当事人基本信息行政处罚决定书文号违法行为类型处罚内容处罚决定日期处罚机关行政相对人名称行政相对人类别行政相对人代码_1（统一社会信用代码）法定代表人  王新卓自然人372928197005243611 陕药监药罚〔2024〕26号 未经许可销售药品 1、没收违法所得127220元；2、处货值金额127220元6倍763320元罚款。罚没款合计890540元。   2025年7月28日 陕西省药品监督管理局陕西省药品监督管理局行政处罚决定书公示信息当事人基本情况行政处罚决定书文号违法行为类型违法事实行政处罚的内容及依据没收违法所得、没收非法财物的金额暂扣或吊销证照名称及编号处罚决定日期处罚机关当事人主体资格证照名称统一社会信用代码住所法定代表人身份证联系电话联系地址行政处罚的内容行政处罚的依据王新卓身份证 /  西安市未央区浐灞二路荣德小区8号楼2单元1702室  / 37292819700524361113119156395西安市未央区浐灞二路荣德小区8号楼2单元1702室 陕药监药罚〔2024〕26号未经许可销售药品当事人在公司不知情的情况下，套用公司客户单位的抬头，开具“吲哚美辛”、“醋酸波尼松”、“西咪替丁”、“氢氯噻嗪片”四种药品，并将套开的药品销售给了没有药品经营资质或医疗机构许可资质的个人何桂莲、何庆芝。违法所得金额共计127220元（何桂莲：102720元、何庆芝：24500元）。1、没收违法所得127220元；2、处货值金额127220元6倍763320元罚款。罚没款合计890540元。   依据《中华人民共和国药品管理法》（2019年版）第五十一条第一款、第一百一十五条没收违法所得127220元无2025.7.28 陕西省药品监督管理局

Delivery Method:VIA Electronic MailProduct:Medical DevicesRecipient:Dr. Ken-Shwo DaiPresident and CEOVisgeneer, IncNo. 335 Zhong Hua Rd., Sec. 6Xiangshan District,Hsinchu City300104Taiwan(b)(6)@visgeneer.comIssuing Office:Center for Devices and Radiological HealthUnited StatesWARNING LETTERCMS # 709010June 13, 2025Dear Dr. Ken-Shwo Dai:During an inspection of your firm located in Hsinchu City, Taiwan from February 24 through February 27, 2025, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures the eBchek Blood Glucose Monitoring System and eBuricacid/Uritouch Blood Uric acid Monitoring System. 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 function of the body.This inspection revealed that the eBchek Blood Glucose Monitoring System is adulterated within the meaning of section 501(h) of the Act, 21 U.S.C. § 351(h), in that the methods used in, or the facilities or controls used for, their manufacture, packing, storage, or installation are not in conformity with the current good manufacturing practice requirements of the Quality System regulation found at Title 21, Code of Federal Regulations (CFR), Part 820. We received a response from Ken-Shwo Dai, Ph.D., President and CEO, dated March 13, 2025, concerning our investigator’s observations noted on the Form FDA 483 (FDA 483), List of Inspection Observations, which was issued to your firm. We address this response below, in relation to each of the noted violations. These violations include, but are not limited to, the following:1. Failure to adequately establish and maintain procedures for validating device design, as required by 21 CFR 820.30(g). For example, the eBchek Blood Glucose Monitoring System design was not validated using initial production units, lots, batches or their equivalents.Specifically, your firm has no documentation of the parts or software version used in the manufacturing of the devices used for, or production records or dates of production, for units(s) used in the “development pilot product” tests, electrical safety test, and EMC test. Also, during the inspection, Mr. Chiu-Yi Huang (Ivan), R&D Manager, confirmed that your firm did not have the documentation for the devices used for testing.The adequacy of your firm’s response dated March 13, 2025, cannot be determined at this time. Your response explained that your firm tried to retrieve the missing design validation, EMC, and electrical safety data by collecting archives of emails, test reports, engineering notes etc. but was not able to find them. Your firm explained that since no design changes have been made between the initial production unit (IPU) and the mass production unit (MPU) that, therefore, mass production units (MPU) can be considered representative of the initial production unit (IPU) and were used to conduct validation tests in place of the missing validation records since the IPU are considered too old to be reliably tested. In your response you provided a table (Functional Test and Analytical Performance Test Report Using MPU) that briefly describes studies performed on 10 MPU meters and references 12 test reports provided. The test reports provided included assessments of appearance, the voice feature, linearity, accuracy, precision, temperature /humidity etc. However, the columns in Appendix 1 (‘Retrieved documents/Explanation’, ‘Missing document(s)/Explanation’, ‘Attached in Form 483 response’) for the related items do not contain any information and therefore, the reason for the provided information is not clear or why other tests listed were not conducted on MPUs (Report of Drop Testing, Report of Interference Study etc.).The electrical safety and EMC test reports that were reviewed during the inspection by the investigator appear to be referenced in Appendix 1; however, your firm did not provide the missing parts lists, software version, assembly method, and dates of assembly for the devices used in the electrical safety and EMC testing. Therefore, it is not clear how the observation has been addressed.In addition, your firm stated in their response that “The mass production software version is the same as the initial production version, which is version V.2.5”. This is consistent with the test reports provided in your firm’s response (test reports 01-09) that specify the software version as 2.5. However, this differs from the version identified in the software validation report that was reviewed by the investigator during the inspection (version 2.1). Your firm did not explain or otherwise clarify the initial and current software versions and did not describe any changes from the original software version.The table in Appendix 1 of your firm’s response references “2010/8/30 S-QA82401-09 v1.0 issued’ in the existing Device History File (DHF) document column and states, in the Attached in Form 483 response column, that “According to this QC Plan, the production process and inspection method of test strips, meter and control solutions were specified in specific SOP(s)”. The purpose of this procedure is unclear. Your firm did not provide an explanation of the purpose and scope of this procedure and how it evidences that the noted violation has been corrected.Additionally, the test protocols and test results from the new analytical studies provided by your firm as evidence of the validation of your device’s linearity/accuracy, precision, and temperature/humidity (test reports 10, 11, and 12) differ significantly from those performance specifications that were reviewed and cleared by FDA in the eBchek Blood Glucose Monitoring System 510(k) clearance (k122181). For example:i. The results from the repeatability study in your firm’s response differ significantly from the performance specifications reviewed and cleared in k122181 for the eBchek Blood Glucose Monitoring System. For example, in your response the %CV demonstrated in the within day precision study for Level 2 (51-100 mg/dL) and Level 3 (111-150 mg/dL) are 4.81% and 4.65% compared to the performance claims in your device’s 510(k) of 3.32-3.89%, and 3.24-3.35%, respectively.1Similarly, the level 1 (30-50 