根据《中华人民共和国药品管理法》、《中华人民共和国行政许可法》和《药品经营和使用质量监督管理办法》等有关规定，鉴于湖北创展瑞东医药有限公司注销进行兼并重组，经我局审查，准予该公司申请注销《药品经营许可证》。新申报核发竹山九州通药业有限公司《药品经营许可证》，现已经过我局现场认证检查，符合规定要求，准予新核发。现将有关注销和核发信息予以公告，详见附件，请社会各界予以监督。特此公告。附件：注销和核发信息表湖北省药品监督管理局2025年12月16日       附件：注销和核发信息表企业名称法定代表人主要负责人企业质量负责人经营方式经营地址仓库地址经营范围发证日期证书编号备注湖北创展瑞东医药有限公司孟艳丽孟艳丽　程鸣批发湖北省武汉市硚口区解放大道148号汉水熙园2栋1单元1103室委托九州通医药集团物流有限公司第三方存储（1、武汉市东西湖区长青街田园大道99号；2、湖北省十堰市普林工业园普林路25号3栋一楼）中药饮片、中成药（含冷藏、冷冻药品）、化学药（含冷藏、冷冻药品）、生物制品（含冷藏、冷冻药品）。2025.07.24-2030.07.23药品经营许可证：鄂AA027c00585注 销竹山九州通药业有限公司田云王禹胡青芸批发湖北省十堰市竹山县潘口乡通济沟示范产业园7号楼2层委托九州通医药集团物流有限公司第三方储存（地址1.武汉市东西湖区长青街田园大道99号；2.湖北省十堰市普林工业园普林路25号3栋一楼）中药饮片、中成药（含冷藏、冷冻药品）、化学药（含冷藏、冷冻药品）、生物制品（含冷藏、冷冻药品）。2025.12.16-2030.12.15药品经营许可证：鄂AA719e00666新核发

根据《中华人民共和国药品管理法》、《中华人民共和国行政许可法》和《药品经营和使用质量监督管理办法》等有关规定，鉴于湖北宜尔欣药业有限公司注销进行兼并重组，经我局审查，准予该公司申请注销《药品经营许可证》。新申报核发湖北锐格药业有限公司《药品经营许可证》，现已经过我局现场认证检查，符合规定要求，准予新核发。现将有关注销和核发信息予以公告，详见附件，请社会各界予以监督。特此公告。附件：注销和核发信息表湖北省药品监督管理局2025年12月16日       附件：注销和核发信息表企业名称法定代表人主要负责人企业质量负责人经营方式经营地址仓库地址经营范围发证日期证书编号备注湖北宜尔欣药业有限公司张小明张小明向玲批发湖北省长阳龙舟坪镇星城二路11号4楼湖北省长阳龙舟坪镇星城二路11号3楼、4楼中药饮片、中成药、化学原料药、化学药制剂、抗生素原料药、抗生素制剂、生化药品。（不含冷藏冷冻药品）***2023.07.19-2028.07.18药品经营许可证：鄂AA7160039注 销湖北锐格药业有限公司贺炎炎贺炎炎向玲批发湖北省宜昌市长阳土家族自治县龙舟坪镇星城二路11号高效孵化器4楼湖北省宜昌市长阳土家族自治县龙舟坪镇星城二路11号高效孵化器3楼、4楼中药饮片、中成药、化学药、生物制品。2025.12.16-2030.12.15药品经营许可证：鄂AA717i00667新核发

　　依据《中华人民共和国行政许可法》第七十条、《医疗器械生产监督管理办法》第二十一条的规定，现对重庆科斯迈生物科技有限公司的《医疗器械生产许可证》注销情况予以公告。　　附件：注销的许可证内容                               　　　　　　　　　　　　　　　　　　　　　　　　　重庆市药品监督管理局                                 　　　　　　　　　　　　　　　　　　　　　　　　2025年12月4日附件注销的许可证内容 序号企业名称许可证名称许可证编号1重庆科斯迈生物科技有限公司医疗器械生产许可证渝食药监械生产许20170021号

Delivery Method:Via Electronic Mail - Return Receipt RequestedReference #:320-26-35Product:Drugs Over-the-Counter DrugsRecipient:Mr. Daniel RichardsPresidentAbsolutely Natural640 Atlantis RoadMelbourne,FL32904-2315United StatesIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesWarning Letter320-26-35December 30, 2025Dear Mr. Richards:The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, Absolutely Natural, FEI 3004606446, at 640 Atlantis Road, Melbourne, from April 22 to 24, 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 May 15, 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 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).You manufacture(b)(4)over-the-counter (OTC) non-sterile drug products, including those labeled for use in(b)(4).You failed to conduct an adequate investigation in July 2024 when a batch of drug product failed microbiological testing due to out-of-specification (OOS) results for both total plate count andPseudomonas aeruginosa. Although you rejected the batch, you failed to adequately assess the root cause of the microbiological contamination, and you failed to extend the investigation to additional batches that may also have been affected.It is necessary to conduct a thorough, well documented, and scientifically sound investigation to identify the root cause of an OOS, to evaluate all potentially affected batches, and to implement a timely and effective corrective actions and preventive actions (CAPA) plan.In your response, you described the following activities that you initiated after the inspection: (1) You performed a risk analysis; (2) you initiated an investigation into the OOS incident noted above; (3) you revised your OOS investigation procedure to include root-cause determination; (4) you retrained personnel on revised procedures; and (5) you conducted a retrospective review of OOS results.Your response is inadequate because your investigation did not adequately assess additional drug products that may have been affected by this microbiological contamination. Additionally, your response lacks sufficient details about your retrospective review of OOS results.In response to this letter, provide:A retrospective, independent review of all invalidated OOS (including in-process and release/stability testing) results for U.S. products currently in the U.S. market and within expiry as of the date of this letter and a report summarizing the findings of the analysis, including the following for each OOS:o Determine whether the scientific justification and evidence relating to the invalidated OOS result conclusively or inconclusively demonstrates causative laboratory error.o For investigations that conclusively establish laboratory root cause, provide rationale and ensure that all other laboratory methods vulnerable to the same or similar root cause are identified for remediation.o For all OOS results found by the retrospective review to have an inconclusive or no root cause identified in the laboratory, include a thorough review of production (e.g., batch manufacturing records, adequacy of the manufacturing steps, suitability of equipment/facilities, variability of raw materials, process capability, deviation history, complaint history, batch failure history). Provide a summary of potential manufacturing root causes for each investigation, and any manufacturing operation improvements.A comprehensive review and remediation plan for your OOS result investigation systems. The CAPA should include but not be limited to addressing the following:o Quality unit oversight of laboratory investigationso Identification of adverse laboratory control trendso Resolution of causes of laboratory variationo Initiation of thorough investigations of