根据《浙江省药品监督管理局科技计划项目管理办法（修订）》精神，经项目评审、局党组会研究，拟定3个项目为2026年度省局“揭榜挂帅”科技计划项目。现将拟立项的项目予以公示（详见附件），公示期为2026年1月20日至2026年1月26日。 任何单位和个人对公示内容持有异议的，请在公示期内直接联系省药品监督管理局（逾期不予受理）。 联系人：吴爱芳，规划财务与科技处 电话：0571-88903318 电子邮箱：zjsyjcw@163.com 监督人：王建林，局直属机关纪委 电话：0571-88903270附件2026年度拟立项“揭榜挂帅”科技计划项目表 序号 榜单名称 申报人 申报单位 合作单位 领域 类别 项目时间（年） 榜单经费（万元） 1 基于多模态的姜半夏（浙）炮制过程品质控制研究与应用 方翠芬 浙江省食品药品检验研究院 浙江工商大学、浙江省药品化妆品审评中心、浙江中医药大学中药饮片有限公司 药品 应用技术 3 20 2 侵入式脑机接口器械核磁共振兼容性安全评价研究 叶岳顺 浙江省医疗器械检验研究院 中国计量大学 医疗器械 应用技术 3 30 3 基于监管效能提升的化妆品安全风险监测关键技术研究 马临科 浙江省食品药品检验研究院 台州市食品药品检验研究院、温州市食品药品检验科学研究院 化妆品 应用技术 3 25

Delivery Method:VIA UNITED PARCEL SERVICE AND VIA E-MAILReference #:26-HFD-45-01-01Product:DrugsRecipient:Dayan B. Goodenowe, Ph.D.CEOProdrome Sciences USA, LLC27518 Via IndustriaTemecula,CA92590United StatesIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesWARNING LETTERDear Dr. Goodenowe:This Warning Letter informs you of objectionable conditions observed during the U.S. Food and Drug Administration (FDA) inspection conducted between December 17, 2024, and January 10, 2025. The investigator representing FDA reviewed the role of Prodrome Sciences USA, LLC (Prodrome Sciences) as the sponsor of a clinical investigation (Protocol Pro‐040‐Plasm‐01, “ProdromeNeuro: An Open-Label Study of Omega 3 Oil Nutritional Supplementation for Aging-Related Cognitive Decline”) of the investigational drug ProdromeNeuro™ Oil (Omega-3 Plasmalogens).This inspection was conducted as a part of FDA’s Bioresearch Monitoring Program, which includes inspections designed to evaluate the conduct of research and to help ensure that the rights, safety, and welfare of human subjects have been protected.At the conclusion of the inspection, the FDA investigator presented and discussed with you the Form FDA 483, Inspectional Observations. We acknowledge receipt of your written responses to the Form FDA 483, dated January 23 and January 31, 2025.From our review of the FDA Establishment Inspection Report, the documents submitted with that report, and your written responses dated January 23 and January 31, 2025, it appears that Prodrome Sciences did not adhere to the applicable statutory requirements in the Federal Food, Drug, and Cosmetic Act (FD&C Act) and applicable regulations contained in Title 21 of the Code of Federal Regulations, part 312 (21 CFR 312) governing the conduct of clinical investigations and the protection of human subjects. We wish to emphasize the following:You failed to submit an Investigational New Drug application (IND) for the conduct of a clinical investigation with an investigational new drug that is subject to 21 CFR 312.2(a) [21 CFR 312.20(a), 312.20(b), and 312.40(a)].FDA regulations require a sponsor to submit, and to have in effect, an IND before initiating a clinical investigation of a drug that is subject to 21 CFR 312.2(a) [see 21 CFR 312.20 and 312.40(a)] in human subjects, unless the clinical investigation qualifies for an IND exemption under 21 CFR 312.2.1Prodrome Sciences failed to comply with these requirements. Specifically, Prodrome Sciences initiated and conducted Protocol Pro‐040‐Plasm‐01, a clinical investigation of the investigational drug ProdromeNeuro™ Oil, subject to section 505 of the FD&C Act [21 U.S.C. 355], without submitting and having in effect an IND.In Prodrome Sciences’ January 31, 2025, written response to the Form FDA 483, you indicated that the objective of Protocol Pro‐040‐Plasm‐01 was to evaluate the safety and tolerability of ProdromeNeuro™ Oil as a nutritional supplement. Additionally, during the inspection you stated that the investigational product, ProdromeNeuro™ Oil, is a blend of naturally occurring alkylglycerols composed of docosahexaenoic acid (DHA) [22:6], docosapentaenoic acid (DPA) [22:5], and eicosapentaenoic acid (EPA) [20:5] fatty acids. You further stated that these dietary alkylglycerols are found naturally in shark liver oil, which makes ProdromeNeuro™ Oil a dietary supplement that does not require an IND.For the reasons described below, we conclude that the evidence collected during the inspection shows that ProdromeNeuro™ Oil was intended for use as a drug, not as a dietary supplement, for the clinical investigation conducted under Protocol Pro‐040‐Plasm‐01. Therefore, Prodrome Sciences was required to submit an IND before conducting the clinical investigation.Section 201(g)(1) of the FD&C Act [21 U.S.C. 321(g)(1)] defines drug, in part, as “articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease….” Although Protocol Pro-040-Plasm-01 stated that the primary objective was to evaluate the safety and tolerability of ProdromeNeuro™ Oil in subjects with age-related cognitive decline, the inclusion criteria for the study expressly included subjects with mild to moderate dementia, and the protocol stated that one outcome of the study was to provide subjects with some improvement in their cognitive status. The outcome assessments for Protocol Pro-040-Plasm-01 included various validated neurocognitive assessments at baseline, and at follow-up visits at months one through five after baseline. These outcome assessments included the Standardized 25-foot Timed Gait Test, the Nine Hole Pegboard Test, the Montreal Cognitive Assessment, and the Quick Dementia Rating Scale, all of which are instruments used to assess neurocognitive status. Therefore, Protocol Pro-040-Plasm-01 collected study data to assess the effect of ProdromeNeuro™ Oil on cognitive status – as measured by changes in gait and changes in the severity of dementia, as determined by cognitive and functional abilities – of individuals with mild to moderate dementia.Whether an investigational article is a drug depends on the intent of the investigation. Based on the study design of Protocol Pro-040-Plasm-01, the investigational product, ProdromeNeuro™ Oil, as used in the clinical investigation, was a drug as defined in section 201(g)(1) of the FD&C Act, because ProdromeNeuro™ Oil was studied for use in the treatment of mild to moderate dementia.Thus, before initiating the clinical investigation of ProdromeNeuro™ Oil conducted under Protocol Pro-040-Plasm-01, under 21 CFR 312.40, Prodrome Sciences was required to submit an IND to FDA and to have an IND in effect. FDA’s records indicate that Prodrome Sciences failed to submit an IND before conducting Protocol Pro-040-Plasm-01, in which 29 human subjects were enrolled and received investigational drug between July 2020 and March 2021.In your