Delivery Method:Via EmailProduct:DrugsRecipient:Kunjal JoshiProdose, Inc. formerly known as Spirit Pharmaceuticals LLC2004 Orville Drive NorthRonkonkoma,NY11779United Stateskunjal@prodosepharma.comkunjal@spiritpharma.comIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesWARNING LETTERMarch 28, 2025RE: 2851 (CMS 654751)Dear Kunjal Joshi:This letter concerns your firm’s drug listing information provided to FDA’s electronic Drug Registration and Listing System (eDRLS) for your drug product, Maximum Strength Nighttime Sever Cold and Flu, NDC 68210-4210.1FDA has previously communicated to Spirit Pharmaceuticals LLC (“Spirit”) that this drug product is not properly listed. Refer to correspondence sent to Spirit on March 30, 2023.2We reiterate that your firm has not fulfilled its listing obligations under section 510(j) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 360(j), which is a prohibited act under section 301(p) of the FD&C Act, 21 U.S.C. 331(p). These violations are described in more detail below.Drug Listing ViolationsSection 510(j) of the FD&C Act, 21 U.S.C. 360(j), and 21 CFR Part 207 outline the requirements for registration and listing of drug products. Under 21 CFR 207.49(a)(4), a firm must include in the listing submission to FDA, among other requirements, the name and quantity of each active pharmaceutical ingredient in the listed drug. A review of the listing for Maximum Strength Nighttime Sever Cold and Flu, NDC 68210-4210, reveals that the strength of the active ingredient, doxylamine succinate, does not match between the labeling and the structured product labeling (SPL) sections of the listing submission. Specifically, in the labeling, the strength of the active ingredient, doxylamine succinate, is stated as 6.25 mg however, in the SPL’s basis of strength field, the strength of doxylamine succinate is listed as(b)(4)Additionally, the name in the product listing does not match the name on the product labeling. Specifically, while the proprietary name on the principal display panel image is Maximum Strength Nighttime Severe Cold and Flu, in the listed name, the word “severe” is spelled as “sever.”Therefore, your firm has not fulfilled its listing obligations under section 510(j) of the FD&C Act, 21 U.S.C. 360(j), which is a prohibited act under section 301(p) of the FD&C Act, 21 U.S.C. 331(p). In addition, Maximum Strength Nighttime Sever Cold and Flu, NDC 68210-4210, is not properly listed with FDA causing it to be a misbranded drug under section 502(o) of the FD&C Act, 21 U.S.C. 352(o). Introduction or delivery for introduction of such a product into interstate commerce is prohibited under section 301(a) of the FD&C Act, 21 U.S.C. 331(a).Complete, accurate, and up-to-date establishment registration and drug listing information is essential to promote and protect patient safety. FDA relies on establishment registration and drug listing information for several key programs, including drug establishment inspections, supply chain security, and post-market surveillance. Drug registration and listing information is also widely used outside FDA for purposes such as electronic prescribing and electronic health records, insurance reimbursement, and patient education. We note that this warning letter only addresses registration and listing issues associated with your product.ConclusionThis letter is not intended to be an all-inclusive statement of violations that may exist in connection with your products. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations.This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address this matter may result in legal action including, without limitation, seizure, and injunction.Please notify FDA in writing, within 15 working days of receipt of this letter, of the specific steps you have taken to address any violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective actions within 15 working days, state the reason for the delay and the time within which you will do so. In absence of a corrective action, the deficient listing data will not be available for certification under 21 CFR 207.57(b)(2) requirements and will be ultimately inactivated by FDA. If you believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration.Your response should be sent to U.S. Food and Drug Administration, Center for Drug Evaluation and Research/Office of Compliance/Office of Unapproved Drugs and Labeling Compliance by e-mail to eDRLS@fda.hhs.gov. Please be aware that a manual override may be required for certain types of revisions made to an existing drug listing file. If you receive a validation error or have any questions regarding the contents of this letter, please contact us at eDRLS@fda.hhs.gov for further assistance. Include the case identification numbers (2851), (CMS 654751) on all correspondence.Sincerely,/S/James Flahive, J.D.Deputy DirectorOffice of Unapproved Drugs and Labeling ComplianceSigned on behalf of:Tina Smith, M.S.Captain, U.S. Public Health ServiceDirectorOffice of Unapproved Drugs and Labeling ComplianceOffice of ComplianceCenter for Drug Evaluation and ResearchU.S. Food and Drug Administration____________________1On December 30, 2024, we sent your firm a drug listing deficiency letter describing the observed listing deficiencies in the information submitted for the drug listing of Maximum Strength Nighttime Sever Cold and Flu, NDC 68210-4210. On February 13, 2025, we sent your firm a data removal notification informing you of a data removal action. As stated in that email, the continued deficiencies resulted in your product’s data removal from FDA’s National Drug Code Directory. FDA sends listing deficiency letters and data removal notifications to the contact person found in the labeler code SPL submitted to FDA. If this information has changed, it is your responsibility to update your listing(s) within 30 days of any change, under 21 CFR 207.33(c).2An Untitled Letter was sent to Spirit Pharmaceuticals LLC, at 225 Lincoln Highway Suite #205, Fairless Hills, PA 19030, addressed to Kunjal Joshi noting the error in the listing submission. No response from the firm was received and the submission error remains. It appears that Spirit is now known as Prodose, Inc.

Delivery Method:Via EmailReference #:320-25-63Product:DrugsRecipient:Ms. Jennifer A. BooferGeneral Manager/QA ManagerDyno Manufacturing, Inc.2 Fox Industrial Dr.Madison,IL62060-1155United StatesIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesWarning Letter320-25-63April 9, 2025Dear Ms. Boofer:The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, Dyno Manufacturing, Inc., FEI 3017219182, at 2 Fox Industrial Dr., Madison, IL 62060-1155, from October 28 to November 1, 2024.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 November 21, 2024 response to our Form FDA 483 in detail.During our inspection, our investigator observed specific violations including, but not limited to, the following.1. 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 manufactures over-the-counter (OTC) hand sanitizer and antibacterial hand soap drug products without adequate assurance of the quality of raw materials. For example, you did not adequately test incoming raw materials, including identity testing of each shipment of each component lot (e.g., ethanol, glycerin, propylene glycol) used in the manufacture of your OTC drug products. You stated that you were aware of the legal requirement for testing components, but accepted the at-risk components based on their suppliers’ certificate of analysis (COA).GlycerinYou 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 of glycerin you used in manufacturing your drug products to determine its appropriate identity.Identity testing for glycerin and certain other high-risk drug components include a limit test in the United States Pharmacopeia (USP) to ensure that the component meets the relevant safety limits for levels of DEG or EG. 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 documentTesting of Glycerin, Propylene Glycol, Maltitol Solution, Hydrogenated Starch Hydrolysate, Sorbitol Solution, and Other High-Risk Drug Components for Diethylene Glycol and Ethylene Glycolto 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.EthanolYou failed to adequately test your incoming ethanol, used as an active ingredient, for methanol. During the inspection, you indicated that your supplier tests ethanol for methanol prior to shipment. You relied on your suppliers’ COA, and you have not established the reliability of your component suppliers’ test analyses at appropriate intervals. In addition, the supplier’s COA for ethanol did not include test results for methanol.Without adequate testing you do not have scientific evidence that your raw materials conform to appropriate specifications prior to 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 assure adequate quality.The use of ethanol contaminated with methanol has resulted in various lethal poisoning incidents in humans worldwide. See FDA’s guidance document Policy for Testing of Alcohol (Ethanol) and Isopropyl Alcohol for Methanol at: https://www.fda.gov/media/173005/download.In response to this letter, provide: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.A summary of your program for qualifying and overseeing contract facilities that test the drug products you manufacture.A summary of results obtained from testing all components to evaluate the reliability of the COA from each component manufacturer. Include your standard operating procedure (SOP) that describes this COA validation program.