Delivery Method:VIA UPS and Electronic MailReference #:CBER 26-720249Product:BiologicsRecipient:Jeffrey Fisch, MDMedical DirectorGreen Valley Fertility Partners2950 W. Horizon RidgeHenderson,NV89074United Statesmilissa@gvflv.comIssuing Office:Center for Biologics Evaluation and Research (CBER)United StatesWARNING LETTERCBER 26-720249December 3, 2025Dear Dr. Fisch:During an inspection of your firm, Green Valley Fertility Partners located at 2950 W. Horizon Ridge, Henderson, NV, conducted between May 8, 2025, and May 14, 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.The 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 test a specimen from an anonymous or directed reproductive donor of cells or tissue, whether viable or non-viable, for evidence of infection due to relevant communicable disease agents [21 CFR 1271.85(a)]. This includes testing for West Nile Virus (WNV) using an FDA-licensed Nucleic Acid Test (NAT) donor screening test for HCT/Ps recovered between June 1st and October 31st every year. For example, you recovered oocytes from anonymous donor OD,(b)(6), (b)(7)(C)on(b)(6), (b)(7)(C)and the Summary of Records documented the WNVNAT result as “Neg” on June 6, 2024; however, the donor testing results reported on June 6, 2024, do not list any results for WNV NAT. This donor was determined “eligible” on June 10, 2024.We note that this is a repeat violation that was discussed with your firm during the FDA inspection conducted between April 11, 2022, and April 13, 2022. Specifically, oocytes were recovered from anonymous donor OD,(b)(6), (b)(7)(C)on(b)(6), (b)(7)(C), without being tested for WNV NAT. This donor was determined “eligible” on September 7, 2018.2) Failure to screen a donor of reproductive cells or tissue by reviewing the donor’s relevant medical records for risk factors for and clinical evidence of relevant communicable disease agents and diseases [21 CFR 1271.75(a)(1)]. YourGreen Valley Fertility Partners Infectious Disease Questionnaireis used as a relevant medical record to determine donor eligibility. However, the questionnaire does not include screening for all relevant conditions and/or behaviors that increase a donor’s communicable disease risk. For example, the form is missing questions, timeframes, and/or deferral periods to assess a donor’s relevant communicable disease risk for the following:a. Persons who have lived with (resided in the same dwelling) another person who hashepatitis Borclinically active (symptomatic) hepatitis C infectionin the preceding 12 months. (Question 9 incompletely asks, “Have you in the preceding 12 months had close contact with a person who had clinically active hepatitis (e.g. living in the same household, sharing of kitchen and bathroom facilities)?”b. Persons who have had sex in the preceding12 monthswith any person who has injected drugs for non-medical reason in the preceding 5 years including intravenous, intramuscular, or subcutaneous injections.c. Persons who have had a medical diagnosis orsuspicionof WNV infection; a deferral period of 120 days following diagnosis or onset of illness, whichever is later, applies to such individuals.d. Persons who have tested positive or reactive for WNV infection using an FDA-licensed or investigational WNV NAT donor screening test in the preceding 120 days.e. Persons who have received a non-synthetic dura mater transplant.f. Persons who have been diagnosed with Variant Creutzfeldt-Jakob Disease (vCJD).g. Persons who have a history of CJD in a blood relative.h. Persons who have received any transfusion of blood or blood components in France between 1980 and the present.i. Persons who have dementia, demyelinating disease of the central nervous system or other neurological disease of unknown etiology.j. Persons who are current or former U.S. military members, civilian military employees, or dependents of a military member or civilian employee who resided at U.S. military bases in Northern Europe (Germany, Belgium, and the Netherlands) for 6 months or morecumulativelyfrom 1980 through 1990, or elsewhere in Europe (Greece, Turkey, Spain, Portugal, and Italy) for 6 months or morecumulativelyfrom 1980 through 1996.3) Failure to determine as ineligible a donor who is identified as having a risk factor for, or clinical evidence of, any of the relevant communicable disease agents or diseases for which screening is required under 21 CFR 1271.75(a)(1), (b), or (c) [21 CFR 1271.75(d)]. For example, directed oocyte donor(b)(6), (b)(7)(C)answered "yes" to Question #19 on theGreen Valley Fertility