万年县芯智微科技有限公司报告，由于该批次产品收到抽查检验不合格报告，示值检验项目不符合要求等原因，万年县芯智微科技有限公司对其生产的玻璃体温计(注册备案号:赣械注准20212070059)主动召回，召回级别为三级,涉及产品的型号、规格及批次等详细信息见《医疗器械召回事件报告表》。附件：医疗器械召回事件报告表2025-08-13

序号行政处罚决定书文号案件名称违法企业名称或违法自然人姓名违法企业组织机构代码法定代表人姓名主要违法事实行政处罚的种类和依据行政处罚的履行方式和期限做出处罚的机关名称和日期备注1桂药监流稽罚〔2025〕8号广西梧州百姓大药房连锁有限公司经营劣药红参案广西梧州百姓大药房连锁有限公司91450400763078105B蔡勇中销售劣药红参的行为违反了《中华人民共和国药品管理法》第九十八条第一款的规定行政处罚的种类：没收违法所得。              行政处罚的依据：《中华人民共和国药品管理法》第一百一十七条第一款、《中华人民共和国行政处罚法》第二十八条第一款、《中华人民共和国药品管理法实施条例》第七十五条的规定。履行广西壮族自治区药品监督管理局2025年08月05日

海南省药品监督管理统计报告（2024年）

近日，自治区药监局深入落实《中药饮片标签管理规定》要求，聚焦中药饮片经营环节监管，发布专项工作提示，强化中药饮片全流程管控，进一步规范市场秩序，切实保障公众用药安全。各级监管部门将依据工作提示，督促辖区内药品流通企业严格落实主体责任。药品经营企业购进中药饮片，必须严格遵守以下四个方面规定。资质标签双审核。企业务必从具备合法资质的供应商处采购中药饮片，仔细核验对方的营业执照、生产许可证等相关资质文件。同时，依据执行标准，对中药饮片的标签进行全面核查，确保其准确性、完整性。一旦发现标签信息不全或存在错误，企业必须坚决拒绝购进，并及时向监管部门报告。保质期制度全覆盖。企业需要建立完善的保质期管理体系，同时推行“近效期提醒”机制。定期对库存中药饮片进行排查，严禁销售过期产品。对于过期的中药饮片，应立即下架，并按照相关规定进行妥善处置。储运条件严执行。企业必须严格依照中药饮片标签上的要求进行运输和储存。切实落实防潮、防虫、防霉等措施，保障中药饮片在整个流通过程中的质量安全。销售信息要一致。在销售中药饮片时，企业必须向购货方提供合法的票据以及产品合格证明文件，保证销售的实物与标签上的信息完全一致，杜绝任何信息不符等违规行为。对于2025年8月1日之前生产的未标注保质期的中药饮片，自治区药监局也明确了过渡期管理要求。此类饮片可继续在市场上销售流通，直至使用完毕。在此期间，经营企业需要强化质量管控，定期开展质量检查，严格按照规定条件进行储存，确保其在流通环节的质量安全。下一步，自治区药监局将重点指导企业，严格落实主体责任责任，定期排查相关饮片库存；组织人员学习标签规定，提升合规辨识能力；开展法律风险评估，完善合同审核，明确供应商责任，构建全链条质量管理体系。同时，持续加大对中药饮片经营环节的监管力度，确保各项规定落到实处，全力守护公众用药安全。

为探索开展省药监局系统内部“综合查一次”，统筹省局处室、分局和直属单位的监管资源、监管任务，提升检查质效，近日，省药监局出台了《安徽省药品生产融合检查工作机制（暂行）》，推进各类药品生产检查融合开展，最大限度减少入企检查的部门和频次。截至目前,结合许可、日常监管、注册、GMP符合性检查等，已对44家企业开展了融合检查。明确“综合查一次”方式。可通过合并检查、简化检查、检查结论引用与互认等方式开展。新增品种、剂型、生产线的许可检查、注册核查、上市后注册变更核查，可与相关生产线、生产品种上市后日常监督检查合并开展。药物警戒检查与药品生产监督检查融合开展，原则上不单独开展检查。坚持“综合查一次”原则。原则上可只制定一份检查方案，撰写一份检查报告、一份检查缺陷表。检查事项出现不同检查结论的，可就不同检查事项分开进行综合评定。对同样检查范围、相同检查要求的检查结论可基于评估结果开展互认，免于开展检查或只开展未互认部分的检查。守住质量安全底线。结合企业产品特点、缺陷整改情况，精准识别风险，制定差异化检查方案，确保“综合查一次”只减少检查部门和检查频次而不放松、放宽监管。将全省疫苗、血液制品、生物制品、大容量注射剂等高风险品种生产企业以及新中选、委托生产国家集采中选品种列入重点检查范围，坚持检查“全覆盖”。

根据《药品经营和使用质量监督管理办法》第二十七条第一款的规定，该企业主动提出注销《药品经营许可证》，我局已依法办理了福建中外运医药物流有限公司《药品经营许可证》（证号：闽AA5920355）注销手续,现予以公告。请各有关药品监督管理部门监督该企业不得再以已注销《药品经营许可证》企业的名义经营药品，并请社会各界共同监督。监督电话：0591－86296506联系地址：福州市鼓楼区五四路358号福建省药品监督管理局邮编：350003福建省药品监督管理局2025年8月13日

序号行政处罚决定书文号违法企业名称或自然人姓名法定代表人姓名违法企业组织机构代码违法行为类型主要违法事实行政处罚的内容行政处罚的依据履行方式和期限作出处罚决定的行政机关和日期1鄂药监恩施药处罚〔2025〕2 号湖北茂源堂中药饮片有限公司邓占军91422801MACFUXMG7B生产销售劣药该公司生产的白芍（批号：240801）经三峡公共检验检测中心检验为不合格药品，检验报告书编号：SX2025YP00318，不合格项目为二氧化硫残留量，标准为不得过400mg/kg，检验结果为1176mg/g，其余检验项目符合规定。该公司于2024 年 8 月 21日生产白芍（批号：240801）1172kg，经自检合格后放行上市，于 2024年12月13日销售完毕，单价 98元/kg 至 178 元/kg 不等，合计销售金额135776元。1.没收召回的该批次白芍，没收违法所得；2.处罚款。依据《中华人民共和国药品管理法》第 117 条第一款、《行政处罚法》第六条、结合国家药品监督管理局《药品监督管理行政处罚裁量适用规则》第四条第（三）项。该公司于 2025年8月4日主动履行。湖北省药品监督管理局2025 年 8 月5日