January 23 and January 31, 2025, written responses, you stated that Prodrome Sciences has hired a consulting partner to assist with remediation and resolution of the Form FDA 483 observation, and to provide ongoing FDA compliance support.In your written responses, you also outlined a corrective and preventive action plan that includes the following: (1) a comprehensive review of standard operating procedures and training programs to identify and address gaps; (2) employee training overseen by your consulting partner on the FDA requirements for dietary supplements, and the differences between clinical studies involving dietary supplements and clinical studies involving investigational drugs; and (3) regular audits conducted by your consulting partner to monitor the effectiveness of these actions.While we acknowledge the corrective and preventive actions you have taken and plan to take, your written response is inadequate because your corrective action plan did not include sufficient information to address how Prodrome Sciences, as a sponsor, will prevent similar violations in the future. For example, your response does not include sufficient details on how Prodrome Sciences, as a sponsor, will determine whether IND regulations apply to future clinical investigations of products regulated by FDA, as required under 21 CFR part 312.2(a). Additionally, your corrective and preventive action plan does not include sufficient details about developing and implementing procedures to comply with IND regulations, if Prodrome Sciences should decide in the future to initiate another clinical investigation for which an IND is required. Without this information, we are unable to determine whether Prodrome Sciences will comply with IND regulations in the future.As a sponsor, you are responsible to comply with IND requirements, including submitting and having in effect an IND before initiating a clinical investigation; and it is Prodrome Sciences’ responsibility, as a sponsor, to be aware of and to follow all applicable FDA regulations. Prodrome Sciences’ failure to submit, and to have in effect, an IND before initiating Protocol Pro-040-Plasm-01 with an investigational drug raises significant concerns about the safety and welfare of enrolled subjects, and raises concerns about the validity and integrity of the data collected during the conduct of this clinical investigation.This letter is not intended to be an all-inclusive list of deficiencies with your clinical study of an investigational drug. It is your responsibility to ensure adherence to each requirement of the law and relevant FDA regulations. You should address any deficiencies and establish procedures to ensure that any ongoing or future studies comply with FDA regulations.This letter notifies you of our findings and provides you with an opportunity to address the deficiencies noted above. Within 15 business days of your receipt of this letter, you should notify this office in writing of the actions you have taken to prevent similar violations in the future. Failure to address this matter adequately may lead to regulatory action. If you believe you have complied with the FD&C Act and relevant regulations, please include your reasoning and any supporting information for our consideration.Should you have any questions or concerns about this letter or the inspection, please email FDA at CDER-OSI-Communications@fda.hhs.gov.Your written response and any pertinent documentation should be addressed to:Brittany L. Garr, MPHBranch ChiefCompliance Enforcement BranchDivision of Enforcement and Postmarketing SafetyOffice of Scientific InvestigationsOffice of ComplianceCenter for Drug Evaluation and ResearchU.S. Food and Drug AdministrationBuilding 51, Room 535210903 New Hampshire AvenueSilver Spring, MD 20993Sincerely yours,/S/David C. Burrow, Pharm.D., J.D.DirectorOffice of Scientific InvestigationsOffice of ComplianceCenter for Drug Evaluation and ResearchU.S. Food and Drug Administration____________________________1Protocol Pro-040-Plasm-01 does not qualify for any of the exemptions listed at 21 CFR 312.2 from the application of 21 CFR 312. To be IND-exempt under 21 CFR 312.2, the investigational product must, among other things, be lawfully marketed in the United States as a drug product. As stated during the inspection and in your January 31, 2025, written response, ProdromeNeuro™ Oil is marketed as a dietary supplement, not as a drug product.

Delivery Method:Via EmailReference #:320-26-28Product:Drugs、Over-the-Counter DrugsRecipient:Mr. Darren J. BirkelbachChief Executive OfficerIntegrity Partners Group1111 Industry Avenue SERoanoke,VA24013United Statesdbirkelbach@integritypartnersgrp.comIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesWarning Letter320-26-28December 15, 2025Dear Mr. Birkelbach:The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Chemisphere Corporation, FEI 1000158477, at 2101 Clifton Ave., Saint Louis, MO, from June 16 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 July 16, 2025, response to our Form FDA 483 in detail.During our inspection, our investigators observed specific violations including, but not limited to, the following.1. Your firm failed to have, for each batch of drug product, appropriate laboratory determination of satisfactory conformance to final specifications for the drug product, including the identity and strength of each active ingredient, prior to release, and for each batch of drug product required to be free of objectionable microorganisms, appropriate laboratory testing, as necessary (21 CFR 211.165(a) and 211.165(b)).Your firm failed to adequately test your over-the-counter (OTC)(b)(4)drug products for strength (assay) of each active ingredient prior to release and distribution. You also failed to ensure adequate microbiological testing for each batch of your(b)(4)and(b)(4)drug products prior to release.Drug product batches must be tested for identity, strength, quality, and purity prior to release. Testing is an essential part of ensuring that the drug products you manufacture conform to all predetermined quality attributes and are appropriate for their intended use. Without adequate testing, you lack basic data to support that each drug product batch conforms to appropriate specifications before release.In your response, you state that you will develop test methods or identify a contract testing laboratory to ensure product integrity and revise your product release standard operating procedures (SOPs) to require assay for active ingredients and microbiological testing “clearance.”Your response is inadequate. Because you lack adequate testing of each batch of your drug products, you do not know whether they conform to all appropriate finished product specifications and are suitable for release to consumers.