Delivery Method:VIA Electronic MailProduct:Medical DevicesRecipient:John C. KavanaghQA/RA ManagerSpecialty Health Products CO, LLC2514 E Mohawk Ln, Suite 111Phoenix, AZ 85050United States (b)(6), (b)(7)(C)Issuing Office:Center for Devices and Radiological HealthUnited StatesWARNING LETTERCMS # 726564July 7, 2026Dear Mr. Kavanagh:During an inspection of your firm located in Phoenix, AZ, from December 1, 2025, through December 11, 2025, investigators from the United States Food and Drug Administration (FDA) determined that your firm manufactures and markets the Hydro-San Colonic Irrigation System (also known as Hydro-San Plus, Hydro-San, and Hydro-San Plus A Base Unit), the Aqua Cleanse Colonic Irrigation System, and Speculum Kits. 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 Violation(s)Our inspection revealed that the Hydro-San Plus, Aqua Cleanse, and Speculum Kits are adulterated under 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 (CGMP) requirements of the Quality System (QS) Regulation found at 21 CFR Part 820. We received your firm’s responses dated January 5, 2026, February 6, 2026, March 5, 2026, April 10, 2026, May 6, 2026, and June 10, 2026. These responses are not adequate for the reasons described below.1. Failure to establish and maintain design validation procedures to ensure that devices conform to defined user needs and intended uses and shall include testing of production units under actual or simulated use conditions, as required by 21 CFR 820.30(g).Specifically, your firm has not conducted design validation for your biocompatibility or shelf life requirements of the Class II colonic irrigation devices (Hydro-San Plus and Aqua Cleanse).a. Your firm does not have evidence that biocompatibility testing per ISO 10993 standards was conducted for the (b)(4) material used in patient-contacting speculums despite your specifications requiring compliance to ISO 10993: Biological Evaluation of Medical Devices. Your QA/RA Manager stated that no such records exist.b. Your firm does not have shelf-life validation studies or accelerated aging data to support the claimed 7-year shelf life for the Hydro-San Plus, despite your own risk analysis document explicitly acknowledging a 7-year shelf life due to possible deterioration of components.c. Your firm’s risk analysis documents are inadequate and do not address risk associated with biocompatibility of your (b)(4) material. Your risk analysis documents do not reference the specific material ((b)(4)), specific test reports or laboratory names, or ISO 10993 biocompatibility testing standards. Your firm’s risk analysis for the Hydro-San Plus does not evaluate risks from oxygen administration or materials incompatible with high-oxygen environments. The only documentation provided for the oxygen hose does not indicate that the tubing is rated, tested, or approved for medical oxygen delivery applications. Your firm’s risk analysis identified disinfection as a control measure but failed to ensure the control measure was adequately established. The Hydro-San Plus User Guide specifies only 15 seconds of contact time for the Cetylcide disinfectant, which is non-compliant with the manufacturer’s required 1-minute contact time for sanitizing and 10-minute contact time for virucidal activity.Your firm’s responses are not adequate. Your firm’s CAPA-009 response proposes reviewing the (b)(4) Safety Data Sheet (SDS) and conducting a single cytotoxicity test. An SDS is not a substitute for biocompatibility testing per ISO 10993 standards, and a single cytotoxicity test does not constitute adequate biocompatibility assessment for a device that contacts mucous membranes. Regarding shelf life, your firm produced a report concluding the device does not have a shelf life, which directly contradicts your own risk analysis document that stated a 7-year shelf life. Your firm has not adequately explained this discrepancy or provided evidence that components do not degrade over time. Your firm’s progress reports contain no mention of risk analysis, design validation, biocompatibility testing, or shelf-life studies.2. Failure to establish and maintain design change procedures as required by 21 CFR 820.30(i).Specifically, your firm’s Design Controls procedure (Rev B, dated 7/14/2023) requires design changes to be documented in Engineering Change Orders (ECOs). However, your firm could not provide ECOs or design change input approval for multiple changes to the Hydro-San Plus device, including: (b)(4) changes ((b)(4) different valves used in various device models at unknown times with no ECO documentation); and addition of a (b)(4) (implemented at an unknown point in time with no ECO or approval documentation), despite the fact that the work instruction for the Hydro-San Plus Light Unit, Document 020-0003, Rev A, dated 2/5/2024) demonstrates that the (b)(4) strip (part (b)(4)) is a component of the Model A design.Your firm’s responses are not adequate. Your firm’s CAPA-010 response reveals a gap in understanding what constitutes a design change requiring formal control. The planned assessment of the UV light was scheduled for completion by February 27, 2026, but documentation of the assessment has not been provided. Your firm’s progress reports make no specific reference to establishing or improving design change control procedures, and your firm has not explained how it will identify all previously undocumented design changes, retrospectively review, verify, validate as appropriate, and approve those changes, or prevent future unauthorized design modifications.3. Failure to develop, conduct, control, and monitor production processes to ensure that a device conforms to its specifications, as required by 21 CFR 820.70(a).Specifically,a. Your firm’s Aqua Cleanse Work Instruction, which documents your assembly instructions for the Aqua Cleanse device, contains no testing procedures, parameters, or acceptance criteria, and no mention of (b)(4) testing procedures or duration, (b)(4) testing steps or acceptable ranges, or (b)(4) testing protocols.b. Your firm’s disinfection procedures, for the use of Cetylcide disinfectant for disinfecting colonic irrigation devices returned from the field, do not incorporate manufacturer requirements. Your firm’s disinfection procedure, Rev B, dated 6/5/2024 states only “Apply the Cetylcide disinfectant as instructed by the manufacturer” without incorporating specific steps for contact time requirements, dilution ratios, application methods, or verification of disinfection effectiveness.Your firm’s responses are not adequate. Your firm’s CAPA-017 response does not address whether current process parameters are adequate to ensure device safety and effectiveness in that in-process testing instructions are incomplete (missing test durations, steps, and parameters). Your firm’s corrective action regarding contamination control — installing a barrier around the sink while disinfecting field service returns — does not constitute proper contamination control for potentially biohazardous materials, and your firm has not addressed air handling, surface disinfection protocols, or personal protective equipment requirements. Your firm’s progress reports state only that it has “enhanced our processes and practices from receiving to customer service,” which provides no specific information about how process control procedures have been corrected.4. Failure to maintain complaint files and establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit, as required by 21 CFR 820.198(a).Specifically,a. Your firm did not document formal evaluation, review, or investigation of eight complaints. RGA #411 (dated 8/25/2025), which involved a mislabeled speculum shipment, was closed on the same day it was opened without reference to any investigation or evaluation documentation, and no cause analysis was documented.b. Your firm was not consistently documenting all complaints in the RGA Log or on RGA Forms as required by your “Complaint Handling, Rev. B, 6/11/2024”. A Corrective Action Record (CAR #005, dated 1/27/2025) references three customer complaints from January 2025 (customers DM, AD, and SE), but no corresponding RGA numbers or RGA forms exist for these complaints.Your firm’s responses are not adequate. Your firm’s CAPA-008 proposes updating the complaint log and establishing formal complaint meetings but fails to address the fundamental breakdown in complaint investigation methodology. Your firm’s corrective actions focus primarily on documentation updates and form creation but do not establish clear criteria for determining when formal investigations are required, what constitutes an adequate investigation, or how to ensure complaints are properly evaluated for reportability under Medical Device Reporting (MDR) requirements. Your firm’s April 2026 progress report states only that it “started to hold formal CAPA and complaints review meetings,” but provides no evidence that the missing Complaint Report Log has been created, or that a system has been implemented to ensure complaints receive proper evaluation and investigation.5. Failure to establish and maintain procedures to control all documents that are required by this part, as required by 21 CFR 820.40.Specifically,a. Your firm’s current Servicing procedure (Rev B, dated 6/5/2024) contains no servicing steps or requirements. Instead, the body of the Environmental Controls procedure was inadvertently saved under the Servicing procedure title, and this error was not detected before the procedure was released as a controlled document.b. Multiple controlled documents, including the Device Master Record for the Hydro-San Plus and the Aqua Cleanse Work Instruction, were provided as editable MS Word files without password protection, electronic signatures, or any controls preventing unauthorized modification. The Aqua Cleanse work instruction was also undated and unsigned.Your firm’s responses are not adequate. Your firm’s CAPA-020 addresses individual instances of document control failures but does not demonstrate understanding of the systemic breakdown in your firm’s document control system. Your firm has not explained how the body of one procedure was saved under the title of another and has not addressed the need for a comprehensive overhaul of its electronic document management system, including access controls, audit trails, and version control. Your firm’s progress reports make no mention of document control improvements.Unapproved Device Violation(s)FDA has reviewed the Specialty Health Products website, user’s guide, product catalog, and written orders, and determined that the Hydro-San Plus is 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 (IDE) under section 520(g) of the Act, 21 U.S.C. § 360j(g) for the device as described and marketed. The Hydro-San Plus is 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 this device with major changes or modifications to the intended use 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)(ii).Specifically, the Hydro-San Colonic Irrigation System was cleared under K891585 with the following indications: The Hydro-San Colonic irrigation system is to be used when colonic irrigation is indicated. However, your firm’s promotion of the device provides evidence that the device is distributed with an intended use for colon hydrotherapy, which is an alternative practice that flushes the large intestine with warm, filtered water to remove waste typically marketed for general wellbeing, including to boost energy and detoxify the body, rather than for medical indications. This would constitute a major change or modification to its intended use, for which your firm lacks clearance or approval. Examples include:Product catalog for the Hydro-San Plus indicates the firm Specialty Health Products is a leading manufacturer of professional colon hydro-therapy systems.Product webpage states the mission is to “be the premier service provider of professional Colon Hydrotherapy devices and integrated serves [sic].”Product webpage asserts several benefits of professional colon hydrotherapy, including improved digesting health, alleviating constipation and promoting bowel movements, lower risk of cancer, and boosting the body’s retention of vitamins and nutrients.Written orders indicate that the device was approved for sale for colon hydrotherapy to wellness centers.Colonic irrigation systems are classified as Class II if the intended use is “for colon cleansing when medically indicated, such as before radiological or endoscopic examinations” per 21 CFR 876.5220(b)(1). However, per 21 CFR 876.5220(b) (2), a colonic irrigation system is classified as Class III “when the device is intended for other uses, including colon cleansing routinely for general well-being.”Additionally, since the Hydro-San Colonic Irrigation System was cleared under K891585, substantial technological changes were made that significantly affect the safety and effectiveness of the device. Examples include:The Hydro-San Plus System includes the ultra-filtration collection, which are separate filtration canisters for the hot and cold-water filtration (https://shpllc.net/filtration/). Performance and biocompatibility testing is needed to support the safety and efficacy of the filters with the system.The Hydro-San Plus System includes an optional Ultraviolet (UV) Light Unit. Additional performance and electrical safety testing is needed to support the safety and effectiveness of the UV Light Unit.The distribution of colonic irrigation systems with these major changes and without the required premarket authorization may raise serious public health concerns, as colonic irrigation can lead to perforation of the rectum and/or colon, infection, imbalance of electrolytes, dehydration, and microbial dysbiosis.For a device requiring premarket approval, the notification required by section 510(k) of the Act, 21 U.S.C. § 360(k), is deemed satisfied when a PMA is pending before the agency, per 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 marketedOur office requests that Specialty Health Products cease any activities that result in the misbranding or adulteration of the Hydro-San Plus, such as the commercial distribution of the device for the uses discussed above.Unique Device Identifier (UDI)/GUDID ViolationThe device cleared with K891585, Hydro-San Colonic Irrigation System, is misbranded within the meaning of section 502(t)(2) of the Act, 21 U.S.C. § 352(t)(2), in that there was a failure or refusal to furnish any material or information required by or under section 519 of the Act, 21 U.S.C. § 360i, respecting the device. In particular, 21 CFR 801.20(a) requires, with exceptions not relevant here, that the label and device package of every medical device bear a unique device identifier (UDI) that meets the requirements of 21 CFR Part 801, subpart B, and 21 CFR Part 830. Also, 21 CFR 830.300(a) and 830.320(b), both of which were promulgated under section 519 of the Act, among other provisions, require, with exceptions not relevant here, that the labeler of a device submit electronically to FDA’s Global Unique Device Identification Database (GUDID) the information required by 21 CFR Part 830, subpart E, for each version or model required to bear a UDI.FDA has determined that your firm causes a label to be applied to a device with the intent that the device will be commercially distributed without any subsequent replacement or modification of the label. Specialty Health Products is therefore a “labeler” within the meaning of 21 CFR 830.3 and has not submitted to GUDID information required by 21 CFR Part 830, subpart E, respecting this device.The failure or refusal to furnish any notification or other material or information required by or under section 519 of the Act, 21 U.S.C. § 360i, also constitutes a prohibited act under section 301(q)(1)(B) of the Act, 21 U.S.C. § 331(q)(1)(B).Based on a review of the GUDID on June 30, 2026, there are no entries for Hydro-San Colonic Irrigation System under “Specialty Health Products Inc.” or under “Quality Medical Supply.”Your firm’s responses dated January 5, 2026, February 6, 2026, March 5, 2026, April 10, 2026, May 6, 2026, and June 10, 2026, are not adequate. Your firm’s responses do not address GUDID reporting.Registration and Listing ViolationDuring an inspection of your firm, located in Phoenix, AZ, on December 01, 2025, through December 11, 2025, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures (or markets) the Hydro-San Colonic Irrigation System (also known as Hydro-San Plus, Hydro-San, and Hydro-San Plus A Base Unit) and the Aqua Cleanse Colonic Irrigation System. In addition to this, you also develop specifications for packaging and labeling of enema (speculum) kits to be sold with these irrigation devices. Specialty Health Products also imports enema (speculum) kits that are already packaged and labeled to distribute in the U.S.Your firm has registered for Fiscal Year 2026, but you have not identified your establishment as an initial importer. You also have not listed the following devices:The modified Hydro-San Plus, using a new premarket submission numberAqua Cleanse enema (speculum) kitsHydro-San Plus enema (speculum) kitsTherefore, the devices are misbranded in that they were not included in a list required by section 510(j) of the Act (21 U.S.C. § 360(j)).If you are not manufacturing and marketing the device cleared under K891585, you must deactivate that listing. Specialty Health Products must submit a new premarket submission for the Hydro-San Plus device. This device and the Hydro-San Plus enema (speculum) kits cannot be listed until the new premarket submission has been authorized. After the authorization, your firm must list the devices using the new premarket submission number. You must also list the Aqua Cleanse enema (speculum) kits using K150381.In addition to updating your listing information, you must also update the registration information. The owner/operator contact person must log in and change the owner/operator contact person and official correspondent’s email address and add initial importer to Specialty Health Products’ registration.Instructions explaining how to list exempt and non-exempt devices, update the owner/operator contact person and official correspondent information and add initial importer can be found on our website at: How to Register and List | FDAYour 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 device will not be approved until the violations have been addressed. Should FDA determine 