Delivery Method:VIA Electronic MailProduct:Medical DevicesRecipient:Patrick McBrayerPresident & CEOMiach Orthopaedics69 Milk St Ste 100Westborough,MA01581United Statespmcbrayer@miachortho.comIssuing Office:Center for Devices and Radiological HealthUnited StatesWARNING LETTERCMS # 709827August 19, 2025Dear Mr. McBrayer:During an inspection of your firm located in Westborough, MA from March 31, 2025 through April 23, 2025, investigators from the United States Food and Drug Administration (FDA) determined that your firm manufactures the Bridge-Enhanced ACL Restoration (BEAR) Implant intended for the treatment of anterior cruciate ligament (ACL) injuries. 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 function of the body.Quality System Regulation Violation(s)This inspection revealed that these devices are adulterated within the meaning of section 501(h) of the Act, 21 U.S.C. § 351(h), in that the methods used in, or the facilities or controls used for, their manufacture, packing, storage, or installation are not in conformity with the current good manufacturing practice requirements of the Quality System regulation found at Title 21, Code of Federal Regulations (CFR), Part 820.We received a response from Ms. Rita Paparazzo, Vice President of Quality, Regulatory, and Clinical Affairs, dated May 13, 2025, concerning our investigator’s observations noted on the Form FDA 483 (FDA 483), List of Inspectional Observations, which was issued to your firm. We address this response below, in relation to each of the noted violations. These violations include but are not limited to the following:1. Failure to establish and maintain procedures for monitoring and control of process parameters for validated processes to ensure that the specified requirements continue to be met, as required by 21 CFR 820.75(b).Specifically, the(b)(4)dose audits conducted as a process monitoring activity to ensure that the specified sterility assurance level (SAL) of(b)(4)of your firm’s validated E-Beam sterilization process continues to be met for your BEAR Implant devices, is inadequate. The rationale dated 8/2/23 to only use(b)(4)during sterility testing to recover microorganisms from the BEAR Implant devices and remove the use of(b)(4)to detect the presence of anaerobes on the basis that section A.6.1.1 of ISO 11737-1 states “***If evaluation has shown that testing for anaerobes is not indicated, then this test can be eliminated in the future***” and section 6.7 of ISO 11737-2 states “***Culture conditions shall be selected after consideration of the types of microorganisms expected to be present. The results of this consideration and the rationale for the decisions reached shall be recorded***” is unsubstantiated because your historical(b)(4)dose audit data for sterility testing shows that(b)(4)was unable to detect the presence of a strict anaerobe,Tissierella Praeacuta, which was found to only be present in(b)(4)during a(b)(4)dose audit on 10/7/22 (STR-095-006, Lot #(b)(4)). Similarly, the results of other(b)(4)dose audits have shown that facultative anaerobes such asBacillus licheniformisandBacillus megateriumwere only detected in(b)(4)but not(b)(4)despite sampling from the same Lot #(b)(4)and Lot #(b)(4). Hence, the rationale to eliminate(b)(4)for sterility testing from the(b)(4)dose audits is not valid due to examples which demonstrate that(b)(4)lacked the