巴德医疗科技（上海）有限公司报告，由于特定批次产品因树脂原材料原因，导致出现了材料疲劳泄漏投诉的增加，生产商巴德血管通道系统公司Bard Access Systems, Inc.对其生产的外周插管中心静脉导管PowerPICC Catheter（国械注进20173031259）、外周插管中心静脉导管PowerPICC SOLO Catheter（国械注进20153032632）主动召回。召回级别为一级召回。涉及产品的型号、规格及批次等详细信息见《医疗器械召回事件报告表》。附件：医疗器械召回事件报告表　　　　　　　　　　　　　　　　　　　　　　　　　　　　2025年6月4日

柯惠医疗器材国际贸易（上海）有限公司报告，由于 5 毫米和 6 毫米球囊尺寸产品关于放气困难投诉数量有所增加，生产商美敦力公司Medtronic, Inc.对其生产的外周球囊扩张导管NanoCross Elite 0.014” Over-the-Wire PTA Balloon Dilatation Catheter（国械注进20193030436）主动召回。召回级别为二级召回。本次召回涉及的产品未进口至中国，具体型号、规格及批次等详细信息见《医疗器械召回事件报告表》。　　　附件：医疗器械召回事件报告表　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　2025年6月4日

美敦力（上海）管理有限公司报告，由于更新产品欧盟版本说明书的原因，生产商美敦力公司MEDTRONIC INC.对其生产的经导管主动脉瓣膜系统Medtronic Evolut PRO+ System（国械注进20243130221）主动召回。召回级别为三级召回。本次召回涉及的产品未进口至中国，具体型号、规格及批次等详细信息见《医疗器械召回事件报告表》。　　　　附件：医疗器械召回事件报告表　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　2025年6月4日

Delivery Method:VIA EMAIL WITH READ RECEIPTReference #:320-25-68Product:DrugsRecipient:Mr. Roland HolmqvistChief Executive OfficerRechon Life Science ABSoldattorpsvagen 5Limhamn216 13Skane LanSwedenIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesWarning Letter320-25-68April 30, 2025Dear Mr. Holmqvist:The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, Rechon Life Sciences AB, FEI 3002806978, at Soldattorpsvagen 5, Limhamn, Skane Lan, 216 13, Sweden, from August 26 to September 6, 2024.This warning letter summarizes significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals. See Title 21 Code of Federal Regulations (CFR), parts 210 and 211 (21 CFR parts 210 and 211).Because your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your drug products are adulterated within the meaning of section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 351(a)(2)(B).We reviewed your September 27, 2024 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 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)).You failed to ensure adequate aseptic behavior and establish appropriate written procedures designed to prevent microbiological contamination risks during the manufacture of drug products purported to be sterile. On August 26, 2024, our investigators observed an operator touching the(b)(4)of the(b)(4)with their gloved hand during the set up and assembly of the aseptic processing line.This unacceptable practice of touching the(b)(4)with gloved hands was permitted in your standard operating procedure (SOP-0870-3.0) for filling and sealing on the ampoule line. For example, your procedure allowed the operator to adjust the(b)(4), “with the fingertip” of a sanitized gloved hand.Your smoke studies simulated multiple adjustments of the(b)(4)with gloved hands during interventions and assembly. In one smoke study video, the operator made contact with the(b)(4)of the ampoule line(b)(4)during the “Assembly” phase.In your response, you provide corrective actions and preventative actions (CAPAs), including awareness training for all operators, a deviation investigation that examined 2 years of(b)(4)swab samples, a procedure revision, and the rejection of the affected batch.Your response is inadequate. You state that there was no intentional or accidental contact of the gloved hand with the(b)(4)during inspection. You also state the SOP for filling and sealing on the ampoule line “specifically stated that operators are not allowed to touch the(b)(4).” However, this assertion conflicts with your procedure and operator practices demonstrated in your smoke study videos. You did not provide environmental monitoring trend data for the(b)(4)swab samples. Furthermore, your revised procedure still allows for(b)(4)adjustments with sanitized, gloved fingertips, instructing operators to touch the(b)(4)as “(b)(4)” and to not “touch the(b)(4).” It is important that personnel avoid direct contact of critical surfaces with any part of their gown or gloves. Only sterile instruments should be used for manipulations and interventions on the aseptic processing line when handling sterilized materials. These sterile instruments should be stored in ISO 5 conditions when not in use to prevent contamination.For additional guidance on aseptic processing 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:A comprehensive risk assessment of all contamination hazards with respect to your aseptic processes, equipment, and facilities, including an independent assessment 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 Personnel Flows and Material Flows (throughout all rooms used to conduct and support sterile operations)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.Your plan to ensure appropriate aseptic practices and cleanroom behavior during production. Include steps to better assure routine and effective supervisory oversight for all production batches. Also, describe the frequency of quality assurance oversight (e.g., audit) during aseptic processing and other operations.A thorough risk assessment that evaluates how poor aseptic technique and cleanroom behavior, such as those observed during the inspection, may have affected quality and sterility of your drugs.2. 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).Your investigations into environmental monitoring (EM) excursion results and out-of- specification (OOS) assay results were inadequate.A. Your CAPAs to the persistent contamination of objectionable microorganisms were not robust, as evidenced by the continued recovery of gram-negative organisms and spore formers in the ISO 5 and 7 areas and on personnel since 2022. This deficiency was also cited during the previous inspection when an adverse trend of gram-negative rods (Moraxella osloensis) were recovered from operators’ clothing.For example, your investigation into the trend of eight occurrences of gram-negative organisms recovered from either operators’ gowning or from an ISO 7 air sample, was inadequate. You concluded that the adverse trend was due to operators talking in the ISO 7 areas and an increase of staff illness. Your CAPA included awareness training for operators and a procedural update for persons who perform sampling