为进一步加强药品质量监管，保障公众用药安全有效，四川省药品监督管理局根据《2025年四川省药品抽检工作计划》，对全省药品生产、经营、使用环节进行了药品质量抽查检验。现将抽检结果予以通告。附件：药品抽检结果企业名单四川省药品监督管理局2025年12月16日

行政相对人名称张峰行政相对人类别自然人行政相对人代码_1(统一社会信用代码)行政相对人代码_2(工商注册号)行政相对人代码_3(组织机构代码)行政相对人代码_4(税务登记号)行政相对人代码_5(事业单位证书号)行政相对人代码_6(社会组织登记证号)法定代表人法定代表人证件类型法定代表人身份证号证件类型身份证证件号码行政处罚决定书文号皖药监药处罚〔2025〕2-91号违法行为类型《中华人民共和国药品管理法》第四十一条第一款违法事实当事人未取得《药品生产许可证》生产中药饮片暂扣或吊销证照名称及编号处罚依据《中华人民共和国药品管理法》第一百一十五条处罚类别罚款;没收违法所得处罚名称张峰无《药品生产许可证》生产销售中药饮片案处罚内容1.没收违法所得肆万肆仟叁佰壹拾陆元（44316元）；2.罚款拾伍万元（150000元）。罚款金额(万元)15没收违法所得、没收非法财物的金额(万元)4.4316处罚决定日期2025年12月16日处罚有效期2099年12月31日公示截止期2028年12月16日处罚行政机关安徽省药品监督管理局处罚机关统一社会信用代码11340000MB19570665数据来源单位安徽省药品监督管理局数据来源单位统一社会信用代码11340000MB19570665地方编码340000处罚状态有效备注

共晟医药（甘肃）有限公司已向我局完成药品网络销售企业报告，现将该企业报告信息予以公示。欢迎社会各界监督。 附件：共晟医药（甘肃）有限公司药品网络销售报告信息表  甘肃省药品监督管理局 2025年12月16日

Delivery Method:VIA Electronic MailProduct:Medical DevicesRecipient:Danaë KurversOwnerTrans-Missie B.V.Visseringweg 3A1112ASDiemenNetherlandsabuse@untag.comIssuing Office:Center for Devices and Radiological HealthUnited StatesUnited StatesWARNING LETTERCMS #720852December 16, 2025Dear Danaë Kurvers:The United States Food and Drug Administration (FDA) has reviewed Trans-Missie B.V. d/b/a UNTAG’s (“your firm”) website (untag.com) and observed that your website offers various breast binders for sale. 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.Our review of your firm’s website revealed statements that these breast binders (example trade names: “Short Binder black”, “Short Binder – Extra Strong black”, “Gym Binder – Extra strong black”, “Short Binder beige”, “Short Binder – Extra Strong Beige”, “Tank Binder”, “Shirt Binder beige”) are intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, or intended to affect the structure or any function of the body, including:•Per your firm’s website: “A binder works by pressing the breasts flat against the chest, spreading the mass of the breasts. This makes the breasts appear flatter and less present, which can help reduce gender dysphoria or any other uncomfortable feelings that you might have about your chest.”•Per your firm’s website: “Most people wear a binder because it helps reduce any gender dysphoria that they experience about their breasts. Binders can be worn by … people who have just had breast surgery, people who suffer from gender dysphoria.”•Per your firm’s website: “A binder can greatly help to reduce body dysphoria and promote gender euphoria”•Per your firm’s website: “Reduced dysphoria: Binding alleviates the distress associated with a chest that does not align with one’s gender identity…Improved mental health: Participants in multiple studies reported reduced anxiety and depression, increased confidence, and greater comfort in public spaces”•Per your firm’s website: “Gender affirming garments can help you alleviate gender dysphoria by compressing or enhancing body parts that cause you negative feelings. As you can imagine, some of these gender affirming practices (like wearing binders) are not entirely without risk.”Our review also revealed statements that you manufacture these devices within the meaning of section 510 of the Act (21 U.S.C. § 360) (e.g., “UNTAG products are designed and engineered in Diemen - Amsterdam.”). Under section 510 of the Act (21 U.S.C. § 360), manufacturers of medical devices are required to annually register with the FDA. In September 2007, section 510 of the Act was amended by the Food and Drug Administration Amendments Act of 2007 (Pub. L. 110-85) to require domestic and foreign device establishments to submit their annual establishment registration and device listing information to FDA by electronic means [section 510(p) of the Act (21 U.S.C. § 360(p))] during the period beginning October 1st and ending December 31st of each year. Our records indicate that you have not registered or listed these devices for fiscal year 2026.Therefore the devices are misbranded within the meaning of section 502(o) of the Act (21 U.S.C. § 352(0)), in that they were manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act (21 U.S.C. § 360) and were not included in a list required by section 510(j) of the Act (21 U.S.C. § 360(j)).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 and injunction. 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.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, including 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 action (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. Please provide a translation of documentation not in English to facilitate our review. We will notify you regarding the adequacy of your firm’s response(s) and the need to re-inspect your firm’s facility to verify that the appropriate corrections and/or corrective actions have been made. 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 CDRHEnforcement@fda.hhs.gov. Please include in the subject line, “CMS 720852” when replying.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. 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 yours,/s/Michael J. HoffmannDirectorOffice of Health Technology 3 - Gastrorenal, ObGyn,General Hospital, and Urology DevicesOffice of Product Evaluation and QualityCenter for Devices and Radiological HealthFood and Drug Administrationcc: Shopify, Inc.abuse@shopify.comcc: service@untag.com