sensitivity to detect both strict and/or facultative anaerobes on the BEAR Implant devices.Moreover, your decision to only use(b)(4)conflicts with the recommendation from your microbiologist consultant on 10/26/21 (TR-21-12-10) for “***(b)(4)for sterility testing of verification dose samples***” and section 5.2.2 of STR-095-006 which states(b)(4)is for recovering aerobes and(b)(4)is for recovering anaerobes.We reviewed your firm’s response and conclude that it is not adequate. Under CAPA 2025-002, the immediate corrections included quarantining and discarding lot numbers(b)(4)through(b)(4). Starting with Lot #(b)(4), you plan to re-implement use of(b)(4)for bioburden monitoring of facultative and strict anaerobic microorganisms. In addition, you plan to review bioburden data for 12 months and assess whether use of both media still remains appropriate; establish a new procedure for bioburden monitoring to align with the contract manufacturer’s procedure; revise the process validation procedure to ensure that validated parameters are properly monitored; review all other process validations for the BEAR Implant devices; and revise relevant work instructions as needed to ensure that the validated parameters are properly monitored. However, no timelines were provided for these corrections and/or corrective actions. Therefore, please provide a response on how you plan to address the above deficiencies. In addition, please continue to provide updates on the progress of your corrections and/or corrective actions, including any supporting evidence.2. Failure to establish and maintain procedures to control product that does not conform to specified requirements, as required by 21 CFR 820.90(a).You failed to implement sections 1.0 and 4.2 of your “Nonconforming Materials and Processes” procedure (SOP-0017; Rev. B; Effective: 4/12/23) which state “***products that do not conform to specification requirements are identified, segregated, investigated and dispositioned***” and describe the steps for initiation of a nonconformance report, respectively. For example, you did not generate nonconformance reports when the(b)(4)dose audit reports for your BEAR Implant devices indicated that Lot #(b)(4)exceeded the product requirement specification (PRS) of(b)(4)CFU/device (average) (PRS-001; Rev. F; Effective: 7/10/23 – 12/7/23) at(b)(4)CFU/device (average) and Lot #(b)(4)exceeded the PRS of(b)(4)CFU/device (average) (PRS-001; Rev. G; Effective: 12/8/23 – 9/18/24) at(b)(4)CFU/device (average). Moreover, the lack of initiation of nonconformance reports for Lot #(b)(4)and Lot #(b)(4)is inconsistent with past actions to initiate NCR 22-002/CAPA 2022-001 (1/17/22) and CAPA 2022-002 (2/28/22) for Lot #(b)(4)and Lot #(b)(4)which also exceeded the limits of bioburden.We reviewed your firm’s response and conclude that it is not adequate. Under CAPA 2025-001, your immediate corrections are to document decisions and rationale for past production lots (Lot #(b)(4)and(b)(4)) by 5/31/25; establish procedures for bioburden excursions; review a list of process related nonconformances reported to the firm by the contract manufacturer by 5/31/25; and revise the quality agreement with the contract manufacturer (if needed). In addition, you plan to revise the nonconforming product procedure to describe how to evaluate and disposition devices with bioburden excursions and positive tests