in(b)(4). However, your investigation did not provide a holistic evaluation of all potential contamination sources and personnel practices in the facility contributing to the adverse trend.In your response, you state you will implement additional immediate actions, including the requirement for mouth covers in ISO 8 areas and having operators apply a second layer of shoe covers as they pass through the(b)(4).Your response is inadequate. Although you state you do not have a “current issue related to objectionable microorganisms, i.e. spore formers and gram-negative bacteria,” you fail to provide sufficient evidence to support this statement. In addition, you do not address ill operators working in aseptic areas as noted in your deviation as the identified root cause for the trend.B. Your investigations into OOS results were inadequate because they lacked scientific rationale for root cause determinations. For example, you initiated an OOS investigation for(b)(4)assay content for(b)(4)Injection,(b)(4)mg/mL, batch(b)(4). The specification for(b)(4)content was(b)(4)mg/mL. The sample was injected(b)(4), and your initial test yielded an(b)(4)result of(b)(4)mg/mL(b)(4). Your investigation concluded, without adequate scientific justification, that a non-functional injector syringe was the probable root cause. You invalidated the original results without an obvious laboratory error and no manufacturing assessment was performed. A new analysis was performed and the passing results were recorded.In your response, you acknowledge that the laboratory investigations “contain gaps” and your procedure for conducting OOS investigations can be improved. You revised your procedures to include hypothesis testing during the laboratory investigations.Your response is inadequate. Your revised procedures do not require a manufacturing investigation to be conducted prior to invalidating data unless it is an obvious laboratory error. In addition, your company did not conduct a retrospective review of invalidated laboratory data for drug products marketed in the United States to ensure the drug meets the identity, strength, quality and purity it purports.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 assurance unit oversight, and written procedures. Address how your firm will ensure all phases of investigations are appropriately conducted.A comprehensive independent review of your personnel and environmental monitoring program, including but not limited to:o A plan to fully remediate these programs. For example, describe changes to equipment, procedures and practices that will ensure meaningful ongoing data is collected to promptly detect and respond to emerging microbial trends from your classified areas. Provide an updated timeline for implementation of your program, including procedural changes.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 analysis, 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.o A comprehensive review and remediation plan for your OOS result investigation systems. The CAPA should include, but not be limited to, addressing the following: o Quality unit oversight of laboratory investigations. o Identification of adverse laboratory control trends. o Resolution of causes of laboratory variation. o Initiation of thorough investigations of potential manufacturing causes whenever a laboratory cause cannot be conclusively identified. o Adequately scoping of each investigation and its CAPA. o Revised OOS investigation procedures with these and other remediations.3. Your firm failed to establish an adequate system for cleaning and disinfecting the room and equipment to produce aseptic conditions (21 CFR 211.42(c)(10)(v)).A. Your firm failed to validate and assess the effectiveness, distribution, and reproducibility of(b)(4)decontamination to ensure it can safely achieve a state of control in aseptic rooms against objectionable microorganisms.For example, your firm utilized(b)(4)as an(b)(4)decontamination of aseptic filling lines(b)(4). Your investigation reported several instances of spore-forming bacteria during(b)(4), in ISO 7 areas. The identified bacteria included species such asPaenibacillus provencensis/shunpengii/urinalis, Bacillus infantis, Niallia circulans complex, Metabacillus halosaccharovorans, Peribacillus simplex, Bacillus subtilisgroup andBacillus cereusgroup. The root cause was identified as an “inadequate process for(b)(4)sanitization,” which was “unclear and may be causing the growth of spore forming bacteria in Grade B.” Additionally, the same(b)(4)decontamination cycle showed positive biological indicators (BIs) on aseptic lines(b)(4)during(b)(4)periods ((b)(4)). The results indicate the(b)(4)decontamination process is ineffective.In your response, you state the BIs were used for informational purposes only and not as an evaluation of the(b)(4)decontamination process. You acknowledge the title of the SOP “(b)(4)Sanitization – Decontamination of rooms at Bulk Production” is misleading and the use of(b)(4)is not implemented as a routine decontamination process. You corrected the title to be “Disinfection of grade A and B areas within Bulk Production with(b)(4).” You state that you will collaborate with your vendor to perform a mapping study to verify the effectiveness of the disinfection process.Your response is inadequate. You do not provide evidence the(b)(4)decontamination process provides adequate surface coverage of all areas on the aseptic line, is compatible with materials, and ensures that residual(b)(4)that may remain on equipment does not affect product quality. Critical cleaning and sanitization agents must be validated. A mapping study is not validation of the disinfectant. Validation requires documented evidence that the disinfection process consistently removes or inactivates known or possible pathogens.B. Our investigators observed walls and floors of numerous ISO 8 production rooms were sticky and left visible(b)(4)residue when wiped by the hand. The investigators additionally noted fibers from disposable coveralls stuck to the walls in one of