potential manufacturing causes whenever a laboratory cause cannot be conclusively identifiedo Adequately scoping of each investigation and its CAPAo Revised OOS investigation procedures with these and other remediationsA comprehensive, independent assessment of your overall system for investigating deviations, discrepancies, complaints, 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 establish and document the accuracy, sensitivity, specificity, and reproducibility of its test methods (21 CFR 211.165(e)).You failed to adequately validate your alternative rapid microbiological test methods. You use the(b)(4)system for rapid microbiological testing of your finished drug products (for example, total counts, objectionable microorganisms) and failed to demonstrate that it was equivalent to or better than United States Pharmacopeia (USP) compendial methods and suitable for its intended use. For example:Your method did not meet the minimum requirements for quantification and adequate identification of objectionable microorganisms.o The microbiological testing methodology employed uses qualitative pass/fail criteria that did not ensure appropriate quantitative enumeration. This approach is insufficient because it does not provide adequate quantitative data regarding contamination levels, which are essential for trend analysis and evidence-based risk assessment to support patient safety determinations. This is highlighted in the OOS investigation referenced in the violation mentioned above.o You failed to demonstrate that the(b)(4)system is appropriate for detectingBurkholderia cepaciacomplex (BCC), a contamination risk in nonsterile(b)(4)drug products.You stated that this system was validated by the manufacturer, but you failed to verify the manufacturer’s validation or perform appropriate validation studies on the instrument installed at your facility.The validation studies you provided deviated from compendial methods by excluding challenge organisms and reducing sample volumes without providing adequate scientific rationale.In your response, you state that your alternative rapid microbiological test methods are adequately validated. You also state that you performed a risk analysis and “found there is a low risk to the end user.” Your response does not adequately address how you intend to ensure that your method is validated for its intended use.Test methods must be validated to show that they are suitable for their intended use and equivalent to or better than applicable USP compendial methods. The reproducibility of your test methods is essential to determine if your drug products meet established specifications for microbial attributes.In response to this letter, provide:A comprehensive independent 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 evaluation of microbiological tests methods used to perform total counts and identification to evaluate suitability for intended use, followed by systemic CAPA, including but not limited to:o A comprehensive retrospective evaluation review of each test method to determine any inadequacies, including but not limited to those cited in this letter.o Where a method is found unsuitable for its intended use (e.g., inadequate capacity to enumerate), provide information on a new suitable method that will be employedo Improved systems to ensure selection and suitability of microbiological test methods in future before implementation.o Once this full evaluation is complete, provide all findings, data, and deviations encountered.Following review by an independent third-party, provide updated validation protocols and final reports that adequately address methods for each product, including specificity, limit of detection, robustness, ruggedness, and repeatability. This should include an evaluation of whether sample sizes are appropriate. Where you intend to use non-compendial methods, provide studies evaluating the equivalence or superiority of the method to the USP method.A commitment to establish release and stability specifications for the absence of BCC in drug products, and to implement risk-based sampling and testing procedures to monitor and control potential sources of BCC contamination.Updated analytical procedures, including confirmatory testing and speciation, that ensure regulatory compliance for all microbiological testing. This should also include an explanation of whether sample preparations are reserved to assist in conducting OOS investigations.3. Your firm failed to conduct at least one test to verify the identity of each component of a drug product (21 CFR 211.84(d)(1)).You failed to perform adequate identity testing of each incoming component lot, such as(b)(4), used in the manufacture of your OTC drug products.Identity testing of high-risk drug components such as(b)(4)include limit tests in the USP to ensure that the component meets the relevant safety limits for(b)(4)levels, respectively. Because you did not perform identity testing on each shipment of each lot using the USP identification test that detects hazardous impurities, you failed to ensure the acceptability of these components for use in the manufacture of your drug products.