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 component(s) and any related drug product that could contain DEG or EG, including customer notifications and product recalls for any contaminated lots. Identify additional appropriate corrective actions and preventive actions (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.Methanol testing for all hand sanitizer batches released and distributed in the United States within expiry.2. Your firm failed to assure that the drug product bore an expiration date that was supported by appropriate stability testing (21 CFR 211.137(a)).You failed to establish a stability testing program to support the expiry of your distributed drug products. You did not perform any stability studies for your OTC hand sanitizer and antibacterial hand soap drug products to support their assigned(b)(4)expiry period. Also, you did not have an approved stability program procedure at the time of inspection.In your response, you commit to drafting stability protocols for all your hand sanitizer and antibacterial soap products and qualifying a contract laboratory to utilize their stability chambers for your stability studies. Your interim remediation is to test “representative retain samples” of your marketed products for assay to show stability under ambient conditions.Your response is inadequate. Your interim remediation of testing your “retain samples” for assay does not address other critical quality attributes for drug stability, including microbiological and impurity testing.In response to this letter, provide:Your plan for continuing stability studies for your drug products through expiry, including detailed timelines. This plan should also include an assessment of the stability of drug product currently on the U.S. market.Your stability data to demonstrate that the chemical, purity, and microbiological properties of your drug products will remain within specification throughout their expiry period.Your action plan to address any product quality or patient safety risks for your drug products in U.S. distribution, including potential customer notifications and recalls.A comprehensive, independent 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 methods.o Stability studies for each drug product in its marketed container-closure system before distribution is permitted.o 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 valid detailed definition of the specific attributes to be tested at each station (timepoint).o All procedures that describe these and other activities of your remediated stability program.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 (21 CFR 211.100(a)).You failed to validate your production and process controls. You did not have assurance that you are capable of consistently manufacturing your drug product with defined quality attributes. Your firm lacked a process validation program and data to support fundamental process parameters such as mixing speed, time, and temperature.From October 2022 to 2024, you manufactured approximately(b)(4)batches of liquid OTC hand sanitizer and antibacterial hand soap drug products using unvalidated processes.Additionally, you did not perform equipment qualification studies, and the inspection documented that cleaning validation studies have not been completed for your drug product manufacturing equipment. You have not established evidence to show your equipment functions and operates as expected or that your cleaning processes for this equipment prevents product contamination.In your response, you commit to completing process validation studies and equipment qualification activities, however, your response is inadequate because you do not provide product impact assessments for ongoing manufacturing and distributed drug products.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 evaluate 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 the FDA's guidance for industry,Process Validation: General Principles and Practicesfor general principles and approaches that the FDA considers appropriate elements of process validation at https://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 product lifecycle, along with associated procedures. Describe your program for process performance qualification (PPQ), and ongoing monitoring of both intra-batch and inter-batch variation to ensure a continuing state of control.A timeline for performing PPQ for each of your marketed drug products. Also include an explanation how you will ensure proper satisfactory PPQ studies are performed prior to future distribution of any drug products.A risk assessment for the distributed drug product(s) 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.4. Your firm’s quality control unit failed to exercise its responsibility to ensure drug products manufactured are in compliance with CGMP, and meet established specifications for identity, strength, quality, and purity (21 CFR 211.22).Your quality unit (QU) did not adequately exercise its authority and responsibilities including, but not limited to, implementing effective procedures and conducting adequate oversight. For example, you failed to ensure the following:Establishment of written records describing the evaluation of quality standards of each drug product at least annually to determine the need for changes in drug product specifications, manufacturing, or control procedures (21 CFR 211.180(e)).Establishment of adequate written procedures defining QU responsibilities and controls (21 CFR 211.22(d)).Appropriate controls over computer or related systems to assure that only authorized personnel institute changes in master production and control records, or other records as required by 21 CFR 211.68(b).In your response, you initiated a CAPA to complete annual product reviews for all your liquid OTC hand sanitizers and antibacterial hand soaps manufactured. You also state under your effectiveness criteria, you will review and address data trends and implement CAPAs as appropriate based on your findings.Your response is inadequate. You do not provide information on how you will ensure annual product reviews will be completed routinely for all your drug products.Your 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.In response to this letter, provide:A complete assessment of documentation systems used throughout your manufacturing and laboratory 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.A comprehensive assessment and remediation plan to ensure your QU is given the authority and resources to effectively function. The assessment should also include, but not be limited to:o A determination of whether procedures used by your firm are robust and appropriate.o Provisions for QU oversight throughout your operations to evaluate adherence to appropriate practices.o A complete and final review of each batch and its related information before the QU disposition decision.o Oversight and approval of investigations and discharging of all other QU duties to ensure identity, strength, quality, and purity of all products.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 3017219182 and ATTN: Sai Dharmaraj.Sincerely,/S/Francis GodwinDirectorOffice of Manufacturing QualityOffice of ComplianceCenter for Drug Evaluation and Research

Delivery Method:Via EmailReference #:320-25-64Product:DrugsRecipient:Ms. Amanda S. AmbroseOwnerBEO Pharma Inc. dba BEO Pharmaceuticals Inc.16255 Aviation Loop Dr.Brooksville,FL34606United StatesIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesWarning Letter320-25-64April 9, 2025Dear Ms. Ambrose,The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, BEO Pharma Inc. dba BEO Pharmaceuticals Inc., FEI 3027036172, at 16255 Aviation Loop Dr., Brooksville, FL 34606, from October 16 to November 4, 2024.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 November 25, 2024 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 perform adequate incoming testing of each component lot used in the manufacture of your over-the-counter (OTC) liquid drug products, such as(b)(4), and(b)(4). For example, you failed to adequately test each lot of active pharmaceutical ingredient (API) for identity prior to use in your OTC drug products. In addition, you relied on your suppliers’ certificate of analysis (COA) without establishing the reliability of your component suppliers’ test analyses at appropriate intervals.Products Containing High-Risk Drug ComponentsYou also failed to adequately test for identity each shipment of each lot of(b)(4)and(b)(4), components at higher risk of diethylene glycol (DEG) or ethylene glycol (EG) contamination. 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 levels of DEG or EG. 