the production rooms. Such residual contamination can compromise product sterility and safety potentially resulting in patient harm.In your response, you state that your Quality Control Microbiology (QCM) group discovered the sticky floors and walls(b)(4). Your deviation investigation concluded that the probable root causes were a build-up of new cleaning disinfectants and a possible interaction with materials in the facility. Your CAPA included wiping surfaces with(b)(4)after cleaning.Your response is inadequate. You did not provide the deviation investigation for the evaluation and identification of the(b)(4)residue and a risk assessment of contamination to the drug product. Furthermore, you did not provide an assessment of your cleaning validation with regard to the new cleaning agents.In response to this letter, provide:A CAPA plan, based on the retrospective assessment of your cleaning and disinfection program, that includes appropriate remediations to your cleaning and disinfection processes and practices, and timelines for completion. Provide a detailed summary of vulnerabilities in your process for lifecycle management of equipment cleaning and disinfection. Describe 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.Appropriate improvements to your cleaning validation program, with special emphasis on incorporating conditions identified as worst case in your drug manufacturing operation. This should include, but not be limited to, identification and evaluation of all worst-case:o Drugs with higher toxicitieso Drugs with higher drug potencieso Drugs of lower solubility in their cleaning solventso Drugs with characteristics that make them difficult to cleano Swabbing locations for areas that are most difficult to cleano Maximum hold times before cleaningIn addition, describe the steps that must be taken in your change management system before introduction of new manufacturing equipment or a new product.A summary of updated SOPs that ensure an appropriate program is in place for verification and validation of cleaning procedures for products, processes, and equipment.4. Your firm failed to maintain buildings used in the manufacture, processing, packing, or holding of drug products in a good state of repair (21 CFR 211.58).Your firm did not properly maintain classified areas and cleanrooms used in the manufacture of drug products. Our investigators observed peeling paint on the ceiling as well as bubbled paint and rust at the bottom of the door in ISO 7 room(b)(4). Room(b)(4)provides access into aseptic filling line(b)(4).These deficiencies were discussed with your management at the time of the walk-through of the aseptic areas. Management stated the peeling paint surfaces above the(b)(4)door may be caused by the surface material being incompatible with the cleaning agent used to clean the production facility. It is critical that the building is maintained to prevent exposure of sterile articles to potential contamination hazards in the manufacturing operation.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.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 Rechon Life Science AB at Soldattorpsvagen 5, Limhamn, 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 3002806978 and ATTN: Erika V. Butler.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 MailProduct:Medical DevicesRecipient:Jeong-Hee JangPresident and CEODFI Co., Ltd.388-25 Gomo-Ro Jillye-MyeonGimhae-siGyeongsangnam-do50875South Korea(b)(6)@dficare.comIssuing Office:Center for Devices and Radiological HealthUnited StatesWARNING LETTERMay 6, 2025Dear Mr. Jang,During an inspection of your firm located in Gimhae, Gyeongsangnam, Korea on January 6, 2025 through January 9, 2025, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures CYBOW 11 Reagent Strips for Urinalysis (CYBOW 11). Under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 321(h), these products are devices because they are intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body.Quality System Regulation ViolationsThis inspection revealed that these devices are adulterated within the meaning of section 501(h) of the Act, 21 U.S.C. § 351(h), in that the methods used in, or the facilities or controls used for, their manufacture, packing, storage, or installation are not in conformity with the current good manufacturing practice requirements of the Quality System regulation found at Title 21,Code of Federal Regulations(CFR), Part 820. We received a response from Ms. Yong-Ae Park, Chief Research and Development Manager, dated January 23, 2025, concerning our investigator’s observations noted on the Form FDA 483 (FDA 483), List of Inspectional Observations, which was issued to your firm. We address this response below, in relation to each of the noted violations. These violations include, but are not limited to, the following:1. Failure to establish and maintain adequate procedures for receiving, reviewing, and evaluating complaints by a formally designated unit, as required by 21 CFR 820.198(a). Specifically, your firm’s 2022 to 2024 complaint logs showed that not all complaints were entered into your firm’s complaint handling system for evaluation, investigation, and MDR evaluation. For example, the following complaints involving the possible failure of the device to meet any of its specifications were not entered:a. Analyzer complaint #60 in 2022 was received on January 17, 2022, due to “Leukocyte shows false negative, Nitrite shows false positive;”b. Strip complaint #16 in 2022 was received on August 4, 2022, due to “All parameters are showing positive results;”c. Strip complaint #16 in 2023 was received on May 19, 2023, due to “False negative for Blood;”d. Analyzer complaint #6 in 2024 was received on January 15, 2024, due to “After dipping in water, Bld/Nit/Leu appear false positive;” ande. Strip complaint #25 in 2024 was received on December 3, 2024, due to “High concentration shows delayed or no color development.”Your firm’s representative, Ms. Yong-Ae Park, stated to the investigator that many of the complaints were not entered into