Delivery Method:Via EmailProduct:DrugsRecipient:Serge MilbankCEOConfer With81 Rivington StLondonEC2A 3AYUnited Kingdomgetintouch@conferwith.ioIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesWARNING LETTERAugust 1, 2025RE: 707691Dear Mr. Milbank:This letter concerns your firm's distribution of a drug product to bleach and/or lighten the skin. Vivant True Tone is an unapproved new drug introduced into interstate commerce in violation of section 505(a) of the FD&C Act, 21 U.S.C. 355(a) and is misbranded under section 502(ee) of the FD&C Act, 21 U.S.C. 352(ee). Introduction or delivery for introduction of a misbranded product into interstate commerce is prohibited under sections 301 (d) and (a) of the FD&C Act, 21 U.S.C. 331 (d) and (a). These violations are described in more detail below.Unapproved New Drug and Misbranded Drug ViolationsVivant True Tone is a drug as defined by section 201 (g)(1)(B) of the FD&C Act, 21 U.S.C. 321 (g)(1)(B), because it is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or under section 201 (g)(1)(C) of the FD&C Act, 21 U.S.C. 321 (g)(1)(C), because it is intended to affect the structure or any function of the body.Examples from the Vivant True Tone product labeling, including your website, that provide evidence of the intended use (as defined in 21 CFR 201.128) of the product as a drug include, but may not be limited to, the following:" ... this triple-action, targeted corrector serum ... lightens and brightens . .. Ideal for: Hyperpigmentation, Melasma, Dark Spots, Age Spots." [from your website https://conferwith .net/products/bleaching-cream)"The undisputed champion in the pigment wars is hydroquinone .. . For stubborn pigmentation issues, Vivant's True Tone Serum is at the top of the food chain. This targeted serum combines transformative vitamin A with hydroquinone (2%) .... " [from the Vivant Skin Care website https://www.vivantskincare.com/blogs/hyperpigmentation/foursteps-to-even-tone]Based on the above labeling evidence, Vivant True Tone is a skin bleaching drug product subject to section 505G of the FD&C Act, 21 U.S.C. 355h, which governs nonprescription drugs marketed without an approved application. Specifically, this skin bleaching product falls under section 505G(a)(4) of the FD&C Act, 21 U.S.C. 355h(a)(4), because it is subject to a determination to be not generally recognized as safe and effective (GRASE) in a proposed rule that is the most recently applicable proposal issued under 21 CFR part 330.1Thus, Vivant True Tone is deemed to be a new drug under section 201(p)(1) of the FD&C Act and subject to the requirement to have an approved new drug application for marketing under section 505 of the FD&C Act, 21 U.S.C. 355, beginning on September 23, 2020.2No FDA-approved application pursuant to section 505 of the FD&C Act, 21 U.S.C. 355, is in effect for Vivant True Tone. Accordingly, this skin bleaching drug product is an unapproved new drug and its introduction or delivery for introduction into interstate commerce violates section 505(a) of the FD&C Act, 21 U.S.C. 355(a). Introduction or delivery for introduction of such products into interstate commerce is prohibited under section 301(d) of the FD&C Act, 21 U.S.C. 331(d).Moreover, Vivant True Tone is misbranded under section 502(ee) of the FD&C Act, 21 U.S.C. 352(ee) because it is deemed as such under section 505G(a)(4) of the FD&C Act, 21 U.S.C. 355h(a)(4), and because it is a nonprescription drug subject to section 505G of the FD&C Act, 