Product:DrugsRecipient:Glam DermaNetherlandsIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesUnited StatesWARNING LETTERNovember 3, 2025Glam Derma:This is to advise you that the United States (U.S.) Food and Drug Administration (FDA) recently reviewed your website at the Internet address www.glamderma.com and has observed that your website introduces into interstate commerce misbranded and unapproved new drugs in violation of sections 301(a), 301(d), 503(b), and 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) [21 U.S.C. §§ 331(a), 331(d), 353(b), and 355(a)]. As discussed below, FDA has observed that www.glamderma.com introduces into interstate commerce unapproved and misbranded injectable botulinum toxin drug products.There are inherent risks to consumers who purchase unapproved new drugs and misbranded drugs. Unapproved new drugs do not carry the same assurances of safety and effectiveness as those drugs subject to FDA oversight. Drugs that have circumvented regulatory safeguards may be contaminated, counterfeit, contain varying amounts of active ingredients, or contain different ingredients altogether. Furthermore, injectable drug products can pose a serious risk of harm to users because they bypass many of the body’s natural defenses against toxic ingredients, toxins, or dangerous organisms that can lead to serious and life-threatening conditions such as septicemia or sepsis. Accordingly, FDA requests that www.glamderma.com cease offering any unapproved and misbranded drugs for sale to U.S. consumers. This is critical to shielding the American public from harm.Unapproved New Drugs:Certain products offered for sale by www.glamderma.com are drugs within the meaning of section 201(g) of the FD&C Act [21 U.S.C. § 321(g)] because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or because they are intended to affect the structure or function of the body. These drugs are also new drugs as defined by section 201(p) of the FD&C Act [21 U.S.C. § 321(p)], because they are not generally recognized as safe and effective for their labeled uses. With certain exceptions not applicable here, new drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from FDA, as described in section 505(a) of the FD&C Act [21 U.S.C. § 355(a)]. No approved applications pursuant to section 505 of the FD&C Act are in effect for these products. Accordingly, their introduction or delivery for introduction into interstate commerce violates sections 301(d) [21 U.S.C. § 331(d)] and 505(a) of the FD&C Act.An example of an unapproved botulinum toxin drug product you offer for sale on www.glamderma.com is botulinum toxin type A marketed as “NABOTA 100 Type A” and “Nabota 100”. Evidence obtained from your website establishing that this product is a drug intended for human use (as defined in 21 CFR 201.128) includes the claims “Armpits, palms for treating hyperhidrosis” and “It is perfect for treating blepharospasm symptoms.”While there are FDA-approved versions of botulinum toxin drug products on the market in the U.S., there are no approved drug applications pursuant to section 505 of the FD&C Act in effect for “NABOTA 100 Type A” and “Nabota 100” offered by www.glamderma.com. Currently there are several botulinum toxin products FDA-approved for the U.S. market and these products are only available pursuant to a prescription from a licensed practitioner. Examples of FDA-approved botulinum toxin products with a summary of their indications are: BOTOX® (onabotulinumtoxinA), indicated for the treatment of overactive bladder, neurogenic detrusor overactivity, chronic migraine, spasticity, cervical dystonia, severe primary axillary hyperhidrosis, strabismus, and blepharospasm and prophylaxis of headaches in adults with chronic migraines; DAXXIFY® (daxibotulinumtoxinA-lanm), indicated for the temporary improvement in the appearance of glabellar lines and the treatment of cervical dystonia; and MYOBLOC® (rimabotulinumtoxinB), indicated for the treatment of cervical dystonia and chronic sialorrhea.Furthermore, FDA-approved botulinum toxin drug products bear a boxed warning, commonly referred to as a “black box warning,” which is the strongest warning FDA requires, indicating that the drug carries a significant risk of serious or even life-threatening adverse effects. The boxed warning addresses the risk of distant spread of toxin effect to produce symptoms consistent with botulinum toxin effects. In addition, swallowing and breathing difficulties can be life threatening and there have been reports of death.Misbranded Drugs:A drug is misbranded under section 502(f)(1) of the FD&C Act [21 U.S.C. § 352(f)(1)] if its labeling fails to bear adequate directions for use. “Adequate directions for use” means directions under which a layperson can use a drug safely and for the purposes for which it is intended (see 21 CFR 201.5). Prescription drugs, as defined in section 503(b)(1) of the FD&C Act [21 U.S.C. § 353(b)(1)] include those that, because of their toxicity or other potentiality for harmful effect, and/or the method of their use, and/or the collateral measures necessary for their use, are not safe for use except under supervision of a practitioner licensed by law to administer them. Prescription drugs, as defined in section 503(b)(1)(A) of the FD&C Act, can be used safely only at the direction, and under the supervision, of a licensed practitioner.Because the aforementioned drug is a prescription drug intended for conditions that are not amenable to self-diagnosis and treatment by a layperson, adequate directions cannot be written such that a layperson can use the products safely for their intended use. Consequently, the labeling for these drug products fail to bear adequate directions for use, causing them to be misbranded under section 502(f)(1) of the FD&C Act. In addition, because these drugs are not approved in the U.S., they are also not exempt under 21 CFR 201.115(a) from the requirements of section 502(f)(1) of the FD&C Act. By offering these drugs for sale to U.S. consumers, www.glamderma.com is causing the introduction of misbranded drugs into interstate commerce in violation of section 301(a) of the FD&C Act [21 U.S.C. § 331(a)].FDA is sending this warning letter to www.glamderma.com because of the inherent risks to consumers who purchase misbranded and unapproved new drugs. This letter is not intended to identify all the ways in which your products or operations might be in violation of the law. It is your responsibility to ensure that all products you offer for sale are in compliance with the FD&C Act and its implementing regulations. You should take prompt action to address any violations of the FD&C Act (which may include the offer for sale of similarly misbranded and/or unapproved new drugs other than the drug products noted above). We advise you to review your websites, product labels, and other labeling and promotional materials to ensure that you are not misleadingly representing your products as safe and effective for a use for which they have not been approved by FDA and that you are not distributing misbranded and unapproved drug products in violation of the FD&C Act.Please notify this office in writing within 15 working days describing the specific steps you have taken to address any violations and to prevent their recurrence. Include an explanation of each step being taken to remedy and prevent the recurrence of any violations, as well as copies of related documentation. Failure to adequately address this matter may result in legal action, including, without limitation, seizure, and injunction, without further notice. 