the complaint handling system because they were handled informally by the sales department.We reviewed your firm’s response and conclude that it is not adequate. Your firm identified the root cause of the problem as, “the reason for not issuing the report is not clearly indicated, so we have updated it by adding it to the procedures.” Your firm’s response did not include a description or evidence that the specific complaints identified in the FDA 483 have been investigated. Your firm provided DFI-OP-801(V10) titled Customer complaints. While your firm noted that you updated your procedure to include situations where customer complaint reports would not be issued, the updated procedure document is inadequate. The procedure does not ensure that all complaints are processed in a uniform and timely manner, as required by 21 CFR 820.198(a)(1); it does not include timeframes for evaluating and reviewing complaints. Specifically, it does not ensure that complaints which require a 5-day or 30-day report in accordance with 21 CFR Part 803 are evaluated in a timely manner. Additionally, the updated customer complaint document allows for specific complaints involving the possible failure of the device to meet its specifications to not be reviewed, evaluated, and investigated (e.g., when abnormal color development is caused by the interfering substances mentioned in the insert). This procedure, allowing for such complaints to not be reviewed, evaluated, or investigated, does not meet the requirement of 21 CFR 820.198(c).Once an adequate complaint handling procedure is established your firm should provide evidence of training on the new procedure for all personnel who may receive complaints, including the sales department. Additionally, your firm should conduct a retrospective review to determine if corrections are needed in response to other complaints involving the possible failure of the device, labeling, or packaging to meet any of their specifications which were not appropriately investigated. A summary of the findings and a remediation plan, if necessary, should be provided.2. Failure to establish and maintain adequate procedures to control product that does not conform to specified requirements, as required by 21 CFR 820.90. For example:a. The investigator noted that during manufacture of the protein reagent (used in the manufacturing of the CYBOW 11), that the reagent failed the pH test three times but only the third failure(b)(4)was documented in the production record. Your firm’s representative, Ms. Yong-Ae Park, stated to the investigator that the technician did not believe in the failed results, and therefore, he repeated the tests.b. Page 6, Section 5 (subtitled 1st QC check) of the manufacturing process technical file provided during the investigation shows that your firm allows for a recheck of failed QCs during this stage of the workflow (1st QC check).c. Page 15, Section 12 (subtitled 3rd QC check) of the manufacturing process technical file provided during the investigation shows that your firm allows for a recheck of failed QCs during this stage of the workflow (3rd QC check).We reviewed your firm’s response and conclude that it is not adequate. With regards to the retesting failed pH values, your firm indicated that you revised your documentation (DFI-WIC-014(V2) Reagent manufacture_20250113) to include instructions that(b)(4). Additionally, the revision instructs(b)(4). While the revision to the reagent manufacture document addresses the identification, documentation, and evaluation of the nonconformance, it does not address segregation and disposition of the nonconforming product, nor does it specify whether the evaluation and any investigation shall be documented, as required by 21 CFR 820.90 (a). Additionally, your firm has not provided evidence to support that you have procedures that define the responsibility for review and the authority for the disposition of nonconforming product. The procedures must include instruction that disposition of nonconforming product shall be documented and shall include the justification for use of nonconforming product and the signature of the individual(s) authorizing the use, as required by 21 CFR 820.90 (b)(1).Your firm stated in your response, for the 1st QC check (described in the cover letter as semi-product), that, “If the result of the actual QC Inspection (Semi-Product(I) fails, we do not reconfirm, but it is incorrectly recorded in the Manufacturing Process and corrected.” Your firm provided the revised document titled, “2-TCF31D0-10_Manufacture process(b)(4).” However, item 2, section 5.5 in this document subtitled, “Processing of Inspection LOT” states, “Rejected Lot:If passed after a retest, it is put into the next process and discarded when rejected,” (emphasis added). Therefore, this response is inadequate because the revised document still includes language that allows users to retest without requiring that the nonconformance be evaluated and a determination of the need for an investigation be made in accordance with 21 CFR 820.90(a).As pertains to the 3rd QC check, your firm indicated in your response that this stage relates to the finished product and looks at two things: the test paper, and the packaging. Your firm indicates that if there is a problem with the test paper, you would(b)(4). Your firm provided the revised manufacturing process document and your nonconformity procedure to support this response. The revised manufacturing process document now states “(b)(4)” and the nonconformity product management document provided in your firm’s response includes a reference to “(b)(4)”. However, the documentation provided by your firm does not require that(b)(4), including a determination of any adverse effect from the(b)(4)the product, shall be documented in the device history record, as required by 21 CFR 820.90(b)(2). Further, your firm did not include reference to systemic corrective actions to ensure that adequate procedures are in place to control all product that does not conform to specified requirements as required by 