依据《中华人民共和国行政许可法》第七十条第一款，《医疗器械生产监督管理办法》第二十一条第二款之规定，甘肃省药品监督管理局经公示后决定注销甘肃康鼎药业有限公司等8家企业《医疗器械生产许可证》。特此公告。企业名称生产地址许可证编号甘肃康鼎药业有限公司甘肃省定西市安定区经济开发区循环经济产业园河西片南八路甘食药监械生产许20200028号际华三五一二皮革服装有限公司甘肃省兰州市兰州新区华山路900号甘食药监械生产许20200024号兰州洛斯特医疗设备有限公司甘肃省兰州市榆中县和平镇金川大道西侧6号3楼甘食药监械生产许20200027号张掖市众兴药业有限责任公司甘肃省张掖市甘州区张掖经济开发区生态科技产业园北二路南侧甘食药监械生产许20200031号白银振亚卫生材料有限公司甘肃省白银市白银区高新技术产业开发区孵化西路1号甘食药监械生产许20200032号甘肃深呼吸创造智能科技有限公司甘肃省庆阳市镇原县城关镇金龙工业园区新一代院内甘食药监械生产许20200033号甘肃盛益康医疗器械科技有限责任公司甘肃省平凉市工业园区东一路甘食药监械生产许20210001号甘肃诺贝医疗器械科技有限责任公司甘肃省天水市麦积区花牛镇罗沟村2组甘食药监械生产许20210002号甘肃省药品监督管理局2026年5月13日

沈阳珂利尔卫生材料有限公司报告，由于生产的棉片说明书不符合《医疗器械监督管理条例》规定的原因，沈阳珂利尔卫生材料有限公司对其生产的棉片主动召回。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》。

序号1企业名称辽宁北峰药业有限公司企业类型药品生产检查时间2026年1月27日-2026年1月30日所在地市本溪市检查依据《药品管理法》《麻醉药品和精神药品管理条例》《药品生产监督管理办法》《药品生产质量管理规范》等。 检查事项药品生产检查。检查方式常规检查（日常）；专项检查。 检查内容1.执行GMP与《麻醉药品和精神药品管理条例》情况；2.第二类精神药品专项检查。 存在问题在人员培训方面存在培训不到位的问题；在文件管理方面存在记录不规范等问题。 处理措施要求企业按照《药品生产监督检查缺陷整改指南（试行）》的要求进行系统性整改。 整改情况已按要求完成整改。 序号2企业名称辽宁东方人药业有限公司企业类型药品生产检查时间2026年3月9日-2026年3月13日所在地市本溪市检查依据《药品管理法》《药品生产监督管理办法》《药品生产质量管理规范》等。 检查事项药品生产检查。检查方式常规检查（日常）检查内容行GMP情况。存在问题在人员培训方面存在培训不到位的问题；在文件管理方面存在修订不及时等问题。 处理措施要求企业按照《药品生产监督检查缺陷整改指南（试行）》的要求进行系统性整改。 整改情况已按要求完成整改。

经查，执业药师黄沙沙受到刑事处罚，根据《执业药师注册管理办法》第二十四条、第三十六条的规定，我局依法对黄沙沙的《执业药师注册证》予以注销，并将个人不良信息记入全国执业药师注册管理系统，自刑罚执行完毕之日起3年内不予注册。特此通告。附件：注销执业药师注册证人员名单序号执业药师姓名注册证号注册单位备注1黄沙沙64012602593宁夏达美医药源合堂大药房主动注销注册 宁夏回族自治区药品监督管理局2026年5月12日（此件公开发布）        扫一扫在手机打开当前页

辽宁省药品监督管理局行政检查结果公示 序号：1企业名称辽宁广生堂药业有限责任公司企业类型药品批发企业检查时间2026年4月7日-2026年4月9日所在地市沈阳市检查依据《中华人民共和国药品管理法》《中华人民共和国药品管理法实施条例》《药品经营和使用质量监督管理办法》等法律、法规、规章情况。检查事项药品经营检查检查方式常规检查检查内容执行《中华人民共和国药品管理法》《中华人民共和国药品管理法实施条例》《药品经营和使用质量监督管理办法》等法律、法规、规章情况。存在问题在人员培训方面，存在培训内容不完整的问题；在储存养护方面，存在部分药品储存管理不规范的问题。处理措施限期整改整改情况已按要求完成整改序号：2企业名称辽宁省药业发展有限公司企业类型药品批发企业检查时间2026年4月13日-2026年4月14日所在地市沈阳市检查依据《中华人民共和国药品管理法》《中华人民共和国药品管理法实施条例》《药品经营和使用质量监督管理办法》等法律、法规、规章情况。检查事项药品经营检查检查方式常规检查检查内容执行《中华人民共和国药品管理法》《中华人民共和国药品管理法实施条例》《药品经营和使用质量监督管理办法》等法律、法规、规章情况。存在问题在人员培训方面，存在培训内容不完整的问题；在体系文件方面，存在个别文件修订不及时的问题；在设施设备方面，存在防鼠设施不到位的问题。处理措施限期整改整改情况已按要求完成整改

根据《中华人民共和国行政许可法》第七十条、《化妆品生产经营监督管理办法》第二十三条的规定，安徽省药品监督管理局依法注销滁州向日葵药业有限公司《化妆品生产许可证》（详细信息见附件）。特此公告。附件：注销《化妆品生产许可证》清单安徽省药品监督管理局                                                       2026年5月12日    附件注销《化妆品生产许可证》清单企业名称许可证编号生产地址备注滁州向日葵药业有限公司皖妆20210005安徽省滁州市苏滁现代产业园五期现代工业坊2号标准厂房企业申请注销

广东省药品监督管理局通 告2026年 第42号　　近期，广东省药品监督管理局组织开展医疗器械生产企业监督检查，发现深圳市泰美康生物医疗科技有限公司质量管理体系存在严重缺陷，不符合《医疗器械生产质量管理规范》相关规定，已依法采取责令暂停生产的控制措施。序号企业名称生产许可证编号1深圳市泰美康生物医疗科技有限公司粤药监械生产许20255842号　　特此通告。广东省药品监督管理局2026年5月13日

　　国家药监局指导各级药品监督管理部门加强医疗器械网络销售监管，依托国家医疗器械网络销售监测平台，加强医疗器械网络销售监测和违法违规线索处置，严厉打击违法违规行为。各级药品监管部门积极行动，查处了一批违法违规案件，切实维护人民群众身体健康和用械安全。现通报4起医疗器械网络销售违法违规案件信息。　　一、厦门森柠潜友贸易有限公司在京东平台销售医疗器械，未按照要求展示医疗器械注册证　　2025年7月30日，厦门市思明区市场监督管理局根据网络监测线索，对厦门森柠潜友贸易有限公司进行监督检查。经查，当事人在京东平台销售第二类医疗器械一次性使用气管插管导丝，未在产品页面展示上述产品医疗器械注册证，且其在一年内已经因同一性质违法行为被责令整改、给予警告后未按要求改正。上述行为违反了《医疗器械网络销售监督管理办法》第十条规定，2025年12月27日，厦门市思明区市场监督管理局依据《医疗器械网络销售监督管理办法》第四十条规定，给予当事人行政处罚。　　二、广州拾壹美容科技有限公司在拼多多平台经营未依法注册的第二类医疗器械　　2025年12月8日，广州市黄埔区市场监督管理局根据投诉举报线索，对广州拾壹美容科技有限公司进行监督检查。经查，当事人在拼多多平台销售未依法注册的第二类医疗器械强脉冲光脱毛仪。上述行为违反了《医疗器械监督管理条例》第五十五条规定。2026年3月12日，广州市黄埔区市场监督管理局依据《医疗器械监督管理条例》第八十一条规定，给予当事人行政处罚。　　三、成都市优宜佳化妆品店未经许可在淘宝平台销售第三类医疗器械　　2026年1月8日，成都市双流区市场监督管理局根据网络监测线索，对优宜佳化妆品店进行监督检查。经查，当事人未取得医疗器械经营许可证在淘宝平台销售第三类医疗器械软性角膜接触镜。上述行为违反了《医疗器械监督管理条例》第四十二条规定。2026年3月25日，成都市双流区市场监督管理局依据《医疗器械监督管理条例》第八十一条规定，给予当事人行政处罚。　　四、西安泽医宁医疗器械有限公司在美团平台销售说明书和标签不符合规定的医疗器械　　2025年12月21日，西安市市场监督管理局高新分局根据投诉举报线索，对西安泽医宁医疗器械有限公司进行监督检查。经查，当事人在美团平台销售的第一类医疗器械医用退热凝胶，产品标示“适用于面部、背部起痘引起皮肤问题的人群”，上述内容与该产品备案信息“预期用途：用于发热患者的局部降温。仅用于体表完整皮肤”不一致。上述行为违反了《医疗器械监督管理条例》第三十九条规定，2026年2月4日，西安市市场监督管理局高新分局依据《医疗器械监督管理条例》第八十八规定，给予当事人行政处罚。　　医疗器械网络销售安全提示：　　《医疗器械监督管理条例》《医疗器械网络销售监督管理办法》等规定，从事医疗器械网络销售活动的，应当在其主页面显著位置展示其医疗器械生产经营许可证件或者备案凭证，在产品页面应当展示该产品的医疗器械注册证或者备案凭证，依法诚信经营，保证医疗器械质量安全。　　消费者通过网络购买医疗器械时，请关注其主页面显著位置是否展示其医疗器械生产经营资质和产品注册或者备案信息，关注医疗器械名称、型号、规格、结构及组成、适用范围等信息，是否与医疗器械注册证或者备案凭证的相关内容一致，切实维护自身权益。　　为医疗器械网络交易提供服务的电子商务平台经营者应当持续加强网售合规治理工作，对入网医疗器械经营者经营资质和产品资质加强监测和管理，发现违法违规行为及时制止并报告所在地药品监管部门。药品监管部门将认真贯彻落实“四个最严”要求，持续加大监管力度，保持高压态势，严惩重处违法违规行为，保障人民群众用械安全。