Delivery Method:VIA UPSReference #:320-26-23Product:DrugsRecipient:Marc S. Berridge, Ph.D.President3D Imaging Drug Design and Development LLC9015 Carti WayLittle Rock,AR72205United StatesIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesWarning Letter320-26-23December 4, 2025Dear Dr. Berridge:The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, 3D Imaging Drug Design and Development LLC, FEI 3009143510, at 9015 Carti Way, Little Rock, from June 9 to 13, 2025.This warning letter summarizes significant violations of Current Good Manufacturing Practice (CGMP) regulations for positron emission tomography (PET) drugs. See Title 21 Code of Federal Regulations (CFR), part 212 (21 CFR part 212).Because your methods, facilities, or controls for manufacturing, processing, packaging, or holding do not conform to CGMP, your PET 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).In addition, we reviewed your firm’s drug listing submissions in FDA’s electronic Drug Registration and Listing System (eDRLS) and found that you failed to update the listing for your PET human prescription drug product, Fludeoxyglucose F18 (NDC 76451-118), as required under section 510(j) of the FD&C Act (21 U.S.C. 360(j)) and 21 CFR part 207.Thus, Fludeoxyglucose F18 is not properly listed, and your firm has not fulfilled its listing obligations under 510(j) of the FD&C Act (21 U.S.C. 360(j)) and 21 CFR 207, which is prohibited under section 301(p) of the FD&C Act (21 U.S.C. 331(p)). This violation is described in more detail below.We reviewed your June 30, 2025, response to our Form FDA 483 in detail and acknowledge receipt of your subsequent correspondence.During our inspection, our investigator observed specific violations including, but not limited to, the following.1. Your facilities are not adequate to ensure the prevention of contamination of equipment or product by substances, personnel, or environmental conditions that could reasonably be expected to have an adverse effect on product quality. Procedures to ensure that all equipment is clean, suitable for its intended purposes, properly installed, maintained, and capable of repeatedly producing valid results, are not adequately followed (21 CFR 212.30(a) and (b)).Facility SuitabilityYou failed to ensure that your facility is adequately designed and controlled to prevent contamination of the sterile injectable PET drugs you manufacture. For example, our investigator observed your operator making aseptic connections in an open benchtop area, without adequate aseptic environmental conditions. Furthermore, our investigator observed that Hot Cell #(b)(4), which is used to manufacture Fludeoxyglucose F-18 (FDG), was in a poor state of repair, with rust on the manipulator arms and with visible residue on surfaces near where the finished product is filtered into sterile vials.In your response, you state that you made facility and equipment repairs, including removal of rust and replacement of the chipped lead shielding in your hot cell. Your response is inadequate because you do not evaluate your facility, process, and equipment for potential routes of contamination or address how you will improve your process to ensure that your product is properly protected from the environment during aseptic connections.Appropriate aseptic environments should be used for critical aseptic manipulation in the production and testing of PET drugs.Environmental MonitoringYou failed to establish and follow adequate testing procedures for environmental monitoring (EM) for your aseptic manufacturing area. For example, your Hot Cell #(b)(4), where the FDG drug product is filtered into the final product vials, is not monitored. Further, the alert and action levels that you established in your standard operating procedure (“SOP for Environmental Monitoring of Hot Cells”) for EM are not appropriate. For surface samples taken in your hot cell, your procedure does not require an investigation unless(b)(4)or more colony-forming units are recovered from a single sample. Your high action levels allow for an unacceptable risk of contamination to your product.In your response, you indicate that you lack an understanding of where the environmental monitoring should occur, and that you will update your EM to include a location “adjacent to the sterile closure.” Your response is inadequate because you do not address how you will determine the appropriate sampling location and frequency for EM.PET drug products have short expiry periods. Thus, your PET drug products are released and administered before the results of batch specific sterility testing and EM are known. Therefore, adequate microbiological monitoring of the aseptic environment is essential during critical aseptic manipulation. A vigilant, ongoing EM program is essential to detect and respond to potential product contamination hazards in your manufacturing environment in a timely manner. Loss of environmental control in an aseptic manufacturing facility can ultimately pose a serious hazard to patients.In response to this letter, provide:A comprehensive risk assessment of all contamination hazards with respect to your aseptic processes, equipment, and facilities, including an independent assessment that includes but is not limited to:o All human interactions within the ISO(b)(4)areao Equipment placement and ergonomicso Air quality in the ISO(b)(4)area and surrounding roomo Facility layouto Personnel flows and material flows (throughout all rooms used to conduct and support sterile operations)A detailed remediation plan with timelines to address the findings of the contamination hazards risk assessment. Describe specific tangible improvements to be made to aseptic processing operation design and control.Your updated procedure(s) demonstrating that aseptic connections will be conducted in an appropriate environment (e.g., ISO(b)(4)aseptic workstation).An independent assessment of your EM program, including but not limited to establishing appropriate limits, sampling locations and