(b)(4)You failed to adequately test each shipment of each lot of(b)(4), which is used as an inactive ingredient in your drug products, for(b)(4)contamination. Identity testing for(b)(4)and certain other high-risk drug components includes a limit test in the USP to ensure that the component meets the relevant safety limits for levels of(b)(4). Because you did not perform identity testing on each shipment of each lot using the USP identification test that detects these hazardous impurities, you failed to ensure the acceptability of this component for use in the manufacture of your drug products.The use of ingredients contaminated with(b)(4)has resulted in various lethal poisoning incidents in humans worldwide. See FDA’s guidance document(b)(4).(b)(4)You failed to adequately test your incoming(b)(4), which is used as an active pharmaceutical ingredient in your drug products, for(b)(4). The use of(b)(4)contaminated with(b)(4)has resulted in various lethal poisoning incidents in humans worldwide. See FDA’s guidance document(b)(4).In your response, you state that you revised your procedures to ensure adequate identity testing of each component lot used in the manufacture of your OTC drug products. You also state that you resampled the(b)(4)currently in your inventory.Your response is inadequate because it does not consider retrospective identity testing of reserve samples, or assessment by other methods, of the components used in your OTC drug products that were manufactured, distributed, and remain within expiry but were not represented by the(b)(4)currently in your inventory.Without adequate testing, you do not have scientific evidence that your components conform to the appropriate specifications before use in the manufacture of your drug products. As a manufacturer, you have a responsibility to sample, test, and examine drug components before use in production to ensure adequate quality.In response to this letter, provide the following:A comprehensive, independent review of your material system, including but not limited to:o Evaluating all suppliers of materials (components, containers, and closures) to determine if they are reliable and appropriately qualified;o An assessment of all materials to determine whether they are consistently of acceptable quality;o A review to ensure assigned expiration or retest dates are appropriate (supported by data)o Adequacy of the supplier qualification program, and its selection, qualification, and disqualification provisions.o Based on a thorough review, provide a summary of your systemic CAPA to remediate the vendor qualification program and prevent use of unsuitable components, containers, and closures.The chemical and microbiological quality control specifications you use to test and release each incoming lot of each component for use in manufacturing.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 suppliers’ Certificates of Analysis (COAs) instead of testing each component lot for strength, quality, and purity, specify how you will robustly establish the reliability of your suppliers’ results through initial validation as well as periodic re-validation. In addition, include a commitment to always conduct at least one specific identity test for each incoming component lot.A summary of your program for qualifying and overseeing the contract facilities that test the drug products you manufacture.A commitment to provide(b)(4)test results, no later than 30 calendar days from the date of this letter, from testing the retains for all lots of high-risk drug components used in the manufacture of drug products. Alternatively, if a retain of a component lot is unavailable, perform retain sample testing of all implicated finished drug product batches for the presence of(b)(4).A full risk assessment for drug products that are within expiry which contain any ingredient at risk for(b)(4)contamination (including, but not limited to,(b)(4)). Take prompt and appropriate actions to determine the safety of all lots of the component(s) and any related drug product that could contain(b)(4), including customer notifications and product recalls for any contaminated lots. Identify additional appropriate CAPAs that secure supply chains in the future, including, but not limited to, ensuring that all incoming raw material lots are from fully qualified manufacturers and free from unsafe impurities. Detail these actions in your response to this letter.Quality SystemsYour firm’s quality systems are inadequate. See FDA’s guidance documentQuality Systems Approach to Pharmaceutical CGMP Regulationsfor help implementing quality systems and risk management approaches to meet the requirements of CGMP regulations 21 CFR, parts 210 and 211 at https://www.fda.gov/media/71023/download.CGMP Consultant RecommendedBased upon the nature of the violations we identified at your firm, you should 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.Cosmetics Manufactured for Distribution in the United StatesIn addition, some of the products you manufacture may be regulated as cosmetics, as defined in section 201(i) of the FD&C Act [21 U.S.C. 321(i)]. Any cosmetics you manufacture must comply with applicable statutory and regulatory requirements, including the FD&C Act. We note that under section 301(a) of the FD&C Act [21 U.S.C. 331(a)], it is a prohibited act to introduce or deliver for introduction into interstate commerce a cosmetic that is adulterated or misbranded.We also note that the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) provides new requirements with which facilities that manufacture cosmetic products must comply. You may find the FD&C Act, MoCRA, and FDA’s regulations through links on FDA’s website at www.fda.gov.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 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 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 3004606446 and ATTN: CDR Frank Verni.Sincerely,/S/Francis GodwinDirectorOffice of Manufacturing QualityOffice of ComplianceCenter for Drug Evaluation and Research