Delivery Method:Via Electronic Mail - Return Receipt RequestedReference #:320-26-74Product:DrugsRecipient:Mr. Young Joo KimChief Executive OfficerIDO Pharm Co., Ltd.41 Beonnyeong-ro, 15 beon-gilDanwon-gu Ansan-si Gyeonggi-do 15616South KoreaIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesWarning Letter 320-26-74May 4, 2026Dear Mr. Kim:The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, IDO Pharm Co., Ltd., 3017021001, at 41 Beonnyeong-ro, 15 beon-gil, Danwon-gu District, Ansan-si, Gyeonggi-do, from November 10 to 13, 2025.This warning letter summarizes significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals. See Title 21 Code of Federal Regulations (CFR), parts 210 and 211 (21 CFR parts 210 and 211).Because your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your drug products are adulterated within the meaning of section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 351(a)(2)(B).We reviewed your December 4, 2025, response to our Form FDA 483 in detail.During our inspection, our investigator observed specific violations including, but not limited to, the following.1. Your firm failed to establish 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)).You manufacture multiple drug products labelled as (b)(4).Inadequate (b)(4) System ValidationYour firm did not establish procedures describing the operation, cleaning, maintenance, or validation of your (b)(4) system, which is used to make a component of your drug products. Hoses were observed to contain stagnant (b)(4), and your (b)(4) tank contained visible particulate matter floating on the (b)(4) surface, including what appeared to be an insect.In your response, you state that you conducted an immediate inspection of the insanitary conditions in your (b)(4) system, storage tanks, piping, and hoses, and took corrective actions including draining and drying the hose containing stagnant (b)(4). You state that you will establish a (b)(4) system procedure that includes cleaning frequency for tanks, draining and drying criteria for hoses, and controls to prevent stagnant (b)(4). You also state you will conduct personnel training.Your response is inadequate because your firm continues to manufacture drug products using an unqualified (b)(4) system that has not been validated for its intended use. You also failed to address the lack of qualification and validation of your (b)(4) system.Inadequate Process and Equipment Cleaning ValidationYour firm did not conduct process validation or equipment cleaning validation for your (b)(4) over-the-counter drug products.In your response, you state that your firm plans to relocate your facility in April 2026 and that equipment qualification and validation activities which include manufacturing processes, method validation, and cleaning validation will be performed in parallel by July 2026. Your response is inadequate because you failed to provide your interim plans until your corrective actions are completed. You also did not conduct a risk assessment to evaluate the impact of manufacturing with unvalidated processes, nor did you provide an action plan to address any drug product quality or safety risk for batches already distributed to the U.S. market.Process validation evaluates the soundness of design and state of control of a process throughout its lifecycle. Each significant stage of a manufacturing process must be designed appropriately and assure the quality of raw material inputs, in-process materials, and finished drugs. Process qualification