Delivery Method:Via Email Return Receipt RequestedProduct:DrugsRecipient:Mr. Bernard FraisseCEOExcelvision - Fareva1041 Chemin de la Digue du Rhône07300 Tournon-sur-RhôneFranceBFraisse@fareva.comIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesWarning Letter 320-26-98June 25, 2026Dear Mr. Fraisse:The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, Excelvision, FEI 3007058211, at 27 Rue de la Lombardiere, Annonay, from January 12 to 22, 2026.This warning letter summarizes significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals. See Title 21 Code of Federal Regulations (CFR), parts 210 and 211 (21 CFR parts 210 and 211).Because your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your drug products are adulterated within the meaning of section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 351(a)(2)(B).We reviewed your February 12, 2026, 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 failed to adequately investigate customer complaints for the various sterile (b)(4) drug products (prescription and over-the-counter) you manufacture. Your investigations were not thorough, did not appropriately expand in scope, and lacked a scientifically supported determination of root causes. You also failed to identify and implement adequate and timely corrective actions and preventive actions (CAPAs).Your product is intended to maintain sterility of its contents after (b)(4) by the consumer. However, since our previous inspection in November 2024, your firm has received a substantial number of complaints related to the presence of contamination.Visible evidence of contamination included mold, black specks, and discoloration on the tips and inner caps of containers for your (b)(4) drug product, (b)(4). Several complaint samples subsequently failed sterility testing. Notably, nine such non-sterility events have occurred in the last three years.You failed to adequately determine which hazards in your manufacturing operation and container-closure systems led to these critical, repeated incidents of contamination in your (b)(4) drug products.Specifically, you failed to adequately investigate potential container-closure integrity defects that would allow ingress of microbial contamination, which your product is intended to strictly preclude.You also failed to adequately assess potential sources of contamination from the manufacturing process as you neglected to evaluate relevant environmental and personnel monitoring (EM/PM) data. For example, the microorganism recovered from the failed complaint sample sterility test involving (b)(4) batch (b)(4) was identified as Alternaria alternata. This was the same microorganism recovered in EM/PM samples collected both before and after this batch was manufactured, including in the room where this batch was filled. Your complaint investigation report did not include this critical information.Similarly, your firm also failed to adequately investigate numerous contamination complaints related to your (b)(4) products.Instead of conducting a thorough, scientifically supported, and evidence-based root cause analysis, your firm attributed most of the root causes to inadequate handling by customers who used your products and concluded that no further action was necessary.If contaminated, (b)(4) drug products pose a heightened risk of harm because (b)(4). Microbes introduced directly into (b)(4) can pose a serious risk to consumers. Irreversible damage including (b)(4) can occur, and in some cases, may progress to life-threatening systemic infection. In addition, some components in your (b)(4) drugs, such as (b)(4), could serve as a nutrition source for contaminating microorganisms and promote their growth.In your response, you state that you will revise the complaint procedure to include a comparison of the microorganisms recovered from complaint samples with those found during environmental monitoring and to describe how to proceed when a complaint sample fails sterility testing. You also acknowledge that the absence of a (b)(4) in a formulation should be factored into your risk analysis when evaluating complaints. You also state that two of the aseptic processing lines will not be used to manufacture additional drug products for the U.S. market and they will be replaced with new processing lines.Your response is inadequate. It provides no evidence to support the investigation conclusions of inadequate handling by customers. It also provides no explanation for how microorganisms contaminated these drug products if they were sterile when released. We are also very concerned about the suitability of your container-closure system and whether you can effectively assure that every unit released will function as intended throughout its labeled usage period. Finally, although your FDA 483 response includes a letter you sent to the product owner listing specific batches that must be evaluated for recall due to complaint samples with sterility failures, the letter included no decision to recall these batches.It is essential that these unpreserved formulations and associated presentations afford robust protection in each unit produced in order to prevent potential consumer harm resulting from contamination during use of your (b)(4) products.In response to this letter, provide:A comprehensive, independent assessment of your overall system for investigating deviations, discrepancies, complaints, out-of-specification (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 oversight, and written procedures. Address how your firm will ensure all phases of investigations are appropriately conducted.An independent, retrospective review of investigations into all batches with potential microbial contamination or an OOS microbiological result (whether or not later invalidated). The investigations should be updated, wherever necessary, to detail your findings regarding the potential root causes of the contamination.An assessment of microbial hazard and patient risk associated with a unit that becomes contaminated in use. Provide your studies on the growth properties (microbial challenge studies) of each formulation in the event of in-use contamination, based on the maximum number of days of permitted use. In addition, in the event the formulation is deemed suitable following these studies, state whether your firm plans to reduce allowable use periods to no longer than 30 days.A comprehensive, independent evaluation of the suitability of the container-closure systems used for your (b)(4) drug products that are intended to continuously protect against ingress of microbial contamination throughout the period of use. At minimum, provide an evaluation of the following:o Product design considerations A general description of each possible failure mode that could potentially permit ingress of microbial contamination over its used period Detailed description of all influential variables, on their own or in combination, that may lead to lost integrity (irrespective of whether it may be transient) at any time at point of manufacture, or during consumer use. Regarding the latter, address potential vulnerability to (b)(4) and durability issues. Influential variables should include but not be limited to:• internal pressure changes;• list of all possible out-of-tolerance characteristics or defects for each container-closure component;• each potential mechanical failure mode of (b)(4), etc.);• possible assembly errors;• potential for a defective (b)(4), or microbial growth in the (b)(4);• events leading to leaks or punctures;• all other potential variables. Compatibility of the product design with the specific container-closure system(s) (e.g., integrity, functionality).o Container-closure system capability and suitability of incoming lots Detailed container-closure system design and performance specifications that you require of the manufacturer (supplier) who performs the primary container-closure production steps prior to the final filling/closing process performed at your facility. Summary of all studies done by your firm to evaluate whether the container-closure system design (and its related performance specifications) is appropriate to maintain the sterility of all marketed units throughout their use period. For each lot received from your supplier for the last three years, provide the numbers and types of defects obtained during manufacture of the container-closure system, as well as theoretical and actual yields. Whether any incoming container-closure lot was rejected by your firm. Process capability (e.g., Cpk, Ppk) of each significant step in the manufacturing assembly process for each of your product container-closure systems. Describe the various nonconformities that can occur, including a list of each defect type and its criticality classification, all in-process tests and limits, and maximum tolerances for each defect type. Other quality criteria used by your firm to evaluate suitability of each incoming lot of the pre-assembled product container-closure and its ability to assure backflow prevention (e.g., determining if any significant variances or deviations were associated with the specific lot)o Drug product manufacturing and stability All functionality tests, their purposes/capabilities, and associated acceptance criteria A detailed list of defect types and tolerances, as well as theoretical and actual yields for drug product batches manufactured in the last three years. An analysis of when an investigation is triggered, how nonconforming units are removed, how process control is maintained, and how any recurring quality problems are addressed. An assessment of whether the process is capable of detecting and removing all nonconforming units and whether nonconformities are appropriately evaluated to determine root cause and appropriate follow-up action to prevent future nonconformities. A description of how you assure that every unit released in a batch will have a defect-proof mechanism that always prevents microbial ingress so as to protect consumers from severe infection risk throughout its used period.o During use and after opening of sealed units Human factors or other studies to determine if your container-closure systems reproducibly yield functionality that always protects products from contamination under repeated and anticipated consumer use, including under conditions of stress throughout the usage period and for the maximum number of (b)(4).o