Delivery Method:Via Email、Return Receipt RequestedReference #:320-26-31Product:Drugs、Over-the-Counter DrugsRecipient:Mr. Frederick H. MillerPresidentLiquidCapsule Manufacturing, LLC9216 Palm River Road, Suite 203Tampa,FL33619-4478United StatesIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesWarning Letter320-26-31December 19, 2025Dear Mr. Miller:The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, LiquidCapsule Manufacturing, LLC, FEI 3006676534, at 9216 Palm River Road, Suite 203, Tampa, Florida, from June 25 to July 3, 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 July 25, 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 test samples of each component for identity and conformity with all appropriate written specifications for purity, strength, and quality. Your firm also failed to validate and establish the reliability of your component supplier’s test analyses at appropriate intervals (21 CFR 211.84(d)(1) and 211.84(d)(2)).You failed to conduct adequate identity testing on incoming components used in the manufacture of your over-the-counter (OTC) drug products. For example, you failed to adequately test each shipment of each lot of(b)(4)for(b)(4).See FDA’s guidance for industry(b)(4).Identity testing for the high-risk drug component(b)(4)includes a limit test in the United States Pharmacopeia (USP) to ensure the component meets the relevant safety limits for(b)(4). Because you did not perform adequate identity testing using the USP identification test that detects this hazardous impurity, you failed to ensure the acceptability of the component for use in the manufacture of your drug products.Additionally, you relied on your suppliers’ Certificates of Analysis (COAs) without establishing the reliability of each of your component supplier’s test analysis at appropriate intervals.In your response, you state that you will establish or revise raw material specification sheets for appropriate comprehensive testing of all incoming materials, and you will review your program for periodically validating supplier COAs for all raw materials.Your response is inadequate because it does not provide sufficient details to ensure adequate remediation of your incoming materials testing program, and it lacks a retrospective review, analysis, and risk assessment for previously distributed drug products that are within expiry.Without adequate testing and confirmation of the reliability of supplier test results, you lack scientific evidence that the components used in your drug products conform to appropriate specifications before their use in the drug products you manufacture.In response to this letter, please provide a comprehensive, independent review of your material system, including but not limited to:The chemical and microbiological quality control specifications you use to test and release each incoming lot of components for use in manufacturing.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 COAs 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 re-validation. In addition, include a commitment to always conduct the specific identity tests for each incoming component lot.A summary of results obtained from testing all components to evaluate the reliability of the COA from each component manufacturer. Include your SOP that describes this COA validation program.A summary of your program for qualifying and overseeing contract facilities that test the drug products you manufacture.2. Your firm failed to establish laboratory controls that include scientifically sound and appropriate specifications, standards, sampling plans, and test procedures designed to assure that components, drug product containers, closures, in-process materials, labeling, and drug products conform to appropriate standards of identity, strength, quality, and purity (21 CFR 211.160(b)).Your firm failed to demonstrate that your test methods were appropriate to assure that your product conforms to appropriate standards of identity, strength, quality, and purity. For example, your firm performs assay for(b)(4)using a(b)(4)method. The data you provided to support equivalency of the(b)(4)method to the USP compendial method consisted of assay results for(b)(4)lot of material tested by(b)(4)third-party laboratories. A protocol or report describing the(b)(4)method and its validated state, or criteria for determining its equivalency with the USP method, was not provided. Additionally, you have not adequately qualified the third-party laboratories used to perform your analysis.In your response, you stated that you would cease use of the(b)(4)method until its equivalence to the compendial method is scientifically demonstrated.Your response is inadequate because it did not evaluate the distributed batches on which you used the(b)(4)method for your(b)(4)assay test.Test methods must be validated to show that they are suitable for their intended use and are equivalent to or better than applicable USP compendial methods. The reproducibility of your test methods is essential to determine if your drug products meet established specifications.In response to this letter, please provide the following:The method validation protocol, report, and supporting data for your(b)(4)assay method, and any revised methods. Include the scientific rationale for its use as release and stability indicating tests.