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. The recent inspection from December 1, 2025 through December 11, 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 Jeffrey Wooley, Acting Assistant Director, at - CDRHEnforcement@fda.hhs.gov. Please include in the subject line, “CMS Case 726564” when replying. If you have any questions about the contents of this letter, please contact Raymond Brullo at raymond.brullo@fda.hhs.govFinally, 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 Electronic MailProduct:Medical DevicesRecipient:Jason Allen BandyChief Executive Officer (CEO)Lion Street Medical, d/b/a Pensar Medical LLC109 N Post Oak Ln, Suite 525Houston, TX 77024-7862United States(b)(6), (b)(7)(C)Issuing Office:Center for Devices and Radiological HealthUnited StatesWARNING LETTERCMS #733015August 21, 2026Dear Mr. Bandy:During an inspection of your firm located in Houston, TX from April 14, 2026, through April 28, 2026, an investigator from the United States Food and Drug Administration (FDA) determined that your firm, Lion Street Medical, d/b/a Pensar Medical LLC, manufactures the WoundPro Negative Pressure Wound Therapy (NPWT) System, the WoundPro+ NPWT System, and the MicroDoc (PocketDoc) Portable NPWT System (negative pressure wound therapy systems). These products are intended to promote wound healing by draining and removing infectious material and other fluids from the wound site through continuous and/or intermittent negative pressure. 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 cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body.Medical Device Reporting (MDR) ViolationsOur inspection revealed that your firm’s negative pressure wound therapy systems are misbranded under 21 CFR 803.17 in that your firm failed or refused to develop, maintain, and implement written MDR procedures required by or under section 519 of the Act, 21 U.S.C. § 360i. Significant violations include, but are not limited to, the following:1. During the inspection, your firm presented its MDR procedure titled “Medical Device Reporting”, WI103-01, Rev. 2, dated 12/12/2023. Upon review, we noted the following deficiencies:a) The procedure does not establish internal systems that provide for timely and effective identification, communication, and evaluation of events that may be subject to MDR requirements, as required by 21 CFR 803.17(a)(1). For example, the procedure does not include adequate definitions of what constitutes a reportable event under 21 CFR Part 803. Specifically, the procedure does not include a definition of what “reasonably suggests” whether a reportable event has occurred as it is described in 21 CFR 803.20(c)(1); this may lead your firm to make an incorrect reportability decision when evaluating a complaint that may meet the criteria for reporting under 21 CFR 803.50(a).b) The procedure does not describe how your firm will address documentation and record-keeping requirements, as required by 21 CFR 803.17(b). The procedure also does not include documentation of the deliberations and decision-making processes used to determine if a device-related death, serious injury, or malfunction was or was not reportable, as required under 21 CFR 803.18(b)(1)(i).Your firm’s response dated May 19, 2026, did not address the procedural deficiencies noted above as they were not listed on the Form FDA 483. Your firm’s response dated June 19, 2026, is a periodic update that provides the status of its progress and outlines its plan to address MDR reporting requirements by August 2026.Our inspection also revealed that your firm’s negative pressure wound therapy systems 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 803 - Medical Device Reporting. Significant violations include, but are not limited to, the following:2. Failure to report the information required by § 803.52 in accordance with the requirements of § 803.12(a), no later than 30 calendar days after the day that your firm received or otherwise became aware of information, from any source, that reasonably suggests that a device that your firm markets may have caused or contributed to a death or serious injury, as required by 21 CFR 803.50(a)(1).For example, the information included for Complaint C-029 reasonably suggests that, while using your firm’s negative pressure wound therapy System, the patient sustained an infection at the wound site (i.e., purulent drainage). Absent additional information regarding the wound location, severity, or your firm’s rationale for determining that the event was not reportable, the available information reasonably suggests that the patient sustained an infection in the treated wound area that necessitated medical or surgical intervention, including removal of the retained foam, to preclude permanent impairment of a body function or permanent damage to a body structure. Therefore, the information reasonably suggests that the device associated event represents an MDR-reportable serious injury as defined in 21 CFR 803.3(w). Your firm became aware of the event on May 1, 2024, and FDA has not yet received a serious injury MDR for this adverse event.Your firm’s responses dated May 19, 2026, and June 19, 2026, are inadequate. In these responses, your firm states that it initiated CAPA-045 to implement systemic corrective actions, including a retrospective review, streamlining the MDR reporting process, staff retraining, and submission of the reports through its agent, to address the reporting issue. However, these actions are still ongoing, and the responses do not include documentation demonstrating completion or implementation of these corrective actions.Your firm submitted MDR 3007793449-2024-00001 for the serious injury referenced for Complaint C-029. However, the MDR was incorrectly submitted as a malfunction report. As indicated above, the referenced event meets the definition of a serious injury. Therefore, the corresponding MDR should have identified the event in Block H1 of Form FDA 3500A, Type of Reportable Event, as a Serious Injury (21 CFR 803.52(f)). Accordingly, your firm must submit corrected date for this MDR to correct the error and identify the correct Type of Reportable Event. In addition, as required by 21 CFR 803.3(m)(2), the manufacturer report number must include the four-digit calendar year in which the report was submitted. Going forward, please ensure all initial MDRs use the correct submission year when constructing the manufacturer report number. For MDRs already submitted, this requirement is not applicable to the supplemental reports, and the manufacturer report number should not be changed when submitting the supplements.We reviewed your firm’s response dated July 20, 2026, and conclude that it is not adequate. In that response, your firm provided the following draft documents:“Customer Complaints and Customer Feedback”, QP103, Revision 03“Medical Device Reporting”, WI103-01, Revision 03“Customer Complaint Report Form”, FM103-01, Revision 03We collectively reviewed these documents as your firm’s revised MDR procedure and noted that they do not include a definition of the term “reasonably suggests”. In addition, your firm indicated that these draft documents are not expected to be implemented until August 31, 2026.In that response, your firm also provided evidence that it had completed a retrospective review and MDR evaluation of complaints received since October 2023. However, as previously noted, MDR 3007793449-2024-00001 was incorrectly submitted as a malfunction report. Corrected data is required to revise the event type from malfunction to serious injury in Block H1 of the FDA Form 3500A. In addition, please note that, moving forward, the manufacturer report number must include the four-digit calendar year in which the initial report was submitted pursuant to 21 CFR 803.3(m)(2).Corrections and Removals ViolationsOur inspection also revealed that your firm’s MicroDoc (PocketDoc) Portable NPWT System 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: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 firm conducted a correction of your MicroDoc (PocketDoc) Portable NPWT System device software which can lead to an outcome where the probability of adverse health consequences is remote and more likely than not that an event will occur. Your firm conducted software reworks and updates to the newest MicroDoc software for at least (b)(4) customers who purchased the software with the wrong version and updated Revision B (ECO 25-052) of the MicroDoc Programming Work Instruction (Document # 169378-1001) to reflect the correct software revision to be used. This action is a medical device correction or removal initiated to reduce a 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.Your firm’s responses to the FDA-483, dated May 19, 2026, June 19, 2026, and July 20, 2026, do not address this issue. You have not submitted a report of correction or removal to FDA as of August 20, 2026.Quality Management 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 Management System Regulation (QMSR) found at Title 21, Code of Federal Regulations (CFR), Part 820. We received a response dated May 19, 2026, and a follow-up update dated June 19, 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 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 one or more processes