根据《中华人民共和国行政许可法》第七十条、《市场监督管理行政许可程序暂行规定》第四十八条和第七十八条、《药品经营和使用质量监督管理办法》第二十七条的规定，安徽省药品监督管理局依法注销马鞍山市国大药房连锁有限公司《药品经营许可证》（详细信息见附件）。特此公告。附件：注销《药品经营许可证》清单安徽省药品监督管理局2026年8月4日附件注销企业名称许可证号经营地址备注马鞍山市国大药房连锁有限公司皖BA555000008马鞍山市雨山区映翠花园4村6栋101-104号企业申请注销

根据《中华人民共和国行政许可法》第七十条、《药品经营和使用质量监督管理办法》第二十七条第一项规定，经企业申请，本机关拟注销四川禾目医药有限公司《药品经营许可证》[证书编号：川AA028b00005；经营方式：批发；注册地址：眉山市青神县眉青路188号附2号；法定代表人：迟庆东；企业负责人：迟瑶；经营范围：化学药(含冷藏)、中成药(含冷藏)、生物制品(含冷藏）]。自本公示发布之日起10个工作日内，如无单位、个人提出异议，本机关将依法注销该企业《药品经营许可证》。特此公示。联系电话：028-86912503四川省药品监督管理局2026年8月4日

根据《中华人民共和国药品管理法》《互联网信息服务管理办法》《药品网络销售监督管理办法》等相关规定，现依申请注销银川鑫泰互联网医院有限公司《药品网络交易第三方平台备案信息》。特此通告。附件：注销药品网络交易第三方平台备案具体信息列表.wps宁夏回族自治区药品监督管理局2026年8月3日（此件公开发布）

根据《医疗器械监督管理条例》《互联网信息服务管理办法》及《医疗器械网络销售监督管理办法》等相关规定，现依申请注销银川鑫泰互联网医院有限公司《医疗器械网络交易服务第三方平台备案凭证》。特此通告。附件：注销医疗器械网络交易服务第三方平台备案具体信息列表.wps宁夏回族自治区药品监督管理局2026年8月3日（此件公开发布）

Delivery Method:Via Electronic Mail - Return Receipt RequestedReference #:320-26-105Product:DrugsOver-the-Counter DrugsRecipient:Mr. Mohit MalhotraChief Executive OfficerDabur India LimitedDabur Corporate Office, KaushambiSahibabadGhaziabad 201010IndiaIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesWarning Letter 320-26-105July 24, 2026Dear Mr. Malhotra:The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, Dabur India Limited, FEI 3001413302, at Survey No. 225/4/1, Village: Saily, Silvassa, Dadra and Nagar Haveli and Daman and Diu, from January 12 to 16, 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 4, 2026 response to our Form FDA 483 in detail.During our inspection, our investigator observed specific violations including, but not limited to, the following.1. Your firm failed to establish an adequate quality control unit with the responsibility and authority to approve or reject all components, drug product containers, closures, in-process materials, packaging materials, labeling, and drug products and the authority to review production records to assure that no errors have occurred or, if errors have occurred, that they have been fully investigated (21 CFR 211.22(a)).Your firm manufactures over-the-counter drug products including (b)(4) and (b)(4). Your quality unit (QU) failed to exercise its authority and responsibilities over your drug manufacturing operations, including ensuring the integrity of your production records.During the inspection, our investigator requested the equipment usage logbook for Unit (b)(4), Line (b)(4), which your management stated was dedicated exclusively to (b)(4) manufacturing. Your firm delayed providing this record for several days. When your firm finally produced the logbook, it appeared to have been newly created. Subsequently, our investigator discovered the original logbook in the document room. A comparison of the two logbooks revealed that the version provided to our investigator was falsified. The fraudulent logbook listed entries only for (b)(4). It deliberately omitted multiple U.S. marketed OTC drug products that were documented in the original logbook, including (b)(4).Furthermore, our investigator identified multiple discrepancies between the source data in your analytical data books and the final values reported in your batch manufacturing records or certificates of analysis. For multiple batches of (b)(4) and (b)(4), the reported values for quality attributes such as residue on ignition, melting range, pH, and viscosity did not match the original data. While these inaccuracies did not involve out-of-specification results, your QU signed off on these records without ensuring the consistency and accuracy of the data.In your response, you acknowledge these deficiencies, attributing the falsified logbook to “inadequate documentation controls, insufficient oversight, and lack of robust governance.” You attributed other data inaccuracies to your transcription practices and inadequate resources within your QU for proper review. You state that you trained personnel on data integrity and committed to revising procedures and reviewing only the (b)(4) of data for similar transcription errors. You also commit to sending “(b)(4) samples of impacted drug product including (b)(4)” to a contract testing laboratory.Your response is inadequate because it fails to address the severity of the observed data integrity failures. Your proposed corrective actions address the data integrity breaches as isolated procedural gaps rather than as evidence of a systemic breakdown in QU oversight and a deficient quality culture. Your response does not address the fundamental failure of your QU to ensure the integrity and completeness of all data related to your drug manufacturing operations, nor does it include an adequate assessment of the potential impact on the quality of drug products already distributed to the U.S. market. Furthermore, your response lacks a sufficient comprehensive evaluation of your QU’s capabilities to fulfill all required quality-related functions.Your firm’s quality systems are inadequate. See FDA’s guidance document Quality Systems Approach to Pharmaceutical CGMP Regulations for help implementing quality systems and risk management approaches to meet the requirements of CGMP regulations 21 CFR, parts 210 and 211 at https://www.fda.gov/media/71023/download.In response to this letter, provide:A comprehensive assessment of documentation systems used throughout your manufacturing and laboratory operations to determine where documentation practices are insufficient. Include a detailed corrective action and preventive action (CAPA) plan that comprehensively remediates your firm’s documentation practices to ensure you retain attributable, legible, complete, original, accurate, contemporaneous records throughout your operation.A comprehensive assessment and remediation plan to ensure your QU is given the authority and resources to effectively function. The assessment should also include, but not be limited to:o A determination of whether procedures used by your firm are robust and 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 products.2. 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)).Your laboratory records did not include complete data to support the analyses performed. For example, your analytical notebooks documented approximately (b)(4) microbiology plates for finished drug products and approximately (b)(4) media plates for testing (b)(4) samples as incubated, but the plates were physically absent from incubators with no documented explanation about their whereabouts or disposal. In addition, during the inspection you could not produce the test procedures, analytical workbooks, or test data sheets to support the reported certificate of analysis results for approximately (b)(4) batches of U.S. marketed drug products. You also failed to make the required entries in your equipment logbooks to reflect the use of multiple instruments for the specific batch release tests performed.In your response, you indicate that a microbiologist inadvertently discarded the missing microbiological plates due to lack of training. You state that you retrained the microbiologist, re-analyzed the missing finished drug product plates, and introduced a new controlled logbook to improve sample traceability.Regarding the batches released without supporting analytical records, you commit to sending samples for several of the batches to a contract laboratory for retrospective testing and to implementing formal test data sheets for future data recording. Further, you state that you have retrained the personnel responsible for failing to document instrument usage and that you will discontinue the use of separate equipment usage logbooks once the new data sheets are implemented.Your response is inadequate because it does not adequately address major deficiencies in your laboratory system. Your response does not address your oversight of data integrity including, but not limited to, improving your quality assurance function. Your response does not provide a comprehensive retrospective risk assessment or complete testing of all potentially impacted drug products within expiry and fails to adequately assess and mitigate the risk to consumers.Reliability of data is fundamentally compromised when there is a failure to record data or to maintain complete and accurate records of test results. Furthermore, the lack of reliable data compromises the ability of your QU to exercise its function of ensuring compliance to applicable standards.