Delivery Method:Via EmailProduct:DrugsRecipient:Ryan NapierskiChief Executive OfficerNSE Products, Inc. DBA Nu Skin Enterprises, Inc.75 West Center StreetProvo,UT84601United Statesrnaperski@nuskin.comIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesWARNING LETTERMarch 2, 2026RE: 3093 (CMS 722667)Ryan Napierski:This letter concerns your firm’s drug listing information provided to FDA’s electronic Drug Registration and Listing System (eDRLS) for your drug products, “AP-24 Fluoride,” NDC 62839-1151; “AP-24,” NDC 62839-1152; and “AP-24 Whitening,” NDC 62839-1155.1Your 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). Failure to provide listing information for a drug in accordance with 510(j) of the FD&C Act is prohibited 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 207 set forth the requirements for the listing of drugs. In accordance with section 510(j)(2) of the FD&C Act, 21 U.S.C 360(j)(2), and 21 CFR 207.57(b), registrants must review and update their drug listing information each June and December. Furthermore, under 21 CFR 207.57(b)(1)(iv), registrants must submit any material changes in any information previously submitted including, per 21 CFR 207.49(a)(12), manufacturing establishment information. The drug listings stated above reference a manufacturing establishment,(b)(4), that has confirmed that it has not been involved in the manufacturing of these drugs for more than five years, yet they continue to be cited in your listings with no end marketing date. Therefore, your firm has not fulfilled its listing obligations under section 510(j) of the FD&C Act, 21 U.S.C. 360(j). Failure to provide listing information for a drug in accordance with 510(j) of the FD&C Act is prohibited under section 301(p) of the FD&C Act, 21 U.S.C. 331(p).Additionally, your firm has 61 drug listings that have not been updated or certified as required and therefore have been inactivated by FDA. Please update the listing information for these drugs to reflect their current status. If you no longer manufacture and distribute these drugs, then the drugs must be discontinued by adding an end marketing date.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. Establishment registration and drug 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 establishment registration and drug listing issues associated with your products.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 correct 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 believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration. If you cannot complete corrective action within 15 working days, state the reason for the delay and the time within which you will complete the correction. 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.2If 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 (3093) (CMS 722667) on all correspondence.Sincerely,/S/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 10, 2025, we sent your firm a drug listing deficiency letter describing the observed listing deficiencies in the information your firm submitted. In addition, we followed up on December 11, 2025, December 19, 2025, and January 16, 2026, to various points of contact. On January 24, 2026, we sent your firm a data removal notification email informing you of a data removal action. As stated in that email, the continued deficiencies resulted in your products’ data removal from FDA’s Online NDC Directory. FDA sends data deficiency letters and data removal notifications to the contact person found in the labeler code SPL submitted by your firm to FDA. If this information has changed, it is your responsibility to update this within 30 days of any change, under 21 CFR 207.33(c).2See 84 FR 40417.

Delivery Method:VIA UPSReference #:320-26-49Product:DrugsRecipient:Franco NegronChief Executive OfficerSimtra BioPharma SolutionsBuilding C, Suite 270, 2nd Floor400 Interpace ParkwayParsippany,NJ07054United Statesfrnegron@simtra.comIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesWarning Letter320-26-49March 3, 2026Dear Mr. Negron:The United States Food and Drug Administration (FDA) conducted an unannounced inspection of your drug manufacturing facility, Simtra Deutschland GmbH, formerly Baxter Oncology GmbH, FEI 3002806419, at Kantstr. 2, 33790 Halle/Westphalia, Germany, from September 18 to 26, 2025.This warning letter summarizes significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals. See Title 21 Code of Federal Regulations (CFR), parts 210 and 211 (21 CFR parts 210 and 211).Because your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your drug products are adulterated within the meaning of section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 351(a)(2)(B).We reviewed your October 20, 2025 response to our Form FDA 483 in detail and acknowledge receipt of your subsequent correspondence.During our inspection, our investigators observed specific violations including, but not limited to, the following.1. Your firm failed to perform operations within specifically defined areas of adequate size and to have separate or defined areas or such other control systems necessary to prevent contamination or mix-ups in aseptic processing areas (21 CFR 211.42(c)(10)).Significant deficiencies were identified with aseptic processing controls in your(b)(4)and restricted access barrier system (RABS) processing lines used to aseptically manufacture sterile drug products for the U.S. market.Cleaning and DisinfectionYou used(b)(4)extensively to rinse critical, interior surfaces and aseptic processing equipment in your(b)(4)and RABS lines after production. This(b)(4)was fed from(b)(4)cleaning use points inside your(b)(4)and RABS through excessively long (up to approximately(b)(4)) deadlegs from your(b)(4)loop. Deadlegs in(b)(4)systems are known to cause stagnation of(b)(4)and excessive microbial growth.Between June 2023 and September 2025, routine testing of(b)(4)cleaning use points in your ISO 5(b)(4)and RABS resulted in at least 47 microbial recoveries, including 14 that exceeded your action limit. Your routine monitoring samples repeatedly recovered gram-negative, biofilm-forming,(b)(4)organisms includingSphingomonas, Methylobacterium, Bradyrhizobium, andRalstoniaspecies. Investigations for at least two incidents associated with microbial recoveries identified the design of your(b)(4)cleaning use point piping as the most likely root cause. However, your corrective action and preventive action (CAPA) plans have failed to comprehensively address the identified deficiencies in your(b)(4)system design.Furthermore, post-production environmental monitoring (EM) samples taken within your ISO 5(b)(4)and RABS between June 2023 and September 2025 have resulted in repeated recoveries of gram-negative(b)(4)organisms includingSphingomonas, Methylobacterium, andCupriavidusspecies.This sampling identified a worrisome adverse trend in your RABS in late 2023 in which(b)(4)gaskets and(b)(4)were found to be contaminated with gram negative microbes. Significantly, too-numerous-to-count (TNTC) levels were present on RABS(b)(4)gaskets in multiple instances during this period. Your investigations acknowledged that equipment design (including(b)(4)gaskets) and maintenance, in combination with cleaning (e.g., residual(b)(4)from cleaning), caused the deviation.You failed to sufficiently address the underlying cause of residual(b)(4)in a timely manner, instead relying on personnel to(b)(4)dry any observed moisture.In your response, you commit to corrective actions including(b)(4)sanitization of(b)(4)cleaning use point piping and(b)(4)of the(b)(4)used in ISO 5 cleaning. Additionally, you explain your process of(b)(4)-drying your(b)(4)and RABS with(b)(4)drying of residual(b)(4)during visual inspection by operators. You also commit to implementing(b)(4)disinfection of the(b)(4)in your(b)(4)and RABS.Your response is inadequate because your corrective actions fail to address the fundamental, self-identified design flaw in your(b)(4)supply lines” that lead to each of your(b)(4)and RABS processing lines for cleaning. You also fail to holistically address residual(b)(4)from cleaning your(b)(4)and RABS units across your site. The residual(b)(4)issue poses a significant risk to barrier/(b)(4)system control (e.g., interference with decontamination cycle efficacy) and can potentially lead to drug product contamination.