序号检查项目检查结果1企业名称盘锦博菲特医疗技术有限公司2企业类型医疗器械生产企业3检查时间2026年5月12日-2026年5月18日4所在地市盘锦市5检查依据《医疗器械监督管理条例》《医疗器械生产监督管理办法》《医疗器械生产质量管理规范》等法规规章和规范性文件6检查事项医疗器械生产检查7检查方式常规检查8检查内容贯彻落实《医疗器械监督管理条例》《医疗器械生产监督管理办法》及《医疗器械生产质量管理规范》情况9存在问题在厂房与设施方面存在生产操作台上有个人生活用品等问题；在销售和售后服务方面存在未对相关信息进行跟踪分析等问题。10处理措施限期整改11整改情况已按要求完成整改

Delivery Method:VIA Electronic MailProduct:Medical DevicesRecipient:Joseph Carlone Jr.President and CEOLinemaster Switch Corporation29 Plaine Hill RoadWoodstock, CT 06281United States(b)(6), (b)(7)(C)Issuing Office:Center for Devices and Radiological HealthUnited StatesWARNING LETTERCMS #730215May 27, 2026Dear Mr. Carlone:During an inspection of your firm located in Woodstock, CT from February 4, 2026, through March 6, 2026, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures foot pedal accessories for medical devices, including Class II foot pedal controls used with Class IV medical lasers. 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.Quality Management 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 Management System Regulation found at Title 21, Code of Federal Regulations (CFR), Part 820.We received your response dated March 30, 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 this response below, in relation to each of the noted violations. These violations include, but are not limited to, the following:1. Failure to perform rework in accordance with documented procedures that take into account the potential adverse effect of the rework on the product, as required by ISO 13485:2016, Clause 8.3.4.Specifically, your firm did not implement their procedure, Q 006 Rev D3, Nonconforming Material Control, dated October 14, 2025. For example:Section 7.6 of the procedure states "Rework and repair instructions shall be documented on the MRR or a Nonconforming Material Rework/Repair Request form Q6-12 with specific Manufacturing and Inspection Instructions recorded." Rework was not documented when nonconforming units were identified. During the manufacture of Job (b)(4), the Manufacturing Manager explained that Job (b)(4), which consisted of (b)(4) units of (b)(4) (part number (b)(4)) foot pedals had nonconforming product and was being reworked because after calibration, the assembler had failed to (b)(4) screws. The supervisor had the assembler perform rework to apply torque and recalibrate all (b)(4) units, and this rework was not being documented.We are aware that inadequate calibration of your foot pedals may result in unintended laser activation or inadequate laser power delivery.The adequacy of your response cannot be determined at this time. We understand that you plan to review and revise your reprocessing and rework procedures to ensure documentation is appropriate for any lots that do not meet specifications. You also plan to do a retrospective review of reworked lots and assess whether any remedial action is needed. However, you have not provided a timeline for when this work will be completed or any revised documents. In response to this Warning Letter, please provide your revised procedures as well as a summary of the retrospective review when complete and describe any corrective actions that may be required.2. Failure to document one or more processes for risk management in product realization, as required by ISO 13485:2016, Clause 7.1.Specifically,a. Your firm failed to implement Risk Management procedure TM-112, Rev D Section 5.3.2, which states "Process FMEA's are created to assess the highest risk in processing and action is taken to reduce the risk", in that you failed to have a Process FMEA for foot pedal (b)(4) (part number (b)(4)), an accessory device used to control Class IV medical lasers.b. Your firm's Risk Management procedure TM-112 does not define how risk management activities are performed and documented, who is responsible for conducting and approving risk management activities, when risk management documentation must be updated, and how post-market feedback data (including complaints, adverse events, and recalls) is incorporated into risk management.The adequacy of your response cannot be determined at this time. We understand that you plan to update your risk management procedure, perform a retrospective assessment of available post-market and internal quality data and then create or update your current risk management files. However, you have not provided a timeline for when this work will be completed or any revised documents. In response to this Warning Letter please provide updated risk documents as well as a summary of your retrospective review when complete and describe any corrective actions that may be required.3. Failure to document corrective action procedures to define the requirements for determining the causes of nonconformities and reviewing the effectiveness of corrective action taken, as required by ISO 13485: 2016: Clause 8.5.2.Specifically, Nonconforming Material Report Procedure Q 006 Rev D3, section 9.1, which requires that Customer Requests for Corrective Action shall be investigated, and a corrective action plan be developed, was not implemented.For example, SCAR-00014, dated November 14, 2023, was opened because 6 foot pedals, (b)(4), failed the calibration verification test at the customer’s facility. This SCAR was not investigated as required by your procedure. Your SCAR response to the customer on January 26, 2024, shows Root Cause [BLANK] and