南昌市朝阳医疗保健用品有限公司报告,由于公司因气相色谱仪出现故障,怀疑该批次产品环氧乙烷残留量项目存在不合格风险。为防范质量安全风险,保障终端临床使用安全,主动召回该批次产品。等原因,南昌市朝阳医疗保健用品有限公司对其生产的医用棉签(注册备案号:赣械注准20182140032)主动召回,召回级别为三级,涉及产品的型号、规格及批次等详细信息见《医疗器械召回事件报告表》。附件:医疗器械召回事件报告表.pdf2026年7月15日
Delivery Method:VIA UPSReference #:320-26-100Product:DrugsOver-the-Counter DrugsRecipient:Ms. Rena RevivoOwnerSpa De Soleil, Inc.10443 Arminta StreetSun Valley, CA 91352-4109United StatesIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesWarning Letter 320-26-100July 8, 2026Dear Ms. Revivo:The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, Spa De Soleil, Inc., FEI 3003876848, at 10443 Arminta Street, Sun Valley, from January 20 to 26, 2026.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 February 6, 2026 response to our Form FDA 483 in detail. Your response is inadequate because you failed to provide supporting documentation for evaluation or adequate evidence of corrective actions taken to bring your operations into compliance with CGMP.During our inspection, our investigator observed specific violations including, but not limited to, the following.1. Your firm failed to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, whether or not the batch has already been distributed (21 CFR 211.192).You failed to adequately investigate multiple microbiological out-of-limit (OOL) and chemical out-of-specification (OOS) results from testing the water you used to manufacture over-the-counter (OTC) (b)(4) drug products, including (b)(4) and (b)(4). For example, from May 2024 through July 2025, you did not adequately investigate 51 OOL/OOS results from testing your (b)(4). These included results for conductivity and total organic carbon testing that exceeded specifications, as well as the recovery of gram-negative microorganisms from multiple points of use.Your investigations did not include identification of the recovered microorganisms (e.g., genus, species). You resampled and retested the (b)(4) for microbiological quality to obtain passing results and continued to use the (b)(4). Following an OOL recovery, you also placed certain point-of-use valves on hold until you obtained a passing result. However, this practice did not prevent you from using other valves on the same system. Microbiological recoveries from a (b)(4) system are not uniform, and results obtained at any point in the system can be an indicator of the quality of (b)(4) in the system as a whole. Your identified corrective actions did not adequately prevent the use of (b)(4) with potentially objectionable microbial contamination in the manufacture of your drug products.Furthermore, your (b)(4) system was not adequately designed or maintained, which could foster the development of biofilms. Specifically, your (b)(4) system included non-sanitary components such as dead legs, threaded fittings, Teflon tape, and ball valves. You also did not demonstrate that you adequately monitored your (b)(4) system to ensure it consistently produced (b)(4) that met appropriate chemical and microbial attributes. For instance, your sampling frequencies were not reflective of batch production schedules.In your response, you did not provide any supporting documentation, including details of your corrective actions to ensure that future OOS/OOL investigations will be adequate in scope and include root cause determination. You also did not provide a comprehensive review of potentially affected drug products. You state that your historical review of OOS/OOL events from your (b)(4) system determined that no