CAPAs and mitigations to be implemented based on the above data and independent assessment.A list in table format (e.g., spreadsheet) of each complaint for drug product with potential contamination (e.g., foreign matter, discoloration, possible fungi/bacteria) on the container/closure system or in the product from the past three years as of the date of this letter, with the following columns:o Product type ((b)(4)), whether it contains (b)(4), batch number, and date of manufacture.o Date of complaint awareness, and whether a complaint sample was requested and received. If complaint sample was not initially received, describe how many follow-up attempts were made.o Complaint sample analysis results, including sterility test result, microbial identification, and date of analysis.o The potential or confirmed root causes.o If the product is (b)(4), detail any examination of the complaint samples or a reserve sample that was performed to evaluate proper functioning of the container/closure system.o If microorganisms were recovered, detail the number of times the same genus (include species if available) was recovered in EM/PM of your aseptic processing facility within a year (before and after) the date of manufacture.2. Your firm failed to establish and follow appropriate written procedures that are designed to prevent microbiological contamination of drug products purporting to be sterile, and that include validation of all aseptic and sterilization processes (21 CFR 211.113(b)).We observed poor aseptic practices during and after the setup of your filling line (b)(4) which is used in the manufacture of (b)(4) drug products.Personnel blocked unidirectional airflow to (b)(4) with their gloves during installation of the (b)(4) assembly.An operator conducting line clearance after setup leaned their head and torso through (b)(4) into the ISO 5 filling area and failed to disinfect the (b)(4) before (b)(4).In addition, the (b)(4) equipment on this line was poorly designed. The (b)(4) partially blocked unidirectional airflow over the (b)(4) bowl and fully blocked unidirectional airflow over the (b)(4).Your aseptic manufacturing processes should be designed, and operations executed, to prevent contamination hazards to your sterile product. Flaws in the design of cleanrooms and aseptic processing lines or improper execution of aseptic operations can promote influx of contamination into the critical processing area.In your response, you state that you will revise your procedures for proper aseptic behavior and retrain personnel. You also state that third-party consultants will observe personnel and provide corrective feedback before commercial production resumes. In addition, you state that the effectiveness of these corrective actions will be evaluated by observing all media fill activities and trending EM/PM results. You also state that the (b)(4) equipment has been modified to prevent the blocking of unidirectional airflow.Your response is inadequate. It does not include establishing a program to routinely monitor personnel for proper aseptic technique during commercial production, which is especially important considering your previous attempts to correct poor aseptic behavior were unsuccessful. In addition, it does not mention evaluating other aseptic processing line equipment for design deficiencies that are similarly vulnerable to impeded unidirectional airflow.In response to this letter, provide:A remediation plan that better assures ongoing management oversight throughout the manufacturing lifecycle of all drug products. Provide a more data-driven and scientifically sound program that identifies sources of process variability and assures that manufacturing operations meet appropriate parameters and quality standards. This includes, but is not limited to, evaluating suitability of equipment for its intended use, ensuring quality of input materials, determining the capability and reliability of each manufacturing process step and its controls, and vigilant ongoing monitoring of process performance and product quality.A comprehensive, independent risk assessment of all contamination hazards with respect to all aseptic processes, equipment, and facilities including, but not limited to:o all human interactions within the ISO 5 area (e.g., risk reduction or elimination of manual interventions wherever possible)o equipment suitability (e.g., reliability, capability, ergonomics, placement) and sufficient cleanroom spaceo air quality in the ISO 5 area and surrounding room including, but not limited to, air volume and flowo facility layouto personnel flow and material flow (movement throughout all rooms used to conduct and support sterile operations and all material transfers)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 at your facility and explain how this CAPA plan will robustly remediate your deficient sterile manufacturing operations. Include comprehensive changes to the design of both your aseptic processing lines and cleanrooms. Also, describe your plans for qualification and validation of your extensively remediated operations.Your systematic plan to assure adherence to appropriate aseptic practices, cleanroom behavior, and written procedures including, not but limited to, an assessment of the following with accompanying CAPA:o suitability of actual practices based on extensive retrospective review and prospective observation of aseptic processing operationso deficiencies in production management oversight and identification of specific improvements to ensure effective and routine supervisory oversight for all batcheso frequency and depth of quality unit (QU) oversight (e.g., audit, ad hoc, daily interactions) of aseptic processing and its support operationso adequacy of written procedureso the risk assessment should also evaluate how poor aseptic technique and cleanroom behavior may have affected the quality and sterility of your drugs3. Your firm failed to maintain floors, walls, and ceilings of smooth, hard surfaces that are easily cleanable in aseptic processing areas and establish an adequate system for maintaining equipment used to control the aseptic conditions (21 CFR 211.42(c)(10)(i) and 211.42(c)(10)(vi)).Facility Construction and MaintenanceThe floors, walls, and ceilings in your aseptic processing area are not constructed of smooth, hard surfaces that can be easily cleaned, or were not adequately maintained. Many ceilings and partitions in the classified areas of your (b)(4) building are made of (b)(4) which you have stated is “not waterproof” and “cannot be decontaminated.” This material is in areas such as filling rooms, compounding rooms, machine part washing rooms, the weighing area, and corridors. This is especially concerning considering the numerous water incursions you have had in the (b)(4) classified areas between January 2024 and January 2026, along with numerous mold recoveries in the routine production data available between January 2024 and March 2025.Any water leak in cleanrooms of an aseptic processing facility poses an unacceptable risk to environmental control and product sterility.In addition, our investigators documented damage in the floors, ceilings, and walls in classified areas, including cracks and gaps that exposed the base materials underneath. Our investigators also documented cracked (b)(4) material and apparent rust on the (b)(4) used in some of these areas. Given these multiple water incursions and other issues related to materials of construction, it remains unclear whether your facility infrastructure is suitable for aseptic manufacturing.Equipment MaintenanceDuring the inspection, we observed unsuitable conditions in the ISO 5 area of filling line (b)(4) where aseptic processing is conducted. For example:A handle above the cap bowl that holds sterile caps during filling was coated with what appeared to be flaking black paint.The (b)(4) for the (b)(4), which are adjacent to sterile (b)(4) and open bottles, appeared to be corroded.In your response to these equipment maintenance deficiencies, you state that these surfaces have been repaired and cleaned, and all other Grade A and B equipment surfaces have been inspected. You also state that procedures for the inspection of the aseptic processing equipment and overhead surfaces in lines (b)(4) have been revised to require routine documented inspections and immediate escalation if issues are found.Your response is inadequate. It does not sufficiently define routine inspections to determine state of repair of your aseptic processing facility, including but not limited to ensuring these inspections encompass all aseptic processing operations. In addition, it does not address investigating why responsible operations and QU personnel did not recognize and resolve these objectionable conditions when they occurred.In your response addressing your facility deficiencies, you state that you will replace all (b)(4) with smooth, non-porous, waterproof materials in all classified areas in August 2026. You also state that the damaged areas have been “repaired or temporarily sealed” and that you have created a procedure specifying the need for routine checks into facility conditions, including before resuming production after (b)(4).Your response is inadequate because it does not state that you will cease manufacturing all (b)(4) drug products (including (b)(4)) for the U.S. market until all comprehensive remediations in the design and maintenance of your facility and equipment have been implemented. In addition, it does not address investigating why your production personnel did not recognize or address the damaged surfaces when they first occurred.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. Your plan should also ensure that appropriate actions are taken throughout the company network.4. 