21 U.S.C. 355h, but is not the subject of an application approved under section 505 of the FD&C Act, 21 U.S.C. 355, and does not comply with the requirements under section 505G of the FD&C Act, 21 U.S.C. 355h. The introduction or delivery for introduction of a misbranded drug into interstate commerce is prohibited under section 301 (a) of the FD&C Act, 21 U.S.C. 331 (a).ConclusionThe violations cited in this letter are not intended to be an all-inclusive list of violations of your product nor are the skin bleaching/skin lightening drug products named in this letter intended to be an all-inclusive list of products you have manufactured, registered, and listed in FDA's electronic drug registration and listing system (eDRLS), or introduced into interstate commerce. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence and 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 correct the violations cited in this letter. Failure to promptly correct any violations may result in legal action including, without limitation, seizure and injunction.Failure to address violations of the FD&C Act may be cause for FDA to withhold approval of requests for export certificates and approval of pending new drug applications or supplements listing your facility as a supplier or manufacturer.This letter notifies you of our findings and provides you an opportunity to address the above deficiencies. After you receive this letter, respond to this office in writing within 15 working days. Specify what you have done to address any violations and to prevent their recurrence. In response to this letter, you may provide additional information for our consideration as we continue to assess your activities and practices. If you cannot completely address violations within 15 working days, state your reasons for delay and schedule for completion. 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.Your response should be sent to U.S. Food and Drug Administration, CDER/OC/Office of Unapproved Drugs and Labeling Compliance by email to FDAAdvisory@fda.hhs.gov. Please include your firm name and the unique identifier "707691" in the subject line of your email.Sincerely,/S/Tina Smith, M.S.Captain, U.S. Public Health ServiceDirectorOffice of Unapproved Drugs & Labeling ComplianceOffice of ComplianceCenter for Drug Evaluation and ResearchU.S. Food and Drug Administration________________1On August 29, 2006, FDA issued a proposed rule (71 FR 51146) setting forth a determination that OTC skin bleaching drug products, including but not limited to those that contain hydroquinone as an active ingredient, are not generally recognized as safe and effective.2Section 505G(a)(4) of the FD&C Act, 21 U.S.C. 355h(a)(4), authorized FDA to take action before September 23, 2020 to extend the period during which a drug subject to that section may be marketed without an approved new drug application if the Agency determined that such an extension is in the interest of public health. However, FDA did not make such a determination for skin bleaching products.