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 Glycolto 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 provide the COA for(b)(4), in which(b)(4)was used as a component, and the COAs for(b)(4)finished drug products in which(b)(4)and(b)(4)were used as APIs. You state that your testing protocol has been revised to require that all raw materials received will be tested by your third-party laboratory for identity and assay analysis, at a minimum. Additionally, you state that you previously tested the(b)(4)lots of raw materials from each manufacturer against the COA received.Your response is inadequate. You do not provide your revised testing protocol, nor do you provide the results of the(b)(4)lots for each API or other raw materials that were used to qualify your suppliers. Your initial response does not address testing your high-risk drug components for DEG or EG contamination.We acknowledge that after the inspection and a discussion with FDA on January 24, 2025, you sent all lots of(b)(4), and(b)(4)used in finished drug products for analysis of DEG or EG contamination as well as finished drug products within expiry that contain these high-risk drug components for DEG or EG contamination. Based on the provided results, you concluded that there was no DEG or EG contamination in the samples of retains tested.In response to this letter, provide:A comprehensive 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.A full risk assessment for drug products that are within expiry. Take prompt and appropriate actions to determine the safety of all lots of the component(s) and any related drug product that could contain DEG or EG, including customer notifications and product recalls for any contaminated lots. Identify additional appropriate corrective actions and preventive actions (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.A description of how you will test each component lot for conformity with all appropriate specifications for identity, strength, quality, and purity. Include a list of test specifications and test methods for each component. 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 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.A summary of your program for qualifying and overseeing contract facilities that test the drug products you manufacture.A summary of results obtained from testing all components to evaluate the reliability of the COA from each component manufacturer. Include your standard operating procedure that describes this COA validation program.2. Your firm failed to establish an adequate quality unit and the responsibilities and procedures applicable to the quality control unit are not in writing and fully followed (21 CFR 211.22(a) and 211.22(d)).Release of Batch with Incomplete Finished Product TestingYour firm failed to establish an adequate quality unit (QU) to oversee the manufacture of your drug products. For example, your QU approved drug products for release without complete finished product testing. Your firm shipped a batch of(b)(4)to your customer on January 8, 2024; however, microbial testing for that batch was not received until January 10, 2024. Your QU approved the release of this batch, which stipulated all required test results for this batch were complete on December 24, 2023.In your response, although you do not specifically indicate that batch of(b)(4)was shipped under quarantine, you provide your Quality Agreements and Shipping Addendums with your customers, which state that if you ship product “Under Quarantine,” your customers agree to hold the product in their “Quarantine” area until the final COA is received from your contract laboratory. You also state that if you ship product “Under Quarantine,” each pallet is appropriately labeled as such and communicated with each customer.Your response is inadequate. It is not permissible to ship finished drug products “Under Quarantine” status. Full release testing, including microbial testing, must be performed before drug product release and distribution (21 CFR 211.165(a)).Lack of Raw Material Reserve SamplesYour firm failed to retain reserve samples of incoming raw materials, including APIs and high-risk components, in accordance with your written procedure.In your response, you state that you tested the(b)(4)lots from each manufacturer against the manufacturer’s COA to ensure accuracy.Your response is inadequate. You did not commit to retain reserve samples for all lots of API used or explain why you are not retaining reserve samples of raw materials as required by your procedure.In response to this letter, provide:A comprehensive assessment and remediation plan to ensure your QU is given the authority and resources to effectively function. The assessment should also include, but not be limited to:o A determination of whether procedures used by your firm are robust and appropriate.o Provisions for QU oversight throughout your operations to evaluate adherence to appropriate practices.o A complete and final review of each batch and its related information before the QU disposition decision.o Oversight and approval of investigations and discharging of all other QU duties to ensure identity, strength, quality, and purity of all products.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 (21 CFR 211.100(a)).You failed to adequately validate your manufacturing processes for all your OTC drug products and provide assurance that you are capable of consistently manufacturing a drug product with defined quality attributes. The process validation reports provided during the inspection lacked sufficient detail, such as a complete list of the equipment used, the establishment of appropriate critical process parameters, adequate sampling instructions, and acceptance criteria. You provided(b)(4)process validation reports; however, only(b)(4)of these reports included drug manufacturing data generated using your current facility. These(b)(4)reports were only signed as prepared and approved in October 2024, even though you shipped batches of these(b)(4)products as early as May 2023. The other(b)(4)process validation reports included data from manufacturing operations in 2011 to 2015, while under a previous business at a different address.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 evaluate 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/media/71021/download.In addition, the inspection documented that you have not established that your(b)(4)water system is adequately designed, controlled, maintained, and monitored to ensure it is consistently producing water that meets the USP monograph for(b)(4)water and appropriate microbial limits. Water from your system is used as a component in your liquid drug products and used for cleaning your manufacturing equipment and utensils. Your current schedule for(b)(4)water system maintenance and(b)(4)microbiological testing is insufficient.In your response, you state that you have completed process validation for the remaining(b)(4)OTC drug products you have manufactured since 2023 and provided the reports.Your response is inadequate. You do not address why your manufacturing processes for drug products were not validated prior to commercial distribution. In addition, similar to the reports provided during the inspection, the reports provided as part of your response still lack sufficient detail.In response to this letter, provide:A remediation plan that better assures ongoing management oversight throughout the manufacturing lifecycle of all drug products. Provide a more data-driven and scientifically sound program that identifies sources of process variability and assures that manufacturing (including both production and packaging) operations meet appropriate parameters and quality standards. This includes, but is not limited to, evaluating suitability of equipment for its intended use, ensuring quality of input materials, determining the capability and reliability of each manufacturing process step and its controls, and vigilant ongoing monitoring of process performance and product quality.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 (PPQ), and ongoing monitoring of both intra-batch and inter-batch variation to ensure a continuing state of control.A timeline for performing appropriate PPQ for each of your marketed drug products.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 procedure for your water system monitoring that specifies routine microbial testing of water to ensure its acceptability for use in each batch of drug products produced by your firm.The current action/alert limits for total counts and objectionable organisms used for your(b)(4)Water system. Ensure that the total count limits for your(b)(4)water are appropriately stringent in view of the intended use of each of the products produced by your firm.A procedure governing your program for ongoing control, maintenance, and monitoring that ensures the system consistently produces water that meets(b)(4)Water, USP monograph specifications and appropriate microbial limits.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)).Your firm failed to demonstrate that your microbiological test methods were appropriate to assure that your product conforms to appropriate standards of identity, strength, quality, and purity. Specifically, you could not provide evidence of method suitability for microbiological testing performed by your third-party laboratory. The ability of microbial testing methods to detect objectionable microorganisms in the presence of each drug product must be established.In your response, you provide the documentation from your third-party laboratory showing that system suitability has been conducted on all liquid drug products to ensure the recovery of any objectionable organism in your finished product.Your response is inadequate. The system suitability protocols for the methods specified in USP and USP lacked the final step to confirm the identity of the recovered microorganisms in the tests. As a result, the methods were not confirmed as suitable.In response to this letter, provide: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.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 3027036172 and ATTN: Emily Stoklosa.Sincerely,/S/Francis GodwinDirectorOffice of Manufacturing QualityOffice of ComplianceCenter for Drug Evaluation and Research