mg/dL) results demonstrated a standard deviation (SD) of 3.67 mg/dL in the new study compared to the SD of 2.38-2.58 mg/dL established in your 510(k) (k122181).2ii. The linearity/accuracy document provided in your response (test report 10) states that the study was intended to assess the accuracy of the eBchek and to determine the linearity. According to your test report, the comparator method used was the YSI 2500, which differs from the comparator method used to establish the linearity and accuracy performance characteristics of the device in K122181 (which used the YSI 2300).3.The use of an appropriate comparator method is essential to ensure that a device is appropriately validated as the results from a study using this comparator are not reliable and can lead to inaccurate results. Your firm has not provided any information describing how they have transitioned to a new comparator method while maintaining device performance as established in k122181 or provided any evidence demonstrating how the linearity/accuracy report provided, using the YSI 2500 as a comparator, is representative of the performance established using the YSI 2300 in the 510(k) and would be an appropriate comparator method. Therefore, it is unclear how the study report provided by your firm using this new comparator method supports or demonstrates your device’s performance as compared to the performance established in k122181 or how the violation has been addressed.iii. In your response you used the following acceptance criteria in your newly conducted analytical studies (linearity/accuracy and precision) and these acceptance criteria are significantly broader than the acceptance criteria used to establish performance of your device in k1221814and would not ensure that the device is manufactured to conform with the performance specifications established in k122181:“Coefficient of variance (CV): Glucose concentration < 100 mg/dL, SD

Product:Medical DevicesRecipient:Ennio AloisiniChief Executive OfficerMectronic Medicale S.R.L.Via Orio Al Serio 1524050BGItaly(b)(4)@mecmedix.comIssuing Office:Center for Devices and Radiological HealthUnited StatesWARNING LETTERCMS # 707997June 27, 2025Dear Mr. Aloisini:During an inspection of your firm located in Bergamo, Italy from February 24, 2025, through February 27, 2025, an investigator from the United States Food and Drug Administration (FDA, we, or the agency) determined that your firm manufactures CHELT, Ixyon XP, iLux Smart, iLux Plus, Doctor Tecar, Doctor Tecar Smart, and Doctor Tecar Plus devices. 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 function of the body. In addition, under section 531(2) of the Act, 21 U.S.C. § 360hh(2), each of these products is an electronic product because it is (A) a manufactured or assembled product which, when in operation, (i) contains or acts as part of an electronic circuit and (ii) emits (or in the absence of effective shielding or other controls would emit) electronic product radiation, or (B) a manufactured or assembled article which is intended for use as a component, part, or accessory of a product described in clause (A) and which when in operation emits (or in the absence of effective shielding or other controls would emit) such radiation.Quality 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 System regulation found at Title 21, Code of Federal Regulations (CFR), Part 820. These violations include, but are not limited to, the following:1. Failure to establish and maintain a DHF for each type of device, as required by 21 CFR 820.30(j).For example: Your firm’s design control procedures, PO_7.3_Design and Development, state the design elements requirements of the quality system regulation (i.e., Design and Development Planning, Design Input, Design Output, Design Verification, Design Validation, Design Transfer, and Design Changes) and that these design elements should be documented. However, a review of your firm’s therapeutic RF, laser, and laser/cryotherapy family Design History Files (DHF) demonstrated that your firm did not adequately document any of these design elements required per 21 CFR 820.30 Design Controls. For example, the three reviewed DHFs documented short statements or phrases of what occurred during each phase, but your firm failed to document any objective evidence of the activities conducted during all design phases for the three product families.2. Failure to ensure that where the results of a process cannot be fully verified by subsequent inspection and test, the process shall be validated with a high degree of assurance and approved according to established procedures, as required by 21 CFR 820.75(a).For example: Your firm has stated that it has not established process validation where the results of a process cannot be fully verified by subsequent inspection and test. For example, your firm has not validated your output calibration system based on an established procedure. Your firm stated that you have not established process validation and/or test method validation procedures for your output calibration system, consisting of an(b)(4)and(b)(4), used in the production of your therapeutic RF emitting device. Additionally, your firm did not have any records of performing validation of the system3. Failure to establish and maintain procedures to control product that does not conform to specified requirements, as required by 21 CFR 820.90.For example: Your firm did not properly identify and segregate nonconforming products. Your firm’s procedure, PO_8.3_Nonconformity Management, states that defective parts should be identified by means of red sticker, NCM identification code, and product is to be segregated in the area designated for nonconformities. However, during the inspection component was found outside of designated quarantine areas and nonconforming product was found lacking a red sticker and identification code.Additionally, a production record for a Doctor Tecar RF therapeutic device, serial number DT07222, was reviewed during the inspection. The record indicated that the product was nonconforming as it failed to meet the peak-to-peak voltage (Vpp) output specification for one of the frequency/power combinations during device acceptance. However, your firm failed to identify this device as nonconforming and the product was released without justification or assessment.4. Failure to establish and maintain procedures acceptance activities, as required by 21 CFR 820.80.For example: During the inspection your firm was unable to provide procedures for receiving inspection and stated that receiving inspection procedures have not been established. For example, your firm stated that they performed a 100% verification of laser diode power output and identified these as critical components used in your firm’s therapeutic devices. However, the laser diode acceptance