Delivery Method:VIA Electronic MailReference #:320-26-40Product:DrugsRecipient:Dr. Vetukuri Venkata Naga Kali Vara Prasada RajuManaging Director & Chief Executive OfficerCohance Lifesciences Limited202, 2nd Floor, A-wing, Galaxy by Aurobindo Realty, Sy. No. 83/1Hyderabad Knowledge City, TSIIC, Raidurg, Panmaktha, Opp. IKEAHyderabad500081TelanganaIndiaIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesWarning Letter320-26-40January 30, 2026Dear Dr. Raju:The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, Cohance Lifesciences Limited, FEI 3008768274, at Plot No. A-19/C, A-23A, A-23B, Road No. 18, IDA Nacharam, Uppal Mandal, Medchal-Malkajgiri, from August 4 to August 12, 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 September 2, 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 firm failed to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, whether or not the batch has already been distributed (21 CFR 211.192).Your firm manufactures various(b)(4)dosage forms, including(b)(4)and medications for the treatment of(b)(4). Your investigations into drug-product quality issues were inadequate because they lacked thoroughness, adequate root-cause determination, and appropriate corrective action and preventive action (CAPA). For example, you received a customer complaint about(b)(4)tablets USP(b)(4)mg from two different batches that were reported to be crumbling, disintegrating, pitted, and with dust in the bottle. Your complaint investigation could not identify a root cause and concluded that the complaint was “Not Substantiated.” You noted in your investigation that “the appearance of pitted/crumbly tablets is due to the inherent nature of the raw material ‘(b)(4)’ in the formulation.” Furthermore, your investigation noted two additional complaint investigations for the same issue in three other batches of the same drug product.In your response, you state that you re-opened this investigation and revised your attributable root cause to your raw material,(b)(4).Your response is inadequate. Despite identifying a root cause, your response lacks information on chemical testing of reserve samples to confirm that affected tablets meet specifications, and your response does not contain a commitment to perform such testing. Your response lacks remediation for the root cause identified in your re-opened investigation and does not evaluate the quality of your raw materials or consider changes to your formulation to prevent the issue. Additionally, your response fails to consider whether other drug products containing(b)(4)could also be affected.In response to this letter, provide:A summary of analytical testing, including dissolution, of reserve samples exhibiting crumbling, disintegrating, pitted(b)(4)tablets USP(b)(4)mg, and an action plan to address this product-quality issue, such as reformulation studies or additional transportation studies.A comprehensive, independent assessment of your overall system for investigating deviations, discrepancies, complaints, out-of-specification (OOS) results, and failures. Provide a detailed action plan to remediate this system. Your action plan should include but not be limited to significant improvements in investigation competencies, scope determination, root-cause evaluation, CAPA effectiveness, quality unit oversight, and written procedures. Address how your firm will ensure all phases of investigations are appropriately conducted.An independent assessment and remediation plan for your CAPA program. Provide a report that evaluates whether the program includes effective root-cause analysis, ensures CAPA effectiveness, analyzes investigations trends, improves the CAPA program when needed, implements final quality unit decisions, and is fully supported by executive management.2. Your firm failed to clean, maintain, and, as appropriate for the nature of the drug, sanitize and/or sterilize equipment and utensils at appropriate intervals to prevent malfunctions or contamination that would alter the safety, identity, strength, quality, or purity of the drug product beyond the official or other established requirements (21 CFR 211.67(a)).You failed to adequately clean and maintain your nondedicated drug manufacturing equipment. For example, our investigator observed visible stains within the(b)(4)duct of a(b)(4)(PD/(b)(4)-01) and visible residues on a capsule filling machine (PD/CFM-03) that were documented as clean and had undergone drug product changeover cleaning. Your analytical testing of these stains and residues confirmed the presence of multiple active pharmaceutical ingredients (APIs) with values exceeding your allowable limit.In your response, you provide investigations into these findings, including a retrospective review of analytical and stability data for all drug products previously manufactured on the pieces of equipment mentioned above. Your investigations attribute the root cause of the cleaning deficiencies to procedural gaps in the cleaning instructions for the(b)(4)and the capsule-filling machine. You state that you plan to revise your cleaning procedures and cleaning checklists.Your response is inadequate because your review of analytical data and cleaning procedures fails to scientifically demonstrate that your drug products are free of contaminants from the visibly dirty equipment. Your response lacks information about reserve sample testing of drug products released to