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 corrections. This letter notifies you of our concerns and provides you with an opportunity to address them. 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 within 15 working days.If you are not located in the U.S., please note that products that appear to be misbranded or unapproved new drugs may be detained or refused admission. We may advise the appropriate regulatory officials in the country from which you operate that your products referenced above appear to be unapproved and misbranded products that cannot be legally sold to consumers in the U.S.Please direct your response and any inquiries to FDA at FDAInternetPharmacyTaskForce-CDER@fda.hhs.gov.Sincerely,/s/__________________________________Sangeeta Vaswani Chatterjee, Pharm.D.Acting DirectorOffice of Drug Security, Integrity, and ResponseOffice of ComplianceCenter for Drug Evaluation and Research

Delivery Method:Via Electronic Mail - Delivery and Read Receipt RequestedReference #:320-26-06Product:DrugsRecipient:Mr. James Daniel BaileySite/Plant DirectorLiebel-Flarsheim Company LLC8800 Durant RoadRaleigh,NC27616United Statesdaniel.bailey@guerbet.comIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesWarning Letter320-26-06October 17, 2025AMENDED(This letter replaces Warning Letter No. 320-26-06 dated October 15, 2025.)Dear Mr. Bailey:The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, Liebel-Flarsheim Company LLC (a wholly owned subsidiary of Guerbet America LLC), FEI 1028892, at 8800 Durant Road, Raleigh, from March 25 to April 8, 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 April 25, 2025, response to our Form FDA 483 in detail and acknowledge receipt of your subsequent correspondence.During our inspection, our investigators observed specific violations including, but not limited to, the following.1. Your firm failed to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, whether or not the batch has already been distributed (21 CFR 211.192).You manufacture terminally sterilized(b)(4)drug products including(b)(4)for parenteral administration. However, you failed to adequately investigate multiple microbial excursions for in-process drug samples, as well as out-of-specification (OOS) endotoxin results for your finished sterile drugs.Further, your firm failed to adequately implement appropriate and effective corrective actions and preventive actions (CAPAs).(b)(4)Bioburden ExcursionsYour firm performs(b)(4)bioburden(b)(4)testing on in-process samples of your drug products(b)(4)terminal sterilization. Since 2022, despite(b)(4)steps, at least 40(b)(4)test results exceeded your firm’s microbial action-level limits, including results of “too numerous to count” (TNTC). The bioburden included gram-negative microorganisms that may have contributed to elevated endotoxin levels. Your investigations into the excursions were inadequate and lacked scientifically justified root causes. For example, investigations stated, “root cause undetermined” or identified “personnel” or “environment” as potential sources without adequate evidence. Investigations also referenced root cause studies as part of ongoing CAPAs with completion dates through 2026.In your response, you state that you will assign a CAPA, including an effectiveness check, to each of the failures noted and identified during the inspection. You also state the implicated batches are not at risk due to terminal sterilization.Your response is inadequate. You failed to adequately investigate these excursions, and your risk assessment minimizes the potential impact to patients. Your assessment appears to rely on your(b)(4)sterilization process and does not consider factors impacting its effectiveness.Appropriate environmental conditions for drug product manufacturing must be maintained to protect products from microbiological contamination, even when terminally sterilized, to minimize sterilization challenges and the byproducts of excessive bioburden.OOS Endotoxin FailuresAfter terminal sterilization of your drug products, you perform endotoxin testing as part of your sterility assurance and release specifications. Your firm invalidated multiple OOS endotoxin test results for your(b)(4)and(b)(4)drug products without conducting adequate root cause investigations.For example, your firm initiated an investigation into the OOS endotoxin result for your(b)(4)(Lot(b)(4)) drug product. After initially finding no identifiable root cause, your firm retested with new dilutions that yielded passing results and invalidated the OOS. The investigation concluded that “accidental cross-contamination of initial dilution” caused the OOS but failed to identify the contamination source. Additionally, the corrective action of providing “heightened awareness training” to the analyst contradicted the investigation's own initial finding that the analyst and procedure were not the cause of the OOS.Our investigators identified additional OOS endotoxin results for(b)(4)(Lot(b)(4)) and(b)(4)(Lot(b)(4)). Initial retesting confirmed the OOS results, but your firm excluded these confirmatory results, claiming the retesting was not performed per procedure. Both failures were investigated by your firm in tandem, and the investigations concluded no analyst, laboratory, or procedural root cause could be identified. However, the initial OOS results were invalidated after retesting new dilutions yielded passing results.Your investigation of the OOS endotoxin failure for(b)(4)(Lot(b)(4)) referenced that the corresponding(b)(4)sample also failed with TNTC results. However, you concluded this was not the root cause of the endotoxin failure since all other(b)(4)bioburden samples, particulate matter testing, and sterility testing for Lot(b)(4)met specifications.Your investigation concluded that “though the exact root cause for this OOS is unknown, the most probable root cause for this OOS result is materials.” However, your investigation is inadequate and lacked thorough root cause analysis. For example, your investigation did not confirm your conclusion by testing the suspected source of contamination (materials) to attempt to recreate the endotoxin testing failure. You also failed to evaluate the impact on other lots tested during the same timeframe. Further, you failed to implement adequate corrective actions including updated procedures or other measures to prevent recurrence.Your firm released the above batches with OOS endotoxin failures for U.S. distribution.In your response, you affirm that your investigation process was performed according to internal operating procedures and applicable regulations. You also state the products are acceptable based on acceptable results of confirmatory testing.Your response is inadequate. While sterility and endotoxin testing are critical final quality controls for drug products that purport to be sterile, they should not be the sole