for sterility by 5/31/25. However, timelines were only provided for some actions and not others. Therefore, please provide a response on how you plan to address the above deficiencies. In addition, please continue to provide updates on the progress of your corrections and/or corrective actions, including any supporting evidence.3. Failure to establish and maintain procedures to ensure that the design requirements relating to a device are appropriate and address the intended use of the device, including the needs of the user and patient and a mechanism for addressing incomplete, ambiguous, or conflicting requirements, as required by 21 CFR 820.30(c).Specifically, you failed to implement the instructions in the “BEAR® Scaffold Design Requirements Trace Matrix” (DCR 2021-011; Rev. D; Effective: 10/1/21) which requires you to consider areas such as performance and intended use, reliability, and safety when identifying user needs and/or design input requirements for your resorbable BEAR Implant devices intended to treat anterior cruciate ligament (ACL) injuries. For example, your DCR 2021-011 for the BEAR Implant device lacks user need(s) such as (but not limited to) the need for the implant to achieve full absorption of blood (i.e., hydration) without the use of copious volumes of blood in a timely manner, all while remaining intact.In addition, because the aforementioned user need(s) are absent from the DCR 2021-011 for the BEAR Implant device, you failed to (1) validate that your BEAR Implant device meets these user needs as a part of your design validation under “BEAR Implant Design Validation Protocol” (TP-20-010; Approved 6/17/25) and (2) adequately implement section 4.5.2 of the “Design Control” procedure (SOP-0001; Rev. E; Effective: 7/8/20) which requires translation of “***user needs into design inputs and assure the design inputs address***intended use and user needs***functional, performance, and safety requirements***” and resolution of ambiguous or conflicting requirements prior to approval. For example:a. The design input "The BEAR Implant shall be able to absorb whole blood (autologous blood injected during the surgical process)" (9b) in the “BEAR® Scaffold Design Requirements Trace Matrix” (DCR 2021-011; Rev. D; Effective: 10/1/21) is ambiguous because it does not identify parameters (time, volume, technique, etc.) under which the implant must be able to be fully hydrated while remaining intact.Per your instructions for use (IFU) (ML-1002; Rev. H; Effective: 3/2025), the implant “***is intended to be used with up to 10 ml of autologous blood***” and states to “***hydrate the BEAR Implant with 5-10 mL of non-coagulated autologous blood***.” In addition, the “The BEAR® Implant Physeal Sparing Technique” (ML-1274; Rev. A; Effective: 3/2025) describes the technique by which to infuse the implant with blood: “***Massage the autologous blood into the BEAR Implant, starting with approximately 1mL on the proximal side, then to the sides and finishing with the bottom. Add 1-2mL at a time while massaging the blood in, softening the implant. Once the implant is pliable, inject whole blood into the center of the implant***.”b. The DCR 2021-011 includes design inputs which do not directly address the user need under which they are categorized. For example, the above design input (9b) was inappropriately categorized under the user need (UN-2) of “***The BEAR Implant must demonstrate non-inferiority in terms of effectiveness when compared with the current standard of care (ACL reconstruction with an autograft) at 2 years post-surgery***” and there was no other applicable user need which describes user need(s) of the surgeon such as (but not limited to) the need for the implant to achieve full hydration without the use of copious volumes of blood and absorption of blood in a timely manner, all while remaining intact.We reviewed your firm’s response and conclude that it is not adequate. Under CAPA 2025-004, your immediate corrections are to identify a new or existing user need as the basis of the design input “(b)(4);” develop a design output specification tied to the new or revised design input; verify that the design output specification meets the design input specification; and develop a test to provide evidence that the new or revised user need is met. Your corrective action is to revise SOP-0001 to require participation of surgeons and other relevant experts in design review for design inputs. However, no timelines were provided for these corrections and/or corrective actions. In addition, there were no corrective actions identified to require that surgeons and other experts are included in the development of user needs and to retrospectively review all user needs and design inputs for the BEAR Implant device for any missing user needs, adequacy, and appropriate categorization by user need. Therefore, please provide a response on how you plan to address the above deficiencies. In addition, please continue to provide updates on the progress of your corrections and/or corrective actions, including any supporting evidence.4. Failure to ensure that when the results of a process cannot be fully verified by subsequent inspection and test, the process shall be validated with a high degree of assurance and approved according to established procedures, as required by 21 CFR 820.75(a).Specifically, you failed to validate, with a high degree of assurance, that your gelation and lyophilization processes consistently produce BEAR Implant devices which meet the specifications for density (0.062 - 0.072 g/cm3). For example, although your “Miach BEAR 20510-01 Process Qualification Report” (VAL-08164; Rev. AA; Approved 4/24/24) states that your performance qualification (PQ) demonstrates “***with(b)(4), the(b)(4)density of the BEAR devices is between(b)(4)***,” this sampling method to use the(b)(4)density from(b)(4)BEAR Implants per lot (Lot #:(b)(4); and(b)(4)) does not take into account the impact of an individual implant failing to meet specification, outliers, or standard deviation. Review of the raw data in your PQ revealed that 1 out of(b)(4)of the BEAR implants under Lot #(b)(4)failed to meet specification ((b)(4)) for density and over(b)(4)of the density values across lots were at or below the minimum specification, none of which demonstrates a high degree of assurance that your processes result in devices which consistently meet density specifications.We reviewed your firm’s response and conclude that it is not adequate. You provided no corrective actions for this deficiency on the basis that an(b)(4)sampling plan is an acceptable means of showing that a process is able to consistently meet specification because it offers statistical confidence that an average characteristic is