Delivery Method:VIA Electronic MailProduct:Medical DevicesRecipient:John J. StephanPresident & CEOSpectra Therapy, LLC3350 Lapeer RoadPort Huron,MI48060United Statesjohnstephan@spectratherapy.comIssuing Office:Center for Devices and Radiological HealthUnited StatesWARNING LETTERCMS: 698026July 22, 2025Dear Mr. Stephan:During an inspection of your firm located in Port Huron, MI on September 10, 2024, through September 13, 2024, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures therapeutic heating infrared lamps, marketed as the LASERwrap system. The LASERwrap system includes the Spectra A-100 Impulse Laser Unit and accessories such as filament wraps and pads that are applied to the body and connected to the Spectra A-100 Impulse Laser Unit. 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 function of the body.Quality System Regulation Violation(s)This inspection 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 a response from(b)(6), (b)(7)(C), dated September 24, 2024, but received October 3, 2024, on behalf of your firm, concerning our investigator’s observations noted on the Form FDA 483 (FDA 483), List of Inspectional Observations, which was issued to your firm. We address this response below, in relation to each of the noted violations. These violations include but are not limited to the following:1. Failure to establish and maintain procedures to control the design of the device in order to ensure that specified design requirements are met to demonstrate that the design was developed in accordance with the design control requirements as required by 21 CFR § 820.30(a) through § 820.30(j). Specifically,a. Your firm has not established procedures to control the design of the LASERwrap system.b. Your untitled and undated design document provided during the inspection did not provide adequate detail or objective evidence to demonstrate how the specific specifications and operating modes listed in this document were developed, established, verified, and validated to ensure that device conforms to user needs and the proper functioning of the device. Further, your firm was unable to provide evidence that software validation and/or risk analysis were performed.c. Several design changes have been made to the LASERwrap system that have not been verified and/or validated. For example, a design change to the housing (or case) of the A-100 Impulse Laser unit was made in 2021, and this design change was not verified and/or validated and was not conducted in accordance with any established procedure.We reviewed your firm’s response and concluded that it is not adequate. This response promises development of aProduct Design and Developmentprocedure and plans to conduct(b)(4)audit of devices already sold. Your firm’s response does not address how it will establish a design plan, inputs, outputs, verification, and validation for the LASERwrap system. It also does not address reviewing the design changes made to the device to determine if verification and/or validation is required. In your firm’s response to this letter, please address these concerns and provide a copy of the promised procedure, complete documentation for all design control requirements of the LASERwrap system, and the outcome of the(b)(4)audit once these items are completed or a timeframe when these items will be provided.2. Failure to establish and maintain procedures to control product that does not conform to specified requirements. The procedures shall address the identification, documentation, evaluation, segregation, and disposition of nonconforming product. The evaluation of nonconformance shall include a determination of the need for an investigation and notification of the persons or organizations responsible for the nonconformance. The evaluation and any investigation shall be documented, as required by 21 CFR § 820.90.Specifically, your firm has not established a procedure to control nonconforming product found during final acceptance activities. For example, when a laser is found to not conform to specified requirements as part of your final functional testing, your manager stated that it is placed into a “Lasers need repair” bin with details related to the nonconformance occasionally captured on pieces of(b)(4)paper. This bin is subsequently returned to your firm’s contract manufacturer to perform investigation and repair without documentation of these activities.Your firm’s response did not address this violation that was presented as a discussion item during the inspection. In response to this letter, please provide any completed actions taken by your firm to address this item or your planned actions and the timeframe for when these actions will be completed.3. Failure to establish and maintain procedures for implementing corrective and preventive