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 list of chemical and microbial test methods and specifications used to analyze each lot of your drug product before making a lot disposition decision, and the associated written procedures.3. Your firm failed to establish and follow an adequate written testing program designed to assess the stability characteristics of drug products (21 CFR 211.166(a)).Your firm does not have an adequate stability testing program to demonstrate that the chemical and microbiological properties of your drug products meet established specifications, and that they remain acceptable for the duration of their labeled shelf lives(b)(4). For example, you failed to revise the SOP for your stability program, issued March 23, 2020, as you previously committed to do, and the procedure does not address ongoing stability testing to monitor your drug’s quality attributes throughout its shelf life.Without an appropriate stability program, you lack adequate scientific evidence to support whether your drug products meet established specifications and retain their quality attributes through your labeled expiry.In your response, you stated that you will segregate and identify stability samples from retain samples for each manufactured batch, and that you will conduct a thorough inventory and assessment of all existing retain samples to identify batches requiring immediate stability evaluation.Your response is inadequate because you did not provide suitable justification that the selection of retain samples is adequate to support all existing distributed batches through labeled expiry.In response to this letter, please provide the following:A comprehensive assessment and CAPA plan to ensure the adequacy of your stability program. Your remediated program should include, but not be limited to:o Stability indicating methodso Stability studies for each drug product in its marketed container-closure system before distribution is permittedo An ongoing program in which representative batches of each product are added each year to the program to determine if the shelf-life claim remains valido Detailed definition of the specific attributes to be tested at each station (timepoint)All procedures that describe these and other elements of your remediated stability program.4. Your firm failed to prepare batch production and control records with complete information relating to the production and control of each batch of drug product produced (21 CFR 211.188).You failed to ensure that batch records are complete, and that all manufacturing activities and operations are recorded contemporaneously.For example, the batch record for batch(b)(4), manufactured in December 2024, approximately 6 months before the inspection, did not contain complete information including the full results of in-process testing, and shows multiple instances where initials and dates were pre-filled without documentation of performance, or evidence of performance. Information provided by your firm for batch(b)(4)indicates that this batch was distributed on(b)(4), although the “QA Checklist” for batch record review and release was not completed.In your response, you state that you conducted a review of the(b)(4)batch production records to identify any other similar documentation omissions or discrepancies and to assess their potential impact on product quality or safety.Your response is inadequate because you did not expand your review to all drug products, in individual configurations, for lots previously distributed and within expiry. You also did not include an investigation to determine the root cause of the incomplete documentation or assess the impact on finished batches.Complete and accurate batch production and control records are necessary to ensure that manufacturing processes are consistently followed and are reproducible. Additionally, incomplete manufacturing records deprive you of the ability to reliably conduct batch record review, to adequately investigate deviations and batch failures, and to ensure a continued state of validation processes.In response to this letter, please provide the following:A complete assessment of documentation systems used throughout your manufacturing and laboratory operations to determine where documentation practices are insufficient.A detailed CAPA plan that comprehensively remediates your firm’s documentation practices to ensure you retain attributable, legible, complete, original, accurate, contemporaneous records throughout your operation.5. 