for risk management in product realization, as required by ISO 13485:2016, Clause 7.1.For example, your firm failed to document your QMS Process Risk Management (QP116, Rev. 01, 04/24/2026) program across its WoundPro, WoundPro+, and MicroDoc (PocketDoc) device lines. The following specific deficiencies were identified:a) Your Design Failure Mode and Effects Analysis (dFMEA) for the PocketDoc device identifies (b)(4) distinct hazards. The risk control verification entries associated with software, sterilization, storage, packaging, and exudate management (entries P3, P4, P6, P7, P10, and P24 through P27) are all marked “In Progress,” and the corresponding risk controls had not been implemented and verified at the time of inspection.b) Your firm’s formal QMS Process Risk Management (QP116, Rev. 01, 04/24/2026) requires a user FMEA (uFMEA), design FMEA (dFMEA), and process FMEA (pFMEA) for every product. No WoundPro FMEAs of any type were found to exist.c) Your software-specific dFMEA for the MicroDoc device encompasses (b)(4) software hazards. Of the (b)(4) high-risk verification entries, (b)(4) were recorded as “In Progress” at the time of inspection.We reviewed your firm’s responses dated May 19, 2026, June 19, 2026, and July 20, 2026 and conclude that they are not adequate. None of the short-term corrections or corrective actions are complete as of either response date. The WoundPro and MicroDoc FMEAs have critical missing elements, and no interim risk mitigation plan has been described for the period between the inspection and the completion of the FMEAs. The procedure overhaul for six QMS procedures (QP116, QP129, QP106, QP105, QP123, and QP110) has not been finalized, and no FMEA recreation is documented as complete. While we acknowledge receipt of Quality Plan QP 2026-01 (Rev A) and the onboarding of a new Quality Manager, these actions do not constitute a completed corrective action plan. Your targeted completion date for your corrective actions is (b)(4) and therefore, additionally, your response is not adequate.2. Failure to adequately review, verify, validate, and approve design and development changes before implementation, as required by ISO 13485:2016 Clause 7.3.9.For example, your firm’s change records did not include records of necessary actions, in that your firm approved, implemented, and closed out multiple software changes to the MicroDoc and WoundPro+ devices without records that the changes were correctly, completely, or safely implemented. The following specific deficiencies were identified across eleven Engineering Change Orders (ECOs) reviewed during the inspection:a) ECO 25-039 (effective June 23, 2025) documents a WoundPro+ firmware update from revision (b)(4) to (b)(4). No batch record or other record demonstrating implementation of this change was provided upon request to confirm the update was implemented. Your firm’s President confirmed during the inspection that no such batch record had been documented.b) ECO 25-033 (effective May 20, 2025) documents an earlier WoundPro+ firmware update from revision (b)(4) to (b)(4). No batch record or other record demonstrating implementation of this change was provided upon request to confirm the update was implemented. Your firm’s President confirmed during the inspection that no such batch record had been documented.c) ECO 25-022 (effective April 15, 2025), ECO 25-021 (effective March 11, 2025, p. 93), ECO 25-008 (effective March 4, 2025, p. 94), ECO 24-040 (effective November 21, 2024, p. 95), ECO 24-030 (effective September 20, 2024, p. 96), and ECO 24-024 (effective August 15, 2024, pp. 97–98) each document firmware or software changes that took effect at specific serial number thresholds without any batch record or other record provided upon request to confirm implementation. For ECO 25-008 (“clean up all code,” revision (b)(4) to (b)(4)), neither your CEO nor your President could explain what code changes were actually incorporated, and no verification record exists.d) Your Software Validation Procedure (QP123, Rev 02) states that revalidation is required when there is a significant change and lists software updates among the triggers for revalidation. However, your procedure does not address the need to confirm that unchanged but potentially affected portions of the software have not been inadvertently disrupted by a change, leaving a systematic gap in your firm’s ability to detect regression failures.We reviewed your firm’s responses dated May 19, 2026, June 19, 2026, and July 20, 2026, and conclude that they are not adequate. With respect to ECO 25-039 (WoundPro+ firmware update to (b)(4)), your July 17, 2026 Memo to ECO Files references the batch traveler for serial number (b)(4), and the batch traveler, Final QC Inspection Sheet, and Final Acceptance Test Data Sheet submitted with the July 20, 2026 update. However, the memo acknowledges that the hold on ECO 25-033 was communicated verbally only, with no nonconformance report (NCR) or formal documentation generated, and this procedural gap remains unresolved. Furthermore, no documented formal risk assessment has been submitted for ECO 25-039, and your characterization of the (b)(4) noise change as “cosmetic in nature” and unrelated to “safety or effectiveness” continues to be made without a documented risk assessment tied to the device’s design FMEA. Your procedure revisions to QP129, QP106, and QP123, targeted for (b)(4), remain incomplete, the retrospective ECO review for all remaining ECOs has not been documented as complete, and the (b)(4) testing gap in QP123 has not been resolved.3. Failure to document an adequate procedure to define requirements for corrective action, as required ISO 13485:2016 Clause 8.5.2.For example, your “Corrective and Preventive Action” procedure (QP110, Rev 01, 04/14/2026) requires documentation of root causes, corrective action plans, and verified effectiveness before any CAPA record can be closed. The procedure requires these activities be documented on Form110-01, Corrective and Preventive Action (CAPA) Form. A review of five CAPA records revealed a pattern of blank root cause fields, missing corrective actions, and unverified effectiveness across all five records, in direct violation of your firm’s own established procedure:a) CAPA-031, 2/22/23, was opened in response to identified deficiencies in CAPA documentation. The record was closed without any corrective actions, preventive actions, or effectiveness verification having been documented.b) CAPA-036, 1/9/2024 & 1/19/2024 reflects that corrective action was taken; however, that action was never incorporated into your firm’s risk analysis, and the fields designated for effectiveness verification were left blank.c) CAPA-037, 1/9/2024 is entirely incomplete. The root cause section, the corrective and preventive action sections, and the effectiveness verification section are all blank. No substantive documentation was entered into this record.d) CAPA-039, 1/19/2024 shows a blank root cause field, no documented corrective actions, and effectiveness sections containing only unfilled placeholder language carried over from the template.e) CAPA-040, 10/25/2024 shows blank root cause fields, incomplete corrective action entries, and no documented effectiveness verification.We reviewed your firm’s responses dated May 19, 2026, June 19, 2026, and July 20, 2026 and conclude that they are not adequate. Issuing Memos to File to update five CAPA records to “Ineffective” status acknowledges the problem but does not constitute corrective action. None of the short-term corrections for this observation are complete as of the June 19, 2026 update. The QP110 overhaul has not been finalized. Furthermore, all seven new CAPAs (CAPA-041 through CAPA-047) opened in response to this inspection continue to be managed under the same underdefined procedure that was cited as deficient. While we acknowledge receipt of Quality Plan QP 2026-01 (Rev A) and the onboarding of Quality Manager (b)(6), (b)(7)(C), these actions do not constitute completed corrective action. In addition, no completion dates are entered in your Quality Plan for any CAPA-047 action items.This letter notifies you of our findings and provides you an opportunity to address the above deficiencies. Your firm should take prompt action to address the violations identified in this letter. Failure to adequately address this matter may result in regulatory action being initiated by 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 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 (15) 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 (15) 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 all violations included in this Warning Letter. If you believe that your products are not in violation of the 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 Jeffrey Wooley, Acting Assistant Director, at CDRHEnforcement@fda.hhs.gov Please include in the subject line, CMS Case #733015, when replying. If you have any questions about the contents of this letter, please contact Raymond Brullo, Compliance Officer, at Raymond.Brullo@fda.hhs.govFinally, 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/For Barbara C. MarsdenDirectorOffice of Regulatory ProgramsOffice of Product Evaluation and QualityCenter for Devices and Radiological Health