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: Questions and Answers for guidance on establishing and following CGMP compliant data integrity practices at https://www.fda.gov/media/119267/download.We strongly recommend that you retain an independent third-party qualified consultant to assist in your remediation. 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 lapses.o A comprehensive retrospective evaluation of the nature of all 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 lapses.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 lapse of data integrity 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 the data you generate including analytical data, manufacturing records, and all data submitted to FDA.o A comprehensive description of the root causes of your data integrity lapses 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 lapses 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.3. Your firm failed to establish and follow adequate written procedures for cleaning and maintenance of equipment (21 CFR 211.67(b)).You failed to demonstrate that your cleaning practices are adequate to remove potential contaminants and to prevent drug product carry over in shared equipment used to manufacture your OTC drug products.For example, your cleaning validation program for the non-dedicated Unit (b)(4) Line (b)(4) relied exclusively on the visual inspection of (b)(4) to determine adequate cleaning. Your cleaning validation program lacked scientifically determined maximum allowable carryover limits, quantitative residue testing, or direct surface sampling of difficult-to-clean areas. In addition, you did not perform any cleaning validation for Unit (b)(4) Line (b)(4) despite using it to manufacture at least (b)(4) different OTC drug products.In your response, you acknowledge the deficiencies in your cleaning validation program. You commit to enhancing your cleaning validation program by developing validated analytical methods, establishing carryover limits, implementing direct surface swab sampling, and revalidating the cleaning process. You stated that Line (b)(4) is now dedicated to a (b)(4) drug product, and you are conducting a limited retrospective quality review by testing only (b)(4) samples for potential cross-contamination.Your response is inadequate because it does not address the interim controls you will implement to mitigate the risk of cross-contamination during your remediation period. Additionally, testing only (b)(4) samples from the (b)(4) batches manufactured on Line (b)(4) is statistically insufficient to assess the potential for cross-contamination. Further, your response also does not include a retrospective review of all drug products released to the U.S. market and within expiry for potential cross-contamination resulting from the use of a non-validated cleaning process on non-dedicated equipment.Inadequate removal of active ingredients and drug product residues from surfaces of non-dedicated manufacturing equipment can lead to contamination of drug products subsequently manufactured on that equipment.In response to this letter, provide: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. Your plan should also ensure that appropriate actions are taken throughout the company network.A comprehensive, independent retrospective assessment of your cleaning effectiveness to evaluate the scope of cross-contamination hazards. Include the identity of residues, other manufacturing equipment that may have been improperly cleaned, and an assessment whether cross-contaminated drug products may have been released for distribution. The assessment should identify any inadequacies of cleaning procedures and practices, and encompass each piece of manufacturing equipment used to manufacture more than one drug product.Appropriate improvements to your cleaning validation program, with special emphasis on incorporating conditions identified as worst case in your drug manufacturing operation. This should include but not be limited to identification and evaluation of all worst-case:o drugs with higher toxicitieso drugs with higher drug potencieso drugs of lower solubility in their cleaning solventso drugs with characteristics that make them difficult to cleano swabbing locations for areas that are most difficult to cleano maximum hold times before cleaningIn addition, describe the steps that must be taken in your change management system before introduction of new manufacturing equipment or a new drug product.A summary of updated SOPs that ensure an appropriate program is in place for verification and validation of cleaning procedures for drug products, processes, and equipment.4. Your firm failed to establish adequate written procedures for production and process control designed to assure that the drug products you manufacture have the identity, strength, quality, and purity they purport or are represented to possess, and your firm’s quality control unit did not review and approve those procedures, including any changes (21 CFR 211.100(a)).You failed to validate your manufacturing process for your OTC drug products. During the inspection, you stated that you had not performed process validation for (b)(4) of the (b)(4) drug products you manufacture on Unit (b)(4) lines. You also stated you had not performed process validation for (b)(4) of the (b)(4) drug products you manufacture on Unit (b)(4) lines.In your response, you acknowledge the lack of process validation for most of your drug products and commit to preparing process validation plans and protocols using a campaign-based approach.Your response is inadequate because it does not provide a schedule or timeframes for completing process validation activities for each of your drug products. Furthermore, your response lacks an interim plan, such as enhanced finished drug product testing, for any drugs manufactured and distributed before these validation activities are completed to ensure you produce drug products of acceptable quality. You also did not provide drug product impact assessments for U.S. distributed drug products within expiry and ongoing manufacturing.Process validation evaluates the soundness of design and state of control of a process throughout its lifecycle. Each significant stage of a manufacturing process must be designed appropriately and assure the quality of raw material inputs, in-process materials, and finished drugs. Process