the U.S. market and within expiry, that were manufactured on these pieces of nondedicated equipment, for cross-contamination potential posed by all previously manufactured drug products.In response to this letter, provide:A comprehensive, independent retrospective assessment of your cleaning effectiveness to evaluate the scope of cross-contamination hazards. Include the identity of residues, other manufacturing equipment that may have been improperly cleaned, and an assessment whether cross-contaminated drug products may have been released for distribution. The assessment should identify any inadequacies of cleaning procedures and practices, and encompass each piece of manufacturing equipment used to manufacture more than one drug product.A 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 drug products and equipment; and all other needed remediations.In addition to this holistic remediation, provide specific CAPA activities that are being undertaken to effectively remediate the conditions that caused the specific cross-contamination incidents discussed above. Provide an independent review by your consultant that determines the effectiveness of your CAPA, including but not limited to:o A list of all enhancements to cleaning and maintenance procedures, including specific frequencies and locations to be cleaned in all relevant equipment (e.g.,(b)(4))o Identification of any sources of cross-contamination other than(b)(4)equipment,(b)(4), and ductworko Determination of the adequacy of your analytical methodology to identify residual carryovero Your investigations into any unknown (unidentified) peaks detected in your reserve samples3. Your firm failed to establish and follow adequate written procedures for cleaning and maintenance of equipment (21 CFR 211.67(b)).You have not demonstrated that your cleaning practices are adequate to remove contaminants from the shared equipment used to manufacture multiple drug products. Your 2018 cleaning validation study failed to use the identified worst-case drug product, making it inadequate to ensure cleaning effectiveness. You also did not re-evaluate your cleaning validation program when introducing new drug products on shared manufacturing equipment, and you lack routine cleaning verification. Inadequate removal of drug residues during cleaning can cause cross-contamination in subsequently manufactured drugs on the same equipment.In your response, you state that the results of your cleaning verification studies from 2019 to 2024 demonstrate that your cleaning processes are effective. You state that you have engaged an independent third-party consultant to review your cleaning validation program and cleaning practices.Your response is inadequate because your cleaning validation and verification program does not adequately evaluate the effectiveness of your cleaning procedures. Your cleaning verification lacks the ability to detect cross-contamination from carryover.In response to this letter, provide: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 with higher toxicitieso Drugs with higher drug potencieso 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 drug product.A summary of updated SOPs that ensure an appropriate program is in place for verification and validation of cleaning procedures for drug products, processes, and equipment.Drug Production SuspendedWe acknowledge your commitment to temporarily suspend manufacturing and release of drug products from this facility as of August 16, 2025. In response to this letter, clarify when you intend to resume manufacturing of drugs for the U.S. market at this facility.Before you resume any manufacturing operations regulated under the FD&C Act, notify this office. You are responsible for resolving all deficiencies and systemic flaws to ensure your firm is capable of ongoing CGMP compliance. In your notification to the Agency, provide a summary of your remediations to demonstrate that you have appropriately completed all CAPA.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. FDA may withhold approval of new applications or supplements listing your firm as a drug manufacturer until any violations are completely addressed and we confirm your compliance with CGMP. We may re-inspect to verify that you have completed corrective actions to any violations.Failure to address any violations may also result in the FDA refusing admission of articles manufactured at Cohance Lifesciences Limited, FEI 3008768274, at Plot No. A-19/C, A-23A, A-23B, Road No. 18, IDA Nacharam, Uppal Mandal, Medchal-Malkajgiri, into the United States under section 801(a)(3) of the FD&C Act, 21 U.S.C. 381(a)(3). Articles under this authority that appear to be adulterated may be detained or refused admission, in that the methods and controls used in their manufacture do not appear to conform to CGMP within the meaning of section 501(a)(2)(B) of the FD&C Act, 21 U.S.C. 351(a)(2)(B).This letter notifies you of our findings and provides you an opportunity to address the above deficiencies. After you receive this letter, respond to this office in writing within 15 working days.1Specify 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 3008768274 and ATTN: Marisa Heayn.Sincerely,/S/Francis GodwinDirectorOffice of Manufacturing QualityOffice of ComplianceCenter for Drug Evaluation and Research______________________1Under 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.