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)).Your aseptic processing operation is inadequately designed to prevent contamination of your sterile (b)(4) drug products.For example, you do not sterilize critical equipment components, such as bowls, (b)(4) that handle container/closure parts, between batches. Instead, you disinfect the (b)(4) product ISO 5 (Grade A) filling lines (b)(4) using sporicide and (b)(4).It is critical to assure your firm has a program for cleaning and sterilization of all equipment that comes into contact with sterile product constituents (i.e., parts contacting sterilized formulation, containers, and closures).In your response, you state that some of these parts cannot be (b)(4) due to machine design, and you plan to start using sporicide between each batch, increase “microbiological sampling” by (b)(4)%, and begin swabbing container/closure contact equipment.Your response is inadequate. It does not include an impact assessment of this violation on drug product that is currently on the U.S. market, nor a commitment for a CAPA to ensure use of sterilizable equipment in the future. The use of sporicide, increased sampling, and equipment swabbing are not acceptable substitutes for sterilizing your product contact equipment.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. Include the following as part of the assessment and CAPA plan:o a detailed summary of vulnerabilities in your process for lifecycle management of equipment cleaning and disinfectiono a list of improvements, with an explanation how each will enhance cleaning and disinfection effectivenesso improved ongoing verification of proper cleaning and disinfection execution for all products and equipment and,o any other needed remediationsProvide 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.A comprehensive assessment and remediation plan to ensure your QU is given the authority and resources to effectively function. The assessment should also include, but not be limited to:o a determination of whether procedures used by your firm are robust and appropriateo provisions for QU oversight throughout your operations to evaluate adherence to appropriate practiceso a complete and final review of each batch and its related information before the QU disposition decisiono oversight and approval of investigations and discharging of all other QU duties to ensure identity, strength, quality, and purity of all productsDescribe how top management supports quality assurance and reliable operations, including but not limited to, timely provision of resources to proactively address emerging manufacturing/quality issues and to assure a continuing state of control.Drug Production Ceased and SuspendedWe acknowledge your commitment to cease production of (b)(4) drug products on line (b)(4) and suspend production of (b)(4) drug products on lines (b)(4) for the U.S. market until they have been replaced.If you plan to resume any (b)(4) drug product manufacturing operations regulated under the FD&C Act, notify this office before resuming your (b)(4) drug product manufacturing operations. You are responsible for resolving all deficiencies and systemic flaws to ensure your firm is capable of ongoing CGMP compliance. In your notification to the Agency, provide a summary of your remediations to demonstrate that you have appropriately completed all CAPAs.Drug RecallOn April 7, 2026, FDA held a teleconference with you recommending you consider removing any batches of (b)(4) drug products currently in distribution from the U.S. market.Between (b)(4), you issued voluntary recalls of all (b)(4) drug products currently in distribution from the U.S. market due to lack of sterility assurance. The company announcements were posted to the FDA website:(b)(4)Repeat Violations at FacilityIn a previous warning letter (WL 320-25-70), FDA cited similar severe CGMP violations. The recurrence of these violations demonstrates that your firm’s corrective actions were neither effective nor durable. Notably, your failure to correct these issues led to unacceptable drug product being distributed to the U.S. market.Ineffective Quality SystemSignificant findings in this letter demonstrate that your firm does not operate an effective quality system in accord with CGMP. In addition to the lack of effective management oversight of your production operations, we found your QU is not enabled to exercise proper authority and/or has insufficiently implemented its responsibilities. Executive management should immediately and comprehensively assess your company’s global manufacturing operations to ensure that your systems, processes, and products conform to FDA requirements.Additional Guidance on Aseptic ProcessingSee FDA’s guidance document Sterile Drug Products Produced by Aseptic Processing—Current Good Manufacturing Practice to help you meet the CGMP requirements when manufacturing sterile drugs using aseptic processing at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/sterile-drug-products-produced-aseptic-processing-current-good-manufacturing-practice.CGMP ConsultantBased 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 evaluate your operations and to assist your firm in meeting CGMP requirements if your firm intends to resume manufacturing drugs for the U.S. market. The qualified consultant should also perform a comprehensive six-system audit of your entire operation for CGMP compliance and evaluate the completion and efficacy of your CAPA before you pursue resolution of your firm’s compliance status with FDA.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.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.FDA placed all drugs and drug products offered for import into the United States from your firm on Import Alert 66-40 on April 27, 2026.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 continuing to refuse admission of articles manufactured at 27 Rue de la Lombardiere, 07100 Annonay, Ardeche, France, 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 and/or submit a request to schedule an FDA inspection. 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 3007058211 and ATTN: Russell Riley.Sincerely,/S/Francis GodwinDirectorOffice of Manufacturing QualityOffice of ComplianceCenter for Drug Evaluation and ResearchCC: Mr. Cédric VandermeirenGeneral ManagerExcelvisionEmail: cvandermeiren.corporate@fareva.com____________________________1 Under 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 - Return Receipt RequestedReference #:320-26-97Product:Drugs;Over-the-Counter DrugsRecipient:Mr. Ashish Arun DangeManaging DirectorWizcure Pharmaa Private LimitedPGN 02-1403, Emaar Palm Gardens Sector 83Gurgaon 122004 HaryanaIndiaIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesWarning Letter 320-26-97June 24, 2026Dear Mr. Dange:The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, Wizcure Pharmaa Private Limited, 3030304532, located at H-881, Phase III, RIICO Industrial Area Bhiwadi, Rajasthan, India, from December 3 to 10, 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 December 30, 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 ensure that laboratory records included complete data derived from all tests necessary to ensure compliance with established specifications and standards (21 CFR 211.194(a)).You lacked complete and original laboratory data demonstrating that the required testing was performed.For example, our investigator observed (b)(4) personnel monitoring microbial plates in your laboratory incubator with visible microbial growth. The next day, our investigator observed microbial plates with the same identification information with no growth. Both management and a microbiologist confirmed that the original microbial plates were discarded and replaced with new plates. This false data misrepresented the ISO 5 environmental conditions of your aseptic processing line.Additionally, our inspection found that you frequently failed to collect environmental monitoring, personnel monitoring, and (b)(4) samples, as required by your procedure. For example, personnel monitoring contact plates were not collected on November 29, 2025, during the manufacturing of (b)(4) solution USP (b)(4) batches (b)(4) and (b)(4).We also identified critical discrepancies in your sample test results. We found that you failed to reliably incubate samples and record accurate microbial counts. For example, our inspection repeatedly found unreliable and incorrect microbiology data, including, but not limited to, environmental monitoring samples.In addition, we identified other significant discrepancies in sample description, identification, and reconcilability. Our investigators also found laboratory forms were pre-filled with microbial testing information (e.g., sterility and (b)(4) testing results), further demonstrating untrustworthy documentation. Significantly, when your firm actually obtained environmental monitoring samples and we closely tracked the plates during our inspection, we noted several instances in which microbial contamination was present in your ISO 5 processing environment.Our inspectional findings indicate serious recurring data integrity breaches in your laboratory relating to critical microbiological tests and monitoring.Microbial monitoring and testing are essential quality control steps that are integral in preventing distribution of unsafe products. Such programs provide critical information on the state of control of the aseptic processing operation. Substitution of unreliable or false results fundamentally compromises a facility’s ability to identify risks to product sterility.In your response, you acknowledge confirmation of these data integrity breaches based on interviews with personnel and review of documentation. Your firm suspended manufacturing and has initiated a protocol-driven remediation program. Your firm has also engaged an independent third-party consultant to help with a comprehensive investigation and identification of corrective actions and preventive actions (CAPA).Your response is inadequate. While you acknowledge the systemic nature of your data integrity problems and have initiated an investigation, your response does not sufficiently address organizational causes of the observed data integrity practice. For example, you do not provide evidence that your quality unit organization has the resources and expertise to perform its function, including detecting deviations relating to data integrity and sterile drug operations.Your quality system does not adequately ensure the accuracy and integrity of data to support the safety, effectiveness, and quality of the drugs you manufacture. See FDA’s guidance document Data Integrity and Compliance With Drug CGMP for guidance on establishing and following CGMP compliant data integrity practices at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/data-integrity-and-compliance-drug-cgmp-questions-and-answers.In response to this letter, provide:• A comprehensive, independent assessment of your laboratory practices, procedures, methods, equipment, documentation, and analyst competencies. Based on this review, provide a detailed plan to remediate and evaluate the effectiveness of your laboratory system.