Delivery Method:Via UPS and EMAILReference #:CBER 26-730612Product:BiologicsRecipient:Edwin PinosPresidentNexCell Scientific Inc2 Hughes Ste 200Irvine, CA 92618-2055United States ed@nexcellscientific.comIssuing Office:Center for Biologics Evaluation and ResearchUnited StatesWARNING LETTERSeptember 11, 2026CBER 26-730612Dear Edwin Pinos:The United States Food and Drug Administration (FDA) inspected your facility, located at the above address, between December 9 and 12, 2025, and between February 3 and 5, 2026. During the inspection, FDA documented that your company manufactures an umbilical cord blood-derived total nucleated cell (TNC) product, in multiple concentrations, for allogeneic use (hereinafter, “your product”).This letter is to advise you that your product is an unapproved new drug in violation of section 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. § 355(a). Your product is also an unlicensed biological product in violation of section 351(a)(1) of the Public Health Service Act (PHS Act), 42 U.S.C. § 262(a)(1). A biological product for which a biologics license application (BLA) has been approved under section 351(a) of the PHS Act is not required to have an approved application under section 505 of the FD&C Act, 21 U.S.C. § 355; 42 U.S.C. § 262(j). Otherwise, with certain exceptions not applicable here, a new drug may not be introduced or delivered for introduction into interstate commerce without an approved application from FDA in effect, as described in section 505(a) of the FD&C Act. Your introduction or delivery for introduction of your product into interstate commerce, or the causing thereof, is prohibited under section 301(d) of the FD&C Act, 21 U.S.C. § 331(d).This warning letter also summarizes significant violations of current good manufacturing practice (CGMP) requirements, including violations of section 501(a)(2)(B) of the FD&C Act, 21 U.S.C. § 351(a)(2)(B), and 21 CFR parts 210 and 211 in the manufacture of your product. Because your methods, facilities, or controls for manufacturing, processing, packing, or holding drugs do not conform to CGMP, your product is adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act, 21 U.S.C. § 351(a)(2)(B). Your introduction or delivery for introduction of your product into interstate commerce, or the causing thereof, is a prohibited act under section 301(a) of the FD&C Act, 21 U.S.C. § 331(a).Unapproved New Drug and Unlicensed Biological Product ViolationsBased on information and records reviewed by FDA, your product is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease or conditions in humans and/or is intended to affect the structure or function of the body. For example:Your website www.nexcelllabs.com includes the following statements in its “What is Regenerative Medicine?” page, along with assurances that your company “uses exclusively umbilical cord derived cells”:o “Because of their ability to differentiate into cells that carry out the roles needed in a variety of organs, cell allografts are an essential regenerative tool. When these allografts are introduced into a damaged tissue or organ, they have the ability to evolve and carry out necessary functions, compensating for the damaged cells.”o “When injected into a damaged tissue, the cells specialize to carry out the necessary function of that particular area, improving symptoms and function.”o “[Mesenchymal stem cells] reduce the signal cells that promote inflammation… While this is another function that helps them avoid the immune response, it is also essential to the cells’ utility in chronic and autoimmune disease characterized by inflammation.”o Under the heading “How Stem Cells Work”, “Once in the affected area, the cells … begin to produce signaling proteins that work to regulate inflammation, aid in angiogenesis, and promote tissue repair.”The “Characterization of BioGenix® Allograft Products Independent Viability Study,” which you referenced during the FDA inspection as the “White Paper study” used to characterize your product, states:o On page 4, under the heading “Applications and Advantages”: “Research suggests that the use of mesenchymal and hematopoietic stem cells may offer potential benefits for musculoskeletal issues, wound injuries, cirrhosis of the liver, blood disorders, cardiovascular conditions, neurological disorders, and systemic and autoimmune diseases. A number of clinical trials have specifically targeted autoimmune issues, including multiple sclerosis, psoriasis, Crohn's disease, rheumatoid arthritis, lupus erythematosus, and others.” (citations omitted).o On page 10, under the heading “Discussion and Summation”: “Several research studies suggest that umbilical cord-derived allografts may have potential advantages for a range of indications, such as musculoskeletal disorders, modulation of immune responses, neurological conditions, liver cirrhosis, cardiovascular system issues, blood disorders, wound, and multiple variants of systemic or autoimmune disorders.” (citations omitted).Therefore, your product is a drug as defined in section 201(g)(1) of the FD&C Act, 21 U.S.C. § 321(g)(1), and a biological product as defined in section 351(i) of the PHS Act, 42 U.S.C. § 262(i).Your product is also a human cell, tissue, or cellular or tissue-based product (HCT/P) as defined in 21 CFR 1271.3(d) and is subject to regulation under 21 CFR part 1271, issued under the authority of section 361 of the PHS Act, 42 U.S.C. § 264. HCT/Ps that do not meet all the criteria in 21 CFR 1271.10(a) are not regulated solely under section 361 of the PHS Act and the regulations in 21 CFR part 1271. Unless an exception in 21 CFR 1271.15 applies, such products are regulated as drugs, devices, and/or biological products under the FD&C Act and/or the PHS Act and are subject to additional regulation, including applicable premarket review. Based on a review of relevant materials, NexCell Scientific does not qualify for any exception in 21 CFR 1271.15, and your product fails to meet all criteria in 21 CFR 1271.10(a).Your product fails to meet the criterion in 21 CFR 1271.10(a)(2) that the HCT/Ps be “intended for homologous use only.” Homologous use means that the “labeling, advertising, or other indications of the manufacturer’s objective intent” demonstrate that the HCT/P is intended to perform “the same basic function or functions in the recipient as in the donor” (21 CFR 1271.3(c) and 1271.10(a)(2)). Your umbilical cord blood-derived product is not intended solely to perform the same basic function or functions of the HCT/P in the recipient as in the donor (e.g., forming and replenishing the lymphohematopoietic system for umbilical cord blood). Rather, your product is intended for use in the treatment of various diseases and conditions, such as inflammation, injuries, neurological conditions and liver cirrhosis, which are not basic functions of umbilical cord blood in the donor.In addition, your product fails to meet the criterion in 21 CFR 1271.10(a)(4) because it is manufactured from allogeneic umbilical cord blood, is dependent on the metabolic activity of living cells for their primary function, and is not for autologous use, allogeneic use in a first-degree or second-degree blood relative, or reproductive use.Therefore, this HCT/P is not regulated solely under section 361 of the PHS Act, 42 U.S.C. § 264, and the regulations in 21 CFR part 1271.1 See 21 CFR 1271.20. In addition to being regulated under section 361 of the PHS Act and 21 CFR part 1271, your product is regulated as a drug as defined in section 201(g)(1) of the FD&C Act, 21 U.S.C. § 321(g)(1), and a biological product as defined in section 351(i) of the PHS Act, 42 U.S.C. § 262(i), as stated above.Subject to certain exceptions not applicable here, to lawfully introduce or deliver for introduction into interstate commerce a drug that is a biological product, a valid BLA must be in effect under section 351(a)(1) of the PHS Act, 42 U.S.C. § 262(a)(1). Such licenses are issued only after showing that the product is safe, pure, and potent. Your product is not the subject of an approved BLA.CGMP ViolationsFDA’s inspection of your facility documented evidence of significant CGMP violations. At the conclusion of the inspection, the FDA investigators issued a Form FDA-483, List of Inspectional Observations (Form FDA-483). FDA also identified significant violations upon further review of the evidence collected during the inspection, as set forth below.The CGMP violations applicable to your product include, but are not limited to, the following:1. Failure to establish adequate written procedures for production and process control designed to assure that the drug products have the identity, strength, quality, and purity they purport or are represented to possess, as required by 21 CFR 211.100(a). For example, your firm has not validated the manufacturing process for your product with respect to identity, strength, quality, and purity.2. Failure to establish and follow appropriate written procedures designed to prevent microbiological contamination of drug products purporting to be sterile including procedures for validation of all aseptic and sterilization processes, as required by 21 CFR 211.113(b). For example, your firm has not validated the aseptic process used to manufacture your product. Your product purports to be sterile and is expected to be sterile.3. Failure to establish 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, as required by 21 CFR 211.160(b). For example, your firm has not established scientifically sound and appropriate specifications and test procedures to assure your product conforms to appropriate standards of identity, strength, quality, and purity. Your finished product testing is limited to sterility testing, visual inspection, and (b)(4).4. Failure to thoroughly investigate any unexplained discrepancy, or the failure of a batch or any of its components to meet any of its specifications whether or not the batch has already been distributed, as required by 21 CFR 211.192. For example, between August 2023 and June 2025, (b)(4) lots of your finished product failed sterility testing. While you discarded these lots, you did not conduct investigations to determine the root cause(s) and whether other lots were impacted.5. Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment to produce aseptic conditions, as required by 21 CFR 211.42(c)(10)(v). For example, your firm has not validatedthe cleaning and disinfection processes for your ISO (b)(4) cleanroom or ISO (b)(4) where your product is manufactured.6. Aseptic processing areas are deficient regarding the system for environmental monitoring to prevent contamination, as required by 21 CFR 211.42(c)(10)(iv). For example, your firm has not established an adequate program for environmental and personnel monitoring in the aseptic processing area where your product is manufactured. At the time of the inspection, environmental and personnel monitoring was not performed in association with each production shift.7. Failure to establish an adequate quality control unit that has the responsibility and authority to approve or reject all components, drug product containers, closures, in-process materials, packaging material, 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, as required by 21 CFR 211.22(a). For example, at the time of the inspection, your firm had one employee responsible for both manufacturing your product and quality unit responsibilities, with no independent quality unit in place.Response to the Form FDA-483We have reviewed your response, dated February 18, 2026, to FDA’s Form FDA-483 in detail. Your response is inadequate to address the violations noted above. For example, your response does not address your continued distribution of your product or specific plans for disposition of the remaining inventory manufactured under the violative conditions outlined above. Additionally, your corrective actions cannot be adequately evaluated because they lack supporting documentation.Further, for previously distributed lots of your product, your response does not describe actions you have taken or plan to take that adequately address the impact of the above-noted deficiencies on lots that are still within expiry and were manufactured under the above-described violative conditions.Your response also does not adequately address your failure to have an Investigational New Drug (IND) in effect to study your product addressed in this letter or your lack of an approved BLA to lawfully market your product. Your statement that you “are committed to achieving and maintaining compliance with 21 CFR Part 1271” does not resolve these issues, as your product does not meet the criteria to be regulated solely under section 361 of the PHS Act, as explained above. Your product is a drug and/or biological product, which is subject to premarket review and approval requirements.ConclusionNeither this letter nor the observations noted on Form FDA-483, which were discussed with you at the conclusion of the inspection, are intended to be an all-inclusive list of deficiencies that may exist in connection with your product. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure full compliance with all applicable requirements in the FD&C Act, PHS Act, and all applicable regulations.This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address these matters may result in action without further notice including, without limitation, seizure and/or injunction.Please submit your response in writing within fifteen (15) working days from your receipt of this letter, outlining the specific steps you have taken or plan to take to address any violations and prevent their recurrence. Include any documentation necessary to show that the matters have been addressed. If you cannot address these matters within fifteen (15) working days, please explain the reason for your delay and the timeframe for completion. If you do not believe your product is in violation of the FD&C Act, PHS Act, or applicable regulations, include your reasoning and any supporting information for our consideration.Send your electronic response and any questions regarding this letter to CBER’s Office of Compliance and Biologics Quality, Division of Case Management at CBERDCMRecommendations@fda.hhs.gov.Sincerely,/S/Vincent Amatrudo, JDActing DirectorOffice of Compliance and Biologics QualityCenter for Biologics Evaluation and ResearchCc: Edwin Pinos, co-owner(b)(4), (b)(6)(b)(4), (b)(6)(b)(4), (b)(6)___________________________1 Because your product fails to meet at least one criterion in 21 CFR 1271.10(a), this letter does not evaluate all other criteria in 21 CFR 1271.10(a).

Delivery Method:VIA ELECTRONIC MAIL READ/DELIVERY RECEIPTReference #:320-26-124Product:DrugsOver-the-Counter DrugsRecipient:Mr. Peter F. RawsonVice President and General Managerkdc/one Chatsworth, Inc.20320 Prairie St.Chatsworth, CA 91311-6026United States prawson@kdc-one.comIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesSeptember 8, 2026WARNING LETTERReference number: 320-26-124To Mr. Peter F. Rawson:This warning letter advises you of significant violations observed during a U.S. Food and Drug Administration (FDA) inspection of your facility. Promptly address the violations described herein without delay, including ensuring that appropriate resources are allocated to fully address the violations and prevent their recurrence. This is not intended to be an all-inclusive list of the violations that exist at your facility. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations. Failure to adequately address violations may result in regulatory action without further notice including, without limitation, seizure and injunction.Violations were observed and documented during an inspection of your drug manufacturing facility, kdc/one Chatsworth, Inc., FDA Establishment Identifier (FEI) 1000519695, at 20320 Prairie St., Chatsworth, CA, from March 31 to April 3, 2026. This inspection was conducted under FDA’s statutory authority and public health responsibilities to protect the public from unsafe, ineffective, and poor quality drugs.This warning letter summarizes significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals. See Title 21 Code of Federal Regulations (CFR), parts 210 and 211 (21 CFR parts 210 and 211).Because your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your drug products are adulterated within the meaning of section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 351(a)(2)(B).We reviewed your April 24, 2026, response to our Form FDA 483 in detail.Violations of the Federal Food, Drug, and Cosmetic ActThe following are violations identified during our inspection and review. As a reminder, this is not an all-inclusive list of violations at your facility.1. Your firm failed to have, 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. Your firm also failed to establish and follow an adequate written stability testing program that included reliable, meaningful, and specific test methods for assessing the stability characteristics of these drug products (21 CFR 211.165(a) and 211.166(a)).Your firm manufactures various (b)(4) over-the-counter (OTC) drug products, including those containing the active ingredient (b)(4) and the inactive ingredient (b)(4). You failed to establish scientifically sound and appropriate finished product specifications. For example, you did not include (b)(4) testing as a release or stability requirement.Under certain conditions, (b)(4) can degrade through a known mechanism to form (b)(4), a known carcinogen. Also, when (b)(4) is present in a drug formulation in combination with certain chemicals such as (b)(4), it may react under certain conditions to generate (b)(4). Over the drug product's shelf life, (b)(4) can accumulate and increase in concentration. Despite these known degradation and reaction pathways, you distributed at least (b)(4) batch of an OTC (b)(4)-containing drug product into interstate commerce without (b)(4) testing.Your quality unit is responsible for ensuring that appropriate testing and procedures are in place and followed prior to releasing drug products for distribution.Your firm’s inadequate response to a known contamination event further compounds these failures. Your firm was aware that your customer voluntarily recalled (b)(4) products in Canada on (b)(4), due to potential (b)(4) contamination. The recalled batches were manufactured at your facility using the same formulation, packaging, and labeling used for products distributed