Delivery Method:VIA Electronic MailProduct:Medical DevicesRecipient:Christopher ScogginsExecutive Vice President of Diabetes CareAbbott Diabetes Care, Inc.1360 S Loop RdAlameda,CA94502-7000United States(b)(4)Issuing Office:Center for Devices and Radiological HealthUnited StatesWARNING LETTERCMS # 722046January 23, 2026Dear Mr. Scoggins:During an inspection of your firm located at 1360 S. Loop Rd, Alameda, CA 94502-7000, FEI #3002803444, on October 14, 2025, through October 23, 2025, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures FreeStyle Libre Flash and Continuous Glucose Monitoring Systems including the FreeStyle Libre 3. 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 ViolationsThis 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 your firm’s responses dated November 14, 2025, and December 19, 2025, from Christopher Scoggins and Denise Reid concerning our investigator’s observations noted on the Form FDA 483, List of Inspectional Observations (FDA 483) that was issued to your firm on October 23, 2025. These violations include but are not limited to the following:1. Failure to adequately establish and maintain procedures to ensure that the device design is correctly translated into production specifications, as required by 21 CFR § 820.30(h).For example, your firm has not established and maintained procedures for design transfer of your Project(b)(4)(FreeStyle Libre 3), specifically regarding transfer of performance specifications to third-party manufacturers. Your design transfer process did not ensure that performance specifications established in DOC40918 were translated into manufacturing specifications for your third-party manufacturer.Your System Design Requirements,(b)(4)DOC40918 Rev. S, dated September 26, 2025, identifies sensor glucose accuracy performance requirements, including:At least(b)(4)of sensor glucose results within ±(b)(4)or(b)(4)of referenceAt least(b)(4)within ±(b)(4)of reference for adult populationAt least(b)(4)within ±(b)(4)or ±(b)(4)of referenceAt least(b)(4)within ±(b)(4)or ±(b)(4)of reference for adult populationAt least(b)(4)within ±(b)(4)or ±(b)(4)of reference for adult populationYour firm established these requirements to comply with 21 CFR 862.1355 but did not transfer these specifications to your third-party manufacturer or ensure ongoing monitoring of in-process and finished product. Your firm failed to meet 21 CFR 862.1355(b)(3) special controls requirement that states: "design verification and validation must include adequate controls established during manufacturing and at product release to ensure the released product meets the performance specifications." No controls were established at final product release to ensure finished products meet performance specifications.Additionally, DOC42469, Design Transfer Plan, Rev. D, does not describe how accuracy performance specifications derived from iCGM special controls are flowed down to external manufacturing sites or incorporated into their acceptance procedures. Contract manufacturers responsible for final assembly and release were not provided with accuracy performance requirements and were not required to verify finished-device accuracy performance prior to release.We reviewed your firm's November 14, 2025, response and conclude it is not adequate. Your response does not identify whether finished-device accuracy performance release testing will be performed by Abbott or contract manufacturers, nor where these requirements are documented within the Device Master Record (DMR). Your Sensor Manufacturing Process Monitoring lacks: (1) specific performance specifications for