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)).Inadequate Process System ValidationYour firm failed to adequately validate the manufacturing process for your drug products. The validation data provided from 2017 does not include the filling and packaging of your drug product into the final containers. You had previously committed to providing a retrospective validation report; however, to date there does not appear to be any evaluation or documentation establishing equivalency between your validation data from 2017 and your current manufacturing process, including the difference in batch size.In your response, you stated that you would retrospectively assess the 2017 bulk manufacturing process validation and evaluate its adequacy, considering current understanding and practices. You also stated that you would perform prospective process validation for each OTC drug product.Your response is inadequate because it does not address the absence of validation for the filling and packaging process and lacks details regarding your prospective process validation plan.In response to this letter, please provide the following: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 intra-batch and inter-batch variation to ensure a continuing state of control.A timeline for performing appropriate process performance qualification (PPQ) for each of your marketed drug products. Also provide a risk assessment and any follow up actions to be taken for the distributed drug products produced without performing any process validation studies.Process performance protocol(s), and written procedures for qualification of equipment.A detailed program for designing, validating, maintaining, controlling and monitoring each of your manufacturing processes that includes vigilant monitoring of intra-batch and inter-batch variation to ensure an ongoing state of control. Also, include your program for qualification of your equipment and facility.Lack of(b)(4)System ValidationYou failed to adequately validate your(b)(4)system to ensure it produces(b)(4)that meets appropriate chemical and microbial attributes for use in your OTC drug product manufacturing. In addition, you failed to demonstrate that your(b)(4)system was adequately monitored to ensure it consistently produced(b)(4)that met appropriate chemical and microbial quality standards. For example, you failed to conduct(b)(4)testing, and you did not monitor your(b)(4)system forBurkholderia cepaciacomplex (BCC).Furthermore, the COAs you provided for routine testing of(b)(4)samples show that your(b)(4)is tested according to standard methods for(b)(4), and that the specifications listed on the COAs do not match those required by your SOP “MPC-5005 Rev 1(b)(4)System Monitoring, Testing, and Usage.” For example, the COA requires a total plate count

Delivery Method:Via Email、Return Receipt RequestedReference #:320-26-33Product:Drugs、Over-the-Counter DrugsRecipient:Mr. Norman NeedlemanChief Executive OfficerTower Laboratories Ltd.8060 Whitbeck RoadMontague,MI49437-1546United StatesIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesWarning Letter320-26-33December 23, 2025Dear Mr. Needleman:The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, Tower Laboratories Ltd., FEI 1823985, at 8060 Whitbeck Road, Montague, from July 8 to 11, 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 August 1, 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 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).You manufacture over-the-counter (OTC) drug products, including(b)(4)medications. You failed to thoroughly investigate several out-of-specification (OOS) laboratory results from October 2024 to June 2025 and lacked corrective action and preventive action (CAPA). For example,(b)(4)tablets, lot(b)(4), and(b)(4)tablets, lot(b)(4), failed assay testing at the 9-month stability timepoint. Your retest using additional samples also produced failing results. Your laboratory investigations did not include sufficient details and lacked root causes for the failures. Furthermore, you did not notify your customers about the failing stability results for the distributed lots.In your response, you state that while the above investigations did not identify root causes, the OOS results are “representative of microscopic packaging defects” noted in a previous investigation and “are not formula stability related.” You acknowledge that you did not take market action for the failing batches, despite noting the possibility that the defects may impact drug product effectiveness.Your response is inadequate because your investigation lacked sufficient rigor to show how your “packaging defects” led to a failure in product quality. Additionally, you failed to initiate a CAPA at the conclusion of the investigations. This was a repeat observation from FDA's 2021 inspection where you attributed the root cause of assay failures to packaging defects without providing supporting evidence of how these defects impact your analytical methodology and failed to implement appropriate CAPA.Inadequate investigations can lead to unidentified root causes, ineffective CAPA, and recurring problems that compromise the ability to manufacture safe and effective drug products.For more information about handling failing, out-of-specification, out-of-trend, or other unexpected results and documentation of your investigations, see FDA’s guidance documentInvestigating Out-of-Specification (OOS) Test Results for Pharmaceutical Productionat