• A comprehensive, independent assessment of documentation systems used throughout your manufacturing and laboratory operations to determine where documentation practices are insufficient. Include a detailed CAPA plan that comprehensively remediates your firm’s documentation practices to ensure you retain contemporaneous, attributable, legible, complete, original, and accurate records throughout your operation.• A current risk assessment of the potential effects of the observed failures on the quality of your drugs. Your assessment should include analyses of the risks to patients caused by the release of drugs affected by a data integrity deviation and analyses of the risks posed by ongoing operations.• A comprehensive CAPA, overseen by a qualified consultant, for handling microbiological sampling media to ensure robust and reliable data. Establish a system that ensures uninterrupted custody and full reconciliation of all microbiological samples including, but not limited to:o unique labeling of each sampleo signatures of all staff who handle the sampleo complete tracking of sample integrity and custodyo date and time of each activity (e.g., sample collection, transport, delivery, incubation, removal from incubator)o digital time-stamped photos of all plateso signatures of personnel performing reading of microbial countso provisions for verifications and routine quality assurance oversight.• An independent assessment and remediation plan for your CAPA program. Provide a report that evaluates whether the program includes effective root cause analysis, ensures CAPA effectiveness, analyzes investigations trends, improves the CAPA program whenever needed, ensures final quality unit decision authority, and is fully supported by executive management.• An independent review of your microbial effectiveness testing program, including assuring that all multi-use products are evaluated using sound microbial effectiveness study protocols and that each formulation is suitable throughout its use period.2. Your firm failed to perform operations within specifically defined areas of adequate size and to have separate or defined areas or such other control systems necessary to prevent contamination or mix-ups in aseptic processing areas (21 CFR 211.42(c)(10).Your aseptic manufacturing filling line used to produce over-the-counter (OTC) sterile drug products is inadequate.For example, the inspection documented that your filling line has no physical barrier separating and protecting your ISO 5 (Grade A) aseptic filling line from the surrounding ISO 7 (Grade B) room and its personnel. The absence of a physical barrier separating the ISO 5 (Grade A) filling zone from the ISO 7 (Grade B) surrounding environment creates an unacceptable risk to product sterility.Furthermore, several equipment parts in direct contact with drug product, containers, and closures were not sterilized.It is essential that the ISO 5 (Grade A) environment continuously maintains an extremely high level of air cleanliness to protect the exposed sterile drug product from contamination. Without proper physical separation, the integrity of the aseptic processing environment cannot be reliably maintained as air currents, personnel movement, and other variables in the less-controlled ISO 7 space can directly convey contamination into the ISO 5 zone.In addition, to ensure sterility, it is imperative that only sterile equipment comes into direct contact with the sterile formulation, containers, and closures.Your aseptic processing room also had inadequate space to accommodate appropriate ergonomics, personnel flow, and material flow. Our inspection also found that your processing equipment was in poor state of repair, as detailed later in this letter.Finally, you lacked a meaningful environmental monitoring (e.g., critical surfaces, viable air) and personnel monitoring program for your aseptic processing line.Aseptic manufacturing processes operations must be performed in specifically defined areas of adequate size and vigilantly monitored to promptly identify microbial hazards before there is a non-sterility consequence.In your response, you commit to replacing your (b)(4) filling line with a restricted access barrier system (RABS) and implementing a comprehensive environmental monitoring program.Your response is inadequate. Your response lacks a comprehensive evaluation of aseptic processing facility suitability, including but not limited to cleanroom design.In response to this letter, provide:A comprehensive independent risk assessment of all contamination hazards with respect to your aseptic processes, equipment, and facilities, that includes, but is not limited to:o all human interactions within the ISO 5 area (e.g., risk reduction or elimination of manual interventions wherever possible)o equipment placement and suitability, including ergonomics for each human interaction and sufficient cleanroom spaceo air quality in the ISO 5 area and surrounding room including, but not limited to, air volume and flowo reduction or elimination of aseptic manipulationso facility layouto personnel flows and material flows throughout all rooms used to conduct and support sterile operationso specific CAPA recommendations that will comprehensively address the design and control hazards identified in the risk assessmentA 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 at your facility and explain how this CAPA plan will robustly remediate your deficient sterile manufacturing operations. Include comprehensive changes to the design of both your aseptic processing lines and cleanrooms. Also, describe your plans for qualification and validation of your extensively remediated operations.An independent, comprehensive review of your environmental monitoring program to ensure vigilant, timely detection and response to potential product contamination hazards in your manufacturing environment. This assessment should include, but not be limited to:o establishing appropriate limitso sampling methodso sampling locations and frequencieso trend analysiso appropriate investigation of deviations and adverse trendso and a comprehensive CAPA plan based on the findings of the assessment.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.Your CAPA plan to implement routine, vigilant operations management oversight of facilities and equipment. This plan should incorporate oversight from a qualified independent consultant and 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.3. Your firm failed to follow appropriate written procedures that are designed to prevent microbiological contamination of drug products purporting to be sterile, and that include validation of all aseptic and sterilization processes (21 CFR 211.113(b)).Your aseptic process simulations (media fills) were not sufficiently representative of commercial aseptic manufacturing operations. Also, batch records lacked documentation of all personnel present and interventions conducted during aseptic manufacturing.Additionally, the airflow visualization (i.e., smoke studies) was not performed under dynamic conditions to assess the hazards posed by interventions into the aseptic processing line. Your static airflow visualization addressed areas surrounding filling room (b)(4). Notably, we also observed aseptic operator deviations including, but not limited to, wearing safety glasses with exposed skin during aseptic production.In your response, you acknowledge that media fills did not sufficiently document operations and that previously executed media fills were not representative of aseptic processing conditions.Your response is inadequate. You lack sufficient details regarding batch record improvements to document the type, quantity, and duration of interventions during commercial batch production as well as media fill simulations.See FDA’s guidance document Sterile Drug Products Produced by Aseptic Processing—Current Good Manufacturing Practice to help you meet the CGMP requirements when manufacturing sterile drugs using aseptic processing at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/sterile-drug-products-produced-aseptic-processing-current-good-manufacturing-practice.In response to this letter, provide the following:Perform a critical evaluation of airflow unidirectionality in your aseptic process with the assistance of a qualified consultant. Ensure smoke studies are conducted under dynamic conditions with thorough and complete evaluations of aseptic processing line airflow unidirectionality including the impact of dynamic interactions and aseptic interventions. These thorough smoke studies should be performed after you remediate your aseptic operation and conducted using proper practices (e.g., neutrally buoyant media) to appropriately visualize airflow.Your plan to ensure appropriate aseptic practices and cleanroom behavior. Include steps to ensure routine and effective supervisory oversight for all production batches. Also describe the frequency of quality unit oversight (e.g., audit) during aseptic processing and its support operations.A comprehensive, independent assessment of the qualifications and competencies of operations and quality assurance management to conduct their job duties throughout your aseptic manufacturing operations.A comprehensive assessment and remediation plan to ensure your quality unit (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 appropriateo provisions for QU oversight throughout your operations to evaluate adherence to appropriate practiceso a complete and final review of each batch and its related information before the QU disposition decisionoversight and approval of investigations and discharging of all other QU duties to ensure identity, strength, quality, and purity of all products.4. Your firm failed to clean, maintain, and, as appropriate for the nature of the drug, sanitize and/or sterilize equipment and utensils at appropriate intervals to prevent malfunctions or contamination that would alter the safety, identity, strength, quality, or purity of the drug product beyond the official or other established requirements (21 CFR 211.67(a)).You failed to adequately maintain your manufacturing equipment. For example, your filling line was observed with apparent rust on the critical