glucose clinical accuracy; (2) direct linkage to the accuracy performance requirements at product release; and (3) adequate procedures to detect sensors that could produce erroneous glucose results. Your monitoring documents focus on general manufacturing parameters, biocontamination control, and facility requirements but inadequately address sensor glucose accuracy performance requirements. Your responsive attachments fail to demonstrate how the specific accuracy thresholds ((b)(4)) are translated into component-level specifications or systematically translated through all levels of manufacturing control.We reviewed your firm's December 19, 2025, response and conclude it is not adequate. Although procedural updates were described, your firm did not provide objective evidence demonstrating that accuracy performance requirements have been fully transferred into production specifications, incorporated into the DMR, and implemented as acceptance procedures by manufacturing entities responsible for final assembly and release. Your response addresses Bluetooth (BLE) connectivity testing for FreeStyle Libre 2 rather than glucose accuracy performance for(b)(4). The attachment implements interim sampling and testing but doesn't address design transfer procedure inadequacies. Your firm monitors BLE functionality by(b)(4)samples(b)(4), but there is no evidence this correlates with glucose accuracy performance. The attachments contain extensive sampling protocols but do not demonstrate how glucose accuracy performance requirements (±(b)(4), ±(b)(4)) are translated into component specifications in the Bill of Materials (BOM) or provide evidence of updates to design transfer procedures and revised component specifications. Additional testing (PCT and BLE) has been implemented but is not formally documented in design transfer documentation (DOC42469 and DOC42066), and there is no evidence of systematic review/revision of existing design transfer procedures (7.3W04). The new testing procedures lack sufficient detail on how they will detect sensors that could produce erroneous results due to causes in DOC40952-001.Although interim actions are implemented, permanent solutions such as(b)(4)won’t be operational until(b)(4). This creates a(b)(4)gap where you appear to rely primarily on enhanced monitoring rather than systematic design transfer controls.2. Failure to adequately establish and maintain procedures for finished device acceptance to ensure that each production run, lot, or batch of finished devices meets acceptance criteria, as required by 21 CFR 820.80(d).For example, our inspection revealed that your firm releases finished FreeStyle Libre integrated continuous glucose monitoring system (iCGM) devices without performance-testing the finished, fully assembled, sterilized, programmed, and packaged devices for accuracy prior to distribution. The(b)(4)is performed only on unassembled sensor tails, prior to final assembly,(b)(4)sterilization, programming, packaging, and distribution. During the inspection, your firm’s management confirmed that finished devices are not performance-tested for accuracy at product release.The iCGM special controls require that manufacturing and product release controls be established to ensure that released devices meet validated accuracy performance requirements (21 CFR 862.1355(b)(3)). Reliance on upstream, component-level testing performed prior to critical manufacturing steps does not ensure that finished, sterilized, and packaged devices meet accuracy performance requirements at the time of release. In addition, inspectional evidence documents that contract