]癸烷-4-酮基中任意数量的氢原子。上述所列管物质如果发现医药、工业、科研或者其他合法用途，按照《非药用类麻醉药品和精神药品列管办法》第三条第二款规定予以调整。本公告自2026年10月1日起施行。公 安 部 国家卫生健康委 国家药监局2026年9月23日

依据《罕见疾病创新药物研发鼓励试点计划（“关爱计划-延伸”）申报指南》，现将拟纳入“关爱计划-延伸”试点项目的基本信息予以公示，公示时间截至2026年10月8日。品种名称：ICP-B794申报单位：北京诺诚健华医药科技有限公司拟开发适应症：肺外神经内分泌癌如有异议，请将具体意见发送至邮箱：zhaona@cde.org.cn。国家药品监督管理局药品审评中心2026年9月23日

Delivery Method:VIA Electronic MailProduct:DrugsRecipient:Arta Shaun NoorianFounder & Chief Executive OfficerEmpower Clinic Services, LLC dba Empower Pharmacy7601 N. Sam Houston Pkwy W., Ste. 100Houston, TX 77064-3595United States (b)(4)Issuing Office:Center for Drug Evaluation and Research (CDER)United StatesWARNING LETTERWL # 738238September 18, 2026Dear Mr. Noorian:From November 3, 2025, through November 14, 2025, U.S. Food and Drug Administration (FDA) investigators inspected your facility, Empower Clinic Services, LLC dba Empower Pharmacy, located at 7601 N. Sam Houston Pkwy W., Ste. 100, Houston, TX 77064. During the inspection, the investigators collected evidence indicating that drug products you produced failed to meet the conditions of section 503A of the Federal Food, Drug, and Cosmetic Act (FD&C Act) [21 U.S.C. § 353a] for exemption from certain provisions of the FD&C Act. In addition, the investigators noted serious deficiencies in your practices for producing drug products, which put patients at risk.FDA issued a Form FDA 483 to your firm on November 14, 2025. FDA acknowledges receipt of your facility’s responses, dated December 8, 2025, March 18, 2026, and April 30, 2026. Based on this inspection, it appears that you produced drug products that violate the FD&C Act.A. Compounded Drug Products Under the FD&C ActSection 503A of the FD&C Act 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 (CGMP) (section 501(a)(2)(B)); labeling with adequate directions for use (section 502(f)(1)); and FDA approval prior to marketing (section 505) [21 U.S.C. §§ 351(a)(2)(B), 352(f)(1) and 355(a)].1 Receipt of valid prescriptions for individually-identified patients is one of the conditions for the exemptions under section 503A.In addition, for a compounded drug product to qualify for the exemptions under section 503A, a licensed pharmacist or physician must not compound regularly or in inordinate amounts any drug products that are essentially copies of a commercially available drug product.2 Section 503A(b)(2) provides that a compounded drug product is not essentially a copy of a commercially available drug product if “there is a change, made for an identified individual patient, which produces for that patient a significant difference, as determined by the prescribing practitioner, between the compounded drug and the comparable commercially available drug product.” (sections 503A(b)(1)(D) and 503A(b)(2) of the FD&C Act [21 U.S.C. §§ 353a(b)(1)(D) and 353a(b)(2)]).B. Failure to Meet the Conditions of Section 503ADuring the inspection, the FDA investigators collected evidence indicating that drug products produced by your firm failed to meet the conditions of section 503A. For example, the investigators collected evidence indicating that your firm compounded drug products that are essentially copies of commercially available drug products regularly and in inordinate amounts. Specifically, your firm compounded products including TIRZEPATIDE/NIACINAMIDE (4 ML)(17/2 MG/ML), SEMAGLUTIDE/CYANOCOBALAMIN (1 ML)(5/0.5 MG/ML), and TIRZEPATIDE/NIACINAMIDE (2.5 ML)(8/2 MG/ML), which appear to be essentially copies of FDA-approved semaglutide and tirzepatide products.3, 4 FDA is aware of high demand for compounded versions of FDA-approved semaglutide and tirzepatide products. The volume of products you are producing suggests that differences between products you are compounding and the FDA-approved products are pretextual.According to your firm's records, for example, you compounded and filled orders for the aforementioned drug products in the following quantities:During July 2025, you compounded and filled more than (b)(4) orders of TIRZEPATIDE/NIACINAMIDE (4 ML)(17/2 MG/ML).During August 2025, you compounded and filled more than (b)(4) orders of TIRZEPATIDE/NIACINAMIDE (4 ML)(17/2 MG/ML).During September 2025, you compounded and filled more than (b)(4) orders of TIRZEPATIDE/NIACINAMIDE (4 ML)(17/2 MG/ML).During October 2025, you compounded and filled more than (b)(4) orders of TIRZEPATIDE/NIACINAMIDE (4 ML)(17/2 MG/ML).During July 2025, you compounded and filled more than (b)(4) orders of SEMAGLUTIDE/CYANOCOBALAMIN (1 ML)(5/0.5 MG/ML).During August 2025, you compounded and filled more than (b)(4) orders of SEMAGLUTIDE/CYANOCOBALAMIN (1 ML)(5/0.5 MG/ML).During September 2025, you