Delivery Method:Via UPS and EMAIL、Signature RequiredProduct:BiologicsRecipient:Mekonnen AbebeOwner and Chief Executive OfficerLux Therapeutics LLC dba Ponya Therapeutics LLC13 Corporate Blvd NEBrookhaven,GA30329United StatesMAbebe@ponyadx.comIssuing Office:Office of Compliance and Biologics QualityUnited StatesWARNING LETTERCBER 26-720001November 25, 2025Dear Mr. Abebe:During an inspection of your firm, Lux Therapeutics LLC dba Ponya Therapeutics LLC located at 13 Corporate Blvd NE, Brookhaven, GA, conducted between June 2, 2025, and June 6, 2025, the United States Food and Drug Administration (FDA) documented significant violations from the regulations for human cells, tissues, and cellular and tissue-based products (HCT/Ps) set forth in Title 21, Code of Federal Regulations (21 CFR) Part 1271 (21 CFR 1271) and issued under the authority of Section 361 of the Public Health Service Act [42 U.S.C. § 264].1The observations documented on the Form FDA-483, List of Inspectional Observations (FDA 483), were presented to and discussed with you at the conclusion of the inspection, and following FDA’s review, your violations include, but are not limited to, the following:1) Failure to validate and approve a process according to established procedures where the results of processing cannot be fully verified by subsequent inspections and tests. The validation activities and results must be documented, including the date and signature of the individual(s) approving the validation [21 CFR 1271.230(a)]. For example, you failed to validate the manufacturing process for your dehydrated, dual layer amniotic membrane patch, TheraMend, which cannot be fully verified, to ensure that your process does not cause contamination or cross-contamination and prevents the introduction, transmission or spread of communicable disease through the use of the HCT/P. Since August 2023, your firm has processed TheraMend products and distributed those products without a validated process.2) Failure to provide a summary of records to accompany an HCT/P, that contains a listing and interpretation of the results of all communicable disease tests performed [21 CFR 1271.55(b)(2)]. Specifically, a listing and interpretation of the results of all communicable disease tests is not included on theNotification of Requirements to Maintain Traceability of Human Tissue-Based Products or Instructions for Use and Product Informationforms, which are considered accompanying records as described in 21 CFR 1271.55(a).The violations identified above are not intended to be an all-inclusive list of violations at your facility. It is your responsibility to ensure that your establishment complies with all applicable federal regulations. You are responsible for reviewing your firm’s operations, including firms within the same organization, as a whole to ensure that you are in compliance with the law.We acknowledge receipt of your email correspondence submitted on June 30, 2025, responding to the inspectional observations. We have reviewed your response, and we have determined that the response is inadequate to address our concerns. We have the following comments regarding your FDA 483 response:• In response to Observation 1, you state that you discontinued manufacturing your Luxegen product, derived from human umbilical cord tissue, but will continue distributing Luxegen until December 1, 2025. We remain concerned about the Luxegen product that you previously distributed as well as your continued distribution of this product given its lack of approval as well as the conditions under which it was manufactured, as described in the FDA-483. We ask that you respond to this letter with your plans for addressing the Luxegen product that remains in the marketplace, within expiry, as well as confirmation that you have ceased distribution by December 1, 2025, and documentation demonstrating that you have done so.• In response to Observation 4a, you stated “Validation planning will being [sic] in July 2025 with all process validation activities anticipated to be completed by the end of Q2 2026.” Your response does not indicate that you will halt distribution of TheraMend products until your process has been validated. Your response also does not indicate any planned actions for the TheraMend products that have already been distributed.Additionally, your response states, “Regarding product in the field, to date, we have not received any product complaints or adverse events. Similarly, the product has a straightforward manufacturing process, and an approximately 99.99% change of passing validation. It is intended as a protective covering, so we believe any product in the field is safe and of a quality manner.” This justification is insufficient. You are required to validate your process to ensure that processing prevents the introduction, transmission, or spread of communicable disease through use of the HCT/P. It is your responsibility to ensure you validate all processing activities for the product(s) you are manufacturing.• In response to Observation 7, we acknowledge your commitment to revise procedures and retrain staff on the required summary of records as part of your CAPA #CPAR25-010. Please also ensure that a statement whether, based on the results of screening and testing, the donor has been determined to be eligible or ineligible accompanies your HCT/P at all times once a donor-eligibility determination has been made in accordance with 21 CFR 1271.55(a)(2).You should take prompt action to correct any violations addressed in this letter and prevent their recurrence. Failure to promptly correct any violations may result in regulatory action being initiated by FDA without further notice.We request that you respond in writing within fifteen (15) working days from your receipt of this letter, outlining the specific steps you have taken or plan to take to correct any violations, including an explanation of how you plan to prevent them, or similar violations, from occurring again. Additionally, include any documentation necessary to show that correction has been achieved. If you believe that your products are not in violation of the law, include your reasoning and any supporting information for our consideration. If you cannot complete all corrective actions within fifteen (15) working days, please explain the reason for your delay and the timeframe within which the remaining corrections will be completed.Your written response should be sent to the following address: U.S. Food and Drug Administration, Center for Biologics Evaluation and Research, Document Control Center, 10903 New Hampshire Avenue, WO71-G112, Silver Spring, MD 20993-0002. Please also email your response to CBERDCMRecommendations@fda.hhs.gov.If you have any questions regarding this letter, please contact CBER’s Division of Case Management at CBERDCMRecommendations@fda.hhs.gov. Please be advised that only written communications are considered official.Sincerely,/s/Melissa J. MendozaDirectorOffice of Compliance and Biologics QualityCenter for Biologics Evaluation and Research