qualification studies include intensive monitoring and testing throughout each significant process stage to characterize intra-batch variation and evaluate batches to determine whether an initial state of control has been established.Successful process qualification studies are necessary before commercial distribution. Thereafter, ongoing vigilant oversight of process performance and drug product quality is necessary to ensure you maintain a stable manufacturing operation throughout the drug product lifecycle. See FDA’s guidance for industry, Process Validation: General Principles and Practices, for general principles and approaches that the FDA considers appropriate elements of process validation athttps://www.fda.gov/media/71021/download.In response to this letter, provide:A detailed summary of your validation program for ensuring a state of control throughout the product lifecycle, along with associated procedures. Describe your program for process performance qualification and ongoing monitoring of both intra-batch and inter-batch variation to ensure a continuing state of control.A timeline for performing process performance qualification for each of your marketed drug products.Process performance protocols, and written procedures for qualification of equipment and facilities.A detailed program for designing, validating, maintaining, controlling, and monitoring each of your manufacturing processes that includes vigilant monitoring of intra-batch and inter-batch variation to ensure an ongoing state of control. Also, include your program for qualification of your equipment and facility.Drug RecallOn May 13, 2026, FDA held a teleconference with you recommending you consider removing batches of all (b)(4) currently in distribution from the U.S. market.On June 2, 2026, you issued a voluntary recall of all (b)(4), and (b)(4) due to due to systemic quality failures at your facility. To date, you have not recalled your (b)(4) drug products.CGMP Consultant RecommendedBased upon the nature of the violations we identified at your firm, you should engage a consultant qualified 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.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 June 5, 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 Dabur India Limited, at Survey No. 225/4/1, Village: Saily, Silvassa, Dadra and Nagar Haveli and Daman and Diu, 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 3001413302 and ATTN: Rokhsana Safaai-Jazi.Sincerely,/S/Francis GodwinDirectorOffice of Manufacturing QualityOffice of ComplianceCenter for Drug Evaluation and Research

Delivery Method:VIA Electronic MailProduct:Medical DevicesRecipient:Heather S. BellPresidentKoven Technologies, Inc.477 N. Lindbergh Blvd. Ste. 220Saint Louis, MO 63141United States(b)(6), (b)(7)(C)Issuing Office:Center for Devices and Radiological HealthUnited StatesWARNING LETTERCMS # 734643July 21, 2026Dear Ms. Bell:During an inspection of your firm located in Saint Louis, MO, conducted from February 2, 2026, through February 6, 2026, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures and/or markets the Bidop 3 Doppler. Under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 321(h), this product is a device because it is intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body.Quality Management System Regulation Violation(s)This 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 Management System Regulation found at Title 21, Code of Federal Regulations (CFR), Part 820. We received responses from Heather Bell, President, on February 27, 2026; April 17, 2026; and May 28, 2026, concerning our investigator’s observations noted on the Form FDA 483 (FDA 483), List of Inspectional Observations, which was issued to your firm. We address these responses below, in relation to each of the noted violations. These violations include but are not limited to the following:1. Failure to document procedures to control design and development changes, and determine the significance of these changes to function, performance, usability, safety and regulatory requirements for the medical device and its intended use, as required by ISO 13485:2016 Clause 7.3.9.Specifically, your firm failed to follow procedure 1-SOP-014, Design Control, which states, “All design changes must be identified, documented, where appropriate validated, reviewed and approved before the changes may be implemented.” Additionally, your firm failed to follow procedure 2-SOP-010, Device Registration, Submission and Notification, which requires that once a device or process is changed, (b)(4). Your firm did not document design and development changes related to expanding the indications for use of the Bidop 3 (K954397) to include a fetal application which was not cleared as an intended use. During the inspection, the Bidop 3 operations manual noted the indications for use include detection of fetal heart sounds. Your firm has not provided documentation of:A. The review and approval of design change documentation, including:i. Specific modifications made to the device (hardware, software, or performance specifications) to support fetal use.ii. Validation data demonstrating the device's safety and effectiveness for fetal applications.B. An evaluation to determine whether the change in indications for use (from non-fetal to fetal application) required a new 510(k) submission.C. The date when distribution was initiated for the Bidop 3 as a Fetal Doppler.The adequacy of your firm’s responses cannot be determined at this time. Your corrective actions are in progress. Your responses mention that your firm notified customers via certified mail to suspend the use of fetal probes with Bidop 3 doppler units and that you conducted a 21 CFR 806 reportability assessment. FDA received your 806 report on 03/06/2026 and it is being processed under RES ID: 98556. The recall is on-going.2. Failure to document one or more processes for risk management in product realization and determine, as appropriate, quality objectives and requirements for the product, as required by ISO 13485:2016 Clause 7.1.Specifically, your firm’s risk management analysis for your devices revealed inadequate hazard identification and risk analysis as evidenced by the two (2) fetal dopplers below:A. Product ES-100V3 (Bidop 3), 510(k) K954397, cleared March 29, 1996: The risk management report (Document (b)(4), dated September 3, 2025) was revised to include an indication for use as a fetal heart rate doppler, according to management. However, this report fails to evaluate risks to the fetus, despite the device being labeled for determining fetal heart rate and sounds.B. Product Bidop 7, 510(k) K201114, cleared January 5, 2021: The risk management report (Document (b)(4), dated February 5, 2020) contains no evaluation of risks to the fetus, despite the device's indication for use, which includes displaying bi-directional velocity waveforms, numerical data, and fetal heart rate with a heartbeat indicator.The fetus is directly exposed to ultrasound energy and is the primary patient population for these devices. Failure to evaluate fetal-specific hazards (e.g., thermal effects, acoustic exposure, diagnostic accuracy affecting clinical decisions) represents inadequate risk analysis for the devices' intended use. Use of doppler ultrasound devices for fetal monitoring entails additional risks as compared to their use for blood flow