compounded and filled more than (b)(4) orders of SEMAGLUTIDE/CYANOCOBALAMIN (1 ML)(5/0.5 MG/ML).During October 2025, you compounded and filled more than (b)(4) orders of SEMAGLUTIDE/CYANOCOBALAMIN (1 ML)(5/0.5 MG/ML).During July 2025, you compounded and filled more than (b)(4) orders of TIRZEPATIDE/NIACINAMIDE (2.5 ML)(8/2 MG/ML).During August 2025, you compounded and filled more than (b)(4) orders of TIRZEPATIDE/NIACINAMIDE (2.5 ML)(8/2 MG/ML).During September 2025, you compounded and filled more than (b)(4) orders of TIRZEPATIDE/NIACINAMIDE (2.5 ML)(8/2 MG/ML).During October 2025, you compounded and filled more than (b)(4) orders of TIRZEPATIDE/NIACINAMIDE (2.5 ML)(8/2 MG/ML).Evidence collected includes (1) orders/prescriptions that lack any prescriber determination of significant difference from the commercially available product; (2) orders/prescriptions with purported prescriber determinations of “significant difference” that appear to be repeated verbatim across many records, suggesting that they may be pre-generated for selection by the prescriber, rather than written by the prescriber for an identified individual patient; and (3) the volume of particular products compounded and orders filled. Generating prescriptions through means that undermine the individualized nature of a prescriber's clinical judgment (for example through third-party technology platforms that provide prescribers with pre-selected menu options for choosing a statement of significant difference) call the individualized nature of those determinations into question, potentially undermining claims that such prescriber determinations of significant difference are sufficient to meet the conditions of section 503A.Furthermore, production records collected during the inspection indicate that your firm compounded these drug products regularly or in inordinate amounts.Therefore, you compounded drug products that do not meet the conditions of section 503A and are not eligible for the exemptions in that section, including the FDA approval requirement of section 505 of the FD&C Act, the requirement under section 502(f)(1) of the FD&C Act that labeling bear adequate directions for use, and the requirement of compliance with CGMP under section 501(a)(2)(B) of the FD&C Act. In the remainder of this letter, we refer to your drug products that do not qualify for exemptions under section 503A as the “ineligible drug products.”Specific violations are described below.C. Violations of the FD&C ActAdulterated Drug ProductsThe FDA investigators noted that drug products intended or expected to be sterile were prepared, packed, or held under insanitary conditions, whereby they may have become contaminated with filth or rendered injurious to health, causing your drug products to be adulterated under section 501(a)(2)(A) of the FD&C Act. For example, the investigators observed the following:1. Your firm failed to perform adequate smoke studies under dynamic conditions to demonstrate unidirectional airflow within the ISO 5 area. Therefore, your products intended to be sterile are produced in an environment that may not provide adequate protection against the risk of contamination.2. Your media fills were not performed under the most challenging or stressful conditions. Therefore, there is a lack of assurance that your firm can aseptically produce drug products within your facility.Furthermore, the manufacture of the ineligible drug products is subject to FDA’s CGMP regulations, Title 21, Code of Federal Regulations (CFR), parts 210 and 211. The FDA investigators observed significant CGMP violations at your facility, causing the ineligible drug products to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act. The violations included, for example:1. Your firm failed to establish an adequate system for maintaining equipment used to control the aseptic conditions (21 CFR 211.42(c)(10)(vi)).2. Your firm failed to establish and follow appropriate written procedures that are designed to prevent microbiological contamination of drug products purporting to be sterile, and that include validation of all aseptic and sterilization processes (21 CFR 211.113(b)).3. Your firm’s quality control unit failed to exercise its responsibility to ensure drug products manufactured are in compliance with CGMP and meet established specifications for identity, strength, quality, and purity (21 CFR 211.22).4. Your firm failed to establish an adequate system for monitoring environmental conditions in aseptic processing areas (21 CFR 211.42(c)(10)(iv)).5. Your firm failed to establish adequate written procedures for production and process control designed to