Delivery Method:Via Electronic Mail - Delivery and Read Receipt RequestedProduct:DrugsRecipient:Jules D’SouzaDirector of QualityEmpower Clinic Services, LLC dba Empower Pharmacy7601 N Sam Houston Pkwy W Ste 100Houston,TX77064-3595United StatesIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesWARNING LETTERWL # 700964April 2, 2025Dear Mr. D’Souza:From September 24, 2024, to October 4, 2024, U.S. Food and Drug Administration (FDA) investigators inspected your facility, Empower Clinic Services, LLC dba Empower Pharmacy, located at 7601 N Sam Houston Pkwy W Ste 100, Houston, TX 77064. During the inspection, the investigators noted serious deficiencies in your practices for producing drug products, which put patients at risk.FDA issued a Form FDA 483 to your firm on October 4, 2024. FDA acknowledges receipt of your facility’s responses, dated October 28, 2024, and January 31, 2025. Based on this inspection, it appears that you produced drug products that violate the Federal Food, Drug, and Cosmetic Act (FDCA).A. Compounded Drug Products Under the FDCASection 503A of the FDCA describes the conditions under which human drug products compounded by a licensed pharmacist in a State licensed pharmacy or a Federal facility, or a licensed physician, qualify for exemptions from three sections of the FDCA: compliance with current good manufacturing practice (CGMP) (section 501(a)(2)(B)); labeling with adequate directions for use (section 502(f)(1)); and FDA approval prior to marketing (section 505) [21 U.S.C. §§ 351(a)(2)(B), 352(f)(1) and 355(a)].B. Violations of the FDCAAdulterated Drug ProductsThe FDA investigators noted that drug products intended or expected to be sterile were prepared, packed, or held under insanitary conditions, whereby they may have become contaminated with filth or rendered injurious to health, causing your drug products to be adulterated under section 501(a)(2)(A) of the FDCA. For example, the investigators observed that:1. Your firm failed to perform adequate routine environmental monitoring. Specifically, your cleanroom certification consists of nonviable airborne particulate and viable airborne particulate sampling of locations surrounding your(b)(4)filling line, but does not include sampling within the critical area where aseptic processing occurs.2. Your media fills were not performed under the most challenging or stressful conditions. Therefore, there is a lack of assurance that your firm can aseptically produce drug products within your facility.3. Your firm failed to appropriately sterilize equipment located in the ISO 5 area. Specifically, your firm did not sterilize the stopper sorting bowl, supply hopper, and insertion station that come into contact with stoppers used in the production of injectable drug products.Under section 301(a) of the FDCA [21 U.S.C. § 331(a)], the introduction or delivery for introduction into interstate commerce of any drug that is adulterated is a prohibited act. Further, it is a prohibited act under section 301(k) of the FDCA [21 U.S.C. § 331(k)] to do any act with respect to a drug if such act is done while the drug is held for sale after shipment in interstate commerce and results in the drug being adulterated.C. Corrective ActionsWe have reviewed your firm’s responses to the Form FDA 483. Regarding your response related to the insanitary conditions, some of your corrective actions appear adequate; however, we cannot fully evaluate the adequacy of the following corrective actions described in your response because you did not include sufficient information or supporting documentation:1. Regarding your certification of your ISO-5 filling room (Room 1267), your response makes reference to sampling in accordance with ISO standard 14644-1:2015. However, we note that the nonviable particulate sampling conducted during your April 2024 and October 2024 certifications did not conform to this standard in that the sampling locations did not appear to be divided across the whole cleanroom and did not appear to be of equal area. In addition, ISO standard 14644-1:2015 states that sampling locations are to be representative in that features such as cleanroom layout as well as equipment disposition be considered and that additional sampling locations may be selected for locations considered critical.Within Room 1267, your(b)(4)filing line area is the most critical because sterilized drug product, containers, and closures are exposed to environmental conditions that must be designed to maintain product sterility. The exposed product is vulnerable to contamination as it will not be subsequently sterilized in its immediate container. One significant aspect of environmental quality is the particle content of the air as particulates can enter a product as an extraneous contaminant and can also act as a vehicle for microorganisms.We acknowledge your commitments that, “the certification procedure will be updated to include assessments of both viable and non-viable air samples within the filler. Additionally, A-SOP-SCP-0013 Environmental Monitoring—Aseptic Suite will be amended to include(b)(4)air-viable sampling at critical locations within the ISO-5 environment during dynamic operations.”Regarding your established environmental monitoring alert and action levels, your response states that your ISO 5 surface sampling action level will remain at greater than or equal to(b)(4)CFU. Please note that any microbial contamination in the ISO 5 area is a serious concern and considered an insanitary condition. If any recovery occurs within the critical aseptic processing area, you should immediately assess the impact on drug products produced. This assessment should include a thorough evaluation of how contamination could have entered this critical area, and over what period of time the contamination could have existed, as well as drug products that remain on the market that could have been affected.2. Regarding your media fills, we acknowledge your commitments to expand your media fill batch sizes and strengthen your personnel qualification as well as revise your existing procedures. However, it is unclear when you plan to conduct media fills within your ISO 5 filling machine in Room 1267 as you did not provide completed media fills according to the recent changes outlined in Protocol – B&S Process Verification Media Fill.3. We reviewed your(b)(4)validation for sterilizing the stopper sorting bowl, supply hopper, and insertion station and acknowledge your process improvements. In your response you stated that, “Empower has also implemented a(b)(4)schedule for the stopper sorting bowl and associated components to improve sterility assurance while awaiting additional spare parts.” It is unclear how you determined the adequacy of “a(b)(4)schedule” to ensure the equipment remains sterile. We remain concerned with your continued injectable drug production while lacking assurance that equipment, which comes into contact with product contact components, is sterile.Please be aware that section 501(a)(2)(A) of the FDCA concerning insanitary conditions applies regardless of whether drug products you compound meet the conditions of section 503A.FDA strongly recommends that your management undertake a comprehensive assessment of operations, including facility design, procedures, personnel, processes, maintenance, materials, and systems. In particular, this review should assess your aseptic processing operations. A third-party consultant with relevant sterile drug manufacturing expertise should assist you in conducting this comprehensive evaluation.D. ConclusionThe violations cited in this letter are not intended to be an all-inclusive statement of violations 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. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations.You should take prompt action to address any violations. Failure to adequately address any violations may result in legal action without further notice, including, without limitation, seizure and injunction.Within fifteen (15) working days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to address any violations. Please include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. This letter notifies you of our concerns and provides you an opportunity to address them. If you believe your products are not in violation of the FDCA, include your reasoning and any supporting information for our consideration. If you cannot completely address this matter within fifteen (15) working days, state the reason for the delay and the time within which you will do so.Your response and any questions regarding the contents of this letter should be sent to compoundinginspections@fda.hhs.gov. In your response, refer to the Warning Letter Number above # 700964 and include a subject line that clearly identifies the submission as a Response to Warning Letter.Sincerely,/S/F. Gail Bormel, JD, RPhDirectorOffice of Compounding Quality and ComplianceOffice of ComplianceCenter for Drug Evaluation and Research