monitoring. Fetal tissue is more vulnerable to prolonged or inappropriate ultrasound exposure than adult tissue. Additionally, improper use of the doppler for fetal monitoring may cause misinterpretation of maternal heartbeats or placental blood flow as fetal heartbeat, creating false reassurance. This can result in missed fetal distress signals, delayed care, and severe outcomes including fetal death. Conversely, failure to correctly detect a fetal heartbeat may cause anxiety and unnecessary clinical interventions.Therefore, the risk analysis of the fetal doppler ultrasound device should clearly assess these specific risks associated with use of the device for fetal monitoring as discussed above and specific hazards including fetal distress or death due to misinterpretation, and delayed care.The adequacy of your firm’s responses cannot be determined at this time. Your corrective actions are in progress. Your firm completed a review of the risk management files for the Bidop 7 to address hazards consistent with the cleared intended use. However, your firm did not provide supporting documentation.3. Failure to establish criteria for the evaluation and selection of suppliers, as required by ISO 13485:2016 Clause 7.4.1.Specifically, your firm has not established adequate criteria for the evaluation and selection of your approved suppliers based on their ability to provide product that meets requirements, the performance of the supplier, and the effect of the purchased product on the quality of the device. For example,A. Your firm holds 25 510(k) clearances for devices designed and manufactured by a contract manufacturer. During the inspection the Bidop 3 Doppler was found to have indications for use that differ from those in the cleared 510(k). The indications for use were changed from non-fetal to fetal application. This design change was implemented by your contract manufacturer and your firm does not have documentation of this change nor could your firm identify when this change occurred. The quality agreement between your firm and your contract manufacturer (Section 5.5, Labeling) requires that any changes to labeling (b)(4). This undocumented change represents a failure to ensure that (b)(4) labeling changes as is established in your quality agreement. Furthermore, the quality agreement fails to (b)(4) design changes beyond labeling.B. Per procedure 1-SOP-020, (b)(4) supplier approval criteria include requirements that must be met such as having a quality agreement, product inspection, and site assessment. There is no documentation that a site assessment (supplier audit) has been conducted for the contract manufacturer, a (b)(4) supplier which your firm’s procedure defines as “Highest/Critical Impact.”The adequacy of your firm’s responses cannot be determined at this time. Your corrective actions are in progress. We acknowledge that one of your corrective actions is that your firm amended the quality agreement with your contract manufacturer to include comprehensive design change notifications, access to change logs, and audit rights commensurate with the planned transfer of the 510(k)’s to your supplier. You mention that CAPA CA2026-3 is complete; however, it is in the effectiveness stage and your firm mentioned open corrective actions. As such, please ensure to keep the CAPA open and documented while you are completing all the steps of a CAPA.4. Failure to maintain records of the review, evaluation, and investigation for any complaints involving the possible failure of a device, labeling, or packaging to meet any of its specifications, as required by 21 CFR 820.35(a).Specifically, your firm failed to evaluate returned devices related to device failures affecting performance and reliability as complaints. Between January 1, 2024, and December 31, 2025, approximately (b)(4) Returned Goods Authorizations (RGAs) were issued for device returns. The investigator reviewed 29 completed RGA forms coded as "(b)(4)" and found that 13 of these forms reported device failures but were not evaluated as complaints. Your firm did not consider these reports as complaints and did not initiate or complete a complaint form as required by your complaint procedure, SOP 4-SOP-050 (Customer Complaint). This procedure defines a complaint as "Any written, electronic, or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, usability, safety, or performance of a medical device that has been released from the organization's control or related to a service that affects the performance of such medical devices.” For example:RGANumberDateDeviceCodeFailure/Inspection109236/26/2024Bidop 7(b)(4)The doppler memory has been cleared and when it is turned off and on, it comes up memory store #11 or memory store #1. The doppler should go straight to the LCD screen.110619/18/2024Bidop 3(b)(4)No consistent waveform with toe pressure sensor112111/8/2025Bidop 3(b)(4)Out of box failure115096/27/2025CRP-20H, cardiovascular probe(b)(4)Not picking up vascular flow114024/22/2025Aneroid Sphygmomanometer(b)(4)Doesn’t measure correctly on toeThe adequacy of your firm’s responses cannot be determined at this time. Your corrective actions are in progress. Your firm provided the training records showing the employees trained to the updated procedures; however, you did not provide specifics on the evaluation conducted for the employees to confirm they understood the updates. Please provide this information.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 Management 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.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 Melissa Michurski, Establishment Assessment Team 2, Assistant Director at CDRHEnforcement@fda.hhs.gov. Please include in the subject line, “CMS Case [734643]” when replying. If you have any questions about the contents of this letter, please contact: Ashley Mutawakkil, Compliance Officer, Ashley.Mutawakkil@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/CAPT Cesar A. Perez, PhD, USPHSActing Deputy DirectorOffice of Regulatory ProgramsOffice of Product Evaluation and QualityCenter for Devices and Radiological Health

Delivery Method:VIA UPSReference #:320-26-107Product:DrugsOver-the-Counter DrugsRecipient:Mr. Stephen A. Kuzyk Jr.Secretary TreasurerWoodbine Products Company Inc.915 W. Smith RoadMedina, OH 44256-2446United StatesIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesWarning Letter 320-26-107July 27, 2026Dear Mr. Kuzyk:The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, Woodbine Products Company Inc., FEI 1519202, at 915 W. Smith Road, Medina, from February 9 to 13, 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 March 5, 2026, response to our Form FDA 483 in detail and acknowledge receipt of your subsequent correspondence.During our inspection, our investigator observed specific violations including, but not limited to, the following.1. Your firm failed to conduct at least one test to verify the identity of each component of a drug product (21 CFR 211.84(d)(1)).Your firm manufactures over-the-counter (OTC) (b)(4) drug products such as (b)(4) and ethanol-(b)(4). You failed to perform adequate identity testing on each shipment of each lot of incoming components (e.g., glycerin, propylene glycol, ethanol) used in the manufacture of your OTC (b)(4) drug products. Moreover, you used nonpharmaceutical-grade propylene glycol to manufacture your drug products.Products