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 list of chemical and microbial specifications, including test methods, used to analyze each batch of your drug products before a batch disposition decision.o An action plan and timelines for conducting full chemical and microbiological testing of reserve samples to determine the quality of all batches of drug product distributed to the United States (U.S.) that are within expiry as of the date of this letter.o A summary of all results obtained from testing reserve samples from each batch. If such testing reveals substandard quality drug products, take rapid corrective actions, such as notifying customers and product recalls.2. Your firm failed to conduct at least one test to verify the identity of each component of a drug product. 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)).Your firm failed to perform adequate testing for your raw materials that were used to manufacture the following:OTC(b)(4)and(b)(4)drug productsSpecially(b)(4), an in-process material used in(b)(4)prescription drug productsFor example, you did not adequately test for identity of each incoming shipment of each lot of raw materials (e.g.,(b)(4)) used in the manufacture of your OTC drug products, drug components, and in-process material. In addition, you relied on your suppliers’ certificates of analysis (COAs) without establishing the reliability of your component suppliers’ test analyses at appropriate intervals.Products Containing(b)(4)Your firm failed to adequately test for(b)(4)in your incoming component(b)(4)used as an active pharmaceutical ingredient (API) and as a component in an in-process material. 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)Products Containing(b)(4)Your firm also failed to adequately test your incoming components at high risk of(b)(4)contamination for identity before using them to manufacture your drug products and in-process material. This includes, but is not limited to, testing of(b)(4)to determine its appropriate identity, prior to use in manufacturing your OTC(b)(4)drug products and in-process material for prescription drug products.Identity testing for(b)(4)and certain other high-risk drug components includes a limit test in the United States Pharmacopeia (USP) to ensure the component meets the relevant safety limits for(b)(4)levels. 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 assure the acceptability of these components for use in the manufacture of your drug products and in-process material.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)In your response, you state that you will develop a test method and/or use a contract testing laboratory to test incoming(b)(4)for(b)(4)and incoming high risk drug components, including but not limited to,(b)(4)for(b)(4). Your response is inadequate because you do not provide adequate details that ensure identity testing for raw materials will meet all USP monograph requirements.In response to this letter, provide: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 corrective actions and preventive actions (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 components for use in manufacturing.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.A commitment to provide(b)(4)test results, no later than 30 calendar days from the date of this letter, from testing retains for all lots of incoming(b)(4)within expiry of manufactured drug products. Alternatively, if a retain of a component lot is unavailable, perform reserve sample testing of all implicated finished drug product batches for the presence of(b)(4).A commitment to provide(b)(4)test results, no later than 30 calendar days from the date of this letter, from testing 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 reserve 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 CAPA 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.A description of how you will test each component lot for conformity with all appropriate specifications for identity, strength, quality, and purity. If you intend to accept any results from your supplier’s COA instead of testing each component lot for strength, quality, and purity, specify how you will robustly establish the reliability of your supplier’s results through initial validation as well as periodic revalidation. In addition, include a commitment to always conduct at least one specific identity test for each incoming component lot. In the case of(b)(4), and certain additional high-risk components we note that this includes the performance of(b)(4)of USP monograph.3. Your firm failed to establish and follow adequate written procedures for cleaning and maintenance of equipment (21 CFR 211.67(b)).Your firm failed to adequately validate your equipment cleaning process to demonstrate its effectiveness to prevent potential cross-contamination between your OTC drug products and non-pharmaceutical products. You manufactured your OTC(b)(4)drug products on non-dedicated equipment, e.g., your(b)(4)tank. This equipment was also used to manufacture(b)(4)including, but not limited to,(b)(4)that is intended for(b)(4).Inadequate removal of residues from manufacturing equipment during cleaning can lead to contamination of drug products subsequently manufactured on the non-dedicated equipment. It is unacceptable as a matter of CGMP to manufacture drugs using the same equipment that you use to manufacture non-pharmaceutical products due to the risk of cross-contamination.In your response, you state that you will develop and implement a site-wide cleaning validation master plan including, but not limited to, identifying equipment and establishing analytical methods and acceptance criteria. You also state you will determine worst-case products and most difficult to clean manufacturing surfaces based on solubility, potency, toxicity, and cleanability.Your response is inadequate because you do not provide a risk assessment for the drug products manufactured on shared equipment potentially impacted by inadequate cleaning. In addition, your target timeline for completing cleaning validations