basis for batch release. While these tests are the final step in a series of design and control measures intended to protect consumers from unsafe drug products, there are limitations to sterility and endotoxin testing. For example, sample sizes are typically smaller as compared to the total number of units in a batch and they may not detect sporadic contamination issues. Over-reliance on final testing can mask problems such as inadequate terminal sterilization validation or inconsistent sterilization cycle execution for extended periods. Any sterility or endotoxin failure represents a serious CGMP issue that requires a comprehensive investigation into the cause and extent of the problem, and prompt review of your terminal sterilization process qualification status.To ensure proper root cause analysis and appropriate CAPA implementation, investigations must be thorough, well-documented, scientifically sound, and timely.In response to this letter, provide:A retrospective, independent review of all invalidated OOS (including in-process and release/stability testing) results for U.S. products currently in the U.S. market and within expiry as of the date of this letter and a report summarizing the findings of the analyses, including the following for each OOS:o Determine whether the scientific justification and evidence relating to the invalidated OOS result conclusively or inconclusively demonstrates causative laboratory error.o For investigations that conclusively establish laboratory root cause, provide rationale and ensure that all other laboratory methods vulnerable to the same or similar root cause are identified for remediation.o For all OOS results found by the retrospective review to have an inconclusive or no root cause identified in the laboratory, include a thorough review of production (e.g., batch manufacturing records, adequacy of the manufacturing steps, suitability of equipment/facilities, variability of raw materials, process capability, deviation history, complaint history, batch failure history). Provide a summary of potential manufacturing root causes for each investigation, and any manufacturing operation improvements.A comprehensive, independent assessment of your overall system for investigating deviations, discrepancies, complaints, OOS results, and failures. Provide a detailed action plan to remediate this system. Your action plan should include, but not be limited to, significant improvements in investigation competencies, scope determination, root cause evaluation, CAPA effectiveness, quality unit oversight, and written procedures. Address how your firm will ensure all phases of investigations are appropriately conducted.A comprehensive, independent assessment of the design and control of your firm’s manufacturing operations, with a detailed and thorough review of all microbiological hazards, that includes, but is not limited to:o All human interactions within the ISO 5 areao Equipment placement and ergonomicso Air quality in the ISO 5 area and surrounding roomo Facility layouto Raw material qualityo Personnel flows and material flows throughout all rooms used to conduct and support sterile operationsA detailed risk assessment addressing the hazards posed by distributing drug products with potentially objectionable contamination. Specify actions you will take in response to the risk assessment, such as customer notifications and product recalls.Complete investigations into all batches with potential objectionable microbial contamination or an OOS microbiological result (whether or not later invalidated). The investigations should detail your findings regarding the root causes of the contamination.Appropriate microbiological batch release specifications and standards (i.e., total counts, accompanied by provisions for identification of bioburden) for each of your drug products.All chemical and microbial test methods used to analyze each of your drug products.A summary of results from testing retain samples of all drug product batches within expiry. You should test microbiological quality (sterility and endotoxin levels) of each batch. If testing yields an OOS result, indicate the corrective actions you will take, including notifying customers and initiating recalls. In addition, identify:o All lots with corresponding(b)(4)bioburden samples of “too numerous to count” results.o The corresponding(b)(4)determination for each microorganism recovered in(b)(4)bioburden results exceeding your microbiological action-level limits.2. Your firm failed to have separate or defined areas or such other control systems necessary to prevent contamination or mix-ups. Your firm also failed to use equipment in the manufacture, processing, packing, or holding of drug products that is of appropriate design, adequate size, and suitably located to facilitate operations for its intended use and for its cleaning and maintenance. (21 CFR 211.42(c) and 21 CFR 211.63)We observed that your facility’s cleanrooms and(b)(4)system used in drug product manufacturing were in a state of disrepair.Facility and Equipment Design and ControlYour cleanrooms (e.g., ISO 5 filling line and ISO 7 weigh and formulation rooms) were inadequately designed and maintained to facilitate adequate cleaning and proper operations. For example, excessive caulking and tape were used to repair gaps around ceiling HEPA filters, air vents, and(b)(4). Rust was observed on various pieces of equipment. Inadequate materials of construction and poor facility maintenance may create potential contamination risks.(b)(4)SystemYour firm manufactures(b)(4)used to(b)(4)your filling equipment lines and as a component in your(b)(4)drug products. However, your(b)(4)system was in a significant state of disrepair. For example, peeling insulation, excessive rust, and corrosion was observed on the(b)(4)system. In addition, leaks and pooling(b)(4)were observed at various points with at least one leaking section where(b)(4)was collecting in a bucket. These conditions can allow filth and the proliferation of microorganisms to spread throughout the manufacturing areas.It is essential that you adequately design, control, maintain, and monitor the(b)(4)system to ensure it consistently produces(b)(4)suitable for pharmaceutical use.Since 2019, your environmental monitoring program showed excessive microbial contamination throughout your facility, particularly in your ISO 5 filling line cleanrooms. Speciation of the isolates recovered were identified as(b)(4)microorganisms, implicating your(b)(4)system as a potential source. While you initiated CAPA and change control in 2023 and 2024 to remediate the environmental excursions, our 2025 inspection found ongoing microbial presence throughout your facility.In your response, you commit to cleanroom reconstruction with quality assurance verification of cleanability by August 2026 and replacement of major components of your(b)(4)system by April 2027. Your response is inadequate. The proposed timelines are unacceptable to adequately address these violations, and an accelerated corrective response is required. You also do not discuss interim measures you will take to ensure your current(b)(4)system remains integral and is capable of producing(b)(4)of appropriate quality until replacement is complete.In response to this letter, provide: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 detailed remediation plan with timelines to address the findings of the contamination hazards risk assessment. Describe specific tangible improvements to be made to sterile processing operation design and control.A comprehensive, independent assessment of your(b)(4)system design, control, and maintenance.A thorough remediation plan to install and operate a suitable(b)(4)system. Include a robust ongoing control, maintenance, and monitoring program to ensure the remediated system design consistently produces(b)(4)adhering to(b)(4), USP monograph specifications and appropriate microbial and endotoxin limits.A detailed risk assessment addressing the potential effects of the observed(b)(4)system failures on the quality of all drug product lots currently in U.S. distribution. Specify actions that you will take in response to the risk assessment, such as customer notifications and product recalls.