Containing Ingredients at Risk for Diethylene Glycol or Ethylene Glycol (DEG or EG) ContaminationYou also failed to adequately test your incoming components at high risk of DEG or EG contamination for identity before using them to manufacture your drug products. This includes, but is not limited to, testing of glycerin to determine its appropriate identity before using it in manufacturing your OTC topical drug products.The use of ingredients contaminated with DEG or EG has resulted in various lethal poisoning incidents in humans worldwide. See FDA’s guidance document Testing of Glycerin, Propylene Glycol, Maltitol Solution, Hydrogenated Starch Hydrolysate, Sorbitol Solution, and Other High-Risk Drug Components for Diethylene Glycol and Ethylene Glycol to help you meet the CGMP requirements when manufacturing drugs containing ingredients at high-risk for DEG or EG contamination at https://www.fda.gov/media/167974/download.Identity testing for glycerin and certain other high-risk drug components includes a limit test in the United States Pharmacopoeia (USP) to ensure that the component meets the relevant safety limits for DEG or EG levels. Because you did not perform identity testing on each shipment of each lot using the USP identification test that detects these hazardous impurities, you failed to ensure the acceptability of these components for use in the manufacture of your drug products.Products Containing EthanolYou manufacture multiple drugs that contain ethanol. You failed to adequately test your incoming component ethanol for methanol. Additionally, you failed to demonstrate that the component alcohol, used to manufacture your drug products, met USP monograph specifications including those for impurities (e.g., acetaldehyde, benzene). The use of ethanol contaminated with methanol has resulted in various lethal poisoning incidents in humans worldwide. See FDA’s guidance document Policy for Testing of Alcohol (Ethanol) and Isopropyl Alcohol for Methanol at https://www.fda.gov/media/173005/download.In your response, you state that you tested retain samples of nine propylene glycol lots for DEG/EG contamination and that samples of three lots were not available. You also state that in the future, you will conduct all USP identity and impurity tests for propylene glycol and glycerin. Your response is inadequate because you do not provide procedural controls to demonstrate adequate identification testing of your components. Also, your response does not investigate the use of nonpharmaceutical-grade components, nor does it evaluate the impact of improperly tested components to drug products on the market.Without adequate testing, you do not have scientific evidence that the components conform to the appropriate specifications before their use in the manufacture of your drug products. You are responsible for sampling, testing, and examining drug components before their use in production to ensure that acceptable quality parameters are met.In response to this letter, provide:A comprehensive, independent review of your material system to determine whether all suppliers of components, containers, and closures are each qualified and the materials are assigned appropriate expiration or retest dates. The review should also determine whether incoming material controls are adequate to prevent use of unsuitable components, containers, and closures.A summary of the adequacy of your supplier qualification program and its selection, qualification, and disqualification provisions. The review should include a corrective action and preventive action (CAPA) plan to remediate the vendor qualification program and prevent use of unsuitable components, containers, and closures.A summary of results obtained from testing all components to evaluate the reliability of the certificate of analysis (COA) from each component manufacturer. Include your standard operating procedure (SOP) that describes this COA validation program.A description of how you will test each component lot for conformity with all appropriate specifications for identity, strength, quality, and purity. If you intend to accept any results from your supplier’s COA instead of testing each component lot for strength, quality, and purity, specify how you will robustly establish the reliability of your supplier’s results through initial validation as well as periodic revalidation. In addition, include a commitment to always conduct at least one specific identity test for each incoming component lot. In the case of alcohol (ethanol), glycerin, propylene glycol, and certain additional high-risk components, we note that this includes the performance of parts A, B, and C of the USP monograph.The chemical quality control specifications you use to test each incoming lot of high-risk drug components to determine acceptability for use in manufacturing.A commitment to provide DEG and EG test results, no later than 30 calendar days from the date of this letter, from testing retains of all implicated finished drug product batches in which a retain of a high-risk drug component lot is unavailable for the presence of DEG and EG.A full risk assessment for drug products that are within expiry which contain any ingredient at risk for DEG or EG contamination including, but not limited to, glycerin. Take prompt and appropriate actions to determine the safety of all lots of the components and any related drug product that could contain DEG or EG, including customer notifications and product recalls for any contaminated lots. Identify additional appropriate CAPA that secure supply chains in the future, including, but not limited to, ensuring that all incoming raw material lots are from fully qualified manufacturers and free from unsafe impurities. Detail these actions in your response to this letter.For manufactured drug products within expiry, a commitment to provide, no later than 30 calendar days from the date of this letter, results from testing retains for all lots of alcohol components, including organic impurities. Alternatively, if a retain of a component lot is unavailable, perform retain sample testing of all implicated finished drug product batches.2. Your firm failed to establish adequate written procedures for production and process control designed to assure that the drug products you manufacture have the identity, strength, quality, and purity they purport or are represented to possess (21 CFR 211.100(a)).Your firm failed to adequately validate the processes used to manufacture your OTC drug products. You have not performed process performance qualification (PPQ) studies, nor do you have an adequate ongoing program for monitoring process control to ensure stable manufacturing operations and consistent drug quality. Your firm also failed to validate your cleaning processes for non-dedicated equipment used to manufacture your OTC drug products.In your response, you state that you will conduct cleaning validation on shared equipment and process validation on three batches of each drug formulation. Your response is inadequate because you failed to provide your interim plans until your corrective actions are completed. You also did not conduct a risk assessment to evaluate the impact of manufacturing with unvalidated processes, nor did you provide an action plan to address any drug product quality or safety risk for batches already distributed to the U.S. market.Process