https://www.fda.gov/regulatory-information/search-fda-guidance-documents/investigating-out-specification-oos-test-results-pharmaceutical-production-level-2-revision.In response to this letter, provide:A retrospective, independent review of all invalidated OOS (including in-process and release/stability testing) results for U.S. products currently in the U.S. market and within expiry as of the date of this letter and a report summarizing the findings of the analysis, including the following for each OOS:o Determine whether the scientific justification and evidence relating to the invalidated OOS result conclusively or inconclusively demonstrate causative laboratory error.o For investigations that conclusively establish laboratory root cause, provide rationale and ensure that all other laboratory methods vulnerable to the same or similar root cause are identified for remediation.o For all OOS results found by the retrospective review to have an inconclusive or no root cause identified in the laboratory, include a thorough review of production (e.g., batch manufacturing records, adequacy of the manufacturing steps, suitability of equipment/facilities, variability of raw materials, process capability, deviation history, complaint history, batch failure history). Provide a summary of potential manufacturing root causes for each investigation, and any manufacturing operation improvements.A comprehensive review and remediation plan for your OOS result investigation systems. The CAPA should include, but not be limited to, addressing the following:o Quality unit oversight of laboratory investigationso Identification of adverse laboratory control trendso Resolution of causes of laboratory variationo Initiation of thorough investigations of potential manufacturing causes whenever a laboratory cause cannot be conclusively identifiedo Adequate scoping of each investigation and its CAPAo Revised OOS investigation procedures with these and other remediationsA comprehensive, independent assessment of your overall system for investigating deviations, discrepancies, complaints, 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.2. Your firm failed to establish laboratory controls that include scientifically sound and appropriate specifications, standards, sampling plans, and test procedures designed to assure that components, drug product containers, closures, in-process materials, labeling, and drug products conform to appropriate standards of identity, strength, quality, and purity (21 CFR 211.160(b)).You failed to demonstrate that your sample preparation methods are suitable for testing drugs or to account for how these methods could affect test results. For example, you use(b)(4)to prepare samples of your(b)(4)tablets and(b)(4)tablets for high-performance liquid chromatography analysis. However,(b)(4), which can lead to inaccurate results showing OOS levels for(b)(4)content.In your response, you acknowledge that you did not fully meet the test method validation requirements, and that you will review and re-validate(b)(4)of your test methods assaying for(b)(4)in(b)(4)of your formulations. You commit to updating your analytical method validation master plan to incorporate all current test method validation requirements. You also commit to reviewing all other test methods used to assay your other OTC drug products.Your response is inadequate in that it did not fully evaluate the scope of this deficiency and the impact to product quality. You did not commit to a retrospective review and risk assessment for all test results generated using these methods. Additionally, you have not established interim controls to use during the review and validation of your test methods.In response to this letter, provide:An evaluation of the adequacy of your analytical sample preparation methods by verifying suitability through documented protocol, analyzing recurring errors throughout the methods’ history, and implementing CAPA measures to address test method deficiencies.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.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 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 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 1823985 and ATTN: Renee A. Marcsisin, Ph.D.Sincerely,/S/Francis GodwinDirectorOffice of Manufacturing QualityOffice of ComplianceCenter for Drug Evaluation and Research

　　根据《中华人民共和国食品安全法》《保健食品注册与备案管理办法》等法律、规章的规定，现将我省2025年第四季度89个保健食品备案信息予以公布。保健食品备案人对所提交的材料的真实性、完整性、可溯源性负责。　　我省保健食品备案产品具体信息，可通过河南省市场监督管理局官网“在线系统—河南省食品许可备案公示查询服务平台—保健食品备案公示”进行查询。　　特此公告。　　