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.1Specify 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 1028892 and ATTN: Bryce Hammer.Sincerely,/S/Francis GodwinDirectorOffice of Manufacturing QualityOffice of ComplianceCenter for Drug Evaluation and Research______________________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 ELECTRONIC MAIL READ/DELIVERY RECEIPT REQUESTEDReference #:320-26-02Product:DrugsRecipient:Ms. Denise KwiatkowskiRegulatory Affairs ManagerScientific Protein Laboratories, LLC700 East Main StreetWaunakee,WI53597United StatesIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesWarning Letter320-26-02October 10, 2025Dear Ms. Kwiatkowski:The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, Scientific Protein Laboratories, LLC, FEI 2111173, at 700 East Main Street, Waunakee, from April 21 to May 2, 2025.This warning letter summarizes significant deviations from Current Good Manufacturing Practice (CGMP) for active pharmaceutical ingredients (APIs).Because your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your APIs are adulterated within the meaning of section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 351(a)(2)(B).We reviewed your May 23, 2025 response to our Form FDA 483 in detail and acknowledge receipt of your subsequent correspondence.During our inspection, our investigators observed specific deviations, including but not limited to the following:1. Failure to ensure that equipment surfaces in contact with raw materials, intermediates and API do not alter the quality of the intermediates and API beyond the official or other established specifications.You manufacture multiple animal-derived APIs. During the inspection, our investigators observed numerous grooves and scratches on the API contact surface of a(b)(4)table, where you perform(b)(4)and initial processing of organs such as pancreases, used in the manufacture of pancrelipase. These grooves and scratches indicate that your process generates(b)(4)and may lead to contamination of your API with particulate matter (e.g.,(b)(4)or particles).In your response, you state that you serviced the affected(b)(4)table to remove scratches, conducted an inspection of all(b)(4)tables in use to identify any additional units with similar wear or damage, and decommissioned and replaced these units. You indicated that you control for(b)(4)particles using(b)(4)that can detect(b)(4)from(b)(4)to(b)(4).Your response is inadequate because it does not provide a preventive maintenance plan to ensure that your resurfaced(b)(4)table is suitable for manufacturing. Additionally, your response lacks an evaluation of whether the(b)(4)table is made of a material that is adequate to minimize the introduction of foreign metal particles into your APIs. Furthermore, you did not provide details about your process for(b)(4)particle removal. FDA is concerned that(b)(4)from(b)(4)to(b)(4)in size may pose a risk to patients. You failed to conduct a risk assessment of APIs within expiry that may have been contaminated with(b)(4).In response to this letter, provide:A retrospective, independent review of all batches within expiry that could have been affected by(b)(4)introduced as a result of your manufacturing process, including an evaluation of retain samples for(b)(4)and a review of consumer complaints for the last three years.An evaluation of your process and equipment to determine whether changes can be implemented to remove the risk of foreign material introduced to APIs because of process design and materials.A validation report of your(b)(4)and a study conducted to justify the presence of extraneous(b)(4)up to(b)(4)in your APIs. Your corrective action and preventive action (CAPA) plan should focus on significantly reducing the maximum size of foreign particles generated by your manufacturing process.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. Your plan should also ensure that appropriate actions are taken throughout the company network.2. Failure to establish and follow written procedures for investigating critical deviations or the failure of intermediates and API lots to meet specifications.You failed to conduct adequate investigations into out-of-specification (OOS) results. For example:Your investigation into(b)(4)assay failures during stability testing of(b)(4)thyroid-powder lots identified your sampling procedure as the potential root cause. You revised the procedure to require(b)(4)samples from(b)(4)locations within the API drum. You performed assay testing on new samples using this revised procedure and obtained passing results. Your investigation did not include sufficient evidence or rationale to support your purported root cause. FDA is concerned with your practice of(b)(4)sampling, which has the capability to mask individually failing testing results. Additionally, this drug is a narrow therapeutic index, where content uniformity is critical.You investigated lipase assay failure during stability testing of(b)(4)distributed pancreatin lots, but you failed to expand your investigation to other pancreatin lots. You also failed to notify your customers about these failing stability results, according to your procedure.Your 2023 investigation into a failure of residual(b)(4)limit, a release specification in pancreatic enzyme concentrate, identified(b)(4)in the(b)(4)as a potential root cause, affecting(b)(4)and subsequent(b)(4)specification failure. You implemented CAPA, but subsequently you had an additional residual(b)(4)limit failure in 2024. While you did not release these batches, your investigation lacked an adequate root cause analysis to assess all sources of variability in your manufacturing process that could be contributing to the failures.FDA documented multiple batch rejections based on positive(b)(4)test results for(b)(4). We acknowledge that you rejected these batches and recognize(b)(4)is a known risk factor in animal-derived APIs. The manufacturing processes for both thyroid and pancrelipase products are inherently high-risk because traditional viral clearance methods are generally not feasible, thus requiring a control strategy of discarding any(b)(4)-positive material. Critical gaps in the investigation of positive(b)(4)results in the affected pancrelipase