adverse impact to drug product quality or safety was identified.This retrospective investigation failed to identify adequate corrective action and preventive action (CAPA) plans. You do not commit to changes in monitoring frequency (e.g., reflective of batch production) or identifying and quantifying recovered microorganisms during routine monitoring of your water system. You also fail to consider how fundamental flaws in design, control and maintenance of your (b)(4) system may contribute to the OOS/OOL results. Your CAPA plan is not sufficient to ensure that your (b)(4) system produces (b)(4) suitable for use in OTC drug products.(b)(4) 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 contamination in the system is integral to ensuring oversight of the ongoing state of control and suitability of (b)(4) for use in pharmaceutical manufacturing operations.In response to this letter, provide:A comprehensive review and remediation plan for your OOS and OOL 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 remediationso A similar review and remediation of your system for handling OOL findings (i.e., data that fall outside action limits)A comprehensive remediation plan for the design, control, and maintenance of the (b)(4) system.o Provide a comprehensive evaluation of vulnerabilities of your (b)(4) system design and control, and summarize all deficiencies found in the system. The summary should, at minimum, describe various system characteristics that were assessed for adequacy (system temperature, materials of construction, slope, any identified dead-legs, any stagnant locations, any unsanitary fittings, flow velocity, etc.)o Provide a validation report for the water system obtained after all identified design issues have been fully corrected and any maintenance repairs have been completed. Include the system validation protocol, the complete test results, and the final validation report.Your total microbial count limits to monitor whether this system is producing (b)(4) suitable for the intended uses for each of your drug products.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 or within expiry. Specify actions that you will take in response to the risk assessment, such as customer notifications and drug 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)).You failed to perform adequate identity testing on each shipment of each lot of incoming components (e.g., (b)(4)) used in the manufacture of your OTC topical drug products. In addition, you relied on your suppliers’ certificates of analysis (COA) without establishing the reliability of your component suppliers’ test analyses at appropriate intervals.Products Containing (b)(4)You failed to adequately test your incoming component (b)(4) at risk of methanol contamination for identity before using it as an active pharmaceutical ingredient (API) in manufacturing your OTC topical drug products. The use of (b)(4) contaminated with methanol has resulted in various lethal poisoning incidents in humans worldwide. See FDA’s guidance document (b)(4) to help you meet the CGMP requirements when manufacturing drugs containing (b)(4).Furthermore, you failed to demonstrate that the component (b)(4) you used to manufacture your (b)(4) drug products meets United States Pharmacopeia (USP) monograph specifications or is of adequate quality for its intended use.Products Containing Ingredients at Risk for Diethylene Glycol or Ethylene Glycol ContaminationYou also failed to adequately test your incoming components at high