Corrective Action "NA".The adequacy of your response cannot be determined at this time. We understand that you plan on revising procedures governing SCAR and customer corrective action responses. We also understand that you plan to do a retrospective review of customer-originated corrective action requests and similar calibration-related nonconformities. However, you have not provided a timeline for when this work will be completed or any revised documents. In response to this Warning Letter, please provide your revised procedures as well as a summary of the retrospective review when complete and describe any corrective actions that may be required.4. Failure to document the requirements for the work environment and the procedures to monitor and control the work environment, when conditions for the work environment can have an adverse effect on product quality, as required by ISO 13485:2016, Clause 6.4.1.Specifically, your firm does not have procedures or controls to monitor the work environment that can have an adverse effect on product quality. Your firm identified an issue with (b)(4), which is the unintended change in a sensor’s output due to temperature fluctuations, causing measurement inaccuracy over time in your Request for Engineering Assistance (REA) #20130763, dated September 26, 2013. However, you have not developed any procedures or put in place any controls to monitor the temperature to demonstrate that these devices maintain accurate calibration under temperature variations. The only control put into place was implementation of a (b)(4) in the device firmware.The adequacy of your response cannot be determined at this time. We understand that you plan to validate (b)(4) across relevant temperature conditions and also plan to establish any needed facility, equipment, or process changes required to maintain the defined work environment during calibration. However, you have not provided a timeline for when this work will be completed or provided any protocols or documents to confirm this work is being done. In response to this Warning Letter please provide documentation of your completed successful validation.5. Failure to document procedures for the validation of the application of computer software used for the monitoring and measurement of requirements, as required by ISO 13485:2016, Clause 7.6Specifically,a. Your firm's Monitor Program (b)(4) software, used in calibration procedure TM-118 Rev C and quality test procedure QTP (b)(4) Rev G for calibration and testing of (b)(4), foot pedal accessory devices, was not adequately validated. For example, the validation, TM-117 Rev A, September 26, 2013, did not include:Raw data from validation testingPass/fail criteria or resultsStatistical analysis or sample size rationaleVerification that the software accurately measures output values and reliably detects nonconforming devicesDuring FDA’s inspection our Investigator observed the testing setup of (b)(4). He observed there were multiple software COM port errors in both in-process assembly and final product testing areas. Firm personnel described these as routine and these errors were not investigated. From 2023 - 2025, we observed that a total of (b)(4) units passed Linemaster's calibration testing using (b)(4) but were subsequently returned because they failed customer calibration testing.b. Your firm has not adequately validated the (b)(4) to prevent calibration drift of the (b)(4), foot pedal accessory. As noted above, your firm identified an issue with (b)(4) in your Request for Engineering Assistance (REA) #20130763, dated September 26, 2013. However, the referenced validation document, TM-83 Rev A "997-P46 Firmware Validation Product: (b)(4)," did not include:Testing at multiple temperatures or temperature rangesCorrelation between temperature and sensor outputDemonstration that (b)(4) maintains calibration accuracy across temperature variationsRaw data showing (b)(4) performanceStatistical analysis of (b)(4) effectivenessPass/fail criteria specific to (b)(4) performanceTemperature cycling or (b)(4) stress testingComparison of calibrated vs. uncalibrated performance across temperaturesThe adequacy of your response cannot be determined at this time. We understand that you plan to revalidate the (b)(4) software as well as assess whether any prior product disposition or calibration decisions require additional review based on software validation findings. However, you have not provided a timeline for when this work will be completed or provided any protocols or documents to confirm this work is being done. In response to this Warning Letter, please confirm when this revalidation will be completed and whether any additional product disposition is required after your review is completed.A follow up inspection will be required to ensure that 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. 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.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 Gina Brackett, Assistant Director at CDRHEnforcement@fda.hhs.gov. Please include in the subject line, “CMS Case #730215” when replying. If you have any questions about the contents of this letter, please contact: Karen Archdeacon, Compliance Officer at karen.archdeacon@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 HealthCc: Edward Ursillo, Director of Quality Assurance, (b)(6), (b)(7)(C)