repeatable and reliable. In addition, you state this approach was used during process validation because the(b)(4)density from the(b)(4)lots was also used during clinical trials. However, this rationale does not take into account the impact of an individual implant failing to meet specification or high standard deviations. In addition, confidence intervals based(b)(4)sampling plans provide a range within which a value is likely to fall, not a high degree of assurance that a process will produce product that consistently meets specification. Therefore, please provide a response on how you plan to address the above deficiency.5. Failure to ensure that sampling plans are written and based on a valid statistical rationale when used, as required by 820.250(b).Specifically, the sampling plan outlined in “7540 Dimensional Inspection” for (FRM-01379; Rev AA) to use the(b)(4)density from the first(b)(4)BEAR Implants per lot to accept lots which meet the density specification ((b)(4)) on the premise that the collagen slurry mixture in the(b)(4)manufacturing step would have met the homogeneity specification is not based on valid statistical rationale. For example, per your Vice President of Research and Development and Manufacturing, if a single implant fails the density acceptance criteria, it will still be released, so long as the(b)(4)density of the(b)(4)implants remain within specification. On the other hand, if the(b)(4)density of the(b)(4)implants fails, then density is calculated on every implant within the lot, and all samples that do not meet specification will be treated as a nonconformance and scrapped. However, the rationale for this sampling plan is not based on valid statistical rationale because (1) samples are not taken at random; (2) samples are not based on lot sizes which can be up to(b)(4)units; (3) individual samples may still fail to meet density specifications, even if the previous collagen slurry specification met the specification for homogeneity; and (4) single implants which do not meet density specifications have the potential to be released if the(b)(4)density specification is met. The practice of releasing product when an individual data point was outside of the specification also constitutes distribution of nonconforming product without valid justification. Your complaint and/or corrective and preventive action investigations have determined that the gelation process affects densities such that implants with low densities can cause rapid blood absorption and those with high densities can delay or hinder blood absorption, both of which can render the implant unusable due to disintegration or lack of proper hydration, the result of which is delayed surgery requiring use of a second implant (if available) or impaired(b)(4)per lines(b)(4)through(b)(4)of your hazard analysis (001-003-HZ; Rev. B; Effective: 7/10/23).We reviewed your firm’s response and conclude that it is not adequate. Per the response to the process validation observation, which employed the same(b)(4)sampling plan strategy as that used during lot release of product, you provided no corrective actions on the basis that an(b)(4)sampling plan is an acceptable means of showing that a process is able to consistently meet specification because it offers statistical confidence that an(b)(4)characteristic is repeatable and reliable. In addition, you state this approach