is not until August 2026, you do not provide your interim plan to ensure that your non-dedicated equipment is adequately cleaned prior to manufacturing your drug products.In response to this letter, provide:Your commitment to discontinue manufacturing drugs on shared equipment with non-pharmaceuticals in your facility. If you intend to resume manufacture of both pharmaceutical and non-pharmaceutical products at your facility, provide a plan to show how you will separate the areas in which you will maintain dedicated manufacturing equipment for your pharmaceutical manufacturing and(b)(4)product manufacturing operations.Your risk assessment for all drugs you have previously manufactured on equipment shared with non-pharmaceutical products. For each product, assess the risk of potential contamination due to shared equipment and provide your plans for addressing the product quality and patient safety risks for any product still in distribution, including potential recalls or market withdrawals.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 products and equipment; and all other needed remediations.A complete assessment of documentation systems used throughout your equipment use and cleaning operations to determine where documentation practices are insufficient. Include 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.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 product.A summary of updated SOPs that ensure an appropriate program is in place for verification and validation of cleaning procedures for products, processes, and equipment.4. Your firm failed to establish 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)).Lack of Process ValidationYour firm failed to adequately validate your manufacturing process for each of your OTC drug products and qualify the manufacturing equipment used for their production. Process validation evaluates the soundness of design and state of control of a process throughout its lifecycle. Each significant stage of a manufacturing process must be designed appropriately and assure the quality of raw material inputs, in-process materials, and finished drugs. Process qualification studies include intensive monitoring and testing throughout each significant process stage to characterize intra-batch variation and evaluates batches to determine whether an initial state of control has been established.Successful process qualification studies are necessary before commercial distribution. Thereafter, ongoing vigilant oversight of process performance and product quality is necessary to ensure you maintain a stable manufacturing operation throughout the product lifecycle. See FDA’s guidance documentProcess Validation: General Principles and Practicesfor general principles and approaches that FDA considers appropriate elements of process validation at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/process-validation-general-principles-and-practices.In your response, you state that you will develop and implement a process validation for all OTC drug products and qualify manufacturing equipment among other corrective actions, as applicable. You also state that your timeframe for completion of validation activities is February 2026.Your response is inadequate because you did not provide your interim plan for drugs distributed before process validation activities are complete to ensure you produce drug products of acceptable quality.Inadequate(b)(4)System ValidationYour firm failed to adequately qualify your(b)(4)system to ensure it produces(b)(4)that meets appropriate chemical and microbial attributes for use in your OTC drug products manufacturing and equipment cleaning. Specifically, you used “(b)(4)” as a component to manufacture your OTC drug products and to clean the associated manufacturing equipment. You have not established that your(b)(4)system is adequately designed, maintained, and monitored to ensure that it consistently produces(b)(4)suitable for its intended use.Additionally, you obtained microbial growth as recently as this year from the(b)(4)holding tank and(b)(4)sampling port locations that exceeds your set action limit of(b)(4)CFU/ml. You did not perform microbiological identification for the microbial growth results and did not sanitize your(b)(4)system following these excursions. The inadequate control of your(b)(4)system poses a potential risk for objectionable microbiological contamination into your drug products.Furthermore,(b)(4)for pharmaceutical use must be suitable for its intended use and routinely tested to ensure ongoing conformance with appropriate chemical and microbiological attributes. Routine monitoring of microbial counts and identity of microbiological contamination in the system is integral to ensuring oversight of ongoing state of control and suitability of(b)(4)for use in manufacturing operations.In your response, you state that you will develop and implement a validation plan to qualify your(b)(4)system. You also state that you will develop a deviation and out-of-specification investigation procedure for(b)(4)system related excursions. The procedure will include speciation of microbial contaminants and sanitization protocols for observations of any contamination or foreign matter.Your response is inadequate because you do not provide adequate details regarding your plan for performing(b)(4)system validation, nor do you provide your interim plan to ensure that the(b)(4)for your drug product manufacturing and equipment cleaning is suitable for its intended use prior to manufacturing your drug products.In response to this letter, provide:A detailed summary of your validation program for ensuring a state of control throughout the product lifecycle, along with associated procedures. Describe your program for process performance qualification, and ongoing monitoring of both intra-batch and inter-batch variation to ensure a continuing state of control.A timeline for performing process performance qualification 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 and facilities.