Delivery Method:VIA UNITED PARCEL SERVICEProduct:Medical DevicesRecipient:Vivek JainCEOICU Medical951 Calle AmanecerSan Clemente,CA92673United States(b)(6), (b)(7)(C)Issuing Office:Center for Devices and Radiological HealthUnited StatesWARNING LETTERCMS 702535April 04, 2025Dear Mr. Jain:During an inspection of Smiths Medical ASD (acquired by your firm ICU Medical in January 2022) FEI: 3012307300 located at 6000 Nathan Lane N., Minneapolis, Minnesota on July 23, 2024, through August 9, 2024, investigators from the United States Food and Drug Administration (FDA) determined that your firm manufactures the Medfusion® Model 4000 Syringe Infusion Pump and CADD® Solis VIP Ambulatory Infusion Pump. Under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 321(h), each of these products is a device because it is an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, which 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.Our inspection revealed that the Medfusion® Model 4000 Syringe Infusion Pump and CADD® Solis VIP Ambulatory Infusion Pump are adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B), because your firm does not for these devices have an approved application for premarket approval (PMA) in effect pursuant to section 515(a) of the Act, 21 U.S.C. § 360e(a), or an approved application for an investigational device exemption under section 520(g) of the Act, 21 U.S.C. § 360j(g). These devices are also misbranded under section 502(o) the Act, 21 U.S.C. § 352(o), because your firm did not timely notify the agency of its intent to begin the introduction or delivery for introduction into interstate commerce for commercial distribution of the devices, as required by section 510(k) of the Act, 21 U.S.C. § 360(k). For a device requiring premarket approval, the notification required by section 510(k) is deemed satisfied when a PMA is pending before the agency. [21 CFR 807.81(b)]. The kind of information that your firm needs to submit in order to obtain approval or clearance for the device is described on the Internet athttp://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/default.htm. The FDA will evaluate the information that your firm submits and decide whether the product may be legally marketed.You currently have clearance, dated August 29, 2011, for a version of the Medfusion® Model 4000 Syringe Infusion Pump which was cleared under K111386 as a Class II device under 21 CFR 880.5725. You also currently have clearance, dated February 1, 2013, for a version of the CADD® Solis VIP Ambulatory Infusion Pump which was cleared under K111275 as a Class II device under 21 CFR 880.5725. However, your firm has failed to submit a premarket notification submission to FDA for significant changes or modifications that could significantly affect the safety or effectiveness of these devices, as required by 21 CFR 807.81(a)(3)(i).In particular, since their last respective clearances, you made multiple changes to the Medfusion® Model 4000 Syringe Infusion Pump and CADD® Solis VIP Ambulatory Infusion Pump that could significantly affect the safety or effectiveness of these devices, including the(b)(4)for the Medfusion® Model 4000 Syringe Infusion Pump as well as(b)(4)changes for both the Medfusion® Model 4000 Syringe Infusion Pump and CADD® Solis VIP Ambulatory Infusion Pump. Specifically, these modifications included(b)(4)changes to address(b)(4)identified via adverse event reports and(b)(4)changes to(b)(4)and(b)(4). Such modifications can significantly impact the functionality of the device with respect to the infusion pumps delivery profile, alarm functionality, etc., and affect the device’s risk profile for risks related to under- or over-infusion, delay in therapy, incomplete therapy, or false alarms leading to adverse health effects for patients such as overdose, volume overload, or cardiorespiratory compromise. Your documentation collected during the recent inspection describing the 510(k) risk-benefit analysis for the Medfusion® Model 4000 Syringe Infusion Pump and CADD® Solis VIP Ambulatory Infusion Pump indicates that these changes were implemented after the most recent clearances of the devices as noted above. Further, you have disseminated updated software(b)(4), which includes the changes described above, in response to a Class I recall intended to remediate the cause(s) of the recall impacting delivery of fluids, false alarms, therapy interruption, etc. However, you have not yet submitted 510(k)s as required by 21 CFR 807.81(a)(3)(i). Adding a statement to your labeling that the device software has not undergone FDA review is not sufficient.Furthermore, in the regulatory change impact assessment for the Medfusion® Model 4000 Syringe Infusion Pump software update dated April 28, 2023, you identified that a risk-based assessment of the changed device identified new risks or significantly modified risks. Further, you identified that the change either creates or necessitates a new risk control measure or modification of an existing risk control measure for a hazardous situation that could result in significant harm. The changes that you made to the risk control measures in an effort to mitigate the hazards that were the basis for a Class I recall were not submitted to FDA in a required 510(k) even though your own procedure indicates that submission of a 510(k) would be required in this situation. However, you only documented to the file that you had made the change and did not submit the required 510(k).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.Please notify this office in writing within fifteen business days from the date you receive this letter of the specific steps your firm has taken to address the noted violations, as well as an explanation of how your firm plans to prevent these violations, or similar violations, from occurring again. Include documentation of the corrections and/or corrective actions (which should address systemic problems) that your firm has taken. If your firm’s planned corrections and/or corrective actions will occur over time, please include a timetable for implementation of those activities. If corrections and/or corrective actions cannot be completed within fifteen business days, state the reason for the delay and the time within which these activities will be completed. Your firm’s response should be comprehensive and address any violations included in this Warning Letter. If you believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration as part of your response.Your firm’s response should be sent to: Melissa Michurski, Assistant Director at CDRHenforcement@fda.hhs.gov. Please include in the subject line, CMS case # 702535 when replying. If you have any questions about the contents of this letter, please contact: Demetria Lueneburg, Compliance Officer at Demetria.Lueneburg@fda.hhs.gov.Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your firm’s facility or associated with your firm’s devices. It is your firm’s responsibility to ensure compliance with applicable laws and regulations administered by FDA. The specific violations noted in this letter may be symptomatic of serious problems in your firm’s manufacturing and quality management systems. Your firm should investigate and determine the causes of any violations and take prompt actions to address any violations and bring the products into compliance.Sincerely,/S/Matthew G. HillebrennerDeputy DirectorOffice of Product Evaluation and QualityCenter for Devices and Radiological Health

国家药品监督管理局组织检查组对吉林省莱沃医疗科技有限公司进行飞行检查，发现该企业质量管理体系存在严重缺陷。　　一、生产管理方面　　企业规定内包装高密度聚乙烯桶吹塑工艺每15分钟需要进行桶重量检测工作，抽查企业部分批次生产记录，显示同一班次人员在相隔一天的两个72小时时间段连续不间断进行操作，后续企业解释有其他人员参与上述活动。相关生产记录不可追溯，不符合《医疗器械生产质量管理规范》中关于企业每批产品均应当有生产记录并满足可追溯的要求。　　二、质量控制方面　　抽查企业某批次透析用水细菌内毒素检验情况，检验记录、使用台账和货位卡上记录的内毒素检查用水使用信息不一致，抽查企业某批次鲎试剂领用情况，其灵敏度复核试验记录与货位卡上记录的领用量和领用时间不相符，相关检验记录存在真实性问题；抽查企业部分批次血液透析浓缩液细菌内毒素项目检验情况，检验记录、鲎试剂使用台账和鲎试剂货位卡上记录的鲎试剂批号不一致，相关检验记录不可追溯；现场查见两份检验结果不一致但其他信息均一致的同一透析用水样品的微生物限度检验记录，抽查企业某批次产品微生物限度检验情况，检验记录、设备使用记录和现场实物三者不一致，相关检验记录不可追溯。上述情形不符合《医疗器械生产质量管理规范》中关于企业每批产品均应当有批检验记录并满足可追溯的要求。　　企业质量管理体系存在严重缺陷，不符合《医疗器械生产质量管理规范》相关要求。针对上述检查发现的问题，吉林省药品监督管理局应当按照《医疗器械监督管理条例》第七十二条规定，依法采取责令暂停生产的控制措施，必要时开展监督抽检；对涉嫌违反《医疗器械监督管理条例》及相关规定的，依法处理；责令企业评估产品安全风险，如有可能导致安全隐患的，要严格按照《医疗器械召回管理办法》规定召回相关产品。　　目前，企业已主动停产，对上述问题开展整改。吉林省药品监督管理局要认真落实属地监管责任，依法严格监督企业开展整改，加强对整改结果的跟踪审核。企业完成全部缺陷项目整改，经吉林省药品监督管理局复查合格后方可恢复生产。　　特此通告。　　 国家药监局2025年4月29日

沪药监通告〔2025〕11号  为加强药品质量监督管理，规范市场秩序，保障上市药品质量安全，上海市药品监督管理局组织相关单位对本市药品生产、经营和使用单位开展了药品质量抽检，现将抽检不符合规定产品予以通告（见附件）。  对抽检不符合规定批次产品，各级药品监管部门已要求相关企业采取停售、停用、召回等风险控制措施，并对相关企业依法查处。  特此通告。  附件：药品抽检不符合规定汇总表  上海市药品监督管理局  2025年4月24日  （公开范围：主动公开）  小贴士  水分是药品中的含水量，水分偏高通常受药品包装或储存环境影响，在储存和流通过程中引湿所导致。  含量测定是测定原料或制剂中的有效成分的指标之一。  总灰分反映药材或制剂中无机盐、氧化物等杂质的含量。  硫酸盐检查旨在排除原料药或辅料中可能混入的无机盐类杂质。  重量差异用于评估药品制剂的均匀性，确保每片药物中活性成分含量的准确性。‌  溶剂残留量是指生产过程中使用的有机溶剂残留。