studies include intensive monitoring and testing throughout each significant process stage to characterize intra-batch variation and evaluate batches to determine whether an initial state of control has been established.Successful process qualification studies are necessary before commercial distribution. Thereafter, ongoing vigilant oversight of process performance and product quality is necessary to ensure you maintain a stable manufacturing operation throughout the product lifecycle.See FDA’s guidance document at www.fda.gov/regulatory-information/search-fda-guidance-documents/process-validation-general-principles-and-practices for general principles and approaches that FDA considers appropriate elements of process validation.In response to this letter please provide:A detailed summary of your validation program for ensuring a state of control throughout the product lifecycle, along with associated procedures. Describe your program for process performance qualification (PPQ), and ongoing monitoring of both intra-batch and inter-batch variation to ensure a continuing state of control.A timeline for performing appropriate process performance qualification (PPQ) for each of your marketed drug products. Also provide a risk assessment and any follow-up actions to be taken for the distributed drug products produced without performing any process validation studies.Process performance protocols and written procedures for qualification of equipment and facilities.A detailed program for designing, validating, maintaining, controlling and monitoring each of your manufacturing processes that includes vigilant monitoring of intra-batch and inter-batch variation to ensure an ongoing state of control. Also, include your program for qualification of your equipment and facility.A comprehensive remediation plan for the design, control, and maintenance of the (b)(4) system.o A (b)(4) system validation report. Also include the summary of any improvements made to system design and to the program for ongoing control and maintenance.Your total microbial count limits to monitor whether this system is producing (b)(4) suitable for the intended uses for each of your drug products.A detailed risk assessment addressing the potential effects of the observed (b)(4) system failures on the quality of all drug product lots currently in U.S. distribution or within expiry. Specify actions that you will take in response to the risk assessment, such as customer notifications and product recalls.A procedure for your (b)(4) system monitoring that specifies routine microbial testing of (b)(4) to ensure its acceptability for use in each batch of drug products produced by your firm.The current action/alert limits for total counts and objectionable organisms used for your (b)(4) system.A procedure governing your program for ongoing control, maintenance, and monitoring that ensures the remediated system consistently produces (b)(4) that meets (b)(4), USP monograph specifications and appropriate microbial limits.2. Your firm failed to establish laboratory controls that include scientifically sound and appropriate specifications, standards, sampling plans, and test procedures designed to assure that components, drug product containers, closures, in-process materials, labeling, and drug products conform to appropriate standards of identity, strength, quality, and purity (21 CFR 211.160(b)).You failed to appropriately establish and validate your gas chromatographic (GC) method for assay testing of (b)(4) in your finished drug products. Also, you failed to validate your GC method for determining (b)(4) and volatile impurities in your (b)(4) raw material. In addition, you failed to test your (b)(4) raw material for the presence of (b)(4) and volatile impurities.In