manufacturers responsible for final assembly and release were not provided accuracy performance specifications and were not required to verify finished-device accuracy performance prior to release. As a result, your firm has not established final acceptance activities to ensure that only conforming finished devices that meet the accuracy performance requirements are distributed, as required by 21 CFR 820.80(d).Your firm’s responses dated November 14, 2025, and December 19, 2025, describe interim inspections, enhanced monitoring activities, and proposed future implementation of(b)(4).We reviewed your firm’s responses and conclude they are not adequate. The interim inspections and monitoring activities described are temporary, are not validated as manufacturing or release controls, and do not ensure that finished devices released to distribution meet validated accuracy performance requirements at the time of release. In addition, the proposed finished-device accuracy release testing has not been implemented and does not demonstrate that devices already release to distribution conform to validated accuracy performance requirements. Additionally, your response states you will continue to rely on the(b)(4)test for part of your acceptance activities, however, as noted below, we do not agree this test has been properly validated. Therefore, your firm has not established adequate manufacturing and product release controls to ensure compliance with 21 CFR 862.1355(b)(3) and 21 CFR 820.80(d).3. Failure to adequately establish and maintain procedures, where appropriate, for identifying valid statistical techniques required for establishing, controlling, and verifying the acceptability of process capability and product characteristics, as required by 21 CFR 820.250(a).For example, our inspection revealed that your firm failed to establish statistically valid acceptance criteria and sampling plans to ensure that only conforming finished devices are released to distribution. DOC42012, Rev. B, Section 9.1 (pp. 5-7) states that an observed in-vivo precision value of approximately(b)(4)CV was decomposed into equal between-subject and between-sensor components, resulting in an estimated between-sensor CV of(b)(4), which was then used to derive(b)(4)precision acceptance limits.The clinical performance monitoring study used to support this composition ((b)(4)) does not permit separation of manufacturing-related sensor variability from subject-related, physiological, behavioral, and reference-method variability because(b)(4). As a result, the observed in-vivo variability reflects a conflation of uncontrolled sources, and no objective evidence was provided demonstrating that subject-related and sensor-related variance components can be reliably partitioned using this study design.We reviewed your firm’s responses and conclude they are not adequate. Your response dated November 14, 2025, Table 1: Summary of Product Release Testing (pp. 4-5), proposes sampling plans for finished-device precision testing, deployment testing, BLE communication testing, and programming verification without providing statistical justification, such as confidence levels, power analyses, assumed defect rates, or risk-based rationale, as required by 21 CFR 820.250(a). Your response further proposes(b)(4)to(b)(4)without demonstrating that the sample size is adequate to detect failures associated with distinct failure modes.Your firm has not established statistically valid acceptance criteria or sampling plans and has not provided objective evidence demonstrating that proposed sampling strategies are sufficient to ensure detection of