assure that the drug products you manufacture have the identity, strength, quality, and purity they purport or are represented to possess (21 CFR 211.100(a)).Under section 301(a) of the FD&C Act [21 U.S.C. § 331(a)], the introduction or delivery for introduction into interstate commerce of any drug that is adulterated is a prohibited act. Further, it is a prohibited act under section 301(k) of the FD&C Act [21 U.S.C. § 331(k)] to do any act with respect to a drug, if such act is done while the drug is held for sale after shipment in interstate commerce and results in the drug being adulterated.Unapproved New Drug ProductsYou do not have any FDA-approved applications on file for the ineligible drug products that you compounded.5 Under sections 505(a) and 301(d) of the FD&C Act [21 U.S.C. § 331(d)], 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 ProductsThe ineligible drug products you compounded are intended for conditions not amenable to self-diagnosis and treatment by individuals who are not medical practitioners; therefore, adequate directions for use cannot be written so that a layman can use these products safely for their intended uses. Consequently, their labeling fails to bear adequate directions for their intended uses.6 Accordingly, these ineligible drug products are misbranded under section 502(f)(1) of the FD&C Act. The introduction or delivery for introduction into interstate commerce of these products therefore violates section 301(a) of the FD&C Act. It is also a prohibited act under section 301(k) of the FD&C Act to do any act with respect to a drug, if such act is done while the drug is held for sale after shipment in interstate commerce and results in the drug being misbranded.D. Corrective ActionsWe have reviewed your firm’s response to the Form FDA 483.Regarding your response related to the insanitary conditions, some of your corrective actions appear adequate; however, we cannot fully evaluate the adequacy of the following corrective actions described in your response because you did not include sufficient information or supporting documentation. Specifically, your response states that the smoke study under Rev. 005 was executed March 30 – April 3, 2026, but the April 2026 study is still under post-execution review and has not been finalized or provided to FDA. Per your response, the study “remains in controlled post-execution review.” It is unclear whether your firm has completed the post-execution review, as no final formal summary report has been provided.Regarding your response related to the insanitary conditions, the following corrective actions appear deficient. With respect to your aseptic media fill simulation executed in January 2026, we note that the summary states, “Following the 14-day incubation period, all vials were visually inspected for turbidity or microbial growth. No contamination was observed in any of the (b)(4) vials, confirming the sterility assurance of the process.” However, our review of the media fill test records and the vials documented across the (b)(4) revealed gaps and discrepancies. The summary report does not appear to match the number of vials inspected per the documents provided in the media fill test records. Specifically, based on the vials recorded across all the (b)(4) records, it appears up to (b)(4) vials were examined. No explanation was provided for the discrepancy in the total number of vials. The documents provided show no records for (b)(4). Furthermore, the records document results for (b)(4), with no documentation or explanation for (b)(4). It is unknown if these (b)(4) exist.Additionally, upon review of the documents, multiple (b)(4) were labeled as “N/A.” It is unknown what the designation “N/A” means, as it is not defined or explained in the records. Based on the documents provided, it is unclear how your firm counted and determined that no contamination was present in a total of (b)(4) vials. There appears to be a gap in the documentation with no explanation provided. The summary report claims all vials were inspected and none showed contamination; however, based on the information provided the claim cannot be supported if records do not clearly demonstrate that all vials were accounted for and inspected.Finally, our review also noted multiple media fill records were transcribed on Form Revision 3 because the original results were documented on the wrong form. Transcribing original data onto a different document, even if done for legitimate administrative reasons, must be carefully controlled, documented, and justified. Without a clear audit trail showing why results were rewritten and who authorized it, this