in both the United States and Canada. Despite being notified of (b)(4) contamination in your product, your firm failed to determine whether the recalled batches were also distributed in the United States and did not evaluate the potential risk to U.S. consumers.During the inspection, your firm confirmed that you do not test OTC drug products that contain (b)(4) or (b)(4) for (b)(4) before release or during stability testing. Your written risk assessments for (b)(4) contamination are inadequate.In your response, you commit to discontinue your manufacturing of (b)(4) and (b)(4) and to deactivate the drug listing for (b)(4) and (b)(4). You also commit to engaging a third-party laboratory for (b)(4) testing, updating release and stability specifications, and completing comprehensive risk assessments for all currently marketed OTC drug products.Your response is inadequate. You did not provide test results to show products still in the market are below the recommended (b)(4) levels. Most critically, your firm failed to evaluate the impact of (b)(4) contamination identified in (b)(4), which was recalled in other markets. You also failed to identify other potentially affected batches or conduct appropriate market action assessments. Further, your response does not demonstrate that your third-party laboratory is qualified to perform (b)(4) testing on your drug products.FDA has alerted drug manufacturers of products at risk for presence of (b)(4) that they should be testing those drug products for (b)(4). For more information see (b)(4).In response to this letter, provide:A list of chemical and microbial specifications, including test methods, used to analyze each lot of your drug product before a batch disposition decision.A detailed description of the method you establish to test for (b)(4) in finished products prior to release.An action plan and timelines for conducting full chemical and microbiological testing of retain samples to determine the quality of all batches of drug product distributed to the United States that are within expiry as of the date of this letter.A summary of all results obtained from testing retain samples from each lot of (b)(4) products and (b)(4) products that are currently on the U.S. market within expiry. If retain samples of component lots are unavailable, perform retain sample testing of all implicated finished drug product batches for the presence of (b)(4). If testing reveals substandard-quality drug products, take rapid corrective actions, such as notifying customers and initiating product recalls. Provide your market action plan to ensure that no batches potentially contaminated with (b)(4) remain in the U.S. market.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 assessment and corrective action and preventive action (CAPA) plan to ensure the adequacy of your stability program. Your remediated program should include, but not be limited to, the following:o Stability indicating methodso Stability studies for each drug product in its marketed container-closure system before distribution is permittedo An ongoing program in which representative batches of each product are added each year to the program to determine whether the shelf-life claim remains valido Detailed definition of the specific attributes to be tested at each station (timepoint), as part of a program that encompasses each quality attribute that may change over the product shelf-lifeAll procedures that describe these and other elements of your remediated stability program.2. Your firm failed to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, whether or not the batch has already been distributed (21 CFR 211.192).Your firm failed to adequately investigate viscosity failures obtained during stability testing of distributed OTC drug products. Specifically, stability testing records documented (b)(4) out-of-specification (OOS) results without adequate root cause determination, CAPA, or documented justification for the established (b)(4) specifications.In your response, you attribute the root cause to inadequate documentation of the (b)(4) specification changes and commit to evaluating the adequacy of supporting data, conducting a retrospective review of past OTC stability failures, updating your procedure, and training staff.Your response is inadequate because you did not include a risk assessment for previously distributed products with viscosity OOS results, a CAPA plan with clear timelines, documented justification for your established (b)(4) specifications, and an updated procedure supported by staff training records.It is essential to conduct thorough well documented, and scientifically sound investigations to identify root causes of OOS results, evaluate all potentially affected batches, and implement timely and effective CAPA plans. For more information about handling failing, out-of-specification, out-of-trend, or other unexpected results and documentation of your investigations, see FDA’s guidance document Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production at https://www.fda.gov/media/158416/download.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 retrospective, independent review of all invalidated OOS (including in-process and release/stability testing) results for products currently in the U.S. market and within expiry as of the date of this letter and a report summarizing the findings of the analysis, including the following for each OOS:o Determine whether the scientific justification and evidence relating to the invalidated OOS result conclusively or inconclusively demonstrates causative laboratory error.o For investigations that conclusively establish laboratory root cause, provide rationale and ensure that all other laboratory methods vulnerable to the same or similar root cause are identified for remediation.o For all OOS results found by the retrospective review to have an inconclusive or no root cause identified in the laboratory, include a thorough review of production (e.g., batch manufacturing records, adequacy of the manufacturing steps, suitability of equipment/facilities, variability of raw materials, process capability, deviation history, complaint history, batch failure history). Provide a summary of potential manufacturing root causes for each investigation and any manufacturing operation improvements.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, the following:o A determination of whether procedures used by your firm are robust and appropriate.o Provisions for QU oversight throughout your operations to evaluate adherence to appropriate practices.o A complete and final review of each batch and its related information before the QU disposition decision.o Oversight and approval of investigations and discharging of all other QU duties to ensure identity, strength, quality, and purity of all products.3. Your firm failed to store drug products under appropriate conditions of temperature, humidity, and light so that the identity, strength, quality, and purity are not affected (21 CFR 211.142(b)).Your firm failed to establish and follow adequate temperature monitoring and warehousing procedures for finished drug products. For example, you released (b)(4), batch (b)(4), on (b)(4), and stored it in Building (b)(4), until you shipped it on (b)(4). The product label specifies storage at (b)(4)°C–(b)(4)°C, however, you recorded high temperatures of (b)(4)°C–(b)(4)°C in Building (b)(4) during this storage period. The temperatures in Building (b)(4) exceeded both the labeled storage conditions and your firm's internal temperature monitoring protocol.A review of Building (b)(4) temperature data from April 2025 through March 2026 identified approximately (b)(4) weeks where temperatures exceeded (b)(4)°C. Exposure to elevated temperatures in (b)(4)-containing products poses a risk of (b)(4) contamination. Furthermore, your firm did not include storage condition requirements on your certificates of analysis (COAs).In your response, you commit to updating the procedure, revising temperature mapping protocols, conducting a retrospective evaluation of temperature monitoring data across all warehouse areas, and completing relevant personnel training.Your response is inadequate. You did not implement immediate corrective actions and did not conduct a thorough retrospective review of product impact for temperature excursions, including for the formation of impurities and degradants when products are exposed to heat.In response to this letter, provide:Your procedure for environmental controls and alarm limits for storage areas.A list of the different types of drug products and related materials you store in your warehouse (for example, finished drug products, unlabeled drug products, expired drug products, raw materials, and components) and a current inventory, including manufacturer-assigned expiration dates and status (for example, released, quarantined, rejected).A risk assessment for batch (b)(4) (vendor lot #(b)(4)) addressing the impact of temperature excursions on product quality, including (b)(4) formation risk.A comprehensive retrospective review of temperature monitoring data across all storage and warehouse areas to identify any instances in which OTC drug products were stored outside of their labeled storage conditions. This review should encompass all products and all time periods for which temperature data is available and should result in a documented assessment of any affected lots, including an evaluation of potential impact on product quality, safety, and efficacy.A comprehensive review of all OTC finished drug product storage conditions across all buildings, comparing labeled storage requirements against recorded temperature data, with documentation of any corrective actions taken.Updated written procedures ensuring storage conditions are included on COAs and shipping labels.CGMP Consultant RecommendedBased upon the nature of the violations we identified at your firm, you should engage a consultant qualified as set forth in 21 CFR 211.34 to assist your firm in meeting CGMP requirements.Your use of a consultant does not relieve your firm’s obligation to comply with CGMP. Your firm’s executive management remains responsible for resolving all deficiencies and systemic flaws to ensure ongoing CGMP compliance.Quality Unit AuthorityYour inspectional history indicates that your quality unit is not able to fully exercise its authority and/or responsibilities. Your firm must provide the quality unit with the appropriate authority and sufficient resources to carry out its responsibilities and consistently ensure drug quality.