frequencies, investigating deviations, and trend analysis, and a comprehensive corrective action and preventive action plan.Your action levels for ISO(b)(4)surfaces, air, and operator gloves, and revised procedures that describe the appropriate response to contamination in critical environments.2. Your firm failed to have adequate production and process controls to ensure the consistent production of a PET drug that meets the applicable standards of identity, strength, quality, and purity (21 CFR 212.50).You failed to ensure that your operators are appropriately gowned to adequately protect the sterile injectable PET drugs you manufacture. For example, our investigator observed exposed skin and hair on your operator during the manufacturing of FDG lot(b)(4). The operators’ skin on their arms was exposed while they were setting up production in an open benchtop area of the room (i.e. with inadequate aseptic environmental conditions). The operators’ skin was also exposed while leaning into Hot Cell #(b)(4)to set up for product(b)(4)into sterile vials. Additionally, another operator was observed reaching into the ISO(b)(4)laminar flow hood with exposed skin on the operator’s arms and face while performing sterility testing for FDG lots(b)(4)and(b)(4).Furthermore, you failed to adequately requalify two of the(b)(4)operators at least annually by conducting a media fill to assess their aseptic processing technique. For example, one of your operators had not been requalified to perform PET drug manufacturing using process simulations (media fills) since April 2021. However, the operator manufactured FDG as recently as June 2025.In your response, you indicate that the two operators were removed from production and a media fill was initiated. However, your response is inadequate because you do not provide a retrospective assessment of the potential impact to drug products manufactured from 2021 to present. Your response is also inadequate because you do not comprehensively address how you will ensure that your gowning program is adequate, including whether appropriate gowning will be used.Adequate gowning is an essential part of environmental control because gowns provide a barrier to prevent operators from contaminating the drug product. Personnel should be adequately trained and qualified to ensure their competence to perform aseptic processing of PET drugs.Media fills should simulate the aseptic production process, including but not limited to the aseptic assembly of the container/closure system through filling of the PET drug into final containers. Operators should be requalified annually by conducting one media fill run. See FDA’s guidance documentMedia Fills for Validation of Aseptic Preparations for Positron Emission Tomography (PET) Drugsat https://www.fda.gov/media/81974/download.In response to this letter, provide:A remediation plan that better assures ongoing management oversight throughout the manufacturing lifecycle of all drug products. Provide a more data-driven and scientifically sound program that identifies sources of process variability and assures that manufacturing operations meet appropriate parameters and quality standards. This includes but is not limited to evaluating suitability of equipment for its intended use, ensuring quality of input materials, determining the capability and reliability of each manufacturing process step and its controls, and vigilant ongoing monitoring of process performance and product quality.A comprehensive assessment of your gowning program, including but not limited to how you will establish adequate gowning.The report and results for the media fill initiated on June 16, 2025, and any subsequent media fills conducted.A comprehensive assessment of your media fill procedure, including but not limited to how you will ensure that operators are requalified annually.3. Your firm failed to have laboratory methods suitable for their intended use and sufficiently sensitive, specific, accurate, and reproducible (21 CFR 212.60).You failed to establish and follow adequate testing procedures for sterility testing of your sterile injectable PET drugs. For example, our investigator observed your operator performing sterility testing using poor aseptic technique, including opening sterile components outside of the ISO(b)(4)laminar flow hood before use. Also, our investigator observed your chemist vigorously shaking the sterility test sample tubes before reading the results. Shaking the sterility test sample tubes may mask the test results and may impact a person’s ability to visually detect turbidity, visible colonies, or other evidence of microorganisms.In your response, you indicate that you updated your sterility testing procedure. However, your response is inadequate because it lacks information about how you will ensure that your procedures are sufficiently detailed for operators to follow and how you will ensure that sterility testing is adequately performed.Testing is a critical control that provides assurance that your PET drug products are sterile and therefore suitable for their intended use. It is important that you follow established, appropriate procedures to ensure that your sterility testing can detect the presence of microorganisms.In response to this letter, provide:A comprehensive assessment of your laboratory practices, procedures, methods, equipment, documentation, and analyst competencies. Based on this review, provide a detailed plan to remediate and evaluate the effectiveness of your laboratory system.A comprehensive assessment of your sterility testing program, including but not limited to material flow and environmental monitoring.A