江西润弘医药有限公司（药品经营许可证：赣AA796000794，注册地址：江西省吉安市遂川县工业园区东区雩云路168号2＃仓库），于2026年4月8日由我局公告暂停药品经营活动。近期，该公司向我局申请恢复药品经营，经现场检查，认定符合重新开业条件，现准允恢复药品经营。江西省药品监督管理局2026年9月2日

附件：湖北部分医用耗材及企业信息变更公示(2026年第十六批)

根据《中华人民共和国药品管理法》《中华人民共和国药品管理法实施条例》和《药品生产监督管理办法》（国家市场监督管理总局令第28号）之规定，非凡（秦皇岛）制药有限公司和安国市承韵本草药业有限公司符合取得药品生产许可证的法定条件和有关规定，依法准予核发《药品生产许可证》。特此公告。附件：《药品生产许可证》核发名单(共计2家）.docx河北省药品监督管理局2026年9月1日

江西润弘医药有限公司（药品经营许可证：赣AA796000794，注册地址：江西省吉安市遂川县工业园区东区雩云路168号2＃仓库），于2026年4月8日由我局公告暂停药品经营活动。近期，该公司向我局申请恢复药品经营，经现场检查，认定符合重新开业条件，现准允恢复药品经营。江西省药品监督管理局2026年9月2日

按照《医疗器械监督管理条例》的规定，根据企业申请，现注销以下1家企业1个产品的医疗器械注册证书:江西修正医疗科技有限公司：体腔器械导入润滑剂，注册证号：赣械注准20232140134。特此公告。江西省药品监督管理局2026年9月1日

根据《中华人民共和国药品管理法》《中华人民共和国药品管理法实施条例》《药品经营和使用质量监督管理办法》等有关规定，海南省药品监督管理局依法注销海南全星药业有限公司、澳美制药（海南）有限公司的《药品经营许可证》。上述企业自《药品经营许可证》注销之日起，须立即停止药品经营活动，请社会各界监督。企业名称经营地址仓库地址经营范围许可证编号备注海南全星药业有限公司海口市南海大道168号海口保税区A06-2三楼海口市南海大道168号海口市保税区A06-2综合车间（综合制剂楼）三楼仓库中成药；化学药（含原料药）（以上不含冷藏、冷冻药品）***琼AA898000105企业主动申请注销澳美制药（海南）有限公司海口国家高新技术产业开发区药谷工业园药谷一路2号澳美制药（海南）有限公司B栋三楼北面、B303室1.海口国家高新技术产业开发区药谷工业园药谷一路2号澳美制药（海南）有限公司F栋2楼；2.上海市康宁路1089号、上海市松江区洞泾镇洞薛路885号普洛斯洞泾物流园P1号U101单元（国药集团医药物流有限公司仓库）中成药、化学药（含原料药）（以上不含冷藏、冷冻药品）***琼AA898000525企业主动申请注销特此公告。海南省药品监督管理局2026年8月14日

根据《中华人民共和国药品管理法》《中华人民共和国药品管理法实施条例》和《药品经营和使用质量监督管理办法》等有关规定，海南省药品监督管理局依法注销海南泰斯特医学科技有限公司《药品经营许可证》。自注销之日起，该企业停止药品经营活动，请社会各界监督。企业名称经营地址仓库地址经营范围许可证编号备注海南泰斯特医学科技有限公司海口市龙华路13-1号华典大厦609室1.海口市海垦路119号海南GSP医药物流商城，海口市向荣路11号物资仓库5栋二层西北侧（海南三叶医药物流管理有限公司仓库）。体外诊断试剂（含冷藏药品）***琼AA898000537企业主动申请注销特此公告。海南省药品监督管理局2026年8月3日