risk of diethylene glycol (DEG) or ethylene glycol (EG) contamination for identity before using them to manufacture your drug products. This includes, but is not limited to, testing glycerin to determine its appropriate identity prior to use in manufacturing your OTC topical drug products.Identity testing for glycerin and certain other high-risk drug components includes a limit test in the USP to ensure the component meets the relevant safety limits for DEG or EG 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.The use of ingredients contaminated with DEG or EG has resulted in various lethal poisoning incidents in humans worldwide. See FDA’s guidance document Testing of Glycerin, Propylene Glycol, Maltitol Solution, Hydrogenated Starch Hydrolysate, Sorbitol Solution, and Other High-Risk Drug Components for Diethylene Glycol and Ethylene Glycol to help you meet the CGMP requirements when manufacturing drugs containing ingredients at high-risk for DEG or EG contamination at https://www.fda.gov/media/167974/download.In your response, you state that your new standard operating procedures require identity and purity testing for all incoming ethanol and identity testing for all incoming OTC materials. You also commit to verifying supplier certificates of analysis prior to raw material release for use in manufacturing your topical OTC drug products. Your response is inadequate because you do not provide sufficient details and supporting data to demonstrate your components meet all compendial requirements. Furthermore, your response does not address testing each shipment of each lot, to include each container, of your high-risk drug components for DEG or EG contamination and ethanol for the presence of methanol contamination.Without adequate testing, you do not have scientific evidence that the components conform to appropriate specifications before use in the manufacture of your drug products. You have a responsibility to sample, test, and examine drug components before use in production to ensure acceptable quality parameters are met.In response to this letter, provide:A commitment to provide DEG and EG 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 retain sample testing of all implicated finished drug product batches for the presence of DEG and EG.A full risk assessment for drug products that are within expiry which contain any ingredient at risk for DEG or EG contamination (including, but not limited to, glycerin). Take prompt and appropriate actions to determine the safety of all lots of the components and any related drug product that could contain DEG or EG, including customer notifications and drug 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 glycerin, propylene glycol, and certain additional high-risk components we note that this includes the performance of parts A, B. and C of the USP monograph.The chemical quality control specifications you use to test each incoming lot of high-risk drug components to determine acceptability for use in manufacturing.A comprehensive, independent review of your material system to determine whether all suppliers of components, containers, and closures, are each qualified and the materials are assigned appropriate expiration or retest dates. The review should also determine whether incoming material controls are adequate to prevent use of unsuitable components, containers, and closures.3. Your firm failed to establish adequate written procedures for production and process control designed to assure that the drug