products included inadequate evaluation of cleaning procedures between contaminated batches, failure to extend the investigation beyond positive batches to all source material, and failure to assess whether thyroid lots and infected pancreas material were sourced from the same supplier.In your response, you state that you revised your investigation procedure to ensure consistent and robust root-cause determination, to establish scope requirements to assess potential impact on other lots and manufacturing processes, to require CAPA determination for all critical and major investigations, and to establish explicit instructions to inform clients to place APIs on hold until the completion of the investigation.Your response is inadequate because it does not demonstrate that you adequately identify root cause, implement effective remediations, and expand the investigation to evaluate the effect(s) on other batches or APIs. Additionally, your response fails to provide adequate details about your CAPAs and fails to provide supporting documentation for your CAPAs.Inadequate investigations can lead to unidentified root causes, ineffective CAPAs, and recurring problems that compromise the ability to manufacture safe and effective APIs.In response to this letter, provide a comprehensive, independent assessment of your overall system for investigating deviations, discrepancies, complaints, OOS results, and failures. Provide a detailed action plan to remediate this system. Your action plan should include but not be limited to significant improvements in investigation competencies, scope determination, root-cause evaluation, CAPA effectiveness, quality unit oversight, and written procedures. Address how your firm will ensure that all phases of investigations are appropriately conducted.ConclusionThe deviations cited in this letter are not intended to be an all-inclusive list of deviations that exist at your facility. You are responsible for investigating and determining the causes of any deviations and for preventing their recurrence or the occurrence of other deviations.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 deviations 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 deviations may also prevent other Federal agencies from awarding contracts.Failure to address deviations 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 deviations 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 deviations.This letter notifies you of our findings and provides you with an opportunity to address the above deficiencies. After you receive this letter, respond to this office in writing within 15 working days.1Specify what you have done to address any deviations 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 provide your schedule for completion.Send your electronic reply to CDER-OC-OMQ-Communications@fda.hhs.gov. Identify your response with FEI 2111173 and ATTN: Rokhsana Safaai-Jazi.Sincerely,/S/Francis GodwinDirectorOffice of Manufacturing QualityOffice of ComplianceCenter for Drug Evaluation and Research_________________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.

Product:DrugsRecipient:onlineotcmeds.comUnited StatesIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesFROM: The United States Food and Drug AdministrationRE: Notice of Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the InternetDATE: October 15, 2025WARNING LETTERThis is to advise you that the United States (U.S.) Food and Drug Administration (FDA) recently reviewed your website at the Internet address onlineotcmeds.com and has observed that your website introduces into interstate commerce misbranded and unapproved new drugs in violation of sections 301(a), 301(d), 301(k), 503(b), and 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) [21 U.S.C. §§ 331(a), 331(d), 331(k), 353(b), and 355(a)].As discussed below, FDA has observed that onlineotcmeds.com introduces into interstate commerce unapproved and misbranded opioids. Opioid addiction and abuse have created an immense public health crisis, and the death toll is staggering. Given the severity of the opioid epidemic, the easy availability of opioids via the Internet poses significant risks to U.S. consumers.FDA has also observed that onlineotcmeds.com introduces into interstate commerce unapproved and misbranded benzodiazepines. Benzodiazepines are drug products with an acknowledged potential for abuse, and it is important to address the public health impact of their nonmedical use. Benzodiazepine nonmedical use is widespread, and individuals frequently co‐use benzodiazepines with alcohol, prescription opioids, and illicit drugs. Associated harms of benzodiazepine nonmedical use are substantial but occur primarily when people use benzodiazepines in combination with other drugs. Further, in cases where benzodiazepines were co‐used with other substances, medical outcomes are typically more severe than in cases involving benzodiazepines alone. Polysubstance overdose deaths account for the vast majority of overdose deaths documenting involvement of benzodiazepines.Additionally, FDA has observed that onlineotcmeds.com introduces into interstate commerce unapproved and misbranded Schedule II stimulants. Schedule II stimulants have an acknowledged high potential for abuse, and it is important to address the public health impact of their diversion and nonmedical use. Diversion is the primary source of prescription stimulants for nonmedical use, and nonmedical use is most frequent among young adults and college students. Polysubstance use is common among those who use prescription stimulants nonmedically, with individuals frequently co-using illicit drugs and/or prescription opioids. These concerns come against a backdrop of rising mortality from psychostimulant-involved overdoses, which involve illicit stimulants the vast majority of the time, but sometimes involve prescription stimulants. The easy availability of benzodiazepines and Schedule II stimulants via the Internet poses additional significant risks to U.S. consumers.There are inherent risks to consumers who purchase unapproved new drugs and misbranded drugs. Unapproved new drugs do not carry the same assurances of safety and effectiveness as those drugs subject to FDA oversight. Drugs that have circumvented regulatory safeguards may be contaminated, counterfeit, contain varying amounts of active ingredients, or contain different ingredients altogether. Accordingly, FDA requests that onlineotcmeds.com cease offering any unapproved and misbranded drugs for sale to U.S. consumers. This is critical to shielding the American public from harm.Unapproved New Drugs:Certain products offered for sale by onlineotcmeds.com are drugs within the meaning of section 201(g) of the FD&C Act [21 U.S.C. § 321(g)] because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or because they are intended to affect the structure or function of the body. These drugs are also new drugs as defined by section 201(p) of the FD&C Act [21 U.S.C. § 321(p)], because they are not generally recognized as safe and effective for their labeled uses. With certain exceptions not applicable here, new drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from FDA, as described in section 505(a) of the FD&C Act [21 