activities were recorded on an uncontrolled document without identifying the test equipment used (e.g., laser power meter), nor its operator performing the test. These were not recorded in your firm’s Device History Record.5. Failure to establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit, as required by 21 CFR 820.198(a).For example: During the inspection, your firm’s management stated that they could not provide any specific complaint records because none had been documented to date. Your firm’s procedure, PO_8.2.1_Return Information section 8.2, requires complaints to be documented on the form, MOD_8.3a_NC and AC/AP. The form is also used in the assessment of the complaints to determine the need to open and manage a corrective action. Your firm provided a complaint log which listed 22 complaints that your firm received. However, your firm was not able to provide evidence that these complaints were reviewed and evaluated by a formally designated unit.6. Failure to establish and maintain instructions and procedures for performing and verifying that the servicing meets the specified requirements, as required by 21 CFR 820.200.For example: Your firm’s servicing procedures, PO_7.5a_Production and delivery of services, section 6.7, generally describe your firm’s service products and generates a corresponding service record for all of your firm’s products. However, the procedures do not contain any specific information about how to perform routine servicing activities, acceptance testing following servicing, nor documentation requirements. Additionally, your firm provided a service record for a Doctor Tecar Plus device, serial# DTP07522, and it did not document the UDI of the service device. Furthermore,(b)(4)quantitative acceptance points were only recorded as two check marks on a separate uncontrolled document.7. Failure to establish procedures for identifying training needs and ensure that all personal are trained to adequately perform their assigned responsibilities, as required by 21 CFR 820.25(b).For example: Your firm’s procedure, PO_6.2_Training, requires management to define the training needs of employees on Form 6.2.3a Training Planning and for the identified internal training to be documented. However, your firm could not provide your training plan and training records for your production employees.8. Failure to maintain device history records as required by 21 CFR 820.184.For example: Your firm failed to document a copy of the primary product labeling for the Doctor Tecar device in each instance based on the inspection for 10 DHRs. This includes the handpiece label with a corresponding serial number and unit/console label with a corresponding serial number and UDI.9. Failure to establish procedures for quality audits and conduct such audits to assure that the quality system is in compliance with the established quality system requirements and to determine the effectiveness of the quality system, as required by 21 CFR 820.22.For example: Your firm’s procedures, for internal audits, P O _8.2.4_Inspection Visits, require that internal auditors to not have direct responsibility in the areas they audit to ensure that the auditors are independent. However, your firm’s Administrative, Financial, & Quality Manager audited the quality system areas that they have direct responsibility over. For example, the Administrative, Financial & Quality Manager audited:CY2025 Internal audit plan – Coverage of monitoring of products and processes (i.e. final device acceptance), CAPA and Non-conformances.CY2024 Internal audit plan and completed internal audit record – Coverage of monitoring of products and processes (i.e. final device acceptance), CAPA and Non-conformances.CY2023 Internal audit plan and completed internal audit record – Coverage of your firm’s entire quality management system.Medical Device Reporting (MDR) Violation(s)Our inspection revealed that your firm has failed to develop, maintain, and implement written Medical Device Reporting (MDR) procedures, as required by 21 CFR 803.17. Specifically, your firm has stated that it has not established any procedures for MDRs. These would include establishing procedures for timely and effective identification, communication, and evaluation of reportable events, a standardized review process for determining when an event meets reportability criteria, timely submission of MDRs to the FDA, and compliance with the applicable documentation and recordkeeping requirements.A device is deemed to be misbranded under section 502(t)(2) of the Act, 21 U.S.C. § 352(t)(2), if there was a failure or refusal to furnish any material or information required by or under section 519 of the Act, 21 U.S.C. § 360i, which includes adverse event reports required under 21 CFR Part 803, respecting the device.In response to this letter, please provide any completed actions taken by your firm to address this item or your planned actions and the timeframe for when these actions will be completed.Unapproved Device Violation(s)Our inspection also revealed that the devices are adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B), because your firm does not have an approved application for premarket approval (PMA) in effect pursuant to section 515(a) of the Act, 21 U.S.C. § 360e(a), or an approved application for an investigational device exemption (IDE) under section 520(g) of the Act, 21 U.S.C. § 360j(g) for the device as described and marketed. These devices are also misbranded under section 502(o) the Act, 21 U.S.C. § 352(o), because your firm did not notify the agency of its intent to introduce the device into commercial distribution, intended for a use different from the intended use of a legally marketed device, without submitting a premarket notification to FDA as required by section 510(k) of the Act, 21 U.S.C. § 360(k).1. Your Doctor Tecar, Doctor Tecar Smart, and Doctor Tecar Plus devices have been cleared for the following indications:K221043 – Doctor Tecar Plus and Doctor Tecar Smart devices are intended to provide topical heating for the purpose of elevating tissue temperature for treatment of selected medical conditions such as: relief of pain, muscle spasms, increase in local circulation.K183693 – The Doctor Tecar device is intended to provide topical heating for the purpose of elevating tissue temperature for treatment of selected medical conditions such as relief of pain, muscle spasms, and increase in local circulation.However, you are marketing these devices without clearance for the following uses in your marketing materials, including but not limited to:“Doctor Tecar Therapy is an innovative, high-performance therapy in the treatment of Carpal Tunnel Syndrome.”“Doctor Tecar Therapy not only provides rapid pain relief, but also accelerates the healing process, significantly reducing recovery time and improving the effectiveness of treatments.”