内容提要　 欧盟非食品类消费产品快速预警通报系统(RAPEX)通报一百零八款化妆品　　　欧盟非食品类消费产品快速预警通报系统(RAPEX)通报一百零八款化妆品　　2025年3月7日，捷克通报一款原产国为德国的Schwarzkopf Palette品牌的染发产品（产品名：LONG-LASTING INTENSITY, PERMANENT, KI7, 8-77, 3x CARE；产品批号：0822395813；产品型号：KI7, 8-77;条形码：9000101032086）。该产品含有丁苯基甲基丙醛（BMHCA）。该产品已被采取销毁的措施。　　　　原文地址：　　https://ec.europa.eu/safety-gate-alerts/screen/webReport/alertDetail/10093500　　　　2025年3月14日，捷克通报一款原产国为德国的Dove品牌的沐浴露（产品名：gentle exfoliating；产品批号：9252PBX 00:50；产品型号：67706309;条形码：8712561614573）。该产品含有丁苯基甲基丙醛（BMHCA）。该产品已被采取销毁的措施。　　　　原文地址：　　https://ec.europa.eu/safety-gate-alerts/screen/webReport/alertDetail/10093573　　　　2025年3月21日，捷克通报一款原产国为德国的syoss品牌的染发产品（产品名：PROFESSIONAL PERFORMANCE PERMANENT COLORATION；产品批号：0208x54020；产品型号：8-6 light fawn;条形码：9000100633161）。该产品含有丁苯基甲基丙醛（BMHCA）。该产品已被采取销毁的措施。　　　　原文地址：　　https://ec.europa.eu/safety-gate-alerts/screen/webReport/alertDetail/10093614　　　　2025年3月21日，捷克通报一款原产国为波兰的Wats élysée品牌的染发摩丝（产品名：COOL COLORS!；产品批号：02129、04309；产品型号：74 brown;条形码：5907813184741）。该产品含有丁苯基甲基丙醛（BMHCA）。该产品已被采取撤市的措施。　　　　原文地址：　　https://ec.europa.eu/safety-gate-alerts/screen/webReport/alertDetail/10093645　　　　2025年3月21日，捷克通报一款原产国为德国的syoss品牌的发用摩丝（产品名：AIR DRY CURL；产品批号：0924Y74312；产品型号：2;条形码：9000101201024）。该产品含有丁苯基甲基丙醛（BMHCA）。该产品已被采取撤市与召回的措施。　　　　原文地址：　　https://ec.europa.eu/safety-gate-alerts/screen/webReport/alertDetail/10093646　　　　2025年3月21日，捷克通报一款原产国为德国的Nivea品牌的沐浴露（产品名：happy time；产品批号：44638190 09:18 4；条形码：9005800222981）。该产品含有丁苯基甲基丙醛（BMHCA）。该产品已被采取撤市的措施。　　　　原文地址：　　https://ec.europa.eu/safety-gate-alerts/screen/webReport/alertDetail/10093648　　　　2025年3月21日，捷克通报一款原产国为波兰的Dove品牌的护发素（产品名：colour care VIBRANCY；产品批号：82781S B C；条形码：8710447232231）。该产品含有丁苯基甲基丙醛（BMHCA）。该产品已被采取撤市的措施。　　　　原文地址：　　https://ec.europa.eu/safety-gate-alerts/screen/webReport/alertDetail/10093649　　　　2025年3月21日，捷克通报一款原产国为德国的Dove品牌的沐浴露（产品名：PURELY pampering pistachio cream & magnolia；产品批号：7343DBX 01:51、8078DBX 13:18；条形码：8712561645256）。该产品含有丁苯基甲基丙醛（BMHCA）。该产品已被采取撤市的措施。　　　　原文地址：　　https://ec.europa.eu/safety-gate-alerts/screen/webReport/alertDetail/10093650　　　　2025年3月21日，捷克通报一款原产国为波兰的LUXURE PARFUMES品牌的香水（产品名：VESTITO CRISTAL BLACK；产品批号：19-220123-B；条形码：5907709921221）。该产品含有丁苯基甲基丙醛（BMHCA）。该产品已被采取撤市的措施。　　　　原文地址：　　https://ec.europa.eu/safety-gate-alerts/screen/webReport/alertDetail/10093651　　　　2025年3月28日，捷克通报一款原产国为德国的Nivea品牌的沐浴露（产品名：Care Shower care & orange；产品批号：44638190 09:18 4、64632790；条形码：9005800222981）。该产品含有丁苯基甲基丙醛（BMHCA）。该产品已被采取撤市的措施。　　　　原文地址：　　https://ec.europa.eu/safety-gate-alerts/screen/webReport/alertDetail/10093654　　　　2025年3月28日，捷克通报一款原产国为波兰的Wats élysée品牌的染发摩丝（产品名：COOL COLORS!；产品批号：01368、03206、03378；产品型号：47 copper；条形码：5907813184475）。该产品含有丁苯基甲基丙醛（BMHCA）。该产品已被采取撤市的措施。　　　　原文地址：　　https://ec.europa.eu/safety-gate-alerts/screen/webReport/alertDetail/10093655　　　　2025年3月28日，捷克通报一款原产国为波兰的Wats élysée品牌的染发摩丝（产品名：COOL COLORS!；产品批号：04428、05469；产品型号：46 mahagony;条形码：5907813184468）。该产品含有丁苯基甲基丙醛（BMHCA）。该产品已被采取撤市的措施。　　　　原文地址：　　https://ec.europa.eu/safety-gate-alerts/screen/webReport/alertDetail/10093656　　　　2025年3月7日，匈牙利通报一款原产国为意大利的Vetyver品牌的须后水（产品名：Malizia；条形码：8003510005055）。该产品含有丁苯基甲基丙醛（BMHCA）。该产品已被采取撤市、禁售与召回的措施。　　　　原文地址：　　https://ec.europa.eu/safety-gate-alerts/screen/webReport/alertDetail/10093467　　　　2025年3月7日，匈牙利通报一款原产国为中国的Scenabella品牌的身体乳（产品名：Sunflower Haze body lotion；条形码：752527840996）。该产品含有丁苯基甲基丙醛（BMHCA）。该产品已被采取撤市、禁售与召回的措施。　　　　原文地址：　　https://ec.europa.eu/safety-gate-alerts/screen/webReport/alertDetail/10093501　　　　2025年3月7日，匈牙利通报一款原产国为中国的Scenabella品牌的身体乳（产品名：Daisy Pink body lotion；产品批号：MFD03082021；条形码：752527840866）。该产品含有丁苯基甲基丙醛（BMHCA）。该产品已被采取撤市、召回与禁售的措施。　　　　原文地址：　　https://ec.europa.eu/safety-gate-alerts/screen/webReport/alertDetail/10093505　　　　2025年3月14日，匈牙利通报一款原产国为德国的Schwarzkopf品牌的发胶 （产品名：taft FüLLE HAARSPRAY；产品批号：0925111562；产品型号：3 WETTER;条形码：4015100201680）。该产品含有丁苯基甲基丙醛（BMHCA）。该产品已被采取撤市、禁售与召回的措施。　　　　原文地址：　　https://ec.europa.eu/safety-gate-alerts/screen/webReport/alertDetail/10093524　　　　2025年3月14日，匈牙利通报一款原产国不详的Greenland 品牌的身体乳（产品名：fruit emotions body butter；产品批号：0615-1608；条形码：8714938004130）。该产品含有丁苯基甲基丙醛（BMHCA）。该产品已被采取召回、撤市与禁售的措施。　　　　原文地址：　　https://ec.europa.eu/safety-gate-alerts/screen/webReport/alertDetail/10093580　　　　2025年3月14日，匈牙利通报一款原产国不详的Greenland品牌的身体乳（产品名：fruit emotions strawberry-anise；产品批号：0615-1607；条形码：5016763922577）。该产品含有丁苯基甲基丙醛（BMHCA）。该产品已被采取撤市、召回与禁售的措施。　　　　原文地址：　　https://ec.europa.eu/safety-gate-alerts/screen/webReport/alertDetail/10093583　　　　2025年3月14日，匈牙利通报一款原产国为斯洛伐克的Schwarzkopf Palette品牌的染发产品（产品名：LONG-LASTING INTENSITY, PERMANENT, G3, 4-5, 3x CARE；产品型号：TRUFFLE;条形码：3838824184180）。该产品含有丁苯基甲基丙醛（BMHCA）。该产品已被采取召回、禁售与撤市的措施。　　　　原文地址：　　https://ec.europa.eu/safety-gate-alerts/screen/webReport/alertDetail/10093586　　　　2025年3月21日，匈牙利通报一款原产国为中国的DAKAR品牌的香水（产品名：STORY OF LOVE；产品批号：L-46；条形码：6930446809759）。该产品含有丁苯基甲基丙醛（BMHCA）。该产品已被采取禁售的措施。　　　　原文地址：　　https://ec.europa.eu/safety-gate-alerts/screen/webReport/alertDetail/10093616　　　　2025年3月21日，匈牙利通报一款原产国为波兰的BI-ES品牌的香水（产品名：LE MALE REBELLE；产品批号：160710 0385/16；条形码：5905009047047）。该产品含有丁苯基甲基丙醛（BMHCA）。该产品已被采取撤市与禁售的措施。　　　　原文地址：　　https://ec.europa.eu/safety-gate-alerts/screen/webReport/alertDetail/10093620　　　　2025年3月21日，匈牙利通报一款原产国为印度的DORALL Collection品牌的化妆品套装（产品名：Fleur De Soleil Gift For Her；产品批号：01/2017；条形码：6291012874671）。该产品含有丁苯基甲基丙醛（BMHCA）。该产品已被采取撤市、召回与禁售的措施。　　　　原文地址：　　https://ec.europa.eu/safety-gate-alerts/screen/webReport/alertDetail/10093628　　　　2025年3月21日，匈牙利通报一款原产国为印度的DORALL Collection品牌的化妆品套装（产品名：DC LIFE Gift For Her；条形码：6291012874978）。该产品含有丁苯基甲基丙醛（BMHCA）。该产品已被采取撤市、召回与禁售的措施。　　　　原文地址：　　https://ec.europa.eu/safety-gate-alerts/screen/webReport/alertDetail/10093638　　　　2025年3月21日，匈牙利通报一款原产国为英国的Shelley Flowers Collection品牌的香体剂（产品名：Tranquility；产品批号：DOM120522 132 UK；条形码：5012233171834）。该产品含有丁苯基甲基丙醛（BMHCA）。该产品已被采取禁售、撤市与召回的措施。　　　　原文地址：　　https://ec.europa.eu/safety-gate-alerts/screen/webReport/alertDetail/10093640　　　　2025年3月21日，匈牙利通报一款原产国为斯洛文尼亚的Subrina Professional品牌的染发产品（产品名：fusion；产品型号：6/7 brown；条形码：3838980520556）。该产品含有丁苯基甲基丙醛（BMHCA）。该产品已被采取撤市、召回与禁售的措施。　　　　原文地址：　　https://ec.europa.eu/safety-gate-alerts/screen/webReport/alertDetail/10093667　　　　2025年3月21日，匈牙利通报一款原产国为斯洛文尼亚的Subrina Professional品牌的染发产品（产品名：fusion；产品型号：2/0 black;条形码：3838980520518）。该产品含有丁苯基甲基丙醛（BMHCA）。该产品已被采取撤市、召回与禁售的措施。　　　　原文地址：　　https://ec.europa.eu/safety-gate-alerts/screen/webReport/alertDetail/10093668　　　　2025年3月28日，匈牙利通报一款原产国为中国的REAL TIME品牌的香水（产品名：Dots &Things Eau de Parfum For Women；产品批号：B13116；条形码：8715658998907）。该产品含有丁苯基甲基丙醛（BMHCA）。该产品已被采取召回、禁售与撤市的措施。　　　　原文地址：　　https://ec.europa.eu/safety-gate-alerts/screen/webReport/alertDetail/10093701　　　　2025年3月28日，匈牙利通报一款原产国不详的Nivea品牌的爽肤水（产品名：Nourishing Face Toner；产品批号：1112060001；产品型号：81106, 921589;条形码：9005800227054）。该产品含有丁苯基甲基丙醛（BMHCA）。该产品已被采取禁售、撤市与召回的措施。　　　　原文地址：　　https://ec.europa.eu/safety-gate-alerts/screen/webReport/alertDetail/10093719　　　　2025年3月28日，匈牙利通报一款原产国为英国的Dove品牌的洗发香波（产品名：Hair therapy Damage Solutions hairfall shampoo；产品批号： 8902311、5226400；条形码：8717644242285）。该产品含有丁苯基甲基丙醛（BMHCA）。该产品已被采取禁售、撤市与召回的措施。　　　　原文地址：　　https://ec.europa.eu/safety-gate-alerts/screen/webReport/alertDetail/10093720　　　　2025年3月28日，匈牙利通报一款原产本国的Solanie品牌的护手霜（产品名：So Fine；产品型号：Cherry Blossom;条形码：5998603397298）。该产品含有丁苯基甲基丙醛（BMHCA）。该产品已被采取召回、撤市与禁售的措施。　　　　原文地址：　　https://ec.europa.eu/safety-gate-alerts/screen/webReport/alertDetail/10093729　　　　2025年3月21日，意大利通报一款原产国不详的GLAMOUR品牌的香水（产品名：Cred Silve；产品批号：07.20/090；条形码：8056157390909）。该产品含有丁苯基甲基丙醛（BMHCA）。该产品已被采取禁售的措施。　　　　原文地址：　　https://ec.europa.eu/safety-gate-alerts/screen/webReport/alertDetail/10009146　　　　2025年3月21日，意大利通报一款原产国不详的GLAMOUR品牌的香水（产品名：Flora；产品批号：1.20/089；条形码：8056157390893）。该产品含有丁苯基甲基丙醛（BMHCA）。该产品已被采取禁售的措施。　　　　原文地址：　　https://ec.europa.eu/safety-gate-alerts/screen/webReport/alertDetail/10009154　　　　2025年3月21日，意大利通报一款原产国不详的GLAMOUR品牌的香水（产品名：Acqua sale；产品批号：L.08.21/068；条形码：8056157390688）。该产品含有丁苯基甲基丙醛（BMHCA）。该产品已被采取禁售的措施。　　　　原文地址：　　https://ec.europa.eu/safety-gate-alerts/screen/webReport/alertDetail/10009156　　　　2025年3月21日，意大利通报一款原产国不详的GLAMOUR品牌的香水（产品名：Luna rossa；产品批号：2.20/050；条形码：8058333440507）。该产品含有丁苯基甲基丙醛（BMHCA）。该产品已被采取禁售的措施。　　　　原文地址：　　https://ec.europa.eu/safety-gate-alerts/screen/webReport/alertDetail/10009157　　　　2025年3月14日，意大利通报一款原产国不详的GLAMOUR品牌的香水（产品名：Angel；条形码：8056157390046）。该产品含有丁苯基甲基丙醛（BMHCA）。该产品已被采取禁售的措施。　　　　原文地址：　　https://ec.europa.eu/safety-gate-alerts/screen/webReport/alertDetail/10009159　　　　2025年3月14日，意大利通报一款原产国不详的GLAMOUR品牌的香水（产品名：Mandorla di Sicilia；产品批号：LO7/22/097；条形码：8056157390978）。该产品含有丁苯基甲基丙醛（BMHCA）。该产品已被采取禁售的措施。　　　　原文地址：　　https://ec.europa.eu/safety-gate-alerts/screen/webReport/alertDetail/10009160　　　　2025年3月14日，意大利通报一款原产国不详的GLAMOUR品牌的香水（产品名：Olimpei；产品批号：L.08.21/025；条形码：8056157390251）。该产品含有丁苯基甲基丙醛（BMHCA）。该产品已被采取禁售的措施。　　　　原文地址：　　https://ec.europa.eu/safety-gate-alerts/screen/webReport/alertDetail/10009165　　　　2025年3月21日，意大利通报一款原产国不详的GLAMOUR品牌的香水（产品名：Code；条形码：8056157390886）。该产品含有丁苯基甲基丙醛（BMHCA）。该产品已被采取禁售的措施。　　　　原文地址：　　https://ec.europa.eu/safety-gate-alerts/screen/webReport/alertDetail/10009167　　　　2025年3月14日，意大利通报一款原产本国的PARFUME DE QUALITE品牌的香水（产品名：MILIONARIO UOMO；产品批号：G60/080；产品型号：080;条形码：8053830060807）。该产品含有丁苯基甲基丙醛（BMHCA）。该产品已被采取禁售的措施。　　　　原文地址：　　https://ec.europa.eu/safety-gate-alerts/screen/webReport/alertDetail/10009176　　　　2025年3月21日，意大利通报一款原产本国的Perfume de Qualitè品牌的香水（产品名：rosa&narciso；产品批号：G15/087；产品型号：087;条形码：8053830060876）。该产品含有丁苯基甲基丙醛（BMHCA）。该产品已被采取禁售的措施。　　　　原文地址：　　https://ec.europa.eu/safety-gate-alerts/screen/webReport/alertDetail/10009177　　　　2025年3月21日，意大利通报一款原产本国的Perfume de Qualitè品牌的香水（产品名：Clorì；产品批号：G18/093；产品型号：093；条形码：8053830060937）。该产品含有丁苯基甲基丙醛（BMHCA）。该产品已被采取禁售的措施。　　　　原文地址：　　https://ec.europa.eu/safety-gate-alerts/screen/webReport/alertDetail/10009178　　　　2025年3月14日，意大利通报一款原产本国的PARFUME DE QUALITE品牌的香水（产品名：Flora；产品批号：G16/089；产品型号：089；条形码：8053830060890）。该产品含有丁苯基甲基丙醛（BMHCA）。该产品已被采取禁售的措施。　　　　原文地址：　　https://ec.europa.eu/safety-gate-alerts/screen/webReport/alertDetail/10009182　　　　2025年3月21日，意大利通报一款原产国为瑞士的DENIM品牌的须后水（产品名：Musk；产品批号：81J226-5；条形码：7640129895014）。该产品含有丁苯基甲基丙醛（BMHCA）。该产品已被采取暂时禁止向经销商供应、展示的措施。　　　　