your response, you state that you will discontinue using the unvalidated methods and intend to establish and validate new GC testing methods. You also state your firm will implement (b)(4) testing for your (b)(4) raw material and conduct impurity testing for every lot of (b)(4) per your updated release requirements.Your response is inadequate because you failed to conduct a risk assessment evaluating the impact of using unvalidated methods and did not address testing of finished product retains that may have been manufactured using untested or inadequately tested raw materials.Analytical methods must be validated to demonstrate they are suitable for their intended use and equivalent or better than applicable United States Pharmacopeia compendial methods. Verifying the accuracy, sensitivity, specificity, and reproducibility of your test methods is essential to ensuring that manufactured drug products meet established specifications for chemical and microbial attributes.In your response to this letter please provide:A list of chemical and microbial specifications, including test methods, used to analyze each lot of your drug products before a lot disposition decision.o An action plan and timelines for conducting full chemical and microbiological testing of retain samples to determine the quality of all batches of drug products distributed to the United States that are within expiry as of the date of this letter.o A summary of all results obtained from testing retain samples from each batch. If such testing reveals substandard quality drug products, take rapid corrective actions, such as notifying customers and product recalls.A comprehensive independent assessment of your laboratory practices, procedures, and methods. Based on this review, provide a detailed plan to remediate and evaluate the effectiveness of your laboratory system.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).Your quality unit (QU) did not adequately exercise its authority and responsibilities including, but not limited to, implementing effective procedures and conducting adequate oversight of the drug products you manufacture. For example, your QU failed to ensure:Establishment of an appropriate written testing program designed to assess the stability characteristics of drug products and to use results of stability testing to determine appropriate storage conditions and expiration dates (21 CFR 211.166(a)).Establishment of adequate batch production and control records that contain the accomplishment of each significant step in the manufacture, processing, packing, or holding of the batch, for each batch of drug product (21 CFR 211.188).Performance of routine calibrations of equipment used in the manufacture, processing, packing, and holding of a drug product (21 CFR 211.68(a)).Your firm’s quality systems are inadequate. See FDA’s guidance documents, as well as for help implementing quality systems and risk management approaches to meet the requirements of CGMP regulations 21 CFR, parts 210 and 211 at https://www.fda.gov/media/71553/download and at https://www.fda.gov/media/71023/download respectively.In response to this letter, provide a comprehensive assessment and remediation plan to ensure your QU is given the authority and resources to effectively function. The assessment should also include, but not be limited to:A determination of whether procedures used by your firm are robust and appropriate.Provisions for QU oversight throughout your operations to evaluate adherence to appropriate practices.A complete and final review of each batch and its related information before the QU disposition decision.Oversight and approval of investigations and discharging of all other QU duties to ensure identity, strength, quality, and purity