validation evaluates the soundness of design and state of control of a process throughout its lifecycle. Each significant stage of a manufacturing process must be designed appropriately and assure the quality of raw material inputs, in-process materials, and finished drugs. Process qualification studies include intensive monitoring and testing throughout each significant process stage to characterize intra-batch variation and evaluate batches to determine whether an initial state of control has been established.Successful process qualification studies are necessary before commercial distribution. Thereafter, ongoing vigilant oversight of process performance and product quality is necessary to ensure you maintain a stable manufacturing operation throughout the product lifecycle.See FDA’s guidance document Process Validation: General Principles and Practices for general principles and approaches that FDA considers appropriate elements of process validation at https://www.fda.gov/media/71021/download.Furthermore, upon review of the inspectional records collected, it appears your (b)(4) is not suitable for its intended use. (b)(4) for pharmaceutical use must be suitable for its intended use and routinely tested to ensure ongoing conformance with appropriate chemical and microbiological attributes. Routine monitoring of microbial counts and identity of microbiological contamination in the system is integral to ensuring oversight of ongoing state of control and suitability of (b)(4) for use in manufacturing operations.In response to this letter, provide:A detailed summary of your validation program for ensuring a state of control throughout the product lifecycle along with associated procedures. Describe your program for PPQ and ongoing vigilant monitoring of both intra-batch and inter-batch variation to ensure a continuing state of control. Also, describe your equipment and facility qualification program.A timeline for performing PPQ for each of your marketed drug products. Also include an explanation how you will ensure that proper satisfactory PPQ studies are performed prior to future distribution of any drug products.A risk assessment for the distributed drug products produced without performing any process validation studies.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.Appropriate improvements to your cleaning validation program with special emphasis on incorporating conditions identified as worst case in your drug manufacturing operation. This should include, but not be limited to, identification and evaluation of all worst-case:o drugs with higher toxicitieso drugs with higher drug potencieso drugs of lower solubility in their cleaning solventso drugs with characteristics that make their manufacturing equipment difficult to cleano swabbing locations for areas that are most difficult to cleano maximum hold times before cleaningA description of the steps that will be taken in your change management system before introduction of new manufacturing equipment or a new product.A summary of updated SOPs that ensure an appropriate program is in place for verification and validation of cleaning procedures for products, processes, and equipment.A comprehensive, independent assessment of your (b)(4) system design, control, and maintenance to ensure the system design consistently produces (b)(4) adhering to (b)(4) USP monograph specifications and appropriate microbial limits. If gaps are identified, perform a risk assessment addressing the potential effects of the observed (b)(4) system failures on the quality of all drug product lots currently within expiry. Specify actions that you will take in response to the risk assessment, such as customer notifications and product recalls.3. Your firm’s quality control unit failed to exercise its responsibility to ensure drug products manufactured are in compliance with CGMP, and meet established specifications for identity, strength, quality, and purity (21 CFR 211.22).Your quality unit (QU) failed to perform adequate oversight for the manufacture of your OTC drug products. For example, your QU failed to ensure the following:Establishment of adequate written responsibilities and procedures applicable to the QU and to follow such written procedures (21 CFR 211.22(d)).Establishment of laboratory controls that include scientifically sound and appropriate specifications, standards, sampling plans, and test procedures designed to assure that components, drug product containers, closures, in-process materials, labeling, and drug products conform to appropriate standards of identity, strength, quality, and purity (21 CFR 211.160(b)).For each batch of drug product, appropriate laboratory determination of satisfactory conformance to final specifications for the drug product, including the identity and strength of each active ingredient, prior to release (21 CFR 211.165(a)).Establishment of an appropriate written testing program designed to assess the stability characteristics of drug products and to use results of stability testing to determine appropriate storage conditions and expiration dates (21 CFR 211.166(a)).Establishment of adequate batch production and control records that contain the accomplishment of each significant step in the manufacture, processing, packing, or holding of the batch, for each batch of drug product (21 CFR 211.188).Significant 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 quality unit 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.See FDA’s guidance document Quality Systems Approach to Pharmaceutical CGMP Regulations for help implementing quality systems and risk management approaches to meet the requirements of CGMP regulations 21 CFR, parts 210 and 211, at https://www.fda.gov/media/71023/download.In your response, you state that you will implement QU procedures. Your response is inadequate because you failed to provide your interim plans until your corrective actions are completed. You also did not conduct a risk assessment to evaluate the impact to batches already distributed to the U.S. market without adequate QU oversight.In response to this letter, provide a comprehensive assessment and remediation plan to ensure your QU is given the authority and resources to effectively function. The assessment should also include, but not be limited to:A determination of whether procedures used by your firm are robust and appropriate.Provisions for QU oversight throughout your operations to evaluate adherence to appropriate practices.A complete and final review of each batch and its related information before the QU disposition decision.Oversight and approval of investigations and discharging of all other QU duties to ensure identity, strength, quality, and purity of all products.CGMP Consultant RecommendedBecause you failed to correct repeat violations, you should engage a consultant qualified as set forth in 21 CFR 211.34 to assist your firm in meeting CGMP requirements.Your use of a consultant does not relieve your firm’s obligation to comply with CGMP. Your firm’s executive management remains responsible for resolving all deficiencies and systemic flaws to ensure ongoing CGMP compliance.Cosmetics Manufactured for Distribution in the United StatesIn addition, some of the products you manufacture may be regulated as cosmetics, as defined in section 201(i) of the FD&C Act [21 U.S.C. 321(i)]. Any cosmetics you manufacture must comply with applicable statutory and regulatory requirements, including the FD&C Act. We note that under section 301(a) of the FD&C Act [21 U.S.C. 331(a)], it is a prohibited act to introduce or deliver for introduction into interstate commerce a cosmetic that is adulterated or misbranded.We also note that the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) provides new requirements with which facilities that manufacture cosmetic products must comply. You may find the FD&C Act, MoCRA, and FDA’s regulations through links on FDA’s website at www.fda.gov.ConclusionThe violations cited in this letter are not intended to be an all-inclusive list of violations that exist at your facility. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations.Correct any violations promptly. Failure to promptly and adequately address this matter may result in regulatory or legal action without further notice including, without limitation, seizure and injunction. Unresolved violations may also prevent other Federal agencies from awarding contracts.Failure to address violations may also cause FDA to withhold issuance of Export Certificates. FDA may withhold approval of new applications or supplements listing your firm as a drug manufacturer until any violations are completely addressed and we confirm your compliance with CGMP. We may re-inspect to verify that you have completed corrective actions to address any violations.This letter notifies you of our findings and provides you an opportunity to address the above deficiencies. After you receive this letter, respond to this office in writing within 15 working days. Specify what you have done to address any violations and to prevent their recurrence. In response to this letter, you may provide additional information for our consideration as we continue to assess your activities and practices. If you cannot complete corrective actions within 15 working days, state your reasons for delay and your schedule for completion.Send your electronic reply to CDER-OC-OMQ-Communications@fda.hhs.gov. Identify your response with FEI 1519202 and ATTN: Sena G. Dissmeyer.Sincerely,/S/Francis GodwinDirectorOffice of Manufacturing QualityOffice of ComplianceCenter for Drug Evaluation and Research

Delivery Method:VIA Electronic MailProduct:Medical DevicesRecipient:Heather S. BellPresidentKoven Technologies, Inc.477 N. Lindbergh Blvd. Ste. 220Saint Louis, MO 63141United States(b)(6), (b)(7)(C)Issuing Office:Center for Devices and Radiological HealthUnited StatesWARNING LETTERCMS # 734643July 21, 2026Dear Ms. Bell:During an inspection of your firm located in Saint Louis, MO, conducted from February 2, 2026, through February 6, 2026, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures and/or markets the Bidop 3 Doppler. Under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 321(h), this product is a device because it is intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body.Quality Management System Regulation Violation(s)This 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 Management System Regulation found at Title 21, Code of Federal Regulations (CFR), Part 820. We received responses from Heather Bell, President, on February 27, 2026; April 17, 2026; and May 28, 2026, concerning our investigator’s observations noted on the Form FDA 483 (FDA 483), List of Inspectional Observations, which was issued to your firm. We address these responses below, in relation to each of the noted violations. These violations include but are not limited to the following:1. Failure to document procedures to control design and development changes, and determine the significance of these changes to function, performance, usability, safety and regulatory requirements for the medical device and its intended use, as required by ISO 13485:2016 Clause 7.3.9.Specifically, your firm failed to follow procedure 1-SOP-014, Design Control, which states, “All design changes must be identified, documented, where appropriate validated, reviewed and approved before the changes may be implemented.” Additionally, your firm failed to follow procedure 2-SOP-010, Device Registration, Submission and Notification, which requires that once a device or process is changed, (b)(4). Your firm did not document design and development changes related to expanding the indications for use of the Bidop 3 (K954397) to include a fetal application which was not cleared as an intended use. During the inspection, the Bidop 3 operations manual noted the indications for use include detection of fetal heart sounds. Your firm has not provided documentation of:A. The review and approval of design change documentation, including:i. Specific modifications made to the device (hardware, software, or performance specifications) to support fetal use.ii. Validation data demonstrating the device's safety and effectiveness for fetal applications.B. An evaluation to determine whether the change in indications for use (from non-fetal to fetal application) required a new 510(k) submission.C. The date when distribution was initiated for the Bidop 3 as a Fetal Doppler.The adequacy of your firm’s responses cannot be determined at this time. Your corrective actions are in progress. Your responses mention that your firm notified customers via certified mail to suspend the use of fetal probes with Bidop 3 doppler units and that you conducted a 21 CFR 806 reportability assessment. FDA received your 806 report on 03/06/2026 and it is being processed under RES ID: 98556. The recall is on-going.2. Failure to document one or more processes for risk management in product realization and determine, as appropriate, quality objectives and requirements for the product, as required by ISO 13485:2016 Clause 7.1.Specifically, your firm’s risk management analysis for your devices revealed inadequate hazard identification and risk analysis as evidenced by the two (2) fetal dopplers below:A. Product ES-100V3 (Bidop 3), 510(k) K954397, cleared March 29, 1996: The risk management report (Document (b)(4), dated September 3, 2025) was revised to include an indication for use as a fetal heart rate doppler, according to management. However, this report fails to evaluate risks to the fetus, despite the device being labeled for determining fetal heart rate and sounds.B. Product Bidop 7, 510(k) K201114, cleared January 5, 2021: The risk management report (Document (b)(4), dated February 5, 2020) contains no evaluation of risks to the fetus, despite the device's indication for use, which includes displaying bi-directional velocity waveforms, numerical data, and fetal heart rate with a heartbeat indicator.The fetus is directly exposed to ultrasound energy and is the primary patient population for these devices. Failure to evaluate fetal-specific hazards (e.g., thermal effects, acoustic exposure, diagnostic accuracy affecting clinical decisions) represents inadequate risk analysis for the devices' intended use. Use of doppler ultrasound devices for fetal monitoring entails additional risks as compared to their use for blood flow monitoring. Fetal tissue is more vulnerable to prolonged or inappropriate ultrasound exposure than adult tissue. Additionally, improper use of the doppler for fetal monitoring may cause misinterpretation of maternal heartbeats or placental blood flow as fetal heartbeat, creating false reassurance. This can result in missed fetal distress signals, delayed care, and severe