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.A comprehensive, independent assessment of your(b)(4)system design, control, and maintenance.A thorough remediation plan to install and operate a suitable(b)(4)system. Include a robust ongoing control, maintenance, and monitoring program to ensure the remediated system design consistently produces(b)(4)adhering to(b)(4), USP monograph specifications and appropriate microbial limits.Regarding the latter, ensure that your total microbial count limit for(b)(4)is appropriate in view of the intended use of the products produced by your firm.A detailed risk assessment addressing the potential effects of the observed(b)(4)system failures on the quality of all drug product lots currently in U.S. distribution within expiry. Specify actions that you will take in response to the risk assessment, such as customer notifications and product recalls.A procedure for your(b)(4)system monitoring that specifies routine microbial testing of(b)(4)to ensure its acceptability for use in each batch of drug products produced by your firm.A procedure governing your program for ongoing control, maintenance, and monitoring that ensures the remediated system consistently produces(b)(4)that meets(b)(4), USP monograph specifications and appropriate microbial limits.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/regulatory-information/search-fda-guidance-documents/quality-systems-approach-pharmaceutical-current-good-manufacturing-practice-regulations.Responsibilities as a ContractorDrugs must be manufactured in conformance with CGMP. FDA is aware that many drug manufacturers use independent contractors such as production facilities, testing laboratories, packagers, and labelers. FDA regards contractors as extensions of the manufacturer.You are responsible for the quality of drugs you produce as a contract facility regardless of agreements in place with product owners. You are required to ensure that drugs are made in accordance with section 501(a)(2)(B) of the FD&C Act for safety, identity, strength, quality, and purity. See FDA’s guidance document Contract Manufacturing Arrangements for Drugs: Quality Agreements at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/contract-manufacturing-arrangements-drugs-quality-agreements-guidance-industry.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.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 1000158477 and ATTN: Christina Alemu-Cruickshank.Sincerely,/S/Francis GodwinDirectorOffice of Manufacturing QualityOffice of ComplianceCenter for Drug Evaluation and Research

Delivery Method:Via EmailReference #:CBER 26-720554Product:BiologicsRecipient:GenovateUnited Statessupport@genovate.comIssuing Office:Center for Biologics Evaluation and Research (CBER)United StatesWARNING LETTERJanuary 8, 2026CBER 26- 720554To Whom It May Concern:The United States Food and Drug Administration (FDA or the Agency) has learned that your firm, Genovate, has offered for sale in the United States a human immunodeficiency virus (HIV) serological diagnostic dried blood spot (DBS) card self-collection kit (hereinafter, your “HIV DBS card self-collection kit”) without marketing authorization, in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act). Under section 201(h)(1) of the FD&C Act, 21 U.S.C. 321(h)(1), your HIV DBS card isself-collection kit is a device because it is intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body.FDA has reviewed your company’s website at www.genovate.com (last visited January 2026). Based on our review, your firm has offered its HIV DBS card self-collection kit for delivery to individuals and has intended for these individuals to use the kit to self-collect DBS samples and ship those samples to laboratories for HIV testing. FDA has determined that your HIV DBS card self-collection kit is adulterated under section 501(f)(1)(B) of the FD&C Act, 21 U.S.C. 351(f)(1)(B) because it does not have an approved premarket approval application (PMA) in effect pursuant to section 515(a) of the FD&C Act, 21 U.S.C. 360e(a), or an approved application for an investigational device exemption (IDE) under section 520(g) of the FD&C Act, 21 U.S.C. 360j(g). Your HIV DBS card self-collection kit is also misbranded under section 502(o) the FD&C Act, 21 U.S.C. 352(o), because notification of the intent to introduce the device into commercial distribution has not been provided to the agency, as required by section 510(k) of the FD&C Act, 21 U.S.C. 360(k).FDA has not authorized your firm’s HIV DBS card self-collection kit for any use, including for use in HIV serological diagnostic testing.In a letter dated March 31, 2025, FDA informed you that you appeared to be offering for sale and distributing your HIV serological diagnostic self-collection kits in a manner that may violate the FD&C Act. However, as noted above, your firm’s HIV DBS card self-collection kit has not received FDA marketing authorization for any use and to date, your firm has not submitted any premarket submission to FDA seeking authorization to market this kit.Without appropriate testing, data review, and marketing authorization, there is a lack of assurance of the safety and effectiveness of your HIV DBS card self-collection kit. Self-collection raises several issues of importance, including, for example, whether the user can safely and properly collect the specimen, if the sample has been properly shipped, and if there is adequate stability of the specimen given the time lapse between collection and testing and the potential impact of shipping conditions. We also note that there is an FDA-approved over-the-counter HIV test that can help meet the needs of individuals who wish to test themselves at home or who are unable to access other testing options.The violations cited in this letter are not meant to be an all-inclusive list of violations that may exist in connection with your products. FDA requests that your firm immediately cease any activities that result in the misbranding or adulteration of your HIV DBS card self-collection kit. Your firm should take prompt action to address the 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.This letter notifies you of our findings and provides you an opportunity to address the above deficiencies. If you believe that your product is not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration in your response to this letter.Within fifteen working days of receipt of this letter, please notify FDA in writing of the specific steps that you have taken to correct any violations. Your response should include an explanation of each step being taken to prevent the recurrence of violations as well as related documentation. If you cannot complete all corrective actions within fifteen working days, state the reason for the delay and the date by which you will complete the correction.Send your electronic response and any questions regarding this letter to CBER’s Office of Compliance and Biologics Quality, Division of Case Management at CBERDCMRecommendations@fda.hhs.gov.Sincerely,/S/Melissa J. MendozaDirectorOffice of Compliance and Biologics QualityCenter for Biologics Evaluation and Research

