2025年国庆、中秋“双节”将至，为进一步营造安全放心的药品市场消费环境，切实保障消费者合法权益，赤峰市市场监管局特发布以下药品安全消费提示：请从持有《药品经营许可证》的零售药店或持有《医疗机构执业许可证》的医疗机构购买药品，购买时要注意索取保存有关票据；通过网络购买药品时，要注意网站首页或者经营活动的主页面显著位置是否公示《药品经营许可证》，并注意核对相关资质是否在有效期内。请勿通过社交软件、短视频直播平台等非正规渠道或从无资质的商家、个人处购买药品。购药时要认准“国药准字”的药品批准文号；并认真查看药品说明书，核验外包装盒上标注的药品通用名、生产日期、批号和有效期等信息是否齐全，必要时可登录国家药品监督管理局官网进行查询。购买处方药应向药店提供处方，经过执业药师处方审核调配后再购买。购买非处方药时要根据用药需求购买并按照说明书科学使用。要警惕虚假夸大宣传，避免盲目购买、误用药品以及造成不必要的浪费。购买药品后，要按说明书标明的贮藏条件保存药品，避免药品受潮、暴晒或冷冻，确保药效稳定。使用药品后若出现不良反应，应立即停止使用，不良反应严重者需立即就医。如在消费过程中发现经营者存在违法违规经营行为或自身合法权益受到侵害，应注意保留剩余药品及包装、交易聊天记录、交易凭证等证据并及时拨打“12345”热线电话或直接向市场监管部门投诉举报。

肌因肽克（贵州）生物技术有限公司报告，由于投料比例与工艺规程配比不一致原因，肌因肽克（贵州）生物技术有限公司对其生产的GTEG025005批次医用重组胶原蛋白修复凝胶（注册号： 黔械注准20232140040 ）主动召回。召回级别为 三级 。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

Delivery Method:Via Electronic Mail Return Confirmation RequestedReference #:320-25-109Product:DrugsRecipient:Mr. Zeng DongGeneral ManagerChengdu Brilliant Biopharmaceutical Co., Ltd.#33, Tengfei 12th Rd, Southwest Airport Economic Dev ZnShuangliu XianChengdu ShiSichuan Sheng,610207ChinaIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesWarning Letter320-25-109September 11, 2025Dear Mr. Zeng Dong:Your facility is registered with the United States Food and Drug Administration (FDA) as a manufacturer of active pharmaceutical ingredients (APIs). FDA has reviewed the records you submitted in response to our March 12, 2025, request for records and other information pursuant to section 704(a)(4) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) for your facility, Chengdu Brilliant Biopharmaceutical Co., Ltd., FEI 3015530591, at #33, Tengfei 12th Road, Southwest Airport Economic Dev Zn, Shuangliu District Chengdu, Sichuan.This warning letter summarizes significant deviations from Current Good Manufacturing Practice (CGMP) for active pharmaceutical ingredients (APIs).Because your methods, facilities, or controls for manufacturing, processing, packing, or holding of drugs as described in your response to our 704(a)(4) request do not conform to CGMP, your APIs 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).Following review of records and other information provided pursuant to section 704(a)(4) of the FD&C Act, significant deviations were observed including, but not limited to, the following:1. Failure to demonstrate that your manufacturing process can reproducibly manufacture an API meeting its predetermined quality attributes.Based on the records and information you provided, your firm has not conducted process validation for the Glucagon-Like Peptide-1 Receptor Agonist (GLP-1) API Semaglutide manufactured at your site.Process validation evaluates the soundness of design and state of control of a process throughout its lifecycle. Each significant stage of a manufacturing process must be designed appropriately and ensure the quality of raw material inputs, in-process 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 is necessary to ensure that you maintain a stable manufacturing operation throughout the product lifecycle.Without adequate process validation, your firm lacks basic assurance that you can reproducibly deliver products that meet specifications. 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 the following: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.A timeline for performing PPQ for each of your marketed drug products.Process performance protocol(s) and written procedures for qualification of equipment and facilities.A detailed program for designing, validating, maintaining, controlling and monitoring each of your manufacturing processes that includes vigilant monitoring of intra-batch and inter-batch variation to ensure an ongoing state of control. Also, include your program for qualification of your equipment and facility.2. Failure to test the identity of each batch of incoming production material.Based on the records and information you provided, you failed to conduct an identity test on the raw materials used for manufacturing of your API during(b)(4), e.g.,(b)(4).Without adequate testing, there is no scientific evidence to assure that your raw materials conform to appropriate specifications before release.In response to this letter, please provide the following:A comprehensive, independent review of your material system to determine whether all suppliers of components, containers, and closures, are each qualified and the materials are assigned appropriate expiration or retest dates. The review should also determine whether incoming material controls are adequate to prevent use of unsuitable components, containers, and closures.The chemical and microbiological quality control specifications you use to test and release each incoming lot of component for use in manufacturing.A description of how you will test each component lot for conformity with all appropriate specifications for identity, strength, quality, and purity. If you intend to accept any results from your supplier’s Certificates of Analysis (COA) instead of testing each component lot for strength, quality, and purity, specify how you will robustly establish the reliability of your supplier’s results through initial validation as well as periodic re-validation. In addition, include a commitment to always conduct at least one specific identity test for each incoming component lot.A summary of results obtained from testing all components to evaluate the reliability of the COA from each component manufacturer. Include your SOP that describes this COA validation program.A summary of your program for qualifying and overseeing contract facilities that test the drug products you manufacture.ConclusionThe deviations cited in this letter are not intended to be an all-inclusive list of deviations that exist at your facility. You are responsible for investigating and determining the causes of any deviations and for preventing their recurrence or the occurrence of other deviations.FDA placed all drugs and drug products offered for import into the United States from your firm on Import Alert 66-40 on July 9, 2025.Correct any deviations promptly. FDA may withhold approval of new applications or supplements listing your firm as a drug manufacturer until any deviations are completely addressed and we confirm your compliance with CGMP. We may inspect to verify that you have completed corrective actions to any deviations.Failure to address any deviations may also result in the FDA continuing to refuse admission of articles manufactured at Chengdu Brilliant Biopharmaceutical Co., Ltd., FEI 3015530591, at #33, Tengfei 12th Road, Southwest Airport Economic Dev Zn, Shuangliu District Chengdu into the United States under section 801(a)(3) of the FD&C Act, 21 U.S.C. 381(a)(3). Articles under this authority that appear to be adulterated may be detained or refused admission, in that the methods and controls used in their manufacture do not appear to conform to CGMP within the meaning of section 501(a)(2)(B) of the FD&C Act, 21 U.S.C. 351(a)(2)(B).This letter notifies you of our findings and provides you an opportunity to address the above deficiencies. After you receive this letter, respond to this office in writing within 15 working days. Specify what you have done to address any deviations 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 3015530591 and ATTN: Chhaya Shetty.Sincerely,/S/Francis GodwinDirectorOffice of Manufacturing QualityOffice of ComplianceCenter for Drug Evaluation and Research