21 CFR 820.90.Once an adequate nonconforming product procedure is established, your firm should provide evidence of training on the new procedures. Additionally, your firm should conduct a retrospective review to determine if other nonconforming product was appropriately handled. A summary of the findings and a remediation plan, if necessary, should be provided.3. Failure to establish and maintain adequate procedures to control labeling activities, as required by 21 CFR 820.120. Specifically, your firm’s representative, Ms. Yong-Ae Park, stated to the investigator that your firm does not have a written procedure to control labeling activities, and that your firm’s device history records (DHR) do not include or refer to the location of the primary identification labeling nor the unique device identifiers (UDI) used for each production unit/lot/batch for the CYBOW 11. The DHRs reviewed during the investigation did not include or refer to the location of the label and labeling used (primary label/UDI label) for each production unit/lot/batch. Ms. Yong-Ae Park informed the investigator that she did not know that the primary labeling (including UDIs) needs to be included as part of the DHRs.We reviewed your firm’s response and conclude that it is not adequate. Your firm provided documentation indicating that you added information relating to labeling to your inspection standard forms for raw and finished products related to the CYBOW 11, as well as an import inspection certificate for the label and a QC inspection report form with a location for the label. Your firm also provided documentation from a specific lot showing the implemented changes as well as training records demonstrating that staff have been trained on the inspection of finished products. However, while the documents mention label integrity, your firm has not provided evidence to show that you have implemented activities to ensure that labels shall be printed and applied so as to remain legible and affixed during the customary conditions of processing, storage, handling, distribution, and where appropriate use as required by 21 CFR 820.120(a).Additionally, your firm’s test inspection standard, which applies to the finished product, does not include information to show, as required by 21 CFR 820.120(b), that the labeling shall not be released for storage or use until a designated individual(s) has examined the labeling for accuracy including, where applicable, the correct UDI or universal product code (UPC), expiration date, control number, storage instructions, handling instructions, and any additional processing instructions. It also does not require that the release, including the date and signature of the individual(s) performing the examination, be documented in the DHR. Also, the documentation provided does not include information on labeling storage as required by 21 CFR 820.120(c), to support that labeling shall be stored in a manner that provides proper identification and is designed to prevent mix-ups.Further, the response is inadequate because your firm did not include reference to systemic corrective actions to ensure that you have procedures to control labeling activities for products other than the CYBOW 11, as required by 21 CFR 820.120. Once adequate labeling control procedures are established, your firm should provide evidence of training on the new procedures.4. Failure to establish and maintain procedures to ensure that DHRs for each batch, lot, or unit are maintained to demonstrate that the device is manufactured in accordance with the DMR and the requirements of 21 CFR 820.184. For example, per your firm’s mixing procedure forms listed below, technicians are not required to document the time and speed for the mixing procedures for the reagents of the CYBOW 11 reagent strips for urinalysis:Urobilinogen Operation ProcedureGlucose Operation ProcedureBilirubin Operation ProcedureKetones Operation ProcedureSG Operation ProcedureBlood Operation ProcedurePH Operation ProcedureProtein Operation ProcedureNitrite Operation ProcedureLeukocytes Operation ProcedureASA Operation ProcedureSpecifically, two DHR logs reviewed during the inspection (DHR for Lot 240104 and lot 240619) confirm that technicians do not document the time and speed for the mixing procedures to show that these activities were performed.We reviewed your firm’s response and conclude that it is not adequate. Your firm provided operation procedure documents for each of the reagents of the CYBOW 11. While your firm updated your reagent operating procedures with temperature, speed, and time ranges for each step of the process that requires mixing, the updated operating procedure documents are inadequate because you do not demonstrate that the device is manufactured in accordance with the DMR as required by 21 CFR 820.184. Specifically, the updated operating procedure documents do not instruct technicians to document in the production record, the exact temperatures, speed, and times at which you mixed the reagents. The DHR is intended to provide objective evidence that the requirements of the DMR were met and information to facilitate failure investigations and corrective or preventive actions. Lack of detail in the DHR will prevent a manufacturer from adequately investigating nonconformances.Additionally, the response is inadequate because your firm did not include reference to systemic corrective actions to ensure that DHRs for products other than the CYBOW 11 are maintained to demonstrate that they are manufactured in accordance with the DMR and the requirements of 21 CFR 820.184. Once adequate reagent operating procedures are established, your firm should provide evidence of training on the new procedure. Additionally, your firm should conduct a review to determine if all DHRs are complete. A summary of the findings and a remediation plan, if necessary, should be provided.5. Failure to adequately identify by suitable means the acceptance status of product, to indicate the conformance or nonconformance of product with acceptance criteria, as required by 