PartnersInfectious Disease Questionnaire, "Have you lived cumulatively for 5 years or more in Europe from 1980 until the present (note this criterion includes time spent in the U.K. from 1980 through 1996)?" Donor(b)(6), (b)(7)(C)was determined “eligible” on October 10, 2022, and August 8, 2022.4) Failure to determine whether a donor is eligible based upon the results of donor screening in accordance with 21 CFR 1271.75 and donor testing in accordance with 21 CFR 1271.80 and 21 CFR 1271.85 [21 CFR 1271.50(a)]. The eligibility of two oocyte donors was determined and documented prior to the receipt of the results of donor testing for relevant communicable disease agents and/or the completion of the physical examination. For example:a. Directed oocyte donor(b)(6), (b)(7)(C)was determined “eligible” on January 30, 2024. However, the physical examination was not completed until(b)(6), (b)(7)(C), and the results of donor testing were not received until January 31, 2024.b. Anonymous oocyte donor OD,(b)(6), (b)(7)(C)was determined “eligible” on September 5, 2022. However, the physical examination and theGreen Valley Fertility Partners Infectious Disease Questionnairewere not completed until(b)(6), (b)(7)(C).5) Failure to omit the donor’s name and other personal information on the accompanying records [21 CFR 1271.55(c)]. For example, the names and birthdates of anonymous oocyte donors are included on the Summary of Records, which is considered an accompanying record as described in 21 CFR 1271.55(a).6) Failure to affix a distinct identification code to the HCT/P container, e.g., alphanumeric, that relates the HCT/P to the donor and all records pertaining to the HCT/P and, except in the case of autologous donations, directed reproductive donations, or donations made by first-degree blood relatives, does not include an individual’s name, social security number, or medical record number [21 CFR 1271.55(a)(1)]. For example, your firm identifies anonymous oocyte donors with “OD” followed by their first name on the Summary of Records, which is considered an accompanying record 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.Additional information regarding the regulation of HCT/Ps is available at:https://www.fda.gov/vaccines-blood-biologics/tissue-tissue-productshttps://www.fda.gov/vaccines-blood-biologics/biologics-guidances/tissue-guidancesFDA Workshop for the Reproductive Tissue Industry - Sept 29 and Oct 1, 2020 -09/29/2020 - 10/01/2020 | FDAPlease note that if you still have oocytes and/or semen in storage from donors whose screening and/or testing was not completed in accordance with 21 CFR Part 1271, FDA considers the donor eligibility determinations to be incomplete for these donors. For example, this includes donors who were not appropriately tested for relevant communicable disease agents and diseases and/or who were not appropriately screened for relevant communicable disease risk factors. Therefore, as required by 21 CFR 1271.60(a), you must keep these HCT/Ps in quarantine.Should the need arise in the future to remove any of these HCT/Ps from quarantine, either for use in your own establishment or for transport to another establishment, you may request an exemption or alternative from a requirement in Subpart C, 21 CFR Part 1271, as specified in 21 CFR 1271.155. Additional information can be found at Exemptions and Alternatives | FDA. The email address for submissions is HCTPExemptions@fda.hhs.gov.Please note that 21 CFR 1271.155 requires that you provide justification for use of HCT/Ps from these donors, as well as information on how you have mitigated the risk consistent with the goals of protecting the public health and/or preventing the introduction, transmission, or spread of communicable diseases. Before any of these HCT/Ps can be removed from quarantine, the request must be granted by FDA.If you still have embryos in storage for which the donor eligibility requirements under 21 CFR 1271, Subpart C are not met, please note that FDA considers the donor eligibility determinations to be incomplete for these donors. Therefore, as required by 21 CFR 1271.60(a), you must keep these HCT/Ps in quarantine. Should the need arise in the future to remove any of these HCT/Ps from quarantine, either for use in your own establishment or for transport to another establishment, you may release these HCT/Ps from quarantine (21 CFR 1271.90(b)) provided they are labeled in accordance with the applicable regulations at 21 CFR 1271.90(c).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