aseptic processing equipment, including the (b)(4).Also, our investigators observed stains and apparent rust on the HEPA filters and their diffuser grids above the filling line.We are concerned with your management’s lack of oversight of manufacturing operations that allowed insanitary equipment to be used in sterile drug manufacturing.An effective equipment management program requires a proactive lifecycle approach with systematic monitoring, maintenance, and timely replacement to ensure continued process capability. Pharmaceutical quality systems must integrate equipment performance data, maintenance oversight, and risk assessment to drive timely CAPA.In your response, you acknowledged the presence of what appeared to be rust and deterioration in the (b)(4) filling line. You attributed the root cause to a systematic gap in equipment lifecycle management. You indicate that you conducted an assessment and remediation of equipment.Your response is inadequate. While you acknowledge the identified systemic gaps in equipment lifecycle management, your corrective action appears to include limited remediations. Also, you did not conduct a retrospective risk assessment for batches that were processed using equipment in unsuitable condition for manufacturing sterile drug products.In response to this letter, provide the following:A remediation plan that better assures ongoing management oversight throughout the manufacturing lifecycle of all drug products. Provide a more data-driven and scientifically sound program that identifies sources of process variability and assures that manufacturing (including both production and packaging) operations meet appropriate parameters and quality standards. This includes, but is not limited to, evaluating suitability of equipment for its intended use, ensuring quality of input materials, determining the capability and reliability of each manufacturing process step and its controls, and vigilant ongoing monitoring of process performance and product quality.A summary of updated SOPs that ensure an appropriate program is in place for verification of equipment condition and validation of cleaning procedures for products, processes, and equipment.Provide a detailed remediation plan, performance protocols, and written procedures that include a defined timeline, milestones, and documentation to conduct the qualification of equipment (e.g., aseptic filling lines) and facilities (e.g., aseptic filling rooms).Data Integrity RemediationYour quality system does not adequately ensure the accuracy and integrity of data to support the safety, effectiveness, and quality of the drugs you manufacture. See FDA’s guidance document Data Integrity and Compliance With Drug CGMP: Questions and Answers for guidance on establishing and following CGMP compliant data integrity practices at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/data-integrity-and-compliance-drug-cgmp-questions-and-answers.We acknowledge that you are using an independent third-party consultant to audit your operation and assist in meeting FDA requirements. In response to this letter, provide:A comprehensive investigation into the extent of the inaccuracies in data records and reporting. Your investigation should include:o A detailed investigation protocol and methodology; a summary of all laboratories, manufacturing operations, and systems to be covered by the assessment; and a justification for any part of your operation that you propose to exclude.o Interviews of current and former employees to identify the nature, scope, and root cause of data inaccuracies. We recommend that these interviews be conducted by a qualified third party.o An assessment of the extent of data integrity deficiencies at your facility. Identify omissions, alterations, deletions, record destruction, non-contemporaneous record completion, and other deficiencies. Describe all parts of your facility’s operations in which you discovered data integrity deviations.o A comprehensive retrospective evaluation of the nature of the testing/manufacturing/other data integrity deficiencies. We recommend that a qualified third party with specific expertise in the area where potential breaches were identified should evaluate all data integrity deviations.A current risk assessment of the potential effects of the observed failures on the quality of your drugs. Your assessment should include analyses of the risks to patients caused by the release of drugs affected by a data integrity deviations and analyses of the risks posed by ongoing operations.A management strategy for your firm that includes the details of your global corrective action and preventive action plan. Your strategy should include:o A detailed corrective action plan that describes how you intend to ensure the reliability and completeness of all data including analytical data, manufacturing records, and all data submitted to FDA.o A comprehensive description of the root causes of your data integrity deviations including evidence that the scope and depth of the current action plan is commensurate with the findings of the investigation and risk assessment. Indicate whether individuals responsible for data integrity deviations remain able to influence CGMP-related or drug application data at your firm.o Interim measures describing the actions you have taken or will take to protect patients and to ensure the quality of your drugs, such as notifying your customers, recalling product, conducting additional testing, adding lots to your stability programs to assure stability, drug application actions, and enhanced complaint monitoring.o Long-term measures describing any remediation efforts and enhancements to procedures, processes, methods, controls, systems, management oversight, and human resources (e.g., training, staffing improvements) designed to ensure the integrity of your company’s data.o A commitment to have a qualified consultant conduct extensive annual audits, for at least two years, to assist in evaluating CAPA effectiveness after you have executed your data integrity remediation protocol.o Inform FDA if you will be hiring a chief integrity officer who is fully empowered to receive anonymous complaints from employees reporting data integrity concerns and with the authority to ensure any potential breach is promptly investigated by independent quality assurance function, along with expertise from outside entities whenever needed.o A status report for any of the above activities already underway or completed.Drug Production SuspendedWe acknowledge your commitment to suspend production of all (b)(4) OTC (b)(4) drug products for the U.S. market. In response to this letter, clarify whether you intend to resume manufacturing drugs for the U.S. market at this facility in the future.If you plan to resume any manufacturing operations regulated under the FD&C Act, notify this office before resuming your drug manufacturing operations. You are responsible for resolving all deficiencies and systemic flaws to ensure your firm is capable of ongoing CGMP compliance. In your notification to the Agency, provide a summary of your remediations to demonstrate that you have appropriately completed all CAPAs.Quality SystemSignificant findings in this letter demonstrate that your firm does not operate an effective quality system in accord with CGMP. In addition to the lack of effective management oversight of your production, laboratory operations, we found your quality unit is not enabled to exercise proper authority and has insufficiently implemented its responsibilities. Executive management should immediately and comprehensively assess your company’s operations to ensure that your systems, processes, and products conform to FDA requirements.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 evaluate your operations and to assist your firm in meeting CGMP requirements if your firm intends to resume manufacturing drugs for the U.S. market. The qualified consultant should also perform a comprehensive six-system audit of your entire operation for CGMP compliance and evaluate the completion and efficacy of your corrective actions and preventive actions before you pursue resolution of your firm’s compliance status with FDA.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.Drug RecallOn December 18, 2025, FDA held a teleconference with you recommending you remove any batches of (b)(4) OTC (b)(4) drug products and (b)(4) from the U.S. market.On December 30, 2025, you communicated your commitment to cease manufacturing and distribution of all drugs for U.S. market. You also agreed to voluntary recall all drugs in current distribution in U.S.On (b)(4), you issued a voluntary recall of all (b)(4).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.FDA placed all drugs and drug products offered for import into the United States from your firm on Import Alert 66-40 on December 23, 2025.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 continuing to refuse admission of articles manufactured at Wizcure Pharmaa Private Limited located at H-881, Phase III, RIICO Industrial Area Bhiwadi, Rajasthan, India, 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 days. Specify what you have done to address any violations and to prevent their recurrence. In response to this letter, you may provide additional information for our consideration as we continue to assess your activities and practices. If you cannot complete corrective actions within 15 working days, state your reasons for delay and your schedule for completion.Send your electronic reply to CDER-OC-OMQ-Communications@fda.hhs.gov. Identify your response with FEI 3030304532 and ATTN: Rafael E. Arroyo.Sincerely,/S/Francis GodwinDirectorOffice of Manufacturing QualityOffice of ComplianceCenter for Drug Evaluation and Research