Delivery Method:VIA UNITED PARCEL SERVICEReference #:320-26-118Product:DrugsRecipient:Dr. Melinda C. O’RourkeOwnerPReye, LLC4855 Ward Rd.Wheat Ridge, CO 80033United States(b)(6)Issuing Office:Center for Drug Evaluation and Research (CDER)United StatesAugust 18, 2026WARNING LETTERReference number: 320-26-118To Dr. Melinda C. O’Rourke:This warning letter advises you of significant violations observed during a U.S. Food and Drug Administration (FDA) inspection of your products and facilities. 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.FDA InspectionViolations were observed and documented during an inspection of your drug manufacturing facility, PReye, LLC, FDA Establishment Identifier (FEI) 3031057987, at 4855 Ward Road, Wheat Ridge, from March 17 to 19, 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).In addition, violations were identified and documented during the review of your website https://essencelaser.com/vitaminsee/ in June 2026. Based on our review, “PReye Vitamin SEE” is an unapproved new drug under section 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 355(a). As explained further below, introducing or delivering this product for introduction into interstate commerce violates sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a).We reviewed your March 22, 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.CGMP Violations1. Your firm failed to perform operations within specifically defined areas of adequate size and to have separate or defined areas or such other control systems necessary to prevent contamination or mix-ups in aseptic processing areas. Your firm also failed to use equipment in the manufacture, processing, packing, or holding of drug products that is of appropriate design, adequate size, and suitably located to facilitate operations for its intended use and for its cleaning and maintenance (21 CFR 211.42(c)(10) and 21 CFR 211.63).Your firm was registered as a drug repacker and produced drug products solely for distribution through the co-located med spa, Essence Laser and Wellness, which you own. Your repackaging operations consisted of a small flow hood on a desk in your office. These operations were performed in a non-certified, non-qualified flow hood within an unclassified office space that lacked a high-efficiency particulate air (HEPA) filtration system.You obtained bulk liquid drug and manually filled multiple (b)(4) drug products. The drug product was labeled with directions to use “(b)(4)”. Your (b)(4) products were filled under unsuitable aseptic processing conditions, in that they lacked appropriate facilities, equipment, and process controls to protect the drug product from microbiological contamination.Your manufacturing facility, equipment, and process must be designed, and operations must be executed, to prevent contamination risks to sterile drug products (e.g., (b)(4) drug products).2. Your firm’s quality control unit failed to exercise its responsibility to ensure drug products manufactured are in compliance with CGMP, and meet established specifications for identity, strength, quality, and purity (21 CFR 211.22).Your firm's quality systems are inadequate. Your firm lacked a quality unit (QU) function and associated written procedures defining QU responsibilities and controls. You failed to establish basic procedures including, but not limited to, complaint review, supplier qualification, release testing, change management, cleaning, disinfection, and deviation handling. In addition, your ophthalmic drug products lack traceability because you did not issue batch numbers for all sterile drug products manufactured since 2024.An adequate QU overseeing all manufacturing operations is necessary to consistently ensure drug quality. You failed to implement fundamental procedures and practices to ensure the safety, identity, strength, quality, and purity of your drug products. See FDA's guidance document Quality Systems Approach to Pharmaceutical CGMP Regulations for help implementing quality systems and risk management approaches to meet the requirements of CGMP regulations 21 CFR, parts 210 and 211 at https://www.fda.gov/media/71023/download.Unapproved New Drug ViolationsBased on a review of your website, “PReye Vitamin SEE” is a drug under section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1), because it is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease, and/or intended to affect the structure or any function of the body. Examples from your product labeling, including on your website, that provide evidence of the intended use (as defined in 21 CFR 201.128) of the product as a drug include, but may not be limited to, the following:PReye Vitamin SEEOn the webpage https://essencelaser.com/vitaminsee/:“Antioxidant Vitamins provide protection against the damaging effects of UV light from sun exposure. . . . In the eye, UV light ages all the structures. Ocular surface damage, cataracts and macular degeneration are all possible effects from UV exposure and can ultimately lead to decreased vision, and blindness.”“Both Ascorbic Acid and Acetylcysteine have been used independently to treat pathology in the eye, including corneal alkali burns and filamentary keratitis in severe dry eye. But, never have they been combined as a vitamin supplement eyedrop to prevent eye disease related to UV exposure, including cataracts and macular degeneration.”“PReye Vitamin SEE” is a "new drug" under section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because it is not generally recognized as safe and effective (GRASE) for use under the conditions prescribed, recommended, or suggested in the labeling. 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, 21 U.S.C. 355(a). No approved application pursuant to section 505 of the FD&C Act, 21 U.S.C. 355, is in effect for this product. Accordingly, this product is an unapproved new drug. The introduction or delivery for introduction into interstate commerce of this unapproved new drug product violates sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a).Additional Guidance on Drug ListingWe note that your firm’s drug listing for “PReye Vitamin SEE” has not been updated or certified as required and therefore has been inactivated by FDA. Please update the listing information for this drug to reflect its current status. If you no longer manufacture and distribute this drug, it must be discontinued by adding an end marketing date.Additional Guidance on Aseptic ProcessingSee FDA’s guidance document Sterile Drug Products Produced by Aseptic Processing—Current Good Manufacturing Practice to help you understand CGMP requirements for sterile drugs produced by aseptic processing at https://www.fda.gov/media/71026/download.Container Closure for (b)(4) FormulationsWhen contaminated, (b)(4) drug products pose a significant risk of harm because (b)(4) administration bypasses some of the body’s natural defenses. Irreversible damage, including (b)(4) can occur, and in some cases, may progress to life-threatening systemic infection. The risk is exacerbated when (b)(4) drug products lack a (b)(4) and lack data to demonstrate that the container-closure system can prevent microbiological ingress, contamination, and proliferation.Drug Production CeasedOn March 22, 2026, you communicated your commitment to cease manufacturing and distribution of PReye Vitamin SEE for the U.S. market for the future. We acknowledge your commitment to cease production of PReye Vitamin SEE drugs at this facility.If you plan to resume any drug manufacturing operations, including repackaging, notify this office before commencing operations. If you resume CGMP activities, you are responsible for resolving all deficiencies and systemic flaws to ensure your firm is capable of ongoing CGMP compliance. In addition, based 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. The qualified consultant should also perform a comprehensive six-system audit of your entire operation for CGMP compliance and evaluate the completion and efficacy of all corrective action and preventive action, before you pursue resolution of your firm’s compliance status with FDA.In your notification to the Agency, provide a summary of your remediations to demonstrate that you have appropriately completed all corrective action and preventive action (CAPA).Drug RecallOn May 11, 2026, FDA held a teleconference with you recommending you consider removing any batches of PReye Vitamin SEE currently in distribution from the U.S. market.On May 18, 2026, you issued a voluntary recall of PReye Vitamin SEE due to lack of sterility testing.ConclusionYou are responsible for 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 3031057987 and ATTN: Compliance Officer Nancy Scheraga in the letter or in 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 on www.FDA.gov.Sincerely,Francis GodwinDirectorOffice of Manufacturing QualityOffice of ComplianceCenter for Drug Evaluation and ResearchU.S. Food and Drug Administration/S/Tina Smith, M.S.Captain, U.S. Public Health ServiceDirectorOffice of Unapproved Drugs and Labeling ComplianceOffice of ComplianceU.S. Center for Drug Evaluation and Research

经监督检查，重庆盛全堂医药有限公司存在安全隐患。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重庆盛全堂医药有限公司渝AA023000165重庆市经开区长生桥镇迎春路7号1幢2-1号（自编号2-1-2号）重庆市经开区长生桥镇迎春路7号1幢2-1号（自编号2-1-3号）中成药、化学药***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8月28日