products you manufacture have the identity, strength, quality, and purity they purport or are represented to possess, and your firm’s quality control unit did not review and approve those procedures, including any changes (21 CFR 211.100(a)).You failed to ensure adequate validation for each of the manufacturing processes used to produce your OTC drug products. Additionally, your completed batch records did not include details pertaining to critical processing steps subject to variation (e.g., (b)(4) times, speeds) or identification of certain equipment including scales used for your weight-based manufacturing processes.In your response, you state that you will execute process validation with a target completion date of April 2026. However, your response is inadequate because you provide no assurance of your proposed process validation for each drug product. You did not provide validation plans, and you did not include details pertaining to critical attributes of a (b)(4) process. In addition, you did not consider a retrospective assessment of the potential impact to your drug product distributed in the United States and within expiry.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.Also, process qualification studies characterize intra-batch variation and evaluate batches to determine whether an initial state of control has been established. They include intensive monitoring and testing throughout each significant process stage.Successful process qualification studies are necessary before commercial distribution. Thereafter, ongoing vigilant oversight of process performance and drug product quality is necessary to ensure you maintain a stable manufacturing operation throughout the drug product lifecycle. See FDA’s guidance for industry, Process Validation: General Principles and Practices, for general principles and approaches that the FDA considers appropriate elements of process validation athttps://www.fda.gov/media/71021/download.In response to this letter, provide:A detailed summary of your validation program for ensuring a state of control throughout the drug 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. Also, describe your equipment and facility qualification program.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 protocols and written procedures for qualification of equipment and facilities.4. 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 adequately validate your alternative (b)(4) microbiological test methods. Your firm used the (b)(4) system for (b)(4) microbiological testing of your (b)(4), raw materials, and finished drug products (e.g., total counts, objectionable microorganisms). However, you failed to demonstrate that this system was equivalent to or better than USP compendial methods and suitable for its intended use. Specifically, your method validation was fundamentally flawed because you treated a quantitative test as a qualitative limit test, which resulted in unsubstantiated USP equivalency claims.In your response, you state that you have updated your sampling procedures and now perform growth promotion testing on every lot of (b)(4) microbiological media used by your (b)(4) microbiological testing system. However, your response is inadequate because you do not adequately address how you will ensure that your microbiological limits test method is properly 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 whether your (b)(4), components, and drug products meet established specifications for microbial attributes.In