Delivery Method:VIA Electronic MailProduct:Medical DevicesRecipient:William H. ShoopCEO3B Medical, Inc. dba Reach Health, Inc.5475 Rings RoadDublin, OH 43017United States(b)(4)Issuing Office:Center for Devices and Radiological HealthUnited StatesWARNING LETTERCMS # 725108May 20, 2026Dear Mr. Shoop:During an inspection of your firm located in Dublin, OH from December 1, 2025 through December 10, 2025, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures iCodeConnect, a cloud-based software device, intended for use in conjunction with Continuous Positive Airway Pressure (CPAP) and Auto-Adjusting Positive Airway Pressure (Auto-CPAP or APAP) ventilator devices, in treating obstructive sleep apnea (OSA) in adults. Your firm also imports and provides complaint handling for APAP and Bilevel Positive Airway Pressure (BPAP) ventilator devices from BMC Medical Co., Ltd. (Beijing, China) to include, but not limited to, Luna G3 APAP (LG3600), G3X APAP (G4600), Luna G3 BPAP (LG3700), Luna G3 30VT (LG3800), and Luna G2 APAP (LG2A02). 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 Rebecca Legare, Quality Systems and Compliance Director, dated January 2, 2026, and February 13, 2026, and from Shalini Yadav, Senior Manager of Regulatory Affairs on March 27, 2026, concerning our investigator’s observations noted on the Form FDA 483 (FDA 483), List of Inspectional Observations, that 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 procedures for receiving, reviewing, and evaluating complaints by a formally designated unit to ensure that all complaints are processed in a uniform and timely manner and complaints are evaluated to determine whether the complaint represents an event which is required to be reported to FDA under part 803 or 804 of this chapter, Medical Device Reporting (MDR), as required by 21 CFR 820.198(a), 820.198(a)(1), and 820.198(a)(3).Specifically:A. Your firm failed to implement section 9.1.1 of your “Customer Complaints” procedure (SP.QA.0011; Rev. G-I; Effective: 8/27/24, 12/5/24, 6/27/25) which requires you to “***determine if there is a complaint based on the definition of a complaint above and Complaint Decision Tree***,” as required by 21 CFR 820.198(a). For example:1. Seven (7) out of eleven (11) complaint records reviewed were cancelled although they met the definition of a complaint defined in your procedure as “Any written, electronic, or verbal communication that alleges deficiencies related to the identity, quality, durability, reliability, safety, effectiveness, or performance of a device following release for distribution.” Examples include: CN-028565 (9/5/25) for Luna G3 APAP states “***used it Wednesday and Thursday nights. It collected data that shows in the machine display. But, using the React Health Plus app on my iPhone, when I try to upload the data by scanning the iCode QR+ code, the app appears to scan successfully, but the data does not show in the app***.” The documented justification for cancelling the complaint was “***The device was not returned. Tech Support provided information to the customer about data transmission, and the customer later confirmed that data was being displayed. The ticket was canceled. No issue was confirmed***.” However, this incident meets the definition of a complaint due to alleged concern with performance regardless of whether it was determined to be a use error. CN-030142 (10/3/25) for Luna 2 Auto states “***Pt dropped machine and it stopped working***.” The documented justification for cancelling the complaint was “***This issue is not a complaint because the patient dropped the device.***” However, this incident meets the definition of a complaint due to alleged concern with durability, regardless of whether it was determined to be a use error.From August 28, 2024 to November 21, 2025, your firm cancelled (b)(4) complaints despite allegations for pressure delivery issues (fluctuations, pulsating, surging, etc.), shutdowns, and electronic and software failures (data transmission, modem connectivity, error codes, etc.) with your Luna G3 APAP/BPAP devices; abnormal pressure readings, low oxygen output, and persistent red-light alarms for your Stratus oxygen concentrators; abnormal smells from your Phoenix 5L oxygen concentrators; and durability issues with your Rio masks.2. Thirteen (13) out of fifteen (15) inquiries reviewed met the definition of a complaint defined in your procedure. Examples include: INQ-26292 (8/18/25) for Luna G3 APAP states “***Pt turned machine over on nightstand, causing water to flow back into machine. Machine pressure now fluctuates heavily and constantly***.” The documented justification for not logging this incident as a complaint was “***Because the patient turned the device over on the nightstand, this is considered patient damage, not a complaint***.” However, this incident meets the definition of a complaint due to alleged concern with performance regardless of whether it was determined to be a use error. INQ-23277 (6/23/25) for Luna 2 Auto states “***Button on machine is broken***.” The documented justification for not logging this incident as a complaint was “***The device was not confirmed to be received from React Health with a broken button. Since the device is out of warranty, it has been used, and the damage is considered to be customer induced. Therefore, this is not a complaint***.” However, this incident meets the definition of a complaint due to alleged concern with durability regardless of whether it was determined to be a use error or out of warranty.Your firm has received over (b)(4) records from August 26, 2024, to December 23, 2025, that you classified as inquiries and found that several should have been categorized as complaints because they contained allegations similar to 1(A)(1) for your Luna G3 APAP/BPAP ventilator devices, Stratus and Phoenix oxygen concentrators, and Rio masks. For example, on August 1, 2025, you received an allegation that "***CPAP suddenly started to pulsating in pressure after ramp up***” (INQ-25644) that was logged as an inquiry instead of a complaint.B. Your firm’s “Customer Complaints” procedure (SP.QA.0011; Rev. G-I; Effective: 8/27/24, 12/5/24, 6/27/25) and “Incident Reporting Procedure” (SP.QA.0013; Rev. G-I; Effective: 8/27/24, 12/5/24, 6/27/25) do not ensure that additional information is requested to evaluate the need for medical device reportability when the alleged issue has the potential to result in a serious injury, as required by 21 CFR 820.198(a)(3). For example, in three (3) out of eleven (11) complaints reviewed, there was no documentation of follow-up questions asked of complainants to determine whether the incidents were reportable although complainants reported incidents of choking and shortness of breath. CN-011887 (1/31/25) for Luna G3 APAP states “***that the machine shuts off in the middle of the night***chokes her out and she is afraid to use it***.” There is no additional documentation in the complaint record about whether medical complications occurred, including the nature of the complication, and/or if medical or surgical intervention was required to preclude permanent impairment of a body function/structure. No medical device report (MDR) was filed. CN-026089 (7/24/25) for Luna G3 APAP states “***that in the middle of therapy the device will suddenly send burst of hard rapid airflow that wakes him and makes him short of breath***.” There is no additional documentation in the complaint record about whether medical complications occurred, including the nature of the complication, and/or if medical or surgical intervention was required to preclude permanent impairment of a body function/structure. No MDR was filed. CN-014116 (2/21/25) for Luna G3 APAP states that the “***device not auto adjusting, pt woke up short of air, device not tracking***.” There is no additional documentation in the complaint record about whether medical complications occurred, including the nature of the complication, and/or if medical or surgical intervention was required to preclude permanent impairment of a body function/structure. No MDR was filed.C. Your firm failed to implement section 9.1.2 of your “Customer Complaints” procedure (SP.QA.0011; Rev. G-I; Effective: 8/27/24, 12/5/24, 6/27/25) which states that “***Complaints shall be processed in a uniform and in a timely manner***,” as required by 21 CFR 820.198(a)(1). For example, your June 18, 2025 Quality Data Review documents that as of May 2025, there were backlogs of over (b)(4) complaints for your Stratus oxygen concentrator devices and over (b)(4) complaints for your Luna ventilator devices. In addition, review of the (b)(4) complaints received between August 27, 2024 and December 2, 2025 revealed that over (b)(4) complaints were in the workflow status of “open”, “pending approval”, “evaluation in process”, or “investigation in process” for at least (b)(4) or more.We reviewed your firm’s responses and conclude that they are not adequate. Under CAPA 2504, your firm reviewed FDA-483 observation 1 with your complaint team; re-launched complaint awareness training; updated SP.QA.0011 with an end-to-end complaint investigation workflow to ensure collection of medical and patient outcome information in cases of potential or suspected patient harm; developed a complaint intake tool; provided training on identification of potential patient harm to complaint handling employees; and initiated a retrospective review project of all cancelled complaints and inquiries with a target date of November 1, 2026; and developed an intake ticketing system that defines complaint sources. However, neither the updated SP.QA.0011 or “Customer Contact Form” provide assurance that additional follow-up questions are requested of complainants in cases where sufficient information is not provided (but there is a possibility of patient harm) in order to determine whether the complaint represents an MDR reportable event. Furthermore, no actions were identified to address the backlog of open complaints noted in the 1(C) above or to assess whether staffing levels are adequate. The inspection found that (b)(4) employees, (b)(4) of whom were temporary, were tasked with the responsibility of processing over (b)(4) complaints received during the 15-month period prior to the inspection. Please provide a response on how you plan to address the above deficiencies. In addition, please continue to provide updates on the progress of your corrections and/or corrective actions, including any supporting evidence.2. Failure to establish and maintain procedures for implementing corrective and preventive action, as required by 21 CFR 820.100(a).Specifically, your firm failed to implement section 10.4 of your “Corrective and Preventive Action (CAPA) Procedure” (SP.QA.0012; Rev. D; Effective: 7/12/23) which requires that the containment phase “***(b)(4).” For example, you initiated CAPA 2408, dated November 25, 2024, due to the shipment of expired Ultra Soft 12 Food Oxygen Cannulae (Part # 02U2012; Lot # (b)(4); Exp: 4/2022) from your warehouse to a