outcomes including fetal death. Conversely, failure to correctly detect a fetal heartbeat may cause anxiety and unnecessary clinical interventions.Therefore, the risk analysis of the fetal doppler ultrasound device should clearly assess these specific risks associated with use of the device for fetal monitoring as discussed above and specific hazards including fetal distress or death due to misinterpretation, and delayed care.The adequacy of your firm’s responses cannot be determined at this time. Your corrective actions are in progress. Your firm completed a review of the risk management files for the Bidop 7 to address hazards consistent with the cleared intended use. However, your firm did not provide supporting documentation.3. Failure to establish criteria for the evaluation and selection of suppliers, as required by ISO 13485:2016 Clause 7.4.1.Specifically, your firm has not established adequate criteria for the evaluation and selection of your approved suppliers based on their ability to provide product that meets requirements, the performance of the supplier, and the effect of the purchased product on the quality of the device. For example,A. Your firm holds 25 510(k) clearances for devices designed and manufactured by a contract manufacturer. During the inspection the Bidop 3 Doppler was found to have indications for use that differ from those in the cleared 510(k). The indications for use were changed from non-fetal to fetal application. This design change was implemented by your contract manufacturer and your firm does not have documentation of this change nor could your firm identify when this change occurred. The quality agreement between your firm and your contract manufacturer (Section 5.5, Labeling) requires that any changes to labeling (b)(4). This undocumented change represents a failure to ensure that (b)(4) labeling changes as is established in your quality agreement. Furthermore, the quality agreement fails to (b)(4) design changes beyond labeling.B. Per procedure 1-SOP-020, (b)(4) supplier approval criteria include requirements that must be met such as having a quality agreement, product inspection, and site assessment. There is no documentation that a site assessment (supplier audit) has been conducted for the contract manufacturer, a (b)(4) supplier which your firm’s procedure defines as “Highest/Critical Impact.”The adequacy of your firm’s responses cannot be determined at this time. Your corrective actions are in progress. We acknowledge that one of your corrective actions is that your firm amended the quality agreement with your contract manufacturer to include comprehensive design change notifications, access to change logs, and audit rights commensurate with the planned transfer of the 510(k)’s to your supplier. You mention that CAPA CA2026-3 is complete; however, it is in the effectiveness stage and your firm mentioned open corrective actions. As such, please ensure to keep the CAPA open and documented while you are completing all the steps of a CAPA.4. Failure to maintain records of the review, evaluation, and investigation for any complaints involving the possible failure of a device, labeling, or packaging to meet any of its specifications, as required by 21 CFR 820.35(a).Specifically, your firm failed to evaluate returned devices related to device failures affecting performance and reliability as complaints. Between January 1, 2024, and December 31, 2025, approximately (b)(4) Returned Goods Authorizations (RGAs) were issued for device returns. The investigator reviewed 29 completed RGA forms coded as "(b)(4)" and found that 13 of these forms reported device failures but were not evaluated as complaints. Your firm did not consider these reports as complaints and did not initiate or complete a complaint form as required by your complaint procedure, SOP 4-SOP-050 (Customer Complaint). This procedure defines a complaint as "Any written, electronic, or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, usability, safety, or performance of a medical device that has been released from the organization's control or related to a service that affects the performance of such medical devices.” For example:RGANumberDateDeviceCodeFailure/Inspection109236/26/2024Bidop 7(b)(4)The doppler memory has been cleared and when it is turned off and on, it comes up memory store #11 or memory store #1. The doppler should go straight to the LCD screen.110619/18/2024Bidop 3(b)(4)No consistent waveform with toe pressure sensor112111/8/2025Bidop 3(b)(4)Out of box failure115096/27/2025CRP-20H, cardiovascular probe(b)(4)Not picking up vascular flow114024/22/2025Aneroid Sphygmomanometer(b)(4)Doesn’t measure correctly on toeThe adequacy of your firm’s responses cannot be determined at this time. Your corrective actions are in progress. Your firm provided the training records showing the employees trained to the updated procedures; however, you did not provide specifics on the evaluation conducted for the employees to confirm they understood the updates. Please provide this information.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 Management 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.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 Melissa Michurski, Establishment Assessment Team 2, Assistant Director at CDRHEnforcement@fda.hhs.gov. Please include in the subject line, “CMS Case [734643]” when replying. If you have any questions about the contents of this letter, please contact: Ashley Mutawakkil, Compliance Officer, Ashley.Mutawakkil@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/CAPT Cesar A. Perez, PhD, USPHSActing Deputy DirectorOffice of Regulatory ProgramsOffice of Product Evaluation and QualityCenter for Devices and Radiological Health

按照《医疗器械监督管理条例》的规定，根据企业申请，海南省药品监督管理局现注销海南景卓盛生物科技有限公司以下2个产品的医疗器械注册证：海水鼻腔喷雾（琼械注准20252140072）；鼻腔润滑剂（琼械注准20252140017）。特此公告。海南省药品监督管理局2026年8月3日

全省各级药品监管部门认真落实“四个最严”要求，扎实推进药品经营环节“清源”巩固提升行动、医疗器械经营环节清查治理、医疗机构药械质量安全突出问题整治成效“回头看”，持续加强化妆品安全监管，依法查处一批违法违规案件，切实保障了人民群众用药用械用妆安全。现将5起违法违规典型案例公布如下。一、新余某药店非法渠道购进药品案2025年8月，新余市市场监督管理局根据举报线索，对某药店开展现场检查，发现当事人从不具备药品经营资质的个人及零售药店处购进药品，并通过第三方平台进行销售。当事人的行为违反了《中华人民共和国药品管理法》第五十五条的规定。新余市市场监督管理局依据《中华人民共和国药品管理法》第一百二十九条的规定，责令当事人改正，并对当事人处以没收违法所得、罚款的行政处罚。二、赣州某药房公司未遵守药品经营质量管理规范从事药品经营活动案2025年7月，赣州市市场监督管理局根据医保部门移送的线索，对某药房公司开展检查。经查，当事人存在未凭处方销售处方药的行为，且执业药师现场未在岗履职，执法人员当场下达《责令改正通知书》，要求其限期整改。整改期满后，执法人员依法对当事人开展整改情况复核，发现仍存在执业药师未在岗履职、未凭处方销售处方药的行为，且该执业药师实际为某医疗机构在职人员，并未在当事人处从事执业药师相关工作。当事人的行为违反了《中华人民共和国药品管理法》第五十三条第一款、《药品经营质量管理规范》第一百二十五条、第一百三十五条、第一百六十七条的规定。赣州市市场监督管理局依据《中华人民共和国药品管理法》第一百二十六条的规定，对当事人处以警告、罚款的行政处罚，并报上级主管部门依法注销该执业药师的执业药师注册资格。三、宜春某医疗器械有限公司出租、出借医疗器械经营许可证案 2026年4月，樟树市市场监督管理局根据某单位移送的案件线索，对某医疗器械有限公司进行检查。经查，当事人将《医疗器械经营许可证》出租、出借给南昌市某医疗器械有限公司业务员刘某用于采购、销售第三类医疗器械，并从中收取使用费。当事人的行为违反了《医疗器械经营监督管理办法》第二十八条的规定。鉴于当事人已于2026年2月注销医疗器械经营许可证，樟树市市场监督管理局依据《医疗器械监督管理条例》第八十三条第二款的规定，对当事人处以没收违法所得并处罚款的行政处罚。四、萍乡某医院使用过期医疗器械案2025年12月，莲花县市场监督管理局对某医院进行日常检查。经查，当事人使用过期医疗器械“类风湿因子（RFⅡ） 测定试剂盒”“乳酸脱氢酶（LDH）测定试剂盒”等产品。当事人的行为违反了《医疗器械监督管理条例》第五十五条的规定。莲花县市场监督管理局依据《医疗器械监督管理条例》第八十六条第一款第三项的规定，责令当事人改正，对当事人处以没收过期医疗器械、罚款的行政处罚。五、姜某经营未经注册、标签标示不符合规定的特殊化妆品及未履行化妆品进货查验记录制度案2025年3月，南昌市市场监督管理局在核查化妆品抽检风险线索过程中，发现姜某存在违法经营特殊化妆品行为。经查，姜某向某美发店销售标称进口某品牌的染发膏，经检验，该产品标签与产品注册资料载明的技术要求不一致，并检出标签未标示的染发剂。经品牌方出具鉴定报告，认定涉案产品为假冒注册商标商品。调查期间姜某无法提供供货商资质、特殊化妆品注册证、进货查验记录等资料，未履行化妆品进货查验法定义务。当事人的行为违反《化妆品监督管理条例》第十七条、第三十六条第（五）项、第三十八条第一款、《中华人民共和国商标法》第五十七条第（三）项规定。南昌市市场监督管理局依据《化妆品监督管理条例》第五十九条第（二）项的规定，对当事人处以没收违法所得、罚款的行政处罚。