Delivery Method:Via UPS and EMAILReference #:CBER 26-720762Product:BiologicsRecipient:Andreas Kogelnik, MD, PhDFounder & Chief Executive OfficerProDx Health1190 O'Brien DrMenlo Park,CA94025United Statessupport@prodxhealth.comIssuing Office:Center for Biologics Evaluation and Research (CBER)United StatesWARNING LETTERJanuary 8, 2026CBER 26-720762Dear Dr. Andreas Kogelnik:The United States Food and Drug Administration (FDA or the Agency) has learned that your firm, ProDx Health, is offering for sale in the United States a human immunodeficiency virus (HIV) serological diagnostic dried blood spot (DBS) card self-collection kit (hereinafter, your “HIV DBS card self-collection kit”) without marketing authorization, in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act). Under section 201(h)(1) of the FD&C Act, 21 U.S.C. 321(h)(1), your HIV DBS card self-collection kit is a device because it is intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body.FDA has reviewed your company’s website at https://prodxhealth.com (last visited January 2026). Based on our review your website, your firm offers its HIV DBS card self-collection kit for delivery to individuals and intends for these individuals to use the kit to self-collect DBS samples and ship those samples to laboratories for HIV testing. FDA has determined that your HIV DBS card self-collection kit is adulterated under section 501(f)(1)(B) of the FD&C Act, 21 U.S.C. 351(f)(1)(B) because it does not have an approved premarket approval application (PMA) in effect pursuant to section 515(a) of the FD&C Act, 21 U.S.C. 360e(a), or an approved application for an investigational device exemption (IDE) under section 520(g) of the FD&C Act, 21 U.S.C. 360j(g). Your HIV DBS card self-collection kit is also misbranded under section 502(o) the FD&C Act, 21 U.S.C. 352(o), because notification of the intent to introduce the device into commercial distribution has not been provided to the agency, as required by section 510(k) of the FD&C Act, 21 U.S.C. 360(k).FDA has not authorized your firm’s HIV DBS card self-collection kit for any use, including for use in HIV serological diagnostic testing.Without appropriate testing, data review, and marketing authorization, there is a lack of assurance of the safety and effectiveness of your HIV DBS card self-collection kit. Self-collection raises several issues of importance, including, for example, whether the user can safely and properly collect the specimen, if the sample has been properly shipped, and if there is adequate stability of the specimen given the time lapse between collection and testing and the potential impact of shipping conditions. We also note that there is an FDA-approved over-the-counter HIV test that can help meet the needs of individuals who wish to test themselves at home or who are unable to access other testing options.The violations cited in this letter are not meant to be an all-inclusive list of violations that may exist in connection with your products. FDA requests that your firm immediately cease any activities that result in the misbranding or adulteration of your HIV DBS card self-collection kit. Your firm should take prompt action to address the 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.This letter notifies you of our findings and provides you an opportunity to address the above deficiencies. If you believe that your product is not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration in your response to this letter.Within fifteen working days of receipt of this letter, please notify FDA in writing of the specific steps that you have taken to correct any violations. Your response should include an explanation of each step being taken to prevent the recurrence of violations as well as related documentation. If you cannot complete all corrective actions within fifteen working days, state the reason for the delay and the date by which you will complete the correction.Send your electronic response and any questions regarding this letter to CBER’s Office of Compliance and Biologics Quality, Division of Case Management at CBERDCMRecommendations@fda.hhs.gov.Sincerely,/S/Melissa J. MendozaDirectorOffice of Compliance and Biologics QualityCenter for Biologics Evaluation and Research

Delivery Method:Via UPS and EMAILReference #:CBER 26-720529Product:BiologicsRecipient:Genetrace1210 3rd StreetBlaine,WA98230United Statessupport@genetrace.comIssuing Office:Center for Biologics Evaluation and Research (CBER)United StatesWARNING LETTERJanuary 8, 2026CBER 26- 720529To Whom It May Concern:The United States Food and Drug Administration (FDA or the Agency) has learned that your firm, Genetrace, has offered for sale in the United States a human immunodeficiency virus (HIV) serological diagnostic dried blood spot (DBS) card self-collection kit (hereinafter, your “HIV DBS card self-collection kit”) without marketing authorization, in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act). Under section 201(h)(1) of the FD&C Act, 21 U.S.C. 321(h)(1), your HIV DBS card self-collection kit is a device because it is intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body.FDA has reviewed your company’s website at https://www.genetrace.com (last visited January 2026). Based on our review, your firm has offered its HIV DBS card self-collection kit for delivery to individuals and has intended for these individuals to use the kit to self-collect DBS samples and ship those samples to laboratories for HIV testing. FDA has determined that your HIV DBS card self-collection kit is adulterated under section 501(f)(1)(B) of the FD&C Act, 21 U.S.C. 351(f)(1)(B) because it does not have an approved premarket approval application (PMA) in effect pursuant to section 515(a) of the FD&C Act, 21 U.S.C. 360e(a), or an approved application for an investigational device exemption (IDE) under section 520(g) of the FD&C Act, 21 U.S.C. 360j(g). Your HIV DBS card self-collection kit is also misbranded under section 502(o) the FD&C Act, 21 U.S.C. 352(o), because notification of the intent to introduce the device into commercial