customer on October 28, 2024. However, the containment activities only included (b)(4) out of (b)(4) possible warehouses that could receive product. Your firm did not consider the other (b)(4) warehouses to ensure that they were also unable to ship products that are past expiration date.Moreover, although section 10.4 of SP.QA.0012 states a “***recall, correction, or removal requires CAPA initiation***” and your Manager of Quality Systems and Compliance stated that CAPA 2408 was opened in part to control the field action initiated on November 27, 2024, there is no mention of this field action (RES 95918) in this CAPA record.We reviewed your firm’s responses and conclude that they are not adequate. Under CAPA 2505, your firm ran a full inventory report for all expiry-dated products across all warehouses; performed a gap assessment on all active Supplier Quality Agreements (SQAs); updated the CAPA 2408 record to document containment verification and include linkage to the field action; and conducted a for-cause supplier audit at the (b)(4) as a follow-up to the Expired Cannula Recall (RES 95918). By May 15, 2026, your firm also plans to add expiration controls to ensure expired products cannot be released or shipped; a requirement for routine inventory checks at all warehouses, including third-party logistics (b)(4) partners; and mandatory review of these results at Management Review meetings. However, there was no action identified to conduct a risk assessment on whether a field action is needed for product released from the additional warehouses which were not accounted for in CAPA 2408 and subsequent field action under RES 95918. This includes the (b)(4) distribution centers operated by (b)(4). Please provide a response on how you plan to address the above deficiencies. In addition, please continue to provide updates on the progress of your corrections and/or corrective actions, including any supporting evidence.3. Failure to establish and maintain adequate procedures for implementing corrective and preventive action, including requirements for analyzing processes, work operations, concessions, quality audit, reports, quality records, service records, complaints, returned product, and other sources of quality data to identify existing and potential causes of nonconforming product, or other quality problems. Appropriate statistical methodology shall be employed where necessary to detect recurring quality problems, as required by 21 CFR 820.100(a)(1).Specifically, the “Matrix, Quality Data Metrics” form (SP.QA.0035.F1; Rev. D; Effective: 10/29/24) used by your firm to trend quality data is inadequate because it does not ensure that reported complaints are analyzed in a manner which detects all potential sources of nonconforming product and other quality problems, as required by 21 CFR 820.100(a)(1). Your Quality Data Review (QDR) dated June 18, 2025 identified "Pressure Fluctuation/ Pulsating" as the most frequently reported issue in complaints received from June 2024 to May 2025 across all ventilator devices (G3X APAP, Luna G3 APAP, Luna G3 BPAP, and Luna G3 30VT, and Luna G2 APAP) but no additional analysis was performed to uncover other potential issues that may warrant evaluation for the need for corrective actions. For example, when this same analysis was applied to complaint data from August 27, 2024, to December 2, 2025 for the G3X APAP and Luna G3 APAP devices individually, the highest reported issues differed, with “Damaged/Broken” and “Error Code Message” reported as the most frequently reported allegations, respectively. Your CAPA Log from December 2022 to December 2025 shows that no CAPA has been initiated for damaged or broken G3X APAP devices or error codes associated with Luna G3 APAP devices.We reviewed your firm’s responses and conclude that they are not adequate. Under CAPA 2505, your firm re-ran complaint trending QDR for December 2024 through May 2025 (6-month review) to depict data by Luna model; re-evaluated "Pressure Fluctuation" Dec 2024 through May 2025 (6-month review) trend that triggered review for potential CAPA or SCAR; and added “investigated issue (root cause)” charts to QDR. However, no supporting evidence was provided to allow review of the adequacy of the revised analysis method applied to the December 2024 to May 2025 complaint data, including the outcome of the assessment for the need for CAPAs as well as the added corrective action in CAPA 2505 to revise SP.QA.0015 and SP.QA.0035 to require ongoing complaint trending by 510(k) model, failure mode, and root cause. Please provide a response on how you plan to address the above deficiencies. In addition, please continue to provide updates on the progress of your corrections and/or corrective actions, including any supporting evidence.4. Failure to establish and maintain procedures for validating the device design, including risk analysis, as required by 21 CFR 820.30(g).Specifically, your firm failed to implement section 9.10 of your “Risk Management Process” procedure (SP.QA.0025; Rev. C; Effective: 3/27/23) which states that “***Prior to, or commensurate with, the release for commercial distribution of the medical device***The risk management report shall (b)(4)***.” For example, upon acquisition of the iCodeConnect software on May 8, 2025, your firm accepted an outdated version 1.1 of the Risk Management Report (YF-CSP1-3-02; Effective: 8/13/16) instead of version 4.0 listed in Appendix A of the “Software Copyright Transfer Contract”. Consequently, this 2016 version of the Risk Management Report fails to include an assessment of the risk acceptability of post-production design changes to the iCodeConnect software which transpired between 2018 and 2025 such as (but not limited to) the release of a refactored version in July 2024 and added ability for use with the following ventilator devices: Luna G2 APAP in October 2018 Luna G3 APAP in January 2022 Luna G3 25A Bilevel in January 2022 Luna G3 30VT BiPap in February 2023 G3 X APAP in July 2025The adequacy of your firm’s responses cannot be determined at this time. Under CAPA 2508, your firm froze software development and design changes for the iCodeConnect software; performed a regulatory assessment for the intent of a health hazard evaluation; created an iCodeConnect quality plan to establish a comprehensive Design History File (DHF), including the risk management file in the QMS; performed training for personnel supporting regulated stand-alone software, DHF requirements, and document control expectations under 21 CFR 820 and ISO 13485; updated the Design Controls procedures to clarify the process that will be used for developing & maintaining regulated software; created an architecture document that describes the scope of iCodeConnect; and performed a Regulatory Assessment of the iCodeConnect software. By May 15, 2026, your firm plans to establish a new, complete and compliant DHF based on the results of the Regulatory Assessment of the iCodeConnect and update and formalize the risk management file for the current version 3.0 of the iCodeConnect. Please continue to provide updates on the progress of your corrections and/or corrective actions, including any supporting evidence.5. Failure to establish and maintain procedures to ensure that all personnel are trained to adequately perform their assigned responsibilities, as required by 21 CFR 820.25(b).Specifically, your firm failed to implement section 8 of the “Training and Competency Procedure” (SP.HR.004; Rev. C; Effective: 6/28/24) which includes the requirement to “Evaluate Training Effectiveness” after conducting assigned training in the process flow chart. For example, the training record forms (FO.HR.0004) for (b)(4) out of (b)(4) employees who conduct complaint handling and incident reporting revealed that no “Effectiveness Check(s)” were conducted after receiving training on the “Customer Complaint Procedure” (SP.QA.0011) or Electronic Medical Device Reporting (eMDR) Procedure (SP.QA.0013).The adequacy of your firm’s responses cannot be determined at this time. Under CAPA 2509, your firm performed a training gap assessment, verified training completeness, and conducted training effectiveness checks for the (b)(4) identified employees; updated SP.HR.004 to establish role-based training needs identification, training effectiveness verification methods, and management governance controls; and implemented standardized training tools (e.g., training needs assessment criteria, instructions for use of training effectiveness templates, and monitoring mechanisms) followed with training. Please continue to provide updates on the progress of your corrections and/or corrective actions, including any supporting evidence.Unapproved Device ViolationsOur inspection revealed that the APAP devices that your firm distributes as Luna G3 APAP and Luna G3X APAP are adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B), because your firm does not have an approved application for premarket approval (PMA) in effect pursuant to section 515(a) of the Act, 21 U.S.C. § 360e(a), or an approved application for an investigational device exemption under section 520(g) of the Act, 21 U.S.C. § 360j(g). The devices are also misbranded under section 502(o) of the Act, 21 U.S.C. § 352(o), because your firm introduced or delivered for introduction into interstate commerce for commercial distribution these devices with significant changes or modifications without submitting a new premarket notification to FDA, as required by section 510(k) of the Act, 21 U.S.C. § 360(k), and 21 CFR 807.81(a)(3). For a device requiring premarket approval, the notification required by section 510(k) is deemed satisfied when a PMA is pending before the agency. [21 CFR 807.81(b)]. The kind of information that your firm needs to submit in order to obtain approval or clearance for the device is described on the Internet at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/default.htm. The FDA will evaluate the information that your firm submits and decide whether the product may be legally marketed.According to our records, the most recent FDA clearance for the APAP devices was granted on September 8, 2016, under 510(k) number K153387. The cleared intended use for these APAP devices, branded as Luna® CPAP and Auto CPAP System, was "for single-patient use by prescription in the home or hospital/institutional environment on adult patients." However, the