action, as required by 21 CFR § 820.100.Specifically, your firm’s corrective and preventive procedure, BSP-05 Corrective and Preventative Actions Procedure, has not been implemented and remains in a draft status.We reviewed your firm’s response and concluded that it is not adequate. In this response your firm indicates that it plans to complete and initiate a “Corrective Action/Preventive Action” (CAPA) procedure to address this observation. Please provide this procedure for our review.4. Failure to maintain an adequate record of investigation as required by 21 CFR § 820.198(e). The record of investigation shall include:a. The name of the device;b. The date the complaint was received;c. Any unique device identifier (UDI) or universal product code (UPC), and any other device identification(s) and control number(s) used;d. The name, address, and phone number of the complainant;e. The nature and details of the complaint;f. The dates and results of the investigation;g. Any corrective action taken; andh. Any reply to the complainant.Specifically, your firm has failed to document investigations performed by your firm and/or contract manufacturers utilized by your firm that contain the above required information. For example, you provided a “(b)(4)” spreadsheet that your firm utilizes to log complaints received as well as lasers returned to your firm. This document contains approximately(b)(4)lines of complaints received over a(b)(4)-month period. However, this document is not being adequately maintained in that several rows are blank and missing the above required information.Your firm’s response did not address this violation that was presented as a discussion item during the inspection. In response to this letter, please provide any completed actions taken by your firm to address this item or your planned actions and the timeframe for when these actions will be completed.5. Failure to evaluate and select potential suppliers, contractors, and consultants on the basis of their ability to meet specified requirements, including quality requirements. The evaluation shall be documented, as required by 21 CFR § 820.50(a)(1).Specifically, your firm’s purchasing control procedure (BSP-03 Purchasing Controls Procedure; no Rev.; no date) includes the following requirements:a. Section 4.2.1C requires a copy of the vendor’s ISO 134865 or ISO 9001 certification of registration OR results of the vendor’s self-assessment conducting in accordance with their Quality Management System.Documented proof of these documents or any other documented vendor selection and evaluation was not provided.b. Section 4.4.1 of your purchasing control procedure requires your firm to perform(b)(4)vendor evaluations to review the suppliers’ performance.Documented incidences of periodic reviews being conducted were not provided.However, despite no initial or periodic evaluation of your suppliers being performed, all suppliers are listed as ‘Active’ on your firm’s qualified supplier list (Production Supplier List; Effective 9-1-2024).Your firm’s response did not address this violation that was presented as a discussion item during the inspection. In response to this letter, please provide any completed actions taken by your firm to address this item or your planned actions and the timeframe for when these actions will be completed.6. Failure to establish and maintain procedures for finished device acceptance to ensure that each production run, lot, or batch of finished devices meets acceptance criteria, as required by 21 CFR § 820.80(d).Specifically, your firm’s manager explained that she is responsible for performing(b)(4)testing of finished devices. This process and activities are not performed according to an established procedure or work instruction, nor are the results of these activities documented.We reviewed your firm’s response and concluded that it is not adequate. Your firm’s response indicates it will create documents for acceptance activities. Please provide these acceptance activity documents for our review.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 and to determine the effectiveness of the quality system, as required by 21 CFR § 820.22.Specifically, your firm has not established procedures for quality audits, nor have you conducted a quality audit since your firm began manufacturing devices in 2008.We reviewed your firm’s response and concluded that it is not adequate. In this response you indicate that your firm will initiate a quality audit as soon as possible and provide procedures and associated forms (“Quality Audits”) with an estimated completion date of 11-29-2024. However, these promised documents have not been provided. In your response to this letter, provide the promised forms or a date that they will be provided. Additionally, provide