distribution has not been provided to the agency, as required by section 510(k) of the FD&C Act, 21 U.S.C. 360(k).FDA has not authorized your firm’s HIV DBS card self-collection kit for any use, including for use in HIV serological diagnostic testing.In a letter dated March 31, 2025, FDA informed you that you appeared to be offering for sale and distributing your HIV serological diagnostic self-collection kits in a manner that may violate the FD&C Act. However, as noted above, your firm’s HIV DBS card self-collection kit has not received FDA marketing authorization for any use and to date, your firm has not submitted any premarket submission to FDA seeking authorization to market this kit.Without appropriate testing, data review, and marketing authorization, there is a lack of assurance of the safety and effectiveness of your HIV DBS card self-collection kit. Self-collection raises several issues of importance, including, for example, whether the user can safely and properly collect the specimen, if the sample has been properly shipped, and if there is adequate stability of the specimen given the time lapse between collection and testing and the potential impact of shipping conditions. We also note that there is an FDA-approved over-the-counter HIV test that can help meet the needs of individuals who wish to test themselves at home or who are unable to access other testing options.The violations cited in this letter are not meant to be an all-inclusive list of violations that may exist in connection with your products. FDA requests that your firm immediately cease any activities that result in the misbranding or adulteration of your HIV DBS card self-collection kit. Your firm should take prompt action to address the 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.This letter notifies you of our findings and provides you an opportunity to address the above deficiencies. If you believe that your product is not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration in your response to this letter.Within fifteen working days of receipt of this letter, please notify FDA in writing of the specific steps that you have taken to correct any violations. Your response should include an explanation of each step being taken to prevent the recurrence of violations as well as related documentation. If you cannot complete all corrective actions within fifteen working days, state the reason for the delay and the date by which you will complete the correction.Send your electronic response and any questions regarding this letter to CBER’s Office of Compliance and Biologics Quality, Division of Case Management at CBERDCMRecommendations@fda.hhs.gov.Sincerely,/S/Melissa J. MendozaDirectorOffice of Compliance and Biologics QualityCenter for Biologics Evaluation and Research

Delivery Method:Via UPS and EMAILReference #:CBER 26-720555Product:BiologicsRecipient:Jon TavarezFounder & Chief Executive OfficerGermaphobix6950 E Adamo DrTampa,FL33619United Statesinfo@germaphobix.comIssuing Office:Center for Biologics Evaluation and Research (CBER)United StatesWARNING LETTERJanuary 09, 2026CBER 26-720555Dear Jon Tavarez:The United States Food and Drug Administration (FDA or the Agency) has learned that your firm, Germaphobix, is offering for sale in the United States a human immunodeficiency virus (HIV) serological diagnostic dried blood spot (DBS) card self-collection kit (hereinafter, your “HIV DBS card self-collection kit”) without marketing authorization, in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act). Under section 201(h)(1) of the FD&C Act, 21 U.S.C. 321(h)(1), your HIV DBS card self-collection kit is a device because it is intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body.FDA has reviewed your company’s website at https://germaphobix.com (last visited January 2026) and your firm’s responses to previous FDA correspondence. Based on our review of these materials, your firm offers a HIV DBS card self-collection kit for delivery to individuals and intends for these individuals to use the kit to self-collect DBS samples and ship those samples to laboratories for HIV testing. FDA has determined that your HIV DBS card self-collection kit is adulterated under section 501(f)(1)(B) of the FD&C Act, 21 U.S.C. 351(f)(1)(B) because it does not have an approved premarket approval application (PMA) in effect pursuant to section 515(a) of the FD&C Act, 21 U.S.C. 360e(a), or an approved application for an investigational device exemption (IDE) under section 520(g) of the FD&C Act, 21 U.S.C. 360j(g). Your HIV DBS card self-collection kit is also misbranded under section 502(o) the FD&C Act, 21 U.S.C. 352(o), because notification of the intent to introduce the device into commercial distribution has not been provided to the agency, as required by section 510(k) of the FD&C Act, 21 U.S.C. 360(k).FDA has not authorized your HIV DBS card self-collection kit for any use, including for use in HIV serological diagnostic testing.In a letter dated March 31, 2025, FDA informed you that you appeared to be offering for sale and distributing your HIV serological diagnostic self-collection kits in a manner that may violate the FD&C Act. In your response dated April 18, 2025, you assert that you operate solely as a distributor and that the HIV dried blood spot tests offered on your website are Lab-Developed Tests (LDTs). On September 23, 2025, FDA notified you that HIV DBS card self-collection kits are not considered LDTs and that the distribution or causing the distribution of your HIV DBS card self-collection kit violates the FD&C Act. As noted above, your firm’s HIV DBS card self-collection kit has not received FDA marketing authorization for any use and to date, your firm has not submitted any premarket submission to FDA seeking authorization to market this kit.Without appropriate testing, data review, and marketing authorization, there is a lack of assurance of the safety and effectiveness of your HIV DBS card self-collection kit. Self-collection raises several issues of importance, including, for example, whether the user can safely and properly collect the specimen, if the sample has been properly shipped, and if there is adequate stability of the specimen given the time lapse between collection and testing and the potential impact of shipping conditions. We also note that there is an FDA-approved over-the-counter HIV test that can help meet the needs of individuals who