response to this letter, provide:A comprehensive, independent assessment of the design and control of your firm’s manufacturing operations with a detailed and thorough review of all microbiological hazards.A detailed risk assessment addressing the hazards posed by distributing drug products with potentially objectionable contamination. Specify actions you will take in response to the risk assessment, such as customer notifications and drug product recalls.Complete investigations into all batches with potential objectionable microbial contamination or an OOS microbiological result (whether or not later invalidated). The investigations should detail your findings regarding the root causes of the contamination.Appropriate microbiological batch release specifications (i.e., total counts, identification of bioburden to detect objectionable microbes) for each of your drug products.All microbial test methods used to analyze each of your drug products.A summary of results from testing retain samples of all drug product batches within expiry. You should test microbiological quality (total counts and identification of bioburden to detect any objectionable microbes) of each batch. If testing yields an OOS result, indicate the corrective actions you will take, including notifying customers and initiating recalls.5. Your firm failed to establish an adequate quality control unit with the responsibility and authority to approve or reject all components, drug product containers, closures, in-process materials, packaging materials, labeling, and drug products and the authority to review production records to assure that no errors have occurred or, if errors have occurred, that they have been fully investigated (21 CFR 211.22(a)).The records and information you provided demonstrate that your quality unit (QU) did not effectively exercise its responsibilities to oversee the quality of your drug manufacturing operations. Specifically, your quality unit failed to ensure:The adequacy and qualification of contract laboratories used for microbiological testing of raw materials, in-process materials, and finished drug products (21 CFR 211.22(b)).Evaluation of the quality standards of each of your (b)(4) drug products at least annually to determine the need for changes in drug product specifications, manufacturing, or control procedures (21 CFR 211.180(e)).Proper validation of procedures for cleaning and maintenance of common equipment (21 CFR 211.67(b)).In your response, you state that you have established a formal contract laboratory qualification program that includes a review of historical data. You also state that you have implemented an annual drug product review written procedure and that you will complete a formal cleaning validation by December 2026. However, your response is inadequate because you provide no supporting documentation to verify your proposed corrective actions. Additionally, your written commitments are similar to those you submitted in response to the FDA inspections conducted in 2021, demonstrating repetitive failures to follow through on implementing your proposed corrective actions.Significant findings in this letter demonstrate that your firm does not operate an effective quality system in accordance with CGMP. In addition to the lack of effective management oversight of your production and laboratory operations, we found that your QU was not enabled to exercise proper authority and insufficiently implemented its responsibilities. Executive management should