user manuals obtained during the inspection, authored by your firm, and available for public download from your firm's website (https://www.reacthealth.com/sleep/pap-devices) as of May 19, 2026, indicate that the APAP devices are intended "for single-patient re-use in the home environment or for multi-patient re-use in the hospital/institutional environment." This constitutes a major change or modification to the intended use of these devices for which they lack clearance or approval. This major change or modification to the intended use could significantly affect the safety and effectiveness of these devices because multi-patient use introduces risks of cross-contamination and transmission of infectious pathogens between patients, including respiratory viruses and bacteria, that are not present in single-patient use. These risks are new and not addressed by the cleared device's labeling or existing reprocessing instructions, as the device was not evaluated or cleared for the decontamination protocols necessary to ensure patient safety between uses.FDA’s regulations at 21 CFR 807.81(a)(3)(i) provide that submission of a 510(k) is required for “a change or modification in the device that could significantly affect the safety or effectiveness of the device, e.g., a significant change or modification in design, material, chemical composition, energy source, or manufacturing process.” FDA requests that your firm cease any activities that result in the misbranding or adulteration of these devices.For further explanation on the need for a new premarket notification, or "510(k)," for changes to the intended use or design affecting safety and effectiveness, consult the guidance document "Deciding When to Submit a 510(k) for a Change to an Existing Device — Guidance for Industry and Food and Drug Administration Staff (fda.gov)." The “Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program Guidance for Industry and Food and Drug Administration Staff,” is also recommended for obtaining FDA feedback on the 510(k) submission for the modified Luna G3 APAP devices.Corrections and Removals ViolationsOur inspection also revealed that your firm’s Rio II Nasal Pillows devices are misbranded under section 502(t)(2) of the Act, 21 U.S.C. § 352(t)(2), in that your firm failed or refused to furnish material or information respecting the device that is required by or under section 519 of the Act, 21 U.S.C. § 360i, and 21 CFR Part 806 – Medical Devices; Reports of Corrections and Removals. Significant violations include, but are not limited to, the following:1. Failure to submit a Report required by 21 CFR 806.10 to FDA, within 10 working days of initiating the correction or removal. For example: your Rio II Nasal Pillows devices were packaged in boxes that incorrectly all had one part number on the front and all size checkboxes filled in. The box labels for all sizes incorrectly had the same UDI number, regardless of size. An incorrect sized mask can result in high leaks (when using larger size) or inability to use the mask (when incorrectly using small size). When this happens, the therapy is not provided to the patients with obstructive sleep apnea, which presents a risk to health. You notified Durable Medical Equipment (DME) companies beginning June 22, 2023, to remedy the violation or reduce the risk to health posed by the device. This action is a medical device correction or removal initiated to reduce the risk to health posed by the device or to remedy a violation of the Act caused by the device which may present a risk to health, for which you are required to submit a Report of Correction or Removal to FDA. As of December 10, 2025, you did not submit a Medical Device Report of Correction or Removal to FDA for this action.We reviewed your firm’s responses and conclude that they are not adequate. Your responses do not address Reports of Correction or Removal, and your firm has not submitted a Report of Correction or Removal to FDA for the incorrectly labeled Rio II Nasal Pillows as of May 19, 2026.Your firm should take prompt action to address any violations identified in this letter. Failure to adequately address this matter may result in regulatory action being initiated by the FDA without further notice. These actions include, but are not limited to, seizure, injunction, and civil money penalties.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. Should FDA determine that your devices or facilities do not meet the requirements of the Act, requests for Certificates to Foreign Governments (CFG) may not be granted.On February 2, 2024, the FDA issued a final rule amending the device current good manufacturing practice (CGMP) requirements of the Quality System (QS) Regulation under 21 CFR 820 to align more closely with the international consensus standard for Quality Management Systems for medical devices used by many other regulatory authorities around the world. The revised part 820, referred to as the Quality Management System Regulation (QMSR), became effective on February 2, 2026. Your most recent inspection from December 1, 2025 to December 10, 2025 was conducted pursuant to the QS Regulation, which was in effect at the time of the inspection. However, any corrective actions you propose, or implement must be pursuant to the QMSR requirements in effect as of February 2, 2026. For more information on the QMSR please refer to our frequently asked questions webpage:https://www.fda.gov/medical-devices/quality-system-qs-regulationmedical-device-current-good-manufacturing-practices-cgmp/quality-management-system-regulation-final-rule-amending-quality-system-regulation-frequently-asked.Please notify this office in writing within fifteen business days from the date you receive this letter of the specific steps your firm has taken to address the noted violations, as well as an explanation of how your firm plans to prevent these violations, or similar violations, from occurring again. Include documentation of the corrections and/or corrective actions (which 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. Your firm’s response should be comprehensive and address any violations included in this Warning Letter. If you believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration as part of your response.Your firm’s response should be sent via email to Gina Brackett, Establishment Assessment Team 1 Assistant Director at CDRHEnforcement@fda.hhs.gov. Please include in the subject line, “CMS Case 725108” when replying. If you have any questions about the contents of this letter, please contact: Sargum Morgan, Compliance Officer at sargum.morgan@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 the Inspectional 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,/S/Barbara A. MarsdenDirectorOffice of Regulatory ProgramsOffice of Product Evaluation and QualityCenter for Devices and Radiological Health

吉安卓顺医药有限公司：你公司（药品经营许可证：赣AA796000646，注册地址：江西省吉安市吉州区井冈山大道159号1栋三楼）,于2026年5月25日由我局公告暂停第二类精神药品经营活动。近期你公司向我局申请恢复药品经营，经现场检查，认定符合重新开业条件，现准允你公司恢复第二类精神药品经营。江西省药品监督管理局2026年6月29日

行政相对人名称景洪市大渡岗卫生院统一社会信用代码12532801432501773K行政处罚决定文书号景医保处字〔2026〕第17号违法事实2023年1月1日至2024年12月31日期间，通过“超标准收费、造成医保保障基金损失的其他违法行为”等违规申报和使用医保基金，造成医保基金损失共计5868.61元。处罚类别罚款处罚机关景洪市医疗保障局处罚内容处以人民币2934.30元(大写:贰仟玖佰叁拾肆元叁角整)的罚款。处罚决定日期2026-06-29处罚依据依据《医疗保障基金使用监督管理条例》第三十八条第一款第(三)项、第(七)项和《云南省医疗保障行政处罚裁量基准规则(修订版)》第七条第(五)项的规定。

行政相对人名称：毕节市七星关区层台镇卫生院行政相对人代码_1(统一社会信用代码)：125224014298115510行政相对人代码_2(工商注册号)：行政相对人代码_3(组织机构代码)：行政相对人代码_4(税务登记号)：行政相对人代码_5(事业单位证书号)：行政相对人代码_6(社会组织登记证号)：行政相对人类别：法人及非法人组织行政处罚决定文书号：七星医保处字〔2026〕第014号违法行为类型：行政违法违法事实：2026年5月19日在毕节市七星关区层台镇卫生院负责人穆华超的陪同下，对毕节市七星关区层台镇卫生院部分病案资料、健康体检相关处方及查看医保系统记录等进行检查，检查发现该院存在将不属于医疗保障基金支付范围的医药费用纳入医疗保障基金结算造成医保基金损失的行为，具体如下：1.将部分患者不属于医保报销的“健康查体、职业性健康检查、儿童常规健康检查”费用纳入医保报销，共涉及违规计费613人次，涉及总费用4710.95元，医保报销3906.08元；2.将部分患者使用超声骨密度仪检查的“骨密度测定”按核医学下的“骨密度测定”上传到医保系统并纳入报销，共涉及违规计费3人次，涉及总费用189元，医保报销144.59元 。处罚依据：中华人民共和国行政处罚法第4条/款/项,中华人民共和国行政处罚法第19条/款/项,医疗保障基金使用监督管理条例第38条1款6项处罚类别：罚款处罚内容：1.约谈你（单位）有关负责人；2.责令你（单位）退回因将不属于医疗保障基金支付范围的医药费用纳入医疗保障基金结算造成损失的医保基金4050.67元，并处造成医保基金损失金额的1倍罚款4050.67元。处罚金额（元）：4050.670000没收违法所得、没收非法财务金额（元）：暂扣或吊销证称及编号：处罚决定日期：2026-06-25处罚有效期：2099-12-31公示截止日期：处罚机关：毕节市七星关区医疗保障局处罚机关统一社会信用代码：11522401MB18621206数据来源单位：贵州省司法厅数据来源统一社会信用代码：115200000093905194备注：入库日期：2026-06-30 08:40:43最后一次更新日期：2026-07-01 10:50:50公示日期：2026-06-30 08:40:29报送部门：贵州省司法厅

行政相对人名称景洪市嘎栋卫生院统一社会信用代码12532801432501722B行政处罚决定文书号景医保处字〔2026〕第10号违法事实2023年1月1日至2024年12月31日期间，通过“超标准收费、重复收费、过度检查”等违规申报和使用医保基金，造成医保基金损失共计4748.08元。处罚类别罚款处罚机关景洪市医疗保障局处罚内容处以人民币2374.04元(大写:贰仟玖佰叁拾肆元叁角整)的罚款。处罚决定日期2026-06-29处罚依据依据《医疗保障基金使用监督管理条例》第三十八条第(二)项、第(三)项和《云南省医疗保障行政处罚裁量基准规则(修订版)》第七条第(五)项的规定。

辽宁省药品监督管理局行政检查结果公示 企业名称沈阳维康医药连锁有限公司企业类型药品零售连锁总部检查时间2026年6月16日-2026年6月17日所在地市沈阳市检查依据《中华人民共和国药品管理法》《中华人民共和国药品管理法实施条例》《药品经营和使用质量监督管理办法》等法律、法规、规章。检查事项药品经营检查检查方式常规检查检查内容执行《中华人民共和国药品管理法》《中华人民共和国药品管理法实施条例》《药品经营和使用质量监督管理办法》等法律、法规、规章情况。存在问题在采购方面，存在企业个别留存的首营企业随货同行单样式与实际经营样式不一致；在收货与验收方面，存在企业养护人员未指导储存人员对药品进行合理储存与作业，部分中药饮片未在中药饮片库房储存的问题。处理措施限期整改整改情况已按要求完成整改

行政相对人名称：息烽县鹿窝镇卫生院行政相对人代码_1(统一社会信用代码)：125201224299610828行政相对人代码_2(工商注册号)：行政相对人代码_3(组织机构代码)：行政相对人代码_4(税务登记号)：行政相对人代码_5(事业单位证书号)：行政相对人代码_6(社会组织登记证号)：行政相对人类别：法人及非法人组织行政处罚决定文书号：息医保罚字〔2026〕第8号违法行为类型：造成医保基金损失的违法行为。违法事实：息烽县鹿窝镇卫生院存在“重复收费、超标准收费、过度诊疗、将不符合基本医疗保险基金支付范围的费用纳入基本医疗保险基金支付”造成医疗保障基金损失的违法事实，涉及医药总费用4501.99元，违法违规使用医保基金3448.49元。处罚依据：医疗保障基金使用监督管理条例第38条/款/项处罚类别：罚款处罚内容：1.退回医疗保障基金损失人民币叁仟肆佰肆拾捌元肆角玖分（¥3448.49）（该笔资金息烽县医疗保障服务中心已通过协议处理追回）；2.处造成医保基金损失金额1.5倍罚款人民币伍仟壹佰柒拾贰元柒角肆分（¥5172.74）处罚金额（元）：5172.740000没收违法所得、没收非法财务金额（元）：暂扣或吊销证称及编号：处罚决定日期：2026-06-23处罚有效期：2099-12-31公示截止日期：2026-09-28处罚机关：息烽县医疗保障局处罚机关统一社会信用代码：11520122MB19706745数据来源单位：贵州省司法厅数据来源统一社会信用代码：115200000093905194备注：入库日期：2026-06-30 08:40:43最后一次更新日期：2026-07-01 10:50:50公示日期：2026-06-30 08:40:29报送部门：息烽县医疗保障局

行政相对人名称：六盘水市水城区都格镇卫生院（妇幼保健计划生育服务中心）行政相对人代码_1(统一社会信用代码)：125202217457044320行政相对人代码_2(工商注册号)：行政相对人代码_3(组织机构代码)：行政相对人代码_4(税务登记号)：行政相对人代码_5(事业单位证书号)：行政相对人代码_6(社会组织登记证号)：行政相对人类别：法人及非法人组织行政处罚决定文书号：水医保罚字〔2026〕112号违法行为类型：行政违法违法事实：2026年6月22日，六盘水市水城区医疗保障局对六盘水市水城区都格镇卫生院垭口村卫生室现场检查，发现该卫生室存在串换药品违法行为。已违反了《医疗保障基金使用监督管理条例》第十五条第一款、第三十八第一款第四项之规定。处罚依据：医疗保障基金使用监督管理条例第15条1款/项,医疗保障基金使用监督管理条例第38条1款4项处罚类别：罚款处罚内容：1.责令立即改正；2.责令退回因串换药品造成医保基金损失120.9元；处违法违规使用医保基金金额1倍罚款120.9元。处罚金额（元）：120.900000没收违法所得、没收非法财务金额（元）：暂扣或吊销证称及编号：处罚决定日期：2026-06-22处罚有效期：2099-12-31公示截止日期：处罚机关：六盘水市水城区医疗保障局处罚机关统一社会信用代码：11520221MB1676686N数据来源单位：贵州省司法厅数据来源统一社会信用代码：115200000093905194备注：入库日期：2026-06-30 08:40:43最后一次更新日期：2026-07-01 10:50:50公示日期：2026-06-30 08:40:29报送部门：水城区医疗保障局