evidence of a quality audit or the date one is planned.8. Failure of management with executive responsibility to review the suitability and effectiveness of the quality system at defined intervals and with sufficient frequency according to established procedures to ensure that the quality system satisfies the requirements of this part and the manufacturer's established quality policy and objectives, as required by 21 CFR § 820.20(c).Specifically, your firm has not established procedures for conducting management reviews nor have you conducted a management review since your firm began manufacturing devices in 2008.We reviewed your firm’s response and concluded that it is not adequate. In this response you indicate that your firm will provide procedures and associated forms (“Management Review”) with an estimated completion date of 12-31-2024. However, these promised documents have not been provided. In your response to this letter, provide the promised forms or a date that they will be provided. Additionally, your response does not address if your firm plans to conduct a management review. Please explain if one has been conducted or the date one is planned.9. Failure to establish and maintain procedures to control all documents, as required by 21 CFR § 820.40.Specifically, your firm has not established procedures to control documents (policies, procedures, forms, etc.) utilized by your firm for the operations related to medical devices manufactured by your firm.We reviewed your firm’s response and concluded that it is not adequate. In this response your firm indicated that it would complete and initiate a “Document Control” procedure with an estimated completion date of 12-31-2024. In your response to this letter, provide the promised document or a date that they will be provided.10. Failure to establish procedures for identifying training needs and ensure that all personnel are trained to adequately perform their assigned responsibilities. Training shall be documented, as required by 21 CFR § 820.25(b).Specifically, your firm has not established a training procedure nor has training been documented for any employee.Your firm’s response did not address this violation that was presented as a discussion item during the inspection. In response to this letter, please provide any completed actions taken by your firm to address this item or your planned actions and the timeframe for when these actions will be completed.Unapproved Device Violation(s)Our inspection also revealed that the LASERwrap system 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 you market it.The LASERwrap system 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 under 21 CFR 890.5500 Infrared lamp without submitting a premarket notification to FDA as required by section 510(k) of the Act and 21 U.S.C. § 360(k).Devices classified under 21 CFR 890.5500 Infrared lamp are exempt from premarket notification unless they exceed the limitations on exemption at 21 CFR 890.9(a). Generic devices of this type emit energy at infrared frequencies (approximately 700 to 50,000 nanometers) to provide topical heating and are intended for medical purposes including, but not limited to, temporary increase in local blood circulation and temporary relief of: muscle spasms, minor joint pain and stiffness, minor muscle pain and stiffness, and minor arthritis pain.There is evidence that the LASERwrap system is intended for uses that are different from those of legally marketed devices classified under 21 CFR 890.5500 (Infrared lamp). Based on the user manual collected during the inspection and a review of your firm’s website, https://spectratherapy.com/human-treatable-%20%20%20conditions/ (accessed July 9, 2025) your firm is marketing the LASERwrap system for different intended uses, including treatment of diseases or conditions such as irritable bowel syndrome, wounds, and urinary tract infections, and cure of “inflammatory issues” such as tendonitis, bursitis, and plantar fasciitis. For example, the product user manual includes the following claims:• “The Physiological Effects of [Low-level laser therapy] LLLT are:1. Bio-stimulation  Improved metabolism  Increase of cell metabolism. . .5. Stimulation of wound healing…”• “How has LLLT worked for others? . . . o Increases . . . tensile strength of tissue repair o Stimulates the immune system and nerve function o Develops collagen ... o Promotes faster wound healing and clot formation ...”• “Abdominal & Back LASERwrap® Treatments ... o Reduce IBS [Irritable Bowel Syndrome] & UTI [Urinary Tract Infection]”Your website also https://spectratherapy.com/human-treatable-%20%20%20conditions/ includes the following statements:• Under “Wounds” your website provides the following testimonial: “LASERwrap® eliminated PAIN from 7 patients in less than a week to 10 days, that had been fighting neuropathy & plantar fasciitis conditions from 6 MONTHS to 2 YEARS. Good news for lower extremity diabetic patients with wounds on the bottom of their feet, LASERwrap® healed decubitus wounds in 2 weeks versus 4-5 months using conventional debriefing methods.”