wish to test themselves at home or who are unable to access other testing options.The violations cited in this letter are not meant to be an all-inclusive list of violations. FDA requests that your firm immediately cease any activities that result in the misbranding or adulteration of your HIV DBS card self-collection kit. Your firm should take prompt action to address the 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.This letter notifies you of our findings and provides you an opportunity to address the above deficiencies. If you believe that your product is not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration in your response to this letter.Within fifteen working days of receipt of this letter, please notify FDA in writing of the specific steps that you have taken to correct any violations. Your response should include an explanation of each step being taken to prevent the recurrence of violations as well as related documentation. If you cannot complete all corrective actions within fifteen working days, state the reason for the delay and the date by which you will complete the correction.Send your electronic response and any questions regarding this letter to CBER’s Office of Compliance and Biologics Quality, Division of Case Management at CBERDCMRecommendations@fda.hhs.gov.Sincerely,/S/Melissa J. MendozaDirectorOffice of Compliance and Biologics QualityCenter for Biologics Evaluation and Research

行政处罚相对人类别:法人及非法人组织行政处罚决定书文号:穗云市监处罚〔2024〕2439号处罚类别:罚款;没收违法所得、没收非法财物罚款金额(万元):5没收违法所得、没收非法财物的金额(万元):0.0345暂扣或吊销证照名称及编号:违法事实:2024年8月15日，我局执法人员根据线索依职权前往位于1633号广州民营科技园科兴路2号之一绿地汇创广场5栋11层1103房的广州荻薇化妆品有限公司进行检查。执法人员现场送达该公司由西安市食品药品检验所出具的《检验报告》（报告编号：XAHZ202400186），报告显示被抽样产品“荻薇染发膏（莺茶棕红色）”（生产日期/批号：20220702）检验项目：对苯二胺不符合规定，当事人承认上述产品为其产品，并提供上述产品相关材料备查。因当事人涉嫌经营未经注册的特殊化妆品的行为，遂依法立案调查。因涉事产品“荻薇染发膏（莺茶棕红色）”经检验检出产品标签及注册资料载明的技术要求未标示的染发剂对苯二胺，我局认定该产品为未经注册的特殊化妆品。经查明，当事人于2022年7月2日委托广州市白云区人和荻薇日用化妆品厂生产被抽检的“荻薇染发膏（莺茶棕红色）（生产日期/批号：20220702）”，2022年7月2日广州市白云区人和荻薇日用化妆品厂共生产“荻薇染发膏（莺茶棕红色）（生产日期/批号：20220702）”490支，其中留样10支，2022年8月4日将剩余480支以1.1元/支的价格全部销售给当事人，当事人将收到的480支“荻薇染发膏（莺茶棕红色）（生产日期/批号：20220702）”全部销售给了广州承谦生物科技有限公司，销售价格是1.38元/支。2024年7月17日，当事人在得知涉事产品抽检不合格后，便于2024年7月30日将库存的230盒涉事产品进行了销毁处理。鉴此，上述抽检不合格产品的货值为676.2元，违法所得为345元。上述事实，主要有以下证据证明：1.当事人的《营业执照》、法定代表人身份证复印件，证明本案的违法主体信息。2.现场笔录，证明当事人现场检查情况；3.证据复制单，证明当事人违法事实；4.询问笔录，证明当事人违法事实；处罚依据:罚则依据：第五十九条　有下列情形之一的，由负责药品监督管理的部门没收违法所得、违法生产经营的化妆品和专门用于违法生产经营的原料、包装材料、工具、设备等物品；违法生产经营的化妆品货值金额不足1万元的，并处5万元以上15万元以下罚款；货值金额1万元以上的，并处货值金额15倍以上30倍以下罚款；情节严重的，责令停产停业、由备案部门取消备案或者由原发证部门吊销化妆品许可证件，10年内不予办理其提出的化妆品备案或者受理其提出的化妆品行政许可申请，对违法单位的法定代表人或者主要负责人、直接负责的主管人员和其他直接责任人员处以其上一年度从本单位取得收入的3倍以上5倍以下罚款，终身禁止其从事化妆品生产经营活动；构成犯罪的，依法追究刑事责任：（一）未经许可从事化妆品生产活动，或者化妆品注册人、备案人委托未取得相应化妆品生产许可的企业生产化妆品；（二）生产经营或者进口未经注册的特殊化妆品；　　（三）使用禁止用于化妆品生产的原料、应当注册但未经注册的新原料生产化妆品，在化妆品中非法添加可能危害人体健康的物质，或者使用超过使用期限、废弃、回收的化妆品或者原料生产化妆品。;处罚内容:当事人经营未经注册的特殊化妆品的化妆品行为，违反了《化妆品监督管理条例》第十七条的规定“特殊化妆品经国务院药品监督管理部门注册后方可生产、进口”的规定，依据《化妆品监督管理条例》第五十九条第二项“有下列情形之一的，由负责药品监督管理的部门没收违法所得、违法生产经营的化妆品和专门用于违法生产经营的原料、包装材料、工具、设备等物品；违法生产经营的化妆品货值金额不足1万元的，并处5万元以上15万元以下罚款；……（二）生产经营或者进口未经注册的特殊化妆品。”的规定，决定对当事人经营未经注册的特殊化妆品的化妆品行为作出如下处罚：一、没收违法所得345元；二、罚款人民币50000元；罚没合计50345元违法行为类型:化妆品经营企业违法行为行政相对人名称:广州荻薇化妆品有限公司行政相对人代码:统一社会信用代码组织机构代码工商登记码税务登记号事业单位证书号社会组织登记证号91440101MA9UWKW70B法定代表人:张崑雄处罚决定日期:2024-12-10公示截止期:2027-12-10处罚机关:广州市白云区市场监督管理局数据来源单位:广州市市场监督管理局（广州市知识产权局）

行政处罚相对人类别:法人及非法人组织行政处罚决定书文号:穗云市监处罚〔2026〕22号处罚类别:罚款;没收违法所得、没收非法财物罚款金额(万元):1没收违法所得、没收非法财物的金额(万元):0.07665暂扣或吊销证照名称及编号:违法事实:我局于2025年10月9日对当事人涉嫌生产不符合技术规范的违法行为进行立案调查。经查明，当事人于2025年2月15日接受客户订单生产“洛芮琪靓肤精萃水”（批号：ZYBEB17A03、限用日期：2028/02/16、规格：30ml/盒）产品548盒，产品的包装材料（瓶子、盒子）均由客户提供，其中瓶子单价为2.8元/个，盒子单价为1.5元/个。其标称的功效为“呵护肌肤水分，补充肌肤养分，改善娇嫩肌肤”，属于普通化妆品，备案编号：粤G妆网备字2024517667。上述548盒产品中，有3盒用于自检，3盒用于留样；留样的3盒中，有2盒于2025年8月15日被广东省药品监督管理局用于抽样检查，1盒由于包装破损，当事人已自行丢弃，剩余542盒于2025年8月15日以3.5元/盒的价格售出，销售收入1897元；当事人共召回323盒，其余219盒无法召回。上述产品由广东省药品监督管理局委托广东产品质量监督检验研究院检验并出具的《检验报告》（No.SC2504638），检验结论为“本品按《化妆品安全技术规范》（2015年版）检验下述项目，结果不符合规定”，不符合规定项目为检出“巯基乙酸”（该原料为化妆品限用组分，仅用于烫发产品、脱毛产品以及其他淋洗类发用产品中，不能用于涉事产品）。当事人不按照强制性国家标准使用原料生产化妆品的货值金额为4274.4元，违法所得合计766.5元。以上事实有《营业执照》、法定代表人复印件、广东产品质量监督检验研究院出具的《检验报告》（No.SC2504638）、涉案产品的生产指令单、生产批记录、产品销售记录表、现场笔录、证据复制单、询问笔录、召回通知单等证据证实并确认。我局于2025年12月25日向当事人送达《行政处罚告知书》，依法告知当事人我局拟作出行政处罚的事实、理由、依据和内容，并告知当事人依法享有提出陈述、申辩意见的权利，当事人在法定期限内未提出陈述、申辩意见。处罚依据:①《化妆品监督管理条例》（2021年1月1日起施行）第六十条：有下列情形之一的，由负责药品监督管理的部门没收违法所得、违法生产经营的化妆品和专门用于违法生产经营的原料、包装材料、工具、设备等物品；违法生产经营的化妆品货值金额不足1万元的，并处1万元以上5万元以下罚款；货值金额1万元以上的，并处货值金额5倍以上20倍以下罚款；情节严重的，责令停产停业、由备案部门取消备案或者由原发证部门吊销化妆品许可证件，对违法单位的法定代表人或者主要负责人、直接负责的主管人员和其他直接责任人员处以其上一年度从本单位取得收入的1倍以上3倍以下罚款，10年内禁止其从事化妆品生产经营活动；构成犯罪的，依法追究刑事责任：　　（一）使用不符合强制性国家标准、技术规范的原料、直接接触化妆品的包装材料，应当备案但未备案的新原料生产化妆品，或者不按照强制性国家标准或者技术规范使用原料；　　（二）生产经营不符合强制性国家标准、技术规范或者不符合化妆品注册、备案资料载明的技术要求的化妆品；　　（三）未按照化妆品生产质量管理规范的要求组织生产；　　（四）更改化妆品使用期限；　　（五）化妆品经营者擅自配制化妆品，或者经营变质、超过使用期限的化妆品；　　（六）在负责药品监督管理的部门责令其实施召回后拒不召回，或者在负责药品监督管理的部门责令停止或者暂停生产、经营后拒不停止或者暂停生产、经营。②《广东省化妆品安全条例》（2019年7月1日起施行）第五十二条：违反本条例第十三条第二项、第四项、第五项规定，超量或者超范围使用国家规定的化妆品限用原料生产化妆品，使用超过使用期限、废弃、回收等不符合国家有关标准或者处罚内容:鉴于当事人积极配合调查，如实交代违法事实，主动提供证据材料，积极采取召回措施减轻危害后果，不合格产品召回率较高（59.6%），符合《广州市市场监督管理部门规范行政处罚自由裁量权规定》第十四条第（一）项“有下列情形之一的，可以依法从轻或者减轻行政处罚：（一）积极配合市场监督管理部门调查，如实交代违法事实并主动提供证据材料的；”规定的从轻处罚情形，决定给予从轻处罚。当事人不按照强制性国家标准使用原料生产化妆品的违法行为，违反《化妆品监督管理条例》第六条第二款规定，对其处罚适用《化妆品监督管理条例》第六十条“有下列情形之一的，由负责药品监督管理的部门没收违法所得、违法生产经营的化妆品和专门用于违法生产经营的原料、包装材料、工具、设备等物品；违法生产经营的化妆品货值金额不足1万元的，并处1万元以上5万元以下罚款；货值金额1万元以上的，并处货值金额5倍以上20倍以下罚款；情节严重的，责令停产停业、由备案部门取消备案或者由原发证部门吊销化妆品许可证件，对违法单位的法定代表人或者主要负责人、直接负责的主管人员和其他直接责任人员处以其上一年度从本单位取得收入的1倍以上3倍以下罚款，10年内禁止其从事化妆品生产经营活动；构成犯罪的，依法追究刑事责任：（一）使用不符合强制性国家标准、技术规范的原料、直接接触化妆品的包装材料，应当备案但未备案的新原料生产化妆品，或者不按照强制性国家标准或者技术规范使用原料；”规定，决定对当事人作出如下处罚：一、没收违法所得766.5元；二、没收违法专用生产原料“巯基臭水美白剂”（生产商：广州博之越精细化工有限公司，含瓶823g）；三、没收“洛芮琪靓肤精萃水”（批号：ZYBEB17A03、限用日期：2028/02/16、规格：30ml/盒）产品323盒；四、罚款10000元。（罚没款合计10766.5元）。另根据《中华人民共和国行政处罚法》第二十八条第一款规定，决定责令当事人禁止使用“巯基乙酸”用于化妆品生产的违法行为。违法行为类型:化妆品生产企业违法行为行政相对人名称:广州中樱化妆品有限公司行政相对人代码:统一社会信用代码组织机构代码工商登记码税务登记号事业单位证书号社会组织登记证号91440101MA5CK9F9X0法定代表人:张乔峰处罚决定日期:2026-01-05公示截止期:2029-01-05处罚机关:广州市白云区市场监督管理局数据来源单位:广州市市场监督管理局（广州市知识产权局）

行政相对人名称宁安市中医院行政相对人代码(统一社会信用代码)122310844143726488法定代表人薛爱芝行政处罚决定书文号宁市监处罚〔2026〕4号违法行为类型未取得《医疗机构制剂许可证》生产销售药品违法事实2025年12月1日，我局接到举报信，举报人称：宁安市中医院销售鼻炎胶囊，对该药品存在违法行为进行查处。2025年12月2日执法人员在对宁安市中医院检查时发现，该医院中药局内正在使用自配的幸苍鼻炎胶囊，该医院无《医疗机构制剂许可证》。涉嫌无证配制医疗机构制剂处罚依据《药品监督管理行政处罚裁量适用规则》第十一条第（二）项、第（四）项《中华人民共和国药品管理法》第一百一十五条处罚类别罚款处罚内容1.没收违法生产、使用制剂。 2..没收违法销售药品的违法所得人民币叁佰叁拾玖元整（￥339.00元）； 3.罚款人民币贰万元整（￥20，000.00元）；罚没款共计人民币贰万零叁佰叁拾玖元整（￥20，339.00元）。罚款金额（万元）2没收违法所得没收非法财物的金额（万元）0.0739处罚决定日期2026-01-20处罚有效期2028-01-20公示截止期2026-04-19处罚机关宁安市市场监督管理局