Delivery Method:Via UPS and EMAIL、Signature RequiredProduct:BiologicsRecipient:Bruce R. Werber, DPMChief Executive Officer and FounderBioXtek LLC316 NE 1st StPompano Beach,FL33060United Statesdocw@bioxtek.comIssuing Office:Office of Compliance and Biologics QualityUnited StatesWARNING LETTERDecember 1, 2025CBER 26-715478Dear Dr. Werber:The United States Food and Drug Administration (FDA) inspected your facility, located at the above address, between February 18, 2025, and February 26, 2025. During the inspection, FDA documented that your company manufactures products derived from human amniotic membrane, Sanoplast ECM and Sanoplast Duo, for allogeneic use (collectively, “your products”).This letter is to advise you that your products are unapproved new drugs in violation of section 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. § 355(a). Your products are also unlicensed biological products in violation of section 351(a)(1) of the Public Health Service Act (PHS Act), 42 U.S.C. § 262(a)(1). A biological product for which a biologics license application (BLA) has been approved under section 351(a) of the PHS Act is not required to have an approved application under section 505 of the FD&C Act, 21 U.S.C. § 355; 42 U.S.C. § 262(j). Otherwise, 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. Your introduction or delivery for introduction of your products into interstate commerce, or the causing thereof, is prohibited under section 301(d) of the FD&C Act, 21 U.S.C. § 331(d).Unapproved New Drug and Unlicensed Biological Product ViolationsBased on information and records reviewed by FDA, including your website, https://bioxtek.com, (last visited November 2025), your products are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease or conditions in humans and/or are intended to affect the structure or function of the body. For example, in a video embedded on your website at https://bioxtek.com/about/, you indicate that your membrane patch products, including those derived from amniotic membrane, have the following applications:• “They are used most notably for wound care. They accelerate the healing of wounds—diabetic wounds, third degree burns without any scarring.”• “Secondarily uses are in orthopedic uses for tendon repair and making little nerve tunnels to help nerves regrow or nerves to grow without scarring.”• “These membranes are very powerful anti-fibrotics so they stop scarring and they also provide [a] anti-inflammatory environment…”Therefore, your products are drugs as defined in section 201(g)(1) of the FD&C Act, 21 U.S.C. § 321(g)(1), and biological products as defined in section 351(i) of the PHS Act,42 U.S.C. § 262(i).Your Sanoplast ECM and Sanoplast Duo products are also human cells, tissues, or cellular or tissue-based products (HCT/Ps) as defined in 21 CFR § 1271.3(d) and are subject to regulation under 21 CFR part 1271, issued under the authority of section 361 of the PHS Act, 42 U.S.C. § 264. HCT/Ps that do not meet all the criteria in 21 CFR § 1271.10(a) are not regulated solely under section 361 of the PHS Act and theregulations in 21 CFR part 1271. Unless an exception in 21 CFR § 1271.15 applies, such products are regulated as drugs, devices, and/or biological products under the FD&C Act and/or the PHS Act and are subject to additional regulation, including applicable premarket review. Based on a review of relevant materials, BioXtek LLC does not qualify for any exception in 21 CFR § 1271.15, and your products fail to meet all criteria in 21 CFR § 1271.10(a).For example, your Sanoplast ECM and Sanoplast Duo products fail to meet the criterion that the HCT/Ps be “intended for homologous use only.” Homologous use means that the “labeling, advertising, or other indications of the manufacturer’s objective intent” demonstrate that the HCT/P is intended to perform “the same basic function or functions in the recipient as in the donor.” 21 CFR §§ 1271.3(c) & 1271.10(a)(2). Your products are not intended solely to perform the same basic function or functions of the HCT/P in the recipient as in the donor (e.g., in the donor, amniotic membrane serves as a selective barrier for the movement of nutrients between the external and in utero environment, protecting the fetus from the surrounding maternal environment, and serving as a covering to enclose the fetus and retain fluid in utero). Rather, your products are intended for certain wound care applications, including by accelerating the healing of wounds, that is not a basic function of amniotic membrane in the donor. Therefore, Sanoplast ECM and Sanoplast Duo fail to meet the criterion for homologous use. 21 CFR § 1271.10(a)(2).Therefore, these HCT/P are not regulated solely under section 361 of the PHS Act, 42 U.S.C. § 264, and the regulations in 21 CFR part 1271.1See 21 CFR § 1271.20. In addition to being regulated under section 361 of the PHS Act and 21 CFR part 1271, your products are regulated as drugs as defined in section 201(g)(1) of the FD&C Act, 21 U.S.C. § 321(g)(1), and biological products as defined in section 351(i) of the PHS Act, 42 U.S.C. § 262(i), as stated above.Subject to certain exceptions not applicable here, to lawfully introduce or deliver for introduction into interstate commerce a drug that is a biological product, a valid BLA must be in effect under section 351(a)(1) of the PHS Act, 42 U.S.C. § 262(a)(1). Such licenses are issued only after showing that the product is safe, pure, and potent. Your products are not the subject of an approved BLA.Response to the Form FDA-483We have reviewed your response, dated March 18, 2025, to FDA’s Form FDA-483 in detail. We acknowledge your representation that you have corrected the deficiencies documented on the FDA-483. However, your response does not address the violations noted above.ConclusionThis letter addresses certain issues regarding your products and is not intended to be an all-inclusive list of deficiencies that may exist in connection with your products. We advise you to comprehensively review your website and other labeling and marketing materials to ensure that you are lawfully marketing your products in full compliance with the FD&C Act, the PHS Act, and their implementing regulations. 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 full compliance with all applicable statutory and regulatory requirements.This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address these matters may result in action without further notice including, without limitation, seizure and/or injunction.Please submit your response in writing within fifteen (15) working days from your receipt of this letter, outlining the specific steps you have taken or plan to take to address any violations and prevent their recurrence. Include any documentation necessary to show that the matters have been addressed. If you cannot address these matters within fifteen (15) working days, please explain the reason for your delay and the timeframe for completion. If you do not believe your products are in violation of the FD&C Act, PHS Act, or applicable regulations, include your reasoning and any supporting information for our consideration.Send your electronic response and any questions regarding this letter to CBER’s Office of Compliance and Biologics Quality, Division of Case Management at CBERDCMRecommendations@fda.hhs.gov.Sincerely,/s/Melissa J. MendozaDirectorOffice of Compliance and Biologics QualityCenter for Biologics Evaluation and Research