附件：河南省2025年第四季度保健食品备案信息表　　 2026年1月5日　附 件　　 河南省2025年第四季度保健食品备案信息表序号产品名称备案号备案人所在地市是否注册转备案首次批准日期备案状态1珑熙祥牌多种矿物质咀嚼片食健备G202541002898河南邦瑞特实业有限公司南阳市否2025年10月9日已发凭证2顺禄堂牌破壁灵芝孢子粉食健备G202541002961新郑市泽之润生物科技有限公司郑州市否2025年10月15日已发凭证3希乐康牌硒片(甜橙味)食健备G202541002979河南希百康健康产业有限公司济源市否2025年10月17日已发凭证4希乐康牌硒片(蓝莓味)食健备G202541002980河南希百康健康产业有限公司济源市否2025年10月17日已发凭证5希吉康牌锌硒片食健备G202541002981河南希百康健康产业有限公司济源市否2025年10月17日已发凭证6香语云海牌维生素E软胶囊食健备G202541003020绿健园（新乡）生物工程有限公司新乡市否2025年10月21日已发凭证7珑熙祥牌富硒酵母片食健备G202541003021河南邦瑞特实业有限公司南阳市否2025年10月21日已发凭证8上工强生堂®辅酶Q10胶囊食健备G202541003022洛阳新春都生物制药有限公司洛阳市否2025年10月21日已发凭证9LJYJK®维生素E软胶囊食健备G202541003036绿健园（新乡）生物工程有限公司新乡市否2025年10月22日已发凭证10雅力兰牌硒软胶囊食健备G202541003073郑州清华园生物工程有限公司郑州市否2025年10月28日已发凭证11诺瑞特牌辅酶Q10胶囊食健备G202541003089河南树铭药业有限公司南阳市否2025年10月29日已发凭证12斯依可®锌硒咀嚼片(甜橙味)食健备G202541003091洛阳众康生物工程有限公司洛阳市否2025年10月29日已发凭证13美安宜品牌硒口服液(柠檬味)食健备G202541003092洛阳众康生物工程有限公司洛阳市否2025年10月29日已发凭证14希百康牌硒口服液(柠檬味)食健备G202541003093洛阳众康生物工程有限公司洛阳市否2025年10月29日已发凭证15汉方兴州牌破壁灵芝孢子粉食健备G202541003155河南天珍谷药业有限公司漯河市否2025年11月3日已发凭证16汉方兴州牌破壁灵芝孢子粉颗粒食健备G202541003156河南天珍谷药业有限公司漯河市否2025年11月3日已发凭证17希维康牌硒多种维生素胶囊食健备G202541003157河南希百康健康产业有限公司济源市否2025年11月3日已发凭证18希润康牌硒多种维生素胶囊食健备G202541003158河南希百康健康产业有限公司济源市否2025年11月3日已发凭证19汉苑良方牌褪黑素片食健备G202541003159河南天珍谷药业有限公司漯河市否2025年11月3日已发凭证20树铭牌辅酶Q10颗粒食健备G202541003200河南树铭药业有限公司南阳市否2025年11月6日已发凭证21汤普生牌鱼油软胶囊食健备G202541003201新乡市京粤健康科技有限公司新乡市否2025年11月6日已发凭证22SCH®鱼油软胶囊食健备G202541003202新乡市京粤健康科技有限公司新乡市否2025年11月6日已发凭证23西健元®硒胶囊食健备G202541003211郑州桂仁营养科技有限公司郑州市否2025年11月7日已发凭证24希力康牌硒胶囊食健备G202541003230河南希百康健康产业有限公司济源市否2025年11月10日已发凭证25希好康牌硒胶囊食健备G202541003231河南希百康健康产业有限公司济源市否2025年11月10日已发凭证26希吉康牌硒胶囊食健备G202541003232河南希百康健康产业有限公司济源市否2025年11月10日已发凭证27希喜康牌硒胶囊食健备G202541003233河南希百康健康产业有限公司济源市否2025年11月10日已发凭证28希倍康牌硒胶囊食健备G202541003234河南希百康健康产业有限公司济源市否2025年11月10日已发凭证29维健康®维生素K2（发酵法）胶囊食健备G202541003250洛阳新春都生物制药有限公司洛阳市否2025年11月11日已发凭证30泰康海恩牌破壁灵芝孢子粉胶囊食健备G202541003254太康海恩药业有限公司周口市否2025年11月11日已发凭证31泰康海恩牌西洋参含片食健备G202541003266太康海恩药业有限公司周口市否2025年11月12日已发凭证32SCH®维生素D软胶囊食健备G202541003278新乡市京粤健康科技有限公司新乡市否2025年11月13日已发凭证33希健康牌硒胶囊食健备G202541003279河南希百康健康产业有限公司济源市否2025年11月13日已发凭证34旨雪新®辅酶Q10胶囊食健备G202541003291郑州桂仁营养科技有限公司郑州市否2025年11月13日已发凭证35LJYZX®蛋白粉食健备G202541003306绿健园（新乡）生物工程有限公司新乡市否2025年11月18日已发凭证36西健元®硒维生素E片食健备G202541003307郑州桂仁营养科技有限公司郑州市否2025年11月18日已发凭证37西健元®硒颗粒食健备G202541003308郑州桂仁营养科技有限公司郑州市否2025年11月18日已发凭证38桂贝儿®破壁灵芝孢子粉食健备G202541003365郑州桂仁营养科技有限公司郑州市否2025年11月19日已发凭证39桂贝儿®维生素C含片食健备G202541003366郑州桂仁营养科技有限公司郑州市否2025年11月19日已发凭证40龙欣康牌褪黑素片食健备G202541003367新乡市国御堂生物技术有限公司新乡市否2025年11月19日已发凭证41择康乐牌L-硒-甲基硒代半胱氨酸片食健备G202541003411河南载德药业有限公司郑州市否2025年11月24日已发凭证42希民康牌硒维生素E胶囊食健备G202541003412河南希百康健康产业有限公司济源市否2025年11月24日已发凭证43希民康牌硒胶囊食健备G202541003413河南希百康健康产业有限公司济源市否2025年11月24日已发凭证44希安康牌硒维生素E胶囊食健备G202541003417河南希百康健康产业有限公司济源市否2025年11月24日已发凭证45希乐康牌硒胶囊食健备G202541003421河南希百康健康产业有限公司济源市否2025年11月24日已发凭证46AGYT®多种B族维生素咀嚼片(哈密瓜味)食健备G202541003474新乡市国御堂生物技术有限公司新乡市否2025年11月28日已发凭证47LJYXX®蛋白粉食健备G202541003557绿健园（新乡）生物工程有限公司新乡市否2025年12月5日已发凭证48LJYSW®蛋白粉食健备G202541003558绿健园（新乡）生物工程有限公司新乡市否2025年12月5日已发凭证49AGYT®多种维生素咀嚼片(草莓味)食健备G202541003583新乡市国御堂生物技术有限公司新乡市否2025年12月9日已发凭证50靓健牌硒胶囊食健备G202541003584河南希百康健康产业有限公司济源市否2025年12月9日已发凭证51希康牌硒胶囊食健备G202541003585河南希百康健康产业有限公司济源市否2025年12月9日已发凭证52舒力兰牌硒片食健备G202541003604郑州清华园生物工程有限公司郑州市否2025年12月10日已发凭证53献善堂牌锌胆碱片食健备G202541003605河南舆璟药业有限公司驻马店市否2025年12月10日已发凭证54雅力兰牌硒片食健备G202541003628郑州清华园生物工程有限公司郑州市否2025年12月12日已发凭证55AGYT®维生素A咀嚼片(蓝莓味)食健备G202541003692新乡市国御堂生物技术有限公司新乡市否2025年12月18日已发凭证56LJYYY®蛋白粉食健备G202541003733绿健园（新乡）生物工程有限公司新乡市否2025年12月25日已发凭证57素立达surida®辅酶Q10片（甜橙味）食健备G202441004251绿健园（新乡）生物工程有限公司新乡否2024年12月23日2025年10月13日变更58BIOSUVIT®辅酶Q10片食健备G202441004270绿健园（新乡）生物工程有限公司新乡否2024年12月25日2025年10月13日变更59健尔金维®蛋白粉食健备G202541000808绿健园（新乡）生物工程有限公司新乡否2025年3月20日2025年10月16日变更60素立达surida®维生素E片食健备G202541002689绿健园（新乡）生物工程有限公司新乡否2025年9月10日2025年10月17日变更61润美倍健®多种B族维生素咀嚼片食健备G202541002058开封红枫叶生物科技有限公司开封否2025年7月9日2025年10月17日变更62红枫叶®多种B族维生素咀嚼片食健备G202241001379开封红枫叶生物科技有限公司开封否2022年6月16日2025年10月17日变更63金维盖宝®蛋白粉食健备G202441004204绿健园（新乡）生物工程有限公司新乡否2024年12月18日2025年10月20日变更64素立达surida®B族维生素片食健备G202541002316绿健园（新乡）生物工程有限公司新乡否2025年7月30日2025年10月20日变更65青源堂®硒片食健备G202341001378绿健园（新乡）生物工程有限公司新乡否2023年5月10日2025年10月29日变更66行義堂牌蛋白粉食健备G202441004203绿健园（新乡）生物工程有限公司新乡否2024年12月18日2025年10月29日变更67御盖®多种维生素咀嚼片(草莓味)食健备G202241000140新乡市国御堂生物技术有限公司新乡否2022年1月14日2025年10月29日变更68Ozan®多种维生素矿物质咀嚼片食健备G202241001770开封红枫叶生物科技有限公司开封否2022年7月21日2025年10月29日变更69普惠天成®硒颗粒食健备G202441004272河南普惠天成生物科技有限公司濮阳否2024年12月25日2025年10月29日变更70Ozan®硒多种维生素片食健备G202541000321开封红枫叶生物科技有限公司开封否2025年1月23日2025年11月4日变更71美安宜品牌硒口服液(柠檬味)食健备G202541003092洛阳众康生物工程有限公司洛阳否2025年10月29日2025年11月4日变更72希百康牌硒口服液(柠檬味)食健备G202541003093洛阳众康生物工程有限公司洛阳否2025年10月29日2025年11月10日变更73BJLJY®富硒酵母口服液食健备G202541002658绿健园（新乡）生物工程有限公司新乡否2025年9月8日2025年11月10日变更74御盖®多种维生素咀嚼片(哈密瓜味)食健备G202241000139新乡市国御堂生物技术有限公司新乡否2022年1月14日2025年11月10日变更75御盖®多种维生素咀嚼片(水蜜桃味)食健备G202241000138新乡市国御堂生物技术有限公司新乡否2022年1月14日2025年11月10日变更76阿富倍聪牌多种维生素口服液食健备G201941002294洛阳众康生物工程有限公司洛阳否2019年12月19日2025年11月10日变更77希百康牌硒维生素C维生素E胶囊食健备G202441003697河南希百康健康产业有限公司济源否2024年11月4日2025年11月13日变更78丹膳房牌氯化高铁血红素片食健备G202441000649河南时珍汉方医药科技有限公司郑州否2024年2月23日2025年11月14日变更79素立达surida®维生素E片食健备G202541002689绿健园（新乡）生物工程有限公司新乡否2025年9月10日2025年11月19日变更80北同大掌柜®硒片食健备G202341001378绿健园（新乡）生物工程有限公司新乡否2023年5月10日2025年11月19日变更81素立达surida®褪黑素片食健备G202541002040绿健园（新乡）生物工程有限公司新乡否2025年7月7日2025年12月8日变更82蒙肽®螺旋藻咀嚼片食健备G202141102620河南树铭药业有限公司南阳否2021年12月20日2025年12月8日变更83汉方兴州牌破壁灵芝孢子粉颗粒食健备G202541003156河南天珍谷药业有限公司漯河否2025年11月3日2025年12月18日变更84汉方兴州牌破壁灵芝孢子粉食健备G202541003155河南天珍谷药业有限公司漯河否2025年11月3日2025年12月18日变更85树铭®多种维生素矿物质片食健备G202141000029河南树铭药业有限公司南阳否2021年1月13日2025年12月22日变更86神颜牌钙维生素D维生素K咀嚼片(甜橙味)食健备G202241002818开封神颜药业有限公司开封否2022年11月3日2025年12月25日变更87绿健园牌多种维生素矿物质片食健备G201841000916绿健园（新乡）生物工程有限公司新乡否2018年8月14日2025年12月31日变更88汉苑良方牌破壁灵芝孢子粉颗粒食健备G202141101914河南汉方药业有限责任公司郑州否2021年10月20日2025.10.20取消备案89汉苑良方牌破壁灵芝孢子粉食健备G202141101792河南汉方药业有限责任公司郑州否2021年9月29日2025.10.20取消备案

沪药监械主召2026-006美敦力（上海）管理有限公司报告，由于涉及产品因当前软件版本（5.0和5.1）中存在7个问题，可能由于非正确操作导致患者手术延误、转为非机器人手术或需额外手术，Medtronic计划将系统软件升级至5.2版本，以进一步提升系统可靠性和患者安全性。美敦力（上海）管理有限公司对其代理的脊柱外科手术导航定位系统（注册证号：国械注进20213010107）主动召回。召回级别为二级。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》。附件：医疗器械召回事件报告表(点击下载)2026年01月06日

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