21 CFR 820.86. Specifically, the original production identification (Pass/Fail) label used in the manufacture of the CYBOW 11 was not maintained. For example, while the manufacturing process document reviewed during the inspection states that all production processes are documented and controlled, the investigator noted that during manufacturing, the label used to track the reagent to show it was approved for use by QC is discarded after the product is moved to the next process. Your firm’s representative, Ms. Yong-Ae Park, stated to the investigator that the label is discarded once the reagent is moved to the next process.We reviewed your firm’s response and conclude that it is not adequate. In your response, your firm addressed the observation by providing multiple updated documents including: (i) the standard operating procedures for the(b)(4)processes, with added language to ensure that users confirm the presence of the QC approval seal, (ii)(b)(4)working forms, with a check box added to confirm the Lot number and QC acceptance for the dipping work product, and (iii) training forms to show that users were trained on the revised steps. However, the response is inadequate because your firm did not conduct a review to ensure that products other than the CYBOW 11 are also subjected to adequate acceptance status activities. A summary of the findings and a remediation plan, if necessary, should be provided.Medical Device Reporting (MDR) ViolationsOur inspection also revealed that you have failed to develop, maintain, and implement written Medical Device Reporting (MDR) procedures, as required by 21 CFR 803.17. For example: during the inspection, your firm presented the document titled “FDA Medical Decivice [sic] Reporting”, DFI‐OP‐816, Revision No. 1, dated 2023.05.01 as its written MDR procedure. Upon review, we conclude that the procedure does not establish internal systems that provide for timely and effective identification, communication, and evaluation of events that may be subject to MDR requirements, as required by 21 CFR 803.17(a)(1). For example, the procedure omits the definition of the term “malfunction” from 21 CFR 803.3(k), and fails to specify what kind of information “reasonably suggests” that an MDR reportable event has occurred per 21 CFR 803.20(c)(1). The exclusion of the definitions for these terms from the procedure may lead your firm to make an incorrect reportability decision when evaluating a complaint that may meet the criteria for reporting under 21 CFR 803.50(a).We reviewed your firm’s response and conclude that it is not adequate. The response includes a copy of your firm’s revised MDR procedures titled “FDA Medical Decivice [sic] Reporting”, DFI‐OP‐816, Revision No. 2, dated 2025.01.15. Upon review of the revision, we note that it still fails to specify what kind of information “reasonably suggests” that an MDR reportable event has occurred per 803.20(c)(1). Additionally, we encourage your firm to conduct a retrospective review to determine if corrections are needed for other complaints involving the possible failure of the device, labeling, or packaging to meet any of their specifications which were not appropriately investigated for reportability.We note that a device is deemed to be misbranded under section 502(t)(2) of the Act, 21 U.S.C. § 352(t)(2), if there was a failure or refusal to furnish any material or information required by or under section 519 of the Act, 21 U.S.C. § 360i, respecting the device, including adverse event reports required under 21 CFR Part 803.Other federal agencies may take your compliance with the FD&C Act and its implementing regulations into account when considering the award of federal contracts. Additionally, should FDA determine that you have Quality System regulation violations that are reasonably related to premarket approval applications for Class III devices, such devices will not be approved until the violations have been addressed.Please notify this office in writing within fifteen business days from the date you receive this letter of the specific steps your firm has taken to address the noted violations, including an explanation of how your firm plans to prevent these violations, or similar violations, from occurring again. Include documentation of the corrections and/or corrective actions (which must address systemic problems) that your firm has taken. If your firm’s planned corrections and/or corrective actions will occur over time, please include a timetable for implementation of those activities. If corrections and/or corrective actions cannot be completed within fifteen business days, state the reason for the delay and the time within which these activities will be completed. Please provide a translation of documentation not in English to facilitate our review. We will notify you regarding the adequacy of your firm’s response(s) and the need to re-inspect your firm’s facility to verify that the appropriate corrections and/or corrective actions have been made. If you believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration as part of your response.Your firm’s response should be sent via email to CDRHWarningLetterResponses@fda.hhs.gov. Refer to CMS case # 705464 when replying. If you have any questions about the contents of this letter, please contact: Christine Kilonzo at Christine.kilonzo@fda.hhs.gov.Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your firm’s facility. It is your firm’s responsibility to ensure compliance with applicable laws and regulations administered by FDA. The specific violations noted in this letter and in theInspectional Observations, FDA 483, issued at the close of the inspection may be symptomatic of serious problems in your firm’s manufacturing and quality management systems. Your firm should investigate and determine the causes of any violations and take prompt actions to address any violations and bring the products into compliance.Sincerely yours,/S/Courtney H. Lias, Ph.D.DirectorOHT 7: Office of In Vitro Diagnostic DevicesOffice of Product Evaluation and QualityCenter for Devices and Radiological HealthCC:Ms. Young Ae ParkChief Research and Development Manager DFI Co., Ltd.(b)(6)@dficare.comPriscilla ChungLK Consulting Group USA, Inc.US Agentjuhee.c@lkconsultinggroup.com