根据核查确认，曹有林等31人存在“挂证”行为，依据《执业药师注册管理办法》（国药监人〔2021〕36号）之规定，青海省药品监督管理局依法注销曹有林等31人的《执业药师注册证》；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。附件：曹有林等31人“挂证”执业药师人员名单青海省药品监督管理局 2025年12月9日 附件曹有林等31人“挂证”执业药师人员名单序号姓名注册证书号码资格证书号码有效日期1曹有林ZY00408955,20170266302620176363110007606332242100062026-12-262韩 英63122421011620170266302620176363220001532029-10-313王鹏程63122421011001958642029-10-214郭桂梅6322242100292019100266100039102029-4-85许婧芳6322232100072019100266300001652025-9-166李 英631222210046ZY004091882025-6-297张玉萍63122221006920170266302620156363010027012027-9-128刘海红631222210015ZY004090462025-6-219丁晓玲631221210027ZY005321992026-4-1810史成威631221210030ZY004732482026-4-2111邓红霞632225210152202212026620000001912028-8-2112李延花6312242100752018100264100017272029-8-613陈刚洋63122521001620150266202620156206250025722026-2-714刘羽丰632225210055026202410110000014782030-3-915周 雪632225210056026202410510000019702030-03-0916刘 辉632225210057026202410370000051662030-03-0917代丽娇6322252100812620241043999999936330770235885040435202030-03-1618安永娟631223210022zy003965092025-07-0819张维林632224210163202010026620000001692029-12-2220何志贞6312242101682018100266200002392029-12-3021张子兢631224210157202212026630000002632029-12-1722魏 霞632225210134026202410620000008332030-04-2023李永文631225210114026202410630000000322030-04-0224龙尚君63122521007300868522030-03-1325王建涛631224210162ZY004736602029-12-1926贾 宏631223210033ZY005296692028-7-227王秀珍631223230001ZY002396202028-04-1928张玉娇632225210059202212026630000000452030-03-0929马富荣631224270013202212026620000004062029-10-1030张 娟6322232700082019100266200006092028-11-2331姚 遥632223270009202211026510000053242028-04-23