comprehensive review of your sterility testing procedure relative to the expectations in the United States Pharmacopeia (USP) General Chapter Sterility Tests.Your most recent static and dynamic smoke studies performed for the laminar flow hood.Drug Listing ViolationsSection 510(j) of the FD&C Act (21 U.S.C. 360(j)) and 21 CFR part 207 set forth the requirements for the listing of drugs. Under 21 CFR 207.57(b), registrants are required to update drug listing information twice each year, in June and December. Under 21 CFR 207.57(b)(2), registrants may satisfy the listing update requirement with respect to unchanged listing information by making a single “no changes” certification during the October 1 through December 31 annual registration period. If the drug listing data is not updated or certified, the outdated listing data will get inactivated at the next scheduled FDA inactivation period.1You failed to update or certify Fludeoxyglucose F18 as required.Therefore, Fludeoxyglucose F18 is not properly listed under section 510(j) of the FD&C Act. Failure to properly list a drug in accordance with 510(j) of the FD&C Act is prohibited under section 301(p) of the FD&C Act (21 U.S.C. 331(p)).Complete, accurate, and up-to-date establishment registration and drug listing information is essential to promote and protect patient safety. FDA relies on establishment registration and drug listing information for several key programs, including drug establishment inspections, supply-chain security, and postmarket surveillance. Establishment registration and drug listing information is also widely used outside FDA for purposes such as electronic prescribing and electronic health records, insurance reimbursement, and patient education.In addition, we note that your drug listings for Ammonia N 13 (NDC 76451-013) and Sodium Fluoride F-18 (NDC 76451-018) also have not been updated or certified. Please update the listing information for these drugs to reflect their current status. If you no longer manufacture and distribute these drugs, then the drugs must be discontinued by adding an end marketing date. Please be aware that a manual override may be required for certain types of revisions made to an existing drug listing file. If you receive a validation error or have any questions regarding your drug listings, please contact us at eDRLS@fda.hhs.gov for further assistance.It is your responsibility to ensure that all drugs manufactured at your establishment comply with all establishment registration and drug listing requirements under section 510 of the FD&C Act, 21 U.S.C. 360, 21 CFR part 207, and all other applicable FDA regulations. Registration and listing information and instructions on how to properly register an establishment or submit drug listings can be found atElectronic Drug Registration and Listing Instructions.Guidance on Positron Emission Tomography (PET) DrugsSee FDA’s guidance document,PET Drugs—Current Good Manufacturing Practice, to help you meet the CGMP requirements when manufacturing PET drugs, at https://www.fda.gov/media/71013/download. This guidance document also references FDA’s guidance document,Sterile Drug Products Produced by Aseptic Processing—Current Good Manufacturing Practicefor additional concepts and expectations that may apply to PET drug manufacturing, at https://www.fda.gov/media/71026/download.CGMP Consultant RecommendedBased upon the nature of the violations we identified at your firm, we strongly recommend engaging a consultant qualified to evaluate your operations to assist your firm in meeting CGMP requirements.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.If you are considering an action that is likely to lead to a disruption in the supply of drugs produced at your facility, FDA requests that you contact CDER’s Drug Shortages Staff immediately, at drugshortages@fda.hhs.gov, so that FDA can work with you on the most effective way to bring your operations into compliance with the law. Contacting the Drug Shortages Staff also allows you to meet any obligations you may have to report discontinuances or interruptions in your drug manufacture under 21 U.S.C. 356C(b). This also allows FDA to consider, as soon as possible, what actions, if any, may be needed to avoid shortages and protect the health of patients who depend on your products.Correct any violations promptly. Failure to promptly and adequately address this matter may result in regulatory or legal action without further notice including, without limitation, seizure and injunction. Unresolved violations may also prevent other Federal agencies from awarding contracts.Failure to address violations may also cause FDA to withhold issuance of Export Certificates. 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 address any violations.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 days2. 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 3009143510 and ATTN: Lynnsey Renn.Sincerely,/S/Francis GodwinDirectorOffice of Manufacturing QualityOffice of ComplianceCenter for Drug Evaluation and Research/S/Tina SmithCaptain, U.S. Public Health ServiceDirectorOffice of Unapproved Drugs & Labeling ComplianceOffice of ComplianceCenter for Drug Evaluation and Research_________________1See 84 FR 40417 (https://www.regulations.gov/document/FDA-2019-N-2374-0001).2Under program enhancements for the Generic Drug User Fee Amendments (GDUFA) reauthorization for fiscal years (FYs) 2023-2027, also known as the GDUFA III Commitment Letter, your facility may be eligible for a Post-Warning Letter Meeting to obtain preliminary feedback from FDA on the adequacy and completeness of your corrective action plans.