U.S.C. § 355(a)]. No approved applications pursuant to section 505 of the FD&C Act are in effect for these products. Accordingly, their introduction or delivery for introduction into interstate commerce violates sections 301(d) [21 U.S.C. § 331(d)] and 505(a) of the FD&C Act.An example of an unapproved opioid you offer for sale on onlineotcmeds.com is fentanyl marketed as “Buy Fentanyl Patches Online” and “NDC 0591-3213-54 Fentanyl Transdermal System.” Evidence obtained from your website establishing that this product is a drug intended for human use (as defined in 21 CFR 201.128) includes the claim “Fentanyl is a prescription opioid drug.” While there are FDA-approved versions of fentanyl on the market in the U.S., including for the transdermal route of administration, there are no approved drug applications pursuant to section 505 of the FD&C Act in effect for “Buy Fentanyl Patches Online” and “NDC 0591-3213-54 Fentanyl Transdermal System” offered by onlineotcmeds.com. FDA-approved fentanyl transdermal system is indicated for the management of severe and persistent pain in opioid-tolerant patients that requires an extended treatment period with a daily opioid analgesic and for which alternative treatment options are inadequate.Another example of an unapproved opioid you offer for sale on onlineotcmeds.com is hydromorphone HCl marketed as “Buy Dilaudid online” and “Dilaudid® (Hydromorphone Hydrochloride).” Evidence obtained from your website establishing that this product is a drug intended for human use (as defined in 21 CFR 201.128) includes the claims “Hydromorphone belongs to a class of drugs known as opioid (narcotic) analgesics” and “Dilaudid is used to treat moderate to severe pain.” While there are FDA-approved versions of hydromorphone HCl on the market in the U.S., there are no approved drug applications pursuant to section 505 of the FD&C Act in effect for “Buy Dilaudid online” and “Dilaudid® (Hydromorphone Hydrochloride)” offered by onlineotcmeds.com. FDA-approved hydromorphone HCl (brand name DILAUDID) is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.An additional example of an unapproved opioid you offer for sale on onlineotcmeds.com is oxymorphone HCl marketed as “Buy Opana online” and “OPANA® ER (Oxymorphone Hydrochloride).” Evidence obtained from your website establishing that this product is a drug intended for human use (as defined in 21 CFR 201.128) includes the claims “Opana is used to help relieve moderate to severe pain. It belongs to a class of drugs known as opioid (narcotic) analgesics. It works in the brain to change how your body feels and responds to pain.” While there are FDA-approved versions of oxymorphone HCl on the market in the U.S., there are no approved drug applications pursuant to section 505 of the FD&C Act in effect for “Buy Opana online” and “OPANA® ER (Oxymorphone Hydrochloride)” offered by onlineotcmeds.com. FDA-approved oxymorphone HCl (brand name OPANA discontinued) is indicated for the management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. FDA-approved oxymorphone HCl extended release (brand name OPANA ER discontinued) is indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.FDA-approved fentanyl, hydromorphone HCl (brand name DILAUDID), and oxymorphone HCl are only available pursuant to a prescription from a licensed practitioner. Furthermore, these drug products each bear a boxed warning, commonly referred to as a “black box warning,” which is the strongest warning FDA requires, indicating that the drug carries a significant risk of serious or even life-threatening adverse effects. This boxed warning addresses risks including addiction, abuse, misuse, life-threatening respiratory depression (breathing problems), neonatal opioid withdrawal syndrome (withdrawal symptoms in newborn baby), and accidental exposure resulting in death. In addition, when these drug products are taken in conjunction with other central nervous system (CNS) depressants, including alcohol and benzodiazepines, use may result in coma or death.An example of an unapproved benzodiazepine you offer for sale on onlineotcmeds.com is brotizolam marketed as “Buy Brotizolam Online,” “BROTIZOLAM,” and “Brotizolam.” Evidence obtained from your website establishing that this product is a drug intended for human use (as defined in 21 CFR 201.128) includes the claims “Brotizolam is a triazole-benzodiazepine derivative with sedative, hypnotic, anxiolytic and anticonvulsant activities. Brotizolam binds to the benzodiazepine binding site on the gamma-aminobutyric acid (GABA)-A receptor in the central nervous system (CNS).” There are no FDA-approved versions of brotizolam on the market in the U.S., and there are no approved drug applications pursuant to section 505 of the FD&C Act in effect for brotizolam offered by onlineotcmeds.com.Another example of an unapproved benzodiazepine you offer for sale on onlineotcmeds.com is diazepam marketed as “Buy Diazepam online,” “Valium (Diazepam),” and “Valium® 10 mg.” Evidence obtained from your website establishing that this product is a drug intended for human use (as defined in 21 CFR 201.128) includes the claims “Diazepam is a benzodiazepine. It affects chemicals in the brain that may be unbalanced in people with anxiety. Diazepam is used to treat anxiety disorders, alcohol withdrawal symptoms, or muscle spasms.” While there are FDA-approved versions of diazepam on the market in the U.S., there are no approved drug applications pursuant to section 505 of the FD&C Act in effect for “Buy Diazepam online,” “Valium (Diazepam),” and “Valium® 10 mg” offered by onlineotcmeds.com. FDA-approved diazepam (brand name VALIUM) is indicated for the management of anxiety disorders, acute alcohol withdrawal symptoms, relief of skeletal muscle spasm and spasticity, and as adjunctive therapy in convulsive disorders.An additional example of an unapproved benzodiazepine you offer for sale on onlineotcmeds.com is lorazepam marketed as “Buy Lorazepam Online,” “Ativan®,” “Ativan® (Lorazepam), Lorcam-1.” Evidence obtained from your website establishing that this product is a drug intended for human use (as defined in 21 CFR 201.128) includes the claims “Lorazepam belongs to a class of drugs known as Benzodiazepines which is used to treat anxiety disorders in children and adults. This medicine produces a calming effect on the brain and nerves and enhances the effects of a certain natural chemical in the body.” While there are FDA-approved versions of lorazepam on the market in the U.S., there are no approved drug applications pursuant to section 505 of the FD&C Act in effect for “Buy Lorazepam Online,” “Ativan®,” “Ativan® (Lorazepam), Lorcam-1” offered by onlineotcmeds.com. FDA-approved lorazepam (brand name ATIVAN) is indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety or anxiety associated with depressive symptoms.FDA-approved diazepam (brand name VALIUM) and lorazepam (brand name ATIVAN) are only available pursuant to a prescription from a licensed practitioner. Furthermore, these drug products each bear a boxed warning addressing risks including abuse, misuse, addiction, and physical dependence. In addition, the concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death.An example of an unapproved Schedule