按照《医疗器械监督管理条例》《医疗器械生产监督管理办法》有关规定，根据企业申请，广东省药品监督管理局依法注销广东祺达医疗器械有限公司等7家企业的《医疗器械生产许可证》。特此通告。附件：企业信息广东省药品监督管理局2026年7月21日附件企业信息序号企业名称许可证编号生产地址1广东祺达医疗器械有限公司粤食药监械生产许20142644号广州白云区江高镇兴盛路100号03室2深圳市康达安生物科技有限公司粤食药监械生产许20183250号深圳市南山区西丽街道留仙洞工业区顺和达厂区第一栋第二层东3金进精密科技（深圳）有限公司粤药监械生产许20234984号深圳市龙岗区平湖街道山厦社区科园西路100号1号及4号厂房4深圳世强生物医疗电子有限公司粤食药监械生产许20162907号深圳市南山区西丽街道阳光社区松白路1008号港鸿基高新智能产业园C栋5045德凯创电子科技（东莞）有限公司粤药监械生产许20245612号广东省东莞市凤岗镇理光路1号1号楼602室6深圳市雅洁康科技有限公司粤药监械生产许20235078号深圳市龙华区大浪街道同胜社区南江工业区2栋4017广州暨创医疗生物科技有限公司粤药监械生产许20245649号广州市白云区江高镇雄郭东路223号3栋401房、501房

近年来，医保部门在坚持严查严打、保持基金监管高压态势的同时，高度重视打防结合、关口前移，积极推动事前提醒在定点医药机构落地应用，把各类违法违规问题消灭在“萌芽”状态，从源头上减少违法违规问题的发生。一是主动公开监管规则，公开发行《医疗保障基金智能监管规则库、知识库（2025年版）》，全量收录了近25万条规则和知识点。通过国家医保局官网和公众号持续公开发布智能监管规则和知识点，帮助医务人员更好的了解和掌握医保基金监管规则，助力定点医药机构提升自我管理。二是大力推进事前提醒系统建设，依托医保信息平台，建设完善事前智能提醒系统，所有定点医药机构都可以免费接入，免费调用，在医务人员诊疗过程中即可对违规风险进行提醒、预警和拦截。三是支持个性化管理应用，对于技术实力较强、信息化基础较好的医药机构，鼓励其将国家公开的“两库”规则和知识点嵌入医院HIS系统，提高运行效率，满足个性化管理需要。根据国家医保信息平台数据，截至6月30日，全国定点医药机构事前提醒系统接入率已达到71%，提前完成了年初提出的70%的接入率目标。其中，定点零售药店接入率82%，定点医疗机构接入率65%，三级、二级、一级及以下医疗机构接入率分别为92%、85%、64%。公立医疗机构和民营医疗机构接入率分别为62%和76%。分省份看，全国已有安徽、湖北、天津、河北、吉林、黑龙江、福建、甘肃、贵州9个省份和新疆生产建设兵团接入率超90%。今年1-6月，医保智能监管事前提醒已累计5605万人次，涉及金额129亿元。下一步，国家医保局将指导各级医保部门，不断优化完善事前提醒系统，动态完善智能监管规则库、知识库并向社会公开，为事前提醒工作提供有力支撑，持续赋能广大定点医药机构，力争“十五五”期间实现定点医药机构事前提醒全覆盖。中国医保，一生守护！维护医保基金安全，人人有责！打击欺诈骗保举报电话：010-89061396，010-89061397；邮箱：jubao@nhsa.gov.cn。