(b)(4)Integrity TestingYou failed to adequately maintain equipment to assure aseptic conditions. Your(b)(4)integrity testing program for(b)(4)was found to be deficient. For example:Your(b)(4)integrity testing program for(b)(4)permitted(b)(4)to fail acceptance criteria during pressure decay testing(b)(4)times before requiring replacement. Your translated procedure states, “All(b)(4)that fail the leak test (pressure drop test) may be retested. If the(b)(4)fails more than(b)(4)times, it must be replaced.”When(b)(4)failed leak testing, retesting was often not performed the same day but at a later date. As a result, you manufactured drug products using(b)(4)that had failed leak testing without confirming their integrity. For example,(b)(4)on line(b)(4)failed to meet acceptance criteria on July 1, 2025, and did not pass testing until July 19, 2025. In the 18-day period between these tests, your production schedule indicated you manufactured at least(b)(4)batches of drug products.You lacked raw(b)(4)testing data. During the inspection, you were unable to locate raw(b)(4)integrity testing data from(b)(4)for line(b)(4).Instead of reviewing raw(b)(4)testing data, your quality assurance unit relied on forms containing transcribed information.In your response, you commit to enhancing your(b)(4)integrity testing program through procedural updates requiring additional quality oversight, defining actions following test failures including not permitting production to proceed “following an invalid or failed test,” and implementing quality review of visual and(b)(4)testing results.You indicate that inappropriate acceptance criteria programmed into your(b)(4)integrity testing device caused many of the failures. You also assert, “[T]here has been no impact to any released batches or the overall control of sterility assurance at the site.”Furthermore, your response states that in your operators’ experience, pressure decay failures are generally not indicative of non-integral(b)(4), and they instead relied upon visual inspection.Your response calls into question the reliability of your(b)(4)integrity testing program. Visual inspections, on their own, are insufficient to monitor(b)(4)integrity. Visual(b)(4)examinations provide far lower detectability than, and cannot be substituted for,(b)(4)integrity testing devices. It is essential that your firm use(b)(4)integrity testing devices that are capable of reliably detecting sub-visible breaches in(b)(4)integrity.You also failed to perform retrospective evaluation of potentially impacted products and processes. In response to the uninvestigated(b)(4)integrity failures, you concluded there was no quality impact to released batches or overall contamination risk at the site. However, you appear to have limited your review only to examples cited during the inspection.Additionally, you failed to assess equipment management across your site to identify other potentially impacted critical equipment that may affect aseptic conditions. You should give continual attention to the integrity of critical equipment. This includes comprehensive maintenance procedures that establish adequate integrity testing and proactive replacement before breakdown.Protective Equipment MaterialsYou failed to implement other adequate equipment control systems to prevent contamination during aseptic processing. Our investigators observed particles shedding from(b)(4)material in aseptic areas. For example, loose, visible fibers were observed on and dislodging from(b)(4)covers during(b)(4)installation within critical aseptic filling areas. Fibers also were observed on tubing in two locations in line(b)(4). Subsequently, unused(b)(4)covers were inspected and observed to have loose fibers indicating the material itself was the source of contamination. You use the material is used to protect(b)(4)and the end of sterile tubing.Furthermore, this is an ongoing issue. Your customer reported your previous non-pharmaceutical grade(b)(4)material as a source of particulate contamination. In response, you introduced your current(b)(4)material across your(b)(4)and RABS processing lines without evaluating its particle generating characteristics.In your response, you explain the(b)(4)seams on the(b)(4)are the apparent source of visible fibers and they appear to be statically charged. You also indicate you are working with your supplier to address this issue while taking interim controls including awareness training, visual checks of equipment at risk of fibers, removal of observed fibers with sterile lint-free wipes, and the exchange of equipment when fibers are observed attached to product contact surfaces.Your response is inadequate. You limited your retrospective batch review to only the two batches observed to be exposed to loose fibers during the inspection. Your response also fails to assess the particles generated by the(b)(4)material to determine their characteristics (e.g., size). Additionally, your response fails to support the adequacy of visual inspection as an interim control or to review quality indicators for particle related issues (e.g., complaints, deviations). Finally, your response did not address your failure to evaluate particle generation in the replacement material when you implemented a change control for(b)(4)in response to a particle generation complaint. This is a quality oversight failure.Aseptic processing operations should be designed and executed to minimize exposure of sterile articles to potential contamination hazards in the manufacturing operation. Flaws in the design of cleanrooms and aseptic processing lines or improper execution of aseptic operations can enable entry of contaminants into the critical (ISO 5) processing area and lead to product contamination.(b)(4)technology represents a significant advance over traditional operational designs. However, all technologies have failure modes that require ongoing, vigilant monitoring and maintenance to ensure a state of control, including(b)(4). A strong quality system is essential to oversee design and construction of aseptic processing lines and supporting utilities, and to ensure ongoing proper operational control to safeguard against contamination hazards throughout the facility lifecycle.See FDA’s guidance documentSterile Drug Products Produced by Aseptic Processing—Current Good Manufacturing Practiceto help you meet the CGMP requirements when manufacturing sterile drugs using aseptic processing at https://www.fda.gov/media/71026/download.In response to this letter, provide the following:A comprehensive assessment of your(b)(4)system design, control, and maintenance including, but not limited to:o Identification of deadlegs and any other insanitary elements of your(b)(4)system.o A comprehensive remediation plan and detailed CAPA timeline for improving design, control, and maintenance of your(b)(4)system. Include re-piping and modifications to eliminate deadlegs, removal of insanitary fittings, assurance of appropriately designed recirculating loops, and completion of all other needed remediations to ensure sanitary systems. Place special emphasis on identifying and eliminating any deadlegs that feed(b)(4), RABS, or other sterile production equipment.o The validation report for the(b)(4)system 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. Include the summary of all improvements made to system design, as well as the program for ongoing control and maintenance.A comprehensive, independent retrospective assessment of your cleaning effectiveness to evaluate the scope of potential contamination from residual moisture after cleaning. For each production line, assess(b)(4)cleaning and(b)(4)drying cycles, identify specific equipment parts which remain within the(b)(4)and RABS after cleaning, and address the potential for(b)(4)to remain stagnant within equipment between production operations. The assessment should identify any inadequacies of cleaning procedures and practices, and encompass each piece of manufacturing equipment used to manufacture products intended to be sterile.Based upon the cleaning effectiveness assessment, provide a CAPA detailing improvements to your cleaning and disinfection program including enhancements to cleaning effectiveness, improved ongoing verification of proper cleaning and disinfection execution for all products and equipment, and all other needed remediations.A comprehensive assessment of the design and control of your firm’s manufacturing operations with a detailed and thorough review of all microbiological hazards.Your CAPA plan to implement routine, vigilant operations management oversight of facilities and equipment. This plan should ensure, among other things, prompt detection of equipment/facilities performance issues, effective execution of repairs, adherence to appropriate preventive maintenance schedules, timely technological upgrades to the equipment/facility infrastructure, and improved systems for ongoing management review.A comprehensive evaluation of your ongoing(b)(4)maintenance program.o Address elements including, but not limited to, frequency of integrity tests (e.g., at least(b)(4)),(b)(4)testing procedure and methodology, and appropriate practices to reduce the occurrence of invalid tests.o Conduct an analysis of the various failure scenarios that have occurred during your(b)(4)leak testing (e.g., device set-up problems, failure to meet initial