II stimulant you offer for sale on onlineotcmeds.com is amphetamine (MAS) marketed as “Buy Adderall online” and “54092-391-01 ADDERALL No-Rx”. Evidence obtained from your website establishing that this product is a drug intended for human use (as defined in 21 CFR 201.128) includes the claims “Adderall is the brand name of prescription medicine for treating Attention Deficit Hyper Activity Disorder (ADHD) in children and adults” and “To treat narcolepsy doctors also prescribe Adderall (but not Adderall XR).” While there are FDA-approved versions of amphetamine (MAS) on the market in the U.S., there are no approved drug applications pursuant to section 505 of the FD&C Act in effect for “Buy Adderall online” and “54092-391-01 ADDERALL No-Rx” offered by onlineotcmeds.com. FDA-approved amphetamine (MAS) (brand name ADDERALL) is indicated for the treatment of attention deficit hyperactivity disorder (ADHD) and narcolepsy. Using the brand name of the drug product ADDERALL indicates that this product is intended to treat ADHD and narcolepsy. FDA-approved amphetamine (MAS extended release) (brand name ADDERALL XR) is indicated for the treatment of ADHD in adults and pediatric patients 6 years and older.Another example of an unapproved Schedule II stimulant you offer for sale on onlineotcmeds.com is methylphenidate HCl marketed as “Buy Ritalin Online,” “Ritalin (methylphenidate HCl) extended-release capsules,” and “Ritalin® 10 mg tablety.” Evidence obtained from your website establishing that this product is a drug intended for human use (as defined in 21 CFR 201.128) includes the claims “It works by changing the amounts of certain natural substances in the brain” and “Ritalin can help increase your ability to pay attention, stay focused on an activity, and control behavior problems.” While there are FDA-approved versions of methylphenidate HCl on the market in the U.S., there are no approved drug applications pursuant to section 505 of the FD&C Act in effect for “Buy Ritalin Online,” “Ritalin (methylphenidate HCl) extended-release capsules,” and “Ritalin® 10 mg tablety” offered by onlineotcmeds.com. FDA-approved methylphenidate HCl tablet (brand name RITALIN) is indicated for the treatment of ADHD in pediatric patients 6 years and older and adults, and narcolepsy. Using the brand name of the drug product RITALIN indicates that this product is intended to treat ADHD and narcolepsy. FDA-approved methylphenidate HCl extended-release capsule (brand name RITALIN LA) is indicated for the treatment of ADHD, in pediatric patients 6 to 12 years of age. FDA-approved methylphenidate HCl extended-release tablet (brand name CONCERTA) is indicated for the treatment of ADHD in children 6 years of age and older, adolescents, and adults up to the age of 65.FDA-approved amphetamine (MAS) (brand names ADDERALL and ADDERALL XR) and methylphenidate HCl (brand names RITALIN, RITALIN LA, and CONCERTA) are only available pursuant to a prescription from a licensed practitioner. Furthermore, these drug products each bear a boxed warning addressing risks including abuse, misuse, and addiction. In addition, these drug products can be diverted for non-medical use into illicit channels or distribution. Misuse and abuse of CNS stimulants, including these drug products, can result in overdose and death, and this risk is increased with higher doses or unapproved methods of administration.Misbranded Drugs:A drug is misbranded under section 502(f)(1) of the FD&C Act [21 U.S.C. § 352(f)(1)] if its labeling fails to bear adequate directions for use. “Adequate directions for use” means directions under which a layperson can use a drug safely and for the purposes for which it is intended (see 21 CFR 201.5). Prescription drugs, as defined in section 503(b)(1) of the FD&C Act [21 U.S.C. § 353(b)(1)] include those that, because of their toxicity or other potentiality for harmful effect, and/or the method of their use, and/or the collateral measures necessary for their use, are not safe for use except under supervision of a practitioner licensed by law to administer them. Prescription drugs, as defined in section 503(b)(1)(A) of the FD&C Act, can be used safely only at the direction, and under the supervision, of a licensed practitioner.Because the aforementioned drugs are prescription drugs intended for conditions that are not amenable to self-diagnosis and treatment by a layperson, adequate directions cannot be written such that a layperson can use the products safely for their intended use. Consequently, the labeling for these drugs fail to bear adequate directions for use, causing them to be misbranded under section 502(f)(1) of the FD&C Act. In addition, because these drugs are not approved in the U.S., they are also not exempt under 21 CFR 201.115(a) from the requirements of section 502(f)(1) of the FD&C Act. By offering these drugs for sale to U.S. consumers, onlineotcmeds.com is causing the introduction of misbranded drugs into interstate commerce in violation of section 301(a) of the FD&C Act [21 U.S.C. § 331(a)].FDA has also observed that onlineotcmeds.com offers prescription drugs for sale without a prescription. Under U.S. law, prescription drugs can be dispensed only pursuant to a prescription from a healthcare practitioner licensed by law to administer prescription drugs. By offering the aforementioned drugs without requiring a prescription, onlineotcmeds.com jeopardizes patient safety and misbrands the drugs under section 503(b)(1) of the FD&C Act. Dispensing a prescription drug without a prescription is an act which results in the drug being misbranded while held for sale, in violation of section 301(k) of the FD&C Act [21 U.S.C. § 331(k)].FDA is sending this warning letter to onlineotcmeds.com because of the inherent risks to consumers who purchase misbranded and unapproved new drugs. This letter is not intended to identify all the ways in which your products or operations might be in violation of the law. It is your responsibility to ensure that all products you offer for sale are in compliance with the FD&C Act and its implementing regulations. You should take prompt action to address any violations of the FD&C Act (which may include the offer for sale of similarly misbranded and/or unapproved new drugs other than the drugs noted above). We advise you to review your websites, product labels, and other labeling and promotional materials to ensure that you are not misleadingly representing your products as safe and effective for a use for which they have not been approved by FDA and that you are not distributing misbranded and unapproved drug products in violation of the FD&C Act.Please notify this office in writing within 15 working days describing the specific steps you have taken to address any violations and to prevent their recurrence. Include an explanation of each step being taken to remedy and prevent the recurrence of any violations, as well as copies of related documentation. Failure to adequately address this matter may result in legal action, including, without limitation, seizure, and injunction, without further notice. 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 corrections. This letter notifies you of our concerns and provides you with an opportunity to address them. 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 within 15 working days.If you are not located in the U.S., please note that products that appear to be misbranded or unapproved new drugs may be detained or refused admission. We may advise the appropriate regulatory officials in the country from which you operate that your products referenced above appear to be unapproved and misbranded products that cannot be legally sold to consumers in the U.S.Please direct your response and any inquiries to FDA at FDAInternetPharmacyTaskForce-CDER@fda.hhs.gov.Sincerely,/S/Sangeeta Vaswani Chatterjee, Pharm.D.Acting DirectorOffice of Drug Security, Integrity, and ResponseOffice of ComplianceCenter for Drug Evaluation and Research