“Accelerated Healing: Boosts cellular metabolism for faster and more effective rehabilitation.”These statements were not reviewed as part of your premarket notification materials submitted to FDA and are outside of the scope of the clearances issued under K221043 and K183693. FDA is currently unaware of any evidence that could support the above intended uses. These statements appear to constitute changes in the intended use of the products that require submission of a new 510(k), as provided by 21 CFR 807.81(a)(3)(ii). These new intended uses raise effectiveness concerns that are different from those normally associated with the cleared uses of the device. These topical heating devices use energy to generate heat within layers of the skin and require performance testing for specific indications for use that presume a specific clinical outcome. The above-mentioned new treatment claims have not been evaluated in the 510(k) submissions and substantiated by supporting data for the new treatment claims such as any clinical data demonstrating the treatment of Carpal Tunnel Syndrome, reduced recovery time and boosting of cellular metabolism. Patients who use this device may forego other known therapies and delay addressing their health concerns that may result in serious injury or lengthen recovery times.2. The FDA has reviewed the user manuals for the CHELT, iLux Plus, iLux Smart, and Ixyon XP devices, which your firm introduced or delivered for introduction these devices into interstate commerce for commercial distribution, and which you have listed in FDA’s registration and listing database as intended for use in the generic type of device described at 21 CFR 890.5500 (infrared lamp) and product code ILY (lamp, infrared, therapeutic heating). Devices regulated under 21 CFR 890.5500 and ILY are exempt from premarket notification unless they exceed the limitations of exemption described in 21 CFR 890.9(a). However, there is evidence that the CHELT, Ixyon XP, iLux Smart, and iLux Plus are intended for uses that are different from those of legally marketed devices regulated under 21 CFR 890.5500 and ILY.Generic devices of this type emit energy at infrared frequencies (approximately 700 to 50,000 nanometers) to provide topical heating and are intended for medical purposes including, but not limited to, temporary increase in local blood circulation and temporary relief of: muscle spasms, minor joint pain and stiffness, minor muscle pain and stiffness, and minor arthritis pain. However, your firm is marketing the CHELT, Ixyon XP, iLux Smart, and iLux Plus for different specific intended uses, namely “for the treatment of pathologies of the musculoskeletal system such as lumbago, cervicalgia, epicondylitis, medial epicondylitis, . . . as well as contractures . . .” FDA is currently unaware of any clinical evidence that could support these intended uses. These uses increase the risk of injury because of deeper tissue penetration, and potentially higher energy and temperature delivery to target structures not addressed in legally marketed ILY devices. The specific conditions including lumbago, cervicalgia, epicondylitis, medial epicondylitis, and contractures, involve anatomical sites that are more sensitive than superficial muscle groups. Treating these conditions with infrared heating or high-intensity laser therapy can result in overheating of deeper tissues, burns, nerve injury, or damage to underlying structures. Additionally, these new indications introduce uncertainty about safety and efficacy because there is no validated clinical evidence to support the benefits outweighing the risks for these specific treatment indications. These risks are not present in currently cleared or exempted ILY indications, which are limited to superficial, non-specific pain relief through mild, topical heating. The devices are therefore not exempt from the 510(k) requirement as described in 21 CFR 807.81(a)(3)(ii).In addition, the CHELT, Ixyon XP, iLux Smart, and iLux Plus devices include a maximum threshold for a skin surface temperature of 50°C. A safe and effective therapeutic skin surface temperature range for infrared lamps is 40 - 45°C because skin surface temperatures greater than 45°C present a risk of skin burns in generic devices of this type. The 50°C maximum skin surface temperature threshold is a different technological characteristic for this generic device type. Because there is evidence that the CHELT, Ixyon XP, iLux Smart, and iLux Plus have different intended uses and technology compared with that of legally marketed devices classified under 21 CFR 890.5500, the devices exceed the limitations described in 21 CFR 890.9(b) and are not exempt from premarket notification requirements. They are also therefore subject to the requirement under 21 CFR 807.81(3)(a)(i).For a device requiring premarket approval, the notification required by section 510(k) is deemed satisfied when a PMA is pending before the agency. [21 CFR 807.81(b)] The kind of information that your firm needs to submit in order to obtain approval or clearance for the device is described on the Internet at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/default.htm. The FDA will evaluate the information that your firm submits and decide whether the product may be legally marketed.Electronic Product Radiation Control Device Violation(s)Our inspection also revealed that your firm failed to comply with reporting requirements applicable to electronic products under 21 CFR Chapter I, Subchapter J – Radiological Health. Section 538(a) of the Act (21 U.S.C. 360oo(a)) prohibits, in part, any person to fail or refuse to make any report, or furnish or preserve any information required by section 537 of the Act (21 U.S.C. 360nn).In addition to being a "device," Ixyon therapeutic laser family of devices are "electronic products" subject to compliance with Chapter V, Subchapter C of the Act, Electronic Product Radiation Control (21 U.S.C. 360hh et seq.) and the general requirements at 21 CFR Parts 1000-1005, including reporting requirements at 21 CFR Part 1002, which are prescribed pursuant to section 537 of the Act.Significant violations include, but are not limited to, failure to submit a radiation safety product report followed by annual reports as required by 21 CFR 1002.10 and 1002.13, respectively. For example, during the inspection, Ms. Chiara (NMI) Borgonovo, Export Area Manager, clarified that Mectronic Medicale S.R.L. has shipped eight (8) laser devices to the US for sales purposes. A review of our records indicates that the required radiation safety report (21 CFR 1002.10) for your company’s Ixyon therapeutic laser family of devices has not been received by FDA. In addition, FDA has not received the required annual reports for the CHELT model of products (21 CFR 1002.13).Manufacturers of laser products are responsible for assuring their products comply with all applicable mandatory federal radiation safety performance standards prior to entry of those products into US commerce. For medical lasers, the applicable performance standards are 21 CFR Part 1010, 1040.10, and 1040.11(a). Additionally, manufacturers of these products are subject to all applicable requirements of Title 21 CFR Parts 1000 – 1005, which includes the reporting and record keeping requirements found in Title 21 CFR Part 1002.We also note that, while FDA has stated the agency does not intend to enforce the requirements of 21 CFR 1040.10 and 1040.11(a) if the laser products have incorporated the comparable clause of IEC 60825-1 Ed. 3 (see FDA’s Laser Notice 56 available here: https://www.fda.gov/media/110120/download), the applicable “DANGER” phrase (see IEC 60825-1 Ed. 3, clause 7.7) is missing from the warning logotype label as depicted in the user manuals of the Ixyon, iLux, and CHELT therapeutic laser family of devices.Please revise your warning logotype labels for compliance with the applicable requirements outlined in 21 CFR 1040.10(g)(3), which FDA considers to be comparable to conformance with IEC 60825-1 Ed. 3, clause 7.7. Please submit the revised labels as part of your response to this correspondence.For therapeutic laser devices that do not currently have a radiation safety report on file, please ensure that copies of compliant warning logotype labels are included in all future submissions.Additionally, you should update your company’s quality control procedures to ensure that all future production units intended to enter the U.S. commerce bear the required warning logotype label. Copies of the labels must also be included in relevant promotional materials, such as the device user manual as required per 21 CFR 1040.10(h)(1)(iii).Please also provide the following information: (a) list all models of laser products your firm manufactured and imported to the US, and (b) whether Mectronic Medicale S.R.L. certified each laser product which entered commerce as required by Title 21 CFR 1010.2. Please note that medical laser product certification according to 21 CFR 1010.2 and ISO 13485 certification are not the same. The FDA regulation (21 CFR 1010.2) specifically addresses laser product safety and performance standards in the U.S., while ISO 13485 is an international standard for quality management systems in medical device manufacturing. The FDA certification focuses on the product itself, whereas ISO 13485 covers broader organizational processes and quality management. While both are relevant for medical laser manufacturers, they serve distinct purposes in regulatory compliance and quality assurance.Copies of the Federal Performance Standards, compliance guides, radiation safety product report guides, and other documents related to laser products are available on FDA’s web site at: http://www.fda.gov/Radiation-EmittingProducts/default.htm, and https://www.fda.gov/radiation-emitting-products/surgical-and-therapeutic-products/medical-lasers.Please submit the missing radiation safety reports for all models that are already imported into the US, or that you plan to enter the US market. Please use Form FDA 3632 to prepare your radiation safety product reports, and form FDA 3636 for the annual report. All Radiation Safety reports and supporting materials can be submitted to the FDA by email at: RadHealthCustomerService@fda.hhs.gov.Other federal agencies may take your compliance with the FD&C Act and its implementation regulations into account when considering the award of federal contracts. Additionally, should FDA determine that you have Quality System regulation violations that are reasonably related to premarket approval applications for Class III devices, such devices will not be approved until the violations have been addressed.This letter notifies you of our findings and provides you an opportunity to correct the above deficiencies. Please notify this office in writing within fifteen business days from the date you receive this letter of the specific steps your firm has taken to address the noted violations, including an explanation of how your firm plans to prevent these violations, or similar violations, from occurring again. Include documentation of the corrections and/or corrective action (which must address systemic problems) that your firm has taken. If your firm’s planned corrections and/or corrective actions will occur over time, please include a timetable for implementation of those activities. If corrections and/or corrective actions cannot be completed within fifteen business days, state the reason for the delay and the time within which these activities will be completed.Please provide a translation of documentation not in English to facilitate our review. We will notify you regarding the adequacy of your firm’s response and the need to re-inspect your firm’s facility to verify that the appropriate corrections and/or corrective actions have been made. If you believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration as part of your response.Your firm’s response should be sent via email to James Jang at CDRHEnforcement@fda.hhs.gov. Please include in the subject line, “CMS Case 707997” when replying. If you have any questions about the contents of this letter, please contact: Andrew Keys at Andrew.Keys@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 or associated with your firm’s devices and electronic products. 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/Bleta Vuniqi HoutkampDeputy Office DirectorOHT4: Office of Surgical and Infection Control DevicesOffice of Product Evaluation and QualityCenter for Devices and Radiological HealthCC:Jerry DoanePragmatic Compliance dba FDAbasics15815 SW 11th Court RdOcala, FL US 34473Usagent@fdabasics.com