• Under “Chronic Pain” your website provides the following testimonial: “This laser has a multiplicity of effects. It can cure both acute and chronic inflammatory issues including tendonitis, ankle sprains, bursitis, plantar fasciitis and back strain all without the use of anti-inflammatory or pain medicine. It can markedly decrease the pain of neuropathy in the lower extremeities [sic] and improve restless leg syndrome to the pint [sic] where patients can eliminate medication. It can decrease the time it takes to heal stasis and vascular ulders [sic]...”• Under “Fibromyalgia” your website provides the following testimonial: “...The most common types include osteoarthritis (OA), rheumatoid arthritis (RA), psoriatic arthritis (PsA), fibromyalgia and gout. Since all of them cause pain in different ways, LASERwrap® treats a large AREA of concern, rather than just a small spot of interest, providing improved circulation around the entire extremity, across shoulders & neck or entire lower back & sciatica area.”• Fractures• Insomnia• Migraines• Oral...Pain• Respiratory (COPD)• Spine Injuries• TMJ/TMD DisorderBecause there is evidence as described above that the LASERwrap system is intended for uses that are different from those of legally marketed devices classified under 21 CFR 890.5500, the device exceeds the limitations described in 21 CFR 890.9(a) and is not exempt from premarket notification.Further, FDA cleared a 510(k) (K080689) for the “Spectra Therapy Spectra A1000 Laser Device” on July 9, 2008, with the following indications for use: “The Spectra Therapy Spectra A1000” is an infrared lamp intended to provide topical heating . . . [and] is indicated for the temporary relief of minor muscle and joint pain, arthritis and muscle spasm, relieving stiffness, promoting relaxation of muscle tissue, and to temporarily increase local blood circulation where heat is indicated.” However, the statements in your firm’s user manual for the LASERwrap system and on your firm’s website provide evidence that the device is intended to treat diseases or conditions such as irritable bowel syndrome, wounds, and urinary tract infections, and to cure “inflammatory issues” such as tendonitis, bursitis, and plantar fasciitis, which would constitute a major change or modification to the intended use of the device cleared under K080689, for which your firm lacks clearance or approval. Examples of these statements are included above.Your firm has provided no evidence to FDA supporting the above listed claims. The lack of supporting information demonstrating the safety and effectiveness of your device raises public health concerns, including the risk of a delay in definitive treatment if the LASERwrap systems are used as advertised. For example, delayed or ineffective treatment for wound care can lead to tissue death, infection, amputation, or death. Additionally, delayed or ineffective treatment of neuropathy can lead to permanent nerve damage and loss of function.Your firm’s response did not address your firm’s marketing of the LASERwrap system for intended uses that are different from the intended use of legally marketed devices classified under 21 CFR 890.5500.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.Medical Device Reporting (MDR) Violation(s)Our inspection also revealed that your firm failed to adequately develop, maintain, and implement written MDR procedures as required by 21 CFR 803.17. A device is deemed to be misbranded under section 502(t)(2) of the Act, 21 U.S.C. § 352(t)(2), if there is a failure or refusal 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 803 - Medical Device Reporting.During the inspection, your firm identified the document titled “BSP-02 Medical Device Reporting (MDR) Procedure,” undated, as its written MDR procedure.After reviewing the procedure, the following deficiencies were noted:1. BSP-02 Medical Device Reporting (MDR) Procedure does not establish internal systems that provide for timely and effective identification, communication, and evaluation of events that may be subject to MDR requirements, as required by 21 CFR 803.17(a)(1). For example:a. There are inadequate definitions of what constitutes a reportable event under 21 CFR Part 803. The fact that your procedure does not include definitions from 21 CFR 803.3 for the terms “become aware,” “caused or contributed,” “malfunction,” “MDR reportable event,” and “serious injury,” and the definition for the term “reasonably suggests,” found in 803.20(c)(1) may