of all products.CGMP Consultant RecommendedBased upon the nature of the violations we identified at your firm, you should engage a consultant qualified as set forth in 21 CFR 211.34 to evaluate your operations and to assist your firm in meeting CGMP requirements. The qualified consultant should also perform a comprehensive six-system audit of your entire operation for CGMP compliance and evaluate the completion and efficacy of your corrective actions and preventive actions before you pursue resolution of your firm’s compliance status with FDA.Your use of a consultant does not relieve your firm’s obligation to comply with CGMP. Your firm’s executive management remains responsible for resolving all deficiencies and systemic flaws to ensure ongoing CGMP compliance.ConclusionThe violations cited in this letter are not intended to be an all-inclusive list of violations that exist at your facility. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations.FDA placed all drugs and drug products offered for import into the United States from your firm on Import Alert 66-40 on March 31, 2026.Correct any violations promptly. FDA may withhold approval of new applications or supplements listing your firm as a drug manufacturer until any violations are completely addressed and we confirm your compliance with CGMP. We may re-inspect to verify that you have completed corrective actions to any violations.Failure to address any violations may also result in the FDA continuing to refuse admission of articles manufactured at IDO Pharm Co., Ltd., located at 41 Beonnyeong-ro, 15 beon-gil, Danwon-gu District, Ansan-si, Gyeonggi-do, 15616, Republic of Korea, into the United States under section 801(a)(3) of the FD&C Act, 21 U.S.C. 381(a)(3). Articles under this authority that appear to be adulterated may be detained or refused admission, in that the methods and controls used in their manufacture do not appear to conform to CGMP within the meaning of section 501(a)(2)(B) of the FD&C Act, 21 U.S.C. 351(a)(2)(B).This letter notifies you of our findings and provides you an opportunity to address the above deficiencies. After you receive this letter, respond to this office in writing within 15 working days. Specify what you have done to address any violations and to prevent their recurrence. In response to this letter, you may provide additional information for our consideration as we continue to assess your activities and practices. If you cannot complete corrective actions within 15 working days, state your reasons for delay and your schedule for completion.Send your electronic reply to CDER-OC-OMQ-Communications@fda.hhs.gov. Identify your response with FEI 3017021001 and ATTN: Yvette Johnson.Sincerely,/S/Francis GodwinDirectorOffice of Manufacturing QualityOffice of ComplianceCenter for Drug Evaluation and Research

Delivery Method:Via EmailProduct:DrugsRecipient:Tal Bornstein, CEORoei Farhi, CEONaveh Pharma LTD/Bigdam Inc.19, Yad Kharutsim St.Netanya, Sharon areaIsraelTal@navehpharma.cominfo@navehpharma.comroei@navehpharma.comhello@u-better.comIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesWARNING LETTERMay 4, 2026Bigdam Inc1441 Woodmont Ln NW,Atlanta GA 30318, United StatesRE: 724669Dear Tal Bornstein and Roei Farhi:This letter is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your websites https://www.navehpharma.com/ and https://u-better.com/, and your Amazon storefront1 in March 2026. The FDA has observed that you offer your products, “RSV Hypertonic Saline 3%” and “Hypertonic Saline 7%” for sale in the United States. Based on our review, these products are unapproved new drugs 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 these products for introduction into interstate commerce violates sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a).In addition, FDA reviewed the records you submitted in response to our initial April 28, 2025, request for records and other information, and subsequent correspondence, pursuant to section 704(a)(4) of the FD&C Act for your facility, Naveh Pharma (1966) LTD, FEI 3027300316, at 19 Yad Kharutsim, Netanya, Sharon Area, Israel.Unapproved New DrugsBased on a review of your websites, your “RSV Hypertonic Saline 3%” and “Hypertonic Saline 7%” products are drugs under section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1), because they are 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. Examples from your product labeling, including on your websites that provide evidence of the intended use (as defined in 21 CFR 201.128) of these products as drugs include, but may not be limited to, the following:RSV Hypertonic Saline 3%From the “RSV Hypertonic Saline 3%” document2 available on the webpage https://www.navehpharma.com/products/advanced-ent-line/hypertonic-saline/:“For treatment of Bronchiolitis (RSV - respiratory syncytial virus)”“In recent years quite a number of studies around the world, proved the effectiveness of treatment with Hypertonic saline inhalation in infants hospitalized suffering from acute bronchiolitis.”“Hypertonic saline inhalation therapy resulted in clinical improvement and shortening the duration of hospitalization.”“Hypertonic saline works by raising fluid lining in the airway walls, reducing the edema layer of the submucosa, improving Rheological properties of sputum and acceleration of the mucus clearance (MC).”“For respiratory use with inhalators in cases of bronchiolitis- RSV infections”On the webpage https://u-better.com/products/saline-solution-3-for-daily-inhalation-25-vials:“This 3% saline solution is ideal for nebulizer therapy and nasal irrigation. It helps clear mucus and supports easier breathing.”“Gentle On Airways And Clinically Sterile Saline (NaCl + water) That Helps Loosen Mucus and Hydrate Nasal & Respiratory Passages—For Clear, Comfortable Breathing.”The product name: “RSV Hypertonic Saline”Hypertonic Saline 7%On the webpage https://www.navehpharma.com/products/advanced-ent-line/hypertonic-saline-7/:“Hypertonic saline creates an osmotic pressure that increases the volume of airway surface liquid, restore mucus clearance, and improve lung function.”“Recent clinical studies in patients with cystic fibrosis, have shown that inhalation of hypertonic saline produced a sustained acceleration of mucus clearance and improved lung function. This treatment improves sputum viscosity and ease expectoration.”“The advantages of treatment with 7% hypertonic saline in lung diseases are:o Improving lung functiono Stimulate mucociliary clearanceo Improving quality of lifeo Decreases hospital admissions. . .o Effective treatment of moderately and severe lung diseases.”On the webpage https://u-better.com/products/saline-solution-7-for-respiratory-relief-25-vials“This 7% saline solution is a powerful option for respiratory support, ideal for clearing mucus and promoting easier breathing. Designed for inhalation and nasal irrigation, it’s perfect for adults and seniors managing respiratory health.”Your “RSV Hypertonic Saline 3%” and “Hypertonic Saline 7%” products are “new drugs” under section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because they are not generally recognized as safe and effective (GRASE) for use under the above-described conditions prescribed, recommended, or suggested in their 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, 21 U.S.C. 355(a). No approved applications pursuant to section 505 of the FD&C Act, 21 U.S.C. 355, are in effect for these products. Accordingly, these products are unapproved new drugs. The introduction