practice raises concerns about whether the data accurately reflects what actually occurred during the media fill.Please be aware that section 501(a)(2)(A) of the FD&C Act concerning insanitary conditions applies regardless of whether drug products you compound meet the conditions of section 503A, including the condition that drug products that are essentially copies of commercially available drug products not be compounded regularly or in inordinate amounts.Should you continue to compound and distribute drug products that do not meet the conditions of section 503A, the compounding and distribution of such drugs would be subject to the new drug approval requirement, the requirement to label drug products with adequate directions for use, and the drug CGMP regulations. Before doing so, you must comply with the requirements of section 505 and 502(f)(1) and fully implement corrections that meet the minimum requirements of the CGMP regulations.7In addition to the issues discussed above, you should note that CGMP requires the implementation of quality oversight and controls over the manufacture of drugs, including the safety of raw materials, materials used in drug manufacturing, and finished drug products. See section 501 of the FD&C Act. If you choose to contract with a laboratory to perform some functions required by CGMP, it is essential that you select a qualified contractor and that you maintain sufficient oversight of the contractor’s operations to ensure that it is fully CGMP compliant. Regardless of whether you rely on a contract facility, you are responsible for assuring that drugs you produce are neither adulterated nor misbranded. [See 21 CFR 210.1(b), 21 CFR 200.10(b)].FDA strongly recommends that your management undertake a comprehensive assessment of operations, including facility design, procedures, personnel, processes, maintenance, materials, and systems. In particular, this review should assess your aseptic processing operations. A third party consultant with relevant sterile drug manufacturing expertise should assist you in conducting this comprehensive evaluation.E. ConclusionThe violations cited in this letter are not intended to be an all-inclusive statement of violations at your facility. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations.You should take prompt action to address any violations. Failure to adequately address any violations may result in legal action without further notice, including, without limitation, seizure and injunction.Within fifteen (15) working days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to address any violations. Please include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. This letter notifies you of our concerns and provides you an opportunity to address them. If you believe your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration. If you cannot completely address this matter within fifteen (15) working days, state the reason for the delay and the time within which you will do so.Your response and any questions regarding the contents of this letter should be sent to compoundinginspections@fda.hhs.gov. In your response, refer to the Warning Letter Number above (# 738238) and include a subject line that clearly identifies the submission as a Response to Warning Letter.Sincerely,/S/Clint L. Narver, JDDirectorOffice of Compounding Quality and ComplianceOffice of ComplianceCenter for Drug Evaluation and ResearchU.S. Food and Drug Administration_________________________1 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.2 FDA considers a drug product to be commercially available if it is a marketed drug product.3 FDA previously exercised enforcement discretion for state-licensed pharmacies compounding semaglutide and tirzepatide injection products that are essentially copies of commercially available drug products under section 503A. That enforcement discretion period ended with respect to tirzepatide injection products on March 5, 2025, and with respect to semaglutide injection products on April 24, 2025.4 See, e.g., (b)(6).5 The specific products made by your firm 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 diseases and/or because they are intended to affect the structure or any function of the body. Further, they are “new drugs” within the meaning of 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.6 Your ineligible drug products are not exempted from the requirements of section 502(f)(1) of the FD&C Act by regulations issued by the FDA (see, e.g., 21 CFR 201.115).7 In this letter we do not address whether your proposed corrective actions would resolve the CGMP violations noted above.