pressure, employee interference). Also include further clarity on whether supervisors will be notified immediately, prior to initiation of a retest, of any instance of a(b)(4)integrity test failure.o Include a product impact assessment.o Provide associated CAPA.A comprehensive risk assessment of all contamination hazards with respect to your aseptic processes, equipment, and facilities. A detailed remediation plan with timelines to address the findings of the contamination hazards risk assessment. Describe specific tangible improvements to be made to aseptic processing operation design and control. Specify actions you will take in response to the risk assessment, such as customer notifications and product recalls.A risk assessment addressing the use of shedding material within your critical ISO 5 production areas. Include a detailed summary of how you determined that your interim controls are adequate to prevent the contamination of products. Include details of your investigation such as evaluation of particle generation, particle size distribution, and the likelihood of detection by visual inspection. Discuss your investigation into potentially impacted lots of product including your evaluation of quality indicators such as complaints and deviations. Specify actions you will take in response to the risk assessment, such as customer notifications and product recalls.2. Your firm failed to establish and follow appropriate written procedures that are designed to prevent microbiological contamination of drug products purporting to be sterile, and that include validation of all aseptic and sterilization processes (21 CFR 211.113(b)).Your(b)(4)cycles were inadequately validated to ensure that they were capable of consistently decontaminating all interior surfaces of your(b)(4)and multiple RABS lines in preparation for aseptic production.Biological Indicator RecoveriesInadequacies in your(b)(4)process were demonstrated through a trend of routine recoveries of biological indicator (BI) growth at completion of validation cycles executed in your(b)(4)since 2022.Notably, your acceptance criteria were inappropriate in that they allowed routine recovery of multiple BI survivors. For example, positive BIs (upwards of 8 recoveries) were identified in nearly all validation cycles ((b)(4)of(b)(4)) between 2022 and 2025 on your lines(b)(4)lines. These positive BIs occurred at various locations within each line. However, based upon your inappropriate acceptance criteria, only two of the(b)(4)validation cycles were found to be unacceptable.Furthermore, you attributed recent validation failures in 2025 to “rogue” phenomenon in a BI lot, but this fails to recognize the multiple positive BIs that occurred with other BI lots in the same year. You also failed to acknowledge your long-term trend of routine BI positives in most of your(b)(4)validation studies.Inadequate(b)(4)ValidationYour(b)(4)validation did not demonstrate reliable decontamination cycle capability. For example:(b)(4)were not(b)(4)during the(b)(4)validation cycles such that(b)(4)were present in the(b)(4). Your validation instruction, PPVA VA 48074e/03, appears to permit(b)(4)to rest on the bottom of(b)(4), creating an occluded surface which undermines the ability of(b)(4)to decontaminate this critical location.You did not document or adequately specify each location of BI placement. You also lacked scientific evidence to support the triplicate BIs being representative of each location.You allowed repetition of validation cycles without proper investigation in each instance of observed BI growth. Your(b)(4)validation cycle was repeated in your(b)(4)after initially failing to meet its acceptance criteria for positive BIs ((b)(4)out of(b)(4)).In your response, you committed to assessing your(b)(4)for surface exposure and implementing remediations based on your findings where possible, increasing BIs in(b)(4)with(b)(4)for(b)(4)decontamination process validation, updating your procedures to address failed validation cycles, reducing the allowable BI growth, implementing investigational requirements for any BI growth, and optimizing the(b)(4)cycle in your(b)(4).Your response is inadequate. You failed to address multiple years of consistent recoveries of positive BIs across multiple locations within your(b)(4)during previous validation cycles. Recurrent failures are indicative of poor cycle robustness and require further investigation. Furthermore, your commitment to increase the number of BIs in(b)(4)does not address setup and configuration adaptations that can ensure consistent exposure of all interior surfaces to(b)(4).Incomplete exposure of interior surfaces to(b)(4)compromises decontamination effectiveness and places the(b)(4)and RABS environment at risk. Furthermore, as discussed above, the inconsistent removal of residual moisture prior to(b)(4)treatment of your(b)(4)and RABS could further compromise(b)(4)decontamination efficacy.In response to this letter, provide:A detailed summary of your validation program for ensuring a state of control throughout the product lifecycle, along with associated procedures. Describe your program for process performance qualification and ongoing monitoring of variation to ensure a continuing state of control.A comprehensive, independent review of the adequacy of(b)(4)cycles. Place special attention on(b)(4)cycle stages including(b)(4). Provide a timeline for a detailed report on the findings of the independent review and associated CAPA activities (e.g., cycle parameter changes such as an increased decontamination phase duration; optimized airflow; improved surface exposure).A detailed program for designing, validating, maintaining, controlling and monitoring each of your decontamination cycles that includes vigilant monitoring to ensure an ongoing state of control. Also, include your program for assuring ongoing state of control throughout your facility and equipment infrastructure.Procedures to ensure residual(b)(4)is appropriately removed from RABS and(b)(4)units before execution of(b)(4)cycles.Request for a Meeting with FDAAfter you submit your response to this warning letter, we recommend you reach out to this office to arrange for a teleconference to discuss your corrective actions and preventive actions in detail. Please direct your request to Patricia Warren at patricia.warren@fda.hhs.gov and cc: CDER-OC-OMQ-Communications@fda.hhs.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.If you are considering an action that is likely to lead to a disruption in the supply of drugs produced at your facility, FDA requests that you contact CDER’s Drug Shortages Staff immediately, at drugshortages@fda.hhs.gov, so that FDA can work with you on the most effective way to bring your operations into compliance with the law. Contacting the Drug Shortages Staff also allows you to meet any obligations you may have to report discontinuances or interruptions in your drug manufacture under 21 U.S.C. 356C(b). This also allows FDA to consider, as soon as possible, what actions, if any, may be needed to avoid shortages and protect the health of patients who depend on your products.Correct any violations promptly. FDA may withhold approval of new applications or supplements listing your firm as a drug manufacturer until any violations are completely addressed and we confirm your compliance with CGMP. We may re-inspect to verify that you have completed corrective actions to any violations.Failure to address any violations may also result in the FDA refusing admission of articles manufactured at Simtra Deutschland GmbH located at Kantstr. 2, 33790 Halle/Westphalia, Germany, into the United States under section 801(a)(3) of the FD&C Act, 21 U.S.C. 381(a)(3). Articles under this authority that appear to be adulterated may be detained or refused admission, in that the methods and controls used in their manufacture do not appear to conform to CGMP within the meaning of section 501(a)(2)(B) of the FD&C Act, 21 U.S.C. 351(a)(2)(B).This letter notifies you of our findings and provides you an opportunity to address the above deficiencies. After you receive this letter, respond to this office in writing within 15 working days1. 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 3002806419 and ATTN: Samantha Bradley.Sincerely,/S/Francis GodwinDirectorOffice of Manufacturing QualityOffice of ComplianceCenter for Drug Evaluation and ResearchCC:Rémi HelmigSite DirectorSimtra Deutschland GmbHKantstr. 233790 Halle/WestphaliaGermanyrhelmig@simtra.com_____________________1Under program enhancements for the Generic Drug User Fee Amendments (GDUFA) reauthorization for fiscal years (FYs) 2023-2027, also known as the GDUFA III Commitment Letter, your facility may be eligible for a Post-Warning Letter Meeting to obtain preliminary feedback from FDA on the adequacy and completeness of your corrective action plans.