or delivery for introduction into interstate commerce of these unapproved new drug products violates sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a).Drug CGMP ViolationsBecause your methods, facilities, or controls for manufacturing, processing, packing, or holding of drugs as described in your response to our 704(a)(4) request do not conform to CGMP, your drug products are adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act, 21 U.S.C. 351(a)(2)(B).Following review of records and other information provided pursuant to section 704(a)(4) of the FD&C Act, significant violations were observed including, but not limited to, the following:Your firm failed to establish an adequate quality control unit with the responsibility and authority to approve or reject all components, drug product containers, closures, in-process materials, packaging materials, labeling, and drug products (21 CFR 211.22(a))The records and information you submitted stated that your firm does not have a quality unit (QU) to provide adequate quality oversight over the manufacture and release of finished drug products shipped to the United States.Without an established quality unit, your facility lacks an effective quality system. See FDA’s guidance document ICH Q10 Pharmaceutical Quality System, as well as Quality Systems Approach to Pharmaceutical CGMP Regulations, for help implementing quality systems and risk management approaches to meet the requirements of CGMP regulations 21 CFR, parts 210 and 211 at https://www.fda.gov/media/71553/download, and https://www.fda.gov/media/71023/download, respectively.In response to this letter, provide the following:A comprehensive assessment and remediation plan to ensure you establish a QU that is given the authority and resources to effectively function. The assessment should also include, but not be limited to:o A determination of whether procedures used by your firm are robust and appropriateo Provisions for QU oversight throughout your operations to evaluate adherence to appropriate practiceso A complete and final review of each batch and its related information before the QU disposition decisiono Oversight and approval of investigations and discharging of all other QU duties to ensure identity, strength, quality, and purity of all productsConclusionThe violations cited in this letter are not intended to be an all-inclusive statement of violations that may exist in connection with your products. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations.This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address this matter may lead to regulatory or legal action including, without limitation, seizure and injunction.Please notify FDA in writing, within fifteen working days of receipt of this letter, of the specific steps you have taken to correct any violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. 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. If you cannot complete corrective action within fifteen working days, state the reason for the delay and the time within which you will complete the correction.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 724669 in the subject line of the email.Sincerely,/S/Tina Smith, M.S.Captain, U.S. Public Health ServiceDirectorOffice of Unapproved Drugs and Labeling ComplianceOffice of ComplianceCenter for Drug Evaluation and ResearchFood and Drug Administration/S/Francis GodwinDirectorOffice of Manufacturing QualityOffice of ComplianceCenter for Drug Evaluation and ResearchFood and Drug Administration_______________________1 https://www.amazon.com/stores/page/32459A2E-623E-4FF5-A843-5E2A11377B9E?ingress=0&visitId=41227466-4ab1-4d27-bdf4-403b4beb212f2 https://www.navehpharma.com//wp-content/uploads/2016/09/rsv-flier_en-1.pdf