　根据《广东省食品药品监督管理局关于〈药品经营许可证〉注销的管理规定》（粤食药监法〔2013〕26号），至2025年12月9日，我局已依法注销连平县忠信镇佳委药店等药店的《药品经营许可证》。现予以公布。许可证号许可证标明的有效期限企业名称法人代表/负责人注销日期注销原因粤DB76203122026年4月21日连平县忠信镇佳委药店麦志鹏2025年12月9日企业申请河源市连平县市场监督管理局2025年12月9日

依据《上海市第二类创新医疗器械特别审查程序》要求，上海市药品监督管理局组织有关专家对本市第二类创新医疗器械特别审查申请进行了审查，拟同意以下申请项目进入特别审查程序，现予以公示。  产品名称：磷酸化tau 217蛋白（p-tau 217）检测试剂盒（光激化学发光法）  规格/型号：2×50测试/盒，2×100测试/盒，4×50测试/盒，4×100测试/盒  申 请 人：科美博阳诊断技术（上海）有限公司  公示时间：2025年12月9日至2025年12月22日  公示期内，任何单位和个人有异议的，可填写《第二类创新医疗器械特别审查异议表》，并通过邮寄或电子邮件的方式送达上海市药品监督管理局医疗器械创新审查服务办公室。  传真电话：021-33163589-2803  邮寄地址：上海市黄浦区南昌路210号 邮编:200020  电子邮箱：rzzxzlb@126.com （请发送签字或盖章后的扫描版）  附件：第二类创新医疗器械特别审查异议表  上海市药品监督管理局  2025年12月9日

详见附件行政处罚决定书.docx福建省药品监督管理局行政处罚信息公开表.docx

江西南昌桑海制药有限责任公司（注册地址：南昌市北郊新祺周，生产地址：江西省南昌市北郊新祺周）因企业自身原因，向我局报告延长停产期限，停产延期至2026年12月31日。该公司如需恢复生产，应向我局提出申请，经我局开展药品质量管理规范符合性检查，符合要求后方可恢复生产。特此公告，请社会各界予以监督。江西省药品监督管理局2025年12月9日

行政处罚案件信息摘要行政处罚决定书文号湘药监药罚〔2025〕82号当事人湖南春可回中药饮片有限公司组织机构代码91430521MA4L1RTH6M法定代表人唐作夫违法类型生产销售劣药蜜款冬花（款冬花）行政处罚内容1.没收违法所得13040元；2.处货值金额2倍（货值金额不足十万元的，按十万元计算）罚款，计200000.00元，罚没款合计213040元。作出行政处罚决定的行政机关湖南省药品监督管理局作出行政处罚决定的日期2025年12月8日备注

行政相对人名称成都盛世名妆化妆品有限责任公司行政相对人类别法人及非法人组织行政相对人代码(统一社会信用代码)915101156630153180法定代表人黄浩行政处罚决定书文号川药监罚决〔2025〕1018号违法行为类型未按照备案资料载明的技术要求生产化妆品违法事实未按照备案资料载明的技术要求生产化妆品龙优娃精华组，货值金额91778.64元，违法所得5226.48元。处罚依据《化妆品监督管理条例》第六十条第二项处罚类别罚款、没收违法所得、没收非法财物 处罚内容1.没收龙优娃精华组4270套；2.没收违法所得5226.48元；3.罚款91778.64元。以上罚没款共计97005.12元。罚款金额（万元）9.178864没收违法所得、没收非法财物的金额（万元）8.3574处罚决定日期2025年11月28日处罚机关四川省药品监督管理局处罚机关统一社会信用代码11510000MB1808933T

根据《国家药监局农业农村部国家林草局国家中医药局关于发布〈中药材生产质量管理规范〉的公告》（2022年第22号）《福建省药品监督管理局关于印发福建省中药材生产质量管理规范实施工作方案的通知》（闽药监药生函〔2024〕213号）等文件要求，现对厦门燕来福制药有限公司中药材GAP延伸检查结果予以公告。福建省药品监督管理局2025年12月9日福建省中药材GAP延伸检查结果公示名单（第三批）被检查中药生产企业被检查中药品种中药材品种中药材生产企业基地面积（亩）2025年种植面积（亩）基地地址检查结果备注厦门燕来福制药有限公司中药饮片：甘草甘草内蒙古塞外朔漠中药材有限公司38003800内蒙古自治区鄂尔多斯市杭锦旗独贵塔拉镇、吉日嘎朗图镇符合要求含委托开展中药材产地加工（趁鲜切制）中药饮片：五味子五味子白山林村中药开发有限公司（其母公司盛实百草药业有限公司为中药材供应商）455455吉林省白山市靖宇县三道湖镇燕平村符合要求中药饮片：人参片人参750750辽宁省丹东市凤城市东汤镇东河村符合要求含委托开展中药材产地加工（趁鲜切制）