Delivery Method:VIA UNITED PARCEL SERVICE AND VIA E-MAILReference #:26-HFD-45-03-01Product:DrugsRecipient:Mr. David S. MoorePresidentNovo Nordisk Inc.800 Scudders Mill RoadPlainsboro,NJ08536United StatesIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesWARNING LETTERMr. David S. Moore FDA Ref. No.: 26-HFD-45-03-01PresidentNovo Nordisk Inc.800 Scudders Mill RoadPlainsboro, New Jersey 08536Dear Mr. Moore:This Warning Letter informs you of objectionable conditions observed during the U.S. Food and Drug Administration (FDA) inspection conducted at your firm, Novo Nordisk Inc. (hereinafter referred to as NNI), between January 13 and February 7, 2025. The investigators representing FDA reviewed your compliance with postmarketing adverse drug experience (PADE) regulations. The inspection revealed serious violations of PADE reporting requirements found in section 505(k) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) [21 U.S.C. 355(k)] and Title 21, Code of Federal Regulations (21 CFR) 314.80. Failure to comply with section 505(k) is a prohibited act under section 301(e) of the FD&C Act [21 U.S.C. 331(e)].This inspection was conducted as a part of FDA’s Bioresearch Monitoring Program, which includes inspections designed to ensure that accurate, reliable, and timely safety data are submitted to FDA for the monitoring of product safety, and to ensure compliance with PADE regulations.At the conclusion of the inspection, the investigators presented and discussed with you the Form FDA 483, Inspectional Observations. We acknowledge receipt of your written response to the Form FDA 483 dated March 3, 2025, and your subsequent correspondence dated April 11, 2025; May 2, 2025; June 6, 2025; July 11, 2025; September 19, 2025; October 31, 2025; and January 15, 2026.From our review of the FDA Establishment Inspection Report, the documents submitted with that report, and your written response and correspondence dated March 3, 2025; April 11, 2025; May 2, 2025; June 6, 2025; July 11, 2025; September 19, 2025; October 31, 2025; and January 15, 2026, it appears that you did not adhere to the applicable statutory requirements in the FD&C Act and applicable regulations contained in 21 CFR part 314.We wish to emphasize the following:Failure to develop written procedures for the surveillance, receipt, evaluation, and reporting of postmarketing adverse drug experiences (ADEs) to FDA as required by 21 CFR 314.80(b).As an application holder of products with active ingredients including semaglutide, liraglutide, nedosiran sodium, and estradiol, NNI is required to develop written procedures for the surveillance, receipt, evaluation, and reporting of postmarketing adverse drug experiences (ADEs) to FDA. You developed written procedures that failed to ensure that you, and your contractor acting on your behalf, complied with all applicable PADE regulations for the surveillance, receipt, evaluation, and reporting of ADEs.Examples of this failure include but are not limited to the following:1. You failed to develop written procedures, as required under 21 CFR 314.80(b), that ensured that you, and your contractor acting on your behalf, reported all serious and unexpected ADEs to FDA within 15 calendar days, in accordance with 21 CFR 314.80(c)(1)(i). PADE regulations require the applicant to report each ADE that is both serious and unexpected, whether foreign or domestic, no later than 15 calendar days from the initial receipt of the information by the applicant (21 CFR 314.80(c)(1)(i)). Specifically:a. Your written procedure Q014048, “Handling of Adverse Events and Other Safety Information” (Ver: 28.0, Effective Date: 03 Oct 2024), allowed ADEs reported to NNI to be rejected or cancelled (and therefore not to be reported to FDA) if the ADE was considered by the reporter to be unrelated to the product. Specifically, Q014048 excludes reports from the definition of “adverse reaction” if “the reporters specifically state that they believe the events to be unrelated or that a causal relationship can be excluded.” This definition is inconsistent with FDA regulations, which define an ADE as “[a]ny adverse event associated with the use of a drug in humans, whether or not considered drug-related.” FDA’s regulations require applicants to develop written procedures for, among other things, the reporting of ADEs regardless of whether the event is considered causally related to the product. An ADE that is determined to be both serious and unexpected must be reported to FDA no later than 15 days from the date of initial receipt. Based on your written procedure, your staff or contractor cancelled or rejected serious and unexpected ADEs that were required to be reported within 15 calendar days because they documented these events as being unrelated to the product. For example, Argus1Case #1331385 involves a consumer who was disabled after experiencing a stroke, which is a serious and unexpected ADE, while receiving liraglutide. The consumer reported that the stroke was not related to liraglutide; therefore, you rejected this case. As a result, you failed to report serious and unexpected ADEs to FDA within 15 calendar days, as required by PADE regulations.During the inspection, you stated that you opened deviation DV0166369 in April 2024 after discovering that not all reportable serious and unexpected ADEs were submitted to FDA because the ADEs were cancelled or rejected by your staff or contractor and were documented as being “incidental” or “incidental and unrelated.” You identified your written procedures, including Q014048 (both the current and prior versions), as a root cause for this deviation, because both the current and prior versions allowed ADEs reported to NNI to be rejected or cancelled based on the reporter’s assessment of a lack of causality of the event to the product. The root-cause analysis noted that while the exclusion of certain ADEs from reporting as described in the written procedures was consistent with foreign regulatory authority regulations, it was not consistent with U.S. regulations. Although you closed deviation DV0166369 in December 2024, you did not ensure that your corrective and preventive actions were effectively implemented to resolve the existing issues and to prevent recurrence of the noncompliance. Specifically, while you ensured that prior versions of Q014048 were no longer in use, you did not update the definition of “adverse reactions” to remove references to relatedness and causality in the current version of Q014048. Additionally, you closed deviation DV0166369 without confirming the completion of your corrective action to submit all reportable serious and unexpected ADEs to FDA. Although you stated in your written response that you submitted these ADEs to FDA after the investigators discussed them with you during this inspection, you did not provide the case numbers and dates submitted to FDA for all cases with serious and unexpected ADEs that were identified as part of deviation DV0166369. As a result, FDA cannot verify that all serious and unexpected ADEs identified in this deviation were submitted to FDA. Furthermore, you did not provide sufficient information regarding how you will implement the corrective and preventive actions identified in this deviation to ensure that all serious and unexpected ADEs are reported to FDA.In your written response dated March 3, 2025, and in subsequent correspondence, you described corrective actions including but not limited to: (1) revising procedures and other documents to remove certain terminology that created ambiguity and led to serious and unexpected ADEs not being reported to FDA; (2) updating definitions and documentation of the term “spontaneous cases”; and (3) performing a retrospective review of cases to ensure that all valid cases were submitted to FDA. Further, you stated that all cases that were identified as 15-day Alert reports as part of deviation DV0166369 had been submitted to FDA as of February 6, 2025.While we acknowledge the corrective and preventive actions you have taken or plan to take, your written response and subsequent correspondence are inadequate because you did not provide sufficient details for the Agency to determine whether your actions effectively resolved the existing issues and will prevent similar violations in the future. Specifically, you did not provide sufficient details about how your updated procedures, guidance, and training materials will ensure future compliance with reporting serious and unexpected ADEs to FDA in a timely manner.b. Your written procedure Q014048, “Handling of Adverse Events and Other Safety Information” (Ver: 28.0, Effective Date: 03 Oct 2024), states that the minimum criteria for Individual Case Safety Reports (ICSRs) to qualify for submission in an expedited manner are: (1) one or more identifiable reporters; (2) a single identifiable patient; (3) a suspected NNI product; and (4) a suspected adverse reaction. However, your written procedure did not ensure that you, and the call-center contractors acting on your behalf, correctly received, reviewed, and processed ADE information, which resulted in the failure to submit serious and unexpected ADEs that were required to be reported to FDA within 15 calendar days.Specifically, you and your contractors inappropriately invalidated 15-day Alert reports because of a lack of patient identifiers; however, during the inspection, FDA identified valid patient identifiers in source documents for these