为进一步强化行政执法监督，2025年12月9日至11日，省药监局在肥组织开展2025年全省药械妆行政处罚案卷集中评查活动。为确保评查活动公平公正，事前省药监局从安徽省药品综合监管平台随机抽取每个市5份案卷，力求涵盖市、区和县市场监管局办理的药品、医疗器械、化妆品案卷。本次评查采取“互评+复核”的方式进行，先由各市以推磨评查的方式进行交叉互评，省药监局政策法规处之后逐案进行复核。评查过程中，评查人员就市县药械妆行政处罚案件在办理过程中遇到的难点和困惑问题进行充分交流互动，特别对于药械使用单位“使用”过期药械行为的定性，综合裁量权规范行使、行政强制措施实施、解除的程序性要求，执法文书规范制作等方面的问题展开激烈讨论，并达成一致观点和意见。下一步，省药监局将及时梳理总结评查发现的问题并进行通报反馈，指导市县药品监管部门“举一反三”进行整改，不断规范涉企行政执法行为，切实推动全省药械妆行政处罚案卷质量提升。

（公告 2025年第29号）经哈尔滨市、双鸭山市、黑河市市场监督管理局核查，以下执业药师（名单详见附件）存在“挂证”行为。哈尔滨市、双鸭山市、黑河市市场监督管理局依据《市场监督管理行政许可程序暂行规定》对以上人员，做出撤销《执业药师注册证》的决定。按照《中华人民共和国行政许可法》第七十条、《执业药师注册管理办法》第二十四的规定，黑龙江省药监局现对其51人《执业药师注册证》予以注销。特此公告。附件：注销《执业药师注册证》人员名单黑龙江省药品监督管理局2025年12月12日附件注销《执业药师注册证》人员名单序号姓名注册单位注册证号1李娜哈尔滨北秀医药连锁有限公司靖宇店2322240101412贾艳楠哈尔滨北秀医药连锁有限公司大发店2332240101523高其文黑龙江省瑞泽医药有限公司瑞泽大药房2322220127554王洪晶黑龙江安李泰医药连锁有限公司2312230110405刘继刚尚志市三十四莲百姓药房有限公司2312230101006李云凤依兰县宝芝林大药房有限公司一分店2322250134007李丽丽哈尔滨百年人和大药房有限公司泰和店2312220133628郝艳茹尚志市丹医堂大药房有限公司安康店2312220119159刘晓红黑龙江九衡大药房有限公司23122201373510丁文哈尔滨永和堂大药房有限公司23322501042211许丽哈尔滨康复大药房23222201142112唐亿库哈尔滨康凡大药房有限公司23122401322113王巍巍哈尔滨福汇堂大药房有限公司23122301351114谢芳哈尔滨瑞昇康大药房有限公司23122101226015吴功强哈尔滨隽久大药房有限公司23122201012916李孝国黑河市静泰和医药有限公司23122111004417王玉慧黑河市福利堂中草药有限公司23222511061018岳友家黑河市康之佳医药有限公司23322411032719张鑫黑河市平安医药连锁有限公司鸿鹏大药房三十三部23222411037820纪文北安市富兴医药有限公司23222311002721曹瑞黑龙江省国八医药连锁有限责任公司北安市富康分公司23222511014422林佳鑫黑龙江省国八医药连锁有限责任公司北安市济世堂分公司23222511042423宫雪黑龙江省国八医药连锁有限责任公司北安市龙福分公司23122511021724韩淑磊黑龙江省国八医药连锁有限责任公司北安市通林分公司23222511044125刘国影黑龙江省国八医药连锁有限责任公司北安市新苑分公司23122511014826孔令宇黑龙江省华瑞医药连锁有限公司北安市安裕店23222511019927郑秀玲黑龙江省华瑞医药连锁有限公司北安市保丰店23122511053628孟祥雪北安市汇康医药有限公司23122211009029刘佩佩北安市健民大药房医药有限公司23122211001130刘金玲北安市益春堂医药有限公司23222511029331王妍北安市正康大药房有限公司23122511055732孙丽黑龙江省健康医药连锁有限公司龙镇康健分店23122511039633吕宏伟肇源县瑞仁医药有限公司23222506140134刘海燕五大连池风景区康安堂医疗器械销售有限公司23222511052635王丹逊克县三特医药有限公司23122211001536韩烨黑河众联医药连锁有限公司逊克县平新药店23222511041437杨静思嫩江市康诺医药有限责任公司23222511054638李振强嫩江市盛翔医药有限公司23322211012339郭同臣嫩江市新宝康医药有限公司23122511024240陈利勇孙吴县福寿医药零售有限公司23122411021241张婷婷孙吴县康富医药零售有限公司23322511033442车艳萍黑河众联医药连锁有限公司孙吴县秋林国际大药房23122511001943孙亮孙吴县济康医药零售有限公司23222411036344孟令娟黑河众联医药连锁有限公司北安市康复店23222511055145刘明嫩江市鹤延堂医药有限责任公司23122511056946孟新宇孙吴县新宇药品零售有限公司23122211007747李继红双鸭山市鑫泰峰医药有限公司23122505031948韩锐集贤县华鑫大药房有限公司23122505067949宋超双鸭山元春医药销售有限公司23222505049450邱守刚铁力市利君医药销售有限公司第十二分公司23222507048151孙丽娟铁力市康育嘉医药连锁有限公司232225070432

按照2025年全区特殊管理药品监督检查计划要求，自治区药监局组织对特殊管理药品批发企业开展了现场检查。根据政务信息公开制度要求，现将检查情况予以通告。附件：特殊管理药品批发企业监督检查信息（2025年）.wps宁夏回族自治区药品监督管理局2025年12月12日