迈迪可医疗科技（江苏）有限公司报告，由于生产过程中出现初始过滤器完整性测试/泄露测试不合格率较以往略高的原因，迈迪可医疗科技（江苏）有限公司作为进口代理人，对Medica S.P.A(意大利麦迪卡股份有限公司)生产的血液滤过器主动召回。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》。

Delivery Method:Via EmailReference #:320-26-25Product:DrugsRecipient:Mr. Ross SklarChief Executive OfficerSklar Personal Care Inc.3137 East 26th StreetVernon,CA90058United StatesRoss@starcobrands.comIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesWarning Letter320-26-25December 9, 2025Dear Mr. Sklar,The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, Sklar Personal Care Inc. (DBA BOV Solutions), FEI 3007953761, located at 1105 E Garner Bagnal Boulevard, Statesville, North Carolina 28677, from May 19 to May 23, 2025 and June 9, 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 June 16, 2025, response to our Form FDA 483 in detail and acknowledge receipt of your subsequent correspondence.During our inspection, our investigators observed specific violations, including but not limited to the following:1. Your firm failed to conduct at least one test to verify the identity of each component of a drug product (21CFR 211.84(d)(1).Your firm failed to adequately test your incoming components for identity before using the components to manufacture your OTC drug products. Specifically, your firm did not perform identity testing for the following raw materials:(b)(4), which are used in the production of(b)(4)batch(b)(4).We also note that you use raw material(b)(4)to manufacture your OTC drug products. However, testing for the presence of methanol is not performed for incoming(b)(4).The use of(b)(4)contaminated with methanol has resulted in various lethal poisoning incidents in(b)(4).Without adequate testing, you do not have scientific evidence that your raw materials conform to appropriate specifications before their use in the manufacture of your drug products. As a manufacturer, you have a responsibility to sample, test, and examine drug components before their use in production to ensure adequate quality.In your response, you commit to updating testing specifications and prioritizing the identity testing of raw materials on order for the remaining production planned in 2025. You also commit to ensuring that every(b)(4)container delivered will be tested for methanol by July 31, 2025.Your response is inadequate. You did not provide a risk assessment addressing the use of untested raw material in your finished OTC products. In your response, you did not commit to testing the remaining raw materials or the retain samples of the OTC drug products already distributed.In response to this letter, provide:A comprehensive review of your material system to determine whether all suppliers of components, containers, and closures are each qualified, and the materials are assigned appropriate expiration or retest dates. The review should also determine whether incoming material controls are adequate to prevent use of unsuitable components, containers, and closures.A description of how you will test each component lot for conformity with all appropriate specifications for identity, strength, quality, and purity. If you intend to accept any results from your supplier’s COA instead of testing each component lot for strength, quality, and purity, specify how you will robustly establish the reliability of your supplier’s results through initial validation as well as periodic revalidation. In addition, include a commitment to conduct at least one specific identity test for each incoming component lot as required.Identity test results of raw materials currently in inventory. In the instance of no remaining raw material is available or within expiry, provide the test results for methanol that may be present in your finished OTC drug products.2. Your firm failed to establish and follow adequate written procedures for cleaning and maintenance of equipment (21 CFR 211.67(b)).You lacked the cleaning validation studies required by your written procedures for OTC drug products. You failed to demonstrate your cleaning practices are adequate to remove potential contaminants and to prevent product carry over in shared equipment (for example, fillers and small utensils used for formulation) used to manufacture your OTC drug products.Inadequate removal of residues from manufacturing equipment during cleaning can lead to the contamination of drug products subsequently manufactured on nondedicated equipment.In your response, you commit to conducting cleaning verifications for the removal of residues left by cleaning chemicals and organic materials. Specifically, you commit to completing a cleaning validation by the end of Q4 of 2025.Your response is inadequate. You fail to provide specific details, such as predetermined acceptance criteria, cleaning frequency, and procedures and acceptable holding time limit for dirty equipment, supported by cleaning validation. Furthermore, you fail to assess the impact of your inadequate cleaning processes on product that is currently on the market and within expiry. Of note, cleaning deficiencies were discussed with your firm in a previous FDA inspection.In response to this letter, provide:An interim protocol for your cleaning verification with acceptance criteria, sampling methods, locations, and other considerations relevant to your equipment cleaning program.A corrective action and preventive action (CAPA) plan, based on the retrospective assessment of your cleaning program, that includes appropriate remediations to your cleaning processes and practices and timelines for completion. Provide a detailed summary of vulnerabilities in your process for lifecycle management of equipment cleaning. Describe