reports. These reports were not submitted to FDA until they were discussed with you during the inspection. For example, Argus Case #1342548 includes a consumer reporting a death for a male patient who received semaglutide; however, you invalidated the case because you failed to capture the patient identifier. During the inspection, FDA found the patient identifier in the source documents for this case. As a result of this erroneous invalidation, you failed to report serious and unexpected ADEs to FDA within 15 calendar days, as required.We note that you identified this issue when(b)(4)served as your call-center contractor between May 12 and October 12, 2023. You later terminated your contract with(b)(4)⁽ᵇ⁾ ⁽⁴⁾ and switched your call-center contractor to(b)(4), starting on October 13, 2023. You also opened deviation DV0155511 in December 2023 in response to issues observed with(b)(4). Although you switched your call-center contractor to(b)(4)and completed corrective and preventive actions as part of deviation DV0155511, you continued to invalidate cases of ADEs for lack of a patient identifier, despite the patient identifiers’ being available in accordance with written procedure Q014048 and the cases’ otherwise qualifying as reportable. Therefore, you did not ensure that your corrective and preventive actions (for example, review and creation of training resources and content for vendors) were effectively implemented to resolve the existing issues and to prevent recurrence of the noncompliance.In your March 3, 2025, written response and in subsequent correspondence, you stated proposed corrective actions, including but not limited to: (1) conducting retrospective reviews of cases to ensure that all valid cases were submitted to FDA; (2) drafting work instructions related to ICSR quality checks and verification, including source data verification; (3) planning a phased approach to transition safety case intake from the contracted call-center agents to dedicated insourced patient safety agents, who are health care professionals; (4) performing an assessment of the vendor management program; and (5) creating a Vendor Management team, a Vendor Quality team, and a Training team dedicated to your U.S. Patient Safety team, to ensure adequate vendor training and oversight.While we acknowledge the corrective and preventive actions you have taken or plan to take, your written response is inadequate because you did not provide information about whether your proposed actions will prevent similar violations in the future. For example, you did not provide specific information about how you will ensure that vendors acting on your behalf correctly receive, review, and process ADE information, including how you will maintain oversight related to delegated functions. Specifically, you did not provide sufficient details about how your Vendor Management, Quality, and Training teams will operate, what their activities will be, or how these teams will ensure that contractors acting on your behalf will accurately and completely capture ADEs, perform quality check activities, and comply with all applicable PADE requirements. In addition, you did not describe how the “insourced” call center will operate, nor did you provide adequate information to ensure that your insourced call center will comply with PADE requirements in the future.c. Your written procedure Q040018, “Handling Individual Safety Cases in the Global Safety Database” (Ver 43.0, Effective Date: 17 May 2024), states that most serious adverse reactions should enter medical review by calendar day 9 following the awareness date, and they should complete medical review by calendar day 10 following the awareness date. However, your written procedure failed to ensure that cases completed “medical review” within the timelines specified in your written procedure. Rather, cases remained in “medical review” status longer than specified in your written procedure, resulting in your failure to submit 15-day Alert reports to FDA within the required time frame. During the inspection, FDA identified and made you aware of serious and unexpected ADEs that were not submitted to FDA because they remained in “medical review” status beyond the timeline specified in your written procedures. For example, in Argus Case #1334278, you received information on December 9, 2024, from a consumer who reported suicidal ideation while taking semaglutide. This case entered “medical review” status on December 16, 2024; however, medical review was not performed until February 3, 2025, after being identified during FDA’s inspection, and the case was submitted to FDA on February 5, 2025. As a result, you failed to report serious and unexpected ADEs to FDA within 15 calendar days, as required by PADE regulations.In your March 3, 2025, written response and your April 11, 2025, correspondence, you stated that your corrective actions included but were not limited to a requirement for daily review of patient safety cases across each workflow state. However, your written response is inadequate because you did not provide any information about whether your proposed actions will prevent similar violations in the future. For example, you did not provide sufficient details regarding the root cause of this violation, including why these cases remained in “medical review” status beyond the time frames specified in your written procedure. You also have not provided an assessment of whether, and to what extent, this issue implicates the timely reporting of other cases in your product portfolio.2. You failed to develop written procedures that ensured all ADEs that are the subject of 15-day Alert reports were promptly investigated in accordance with 21 CFR 314.80(c)(1)(ii). PADE regulations require that the applicant must promptly investigate all ADEs that are the subject of postmarketing 15-day Alert reports (21 CFR 314.80(c)(1)(ii)).Your written procedure Q0360683, “Case Management Workflow at Novo Nordisk Inc. Patient Safety” (Ver: 7.0, Approved Date: 04 Nov 2024), stated that you did not require follow-up on reported ADEs if consent was not obtained from the reporter and if the reporter was a non-health care professional. Based on this written procedure, you, and your contractor acting on your behalf, failed to promptly investigate ADEs that were subject to 15-day Alert reporting because you did not follow up with reporters to request additional information unless you explicitly obtained consent from the reporter. PADE regulations do not require the obtaining of consent to acquire additional information. As a result, you failed to investigate serious and unexpected ADEs as required by PADE regulations.For example, Argus Case #1171264 includes a non-health care professional reporting the death of a patient receiving semaglutide; however, you failed to promptly investigate because consent was not obtained from the reporter and the reporter was a non-health care professional, as stated in your written procedure. This case was closed without your reporting it to FDA.Procedure Q0360683 also required that NNI perform two follow-up attempts for serious cases in which a death is reported, to obtain relevant safety information for reporting to FDA. However, you failed to promptly investigate Argus Case #1079792, in which a physician reported to your company representative that a patient taking semaglutide was depressed and committed suicide. Youfailed todocument any attempt to obtain additional information from the reporter, including patient identifiers. As of the date of issuance of this letter, this case has not been submitted to FDA.In your written response dated March 3, 2025, you attributed the failure to promptly investigate serious and unexpected ADEs to a procedural gap that required unnecessary consent from the reporter. In your written response and in subsequent correspondence, you described corrective actions including but not limited to: (1) revising local and global SOPs and trainings to remove the requirement to obtain consent from reporters for follow-up; (2) removing fields requiring reporters’ consent from local IT platforms; (3) sending a communication to all vendors and revising safety data exchange agreement (SDEA) templates to clarify that consent is not a predicate requirement to collecting information from a reporter; and (4) conducting a retrospective review of cases to assess that appropriately timed and documented follow-up attempts with reporters were conducted. However, your written response is inadequate because you did not provide information about how your proposed or completed corrective actions would prevent similar violations in the future. For example, you did not provide sufficient details about your quality-control activities, including how you will maintain oversight of vendors with whom you contract to fulfill any of your ADE responsibilities.Additionally, your written response did not specifically address how you will conduct appropriate follow-up, as required by 21 CFR 314.80(c)(1)(ii), for 15-day Alert reports that were not submitted at the time of the inspection.In your March 3, 2025, written response, and in subsequent correspondence, you described corrective actions including but not limited to your engagement with a consultant to perform reviews of your pharmacovigilance processes and associated interfaces, as well as your deviation system and your corrective and preventive action system, to ensure that all cases have been reported to