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.ConclusionYou are responsible for investigating and determining the root causes of any violations and implementing corrective and preventative measures to ensure future and sustained compliance so that these violations and any others do not occur.Unresolved violations may 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.Send your written response to CDER-OC-OMQ-Communications@fda.hhs.gov within fifteen (15) business days of receipt of this letter. Identify your written response with FEI 1000519695 and ATTN: Chhaya Shetty the subject line of the email.If you have information that you believe demonstrates that your products are not in violation of the FD&C Act and FDA regulations, include that information for our consideration.FDA posts warning letters to www.FDA.gov.Sincerely,/S/Francis GodwinDirectorOffice of Manufacturing QualityOffice of ComplianceCenter for Drug Evaluation and ResearchU.S. Food and Drug Administration

天津市双利医疗器械有限责任公司报告，由于 环氧乙烷残留量超标 等原因，天津市双利医疗器械有限责任公司对其生产的一次性使用无菌阴道扩张器（注册号：津械注准20222180038 ）主动召回。召回级别为 三级召回 。涉及产品的型号、规格及批次等详细信息见《医疗器械召回事件报告表》。附件：《医疗器械召回事件报告表》

经监督检查，怀众堂（重庆）医药有限责任公司存在安全隐患。为防控药品质量安全风险，依据《中华人民共和国药品管理法》第九十九条第三的规定，重庆市药品监督管理局依法对企业采取暂停销售的风险防控措施，停业期间不得擅自开展药品经营活动。现予以公布。序号企业名称许可证编号注册地址仓库地址经营范围1怀众堂（重庆）医药有限责任公司渝AA023000160重庆市沙坪坝区双碑街道自由村100号三楼8-13跨重庆市沙坪坝区双碑街道自由村100号三楼8-13跨中药饮片、化学药、中成药、生物制品企业应当严格落实主体责任，排除质量安全隐患后，向重庆市药品监督管理局提交整改报告，经复查符合条件后予以解除风险防控措施。特此通告。重庆市药品监督管理局2026年9月20日

各市（州）市场监督管理局，各有关医疗机构：为深入贯彻落实《中华人民共和国药品管理法实施条例》，持续提升我省医疗机构中药制剂研发水平，进一步压实医疗机构制剂质量主体责任，规范医疗机构制剂调剂使用行为，严防变相销售、超范围调剂等流通环节使用风险。按照《2026年贵州省药品注册管理工作要点》，现就监督检查有关事宜通知如下：一、工作目标坚持“监管保安全、促发展”原则，聚焦医疗机构制剂调剂使用“先审批后调剂、三限定（期限、数量、范围）”等核心要求，对2026年全省范围内开展制剂调剂使用的医疗机构进行检查，全面排查资质合规、质量安全、药物警戒等环节风险隐患，严肃查处违法违规调剂行为。二、监督检查范围与重点（一）监督检查范围2026年以来全省各级开展医疗机构制剂调剂使用的医疗机构。结合我省调剂使用单位分布广、数量多的实际，为提高检查效率、保证检查质量，本次检查工作采取“调出单位全覆盖、调入单位抽样检查”的方式组织实施：1. 调出单位全覆盖检查。对2026年全省持有制剂批准文号或备案号、开展调剂使用的调出方医疗机构实行全覆盖检查，重点核查资质合规、制剂质量、调剂审批、“三限定”落实及药物警戒等情况。调出方作为调剂制剂质量责任主体，是本次检查工作的核心对象。2. 调入单位抽样检查。原则上按各市（州）随机抽取1至2家；对调剂品种多、调剂量大的，可适当增加抽取数量。抽样应当兼顾二级以上中医院、设有中医科的二级以上医院、对口帮扶受援医院、紧密型医联体及同一医学院校附属医院等不同类型。（二）监督检查重点1. 审批合规情况。调出方、调入方是否具备相应《医疗机构制剂许可证》及诊疗科目；调剂的制剂是否为获批注册（备案）品种，是否在有效期内，标签说明书是否规范。2. “三限定”执行情况。调剂是否未超出批件规定的期限、数量和范围，调剂期限是否在12个月之内；是否存在未经批准擅自调剂、变相调剂的行为。3. 禁止性规定落实情况。制剂是否凭医师处方在本医疗机构使用，是否在市场销售或变相销售（含通过互联网诊疗诱导超量开方）。4. 质量与安全管理情况。调出方是否遵守制剂配制质量管理规范并对调剂制剂质量负责，调入方是否按说明书贮存使用并承担相应责任，调剂记录、不良反应监测、追溯召回机制是否健全。三、监督检查依据1. 《中华人民共和国药品管理法实施条例》（以下简称《实施条例》）第五十九条有关规定；2. 《医疗机构制剂注册管理办法（试行）》第三章调剂使用有关规定；3. 《贵州省医疗机构制剂注册管理实施细则（试行）》（以下简称《实施细则》）第五章调剂使用申请有关规定；4. 《贵州省医疗机构应用传统工艺配制中药制剂备案管理实施细则（试行）》《贵州省医疗机构制剂研究技术指导原则（中药、民族药）（试行）》等相关规定；5. 国家药品监督管理部门关于特殊制剂调剂使用及跨省调剂的具体规定。四、组织分工与时间安排（一）组织分工由省药品监督管理局注册处统一组织，抽调局检查中心相关人员组成检查组，实行组长负责制，采取“省局统筹、分级负责”的方式实施。检查人员应当忠于职守、秉公执法，与被检查单位存在利害关系的应当回避。各市（州）市场监管局负责本辖区检查对象的摸排、协调及整改跟踪。（二）时间安排监督检查自2026年9月下旬开始，至2026年11月底结束，分三个阶段：1. 自查自纠阶段（9月下旬—9月底）。各开展制剂调剂使用的医疗机构对照本通知及监督检查表内容全面自查，逐项填写检查表、建立问题台账、明确整改措施和时限，形成自查报告报所在地市（州）市场监管局。2. 现场检查阶段（10月上旬—11月上旬）。检查组进驻被检查单位开展现场检查，通过听取汇报、查阅资料、实地核查、现场询问、抽查制剂实物等方式逐项核查，如实填写检查表并由双方签字确认。3. 整改复查与总结阶段（11月中旬—11月底）。对检查发现问题责令限期整改并组织复查，依法查处违法违规行为。五、监督检查方式与程序1. 听取汇报。听取被检查单位关于制剂调剂使用管理情况的汇报。2. 查阅资料。查阅调剂批件、调剂合同、资质证照、质量标准、说明书、调剂记录、不良反应报告等资料。3. 实地核查。核查制剂配制、贮存条件，抽查制剂实物与批件、记录的一致性。4. 现场询问。询问药事管理、调剂使用相关岗位人员，核实责任落实和操作规范。5. 结果确认。检查结束后召开反馈会，检查组如实填写检查表，被检查单位负责人签字确认，双方各执一份存档。六、工作要求（一）加强组织领导。各有关单位要高度重视，把监督检查作为规范制剂调剂使用、保障群众用药安全的重要举措，细化措施、落实责任，确保检查取得实效。（二）严格依法检查。坚持问题导向，对照监督检查表逐项核查，做到事实清楚、证据确凿、程序规范，检查结果经得起复核；对检查中发现的程序性、一般性缺陷，责令限期整改并跟踪复查。（三）严肃问题处置。对涉及制剂质量的重大风险，立即采取暂停使用、召回等控制措施，并按程序报告。对未经批准擅自调剂、超范围超期限调剂、销售制剂等违法违规行为，按照《省市场监管局关于进一步完善“两品一械”监管执法联动保障实施方案》相关规定执行。（四）强化结果运用。将检查结果与医疗机构制剂注册、调剂审批、医保支付等挂钩，推动建立长效监管机制，促进中药民族药院内制剂规范发展。（五）严守工作纪律。检查人员要严格遵守廉洁自律各项规定，保守被检查单位商业秘密和技术秘密。请各单位高度重视，认真组织实施。本通知及附件电子版可在贵州省药品监督管理局官方网站下载。联系人：李刚；联系电话：0851-86828658）附件：1.医疗机构制剂调剂使用监督检查表一（批件及资质）2.医疗机构制剂调剂使用监督检查表二（“三限定”与禁止性规定）3.医疗机构制剂调剂使用监督检查表三（质量与安全管理）4.贵州省医疗机构制剂调剂使用监督检查问题台账5.医疗机构制剂调剂使用检查工作自查报告（模板）6.医疗机构制剂调出、调入单位名单贵州省药品监督管理局2026年9月22日

宁夏药监局深入贯彻国家药监局和自治区政府有关决策部署，深入开展药品经营环节“清源”巩固提升行动，坚决守住药品安全底线，切实保障人民群众身体健康和用药安全。现将宁夏药品经营环节“清源”巩固提升行动违法违规典型案例公布如下：案例一：石嘴山市某民营医院未取得药品经营许可证销售网络禁售药品案2025年12月，宁夏石嘴山市惠农区市场监管局根据群众举报，对石嘴山市某民营医院开展执法检查，发现当事人未取得药品经营许可证在网络平台开设店铺，上架销售药品胸腺五肽注射液、司美格鲁肽注射液、丹红注射液、玛仕度肽注射液等17种药品，货值金额达35.34万元。其中部分药品为国家药品监督管理局发布的《药品网络销售禁止清单（第一版）》所列品种，当事人的行为违反了《中华人民共和国药品管理法》第五十一条第一款及《药品网络销售监督管理办法》第七条、第八条的规定，构成未取得药品经营许可证销售网络禁售药品的违法行为，依据《中华人民共和国药品管理法》第一百一十五条及《药品网络销售监督管理办法》第三十三条，结合《药品监督管理行政处罚裁量适用规则》第十一条第（二）项及《宁夏回族自治区药品监管行政处罚裁量基准（2024年修订）》规定，对当事人处以没收违法所得4290.75元，罚款53.01万元的行政处罚。案例二：平罗县某卫生院未从药品上市许可持有人或者具有药品生产经营资格的企业购进药品案根据平罗县医疗保障局移送的药品追溯码重复扫码结算线索，平罗县市场监管局执法人员对平罗县某卫生院进行现场检查。经查，该院从个人处采购129瓶消渴丸，无法提供随货同行单、验收记录、入库记录、供货方资质证明文件等材料，构成未从药品上市许可持有人或者具有药品生产经营资格的企业购进药品的违法行为，违反了《中华人民共和国药品管理法》第五十五条的规定，依据《中华人民共和国药品管理法》第一百二十九条的规定，平罗县市场监管局对该院处以没收违法所得4420.83元，罚款10万元的行政处罚。案例三：银川市兴庆区某药房销售劣药及未履行购进查验义务案2025年7月，银川市市场监管局兴庆区分局开展日常监督检查时，发现银川市兴庆区某药房经营场所货架及中药斗内的西黄胶囊、石膏粒等部分药品，已超过药品标示的有效期，其中石膏粒未按要求留存购进票据，构成销售超过有效期药品且未履行药品购进查验义务的违法行为，违反了《中华人民共和国药品管理法》第九十八条第一款以及《药品经营和使用质量监督管理办法》第七十一条的规定，依据《中华人民共和国药品管理法》第一百一十七条、第一百二十六条，结合《宁夏回族自治区市场监督管理部门行政处罚裁量权适用规则》第十七条第二项的规定，银川市市场监管局兴庆区分局对当事人处以没收涉案药品，没收违法所得88元，罚款3万元的行政处罚。案例四：平罗县某零售药店未从药品上市许可持有人或者具有药品生产经营资格的企业购进药品案2025年12月，平罗县市场监管局在日常监督检查时，发现某零售药店经营使用的中药饮片斗柜内部分药品无标签标识或使用自行违规打印的标签标识，库房货架存放无标识、仅手写品名的中药饮片，现场无法提供供货方资质与购进凭证。经查，当事人从河北药材市场无药品生产经营资质商户购进无标签标识的中药饮片，以现金方式交易，通过物流散户捎带运输，未建立购进验收记录与销售台账，构成未从药品上市许可持有人或者具有药品生产经营资格的企业购进药品的违法行为，违反了《中华人民共和国药品管理法》第五十五条规定，平罗县市场监管局依据《中华人民共和国药品管理法》第一百二十九条，结合《药品监督管理行政处罚裁量适用规则》第九条、第十一条和第十七条规定，对当事人处以没收违法购进中药饮片，罚款6万元的行政处罚。案例五：红寺堡某民营医院销售劣药案2026年5月31日，吴忠市市场监管局红寺堡区分局执法人员根据群众举报对红寺堡某民营医院开展现场检查。经查，该院2026年5月31日向患者销售的批号为240502的盐酸左西替利嗪口服液已超过有效期，该药品依法被判定为劣药，当事人构成销售劣药违法行为，违反了《中华人民共和国药品管理法》第九十八条第一款的规定，吴忠市市场监管局红寺堡区分局依据《中华人民共和国药品管理法》第一百一十七条第一款、第一百一十九条的规定，对当事人处以没收违法所得10元并罚款1万元的行政处罚。案例六：贺兰县某药房未凭处方销售处方药案2026年2月，贺兰县市场监管局执法人员对辖区某药房进行现场检查时，发现该药店在执业药师未在岗的情况下销售处方药6单，执法人员现场向当事人下达了《责令改正通知书》，责令其立即改正违法行为。2026年3月20日，贺兰县市场监管局执法人员对该药店开展复查，发现该药店仍存在未凭处方销售处方药的违法行为。当事人构成未按规定凭处方销售处方药的违法行为，违反了《药品经营和使用质量监督管理办法》第四十二条第一款及第五款的规定。贺兰县市场监管局依据《药品经营和使用质量监督管理办法》第七十二条第一款第一项及第三项的规定，结合《宁夏回族自治区药品监管行政处罚裁量基准（2024年修订）》第四十条规定，对当事人处以罚款1.85万元的行政处罚。

安庆市辰悦化妆品有限公司：本局于2026年7月1日作出《暂停生产通知书》（皖药监妆暂停〔2026〕9-1号），通知你单位暂停生产化妆品。鉴于安全隐患已依法处理，现决定解除化妆品暂停生产措施。安徽省药品监督管理局2026年9月21日

根据工作需要，现将2021年12月至2023年9月期间尚未公告的合并申请药品生产许可的GMP符合性检查结果进行补充公告。序号企业名称生产地址检查范围检查时间检查结论1福建省福抗药业股份有限公司福建省福州市福清市江阴工业集中区高港大道6号原料药（吡拉西坦）2021年12月24日-26日符合2厦门紫旭医药科技有限公司中山火炬开发区国家健康基地内健康路17号盐酸左西替利嗪口服滴剂（10ml:50mg;20ml:100mg）2021年12月26日-27日符合3漳州片仔癀药业股份有限公司山东省德州市齐河县晏北街道办事处齐众大道127号阿哌沙班片2021年12月31日-2022年1月1日符合4林德气体（漳州）有限公司漳州台商投资区角美镇疏港大道8号医用氧（空分）2022年4月12-13日符合5漳州片仔癀药业股份有限公司山东省德州市齐河县晏北街道办事处齐众大道127号口服溶液剂（地氯雷他定口服溶液）2022年4月14-15日符合6福建海西新药创制有限公司南京经济技术开发区惠中路1号硬胶囊剂（塞来昔布胶囊）2022年6月6日-7日符合7福建海西新药创制有限公司海南省海口市秀英区药谷三路2号片剂（缬沙坦氨氯地平片（Ⅰ））2022年6月6日-7日符合8漳州市生物化学制药厂有限公司福建省漳州市平和县文峰镇黄井村工业路12号片剂、硬胶囊剂、散剂（均含中药前处理、提取）2022年6月27日-29日符合9福建省宝诺医药研发有限公司厦门市海沧区翁角西路2010号生物医药产业园6号厂房硬胶囊剂（盐酸美金刚缓释胶囊）2022年6月30日-7月1日符合10万全万特制药（厦门）有限公司海口市南海大道279号口服溶液剂：利托那韦口服溶液（规格：75ml：6g）2022年9月4日-5日符合11福建致淳中药饮片有限公司福建省福州市仓山区盖山镇盘屿路869号金山工业集中区福湾片标准厂房3号楼中药饮片（净制、切制、炒制、炙制、煅制、蒸制、煮制、发酵）2022年10月25日-27日符合12水仙药业（建瓯）股份有限公司福建省建瓯市吉苑路11号中药饮片（净制、切制、炒制）2022年11月30日-12月2日符合13福建省神蜂科技开发有限公司福建省福州市仓山区建新镇劳光村上店88号制剂大楼东侧中药饮片[直接口服饮片]2022年12月21日-23日符合14福建永春制药有限公司福建省永春县桃城镇榜德工业园H区1号散剂生产车间（含中药前处理）：散剂，秋水健脾散（批准文号：国药准字Z35020482；规格：每袋装3g）2023年1月16日-18日符合15泉州中侨药业有限公司福建省永春县桃城镇榜德工业园H区1号散剂：秋水健脾散（批准文号：国药准字Z35020482；规格：每袋装3g）2023年1月18日-20日符合16福建省莆田市德龙药业有限公司福建省莆田市仙游县鲤南镇圣泉村（南二环路南侧）中药饮片（青黛。净制、水飞）2023年2月7日-9日符合17福建广生堂药业股份有限公司福建省宁德市柘荣县富源工业园区1-7幢）口服固体制剂车间（四）片剂四号线：利伐沙班片（10mg）2023年2月7日-9日符合18同溢堂药业有限公司福建省漳州市漳浦县绥安镇威惠路16号丸剂（小蜜丸）（含中药前处理）、中药饮片（净制、切制、蒸制）2023年3月8日-10日符合19福州屏山制药有限公司山东省威海市环翠区张村镇雍江街20号委托品种：蛇伤解毒片（每片重0.5g）2023年3月21日-23日；2023年3月29日-20日符合20南平市金山气体有限公司南平市金山北路177号医用氧（气态、液态）2023年4月13日-14日符合21泰荣（福建）药业有限公司黑龙江安庆县东城区氨苯蝶啶片（规格：50mg/片，批准文号：国药准字H23020053）2023年5月11日-12日符合22厦门宝华生物制药有限公司福建省仙游县郊尾镇梅园街1893号叶酸片（国药准字H19993229）2023年5月22日符合23新生命（福建）生物科技有限公司福建省宁德市柘荣县宝塔路66号中药饮片[净制，直接口服饮片（破壁灵芝孢子粉，鲜竹沥），人工天竺黄]2023年6月13日-16日符合24福建海诚药业有限公司福建省柘荣县制药工业园区中药饮片（净制、切制、炒制、蒸制、煮制）2023年6月16日-18日符合25厦门特伦制药有限公司厦门市同安区二环南路639-8号茶剂（含中药前处理和中药提取）2023年6月28日-29日符合福建省药品监督管理局2026年9月22日