immediately and comprehensively assess your company’s manufacturing operations to ensure that your systems, processes, and drug products meet CGMP.Your firm’s quality systems are inadequate. See FDA’s guidance document Quality Systems Approach to Pharmaceutical CGMP Regulations for help in 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.Repeat Violations at FacilityIn a previous inspection, dated September 13 to 17, 2021, FDA cited similar CGMP violations. You proposed specific remediations for these violations in your response. Repeated failures demonstrate that executive management oversight and control over the manufacture of drugs is inadequate.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 3003876848 and ATTN: Matthew R. Dionne, Pharm.D.Sincerely,/S/Francis GodwinDirectorOffice of Manufacturing QualityOffice of ComplianceCenter for Drug Evaluation and Research
根据抽检计划,广东省市场监督管理局组织抽检粮食加工品、速冻食品、薯类和膨化食品、酒类、水果制品、糕点和餐饮食品等7类食品649批次样品。根据食品安全标准检验和判定,其中抽检项目合格样品626批次、不合格样品23批次(见附件),检出微生物污染、食品添加剂超范围超限量使用及其他指标问题。根据《食品安全抽样检验管理办法》等相关规定,现公开监督抽检结果信息。具体情况如下。一、微生物污染问题(一)东莞市虎门裕和兴副食商行销售的标称潮州市潮安区永胜食品厂生产的啤酒豆膨化食品,大肠菌群不符合食品安全国家标准规定。(二)点蹄·擂椒猪脚饭(广式烧腊·明珠店)(经营者为珠海市香洲区前山一天三餐餐饮店)在美团外卖(手机App)销售的白切鸡(自制),大肠埃希氏菌不符合广东省食品安全地方标准规定。(三)中山市小榄镇冼香餐饮店(个体工商户)使用的肠粉碟,大肠菌群和阴离子合成洗涤剂(以十二烷基苯磺酸钠计)不符合食品安全国家标准规定。(四)陈记烧鹅仔·烧鸡(前山店)(经营者为珠海市香洲区前山邑香餐饮店(个体工商户))在美团外卖(手机App)销售的白切鸡(自制),菌落总数和大肠埃希氏菌不符合广东省食品安全地方标准规定。(五)潮味粥铺(经营者为博罗县石湾镇朝味粥餐饮店(个体工商户))在美团外卖(手机App)销售的现卤好吃鸡腿(自制),菌落总数和大肠埃希氏菌不符合广东省食品安全地方标准规定。(六)老鸭伯·雷州鸭仔饭(大石店)(经营者为广州市番禺区大石老鸭伯雷州鸭仔饭店(个体工商户))在美团外卖(手机App)销售的白切鸡(1整只),菌落总数和大肠埃希氏菌不符合广东省食品安全地方标准规定。(七)王牌烧鹅(南浦碧桂园店)(经营者为广州市番禺区洛浦金铭餐饮店(个体工商户))在美团外卖(手机App)销售的湛江白切鸡(半只),菌落总数和大肠埃希氏菌不符合广东省食品安全地方标准规定。二、食品添加剂超范围超限量使用问题(一)东莞市虎门合茂日用品店销售的标称潮州市佳利香食品有限公司生产的黄瓜片味(膨化食品),三氯蔗糖不符合食品安全国家标准规定。(二)大埔县新润发易购百货有限公司销售的标称广东南台酒业股份有限公司生产的南台御酒(白酒),三氯蔗糖不符合食品安全国家标准规定。(三)广州易初莲花连锁超市有限公司阳江阳西人民大道分公司销售的标称揭西县果色添香食品厂生产的双喜榄(蜜饯),二氧化硫残留量不符合食品安全国家标准规定。(四)乳源瑶族自治县大润欢惠德商贸有限公司销售的标称广东全佳食品有限公司生产的酸甜乌梅,苯甲酸及其钠盐(以苯甲酸计)、亮蓝、苋菜红及相同色泽着色剂混合使用时各自用量占其最大使用量的比例之和不符合食品安全国家标准规定。(五)清远市清城区涛古食品经营部销售的标称普宁市创奕食品有限公司生产的九制榄(凉果类),二氧化硫残留量不符合食品安全国家标准规定。(六)普宁市流沙嘉焱百货商店(个体工商户)销售的标称广东旅揭食品有限公司生产的橄榄王果,二氧化硫残留量不符合食品安全国家标准规定。三、其他指标问题(一)东莞超盛供应链有限公司销售的标称惠州市艺锦食品科技有限公司生产的小米锅巴(香辣味)膨化食品,酸价(以脂肪计)(KOH)不符合食品安全国家标准规定。(二)开平市长沙贸盛商行销售的标称吴川市梅滨酒厂生产的二曲酒(调香白酒),酒精度不符合产品标签标示要求。(三)中山市东凤镇源来旺百货店(个体工商户)销售的标称广东三友酿酒股份有限公司生产的金河源霸王鞭(配制酒),酒精度不符合产品标签标示要求。(四)佛山市顺德区兴万悦甄选超市有限公司销售的标称广东聚仁堂保健酒有限公司生产的国公酒(低糖),酒精度不符合产品标签标示要求。(五)广州三盛友泰商贸有限公司销售的标称韶关市好得亿食品有限公司生产的淮山薏米糕,过氧化值(以脂肪计)不符合食品安全国家标准规定。(六)广州市承民超市有限公司销售的标称东莞市万江港益食品厂生产的老婆饼,过氧化值(以脂肪计)不符合食品安全国家标准规定。(七)博罗县园洲镇云仓叁沣副食百货店销售的标称东莞市隆辉食品有限公司生产的甜香麻花(糕点),酸价(以脂肪计)(KOH)不符合食品安全国家标准规定。(八)普宁市流沙盟隆食品经营部销售的标称潮州市胜荣食品有限公司生产的绿豆饼,酸价(以脂肪计)(KOH)不符合食品安全国家标准规定。(九)中山市东凤镇承云饮食店使用的菜碟,阴离子合成洗涤剂(以十二烷基苯磺酸钠计)不符合食品安全国家标准规定。(十)中山市东凤镇朗焯食店使用的菜碟,阴离子合成洗涤剂(以十二烷基苯磺酸钠计)不符合食品安全国家标准规定。广东省市场监督管理局已要求辖区市场监管部门及时对不合格食品及其生产经营者进行调查处理,督促其查清产品流向,采取下架、召回不合格产品等措施控制风险,分析原因进行整改;同时要求辖区市场监管部门将相关情况记入生产经营者食品安全信用档案,按规定在监管部门网站上公开相关信息。食品安全消费提示:消费者应当通过正规可靠渠道购买所需食品并保存相应购货凭证,要看清外包装上的相关标识,如生产日期、保质期、生产者名称和地址、成分或配料表、食品生产许可证编号等标识是否齐全并符合法律法规规定。不购买无厂名、厂址、生产日期和保质期的产品,不购买超过保质期的产品,不购买公布的监督抽检不合格产品。欢迎广大消费者积极参与食品安全监督,关注食品安全抽检信息公布,如在市场上发现本次公布信息中所涉及的不合格批次食品,请及时拨打当地投诉举报电话12345或12315。特此通告。点击下载:附件1-13.doc1.本次抽检依据和抽检项目2.薯类和膨化食品监督抽检不合格产品信息3.酒类监督抽检不合格产品信息4.水果制品监督抽检不合格产品信息5.糕点监督抽检不合格产品信息6.餐饮食品监督抽检不合格产品信息7.粮食加工品监督抽检产品合格信息8.速冻食品监督抽检产品合格信息9.薯类和膨化食品监督抽检产品合格信息10.酒类监督抽检产品合格信息11.水果制品监督抽检产品合格信息12.糕点监督抽检产品合格信息13.关于部分抽检项目的说明广东省市场监督管理局2026年7月10日