nonconforming finished devices. Therefore, FDA lacks assurance that final acceptance activities are adequate to ensure that only conforming finished devices are released, as required by 21 CR 820.250(a) and 21 CFR 820.80(d).4. Failure to adequately establish and maintain design validation procedures to ensure that devices conform to defined user needs and intended uses and shall include testing of production units under actual or simulated use conditions, as required by 21 CFR 820.30(g).For example, although the FreeStyle Libre iCGM previously demonstrated compliance with accuracy performance requirements during premarket review, the inspection revealed that your firm failed to adequately validate that the(b)(4), as implemented, is an appropriate manufacturing and release control to ensure preservation of that validated performance.Specifically, DOC42012, Rev. B, Section 9.1 (pp. 5-7) states that(b)(4)specifications were derived from the post-market performance monitoring study(b)(4), which uses(b)(4)measurements as the reference method. However, the iCGM special controls require that accuracy performance be ensured using an FDA-accepted laboratory reference method that is precise, accurate, and traceable to a higher-order reference (21 CFR 862.1355(b)(1)(ii)).In addition, DOC42012, Rev. B, Table 2 (pp. 6-7) describes attempts to convert(b)(4)accuracy results to(b)(4)accuracy using(b)(4)derived from comparisons between studies with fundamentally different designs, subject populations, and reference methods. Further DOC42012, Rev. B, Sections 9.1.2-9.1.5 and Section 10 (pp. 12-18) assert equivalence between(b)(4)confidence intervals and the one-sided 95% lower confidence bounds required by regulation, despite evidence that the underlying error distributions violate the assumptions necessary for such substitution. The iCGM Sensor Lot Release Specification Summary Memo dated October 21, 2025, further documents use of a weighted composite ±(b)(4)/±(b)(4)accuracy requirement than independent evaluation of each required glucose range.We reviewed your firm’s responses and conclude that they are not adequate. The interim monitoring activities and proposed future testing do not provide objective evidence validating(b)(4), as currently implemented, as a manufacturing or release control capable of ensuring that finished devices continue to meet validated accuracy performance requirements. Therefore, your firm has not adequately validated its manufacturing and release controls, as required by 21 CFR 820.30(g) and 21 CFR 862.1355(b)(3).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, injunction, and civil money penalties. 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. Additionally, should FDA determine that you have Quality System regulation violations that are reasonably related to premarket approval applications for Class III devices, such devices will not be approved until the violations have been addressed. Should FDA determine that your devices or facilities do not meet the requirements of the Act, requests for Certificates to Foreign Governments (CFG) may not be granted.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, as well as 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 actions (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. Your firm’s response should be comprehensive and address any violations included in this Warning Letter. 