Delivery Method:Via EmailReference #:320-25-93Product:DrugsRecipient:Mr. Norman Craig DelgadoPresident and CEOOasis Medical, Inc.514 S. Vermont AvenueGlendora,CA91741United StatesIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesWarning Letter320-25-93July 15, 2025Dear Mr. Delgado:The United States Food and Drug Administration (FDA) inspected your drug manufacturing facilities, Oasis Medical, Inc., FEI 2083373, at 514 S. Vermont Avenue, Glendora, from January 15 to 27, 2025.This warning letter summarizes significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals. See Title 21 Code of Federal Regulations (CFR), parts 210 and 211 (21 CFR parts 210 and 211).Because your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your drug products are adulterated within the meaning of section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 351(a)(2)(B).We reviewed your February 17, 2025 response to our Form FDA 483 in detail and acknowledge receipt of your subsequent correspondence.During our inspection, our investigators observed specific violations including, but not limited to, the following.1. Your firm failed to 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 ensure the use of reproducible manufacturing processes for the production of sterile ophthalmic drug products. You also lacked an ongoing program to establish stable manufacturing operations, monitor ongoing process control, and provide for consistent drug quality. For example,Your process lacked adequate control and is prone to producing an excessive number of defective units. A substantial portion of batches have been rejected, including total reject levels(b)(4)in a number of cases. Of special concern are the excessive number of defective products due to visible particulate contamination (e.g., recurring instances of levels greater than(b)(4)). Batches with very high defect levels were nonetheless distributed.You failed to establish and follow an adequate visual inspection program for the ophthalmic drugs manufactured by your firm.There was no classification as to the severity of the defects (i.e., critical, major, minor) or limit for the number of defects allowed, if any.The most recently completed requalification study for your(b)(4)cycle was conducted in 2023 and inadequately considered potential changes from previous qualifications and the original validation. The 2023 requalification did not include an assessment of(b)(4)maintenance or changes to the drug product components.The maximum duration of the hold steps in your manufacturing process (e.g., extensive hold times prior to(b)(4)) has not been validated.Your response fails to address your lack of process capability, and the overreliance on visual inspection in an attempt to remove excessive defective units from batches.You do not commit to thoroughly investigate the root causes of the visible particulates and excessive occurrence of these critical defects. You also lack appropriate interim steps to prevent production of further batches from a low capability process while you make efforts to remediate it. In addition, the response lacks a commitment to address potentially contaminated products in distribution.Regarding the visual inspection program, your response lacks a commitment to perform a comprehensive reassessment of this program.Regarding production hold times, your response acknowledges that you have not performed validation of your hold steps. But you do not commit to validating all in-process hold times and include a date by which these studies will be completed.Process validation evaluates the soundness of design and state of control of a process through its lifecycle. Each significant stage of a manufacturing process must be designed appropriately to ensure the quality of raw material inputs, materials, and finished drugs. Process qualification studies 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 are necessary to ensure you maintain a stable manufacturing operation throughout the product lifecycle.See FDA’s guidance documentProcess Validation: General Principles and Practicesfor general principles and approaches that FDA considers appropriate elements of process validation, at https://www.fda.gov/media/71021/download.In response to this letter, provide:A detailed retrospective review and assessment of your(b)(4)program. The retrospective review and assessment should include all changes to the drug product, container closure system, and packaging (e.g., canula sheath); and an evaluation of changes to, and maintenance of, the(b)(4)equipment. If changes are identified, provide your plan to evaluate the safety and quality of distributed finished products that remain within expiry and a plan to ensure the safety and quality of your drug products until the(b)(4)process is successfully validated.Thorough investigation(s), including corrective actions and preventive actions (CAPA), regarding finished product batches manufactured and released for distribution despite high numbers of rejected units.Complete results of your examination of retains/reserve samples for all batches from January 2023 to present for defects, and any related investigation(s) and corrective actions.A list of all batches since January 1, 2023, to present, with the following information:o Product nameo Batch numbero Date of manufactureo Date of expirationo Batch size (original quantity of theoretical syringes)o Actual batch yield (number of pouched syringe units)o Number of rejects due to particulateso Number of rejects due to other defects (include the top 3 other defect types for each batch, beyond particulate defects)o Percent yieldA remediation plan that better assures ongoing management oversight throughout the manufacturing lifecycle of all drug products. Provide a more data-driven and scientifically sound program that identifies sources of process variability, and assures that manufacturing (including both production and packaging) operations meet appropriate parameters and quality standards. This includes, but is not limited to, evaluating suitability of equipment for its intended use, ensuring quality of input materials, determining the capability and reliability of each manufacturing process step and its controls, and vigilant ongoing monitoring of process performance and product quality.A comprehensive, independent assessment and remediation plan for systems used in the visual inspection of sterile drugs for defects (including but not limited to particulate matter). The assessment should include adequacy of inspection methods, acceptance and rejection criteria, personnel training, supervision, equipment and personnel qualification, equipment maintenance, and the procedures governing them. Provide your detailed remediation action plan that includes dates by which each remediation activity will be completed, and provisions for periodic independent reassessment of the plan’s effectiveness.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 (PPQ), and ongoing monitoring of both intra-batch and inter-batch variation to ensure a continuing state of control. Also, summarize the program for qualification of your equipment and facility.Timelines for completing further PPQ studies on remediated processes for marketed drug products for which a state of control has not been adequately established.