7月8日，朔州市市场监管局召开专题部署会，迅速启动处方药违法违规行为拉网式排查整治，以快部署、快落实筑牢群众用药安全防线。会议第一时间传达省药监局工作要求，结合全市药品流通监管实际细化整治方案，压实市、县两级监管责任，联动医保、卫健、公安、网信建立联合执法、线索移送、行刑衔接协同机制，同步组织药店开展自查自纠，压紧企业质量安全主体责任。本次整治聚焦执业药师挂证脱岗、无处方或虚假处方销售处方药、线上违规售药、处方台账管理不规范四大突出问题，线上线下同步发力。线下覆盖全市零售药店、医疗机构，结合“清源”巩固提升专项行动开展拉网式全覆盖检查；线上依托网络售药监管平台，对线上药店、医药直播开展常态化监测。朔州市局将持续保持整治高压态势，常态化开展暗访抽查和问题“回头看”，依托智慧监管手段强化风险预警，畅通群众投诉举报渠道，健全药品安全社会共治体系，全力规范处方药经营使用秩序。（张 枫）

为深入贯彻落实习近平总书记关于药品监管的重要指示批示精神和“四个最严”要求，深刻汲取有关领域安全事故教训，全面排查药品网络销售环节安全风险隐患，严厉打击违法违规销售药品行为，根据国家药监局有关部署，7月20日，山西省药监局制定印发《药品网络零售监督检查工作方案》（以下简称《方案》），在全省组织开展药品网络零售监督检查工作。摸清行业底数，建立动态精准监管档案。《方案》聚焦药品网络交易第三方平台、药品网络零售企业两大核心主体，全面开展拉网式摸排。准确掌握第三方平台数量、基础信息、业务范围及运营模式，确保监管对象无遗漏、数据采集无死角。建立精细化分类监管台账，逐一登记主体证照资质、网络经营渠道、仓储物流地址等关键信息，形成“一户一档”的完整数据闭环。梳理经营行为、产品合规性等重点风险清单，依据风险特征与危害程度，对监管对象实施风险等级划分与动态调整，实现精准监管。聚焦重点任务，全面排查安全风险隐患。《方案》以药品销售主体合法、销售行为合规、质量管理体系运行有效、药品来源合法为根本要求，重点核查平台入驻资质审核、线上亮证、药品资质审核等情况，以及药品零售企业质量负责人履职、药品采购渠道等情况，全面排查药品网络销售环节风险隐患，严厉打击违法违规行为，切实规范药品网络经营秩序。健全工作机制，压实各方监管责任。为确保监督检查工作落地见效，《方案》明确各级药品监管部门职责分工，统筹机关处室、检查分局、直属事业单位协同发力，建立“省市联动、上下协同、部门配合”的工作格局，凝聚上下一体监管合力。坚持“线上线下一起查”“管线下就得管线上”原则，严格执行“同证照、同产品、同人员、同管理”工作标准，压实平台管理责任、零售企业主体责任、零售企业相关人员个人责任和属地监管责任，构建起“各司其职、各负其责、齐抓共管”的责任体系。严格闭环推进，构建长效化监管体系。《方案》细化各阶段工作时限，分步开展信息收集比对、现场核查、违法行为处置等各项工作，实行台账式、清单化闭环管理，严禁以企业自查替代监督检查。省局将通过督导检查、工作调度压实各级监管责任，同步归集网售企业监管数据，系统梳理共性风险短板，推动集中整治转为常态化监管，持续净化全省药品网络经营环境，切实维护人民群众用药安全。（冯 璐）