FDA and all deviations have been handled adequately. You also stated that your consultant is engaged in a retrospective review of all closed pharmacovigilance-related deviations dating back to June 2017, and that you have created a deviation review board. We acknowledge that your retrospective review of deviations is complete and that you have received the final report. For each major deviation that may affect compliance with PADE regulations and that has a Quality Assurance approval date after 01 Jan 2021, including those listed on the Deviations Handling request provided to the investigators during the inspection, you should submit a description of the deviation, date of identification, current status, the root-cause analysis, an assessment of the impact, the status of all corrective and preventive actions, and the timeline and results for effectiveness checks.While we acknowledge the corrective and preventive actions your firm has taken since our inspection, your response is inadequate because you did not provide sufficient details to determine whether your actions will effectively prevent similar violations in the future. Your explanations, when taken into consideration with the violations described above and your failure to adequately address your noncompliance, suggest systemic failures with your surveillance, receipt, evaluation, and reporting of ADEs to FDA. In addition, your failure to identify and assess the root cause(s) of deficiencies discussed in this letter raises concerns about your firm’s ability to monitor the safety of your products, including through oversight of vendors with whom you contract to fulfill any of your ADE responsibilities. While this inspection focused on NNI’s compliance with PADE regulations for a sample of NNI’s products, including semaglutide, liraglutide, nedosiran sodium, and estradiol, based on the nature of the inspection’s findings and your written response and correspondence, we have serious concerns about the scope and impact of these violations on your entire product portfolio.FDA relies on the complete, accurate, and timely submission of ADEs to monitor a product’s safety profile and uphold FDA’s mission to protect and promote public health. Reporting ADEs to FDA within the required time frames is necessary for the ongoing monitoring of drug safety profiles. Failure to report and investigate ADEs may limit the safety information that FDA may need when monitoring potential safety signals.We emphasize that as an application holder, it is your responsibility to ensure that you comply with all applicable PADE requirements, including when you contract with a vendor to fulfill any of your ADE responsibilities. Your failure to develop procedures that ensure the submission of 15-day Alert reports and the prompt investigation of ADEs that were the subject of 15-day Alert reports raises significant concerns about your ability to accurately and completely report product safety information to the FDA in accordance with PADE requirements.This letter is not intended to be an all-inclusive list of deficiencies that exist at NNI. It is your responsibility to ensure adherence to each requirement of the law and relevant FDA regulations. You should address any deficiencies and establish procedures to ensure that you comply with FDA regulations.If you are considering an action that is likely to lead to a disruption in the supply of drugs produced at your facility, FDA requests that you contact CDER’s Drug Shortages Staff immediately, at drugshortages@fda.hhs.gov, so that FDA can work with you on the most effective way to bring your operations into compliance with the law. Contacting the Drug Shortages Staff also allows you to meet any obligations you may have to report discontinuances or interruptions in your drug manufacture under 21 U.S.C. 356C(b) and allows FDA to consider, as soon as possible, what actions, if any, may be needed to avoid shortages and protect the health of patients who depend on your products.This letter notifies you of our findings and provides you with an opportunity to address the deficiencies noted above. Within 15 business days of your receipt of this letter, you should notify this office in writing of the actions you have taken to prevent similar violations in the future. Failure to address this matter adequately may lead to regulatory action. If you believe you have complied with the FD&C Act and relevant regulations, please include your reasoning and any supporting information for our consideration.Should you have any questions or concerns regarding this letter or the inspection, please email FDA at CDER-OSI-ADE@fda.hhs.gov. Your written response and any pertinent documentation should be addressed to:Dipti Kalra R.Ph., M.S., MBA Branch ChiefPostmarketing Safety BranchDivision of Enforcement and Postmarketing Safety Office of Scientific InvestigationsOffice of ComplianceCenter for Drug Evaluation and ResearchU.S. Food and Drug Administration Building 51, Room 534310903 New Hampshire Avenue Silver Spring, MD 20993-0002Sincerely,{See appended electronic signature page}David C. Burrow, Pharm.D., J.D. DirectorOffice of Scientific Investigations Office of ComplianceCenter for Drug Evaluation and ResearchU.S. Food and Drug Administration--------------------------------------------------------------------------------------------This is a representation of an electronic record that was signed electronically. Following this are manifestations of any and all electronic signatures for this electronic record.--------------------------------------------------------------------------------------------/s/------------------------------------------------------------DAVID C BURROW03/05/2026 08:24:50 AM______________________1Argus is NNI’s drug safety database.

Delivery Method:Via EmailProduct:DrugsRecipient:Ryan NapierskiChief Executive OfficerNSE Products, Inc. DBA Nu Skin Enterprises, Inc.75 West Center StreetProvo,UT84601United Statesrnaperski@nuskin.comIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesWARNING LETTERMarch 2, 2026RE: 3093 (CMS 722667)Ryan Napierski:This letter concerns your firm’s drug listing information provided to FDA’s electronic Drug Registration and Listing System (eDRLS) for your drug products, “AP-24 Fluoride,” NDC 62839-1151; “AP-24,” NDC 62839-1152; and “AP-24 Whitening,” NDC 62839-1155.1Your 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). Failure to provide listing information for a drug in accordance with 510(j) of the FD&C Act is prohibited 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 207 set forth the requirements for the listing of drugs. In accordance with section 510(j)(2) of the FD&C Act, 21 U.S.C 360(j)(2), and 21 CFR 207.57(b), registrants must review and update their drug listing information each June and December. Furthermore, under 21 CFR 207.57(b)(1)(iv), registrants must submit any material changes in any information previously submitted including, per 21 CFR 207.49(a)(12), manufacturing establishment information. The drug listings stated above reference a manufacturing establishment,(b)(4), that has confirmed that it has not been involved in the manufacturing of these drugs for more than five years, yet they continue to be cited in your listings with no end marketing date. Therefore, your firm has not fulfilled its listing obligations under section 510(j) of the FD&C Act, 21 U.S.C. 360(j). Failure to provide listing information for a drug in accordance with 510(j) of the FD&C Act is prohibited under section 301(p) of the FD&C Act, 21 U.S.C. 331(p).Additionally, your firm has 61 drug listings that have not been updated or certified as required and therefore have been inactivated by FDA. Please update the listing information for these drugs to reflect their current status. If you no longer manufacture and distribute these drugs, then the drugs must be discontinued by adding an end marketing date.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. Establishment registration and drug 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 establishment registration and drug listing issues associated with your products.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 correct 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 believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration. If you cannot complete corrective action within 15 working days, state the reason for the delay and the time within which you will complete the correction. 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.2If 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 (3093) (CMS 722667) on all correspondence.Sincerely,/S/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 10, 2025, we sent your firm a drug listing deficiency letter describing the observed listing deficiencies in the information your firm submitted. In addition, we followed up on December 11, 2025, December 19, 2025, and January 16, 2026, to various points of contact. On January 24, 2026, we sent your firm a data removal notification email informing you of a data removal action. As stated in that email, the continued deficiencies resulted in your products’ data removal from FDA’s Online NDC Directory. FDA sends data deficiency letters and data removal notifications to the contact person found in the labeler code SPL submitted by your firm to FDA. If this information has changed, it is your responsibility to update this within 30 days of any change, under 21 CFR 207.33(c).2See 84 FR 40417.