Delivery Method:VIA Electronic MailProduct:Medical DevicesRecipient:Kostiantyn SuichmezPresident and CEOAdvance-Esthetic LLC4101 Ravenswood Rd Ste 110Fort Lauderdale, FL 33312-5371United States(b)(6), (b)(7)(C)Issuing Office:Center for Devices and Radiological HealthUnited StatesWARNING LETTERCMS # 729267August 25, 2026Dear Mr. Suichmez:During an inspection of your firm located in Fort Lauderdale, Florida from October 27, 2025, through November 6, 2025, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures and markets Zemits CrystalFrax Pro, Zemits Abigon Pro and Zemits Bionexis Lite Pro. 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 ViolationsOur inspection revealed that the Zemits CrystalFrax Pro, Zemits Abigon Pro and Zemits Bionexis Lite Pro 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 under section 520(g) of the Act, 21 U.S.C. § 360j(g) for the device as described and marketed.The Zemits CrystalFrax Pro, Zemits Abigon Pro, and Zemits Bionexis Lite Pro are also misbranded under section 502(o) of the Act, 21 U.S.C. § 352(o), because your firm did not notify the agency of its intent to introduce the device into commercial distribution, as required by section 510(k) of the Act, 21 U.S.C. § 360(k). For a device requiring premarket approval, the notification required by section 510(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.Specifically, your firm has listed the Zemits CrystalFrax Pro, Zemits Abigon Pro, and Zemits Bionexis Lite Pro devices under product code ISA, classified under 21 CFR 890.5660. Devices classified under 21 CFR 890.5660 Therapeutic Massagers are electrically powered devices intended for medical purposes, such as to relieve minor muscle aches and pains, and are exempt from premarket notification requirements unless they exceed the limitations at 21 CFR 890.9(a)-(b). FDA has reviewed your device listings, information collected during your most recent inspection, and your firm’s website and has determined that none of the subject devices fall within the scope of this classification.The listed devices exceed the limitations in 21 CFR 890.9(a)-(b) applicable to exempt devices because they use a different fundamental scientific technology (radiofrequency energy and light-based technology) and because they are intended by you for uses that are different from the intended use of legally marketed devices in that generic type of device.The Zemits CrystalFrax Pro, Zemits Abigon Pro, and Zemits Bionexis Lite Pro are all devices that use radiofrequency energy and light-based technology for non-invasive body contouring of skin and cellulite. Radiofrequency (RF) energy works by increasing the temperature of skin by deposition of RF waves to relieve minor aches and pain. Light-based technology works through the interaction of light with the fat tissue. In contrast, electric therapeutic massagers classified under 21 CFR 890.5660 are largely air pressure-based devices that deliver massaging vibrations to the tissue. Because your devices operate using a different fundamental scientific technology than legally marketed devices in the generic type of devices of therapeutic massagers regulated under 21 CFR 890.5660, these devices exceed the limitations described in 21 CFR 890.9(b) and are not exempt from premarket notification requirements.Additionally, these devices are intended by you for uses that are different from the intended uses of legally marketed devices in this generic type of device classified under 21 CFR 890.5660 as therapeutic massagers. For example, marketing materials for the Zemits Bionexis Lite Pro on your firm's website indicate that the product can be used to "reduce cellulite appearance," "decrease appearance of stretch marks," and "reduce edema and puffiness." Your firm's website further describes the Zemits CrystalFrax Pro as a device that "stimulates collagen production." Additionally, in a video linked on your firm's website, your firm says that the Zemits Abigon Pro can "stimulate collagen regeneration [and] increase the production of elastin and hyaluronic acid." Therapeutic massagers regulated under 21 CFR 890.5660 are intended for medical purposes such as relieving minor muscle aches and pains. Because your devices are for different intended uses than legally marketed devices in that generic type of devices of therapeutic massagers regulated under 890.5660, the devices exceed the limitations described in 21 CFR 890.9(a) and are not exempt from premarket notification requirements. They are also therefore subject to the requirement under 21 CFR 807.81(a)(3)(i).For a device requiring premarket approval, the notification required by section 510(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.A follow up inspection will be required to evaluate whether corrections and/or corrective actions are adequate.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.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 FD&C Act, include your reasoning and any supporting information for our consideration as part of your response.Your firm’s response should be sent via email to Melissa Michurski, Assistant Director, at CDRHEnforcement@fda.hhs.gov. Please include in the subject line, “CMS Case # 729267” when replying. If you have any questions about the contents of this letter, please contact: Rafael Padilla at Rafael.padilla@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 determine the causes of any violations and take prompt actions to address any violations and bring the products into compliance.Sincerely,/S/Barbara C. MarsdenDirectorOffice of Regulatory ProgramsOffice of Product Evaluation and QualityCenter for Devices and Radiological Health