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 Establishment Assessment Team 3 Acting Assistant Director, Jeffrey Wooley, at CDRHEnforcement@fda.hhs.gov. Please include in the subject line, “CMS Case 722046” when replying. If you have any questions about the contents of this letter, please contact: Compliance Officer, Raymond W. Brullo, via email at raymond.brullo@fda.hhs.govFinally, 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. The specific violations noted in this letter and in the Inspectional Observations, FDA 483, issued at the close of the inspection may be symptomatic of serious problems in your firm’s manufacturing and quality management systems. Your firm should investigate and determine the causes of the violations and take prompt actions to correct the violations and bring the products into compliance.Sincerely,/S/Barbara C. MarsdenActing DirectorOffice of Regulatory ProgramsOffice of Product Evaluation and QualityCenter for Devices and Radiological Healthcc: Ms. Denise Reid, Divisional Vice President Quality Assurance & Compliancedenise.reid@abbott.com

　　为保障元旦春节期间保健食品质量安全，根据年度食品安全监督抽检工作计划，广东省市场监督管理局组织开展2026年元旦春节保健食品专项监督抽检，共抽检保健食品190批次。经检验，样品全部合格，具体信息见附件。　　广东省市场监督管理局提醒广大消费者，应通过正规渠道购买保健食品，索取并保留相关票据。如发现保健食品安全违法行为，可拨打12345或12315热线电话投诉举报。　　附件：　　1.本次抽检依据和抽检项目　　2.保健食品监督抽检产品信息.docx广东省市场监督管理局2026年1月30日

根据《中华人民共和国行政许可法》第七十条、《药品经营和使用质量监督管理办法》第二十七条第一项规定，经企业申请，本机关拟注销凉山福星医药有限公司《药品经营许可证》[证书编号：川AA834000019；经营地址：凉山彝族自治州喜德县光明镇农光村1组11号1层；法定代表人：林智雄；主要负责人：彭泽剑；经营范围：生物制品、中成药、化学药]。自本公示发布之日起10个工作日内，如无单位、个人提出异议，本机关将依法注销该企业《药品经营许可证》。特此公示。联系电话：028-86912503                                                                                    四川省药品监督管理局                        2026年2月3日

江苏汇诚医疗科技有限公司报告，由于收到消费者反馈医用外科口罩夹层内存在异物的原因，经风险评估后，江苏汇诚医疗科技有限公司对其生产的医用外科口罩主动召回。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》。

苏州富士胶片映像机器有限公司报告，由于收到客户反馈，部分产品在使用时出现抬钳器无法顺畅回弹的原因，苏州富士胶片映像机器有限公司对其生产的电子十二指肠内窥镜主动召回。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》。

2025年，运城市认真贯彻落实省委、省政府建设中医药强省战略部署，立足全省中医药发展大局，紧密对接省药监局关于全面提升中药质量的工作要求，以推动中药材产业高质量发展为切入点，积极探索符合地方特色产业发展路径。政府引领，补齐产业发展盲点。运城市中药材资源丰富，现有种植面积76万余亩，年产量37万余吨，占据全省总产量的半壁江山。已建成6个万亩连片中药材产业示范园和20万亩中药材标准化生产基地，积极推进“运药七味”区域公用品牌建设，成功培育“新绛远志”“闻喜柴胡”等一批地理标志产品，产业基础不断夯实。市委、市政府立足高质量发展要求，围绕中医药强市建设和“十五五”规划部署，将中药材产业发展纳入全市战略规划。市委副书记、市长姚逊主持召开中药材产业高质量发展专题座谈会，各相关部门积极行动，制定印发《运城市加快推进中药材产业高质量发展若干措施》，围绕种植、加工、科技、品牌等七个方面提出15条具体举措，强调以全产业链思维推动中药材产业提质增效，并要求各地各部门加强协作，为产业高质量发展提供清晰指引和坚实政策保障。部门联动，打通产业发展堵点。《措施》出台后，各级部门积极响应，初步形成部门联动、协同发展工作格局。一是聚焦政策理解不足问题，组织全市40余家中药材种植企业与合作社代表赴振东制药集团学习，与振东制药集团共同规划打造运城市GAP基地。二是聚焦趁鲜切制加工不规范问题，借鉴其他地区先进经验，结合运城实际，建立规范中药材趁鲜切制企业遴选机制，推动中药材趁鲜切制工作实现关键破局。三是聚焦技术支撑薄弱问题，市果业发展中心、市农业农村局、市市场监管局，与山西农大棉花所、省药物培植场等构建“政产学研用”协同推进机制。四是聚焦市县联动衔接不畅问题，各县（市、区）结合本地产业基础与资源优势，出台一系列针对性政策。万荣县制订《支持中药材加工的若干政策》，稷山县出台《稷山县中药材高质量全产业链发展实施方案》，临猗县印发《临猗县推进中药材高质量发展行动方案（2025-2028）》，形成上下联动、协同发力良好局面。专班推进，解决产业发展难点。推动中药材产业高质量发展，关键在于抓住GAP基地建设这一薄弱环节。一是明职责，成立由市果业发展中心、市市场监管局、市综检中心等部门组成中药材产业高质量发展专班，明确各部门立足职责聚焦中药材GAP基地建设过程中种子培育、管理、标准建设、品牌培育等瓶颈问题，精准发力。二是抓标准，组建专业团队开展“巡回问诊”，覆盖26家企业，编制5个标准体系模板，推广4项省级、3项市级地方标准等多类标准成果，提升企业标准化实操能力。三是重品牌，联动多部门深挖地理标志资源，重点培育“万荣丹参”等品牌，解读市级奖补政策，规范种植标准与申报流程，推动万荣县道地药材品牌化升级，让中药材资源优势加速转化为产业发展优势。四是务实效，赴新绛、绛县、夏县、万荣实地帮扶，搭建种植与生产企业对接桥梁，助力企业完善GAP基地申报材料。目前，山西德济药业有限公司的连翘已通过重庆市药监局GAP延伸检查，新绛县昌盛中药材种植合作社的远志已通过山西省药监局GAP现场检查，为全市中药材企业建设GAP基地做出了良好示范。

根据《药品管理法》《药品生产监督管理办法》《药品生产质量管理规范》等法律法规规章，按照药品生产监督检查工作计划，省药监局组织对34家次药品生产单位开展了监督检查，现将检查结果予以通告（见附件）。附件：药品生产监督检查结果汇总表（2025年第4号）山东省药品监督管理局2026年2月2日

行政相对人名称四川自强药业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(统一社会信用代码)91510115584980830X法定代表人刘亚克行政处罚决定书文号川药监罚决〔2025〕1039号违法行为类型未取得药品经营许可（零售）销售药品违法事实当事人于2024年12月17日，将40盒阿胶补血膏直接销售给个人，违法所得1280元。在销售上述药品时，当事人虚假开具销售出库票据。处罚依据《中华人民共和国药品管理法》第一百二十六条、第一百一十五条处罚类别警告、罚款、没收违法所得处罚内容1.对未遵守药品经营管理质量规范的行为予以警告；    2.对未取得药品零售经营许可销售药品的行为，没收违法所得1280元、罚款10万元。罚款金额（万元）10没收违法所得、没收非法财物的金额（万元）0.128处罚决定日期2026年1月16日处罚机关四川省药品监督管理局处罚机关统一社会信用代码11510000MB1808933T