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 lacked meaningful investigations of failed sterility and bioburden test results. For example:Sterility FailureYour quality unit (QU) did not adequately investigate a failed sterility test result for your(b)(4)drug product, VISCO SHIELD Topical Drops, lot V0724N. Your external testing laboratory performs two sterility tests: one for the contents within the syringe and the other for the sterility of the syringe and cap primary packaging components. Your external testing laboratory reported a sterility failure for the syringe and cap portion of the testing. You concluded in NCR 24014 that, because the contaminant was found only on the syringe and cap and not the contents of the syringe, the likely root cause of the sterility failure was laboratory contamination due to excessive handling during the test. However, your contract testing laboratory’s investigation concluded that there was no laboratory error. You failed to resolve the conflicting root cause conclusions and did not extend your investigation to other potential sources of contamination or ensure it was of appropriate scope. Although the batch remained under your control, your QU had dispositioned this batch “USE AS IS” on September 30, 2024, to be distributed to the U.S. market.In your response to the sterility failure, we acknowledge your intention to create a specific procedure to address external laboratory out-of-specification (OOS) investigations. However, your investigation failed to consider conditions that led to the sterility failure or determine potential root causes to ensure effective CAPAs were promptly initiated. Additionally, you do not adequately address the potential non-integrity failure mode of the packaged finished drug product (e.g., breach in packaging integrity following(b)(4)).Bioburden OOSYour firm did not adequately investigate your firm’s pre-sterilization bioburden results that exceeded their specifications ((b)(4)) for VISCO SHIELD Topical Drops, lot V0724G. One sample exceeded the specification for the aerobic plate count test with a result of 570 CFU/sample and another sample exceeded the specification for the yeast and mold count test with a result of 334 CFU/sample.In your response to the bioburden OOS, your investigation fails to consider the conditions that led to the OOS. You do not identify the microbes recovered or determine resistance of any spore-forming microbes that may have been present. You also do not address potential root causes during the production process that could contribute to excess bioburden. Assessment of the number of types of microbes in pre-sterilization bioburden helps to determine whether the validated(b)(4)process continues to be capable of rendering the finished product sterile.Whenever an investigation lacks conclusive evidence of laboratory error, a thorough investigation of potential manufacturing causes must be performed.For more information about handling failing, OOS, out-of-trend, or other unexpected results and documentation of your investigations, see FDA’s guidance documentInvestigating Out-of-Specification (OOS) Test Results for Pharmaceutical Productionat https://www.fda.gov/media/158416/download. While this guidance generally applies to chemistry-based laboratory testing, many of the principles are relevant to microbiological testing.In response to this letter, provide:The disposition status of the referenced batch, VISCO SHIELD Topical Drops, lot V0724N. If the lot was released for distribution, provide the dates of release and distribution.A comprehensive, independent assessment of your overall system for investigating deviations, discrepancies, complaints, OOS results, and failures. Provide a detailed action plan to remediate this system. Your action plan should include, but not be limited to, significant improvements in investigation competencies, scope determination, root cause evaluation, CAPA effectiveness, QU oversight, and written procedures. Address how your firm will ensure all phases of investigations are appropriately conducted.An independent assessment and remediation plan for your CAPA program. Provide a report that evaluates whether the program includes effective root cause analysis, ensures CAPA effectiveness, analyzes investigations trends, improves the CAPA program when needed, implements final QU decisions, and is fully supported by executive management.A retrospective, independent review of all invalidated OOS (including in-process and release/stability testing) results for US products 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 review and remediation plan for your OOS result investigation systems. The CAPA should include, but not be limited to, addressing the following:o QU oversight of laboratory investigations.o Identification of adverse laboratory control trends.o Resolution of causes of laboratory variation.o Initiation of thorough investigations of potential manufacturing causes whenever a laboratory cause cannot be conclusively identified.o Adequately scoping of each investigation and its CAPA.o Revised OOS investigation procedures with these and other remediations.A detailed retrospective review and assessment of your(b)(4)program. The retrospective review and assessment should include:o All changes to the drug product, container closure system, and packaging (e.g., canula sheath).o An evaluation of changes to, and maintenance of, the(b)(4)equipment.o A plan to evaluate the safety and quality of distributed finished products that remain within expiry if significant changes occurred that may pose a risk to quality or safety.3. Your firm failed 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. You also failed to establish and follow an adequate 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 211.160(b)) and (21 CFR 211.166(a)).Finished Product TestingYour finished product testing for release of ophthalmic drug product batches did not include adequate analytical testing to determine the identification or assay of the active ingredient, hydroxypropyl methylcellulose (Hypromellose).Your response and subsequent updates are inadequate. You commit to updating your finished product specifications. However, you reference an internally-developed, non-specific method for assay (strength) without providing adequate documentation and scientific justification to support its use. In contrast, a method is available in the USP that employs a reference standard and spectrophotometric measurements to determine Hypromellose assay.Stability ProgramYour firm lacked an adequate stability program to support the(b)(4)expiration date. For example:Your firm did not establish appropriate tests and specifications for your ophthalmic drug products to monitor the active ingredient identity or assay at release and throughout expiry. Your stability program did not include an adequate test for assay of the active ingredient, hydroxypropyl methylcellulose (Hypromellose). In place of the USP assay, your firm used an in-house method based on loss-on-drying without scientific justification.Your firm did not follow your Operational Procedure,Control, Testing, and Release of Drug Products, which requires placement of samples from one commercial batch of each product on the stability program each year, and testing at(b)(4)intervals. Your 2023 batch was delayed in its entry to your stability program and your 2024 testing was not initiated. A similar pattern of non-compliance was noted during your 2018 inspection.Your response is inadequate. You reference stability studies from batches made in 2013 and 2016 to justify reduced stability testing intervals. You fail to provide a root cause or an adequate CAPA to address the failure to follow your own stability procedure.Drug product batches must be tested for identity, strength, quality, and purity prior to release. Without sufficient release and ongoing stability testing, defective drug products that may pose a risk to consumers are unlikely to be detected.In response to this letter, provide:The method validation protocol, report, and supporting data for your current Hypromellose assay method, and any revised methods. Include the scientific rationale for its use as release and stability indicating tests.