原文地址：　　https://ec.europa.eu/safety-gate-alerts/screen/webReport/alertDetail/10009183　　　　2025年3月14日，意大利通报一款原产本国的Perfume de Qualitè品牌的香水（产品名：adorabile；产品批号：G4/015；产品型号：015；条形码：8053830060159）。该产品含有丁苯基甲基丙醛（BMHCA）。该产品已被采取禁售的措施。　　　　原文地址：　　https://ec.europa.eu/safety-gate-alerts/screen/webReport/alertDetail/10009184　　　　2025年3月14日，意大利通报一款原产本国的Perfume de Qualitè品牌的香水（产品名：GIOvane UOMO；产品批号：G51/042；产品型号：042；条形码：8053830060425）。该产品含有丁苯基甲基丙醛（BMHCA）。该产品已被采取禁售的措施。　　　　原文地址：　　https://ec.europa.eu/safety-gate-alerts/screen/webReport/alertDetail/10009185　　　　2025年3月21日，意大利通报一款原产本国的Axe品牌的须后水（产品名：Black；产品批号：92834CYA；条形码：8712561622196）。该产品含有丁苯基甲基丙醛（BMHCA）。该产品已被采取禁售的措施。　　　　原文地址：　　https://ec.europa.eu/safety-gate-alerts/screen/webReport/alertDetail/10009186　　　　2025年3月21日，意大利通报一款原产本国的DENIM品牌的须后水（产品名：Dopobarba Original Denim；条形码：8008970004051）。该产品含有丁苯基甲基丙醛（BMHCA）。该产品已被采取禁售的措施。　　　　原文地址：　　https://ec.europa.eu/safety-gate-alerts/screen/webReport/alertDetail/10009187　　　　2025年3月21日，意大利通报一款原产本国的Perfume de Qualitè品牌的香水（产品名：Signora COKò；产品批号：G12/036；产品型号：036；条形码：8053830060364）。该产品含有丁苯基甲基丙醛（BMHCA）。该产品已被采取禁售的措施。　　　　原文地址：　　https://ec.europa.eu/safety-gate-alerts/screen/webReport/alertDetail/10009188　　　　2025年3月21日，意大利通报一款原产本国的SPUMA DI SCIAMPAGNA品牌的沐浴乳（产品名：Benessere RIGENERANTE；产品批号：09289019；条形码：8007750012415）。该产品含有丁苯基甲基丙醛（BMHCA）。该产品已被采取禁售的措施。　　　　原文地址：　　https://ec.europa.eu/safety-gate-alerts/screen/webReport/alertDetail/10009189　　　　2025年3月21日，意大利通报一款原产本国的Axe品牌的须后水（产品名：Peace；产品批号：83064CYB；条形码：8712561196345）。该产品含有丁苯基甲基丙醛（BMHCA）。该产品已被采取禁售的措施。　　　　原文地址：　　https://ec.europa.eu/safety-gate-alerts/screen/webReport/alertDetail/10009190　　　　2025年3月21日，意大利通报一款原产国为英国的Sunsilk品牌的护发素（产品名：sunsilk co creations；产品批号：70493C0；产品型号：9121187;条形码：8718114470504）。该产品含有丁苯基甲基丙醛（BMHCA）。该产品已被采取禁售的措施。　　　　原文地址：　　https://ec.europa.eu/safety-gate-alerts/screen/webReport/alertDetail/10009191　　　　2025年3月14日，意大利通报一款原产国为英国的Sunsilk品牌的护发素（产品名：sciolti & FLUENTI；产品批号：834313；产品型号：9119371；条形码：8717644384848）。该产品含有丁苯基甲基丙醛（BMHCA）。该产品已被采取禁售的措施。　　　　原文地址：　　https://ec.europa.eu/safety-gate-alerts/screen/webReport/alertDetail/10009192　　　　2025年3月21日，意大利通报一款原产本国的Axe品牌的须后水（产品名：Apollo；产品批号：02734CYA；条形码：8711700712248）。该产品含有丁苯基甲基丙醛（BMHCA）。该产品已被采取禁售的措施。　　　　原文地址：　　https://ec.europa.eu/safety-gate-alerts/screen/webReport/alertDetail/10009194　　　　2025年3月21日，意大利通报一款原产本国的Tesori d'Oriente品牌的身体乳（产品名：MUSC BLANC - MUSCHIO BIANCO；条形码：8008970040981）。该产品含有丁苯基甲基丙醛（BMHCA）。该产品已被采取禁售的措施。　　　　原文地址：　　https://ec.europa.eu/safety-gate-alerts/screen/webReport/alertDetail/10009195　　　　2025年3月21日，意大利通报一款原产国不详的GLAMOUR品牌的香水（产品名：Adventur cred；产品批号：1.09.20.043；条形码：8056157390435）。该产品含有丁苯基甲基丙醛（BMHCA）。该产品已被采取禁售的措施。　　　　原文地址：　　https://ec.europa.eu/safety-gate-alerts/screen/webReport/alertDetail/10009196　　　　2025年3月21日，意大利通报一款原产本国的Tesori d'Oriente品牌的沐浴露（产品名：HAMMAM；产品批号：21144；条形码：8008970005621）。该产品含有丁苯基甲基丙醛（BMHCA）。该产品已被采取禁售的措施。　　　　原文地址：　　https://ec.europa.eu/safety-gate-alerts/screen/webReport/alertDetail/10009197　　　　2025年3月21日，意大利通报一款原产国不详的GLAMOUR品牌的香水（产品名：ETERNIT；产品批号：1.20/011；条形码：8058333440118）。该产品含有丁苯基甲基丙醛（BMHCA）。该产品已被采取禁售的措施。　　　　原文地址：　　https://ec.europa.eu/safety-gate-alerts/screen/webReport/alertDetail/10009198　　　　2025年3月21日，意大利通报一款原产国不详的GLAMOUR品牌的香水（产品名：VOR BOM FLOWE；条形码：8056157390985）。该产品含有丁苯基甲基丙醛（BMHCA）。该产品已被采取禁售的措施。　　　　原文地址：　　https://ec.europa.eu/safety-gate-alerts/screen/webReport/alertDetail/10009199　　　　2025年3月21日，意大利通报一款原产本国的Clinians品牌的面霜（产品名：Antirughe repair；产品批号：SAP1081；产品型号：159440；条形码：8003510022236）。该产品含有丁苯基甲基丙醛（BMHCA）。该产品已被采取禁售的措施。　　　　原文地址：　　https://ec.europa.eu/safety-gate-alerts/screen/webReport/alertDetail/10009200　　　　2025年3月21日，意大利通报一款原产国不详的Yesensy Parfum品牌的香水（产品名：RU18；产品批号：301216；条形码：8435102555073）。该产品含有丁苯基甲基丙醛（BMHCA）。该产品已被采取禁售的措施。　　　　原文地址：　　https://ec.europa.eu/safety-gate-alerts/screen/webReport/alertDetail/10009201　　　　2025年3月21日，意大利通报一款原产本国的BOROTALCO品牌的沐浴露（产品名：Original；产品批号：R305777；产品型号：Inconfondibile profumo;条形码：8002410044133）。该产品含有丁苯基甲基丙醛（BMHCA）。该产品已被采取禁售的措施。　　　　原文地址：　　https://ec.europa.eu/safety-gate-alerts/screen/webReport/alertDetail/10009202　　　　2025年3月21日，意大利通报一款原产本国的Dove品牌的泡沫沐浴露（产品名：Bagnoschiuma di bellezza idratante；产品批号：67717857；条形码：8712561899185）。该产品含有丁苯基甲基丙醛（BMHCA）。该产品已被采取禁售的措施。　　　　原文地址：　　https://ec.europa.eu/safety-gate-alerts/screen/webReport/alertDetail/10009204　　　　2025年3月21日，意大利通报一款原产本国的CERA DI CUPRA品牌的身体乳（产品名：Ricette di bellezze；条形码：8002140061219）。该产品含有丁苯基甲基丙醛（BMHCA）。该产品已被采取禁售的措施。　　　　原文地址：　　https://ec.europa.eu/safety-gate-alerts/screen/webReport/alertDetail/10009205　　　　2025年3月21日，意大利通报一款原产本国的香水（产品名：D&M；产品批号：09419；条形码：8004830280283）。该产品含有丁苯基甲基丙醛（BMHCA）。该产品已被采取禁售的措施。　　　　原文地址：　　https://ec.europa.eu/safety-gate-alerts/screen/webReport/alertDetail/10009206　　　　2025年3月21日，意大利通报一款原产本国的D&M品牌的须后水（产品名：POUR HOMME；产品批号：095 18；条形码：8004830281129）。该产品含有丁苯基甲基丙醛（BMHCA）。该产品已被采取禁售的措施。　　　　原文地址：　　https://ec.europa.eu/safety-gate-alerts/screen/webReport/alertDetail/10009207　　　　2025年3月21日，意大利通报一款原产本国的Dottor Ciccarelli品牌的足部滋润凝胶（产品名：Igiene piede - Gel Relax - Senza alcool - Azione rinfrescante defaticante；产品批号：MF616V；条形码：8002140081101）。该产品含有丁苯基甲基丙醛（BMHCA）。该产品已被采取禁售的措施。　　　　原文地址：　　https://ec.europa.eu/safety-gate-alerts/screen/webReport/alertDetail/10009208　　　　2025年3月21日，意大利通报一款原产本国的DENIM品牌的须后水（产品名：ORIGINAL；产品批号：81J126-7；条形码：7640129895007）。该产品含有丁苯基甲基丙醛（BMHCA）。该产品已被采取禁售的措施。　　　　原文地址：　　https://ec.europa.eu/safety-gate-alerts/screen/webReport/alertDetail/10009209　　　　2025年3月21日，意大利通报一款原产本国的Malizia品牌的香水（产品名：VETYVER；产品批号：02-5057；条形码：8003510005611）。该产品含有丁苯基甲基丙醛（BMHCA）。该产品已被采取禁售的措施。　　　　原文地址：　　https://ec.europa.eu/safety-gate-alerts/screen/webReport/alertDetail/10009211　　　　2025年3月21日，意大利通报一款原产本国的Comin parfum品牌的香体剂（产品名：Eli lù Body spray；产品批号：110517；条形码：8004830296208）。该产品含有丁苯基甲基丙醛（BMHCA）。该产品已被采取禁售的措施。　　　　原文地址：　　https://ec.europa.eu/safety-gate-alerts/screen/webReport/alertDetail/10009212　　　　2025年3月21日，意大利通报一款原产本国的Comin parfum品牌的香体剂（产品名：Flò；产品批号：136519；条形码：8004830296222）。该产品含有丁苯基甲基丙醛（BMHCA）。该产品已被采取禁售的措施。　　　　原文地址：　　https://ec.europa.eu/safety-gate-alerts/screen/webReport/alertDetail/10009213　　　　2025年3月21日，意大利通报一款原产本国的DELICE DAYBYDAY品牌的身体乳（产品名：Incontro orchideavaniglia；条形码：8004120907838）。该产品含有丁苯基甲基丙醛（BMHCA）。该产品已被采取禁售的措施。　　　　原文地址：　　https://ec.europa.eu/safety-gate-alerts/screen/webReport/alertDetail/10009214　　　　2025年3月21日，意大利通报一款原产本国的Comin parfum品牌的沐浴露（产品名：Jeux d'Amour；产品批号：409；条形码：004830295331）。该产品含有丁苯基甲基丙醛（BMHCA）。该产品已被采取禁售的措施。　　　　原文地址：　　https://ec.europa.eu/safety-gate-alerts/screen/webReport/alertDetail/10009215　　　　2025年3月21日，意大利通报一款原产本国的LYCIA品牌的香体剂（产品名：DEO EVOLUTION；条形码：8002340016187）。该产品含有丁苯基甲基丙醛（BMHCA）。该产品已被采取禁售的措施。　　　　原文地址：　　https://ec.europa.eu/safety-gate-alerts/screen/webReport/alertDetail/10009218　　　　2025年3月21日，意大利通报一款原产本国的MEDITERRANEO品牌的护手霜（产品名：Crema Mani；产品型号：all'Olio Extravergine di oliva biologico；条形码：8002842130060）。该产品含有丁苯基甲基丙醛（BMHCA）。该产品已被采取禁售的措施。　　　　原文地址：　　https://ec.europa.eu/safety-gate-alerts/screen/webReport/alertDetail/10009222　　　　2025年3月21日，意大利通报一款原产本国的MilMil品牌的泡沫沐浴露（产品名：BAGNO SCHIUMA；条形码：8004120020308）。该产品含有丁苯基甲基丙醛（BMHCA）。该产品已被采取禁售的措施。　　　　原文地址：　　https://ec.europa.eu/safety-gate-alerts/screen/webReport/alertDetail/10009223　　　　2025年3月28日，意大利通报一款原产国为英国的Dove品牌的香体剂（产品名：Men+Care；产品批号：62867LD；条形码：8712561255820）。该产品含有丁苯基甲基丙醛（BMHCA）。该产品已被采取禁售的措施。　　　　原文地址：　　https://ec.europa.eu/safety-gate-alerts/screen/webReport/alertDetail/10009224　　　　2025年3月28日，意大利通报一款原产国不详的GLAMOUR品牌的香水（产品名：Blu；产品批号：LB4.22/061；条形码：8056157390060、8056157390619）。该产品含有丁苯基甲基丙醛（BMHCA）。该产品已被采取禁售的措施。　　　　原文地址：　　https://ec.europa.eu/safety-gate-alerts/screen/webReport/alertDetail/10009226　　　　2025年3月28日，意大利通报一款原产国不详的GLAMOUR品牌的香水（产品名：Pantere；产品批号：1.20/009；条形码：8056157390091）。该产品含有丁苯基甲基丙醛（BMHCA）。该产品已被采取禁售的措施。　　　　原文地址：　　https://ec.europa.eu/safety-gate-alerts/screen/webReport/alertDetail/10009229　　　　2025年3月28日，意大利通报一款原产国不详的GLAMOUR品牌的香水（产品名：Dolce & Gabbiani；条形码：8056157390107）。该产品含有丁苯基甲基丙醛（BMHCA）。该产品已被采取禁售的措施。　　　　原文地址：　　https://ec.europa.eu/safety-gate-alerts/screen/webReport/alertDetail/10009230　　　　2025年3月28日，意大利通报一款原产国不详的GLAMOUR品牌的香水（产品名：Paciouli Narid；条形码：8056157396116）。该产品含有丁苯基甲基丙醛（BMHCA）。该产品已被采取禁售的措施。　　　　原文地址：　　https://ec.europa.eu/safety-gate-alerts/screen/webReport/alertDetail/10009231　　　　2025年3月28日，意大利通报一款原产国不详的GLAMOUR品牌的香水（产品名：La femme；条形码：8056157396147）。该产品含有丁苯基甲基丙醛（BMHCA）。该产品已被采取禁售的措施。　　　　原文地址：　　https://ec.europa.eu/safety-gate-alerts/screen/webReport/alertDetail/10009232　　　　2025年3月28日，意大利通报一款原产国不详的GLAMOUR品牌的香水（产品名：Parma aqua；条形码：8056157395973）。该产品含有丁苯基甲基丙醛（BMHCA）。该产品已被采取禁售的措施。　　　　原文地址：　　https://ec.europa.eu/safety-gate-alerts/screen/webReport/alertDetail/10009233　　　　2025年3月28日，意大利通报一款原产国不详的INTESA品牌的香体剂（产品名：Woody；产品批号：ED120431；条形码：8003510002740）。该产品含有丁苯基甲基丙醛（BMHCA）。该产品已被采取禁售的措施。　　　　原文地址：　　https://ec.europa.eu/safety-gate-alerts/screen/webReport/alertDetail/10009238　　　　2025年3月28日，意大利通报一款原产本国的BasicBeauty品牌的面霜（产品名：VisoFace；产品批号：211004；条形码：800915030062）。该产品含有丁苯基甲基丙醛（BMHCA）。该产品已被采取禁售的措施。　　　　原文地址：　　https://ec.europa.eu/safety-gate-alerts/screen/webReport/alertDetail/10009239　　　　2025年3月28日，意大利通报一款原产本国的BasicBeauty品牌的面霜（产品名：VISO FACE；产品批号：213004；条形码：8009150300055）。该产品含有丁苯基甲基丙醛（BMHCA）。该产品已被采取禁售的措施。　　　　原文地址：　　https://ec.europa.eu/safety-gate-alerts/screen/webReport/alertDetail/10009241　　　　2025年3月28日，意大利通报一款原产本国的BasicBeauty品牌的面霜（产品名：VISO FACE RIGENERANTE；产品批号：214005；条形码：8009150300024）。该产品含有丁苯基甲基丙醛（BMHCA）。该产品已被采取禁售的措施。　　　　原文地址：　　https://ec.europa.eu/safety-gate-alerts/screen/webReport/alertDetail/10009243　　　　2025年3月28日，意大利通报一款原产国不详的GLAMOUR品牌的香水（产品名：BOIS；条形码：8056157395225）。该产品含有丁苯基甲基丙醛（BMHCA）。该产品已被采取禁售的措施。　　　　