Delivery Method:Via EmailReference #:320-25-58Product:DrugsRecipient:Mr. Hongzhi LiCEOYiling Pharmaceutical Ltd.No. 36 Zhujiang StreetShijiazhuang ShiHebei Sheng,050035ChinaIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesWarning Letter320-25-58March 27, 2025Dear Mr. Li:The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Yiling Pharmaceutical Ltd., FEI 3011640199, located at No. 36 Zhujiang Street, Shijiazhuang, Hebei, China, from October 7 to 11, 2024.This warning letter summarizes significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals. See Title 21 Code of Federal Regulations (CFR), parts 210 and 211 (21 CFR parts 210 and 211).Because your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your drug products are adulterated within the meaning of section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 351(a)(2)(B).We reviewed your October 31, 2024 response to our Form FDA 483 in detail and acknowledge receipt of your subsequent correspondence.During our inspection, our investigator observed specific violations including, but not limited to, the following.1. Your firm failed to 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 211.63).Your non-dedicated manufacturing equipment was not designed and maintained appropriately to prevent potential cross-contamination of drug products.For example,(b)(4)were not designed and maintained to ensure that the(b)(4)consistently closes tightly, to prevent backflow of bulk drug powder into the(b)(4)duct. Residues were observed in the(b)(4)duct of(b)(4).Numerous drug substance residues, including(b)(4), were recovered upon swabbing of(b)(4). Your(b)(4), are used to manufacture multiple drug products, including(b)(4)therapeutics such as(b)(4).In addition, junctions on the(b)(4)duct had degraded seals and were covered with tape.In your response, you state you will replace the(b)(4)on(b)(4)to prohibit backflow into the(b)(4)ducting and replace the(b)(4)ducting on(b)(4)for ease of cleaning and sanitization. You further state you are identifying all batches of U.S. product within expiry from these(b)(4)and have initiated testing reserve samples for possible cross-contamination.Your response is inadequate. Your assessment is limited to testing reserve samples of each finished drug product only for the presence of the preceding drug substance processed on the same non-dedicated equipment, instead of testing each reserve sample for all drug substances processed on the equipment. You do not adequately address how you intend to maintain this equipment to ensure the integrity of the seals.Equipment used in pharmaceutical manufacturing operations should be designed to protect drug products from contamination. Air flow over dirty surfaces can cause contamination of the drug being processed in a(b)(4). Robust design, cleaning, and maintenance of this and other equipment are critical to prevent cross-contamination.Contamination is generally not uniformly distributed. Data obtained from retrospectively testing a small proportion of a batch (e.g., reserve samples for the presence of previous active ingredient) is limited in its ability to retrospectively assess the extent of contamination in other portions of a batch. The lowest or highest results obtained from testing a small sample size is unlikely to reveal the true range of minimum and maximum contamination level that exists in a batch exposed to the contamination hazards identified at your firm. Consequently, the range of variability of contamination levels in batches produced by your firm remain characterized by substantial residual uncertainty.Because of the limitations of retrospective testing in gaining a representative understanding of the entire lot, testing reserve samples alone is insufficient to determine the scope of the contamination issues and mitigate the associated risks. Further evaluation and scientific rationale are needed in your firm’s risk assessment to reflect the nature of cross-contamination events and determine the degree of cross-contamination risk that may be posed to portion of marketed batches.In response to this letter, provide the following:Your corrective action and preventive action (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 retrospective risk assessment that addresses all possible cross-contamination, including but not limited to, highly potent substances such as(b)(4).A comprehensive risk assessment from analysis of adverse drug events for all affected drug products. Any side effects possibly attributable to cross-contamination with(b)(4)should be reported.A detailed CAPA plan to implement segregation of highly potent substances such as(b)(4)from equipment shared with other drug products.2. Your firm’s quality control unit failed to exercise its responsibility to ensure drug products manufactured are in compliance with CGMP, and meet established specifications for identity, strength, quality, and purity (21 CFR 211.22).Your quality unit (QU) failed to adequately implement the facility’s quality function and ensure quality oversight. For example:You failed to have an adequate procedure to clean(b)(4). Your approved procedure did not include sufficient directions to clean the(b)(4)ducts, including directions on disassembly and visual inspection for cleanliness. Thus, you failed to identify visible residue with the possibility of cross-contaminated drug products being released to the market.In your response you identify(b)(4), was not designed to facilitate appropriate cleaning. You acknowledge this resulted in residual drug substances inside the(b)(4)duct of your(b)(4). You indicate that you are updating your cleaning procedures to require disassembly and post cleaning inspection.Your response is inadequate. You do not provide a written approved procedure that would ensure adequate disassembly and cleaning of the(b)(4)duct. And you fail to provide evidence you have implemented CAPA measures ensuring QU oversight of cross-contamination risks from highly potent substances, such as(b)(4), on shared equipment.You also manufacture(b)(4), a highly potent drug on the same shared equipment.