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 list of chemical and microbial specifications, including test methods, used to analyze each batch of your drug products before a batch disposition decision.o 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.o A summary of all results obtained from testing retain samples from each batch. If such testing reveals substandard quality drug products, take rapid corrective actions, such as notifying customers and product recalls.A comprehensive, independent assessment and CAPA plan to ensure the adequacy of your stability program. Your remediated program should include, but not be limited to:o Stability indicating methods.o Stability studies for each drug product in its marketed container-closure system before distribution is permitted.o An ongoing program in which representative batches of each product are added each year to the program to determine if the shelf-life claim remains valid.All procedures that describe these and other elements of your remediated stability program.4. Your firm failed to establish an adequate quality unit and the responsibilities and procedures applicable to the quality control unit are not in writing and fully followed (21 CFR 211.22(a) and (d)).Your firm’s QU failed to adequately execute its responsibilities.This includes oversight of both internal and external manufacturing activities, including laboratory services.Regarding functions that occurred at your facility, the records and information you provided demonstrate that your QU did not effectively exercise its responsibilities to oversee the quality of your ophthalmic drug manufacturing operations. Your firm failed to follow established procedures. For example, you had not conducted annual product reviews since 2018, which was cited as an observation in a previous inspection. In addition, your firm did not conduct annual examinations of reserve samples for the past 2 years.Regarding external functions performed on your behalf, your ongoing oversight of critical contract services was insufficient.Your QU is responsible for fully exercising its authority and responsibilities. Our inspectional findings indicate that your QU is not conducting appropriate oversight of drug CGMP operations.Your response is inadequate. Although you commit to addressing the observations we identified, your response lacks detail on systemic remediations needed for your QU and your quality system.Your firm’s quality systems are inadequate. See FDA’s guidance documentQuality Systems Approach to Pharmaceutical CGMP Regulationsfor help implementing quality systems and risk management approaches to meet the requirements of CGMP regulations 21 CFR, parts 210 and 211 at https://www.fda.gov/media/71023/download.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:o A determination of whether procedures used by your firm are robust and appropriate.o Detailed definition of the specific attributes to be tested at each station (timepoint).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.Also describe how top management supports quality assurance and reliable operations, including but not limited to, timely provision of resources to proactively address emerging manufacturing/quality issues and to assure a continuing state of control.CGMP Consultant RecommendedBased upon the nature of the violations we identified at your firm and because 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.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 2083373 and ATTN: Carrie A. Hughes.Sincerely,/S/Francis GodwinDirectorOffice of Manufacturing QualityOffice of ComplianceCenter for Drug Evaluation and Research

案件名称沈阳助邦科技有限公司进口的经颅微电流刺激仪说明书的内容与经注册的相关内容不一致案处罚决定文书号辽药监(稽一)罚〔2025〕11号被处罚企业名称沈阳助邦科技有限公司统一社会信用代码91210105555305481J法定代表人李莉主要违法事实当事人进口的经颅微电流刺激仪说明书的内容与经注册的相关内容不一致。行政处罚种类和依据罚款。 依据《医疗器械监督管理条例》第八十八条第二项。处罚结果处1万元罚款。行政处罚履行方式和期限主动履行；当事人已于2025年7月31日履行完毕。作出处罚的日期2025-07-30

广西壮族自治区药品监督管理局行政处罚案件信息公开表序号行政处罚决定书文号案件名称违法企业名称或违法自然人姓名违法企业组织机构代码法定代表人姓名主要违法事实行政处罚的种类和依据行政处罚的履行方式和期限做出处罚的机关名称和日期备注1桂药监流稽罚〔2025〕7号广西梧州市杰迅医药有限公司经营劣药红参（红参片）案广西梧州市杰迅医药有限公司91450400756533878X王静宇 当事人经营劣药红参的行为，违反了《中华人民共和国药品管理法》第九十八条第一款的规定。  依据《中华人民共和国药品管理法》第一百一十七条第一款、《中华人民共和国行政处罚法》第二十八条第一款、《中华人民共和国药品管理法实施条例》第七十五条的规定，责令当事人立即改正上述违法行为，并给予以下行政处罚：1.没收劣药6.497kg；2.没收违法所得1766.4元（壹仟柒佰陆拾陆元肆角）。主动履行   2025年8月4日广西壮族自治区药品监督管理局2025年7月22日

序号行政处罚决定书文号案件名称违法企业名称或违法自然人姓名违法企业组织机构代码法定代表人姓名主要违法事实行政处罚的种类和依据行政处罚的履行方式和期限做出处罚的机关名称和日期备注1桂药监流稽罚〔2025〕7号广西梧州市杰迅医药有限公司经营劣药红参（红参片）案广西梧州市杰迅医药有限公司91450400756533878X王静宇 当事人经营劣药红参的行为，违反了《中华人民共和国药品管理法》第九十八条第一款的规定。  依据《中华人民共和国药品管理法》第一百一十七条第一款、《中华人民共和国行政处罚法》第二十八条第一款、《中华人民共和国药品管理法实施条例》第七十五条的规定，责令当事人立即改正上述违法行为，并给予以下行政处罚：主动履行   2025年8月4日广西壮族自治区药品监督管理局2025年7月22日1.没收劣药6.497kg；2.没收违法所得1766.4元（壹仟柒佰陆拾陆元肆角）。

序号企业名称经营地址/仓库地址企业类型检查时间检查人员检查结果1合肥九端医药有限公司合肥市高新区云飞路19号办公楼1-4 层/安徽省合肥市高新区KB1-3地块云飞路19号厂房一层药品批发企业2025-07-02李玲,李峰待整改后评定2安徽涵汐福康医药有限公司安徽省合肥市长丰县岗集镇金岗大道88号合肥城市学院别墅区七栋四楼/长丰县岗集镇金岗大道北段88号A15号楼401室、402室药品批发企业2025-07-03李玲,李峰待整改后评定3西安利君制药合肥医药有限公司安徽省合肥市庐江县高新区西河路88号1栋2楼/安徽省合肥市庐江县高新区西河路88号5栋1层药品批发企业2025-07-09李玲,郭梅花待整改后评定4安徽诚益弘医药有限公司安徽省合肥市庐江县高新区西河路88号2栋/安徽省合肥市庐江县高新区西河路88号4栋药品批发企业2025-07-10李玲,郭梅花待整改后评定5合肥未来医药有限公司安徽长丰双凤经济开发区凤麟路19号3幢二层202、203、205、207 室/安徽长丰双凤经济开发区凤麟路19号2幢一层药品批发企业2025-07-16李玲,韩春艳待整改后评定6合肥德顺堂医药有限公司合肥市双凤开发区凤霞路西66号/安徽省合肥市长丰县双凤经济开发区凤霞路西66号2#厂房一楼、二楼药品批发企业2025-07-17李玲,韩春艳待整改后评定7安徽天星医药集团有限公司安徽省合肥市经济技术开发区慈光路118号/安徽省合肥市经济技术开发区慈光路118号药品仓库一层、二层；1#库一层、二层、三层；2#库负一层、一层、三层药品批发企业2025-07-25凌定聪,许漪,沈艳茹,汪乾待整改后评定8安徽骁柔医药有限公司安徽省合肥市肥西县花岗镇规划多云尖路与青草湖路交口丰彦仓储5幢厂房B单元东北角一、二层/安徽省合肥市肥西县花岗镇规划多云尖路与青草湖路交口丰彦仓储5幢厂房B单元5B-1、5B-2一层药品批发企业2025-07-30李玲,王红星待整改后评定

序号企业名称经营地址/ 仓库地址企业类型检查时间检查人员检查结果1安徽韵到家医药有限公司经营地址：安徽省淮南市毛集实验区工业园区文成大道南侧仓库地址：淮南市毛集实验区工业园区文成大道南侧批发企业2025年7月7日-8日李多福、吴旭娟基本符合要求2安徽丽高医药有限公司六安市叶集区皖西中路9号1层、2层、3层批发企业2025年7月17日-18日蔡启文、郑牧垚不符合要求检查结果：1.符合要求；2.基本符合要求；3.不符合要求。

序号检查时间企业名称生产地址检查范围检查依据检查结论处理措施备注12025年07月21日-23日安徽红三七药业有限公司安徽省淮南市经济技术开发区建设路膏霜乳液单元（护肤清洁类）《化妆品监督管理条例》《化妆品生产质量管理规范》《化妆品生产质量管理规范检查要点及判定原则》《化妆品检查管理办法》等。基本符合限期整改无