was used during process validation because the(b)(4)density from the(b)(4)lots was also used during clinical trials. However, this rationale does not take into account the impact of an individual implant failing to meet specification or high standard deviations. Therefore, please provide a response as to how you plan to address the above deficiency.6. Failure to establish and maintain the requirements, including quality requirements, that must be met by suppliers, contractors, and consultants and documented evaluation and selection of potential suppliers, contractors, and consultants on the basis of their ability to meet specified requirements, including quality requirements, as required by 21 CFR 820.50(a)(1).Specifically, you failed to implement:a. Sections 4 and 18 of your “Supplier Quality Agreement” (Approved 1/27/22) which require you to approve protocols and reports for process, sterilization and inspection/test validations performed by the contract manufacturer and “***provide copies of quality records upon request***,” respectively. For example, your contract manufacturer refused to provide unredacted supporting documents, such as the process routers, device history records, and process parameters used to manufacture the BEAR Implant device during the FDA inspection.b. Section 4.8 of your “Supplier Management” (SOP-0025; Rev. D; Effective: 12/8/23) which requires(b)(4)evaluation of major suppliers using the “Supplier Re-evaluation Form” (FRM-0025). For example, your contract manufacturer of the BEAR Implant device has not been evaluated since May 2023 despite being categorized as a major supplier.c. Section 4.1.1 of SOP-0025 which requires “***no products or services associated with the QMS are to be purchased from a supplier not on the Approved Supplier List***.” For example, your firm’s microbiology consultant who authored “Rationale for Eliminating(b)(4)for the Test of Sterility and Anaerobic Bioburden Monitoring” dated 7/30/23 was not on the Approved Supplier List or evaluated. You have been using this consultant since November 2021.We reviewed your firm’s response and conclude that it is not adequate. Under CAPA 2025-007, your immediate correction is to complete the 2024 supplier re-evaluation form for the contract manufacturer and for the consultant and revise the quality agreement to allow alternative methods for reviewing all supporting documentation for process, sterilization, and inspection/test validations such as onsite review, establishing a master file with the FDA, or having a 3rd party consultant review the documents. As a part of corrective actions, you plan to perform a gap analysis for the approved supplier list and revise SOP-0025 to allow alternative methods for review of supporting documents. However, no timelines were provided for these corrective actions. Therefore, please provide a response on how you plan to address the above deficiencies. In addition, please continue to provide updates on the progress of your corrections and/or corrective actions, including any supporting evidence.7. Failure to establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit, including evaluations to determine whether the complaint represents an event which is required to be reported to FDA under part 803 of this chapter, Medical Device Reporting, as required by 21 CFR 820.198(a).Specifically, you failed to implement