为贯彻落实《市场监管总局办公厅关于开展网络食品销售虚假宣传专项整治行动的通知》(市监特食发〔2026〕33号)《市场监管总局、工业和信息化部、民政部联合印发〈保健食品护老提升专项行动工作方案〉的通知》(国市监特食发〔2026〕67号)部署要求,进一步规范网络食品销售秩序,依法严厉打击虚假宣传行为,切实维护老年人消费权益,促进银发经济发展,省市场监管局面向社会公开征集网络食品销售虚假宣传、保健食品违法违规线索。有关事项通告如下。一、征集范围(一)虚假商业营销、欺诈营销行为1.普通食品明示或暗示具有保健、疾病预防、疾病治疗等功能。2.保健食品夸大功效,明示或暗示具有疾病预防、疾病治疗功能。3.以免费体验、健康讲座、专家义诊等为噱头和利用私域销售,旅游销售,会议销售等有组织、套路化的欺诈营销活动。4.对食品及原料商标、产地、成分、功能、适用人群、检验、认证、质量、执行标准等作虚假或者引人误解的商业宣传。5.利用科研机构、行业协会、医疗机构及医护、营养等专业人员或其他人员名义、形象,为食品作虚假推荐、证明,误导消费。6.改变食品真实感官性状,将普通食品、保健食品、药品相互混淆,使用医疗用语营销。7.发布未依法取得资质认定的食品检验机构出具的食品安全检验数据、结果、报告等信息,或者篡改、伪造食品安全检验数据、结果、报告等信息,误导消费。8.采用虚假交易、虚假评价等方式或利用技术手段篡改直播间真实数据、营造虚假人气等。9.其他虚假宣传、欺诈营销违法违规线索。(二)广告违法违规行为1.食品广告涉及疾病治疗功能,使用医疗用语或者易使推销的商品与药品、医疗器械相混淆的用语。2.普通食品广告宣称保健功能。3.食品广告明示或者暗示相关商品为保障健康所必需。4.保健食品广告利用广告代言人作推荐、证明。5.保健食品广告未显著标明“本品不能代替药物”或者“保健食品不是药物,不能替代药物治疗疾病”。6.其他广告违法违规线索。(三)其他违法违规行为1.无证和超范围生产、使用不符合国家法律法规要求的原料生产,以及添加非食用物质和其他可能危害人体健康物质等行为。2.食品标签、说明书不符合法律法规和食品安全国家标准有关规定,存在虚假标注,夸大功效,明示或暗示具有疾病预防、治疗功能等误导性表述,以及未标明联系方式,保健食品标签未标注投诉服务电话。3.网络交易平台经营者食品安全管理制度不健全、落实不到位,对网络交易活动监测、巡查制度不落实,发现食品安全隐患不报告,对消费者投诉举报处置不及时、不到位。4.网络交易平台经营者对平台内经营者、直播间运营者审核查验不严,发现食品安全隐患未及时采取警示、限制功能、限制流量、暂停直播、限期停播、关闭账号、禁止重新注册账号、列入黑名单等处置措施或处置不当。5.网络交易平台经营者发现直播间运营者、直播营销人员存在食品安全违法行为,未及时制止并报告市场监管部门。6.平台内经营者、直播间运营者未建立健全食品安全制度机制,直播间运营者未对直播经营行为实施严格事前合规审核。7.直播营销人员服务机构组织、教唆、帮助直播间运营者、直播营销人员实施违法违规行为。8.直播营销人员未真实、全面、准确发布食品相关信息,实施违法违规行为。9.未在经营活动主页面显著位置持续公示真实、有效的网络食品销售生产经营许可、仅销售预包装食品备案信息,未在销售主页面依法展示预包装食品的食品标签信息;未按规定设置网络保健食品销售专区,未按规定公示注册或备案信息以及未设置消费提示、警示用语。10.其他违反市场监管法律法规的。二、权益保障欢迎社会各界积极提供违法违规线索,我们将对线索提供人和提供内容严格保密,依法保护线索提供人的合法权益,对提供的线索认真核查,切实回应各方关切。三、线索提供要求(一)请线索提供人尽量详细说明问题线索发生的时间、地点、过程等主要情况、相关证据及联系方式,保证内容要真实、客观、具体。(二)线索提供人应对其提供的线索的真实性负责,不得捏造、歪曲事实,不得诬告、陷害他人。对借举报之名故意捏造事实诬告他人或者进行不正当竞争的,依法追究相应法律责任。四、联系方式(一)电话举报可拨打12315热线进行举报。(二)网上举报可登录“全国12315平台”(http://www.12315.cn)、“全国食品安全内部知情人举报系统”或通过微信公众号、微信小程序、支付宝小程序搜索“12315”进行举报。(三)邮寄(来访)举报举报材料可邮寄至全省各级市场监管部门,或于法定工作日办公时间内前往上述部门进行现场举报。五、通告期限自本通告发布之日起至2026年11月30日。广东省市场监督管理局2026年7月10日
根据《中华人民共和国食品安全法》及其实施条例,按照《婴幼儿配方食品原料等事项备案工作指南》要求,美赞臣营养品(中国)有限公司提交的标签备案材料符合要求,我局予以备案。现将美赞臣营养品(中国)有限公司婴幼儿配方食品产品名称、产品标签备案信息予以公开。备案人对备案材料的真实性、完整性、可溯源性负责。附件:1. 美赞臣营养品(中国)有限公司婴幼儿配方食品标签备案信息表.docx2. 美赞臣营养品(中国)有限公司婴幼儿配方食品标签.zip广东省市场监督管理局2026年7月8日
序号:1企业名称盘锦博菲特医疗技术有限公司企业类型医疗器械生产企业检查时间2026年5月12日—2026年5月18日所在地市盘锦市检查依据《医疗器械监督管理条例》检查事项医疗器械生产检查检查方式常规检查检查内容执行GMP情况存在问题在厂房与设施方面存在企业个别生产区域有个人生活用品等问题;在销售和售后服务方面存在企业未对个别相关信息进行跟踪分析等问题。处理措施限期整改整改情况已按要求完成整改
近日,省药监局印发《安徽省中药饮片生产质量管理体系提升三年行动计划(2026—2028年)》(以下简称《行动计划》),全面部署全省中药饮片生产质量管理体系提升工作,推进中药饮片生产过程合规、提质增效、品牌升级,推动实现“皖药饮片”品牌形象和市场竞争力的稳步提升。《行动计划》立足安徽中药资源和产业大省实际,以“四个最严”为根本遵循,着眼于打基础、利长远,从三个维度明确了16项重点任务,并同步细化分解为28条具体举措。一是聚焦筑底夯基,持续优化企业质量体系建设。通过压实企业主体责任,构建“培训+考核+测试”岗位能力提升体系,强化中药材源头管控,规范生产过程和销售发运管理,严格质量放行及强化药品上市许可持有人义务履行等措施,全面夯实企业质量安全根基。二是严格高效监管,切实筑牢产业合规运行底线。通过严把生产准入关口,强化中药标准体系建设,建强专业化监管队伍,深化差异化精准监管与风险闭环管控,严厉打击违法违规行为等措施,构建全链条监管闭环。三是汇聚多元动能,创新驱动产业高质量发展。通过引导企业数智化转型升级,强化中药监管科学研究,推行“执法检查+普法宣传+警示教育”精准帮扶等措施,帮助企业解决技术与管理方面的难题,助力提升合规管理水平。下一步,省药监局将加强统筹协调,强化宣传引导,抓好总结评估,推动各项任务落地见效,持续提升中药饮片生产质量安全保障水平。
为加强医疗器械质量监督管理,保障医疗器械产品使用安全有效,江西省药品监督管理局按照年度工作方案,持续对本省医疗器械生产、经营和使用环节实施了监督抽样检验。现将抽检中发现的9批次不符合规定医疗器械信息予以公告(详见附件):对上述不符合规定产品,我省各级药品监督管理部门已要求相关企业和单位采取暂停销售使用、召回等风险控制措施,对不符合规定原因开展调查并切实整改。监管部门已组织对相关企业和单位进行依法查处。特此公告。附件:江西省医疗器械抽检不符合标准规定产品名单(2026年第2期).pdf 江西省药品监督管理局 2026年7月14日
根据工作要求,现将拟新增2026年自治区本级长期护理保险定点护理服务机构名单公示如下:序号机构名称机构地址1广西旅发健康养老有限公司广西南宁市江南区淡村路6号2南宁市兴宁区嘉和城社区卫生服务中心南宁市兴宁区昆仑大道995号嘉和城塞纳左岸三期16号楼3南宁民生服务集团有限责任公司青山康养中心南宁市青秀区青山路15-1号农贸大楼一至四层4南宁市康乐护老院南宁市兴宁区长堽路二里7号5南宁市心希尔颐养院南宁市西乡塘区路西村红平乐队69号6前海人寿医院投资南宁有限公司(前海人寿南宁护理院)中国(广西)自由贸易试验区南宁片区金海路21号前海人寿南宁医院3#楼公示时间:2026年7月14日至2026年7月22日对上述单位如有异议,请以书面方式,并署真实姓名和联系方式,于2026年7月22日前邮寄或直接送达广西壮族自治区医疗保障事业管理中心(邮寄以邮戳为准,直接送达以送达日期为准)。电话:0771-5881060,地址:广西南宁市青秀区星湖路26号2号楼209室,邮编530022。群众如实反映有关问题受法律保护。广西壮族自治区医疗保障事业管理中心2026年7月14日