近期，我局在监督检查中，发现南昌西尔戴尔医疗科技有限公司生产许可场地已经被租赁给其他公司使用，且与租赁方解除了租赁协议，企业在规定的时间内未向我局提交变更生产地址的申请；不符合《医疗器械生产监督管理办法》第九条、第十五条、第十六条和《医疗器械生产质量管理规范》的相关规定。根据《医疗器械生产监督管理办法》第六十四条的规定，我局决定责令南昌西尔戴尔医疗科技有限公司暂停生产医疗器械产品。暂停生产期间，若发现有违法行为的，将依法予以严肃处理。 特此公告。 江西省药品监督管理局2025年12月15日（公开属性：主动公开）

　　按照《中华人民共和国药品管理法》《中华人民共和国行政许可法》和《药品经营和使用质量监督管理办法》等相关规定，根据河南德圣堂医药物流有限公司申请，现注销河南德圣堂医药物流有限公司的《药品经营许可证》（证书编号：豫AA371000593）。　　特此公告。　　附件：河南德圣堂医药物流有限公司《药品经营许可证》有关信息表　　2025年12月15日附 件河南德圣堂医药物流有限公司《药品经营许可证》（批发）有关信息表企业名称企业法人（负责人）质量负责人经营方式经营范围经营地址仓库地址证书编号河南德圣堂医药物流有限公司齐彦丽(景相粼)董淑珺批发中药饮片河南省郑州市登封市中岳街道产业集聚区工业六路与纵十二路交叉口西北角6号楼向西10米河南省郑州市登封市中岳街道产业集聚区工业六路与纵十二路交叉口西北角《药品经营许可证》（证号：豫AA371000593）

12月10-12日，省药品(医疗器械)不良反应监测中心组织开展了2025年度药物滥用报告质量评估工作，全省17个市、州、直管市、神农架林区药品不良反应监测机构技术骨干参与评估。会前，该中心制定了质量评估工作方案，将抽取的样本和各市工作通过精细化分组、明确各项指标评估标准。各市中心根据方案安排，认真研究评估标准，各小组分工明确，严格对照评估标准开展了全面细致的质量核查。会上，各小组详细汇报了工作总结和发现的相关问题，并提出有关建议。大家一致认为，当前阶段，药物滥用监测工作仍需进一步夯实基础，各市中心应履职尽责，将基础性工作做实做细，提升监测数据可利用度，保障药物滥用监测工作有效发挥为禁毒和麻醉药品精神药品监管提供信息支持。本次质量评估专项工作的开展，为提升全省药物滥用报告质量、优化报告内容、提高报告的规范性、完整性与数据准确性，提升业务人员工作水平起到积极的作用，同时进一步强化省、市两级监测机构协同联动，形成有效工作合力，为做好2026年度药物滥用监测工作奠定了坚实基础。（信息来源：省药品（医疗器械）不良反应监测中心）

广东省药品监督管理局通 告2025年 第103号　　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深圳乐普智能医疗器械有限公司等3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2025年12月12日　　附件企业信息序号企业名称许可证编号生产地址1深圳乐普智能医疗器械有限公司粤食药监械生产许20173019号深圳市南山区西丽街道松白公路百旺信工业区9栋3层北侧；深圳市南山区大勘杨门工业区36号1、2层2广东松下药业有限公司粤食药监械生产许20204222号普宁市大南山街道工业园区（三蓝药业综合车间二层228号）3深圳市汇星数字技术有限公司粤药监械生产许20245492号深圳市宝安区福海街道展城社区和秀西路68号宝祥和工业园第25栋厂房101、201

根据《中华人民共和国行政许可法》《医疗器械生产监督管理办法》等有关规定，依企业申请，我局决定依法注销河北亿口康医疗科技有限公司的《医疗器械生产许可证》。特此公告。附件：《医疗器械生产许可证》注销企业名单《医疗器械生产许可证》注销企业名单序号企业 名称许可证编号社会信用代码法定代表人企业负责人生产地址和生产范围注销 原因1河北亿口康医疗科技有限公司冀药监械生产许20240029号91130682MAD1AUDF3P甄静甄静（2002年分类）：Ⅱ类:6863-16定制式义齿（2017年分类）：Ⅱ类:17-06口腔义齿制作材料企业申请河北省药品监督管理局2025年12月12日（信息公开类型：主动公开）

我局于2025年9月11日发布《关于1家医疗器械生产企业暂停生产的公告》，对扬州晓康医疗器械有限公司采取暂停生产的风险控制措施。鉴于该企业已对检查发现的缺陷进行了整改，现决定解除扬州晓康医疗器械有限公司的暂停生产风险控制措施。特此公告。江苏省药品监督管理局2025年12月15日