section 4.3.6 of your “Customer Feedback” procedure (SOP-0027; Rev. B – C; Effective: 6/27/24 and 12/8/23) which requires you to categorize customer feedback as complaints, to be processed by the “Complaint Management” procedure (SOP-0019; Rev. C – D; Effective: 12/8/23 and 4/26/24), when they meet the definition of complaints as defined under section 3 of SOP-0027. For example, your customer feedback descriptions in 3 out of 6 reviewed customer feedback forms, which met the definition of complaints, were classified as “Observations” instead of “Complaints” and, therefore, did not include documented evaluations for medical device reporting (MDR) and investigations per sections 4.2 and 4.3 of SOP-0019, respectively, as evidenced below:a.CF 2024-006 (6/3/24): BEAR Implant “***hydrating far too quickly (

案件名称大连木兰陶齿医疗科技发展有限公司生产经营的定制式固定义齿产品无标签及说明书内容与注册内容不一致案处罚决定文书号辽药监(稽二)罚〔2025〕3号被处罚企业名称大连木兰陶齿医疗科技发展有限公司统一社会信用代码91210211MACPXUBB3W法定代表人任美君主要违法事实当事人生产经营的定制式固定义齿产品无标签及说明书内容与注册内容不一致行政处罚种类和依据罚款依据《医疗器械监督管理条例》第八十八条第二项处罚结果罚款1万元行政处罚履行方式和期限当事人已于2025年8月18日履行完毕。作出处罚的日期2025-08-15

经查，司伟伟等15人存在《执业药师注册证》挂靠行为，根据《执业药师注册管理办法》有关规定，我局依法对司伟伟等15人的《执业药师注册证》予以撤销、注销，三年内不予注册，并将不良信息录入全国执业药师注册管理信息系统。特此通告。执业药师身份证号码资格证书号“挂证”/执业单位司伟伟622727********4128201910026620002466静宁大众医药连锁有限公司八分店马娅利622727********414X02620241062000002297静宁老百姓知心药房杜滢622726********1520201910026620002420静宁县陈岩药业有限公司黄高松622727********711XZY00471927静宁县春杏堂医药有限公司张军强622727********41362014026620260000002612621084静宁县鸿福信息医药有限公司王永平622727********7130ZZ00411245静宁县华世万康药业有限公司张慧622727********47492017026620262016620630007321静宁县仁益堂药业有限公司穆晓霞622727********0147ZY00472406静宁县万民信医药有限公司韩晶622727********861X2015026620262014620600005413静宁县徐喜旺医药有限公司张选鹏622727********4434201910026620002438静宁县杨娜医药有限公司杨芳431230********032X20221102649000000467静宁县益灵药业有限公司闫云云622727********382220221202662000001902静宁县众仁堂医药有限公司翟晓妍622727********50242017026620262016620601003847静宁益众堂药业有限责任公司徐卓642221********0901201910026620002790静宁众仁医药有限公司二分店高鹏飞622727********35110121641静宁县御草堂医药有限公司甘肃省药品监督管理局2025年8月22日

各申报企业：根据《自治区医保局关于开展医药产品挂网全国联审通办试运行工作的通知》的要求，现将截至2025年8月1日通过国家医疗保障局统一门户向我区提交新增挂网申请且相关协办省份已完成核验的医用耗材产品信息进行公示，有关事宜通知如下：一、公示信息（一）审核通过的产品汇总表（详见附件）。（二）审核不通过的产品请相关企业在系统查看原因并按要求更正后重新申报，重新申报的产品按最后申报时间纳入相应批次审核。二、公示时间2025年8月25日至2025年8月29日。三、注意事项在公示期间，企业对公示结果有异议的，请在公示期间递交纸质申诉材料，逾期不再受理。（递交地址：广西壮族自治区南宁市青秀区星湖路22号自治区公共资源交易中心评标楼一楼业务受理大厅医疗器械受理服务窗口，联系电话：0771-8600407）。 附件：耗材挂网全国联审通办申报挂网审核通过产品表（2025年8月批次2） 广西壮族自治区公共资源交易中心2025年8月25日

药品流通作为药品研制、生产、流通、使用全流程中的关键环节，是连接药品生产与终端消费的核心枢纽，其风险防控水平直接关系到药品质量安全“最后一公里”的坚实度。省药品监督管理局紧盯药品流通（批发）领域的高风险环节，以药品经营环节“清源”行动为契机，坚持最严标准、最实举措和最强力度，全面深入排查风险隐患，推动监管效能与企业主体责任协同发力，切实筑牢人民群众用药安全底线。靶向发力，以“穿透式”监管斩断风险链条。“清源”行动直指药品批发环节“痛点”“难点”，构建“重点聚焦+全域覆盖”的监管格局。一方面，紧盯特殊药品、冷藏冷冻药品等重点品种，围绕违法购进、不规范储存、违规销售等高风险行为，实施“清单式”检查、“销号式”整改，对全省A级批发企业实现深度监督检查全覆盖，现场直指问题核心、明确整改时限，确保风险隐患“即查即改、动态清零”。另一方面，创新推行药品流向票据“穿透式”核查机制，对14个医保高值品种、13个普通品种开展全链条追溯校验，从严核验“票、账、货、款”一致性，以“数据铁证”确保药品来源可溯、去向可追、责任可究，让每一批药品的流通轨迹都晒在“阳光”下。科技赋能，以“智慧化”手段织密监管网络。在数字化监管浪潮下，省药监局将技术创新作为提升监管效能的“加速器”。充分运用药品追溯系统构建“触发式”监管模式，通过扫码溯源、异常数据预警等功能，实现问题线索“秒级锁定”、非法渠道“精准阻断”，让风险隐患无处遁形。同时，深化部门协同，对重大风险线索实行“零延迟”移送、“全流程”督办，目前已对1家票据异常企业启动移案核查，完成7家企业重点药品流向核查，以“闭环管理”彰显监管刚性，形成“不敢违、不能违、不想违”的强大震慑。固本培元，以“全链条”共治夯实安全根基。监管的终极目标是推动企业从“被动合规”向“主动防控”转变。省药监局坚持“严监管”与“强指导”并重，对20余家到期需换证的批发企业开展约谈警示，紧盯质量管理薄弱环节、共性问题，压实企业“换证即整改”的主体责任；创新推行“以查带训”模式，结合现场检查实例，对企业质量管理人员开展“点对点”法规解读与实操指导，全面提升其风险预判、过程管控能力，推动质量管理体系贯穿药品采购、储存、销售全流程。截至目前，已完成28家药品批发企业的审查发证工作。从“查问题”到“教方法”，从“督整改”到“建机制”，监管效能正持续转化为企业规范发展的内生动力。风劲帆满海天阔，奋楫潮头逐浪高。下一步，省药监局将持续巩固“清源”行动成效，把“重点检查、智慧监管、协同共治”等有效实践固化为常态化机制，以“永远在路上”的坚韧执着，持续净化药品流通环境，筑牢药品安全屏障，让每一粒药都成为安全的承诺，让人民群众的用药安全更有保障、获得感更加充实、幸福感可持续提升。