四会市康源大药房店：　　经调查，你公司长期未开展经营活动，已不在注册地址经营，且无法联系企业，已不具备经营药品的基本条件。综上所述，我局依据《广东省食品药品监督管理局关于

根据《中华人民共和国行政许可法》和《广东省食品药品监督管理局关于注销的管理规定》第三条第一款第一项“企业提出《药品经营许可证》注销要求的”和第六条第一款第一项“企业未提出注销要求，但《药品经营许可证》已失效的”，我局决定注销阳江市阳东区东平镇良江药店等36家企业的36张《药品经营许可证》（名单见附件）。　　现根据《广东省食品药品监督管理局关于注销的管理规定》第十二条予以公告。阳江市阳东区市场监督管理局2026年3月3日 附件：阳江市阳东区市场监督管理局2025年10月-2026年2月药品经营企业注销公告名单（第1期）序号许可证号许可证标明的有效期限企业名称注销时间注销原因1粤DB66265462026-04-06阳江市阳东区东平镇良江药店2026-02-06企业申请2粤CA662A1062028-04-20阳江市阳东区伙庆百货店2026-02-26企业申请3粤CB662A0322025-06-30阳江市阳东区利莱食品店2026-02-14企业申请4粤CB662A0472027-08-02阳江市阳东区东城镇睿琪食品便利店2026-02-05企业申请5粤CB662A0722027-11-23广东宜和堂医药连锁有限公司阳江阳东金桂分公司2026-01-27企业申请6粤CA662A0812028-02-23阳江市阳东区东平镇美旦佳食品便利店2026-01-08企业申请7粤CA662A0822028-02-23阳江市阳东区东平镇葛港美又佳食品店2026-01-08企业申请8粤DB66264612026-01-19阳江市阳东区合山惠民堂大药房2025-12-29企业申请9粤CA662A0352027-07-13阳江市阳东区佳兆食品便利店2025-12-22企业申请10粤CA662A0692025-11-08阳江市阳东区东城镇黄喜满堂食品店2025-12-12企业申请11粤CA662A0272027-06-12阳江市阳东区靓昕百货店2025-12-11企业申请12粤CA662A0372027-07-13阳江市阳东区晴俊日用百货店2025-12-11企业申请13粤CA662A0962028-03-30阳江市阳东区怡心食品便利店2025-12-08企业申请14粤CA662A0382027-07-13阳江市阳东区利之华食品店2025-12-05企业申请15粤CA662A1622028-10-22阳江市阳东区华来客百货店2025-12-05企业申请16粤CB662A0732027-11-28阳江市阳东区汇美食品店2025-12-05企业申请17粤CA662A0672027-10-16阳江市阳东区美佳美利食品店2025-12-05企业申请18粤CB662A1492028-10-11阳江市阳东区东城镇美之华食品店2025-12-05企业申请19粤CB662A0342027-07-06阳江市阳东区明日星食品店2025-12-05企业申请20粤CA662A1122028-05-08阳江市阳东区金秋食品商行2025-12-02企业申请21粤CB6620001062029-12-01阳江市沃星医药连锁有限公司阳东强安分公司2025-11-28企业申请22粤DA662A2572028-04-11阳江市正德堂医药有限公司2025-11-28企业申请23粤DB66264022025-12-01阳江市阳东区东城康辉药店2025-11-20企业申请24粤DB66264682026-01-24阳江市阳东区大八镇大康药店2025-11-20企业申请25粤DA66264312025-12-20阳江市阳东区合山镇大往正德堂药店2025-11-05企业申请26粤CA662A1382028-08-29阳江市阳东区北惯镇嘉麟百货商行2025-11-05企业申请27粤CB662A1752028-10-25阳江市阳东区彤之浠食品商行2025-11-05企业申请28粤CA662A1362028-08-24阳江市阳东区东城镇百悦佳汇日用百货贸易商行2025-11-04企业申请29粤CA662A0362027-07-14阳江市阳东区黄月影食品店2025-11-04企业申请30粤DB66263552025-11-04阳江市阳东区东城扬光药店2025-10-29企业申请31粤DA6620001762029-10-14阳江市阳东区民众药店有限公司2025-10-24企业申请32粤CA662A0952028-03-29阳江市阳东区个佳食品店2025-10-23企业申请33粤DB66263562025-11-04阳江市阳东区富又康药店2025-10-15企业申请34粤DB66264942026-02-07阳江市阳东区东城镇药草园药店2026-02-07到期注销35粤DA66264232025-12-14阳江市阳东区名医坊大药房2025-12-14到期注销36粤CB66261062025-11-15阳江市沃星医药连锁有限公司阳东合山勇康堂药店2025-11-15到期注销

根据《广东省食品药品监督管理局关于〈药品经营许可证〉注销的管理规定》（粤食药监法〔2013〕26号），至2026年3月9日，我局已依法注销连平县顺康商贸大药房（个人独资）等药店的《药品经营许可证》。现予以公布。许可证号许可证标明的有效期限企业名称法人代表/负责人注销日期注销原因粤DB7620003642030年01月05日连平县顺康商贸大药房（个人独资）曾媛媛2026年3月9日企业申请连平县市场监督管理局2026年3月9日

沈阳宝康生物工程有限公司报告，由于生产的一次性使用真空采血管不符合经注册的产品技术要求的原因，沈阳宝康生物工程有限公司对其生产的医一次性使用真空采血管（辽械注准20152220039）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：

序号：1企业名称沈阳博林药业有限公司企业类型药品批发企业检查时间2026年1月14日-2026年1月15日,2026年1月20日-2026年1月20日所在地市沈阳市检查依据《中华人民共和国药品管理法》《中华人民共和国药品管理法实施条例》《药品经营和使用质量监督管理办法》等法律、法规、规章 检查事项药品经营检查方式常规检查检查内容执行药品经营质量管理规范情况 存在问题在储存与养护方面，存在中药饮片养护工作不规范的问题；在收货与验收方面，存在个别药品未及时验收的问题。处理措施限期整改整改情况已按要求完成整改序号：2企业名称辽宁嘉和康健药房连锁有限公司企业类型药品零售连锁总部检查时间2026年1月22日-2026年1月23日所在地市沈阳市检查依据《中华人民共和国药品管理法》《中华人民共和国药品管理法实施条例》《药品经营和使用质量监督管理办法》等法律、法规、规章 检查事项药品经营检查方式常规检查检查内容执行药品经营质量管理规范情况 存在问题在机构与质量管理职责方面，存在个别岗位职责不明确的问题；在质量管理体系文件方面，存在个别文件未及时修订的问题。处理措施限期整改整改情况已按要求完成整改

武汉优恩生物科技有限公司申请注销“脂蛋白相关磷脂酶A2（Lp-PLA2）检测试剂盒（荧光免疫层析法）”等43个产品的《医疗器械注册证》（见附表：武汉优恩生物科技有限公司产品注册证信息）。根据《医疗器械监督管理条例》（中华人民共和国国务院令第276号2024年第二次修订）、《体外诊断试剂注册与备案管理办法》（2021年8月26日国家市场监督管理总局令第48号公布 自2021年10月1日起施行）的规定，建议准予注销并公布。