7月10日，山西省药监局党组书记、局长李庭芳赴大宁县调研驻村帮扶和市县药品监管能力标准化建设“三个一批”工作。在三多乡东堡村，李庭芳实地考察宁粹苹果种植基地防雹网改造项目，现场查看项目建设情况和改造成效，对防雹网升级改造提出针对性指导意见。他指出，要聚焦大宁县宁粹苹果主导产业，用好帮扶资金，提升帮扶质效。期间，李庭芳还深入太仙村、东堡村走访慰问困难老党员，与老党员促膝长谈，细致询问身体状况、家庭收入、医疗保障等生活实情，感谢老党员多年来为乡村发展作出的贡献，叮嘱驻村工作队持续做好常态化走访帮扶，用心解决群众急难愁盼。调研组还实地察看了太仙村、东堡村驻村工作队驻地，详细了解队员日常工作、食宿保障等情况。在大宁县市场监督管理局，李庭芳详细了解大宁县药品监管队伍建设、日常风险排查、标准化建设推进等工作进展，认真听取在药品零售、医疗器械监管中遇到的难点。李庭芳指出，实施市县药品监管能力标准化建设“三个一批”是打通药品安全监管“最后一公里”、落实“四个最严”要求的关键举措，大宁县要落实“四方”责任，对照建设标准，补齐短板弱项，用好专项扶持资源，规范基层执法流程，持续提升县域药品安全治理水平，切实守护群众用药安全底线。（庞 荣）

按照《药品经营和使用质量监督管理办法》第二十七条第一项的规定，根据企业申请，我局现依法注销鞍山市凤宇医药科技有限公司光明医药分公司的《药品经营许可证》（许可证编号：辽AB412000015）。特此公告。辽宁省药品监督管理局2026年7月20日

　　根据郑州市市场监督管理局《关于建议撤销杜建阳等《执业药师注册证》的报告》的报告及河南省药品监督管理局准予许可决定书（文号：豫药监审批执许决字(2026)第01473号；豫药监审批执许决字(2026)第01474号；豫药监审批执许决字(2026)第01475号）。依据《执业药师注册管理办法》二十四、三十四和三十六条规定，依法注销杜建阳等三人《执业药师注册证书》，执业药师注册证作废；三年内不予注册，并作为不良信息记入全国执业药师注册管理信息系统。　　详细情况如下：　　序号姓名执业药师注册证号执业药师注册证有效期1杜建阳4112250101922030-04-242李敖4112250101922030-01-193董克纯4122250141262029-10-11　　2026年7月21日

　　根据《中华人民共和国行政许可法》《化妆品生产经营监督管理办法》的有关规定，我局依法注销河南树铭药业有限公司、河南爱视力药业有限公司的《化妆品生产许可证》（详见附件）。　　特此公告。　　附件：注销《化妆品生产许可证》的企业名单　　2026年7月21日附 件注销《化妆品生产许可证》的企业名单序号企业名称许可证号生产地址许可项目有效期注销原因1河南树铭药业有限公司豫妆20190006河南省南阳市卧龙区龙祥路树铭健康产业园1号一般液态单元（护发清洁类、护肤水类）；膏霜乳液单元（护发类、护肤清洁类）；粉单元（散粉类、浴盐类）2024年9月3日至2029年9月21日企业主动申请注销2河南爱视力药业有限公司豫妆20210005河南省南阳市市辖区高新技术产业园（纬八路与经九路交叉口北侧）一般液态单元(护肤水类);膏霜乳液单元(护肤清洁类)2021年7月8日至2026年7月7日有效期届满未申请延续