原文地址：　　https://ec.europa.eu/safety-gate-alerts/screen/webReport/alertDetail/10009245　　　　2025年3月28日，意大利通报一款原产本国的Malizia品牌的香体剂（产品名：Osmanthus；产品批号：ED110331；条形码：8003510005680）。该产品含有丁苯基甲基丙醛（BMHCA）。该产品已被采取禁售的措施。　　　　原文地址：　　https://ec.europa.eu/safety-gate-alerts/screen/webReport/alertDetail/10009254　　　　2025年3月28日，意大利通报一款原产本国的Malizia品牌的香体剂（产品名：Lolita；产品批号：ED301130；条形码：8003510025688）。该产品含有丁苯基甲基丙醛（BMHCA）。该产品已被采取禁售的措施。　　　　原文地址：　　https://ec.europa.eu/safety-gate-alerts/screen/webReport/alertDetail/10009255　　　　2025年3月28日，意大利通报一款原产本国的Malizia品牌的香体剂（产品名：Toujours；产品批号：ED301030；产品型号：124420;条形码：8003510001262）。该产品含有丁苯基甲基丙醛（BMHCA）。该产品已被采取禁售的措施。　　　　原文地址：　　https://ec.europa.eu/safety-gate-alerts/screen/webReport/alertDetail/10009257　　　　2025年3月28日，意大利通报一款原产本国的Malizia品牌的香体剂（产品名：Purple；产品批号：ED271130；条形码：8003510015474）。该产品含有丁苯基甲基丙醛（BMHCA）。该产品已被采取禁售的措施。　　　　原文地址：　　https://ec.europa.eu/safety-gate-alerts/screen/webReport/alertDetail/10009260　　　　2025年3月28日，意大利通报一款原产本国的Malizia品牌的香体剂（产品名：Burlesque；产品批号：ED031130；条形码：8003510024025）。该产品含有丁苯基甲基丙醛（BMHCA）。该产品已被采取禁售的措施。　　　　原文地址：　　https://ec.europa.eu/safety-gate-alerts/screen/webReport/alertDetail/10009263　　　　2025年3月28日，意大利通报一款原产本国的Gian Marco Venturi品牌的香水（产品名：GMV uomo；产品批号：A18271；条形码：8002747005944、8002747006507）。该产品含有丁苯基甲基丙醛（BMHCA）。该产品已被采取禁售的措施。　　　　原文地址：　　https://ec.europa.eu/safety-gate-alerts/screen/webReport/alertDetail/10009270　　　　2025年3月28日，意大利通报一款原产国为西班牙的Amalfi品牌的身体乳（产品名：SKIN CARE - Rosa Mosqueta；条形码：8414227052377）。该产品含有丁苯基甲基丙醛（BMHCA）。该产品已被采取禁售的措施。　　　　原文地址：　　https://ec.europa.eu/safety-gate-alerts/screen/webReport/alertDetail/10009272　　　　2025年3月28日，意大利通报一款原产国为西班牙的Amalfi品牌的香体剂（产品名：Dermo Care Rosa Mosqueta；条形码：8414227043627）。该产品含有丁苯基甲基丙醛（BMHCA）。该产品已被采取禁售的措施。　　　　原文地址：　　https://ec.europa.eu/safety-gate-alerts/screen/webReport/alertDetail/10009281　　　　2025年3月28日，意大利通报一款原产本国的CERA DI CUPRA品牌的面霜（产品名：ANTI-AGE；条形码：8002140051555）。该产品含有丁苯基甲基丙醛（BMHCA）。该产品已被采取禁售的措施。　　　　原文地址：　　https://ec.europa.eu/safety-gate-alerts/screen/webReport/alertDetail/10009288　　　　2025年3月28日，意大利通报一款原产国为中国的Marvel品牌的香水（产品批号：1921902 - 1920501；条形码：81087603031）。该产品含有丁苯基甲基丙醛（BMHCA）。该产品已被采取禁售的措施。　　　　原文地址：　　https://ec.europa.eu/safety-gate-alerts/screen/webReport/alertDetail/10009294　　　　2025年3月28日，意大利通报一款原产国为法国的REAL TIME品牌的香水（产品名：No ordinary；产品批号：B16045；条形码：8715658350118）。该产品含有丁苯基甲基丙醛（BMHCA）。该产品已被采取禁售的措施。　　　　原文地址：　　https://ec.europa.eu/safety-gate-alerts/screen/webReport/alertDetail/10009302　　　　2025年3月28日，意大利通报一款原产国为法国的REAL TIME品牌的香水（产品名：Wonderful Woman；产品批号：B17265；条形码：8715658009238）。该产品含有丁苯基甲基丙醛（BMHCA）。该产品已被采取禁售的措施。　　　　原文地址：　　https://ec.europa.eu/safety-gate-alerts/screen/webReport/alertDetail/10009303　　　　2025年3月28日，意大利通报一款原产国不详的Tesori d'Oriente品牌的沐浴油（产品名：OLIO DOCCIA；产品批号：TD0190819 - 24161；条形码：8008970050256）。该产品含有丁苯基甲基丙醛（BMHCA）。该产品已被采取禁售的措施。　　　　原文地址：　　https://ec.europa.eu/safety-gate-alerts/screen/webReport/alertDetail/10009307　　　　2025年3月28日，意大利通报一款原产本国的Vitalcare品牌的洗发香波（产品名：Vitalcare shampoo；产品批号：L112509E；条形码：8029241127057）。该产品含有丁苯基甲基丙醛（BMHCA）。该产品已被采取禁售的措施。　　　　原文地址：　　https://ec.europa.eu/safety-gate-alerts/screen/webReport/alertDetail/10009308　　　　　　2025年3月28日，意大利通报一款原产本国的Dove品牌的香体剂（产品名：INVISIBLE DRY；产品批号：9183646；条形码：96022313）。该产品含有丁苯基甲基丙醛（BMHCA）。该产品已被采取禁售的措施。　　　　原文地址：　　https://ec.europa.eu/safety-gate-alerts/screen/webReport/alertDetail/10009310　　　　2025年3月28日，意大利通报一款原产本国的Dove品牌的香体剂（产品名：DEO GO FRESH；产品批号：9212174；条形码：96137130）。该产品含有丁苯基甲基丙醛（BMHCA）。该产品已被采取禁售的措施。　　　　原文地址：　　https://ec.europa.eu/safety-gate-alerts/screen/webReport/alertDetail/10009312　　　　2025年3月28日，塞浦路斯通报一款原产国为英国的Party Crazy品牌的面部彩绘套装（产品名：FACE PAINTS；产品批号：2004317；产品型号：5111；条形码：5013922051116）。该产品含有汞。该产品已被采取撤市的措施。　　　　原文地址：　　https://ec.europa.eu/safety-gate-alerts/screen/webReport/alertDetail/10093471　　　　2025年3月14日，保加利亚通报一款原产国为西班牙的足部泡沫霜（产品名：FEETCALM SWEATY FEET MOUSSE；产品批号： P057 2101316、P057 2102761）。该产品含有次氮基三乙酸三钠。该产品已被采取召回的措施。　　　　原文地址：　　https://ec.europa.eu/safety-gate-alerts/screen/webReport/alertDetail/10093329　　　　2025年2月14日，德国通报一款原产国为意大利的CD Softcreme品牌的面霜（产品名：Wasserlilie；产品批号：-24291 281035、-24292 281041、-24293 281041、-24294 281041、-24295 281041、-24324 281169、-24325 281169、-24351 281169；条形码：4045612010388）。该产品被需氧嗜温性细菌（Pluralibacter gergoviae）污染。该产品已被采取撤市、召回与发布警示风险的措施。　　　　原文地址：　　https://ec.europa.eu/safety-gate-alerts/screen/webReport/alertDetail/10093228　　　　2025年3月21日，法国通报一款原产本国的NEUTRADERM品牌的沐浴露（产品名：Gel douche surgras dermo-protecteur；产品批号：24351028、24352028、24352029、24352031、24353030、24353031；条形码：3273816860152）。该产品被需氧嗜温性细菌（Pluralibacter gergoviae）污染。该产品已被采取暂时禁止供应、展示，并召回与销毁的措施。　　　　原文地址：　　https://ec.europa.eu/safety-gate-alerts/screen/webReport/alertDetail/10093635　　　　2025年3月28日，法国通报一款原产国为中国的KURKU-MA品牌的面膜（产品名：ANTI=IMPERFECTIONS）。该产品中锑、砷、硒、钡、钴和锆的含量超标。该产品已被采取撤市与召回的措施。　　　　原文地址：　　https://ec.europa.eu/safety-gate-alerts/screen/webReport/alertDetail/10093672

各市、县（区）市场监督管理局，宁东市场监督管理局，局机关各处室、直属各事业单位：《关于规范药品领域涉企行政检查的实施方案》已经2025年第8次自治区药品监督管理局党组会议审议通过，现印发给你们，请结合实际，抓好贯彻落实。 宁夏回族自治区药品监督管理局2025年4月23日关于规范药品领域涉企行政检查的实施方案为进一步规范药品领域（含医疗器械、化妆品，下同）涉企行政检查行为，提升行政执法质效，持续优化营商环境，切实维护市场主体合法权益，根据《国务院办公厅关于严格规范涉企行政检查的意见》（国办发〔2024〕54号）、自治区人民政府办公厅《关于进一步规范涉企行政执法行为优化法治化营商环境的通知》（宁政办发〔2024〕45号）、《关于严格规范涉企行政检查的实施意见》（宁政办发〔2025〕5号）等有关文件精神，结合我区药监工作实际，制定如下实施方案。一、工作目标聚焦“随意检查、重复检查、多头检查、违法检查”等问题，在严守药品安全底线、实现有效监管的基础上，进一步规范涉企行政检查事项、方式和流程，统筹制定年度检查计划，实施差异化精准监管，强化跨部门跨区域跨层级联合监管，积极推进“综合查一次”，切实减少涉企检查频次，减轻企业负担，推动药品监管向服务型监管、预防型监管、数智化治理转变，促进营造公平公正、诚信有序市场环境。二、适用范围与定义（一）涉企行政检查定义。本方案所称涉企行政检查是指自治区各级药监部门依照法定职权，对检查对象遵守法律、法规、规章和执行行政决定的情况进行了解、核查的行为。  检查对象是指从事药品生产经营活动的个体工商户、法人及非法人组织等经营主体。经营主体以外的其他检查对象，如对医疗机构、养老机构、学校等单位实施的检查参照本方案执行。（二）检查分类。行政检查分为两类：一是有计划行政检查：包括日常检查、专项检查、质量管理规范符合性检查等常规检查，以及其他有检查计划的行政检查。二是触发式行政检查：包括因投诉举报、转办交办、监督抽检、数据监测、舆情处置等线索引起的有因检查。（三）例外情形。行政处罚立案后的询问检查、整改复查等行为；对药品质量安全的抽检行为；对无证经营者的检查行为；按保密规定开展的涉密检查行为。三、工作任务坚持问题导向、效果导向，通过严格涉企行政检查职能履行、实施精准差异化检查、推行“亮码检查”机制、推进协同综合检查等，实现行政检查减量提质不扰企。（一）严格涉企行政检查职能履行1.梳理确认检查机构资质。各级药监部门应全面梳理辖区内行政执法主体是否具备法定资格，不得违法授权或委托其他单位开展行政检查，不得安排未取得行政执法证件的人员实施行政检查，2025年4月底前，将具备行政检查主体资格情况报同级人民政府司法行政部门统一公布。严格按照“三定”方案和事权划分规定的有关要求，切实履行辖区内药品领域行政检查职责，有重大影响或者跨区域的，可提请上一级药监部门组织检查。2.规范涉企行政检查事项和标准。各级药监部门应全面梳理本部门涉企行政检查事项，2025年5月底前向社会公布，并按程序做好动态调整。自治区药监局结合药品领域行政检查标准牵头组织制定涉企行政检查工作指引，依法对检查内容、检查对象、检查频次等进行细化量化，必要时形成行政检查裁量基准。各级药监部门要严格按照检查标准、工作指引和裁量基准开展行政检查，切实提升检查质效。3.统筹检查计划制定与备案。各级药监部门应确定并公布同一企业行政检查年度频次上限，按照国家药监局有关要求，科学统筹制定各业务领域的年度检查计划，要明确检查事项、检查依据、检查频次、检查方式、检查内容等。自治区、设区的市级药监部门要注重行政检查计划的衔接和联动，将各类检查计划进行精简、合并、去重，经本级相关部门统筹合并后印发年度行政检查计划，于每年2月底前报同级司法行政部门和上级药监部门备案。严格控制专项检查，根据上级部门工作部署或监管工作需要，针对重点领域的突出问题，可依法部署专项检查，同性质同类专项检查原则上每年不得超过1次，及时向上一级部门备案并向社会公布。（二）实施精准差异化涉企检查。4.规范行政检查方式和程序。行政检查方式包括现场检查和非现场检查。行政检查前，应制定检查方案并报局分管领导批准，检查时间较集中、内容和形式类同的可合并制定，情况紧急、需要当场实施的，及时报告并补办手续。现场检查应当有两名以上行政执法人员实施，并主动出示行政执法证件，出具行政检查通知书或“检查码”，依法告知享有的权利和承担的义务。实施现场检查，应当由两名以上行政执法人员实施，并严格控制涉企行政检查人员数量，联合检查每个部门不超过2人。5.构建风险分类管理体系。根据药品安全风险分级和信用风险分类管理的有关要求，对检查对象进行综合评价，分高风险、中风险、低风险分类进行管理，实行动态调整，减少日常监督检查、专项检查中的抽查比例和检查频次。高风险企业：Ⅲ级风险、信用风险高（D类、C类）、近3年有严重违规记录、涉及高风险产品的企业。中风险企业：Ⅱ级风险、信用风险一般（B类）、偶发一般性违规的企业。低风险企业：Ⅰ级风险、信用风险低（A类）、无违规记录、质量管理规范的企业。探索制定非现场检查“无事不扰”对象清单，除上级部署、收到违法线索和法律法规规章有明确规定的外，原则上不主动对清单内对象开展现场检查。6.明确差异化检查频次。依据国家药监局及自治区药监局相关检查标准和年度检查频次开展检查，未有规定的，高风险企业：每半年1次，检查方式以必查现场+非现场辅助；中风险企业：每年1次，检查方式以现场与非现场结合；低风险企业：年度抽查比例不低于30%，检查方式以非现场为主，必要时开展触发式检查。对于采用视频监控、书面核查、数据分析处理、智慧监管等非现场检查方式可以达到行政检查目的，且未发现违法行为的，原则上不再进行现场检查。对可以通过非现场方式实现联合监管的，不开展现场联合检查。7.智慧赋能行政检查。依托宁夏药品智慧监管平台，利用AI智慧监管技术赋能，建立“一库一机制”，实现“一企一档”。各级药监部门要建立药品监管行政检查对象库，整合企业基础信息、风险分级、历史检查记录、整改情况等信息。建立触发式检查联动机制，逐步实现与市场监管、卫健委、医保等部门数据互联互通、实时共享，通过投诉举报、监督抽检、舆情监测、稽查执法、飞行检查等大数据分析，在智慧监管平台自动进行风险研判、风险预警，从而触发检查。（三）推行“亮码”检查机制。8.实现“亮码”入企检查。按照自治区政府的统一安排，推动自治区行政执法监督平台和宁夏药品智慧监管平台的数据对接，分阶段逐步实现“亮码”检查。开展涉企现场检查前，行政执法人员应通过登录自治区行政执法监督平台进行检查登记，获得系统“赋码”并将检查方案、主体、内容等实时上传信息系统。现场检查时，执法人员应当出示“检查码”，企业人员可以通过扫码核验此次行政检查任务内容和执法人员资格。检查结束后，执法人员应当及时录入检查结果，企业可以通过“检查码”查看本次检查结果并进行评价，也可以进行投诉举报，促进执法满意度持续提升。（四）推行监管协同与“综合查一次”9.统筹跨类别跨层级联合检查。按照“应协同尽协同”的原则，推动开展跨类别跨层级联合检查。同一药监部门中不同执法机构对同一检查对象实施不同行政检查且可以合并完成的，原则上应当合并实施检查任务；各级药监部门依职责对同一检查对象实施不同行政检查且可以合并完成的，原则上应当合并实施检查任务；各级药监部门对同一行政检查对象同一经营场所就同一行政检查事项的现场检查结果，原则上在一个月内互认复用，不再重复检查。10.深化跨部门综合监管。深入推进自治区关于重点领域跨部门综合监管事项清单部署，实施药品领域综合监管“一业一册”“一业一查”监管制度，不同行政执法主体针对同一企业在相近时段内实施检查的，原则上应当开展联合检查，不得就同一检查事项多次对同一企业实施检查。各级药品监管部门要结合本区域实际，深入推进“综合查一次”，牵头药监部门要梳理企业名录，明确联合检查方式方法程序步骤，形成联合检查提示。四、工作要求（一）加强统筹组织，推动任务落实。各级药监部门要提高政治站位，统一思想认识，强化协同配合，明确规范涉企行政检查工作具体负责部门和责任分工，统筹组织涉企行政检查工作，按照要求推进各项任务有力有效落实。（二）深化培训评估，提升执法效能。将涉企行政检查相关制度要求纳入行政执法培训内容，开展分类分级培训。建立涉企行政检查效能评估机制，以行政检查合法合理性、检查计划执行率、检查问题发现率、“检查码”应用以及检查对象意见建议、投诉举报等情况作为质量评估的依据，并纳入执法监督范围，进一步规范行政检查行为，提升检查质效。（三）强化执法监督，规范涉企检查。贯彻落实自治区规范涉企行政执法专项行动工作要求，通过“四不两直”检查、案卷评查等方式方法，适时开展本方案落实情况，推行服务型执法和包容审慎监管情况、以及严禁下达或变相下达行政处罚案件数量、罚没款等逐利执法情况的监督，杜绝逐利检查、任性检查等行为，严格规范执法人员涉企行政检查行为，做到“五个严禁”“八个不得”，确保严格规范公正文明执法。（四）坚持宣教结合，引导合规整改。加大规范涉企行政检查相关工作的宣传力度，鼓励各单位（部门）因地制宜探索规范涉企行政检查方面的创新做法，及时总结、报送、推广涉企行政检查先进经验和典型做法。行政执法人员要落实“谁执法谁普法”普法责任制要求，在行政检查过程中充分释法说理。要注意做好对高频检查企业依法合规生产经营的宣传、指导和服务工作。综合运用多种方式督促引导受处罚企业加强合规管理、及时整改违法问题，防止以罚代管。

为加强药品质量监督管理，保障公众用药安全，依据《中华人民共和国药品管理法》《药品质量抽查检验管理办法》及安徽省药品质量监督抽验计划要求，安徽省药品监督管理局组织对本行政区域药品生产、经营企业和使用单位的药品质量进行了监督抽检。现将抽查检验发现的不符合规定药品相关情况公告如下：一、抽查检验不符合规定药品（一）经安徽省宿州市食品药品检验检测中心检验，标示为安国市荣华本草中药材有限公司生产的1批次紫苏梗不符合规定，不符合规定项目为【检查】总灰分。（二）经合肥市食品药品安全检验检测中心检验，标示为山西欣晋元中药科技有限公司生产的1批次五加皮不符合规定，不符合规定项目为【检查】总灰分。以上抽检不符合规定药品具体情况见附件。二、对上述不符合规定药品，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进行整改。三、安徽省药品监督管理局已要求辖区有关药品监督管理部门依据《中华人民共和国药品管理法》等法规规定，对相关企业和单位的违法违规行为进行查处，并按规定公开查处结果。特此公告。安徽省药品监督管理局2025年4月28日附件：序号检品名称生产单位或产地批号规格抽样环节供样单位检验依据检验结论不符合规定项目检验机构1紫苏梗安国市荣华本草中药材有限公司C221201103统经营单位宿州市心连心医药有限公司《中国药典》2015年版一部不符合规定【检查】总灰分安徽省宿州市食品药品检验检测中心2五加皮山西欣晋元中药科技有限公司230901选经营单位肥东县立新中药房有限公司中国药典2020年版一部不符合规定【检查】总灰分合肥市食品药品安全检验检测中心