lead your firm to make an incorrect reportability decision when evaluating a complaint that may meet the criteria for reporting under 21 CFR 803.50(a).b. There are no instructions for how the firm will evaluate information about an event to make MDR reportability determinations in a timely manner.2. BSP-02 Medical Device Reporting (MDR) Procedure does not establish internal systems that provide for a standardized review process to determine when an event meets the criteria for reporting under this part, as required by 21 CFR 803.17(a)(2). For example:a. There are no instructions for conducting an investigation of each MDR reportable event and evaluating the cause of the event as required under 21 CFR 803.50(b)(3).b. BSP-02 Medical Device Reporting (MDR) Procedure, as written, does not specify who makes the decision for reporting events to FDA.3. BSP-02 Medical Device Reporting (MDR) Procedure does not establish internal systems that provide for timely transmission of complete medical device reports, as required by 21 CFR 803.17(a)(3). Specifically, the following are not addressed:a. Instructions for how to obtain and complete the MedWatch for Industry FDA 3500A form, including which sections of the 3500A form will need to be completed to include all the information found in the firm’s possession and any information that becomes available as a result of a reasonable follow-up within the firm.b. The circumstances under which the firm must submit an initial report, supplemental or follow-up report, 5-day reports and the requirements for such reports.c. A process for submitting initial reports and supplement or follow-up reports to FDA in an electronic format that FDA can process, review, and archive in accordance with 21 CFR 803.12(a)1.4. BSP-02 Medical Device Reporting (MDR) Procedure does not describe how the firm will address documentation and record-keeping requirements, as required by 21 CFR 803.17(b), including:a. Documentation of adverse event related information maintained as MDR event files.b. Information that was evaluated to determine if an event was reportable.c. Documentation of the deliberations and decision-making processes used to determine if a device-related death, serious injury, or malfunction was or was not reportable.d. Systems that ensure access to information that facilitates timely follow-up and inspection by FDA.Your firm’s response did not include actions that you have completed, nor did it include information addressing the procedural deficiencies listed above. Instead, your firm listed planned actions, only one of which listed a date, December 31, 2024, by which the firm would “attempt” to complete and initiate a “Product Design and Development” procedure.Unique Device Identification Violation(s)The LASERwrap system is also 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 your firm causes a label to be applied to a device with the intent that the device will be commercially distributed without any subsequent replacement or modification of the label. Spectra Therapy, LLC is therefore a “labeler” within the meaning of 21 CFR 830.3 and has not submitted to GUDID any information required by 21 CFR Part 830, subpart E, respecting these devices.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).Our office requests that Spectra Therapy, LLC cease any activities that result in the misbranding or adulteration of the LASERwrap system such as the commercial distribution of the device for the uses discussed above.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 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.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 Establishment Assessment Team 1 Assistant Director Gina Brackett at CDRHEnforcement@fda.hhs.gov. Please include in the subject lineCMS Case 698026when replying. If you have any questions about the contents of this letter, please contact: Sean Moynihan at sean.moynihan@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/Matthew G. HillebrennerDeputy DirectorOffice of Product Evaluation and QualityCenter for Devices and Radiological Health_____________________1Information about the Final Rule for eMDR and the eMDR set-up process can be found on the FDA website at: eMDR – Electronic Medical Device Reporting | FDA

6月以来，为应对极端高温天气，保障药品质量安全，防止因储存、运输不当导致高温高湿环境影响药品稳定性，省局襄阳分局结合“清流”行动开展了药品流通环节夏季药品安全检查。强化监管，排查药品储运条件。紧盯重点单位、锁定重点品种、瞄准关键环节开展检查，监管人员把具备冷藏、冷冻药品经营资质的药品批发企业、零售连锁总部作为主要检查对象，重点围绕易高温变质药品、需低温贮存药品以及易发霉、虫蛀变质药品等品种，严格查验药品购进渠道合法性、药品储存养护制度执行、温湿度监测控制设备运行、冷藏车及保温箱验证等情况，以及冷链运输交接单是否连贯真实等。其中，在药品储存环节，重点查看了常温、阴凉、冷藏等不同储存温度要求药品分区存放情况，严防储存条件不合规影响药品质量。强化服务，引导企业规范管理。在检查过程中，注重加强与企业主要负责人、质量负责人、保管养护人员等关键岗位人员的沟通交流。积极普及夏季药品保管特别是冷链药品、阴凉储存品种以及易生虫霉变中药饮片的储存养护知识，耐心讲解药品储存养护过程中防范排查问题隐患的方法，帮助企业规范药品储存管理，督促企业切实履行主体责任。截至目前，已检查12家企业，排查风险隐患22项，对7家存在风险隐患的企业全部责令整改到位。（信息来源：省局襄阳分局）