依据《儿童抗肿瘤药物研发鼓励试点计划（星光计划）申报指南》，现将拟纳入“星光计划”试点项目的基本信息予以公示，公示时间截至2025年11月11日。 品种名称：安瑞替尼胶囊 申报单位：江苏威凯尔医药科技股份有限公司 拟开发儿童适应症：携带神经营养酪氨酸受体激酶（NTRK）融合基因的实体瘤 如有异议，请将具体意见发送至邮箱：etdrugs@cde.org.cn。国家药品监督管理局药品审评中心 2025年11月04日

广东省药品监督管理局通 告2025年第88号　　根据广东省药品监督管理局《2025年药品经营使用单位监督检查计划》安排，省药品监管局组织对以下17家药品经营企业进行监督检查，现将综合评定结论通告如下：序号企业名称药品经营许可证号综合评定结论所在地市1广东国康医药有限公司粤AA020001298符合要求广州市2广东仁惠堂药业有限公司粤AA020000176符合要求广州市3广州百济新特药业连锁有限公司粤BA020000121符合要求广州市4老百姓大药房连锁广东有限公司粤BA020000096符合要求广州市5广东众翔药业有限公司粤AA020000065符合要求广州市6广东华倍健医药有限公司粤AA756000721符合要求深圳市7深圳市欧健药业有限公司粤AA755001500符合要求深圳市8深圳市欧健药业有限公司粤BA755000233符合要求深圳市9珠海市老街坊医药连锁有限公司粤BA756000264符合要求珠海市10广东省东莞国药集团有限公司粤AA769000245符合要求东莞市11广东益善堂大药房有限公司粤BA769000636符合要求东莞市12东莞市永康堂医药连锁有限公司粤BA769000485符合要求东莞市13东莞市领草堂医药有限公司粤BA769000615符合要求东莞市14东莞市汇国大药房连锁有限公司粤BA769000703符合要求东莞市15广东常青藤药业有限公司粤BA769000541符合要求东莞市16东莞市御济堂医药科技有限公司粤BA769000614符合要求东莞市17东莞市健一医药有限公司粤BA769000714符合要求东莞市广东省药品监督管理局2025年10月31日

国家药品监督管理局组织检查组对扬州晓康医疗器械有限公司、江西锦胜医疗器械集团有限公司、西藏贝珠雅药业（集团）有限公司和青海瑞朗医疗科技开发有限公司进行飞行检查，发现企业的质量管理体系存在严重缺陷。　　一、扬州晓康医疗器械有限公司　　（一）生产管理方面。企业未能提供部分批次一次性使用导尿包和一次性使用无球囊导尿管产品生产记录，不符合《医疗器械生产质量管理规范》（以下简称《规范》）中关于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。企业无菌检验记录中未记录培养基名称、批号、配置过程及相关设备名称编号；企业未能提供部分批次一次性使用导尿包产品检验记录；未能提供部分批次乳胶导尿管、导尿包内包材和镊子的原材料检验记录；企业未按照一次性使用导尿包产品过程检验规程的要求，对密封性、外观等项目进行过程检验。上述检验记录不可追溯，不符合《规范》中关于每批产品均应当有检验记录，并满足可追溯的要求。　　（三）销售和售后服务方面。企业未能提供部分批次一次性使用导尿包产品销售记录，另有部分批次一次性导尿包产品虽能提供销售记录，但未能提供记录中的随货同行单等票据。企业相关销售记录不可追溯，不符合《规范》中关于企业应当建立产品销售记录，并满足可追溯的要求。　　（四）不良事件监测、分析和改进方面。企业未在国家医疗器械不良事件监测信息系统对一次性使用灌肠包产品开展信息维护，不能接收下游企业的报告信息，不符合《规范》中关于企业应当按照有关法规的要求建立医疗器械不良事件监测制度，开展不良事件监测和再评价工作，并保持相关记录的要求。　　二、江西锦胜医疗器械集团有限公司　　（一）设计开发方面。企业产品技术要求中规定的原材料型号与采购合同的规定不一致，未对变更后的个别原材料进行检验或验证，未提供采购后原材料的生物学评价报告，不符合《规范》中关于当选用的材料、零件或者产品功能的改变可能影响到医疗器械产品安全性、有效性时，企业应当评价因改动可能带来的风险，必要时采取措施将风险降低到可接受水平，同时应当符合相关法规的要求。　　（二）质量控制方面。企业产品检验报告不包含具体检验项目，仅体现使用性能、化学性能、生物性能合格；部分批次一次性使用输液器（带针式）成品检验未按照企业《成品检验规程》规定进行滴斗和滴管、输液流速项目检测；产品无菌检查记录无菌培养时间为7天，与产品技术要求规定不一致；企业用于检验的样品无取样记录，不能确定具体的取样点及取样方式、数量及取样人；企业部分检验项目实际操作方法与国家标准和操作规程要求均不一致，且未提供相关验证材料。企业成品质量控制方面不满足要求，不符合《规范》中关于企业应当根据强制性标准以及经注册或者备案的产品技术要求制定产品的检验规程，并出具相应的检验报告或证书的要求。　　（三）不合格品控制方面。现场检查发现企业挤吹塑车间不合格品区存放的部分不合格品无任何标识；部分不合格品仅记录了组件名称、数量和检验结论，但无产品批号、规格型号、生产日期、设备编号、检验员等信息；企业未能提供相关不合格品评审和处置记录。上述情形不符合《规范》中关于企业应当对不合格品进行标识、记录、隔离、评审，根据评审结果，对不合格品采取相应的处置措施的要求。　　（四）不良事件监测、分析和改进方面。企业未针对有关频发不良事件启动纠正预防措施，不符合《规范》中关于企业应当按照有关法规要求建立医疗器械不良事件监测制度，开展不良事件监测和再评价工作，并保持相关记录的要求。　　三、西藏贝珠雅药业（集团）有限公司　　（一）设计开发方面。企业在更换关键原材料重组胶原蛋白供应商以及采购不同规格型号的重组胶原蛋白时，未开展产品生物学评价，未开展原材料及成品中目标蛋白的结构正确性与质量一致性评价，也未制定相应风险控制措施，不符合《规范》中关于当选用的材料、零件或者产品功能的改变可能影响到医疗器械产品安全性、有效性时，企业应当评价因改动可能带来的风险，必要时采取措施将风险降低到可接受水平，同时应当符合相关法规的要求。　　（二）采购方面。企业部分关键原材料质量协议、采购合同中未明确原材料质量标准，购买的部分原材料性能指标不能满足规定要求，不符合《规范》中关于企业应当确保采购物品符合规定的要求，且不低于法律法规的相关规定和国家强制性标准的相关要求。　　（三）生产管理方面。企业部分工序作业指导书中未明确设备的设定参数，未对部分关键工序、特殊过程参数开展合理验证，不符合《规范》中关于企业应当编制生产工艺规程、作业指导书等，明确关键工序和特殊过程的要求。　　（四）不合格品控制方面。企业未对生产过程中出现铝塑复合管残损、报废的原因开展统计分析，也未对不合格品开展相关的评审及处置，不符合《规范》中关于企业应当对不合格品进行标识、记录、隔离、评审，根据评审结果，对不合格品采取相应的处置措施的要求。　　四、青海瑞朗医疗科技开发有限公司　　（一）机构与人员方面。企业未配备专职检验人员，不符合《规范》中关于企业应当配备与生产产品相适应的专业技术人员、管理人员和操作人员，具有相应的质量检验机构或者专职检验人员的要求。　　（二）厂房与设施方面。现场检查发现企业生产、检验共用同一套空气净化机组，无法满足无菌产品生产以及检验要求，存在交叉污染风险，且企业未能提供洁净区环境监测记录，不符合《规范》中关于企业应当配备与产品生产规模、品种、检验要求相适应的检验场所和设施的要求。　　（三）采购方面。企业部分批次股动脉压迫止血器部分原材料进厂日期、入库时间早于采购计划、采购申请单、采购合同、质量协议和采购订单时间，不符合《规范》中关于企业采购记录应当满足可追溯的要求。　　（四）生产管理方面。企业部分批次股动脉压迫止血器生产记录中缺少产品外包装、环氧乙烷灭菌、解析等记录，且灭菌解析台账显示产品灭菌和环氧乙烷解析完成时间为同一天，时间逻辑不合理；部分批次产品生产记录中记录的成品放行和入库数量与环氧乙烷解析出区数量和检验抽样数量不能形成对应关系，与留样和出库销售数量也不一致。企业批生产记录不完整，不能满足追溯要求，不符合《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。　　（五）质量控制方面。企业未能提供部分原材料接收和检验原始记录；企业某批次股动脉压迫止血器成品检验报告未包含产品技术要求中环氧乙烷残留量和无菌等项目，且未提供相关说明、验证记录或其他证据来证明不进行环氧乙烷残留量和无菌检验等的合理性。产品检验记录不可追溯，不符合《规范》中关于每批产品均应当有检验记录，并满足可追溯的要求。　　上述4家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，企业已对上述存在问题予以确认。　　属地省级药品监督管理部门应当按照《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，对有可能导致安全隐患的，按照《医疗器械召回管理办法》规定召回相关产品；企业完成全部缺陷项目整改后，经属地省级药品监督管理部门复查合格方可恢复生产。　　特此通告。　　国家药监局　　2025年11月3日

深圳市鹏瑞智能图像有限公司等15家注册人向广东省药品监督管理局主动提出注销产品注册证的申请。根据《医疗器械监督管理条例》的规定，现对该15家注册人持有的24张《医疗器械注册证》依法予以注销（注销清单见附件）。　　特此通告。　　附件：医疗器械注册证注销清单广东省药品监督管理局2025年11月3日　　附件医疗器械注册证注销清单序号注册人名称注册证编号产品名称1深圳市鹏瑞智能图像有限公司粤械注准20212061066电子内窥镜图像处理器2深圳市鹏瑞智能图像有限公司粤械注准20242060224电子内窥镜图像处理器3深圳市鹏瑞智能图像有限公司粤械注准20242060223一次性使用电子上消化道成像导管4深海精密科技（深圳）有限公司粤械注准20202061997移动式C形臂X射线机5深圳市艾伟迪生物科技有限公司粤械注准20222401308降钙素原（PCT）测定试剂盒（荧光免疫层析法）6广州树德科技股份有限公司粤械注准20242140104医用外科口罩7深圳申瑞医疗有限公司粤械注准20172190261盒式助听器8广州树德科技股份有限公司粤械注准20202141100一次性使用医用口罩9深圳艾素科技有限公司粤械注准20182090671远红外理疗贴10广东彼迪药业有限公司粤械注准20212140396一次性使用医用口罩11伏羲医疗用品（江门）有限公司粤械注准20232141128医用外科口罩12伏羲医疗用品（江门）有限公司粤械注准20222140241医用外科口罩13伏羲医疗用品（江门）有限公司粤械注准20232141347医用防护口罩14伏羲医疗用品（江门）有限公司粤械注准20222141212医用防护口罩15珠海市司迈科技有限公司粤械注准20202061876手术循环排烟装置16深圳源动创新科技有限公司粤械注准20222071993电子体温计17三椒口腔健康股份有限公司粤械注准20212141077医用防护口罩18惠州逗点生物技术有限公司粤械注准20232080657一次性使用鼻氧管19深圳市史丹福实业有限公司粤械注准20212140110一次性使用医用口罩20新产业大健康科技（珠海）有限公司粤械注准20202141674一次性使用医用口罩21广东东方医疗产业管理有限公司粤械注准20202140947一次性使用医用口罩22深圳博真生物科技有限公司粤械注准20222070096电子体温计23深圳市开成亿科技有限公司粤械注准20202071624额温计24广东天爱医疗器械科技有限公司粤械注准20232140091医用防护口罩

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），我局已依法注销“廉江市红景天药房有限公司”等28家企业《药品经营许可证》。现予以公布。编号许可证号许可证有效期限企业名称企业负责人注销时间注销原因1粤DA7590000942026/05/27廉江市红景天药房有限公司宣礼2025/7/14企业申请2粤CB759A2092027/07/24廉江市城北乘源便利店左琪琦2025/7/14企业申请3粤DB7590001752029/06/17廉江市益园堂大药房店（个人独资）宣礼2025/7/16企业申请4粤DB7590003452029/12/02廉江市益园堂大药房店车板分店宣礼2025/7/16企业申请5粤DB75906472025/12/06廉江市廉城西就药店郑仙2025/8/20企业申请6粤DB75905932025/10/22廉江市石角中总大药房陈健宇2025/8/26企业申请7粤CB7590000302026/10/17廉江市博爱国大药房有限公司建民店李莎2025/9/8企业申请8粤CB7590000012026/07/01廉江市博爱国大药房有限公司怡心店李莎2025/9/8企业申请9粤CB7590001572026/01/13廉江市博爱国大药房有限公司平坦店李莎2025/9/8企业申请10粤CB75940762026/05/10广东养天和九济堂医药连锁有限公司车板分店洪海天2025/9/16企业申请11粤DB759A0122026/06/16廉江市益熙药店严辉兰2025/9/16企业申请12粤DB759A6542027/03/24廉江市陈德桥药店张伟2025/9/17企业申请13粤DB759A2482026/08/19廉江市吉康药店刘诗琪2025/9/18企业申请14粤CB75941012028/01/28广东养天和九济堂医药连锁有限公司石岭分店洪海天2025/9/18企业申请15粤CB75908792026/05/10广东养天和九济堂医药连锁有限公司城南分店洪海天2025/9/18企业申请16粤DB7590002132026/11/08廉江廉安大药房梁晓玲2025/9/22企业申请17粤CB759A4142028/06/18湛江市养天和九济堂圣鑫大药房廖玲2025/9/23企业申请18粤CB75910092026/01/25广东养天和九济堂医药连锁有限公司溢杏威堂分店陈治春2025/9/23企业申请19粤DB759A5552026/12/29廉江市君益药房刘莉2025/9/28企业申请20粤CB75909742025/10/25广东养天和九济堂医药连锁有限公司红湖农场分店洪海天2025/9/28企业申请21粤CB7590000802030/01/15广东养天和九济堂医药连锁有限公司圩仔分店洪海天2025/9/28企业申请22粤CB75909972025/12/24广东养天和九济堂医药连锁有限公司坡脊分店洪海天2025/10/21企业申请23粤CB75940052026/06/10湛江市红太阳药业连锁有限公司廉江安铺店谢观妹2025/10/21企业申请24粤DB759A7092027/05/18廉江市民贤药店严辉兰2025/10/24企业申请25粤DB75945352026/08/04廉江市优之乐民大药房陈亚保2025/10/24企业申请26粤DB75905732025/10/12廉江市天星药店李柱梁2025/10/12证件过期27粤DB759A3972026/09/25廉江市亲民药店韩意2025/10/28企业申请28粤DB7590003092026/08/10廉江市友帮药店严辉兰2025/10/30企业申请湛江市廉江市市场监督管理局2025年11月4日