湖北省药品监督管理局    2026年03月02日       附表：　武汉优恩生物科技有限公司产品注册证信息序号产品名称注册证号注册人名称注册日期有效期至注销日期1脂蛋白相关磷脂酶A2（Lp-PLA2）检测试剂盒（荧光免疫层析法）鄂械注准20192402777武汉优恩生物科技有限公司2024-02-192029-02-182026-02-092人绒毛膜促性腺激素（HCG）检测试剂盒（胶体金免疫层析法）鄂械注准20192402770武汉优恩生物科技有限公司2024-02-212029-02-202026-02-093N端-脑钠肽前体（NT-proBNP）检测试剂盒（胶体金免疫层析法）鄂械注准20192402780武汉优恩生物科技有限公司2024-04-172029-04-162026-02-094髓过氧化物酶（MPO）检测试剂盒（荧光免疫层析法）鄂械注准20192402778武汉优恩生物科技有限公司2024-04-172029-04-162026-02-095心型脂肪酸结合蛋白（H-FABP）检测试剂盒（荧光免疫层析法）鄂械注准20192402766武汉优恩生物科技有限公司2024-02-012029-01-312026-02-096N端-脑钠肽前体（NT-proBNP）检测试剂盒（荧光免疫层析法）鄂械注准20192402679武汉优恩生物科技有限公司2023-12-202028-12-192026-02-097尿微量白蛋白(MAU)检测试剂盒(胶体金免疫层析法)鄂械注准20192402689武汉优恩生物科技有限公司2024-02-012029-01-312026-02-098中性粒细胞明胶酶相关脂质运载蛋白（NGAL）检测试剂盒（荧光免疫层析法）鄂械注准20192402693武汉优恩生物科技有限公司2024-01-032029-01-022026-02-099C反应蛋白/降钙素原(CRP/PCT)检测试剂盒（荧光免疫层析法）鄂械注准20192402680武汉优恩生物科技有限公司2024-05-112029-05-102026-02-0910全量程C反应蛋白（常规CRP+HsCRP）检测试剂盒（荧光免疫层析法）鄂械注准20192402751武汉优恩生物科技有限公司2024-06-032029-06-022026-02-0911D-二聚体(D-D)检测试剂盒(荧光免疫层析法)鄂械注准20192402759武汉优恩生物科技有限公司2024-02-012029-01-312026-02-0912胃蛋白酶原I（PGI）、胃蛋白酶原II（PGII）检测试剂盒（荧光免疫层析法）鄂械注准20192402752武汉优恩生物科技有限公司2024-01-032029-01-022026-02-0913肌酸激酶同工酶/心肌肌钙蛋白I/肌红蛋白(CK-MB/cTnI/MYO)三合一检测试剂盒（荧光免疫层析法）鄂械注准20192402699武汉优恩生物科技有限公司2024-01-032029-01-022026-02-0914生长刺激表达蛋白2（ST2）检测试剂盒（免疫荧光层析法）鄂械注准20192402753武汉优恩生物科技有限公司2023-12-212028-12-202026-02-0915降钙素原（PCT）检测试剂盒（荧光免疫层析法）鄂械注准20212403210武汉优恩生物科技有限公司2021-03-102026-03-092026-02-0916血清淀粉样蛋白A（SAA）检测试剂盒（荧光免疫层析法）鄂械注准20212403218武汉优恩生物科技有限公司2021-03-222026-03-212026-02-0917白细胞介素-6（IL-6）检测试剂盒（荧光免疫层析法）鄂械注准20212403233武汉优恩生物科技有限公司2021-03-302026-03-292026-02-1318超敏心肌肌钙蛋白I（Hs-cTnI）检测试剂盒（荧光免疫层析法）鄂械注准20212403219武汉优恩生物科技有限公司2021-03-222026-03-212026-02-1319胃泌素17（G17）检测试剂盒（荧光免疫层析法）鄂械注准20212403232武汉优恩生物科技有限公司2021-03-302026-03-292026-02-1320心型脂肪酸结合蛋白（H-FABP）检测试剂盒（胶体金免疫层析法）鄂械注准20192402781武汉优恩生物科技有限公司2024-04-172029-04-162026-02-1321抗环瓜氨酸肽抗体(Anti-CCP )和类风湿因子(RF)检测试剂盒（胶体金免疫层析法）鄂械注准20192402787武汉优恩生物科技有限公司2024-04-172029-04-162026-02-1322全量程C反应蛋白（常规CRP+HsCRP）检测试剂盒（胶体金免疫层析法）鄂械注准20192402779武汉优恩生物科技有限公司2024-06-032029-06-022026-02-1323肌酸激酶同工酶/心肌肌钙蛋白I/肌红蛋白(CK-MB/cTnI/MYO)三合一检测试剂盒（胶体金免疫层析法）鄂械注准20192402782武汉优恩生物科技有限公司2024-02-012029-01-312026-02-1324尿微量白蛋白（MAU）检测试剂盒（荧光免疫层析法）鄂械注准20222403972武汉优恩生物科技有限公司2022-10-102027-10-092026-02-1325糖化血红蛋白（HbA1c）检测试剂盒（荧光免疫层析法）鄂械注准20222403975武汉优恩生物科技有限公司2022-10-102027-10-092026-02-1326心肌肌钙蛋白T (cTnT)检测试剂盒（荧光免疫层析法）鄂械注准20222403973武汉优恩生物科技有限公司2022-10-102027-10-092026-02-1327肌酸激酶同工酶（CK-MB）检测试剂盒（荧光免疫层析法）鄂械注准20222403968武汉优恩生物科技有限公司2022-10-102027-10-092026-02-1328抗环瓜氨酸肽（CCP）抗体检测试剂盒（荧光免疫层析法）鄂械注准20222403974武汉优恩生物科技有限公司2022-10-102027-10-092026-02-1329C反应蛋白/血清淀粉样蛋白A（CRP/SAA）检测试剂盒（荧光免疫层析法）鄂械注准20222403969武汉优恩生物科技有限公司2022-10-102027-10-092026-02-1330降钙素原/白细胞介素-6(PCT/IL-6)检测试剂盒（荧光免疫层析法）鄂械注准20222403966武汉优恩生物科技有限公司2022-10-102027-10-092026-02-133125-羟基维生素D（25-OH VD）检测试剂盒（荧光免疫层析法）鄂械注准20222403965武汉优恩生物科技有限公司2022-10-102027-10-092026-02-2432孕酮(Prog)检测试剂盒（荧光免疫层析法）鄂械注准20222403970武汉优恩生物科技有限公司2022-10-102027-10-092026-02-2433胰岛素样生长因子结合蛋白-1(IGFBP-1)检测试剂盒（胶体金免疫层析法）鄂械注准20222404004武汉优恩生物科技有限公司2022-10-182027-10-172026-02-2434类风湿因子（RF）检测试剂盒（荧光免疫层析法）鄂械注准20222403971武汉优恩生物科技有限公司2022-10-102027-10-092026-02-2435促卵泡激素（FSH）检测试剂盒（胶体金免疫层析法）鄂械注准20222404003武汉优恩生物科技有限公司2022-10-182027-10-172026-02-2436人绒毛膜促性腺激素β亚单位(β-HCG)检测试剂盒(荧光免疫层析法)鄂械注准20222403967武汉优恩生物科技有限公司2022-10-102027-10-092026-02-2437促黄体生成素（LH）检测试剂盒（胶体金免疫层析法）鄂械注准20222404028武汉优恩生物科技有限公司2022-11-032027-11-022026-02-2438大便隐血（FOB）检测试剂盒（胶体金免疫层析法）鄂械注准20222404023武汉优恩生物科技有限公司2022-10-282027-10-272026-02-2439人绒毛膜促性腺激素（HCG）检测试纸（胶体金免疫层析法）鄂械注准20222404014武汉优恩生物科技有限公司2022-10-242027-10-232026-02-2440铁蛋白（FER）检测试剂盒（荧光免疫层析法）鄂械注准20252405633武汉优恩生物科技有限公司2025-07-112030-07-102026-02-2441同型半胱氨酸（HCY）检测试剂盒（荧光免疫层析法）鄂械注准20252405643武汉优恩生物科技有限公司2025-07-142030-07-132026-02-2442抗链球菌溶血素“O”（ASO）检测试剂盒（荧光免疫层析法）鄂械注准20252405618武汉优恩生物科技有限公司2025-06-302030-06-292026-02-2443干式荧光免疫分析仪鄂械注准20242225136武汉优恩生物科技有限公司2024-08-202029-08-192026-02-24