(b)(4)is a hazardous drug that can cause(b)(4)if administered outside of its therapeutic range.In response to this letter, provide:A comprehensive, independent assessment and remediation plan to ensure your QU is given the authority and resources to effectively function. The assessment should also include, but not be limited to:o A determination of whether procedures used by your firm are robust and appropriate.o Provisions for QU oversight throughout your operations to evaluate adherence to appropriate practices.o A complete and final review of each batch and its related information before the QU disposition decision.o Oversight and approval of investigations and discharging of all other QU duties to ensure identity, strength, quality, and purity of all products.A comprehensive, independent retrospective assessment of your cleaning effectiveness to evaluate the scope of cross-contamination hazards. Include the identity of residues, other manufacturing equipment that may have been improperly cleaned, and an assessment whether cross-contaminated products may have been released for distribution. The assessment should identify any inadequacies of cleaning procedures and practices, and encompass each piece of manufacturing equipment used to manufacture more than one product.A CAPA plan, based on the retrospective assessment of your cleaning program, that includes appropriate remediations to your cleaning processes and practices, and timelines for completion. Provide a detailed summary of vulnerabilities in your process for lifecycle management of equipment cleaning. Describe improvements to your cleaning program, including enhancements to cleaning effectiveness; improved ongoing verification of proper cleaning execution for all products and equipment; and all other needed remediations.A comprehensive assessment of your overall system for investigating deviations, discrepancies, complaints, out-of-specification 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, QU oversight, and written procedures. Address how your firm will ensure all phases of investigations are appropriately conducted.A complete assessment of all investigations where unknown impurities or unknown peaks were detected in marketed product and a determination if these are associated with potential cross-contamination events.Your firm’s quality systems are inadequate. See FDA’s guidance documentQuality Systems Approach to Pharmaceutical CGMP Regulationsfor help implementing quality systems and risk management approaches to meet the requirements of CGMP regulations 21 CFR, parts 210 and 211 at https://www.fda.gov/media/71023/download.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 Yiling Pharmaceutical Ltd., located at No. 36 Zhujiang Street, Shijiazhuang, Hebei, China, 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 3011640199 and ATTN: Brian Nicholson.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.

行政相对人名称XXX有限公司行政相对人类别法人行政相对人代码_1(统一社会信用代码)XXX法定代表人XXX法定代表人证件类型身份证法定代表人证件号码XXX行政处罚决定书文号粤药监械罚〔2025〕2002号违法行为类型生产经营的医疗器械的说明书内容与经注册的相关内容不一致违法事实2024年8月至9月期间，当事人作为牙科综合治疗机（型号：SL8500）的生产厂家，提供给XXX医院牙科综合治疗台采购项目（以下简称牙科采购项目）的中标供应商广州市XXX公司的牙科综合治疗机说明书（A7版），与经注册的说明书（A3版）内容不一致。当事人在广州市XXX公司2024年9月9日中标牙科采购项目后，通过中间代理商销售了1台牙科综合治疗机（型号：SL8500，出厂编号：14206，生产日期：2024-11-16）给广州市XXX公司。广州市XXX公司交付给XXX医院后，因该设备安装调试达不到验收标准，当事人撤回该台机，并把销售款XXX元退回了中间代理商，无违法所得。处罚依据《医疗器械监督管理条例》第八十八条第（二）项处罚类别罚款处罚内容责令当事人立即停止生产、经营说明书内容不符合规定的医疗器械，并依法作出如下行政处罚：罚款10000元（人民币壹万元）处罚决定日期2025年5月28日处罚有效期3个月处罚机关广东省药品监督管理局处罚机关统一社会信用代码11440000MB2D034421数据来源单位广东省药品监督管理局数据来源单位统一社会信用代码11440000MB2D034421

天津市药品监督管理局行政处罚决定书                    津药监（五办）罚〔2025〕6号                  当事人：天津骏发森达卫生用品有限公司主体资格证照名称：《营业执照》统一社会信用代码：91120224738473795K住所：天津市宝坻经济开发区宝旺道17号法定代表人：王贵森我局执法人员于2025年3月27日对当事人进行现场检查，在其成品库发现有批号为AG310101医用护理垫成品50箱，12袋/箱，10片/袋，共计6000片，在产品包装袋正面标示“益柔棉®医用 内裤式 成人纸尿裤”，包装袋侧面标示“产品名称：医用护理垫”，包装袋未标注产品生产日期。2025年4月1日，我局对当事人立案调查。同日，我局执法人员对当事人授权委托人进行询问，调查其生产、检验及产品说明书、标签印制等情况。经查，当事人持有《营业执照》，医用护理垫《第一类医疗器械备案凭证》《第一类医疗器械生产备案凭证》。2024年7月31日，当事人在住所地生产了批号为AG310101的医用护理垫成品60箱，12包/箱，10片/包，共计7200片。在该产品包装袋上，正面标示“益柔棉®医用 内裤式 成人纸尿裤”，侧面标示产品名称为“医用护理垫”，包装袋上未标注产品生产日期。当事人医用护理垫《第一类医疗器械备案凭证》（备案号：津械备20240327号）及经备案的产品说明书、标签中，产品名称为医用护理垫。经备案的产品说明书规定生产日期：见包装。当事人生产医用护理垫包装上的说明书、标签相关内容与其经备案的说明书、标签不一致。上述事实，主要有以下证据证明：1、《营业执照》复印件1页，《第一类医疗器械备案凭证》复印件3页，《第一类医疗器械生产备案凭证》复印件1页，身份证复印件2份，授权委托书1份，证明了当事人主体及相关人员资质情况。2、现场笔录1份（共2页），产品包装袋照片打印件1份（共3页），经备案的产品说明书、标签复印件各1份，证明了当事人生产医用护理垫说明书、标签相关内容与经备案的产品说明书、标签不一致的事实。3、询问笔录1份（共3页）、生产记录复印件1份、检验记录复印件1份、销售发货单复印件1份，证明了当事人医用护理垫生产、入库、销售情况。4、整改报告1份（共3页），证明了当事人医用护理垫包装袋销毁整改情况。2025年5月20日，我局向当事人下达《行政处罚告知书》，告知当事人拟作出的行政处罚内容以及事实、理由、依据，并告知当事人依法享有陈述、申辩的权利。当事人在法定期限内未提出陈述、申辩。当事人生产的医用护理垫说明书、标签的内容与经备案说明书、标签不一致的行为违反了《医疗器械监督管理条例》第三十九条“医疗器械应当有说明书、标签。说明书、标签的内容应当与经注册或者备案的相关内容一致，确保真实、准确。医疗器械的说明书、标签应当标明下列事项：…（三）生产日期，使用期限或者失效日期；…”的规定。调查期间，当事人积极配合调查，如实供述违法事实，提供生产、检验记录和相关材料。依据《中华人民共和国行政处罚法》第三十二条第一款第五项：“当事人有下列情形之一的，应当依法从轻或者减轻行政处罚:…（五）法律、法规、规章规定其他应当从轻或者减轻行政处罚的。”的规定，参照《药品监督管理行政处罚裁量适用规则》第十一条第（二）项“当事人有下列情形之一的，可以从轻或者减轻行政处罚：…（二）积极配合药品监督管理部门调查并主动提供证据材料的；…。”，对当事人从轻处罚。依据《医疗器械监督管理条例》第八十八条第二项“有下列情形之一的，由负责药品监督管理的部门责令改正，处1万元以上5万元以下罚款；拒不改正的，处5万元以上10万元以下罚款；情节严重的，责令停产停业，直至由原发证部门吊销医疗器械生产许可证、医疗器械经营许可证，对违法单位的法定代表人、主要负责人、直接负责的主管人员和其他责任人员，没收违法行为发生期间自本单位所获收入，并处所获收入30%以上2倍以下罚款，5年内禁止其从事医疗器械生产经营活动：（二）生产、经营说明书、标签不符合本条例规定的医疗器械；”的规定，责令当事人改正违法行为，给予以下行政处罚：处罚款10000元。当事人应当自收到本行政处罚决定书之日起十五日内，将罚款缴至指定银行，或者通过电子支付系统缴纳。到期不缴纳罚款的，依据《中华人民共和国行政处罚法》第七十二条的规定，本局将每日按罚款数额的百分之三加处罚款，并依法申请人民法院强制执行。如对本决定不服，可以在收到本决定之日起六十日内向天津市人民政府申请行政复议；也可以在六个月内依法向天津市红桥区人民法院提起行政诉讼。申请行政复议或者提起行政诉讼期间，行政处罚不停止执行。

序号行政处罚决定书文号案件名称违法企业名称或违法自然人姓名违法企业组织机构代码法定代表人姓名主要违法事实行政处罚的种类和依据行政处罚的履行方式和期限做出处罚的机关名称和日期备注1桂药监南分流稽罚〔2025〕1号广西广恒医药有限公司销售劣药白头翁案广西广恒医药有限公司914501007738837814罗富文   当事人销售劣药白头翁（批号：2312026）的行为违反了《中华人民共和国药品管理法》第九十八条第一款的规定。依据《中华人民共和国行政处罚法》第二十八条第一款的规定和《中华人民共和国药品管理法实施条例》第七十五条的规定，责令当事人改正违法行为，给予当事人如下行政处罚：没收违法所得129.6元（壹佰贰拾玖圆陆角）。主动履行2025年6月9日广西壮族自治区药品监督管理局2025年5月23日