improvements to your cleaning program, including enhancements to cleaning effectiveness; improved ongoing verification of proper cleaning execution for all products and equipment; and all other needed remediations.Appropriate improvements to your cleaning validation program, with special emphasis on incorporating conditions identified as worst case in your drug manufacturing operation. This should include but not be limited to, identification and evaluation of all worst-case:o Drugs of lower solubility in their cleaning solventso Drugs with characteristics that make them difficult to cleano Swabbing locations for areas that are most difficult to cleano Maximum hold times before cleaningIn addition, describe the steps that must be taken in your change management system before introduction of new manufacturing equipment or a new product.A summary of updated SOPs that ensure an appropriate program is in place for verification and validation of cleaning procedures for products, processes, and equipment.A detailed risk assessment addressing the hazards posed by distributing drug products (such as(b)(4)) manufactured using shared equipment that may have been improperly cleaned. Specify actions you will take in response to the risk assessment, such as customer notifications and product recalls.3. Your firm failed to establish adequate 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)).Your firm failed to conduct process validations for all your over-the-counter (OTC) drug products, including but not limited to your(b)(4)products. Our investigators also found three instances of bulk lot(b)(4)for your(b)(4)due to out of specification resultsProcess validation evaluates the soundness of design and the 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 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 that you maintain a stable manufacturing operation throughout the product lifecycle. See FDA’s guidance for industryProcess Validation: General Principles and Practicesat https://www.fda.gov/media/71021/download for general principles and approaches that the FDA considers appropriate elements of process validation.In your response, you state that you will perform an evaluation and create a gap analysis to prioritize the completion of products and formulations requiring validation. You commit to have a validation protocol completed before the next scheduled run on nonvalidated products, so the validations can be conducted concurrently.Your response is inadequate. You did not provide an impact assessment on the drugs you distributed without completing validation studies to ensure acceptable quality of your drug products.Additionally, based on inspection findings, your(b)(4)system was not in a state of control because of inadequate testing and monitoring and inadequate sanitization. You use(b)(4)as a component in your drug products and for equipment cleaning.(b)(4)for pharmaceutical purposes must be suitable for its intended use and must be routinely tested to ensure ongoing conformance with appropriate chemical and microbiological attributes. The lack of adequate monitoring provides no assurance the system performs as intended.In your response, you commit to adding additional testing points and reinstating the(b)(4)testing frequency. You also commit to monitoring and documenting the water system maintenance performed by the contractor.Your response is inadequate. You fail to address the effects on the product resulting from the use of(b)(4)that is not adequately tested and monitored for its intended use.In response to this letter, 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 and ongoing monitoring of both intrabatch and interbatch variation to ensure a continuing state of control.A timeline for performing process performance qualification for each of your marketed drug products.Process performance protocol(s) and written procedures for qualification of equipment and facilities.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)monograph specifications and appropriate microbial limits.4. Your firm failed to establish adequate written responsibilities and procedures applicable to the quality control unit and to follow such written procedures (21 CFR 211.22 (d)).You lacked adequate quality unit (QU) oversight for the manufacture of your OTC drug products. For example:You have not performed an annual product review (APR) of your OTC drug products manufactured since 2022.You failed to follow your procedure for raw material sampling, in that multiple different materials were held in the sampling area, which poses the risk of potential contamination and mix-ups.An adequate QU overseeing all manufacturing operations is necessary to consistently ensure drug quality. Your firm’s quality systems are inadequate. See FDA’s guidance documentQuality Systems Approach to Pharmaceutical CGMP Regulationsat https://www.fda.gov/media/71023/download for help in implementing quality systems and risk management approaches to meet the requirements of CGMP regulations (21 CFR parts 210 and 211).In your response, you commit to ensuring that procedures are followed and that programs are up to date and complete going forward.Your response is inadequate. Although you commit to addressing the observations we identified, your response lacks sufficient details about the systemic remediations needed for your QU and your quality system.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, and because you failed to correct repeat violations, we strongly recommend that your firm engage a consultant qualified as set forth in 21 CFR 211.34 to assist your firm in meeting CGMP requirements.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.Correct any violations promptly. Failure to address this matter promptly and adequately may result in regulatory or legal action without further notice, including, without limitation, seizure and injunction. Unresolved violations may also prevent other Federal agencies from awarding contracts.Failure to address violations may also cause FDA to withhold issuance of Export Certificates. 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 address any violations.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 3007953761 and ATTN: Joan Johnson.Sincerely,/S/Francis GodwinDirectorOffice of Manufacturing QualityOffice of ComplianceCenter for Drug Evaluation and Research