按照《药品生产监督管理办法》第五十九条和《药品检查管理办法（试行）》第六十三条的有关规定，贵阳宇顺气体有限公司医用氧（气态分装）生产线已于2025年8月21日前完成前次检查缺陷项目整改，整改结果符合要求。现同意解除《贵州省药品监督管理局2025年药品生产监督检查结果通报（第一期）》中贵阳宇顺气体有限公司医用氧产品的暂停生产、销售控制措施。特此通告。贵州省药品监督管理局2025年8月22日

根据《中华人民共和国药品管理法》《药品生产监督管理办法》《药品检查管理办法（试行）》《药品生产质量管理规范符合性检查工作程序》有关规定及要求，我局对西安利君精华药业有限责任公司等9家药品生产企业进行药品生产质量管理规范符合性检查和审核，经现场检查并综合评定，现将检查结果通告如下：企业名称检查地址检查范围及相关车间、生产线检查时间检查结论西安利君精华药业有限责任公司西安市红光路16号片剂（一车间，片剂生产线）、硬胶囊剂（一车间，胶囊剂生产线）（不含中药前处理及提取）、栓剂（二车间，栓剂生产线）、凝胶剂（二车间，凝胶剂生产线）2025年7月8日-2025年7月11日符合陕西天宇制药有限公司西安市经济技术开发区泾河工业园长庆西路108号原料药（聚多卡醇）（原料药生产车间，聚多卡醇生产线）、小容量注射剂（小容量注射剂生产车间，小容量注射剂生产线）2025年7月8日-2025年7月11日符合西安汉丰药业有限责任公司西安市蓝田县工业园区文姬路15号小容量注射剂（小容量注射剂车间，生产一线（非最终灭菌生产线）、生产二线（最终灭菌生产线））2025年5月7日-2025年5月9日符合西安利君制药有限责任公司西安沣京工业园利君路（沣五西路）1号小容量注射剂（含激素类）（针剂生产中心（二车间），普通生产线一线、普通生产线二线、激素生产线）2025年5月13日-2025年5月16日符合陕西博森生物制药股份集团有限公司陕西省西安市高新区新型工业园创新路7号小容量注射剂（小针剂（十车间），小容量注射剂（最终灭菌生产线、小针剂（七车间），小容量注射剂（非最终灭菌生产线）、冻干粉针剂（冻干粉针剂（八车间），冻干粉针剂生产线）2025年5月6日-2025年5月9日符合委托方：西安汤臣制药有限公司受托方：陕西顿斯制药有限公司委托方：陕西省西安市鄠邑区沣京工业园丰三东路003号203室（陕西顿斯制药院内）受托方：西安沣京工业园标准化厂房一期建设区小容量注射剂（维生素B1注射液、维生素B2注射液、盐酸林可霉素注射液、维生素B6注射液、氯化钾注射液、曲克芦丁注射液、利巴韦林注射液、维生素C注射液、肌苷注射液共11个品规）（小容量注射剂102车间，小容量注射剂生产线（非最终灭菌））2025年4月15日-2025年4月18日符合委托方：陕西奕珩生物科技有限公司受托方：西安利君制药有限责任公司委托方：陕西省西安市鄠邑区沣京工业园正小路西段受托方：西安沣京工业园利君路（沣五西路）1号小容量注射剂（氢化泼尼松注射液（2ml:10mg)）(小容量注射剂车间，小容量注射剂激素生产线）2025年4月9日-2025年4月9日2025年5月13日-2025年5月16日符合陕西开元制药有限公司陕西省西安市高新区西部大道68号片剂（含第二类精神药品）（固体车间，片剂生产线）、小容量注射剂（小容量注射剂车间，小容量注射剂生产线）2025年6月17日-2025年6月20日符合委托方：西安信百欣医药科技有限公司受托方：四川太平洋药业有限责任公司委托方：陕西省西安市沣东新城国际科创商务广场4幢1单元7层10703室受托方：成都高新技术开发区西区新达路6号大容量注射剂（左氧氟沙星氯化钠注射液（100ml:左氧氟沙星（按C18H20FN3O4计）0.5g与氯化钠0.9g）、左氧氟沙星氯化钠注射液（50ml：左氧氟沙星按C18H20FN3O4计）0.25g与氯化钠0.45g）（大容量注射剂输液车间，D线）2025年5月20日-2025年5月22日符合陕西省药品监督管理局2025年8月21日

为进一步强化中药饮片质量监督管理，规范中药饮片经营、使用行为，不断提高中药饮片质量，严厉打击违法违规行为，近期，武山县滩歌市场监管所在辖区内开展了中药饮片专项整治检查督查。此次整治，主要以小诊所、小药店为重点，一是对从业人员的证照、资质查看是否配备符合中药学相关专业的验收和养护人员，是否严格执行中药饮片处方审核、调配、核对等相关制度；二是对中药饮片的储存环境、经营使用场所环境，供货方资质证明文件、中药饮片检验报告、进货票据、储存、养护、出库复核等进行查看；三是查看药斗，是否定时清斗并做好记录，是否存在错斗、串斗情况，是否存在生虫、发霉、变质等情况。截至目前，检查中药饮片经营使用单位15余户下发责令整改通知书5份。通过检查，进一步提高了相关企业和单位的主体责任意识，规范了中药饮片市场秩序。

近日，清水县市场监管局组织城区市场网格化监管力量，组建工作专班，对食品、药品、化妆品经营主体开展“地毯式”执法检查。聚焦食品安全，“紧拧”进货加工销售监管链。检查组重点核查经营主体资质证照、从业人员健康证明、索证索票及产品贮存环境，同时检查食品生产加工卫生、洗消保洁、原料贮存、食品留样，以及“陇上食安”明厨亮灶和“日管控、周排查、月调度”落实情况。针对县一中周边，严厉整治小餐饮店、小食杂店等经营主体环境卫生不达标问题，督促经营主体显著标识“禁止向未成年人售酒”，且200米内禁售高糖高脂肪类“5毛”麻辣食品。对金河市场早餐、夜市，督促经营主体按时办理小摊点登记证、从业人员健康证明，落实“一穿三戴”，确保食品容器设备清洗消毒合格后方可盛装食品。聚焦药械安全，“严扣”进货储存销售质量关。为筑牢药械安全防线，检查组严格把控药械进货、储存、销售全流程质量。药店、诊所、医院需确保证照资质有效，直接接触药械从业人员健康证在有效期内，要求建立质量管理制度，设质量管理机构或专职人员。药械需统一采购，索取供货商资质与进货票据，通过计算机系统台账记录购进、验收、储存、养护、销售各环节；药品按说明书贮存条件分区分类摆放。处方药凭处方销售，严禁开架，执业药师不在岗时停售；单位剂量麻黄碱＞30mg的复方制剂凭处方实名限量销售，“精麻”药品落实“五专管理”。拆零药品设专柜并建销售记录；中药饮片需健全清斗装斗记录，防生虫发霉变质，戥子定期检定。诊所严禁使用非法渠道药械、假劣药品及未注册备案、失效淘汰的医疗器械。聚焦化妆品安全，“紧盯”标识标签强化智慧监管。为守牢化妆品安全底线，检查组对沿街铺面、金河市场内化妆品店及美容美发美体店开展检查。重点核查经营主体进货查验、索证索票制度落实情况，严禁其自行配制化妆品，或使用超期、过期产品。国产化妆品中，普通化妆品需标明生产许可与注册备案证明，特殊化妆品需持国产特殊化妆品注册证；进口化妆品需在许可或备案有效期内经检验检疫入境，普通化妆品标明进口备案凭证，特殊化妆品需取得进口注册证。检查中充分运用化妆品监管APP，通过扫码或输入产品名称两种方式，现场查询化妆品备案信息，提升监管效率。此次检查各类经营主体86户，发现整改问题8大类，下发责令整改意见86条，发现案源线索4件，有力的净化了“食药化”市场。下一步，清水县市场监管局将持续集中力量监管各项薄弱区，以优良作风、坚韧意志，全力争创有序、健康、安全的市场秩序。

近期，我局对浙江一方制药有限公司开展了省级监督检查（药品GMP符合性检查），综合评定结论为不符合要求。为防控药品质量风险，依据《药品管理法》第九十九条第三款、《药品生产监督管理办法》第五十九条第一款第二项的规定，自2025年8月21日起，决定对浙江一方制药有限公司采取暂停生产、销售药品的风险控制措施。 特此通告。 浙江省药品监督管理局 2025年8月25日