Delivery Method:Via UPS and EMAILReference #:CBER 25-710860Product:BiologicsRecipient:Glen G. Gong, PhDChief Executive OfficerMicrovascular Tissue, Inc.6199 Cornerstone Court East, Suite 109San Diego,CA92121United Statesggong@mvtissues.comIssuing Office:Center for Biologics Evaluation and Research (CBER)United StatesWARNING LETTERDecember 3, 2025CBER 25-710860Dear Dr. Gong:The United States Food and Drug Administration (FDA) inspected your facility, located at the above address, between March 31, 2025, and April 8, 2025. During the inspection, FDA documented that your company markets and distributes a product derived from hypodermis that you recover from donors, and marketed as mVASC® (hereinafter, “mVASC” or “your product”), for allogeneic use. Your firm has a contract with(b)(4), for them to manufacture mVASC and you also participate in its manufacture.This letter is to advise you that your product is an unapproved new drug in violation of section 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C § 355(a). Your product is also an unlicensed biological product in violation of section351(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 product into interstate commerce, or the causing thereof, is prohibited under section 301(d) of the FD&C Act, 21 U.S.C. § 331(d).This warning letter also summarizes significant violations of current good manufacturing practice (CGMP) requirements, including violations of section 501(a)(2)(B) of the FD&C Act, 21 U.S.C. § 351(a)(2)(B), and 21 CFR parts 210 and 211 in the manufacture of your product. Because your methods, facilities, or controls for manufacturing, processing, packing, or holding drugs do not conform to CGMP, your product is adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act, 21 U.S.C. § 351(a)(2)(B). Your introduction or delivery for introduction of your product into interstate commerce, or the causing thereof is a prohibited act under section 301(a) of the FD&C Act, 21 U.S.C. § 331(a).Unapproved New Drug and Unlicensed Biological Product ViolationsBased on information and records reviewed by FDA, including your website, www.mvtissues.com, last visited December 2025, your product is 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:Your website states that “mVASC is intended for the repair, reconstruction, replacement, or supplementation of damaged extracellular matrix (ECM) in skin defects that extend through the dermis into and/or through the hypodermis.”Your website’s title tag states, “MicroVascular Tissues – Healing Vascular Deficiences [sic].”Your tissue distributor training presentation titled “mVASC Wound Applications”, dated March 2025 states, “mVASC healed 74% of DFUs [Diabetic Foot Ulcers] at 12 weeks versus 38% for SOC [Standard of Care].”Therefore, your product is a drug as defined in section 201(g)(1) of the FD&C Act, 21 U.S.C. § 321(g)(1), and a biological product as defined in section 351(i) of the PHS Act, 42 U.S.C. § 262(i).Your product is also a human cell, tissue, or cellular or tissue-based product (HCT/P) as defined in 21 CFR 1271.3(d) and is 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 the regulations 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, Microvascular Tissues, Inc. does not qualify for any exception in 21 CFR 1271.15, and your product fails to meet all criteria in 21 CFR 1271.10(a).Because the hypodermis that you recover from donors is predominantly composed of adipocytes and surrounding connective tissues that mainly function to provide physical cushioning and support to the body, FDA considers the hypodermis to be a structural tissue for the purpose of applying the regulatory framework. Under the 21 CFR part 1271 regulatory framework, a structural tissue is minimally manipulated if the processing does not alter the original relevant characteristics of the tissue relating to the tissue’s utility for reconstruction, repair, or replacement. 21 CFR 1271.3(f)(1). Thus, whether processing of hypodermis would meet the regulatory definition of minimal manipulation takes into consideration whether the processing alters the original relevant characteristics of the hypodermis related to its utility to provide cushioning and support to the body.Your product fails to meet the minimal manipulation criterion set forth in 21 CFR 1271.10(a)(1) and defined for structural tissue in 21 CFR 1271.3(f)(1), because your processing alters the original relevant characteristics of hypodermal tissue related to its utility for reconstruction, repair, or replacement. Hypodermis tissue (i.e., subcutaneous layer comprising adipose tissue) is processed by your firm using(b)(4).1(b)(4), thus altering the structure of the extracellular matrix.In addition, your mVASC product fails 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 hypodermis (i.e., subcutaneous layer comprising adipose tissue) derived ECM product is not intended to perform the same basic function or functions in the recipient as in the donor (e.g., providing cushioning and support to the body). Rather, the use of your product for repair, reconstruction, replacement, or supplementation of damaged ECM in skin defects that extend through the dermis into and/or through the hypodermis is not a basic function of hypodermis in the donor (e.g., providing cushioning and support to the body). In contrast to that basic function, mVASC is instead intended to facilitate the healing of full thickness skin wounds via revascularization which would require the biochemical stimulation of a wound healing response in the body via cell signaling. This is a non-homologous use for hypodermis tissue.Therefore, this HCT/P is not regulated solely under section 361 of the PHS Act, 42 U.S.C. § 264, and the regulations in 21 CFR part 1271.2See 21 CFR 1271.20. In addition to being regulated under section 361 of the PHS Act and 21 CFR part 1271, your product is regulated as a drug as defined in section 201(g)(1) of the FD&C Act, 21 U.S.C. § 321(g)(1), and a biological product 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 product is not the subject of an approved BLA.CGMP ViolationsFDA’s inspection of your facility documented evidence of significant CGMP violations. At the conclusion of the inspection, FDA investigators issued a Form FDA-483, List of Inspectional Observations (Form FDA-483).The CGMP violations applicable to your product include, but are not limited to, the following:1. Failure to establish adequate written procedures for production and process controls designed to assure that the drug products have the identity, strength, purity, and quality that they are purported or represented to possess, as required by 21 CFR 211.100(a).You have not validated the manufacturing process for your product with respect to identity, strength, quality, and purity. For example:a. Your firm has not validated critical manufacturing steps for your product, including the(b)(4)using(b)(4)with the(b)(4).b. Your firm has not performed a process validation since moving the “(b)(4)” to a new contract manufacturer in November 2018.2. Failure to conduct at least one test to verify the identity of each component of a drug product, using specific identity tests if they exist, as required by 21 CFR 211.84(d)(1).Identity testing is not performed on each component used in the manufacturing of mVASC, for example(b)(4).Response to the Form FDA-483We have reviewed your response, dated April 29, 2025, to FDA’s Form FDA-483 in detail. Your response is inadequate to address the violations noted above. For example, your response does not adequately address your firm’s continued manufacture and distribution of your product or your plans for disposition of your current inventory manufactured under the violative conditions outlined above. Additionally, you do not describe actions you have taken or plan to take that adequately address the impact of the above-noted deficiencies on your distributed product that carries an(b)(4)shelf life and was manufactured under the above-described conditions.Your firm’s response repeatedly asserts that your product should be regulated solely under section 361 of the PHS Act, and that the violations noted above are not applicable to your product. Based on your position, you have not adequately proposed corrective actions which address the CGMP violations noted above. While you assert that your product should be regulated solely under section 361 of the PHS Act, as explained above, the available evidence shows that your product does not meet all criteria in 21 CFR 1271.10(a) for regulation solely under section 361 of the PHS Act and the regulations in 21 CFR part 1271.As such, your response further does not adequately address your lack of an approved BLA to lawfully market your product. As noted above, to lawfully market a drug that is a biological product, a valid biologics license must be in effect. 42 U.S.C. 262(a). Such licenses are issued only after showing that the product is safe, pure, and potent.ConclusionNeither this letter nor the observations noted on the Form FDA-483, which were discussed with you at the conclusion of the inspection, are intended to be an all-inclusive list of deficiencies that may exist in connection with your product. 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 requirements in the FD&C Act, PHS Act, and all applicable regulations.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 product is 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 ResearchCc:(b)(4)______________________________1FDA. Guidance for Industry and Food and Drug Administration Staff. Regulatory Considerations for Human Cells, Tissues, and Cellular and Tissue-Based Products: Minimal Manipulation and Homologous Use. July 2020. https://www.fda.gov/media/109176/download.2Because your product fails to meet at least one criterion in 21 CFR 1271.10(a), this letter does not evaluate all other criteria in 21 CFR 1271.10(a).

行政相对人名称安徽黄太中药饮片科技有限公司行政相对人类别法人及非法人组织行政相对人代码_1(统一社会信用代码)91341600564981262M行政相对人代码_2(工商注册号)行政相对人代码_3(组织机构代码)行政相对人代码_4(税务登记号)行政相对人代码_5(事业单位证书号)行政相对人代码_6(社会组织登记证号)法定代表人黄振亚法定代表人证件类型法定代表人身份证号证件类型证件号码行政处罚决定书文号皖药监药处罚〔2025〕2-85号违法行为类型《中华人民共和国药品管理法》第九十八条第一款、第三款违法事实当事人生产销售的醋北柴胡，批号240703，经黄冈市公共检验检测中心检验不符合规定（报告编号：SJY20250541），不合格项目为【性状】、【检查】水分【浸出物】。暂扣或吊销证照名称及编号处罚依据《中华人民共和国药品管理法》（2019年修订）第一百一十七条第一款处罚类别罚款;没收违法所得;没收非法财物处罚名称安徽黄太中药饮片科技有限公司生产销售劣药醋北柴胡案处罚内容1.没收劣药醋北柴胡（批号240703）119kg；2.没收违法所得6192.8元；3.处违法生产、销售药品货值金额5.25倍的罚款计525000.00元，罚没共计531192.8元。罚款金额(万元)52.5没收违法所得、没收非法财物的金额(万元)1.0189处罚决定日期2025年12月16日处罚有效期2099年12月31日公示截止期2028年12月16日处罚行政机关安徽省药品监督管理局处罚机关统一社会信用代码11340000MB19570665数据来源单位安徽省药品监督管理局数据来源单位统一社会信用代码11340000MB19570665地方编码340000处罚状态有效备注