Delivery Method:Via EmailProduct:DrugsRecipient:Gennady SirotaPresidentStellalife, Inc.P.O. Box 1204Northbrook,IL60065United Statessupport@StellaLife.comIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesWARNING LETTERSeptember 16, 2025RE: 712804Dear Gennady Sirota:This letter is to advise you that the United States Food and Drug Administration (FDA or Agency) reviewed your website at the internet address www.stellalife.com in July 2025 and has observed that your website offers products for sale in the United States (U.S.), including the following which are labelled as homeopathic drug products: “StellaLife VEGA Oral Care Recovery Kit,” “StellaLife VEGA Oral Care Peppermint Gel,” “StellaLife VEGA Oral Care Spearmint Rinse,” “StellaLife VEGA Oral Care Peppermint Rinse,” and “StellaLife VEGA Oral Care Coconut Rinse” (hereinafter StellaLife homeopathic drug products). We have also reviewed your social media accounts at https://www.instagram.com/stellalifehealing/, https://www.facebook.com/stellalifeheal and www.youtube.com/@StellaLifeHealing. Your social media accounts direct consumers to your www.stellalife.com website to purchase your products. Based on our review, your StellaLife homeopathic drug products are unapproved new drugs introduced or delivered for introduction into interstate commerce in violation of sections 505(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 355(a) and 331(d), as described below.Your StellaLife homeopathic drug products are especially concerning from a public health perspective because they are marketed for use in vulnerable populations, i.e., children and patients at high risk for developing an infection, such as those with open oral wounds or postoral surgery. Use of your products in these populations is even more concerning because some of your products have been recalled due to microbial contamination.1Introduction of certain types of bacteria to the disrupted oral mucosa in patients with oral disease, undergoing dental surgical procedures, or with compromised immune systems could lead to bacteremia and sepsis.Based on our review of your labeling, your StellaLife homeopathic drug products are drugs as defined by section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1), because they are intended to prevent, treat, mitigate, or cure disease conditions and/or affect the structure or any function of the body. Examples from your product labeling, including on your website and social media accounts that provide evidence of the intended use (as defined in 21 CFR 201.128) of your products as drugs include, but may not be limited to, the following:On your “StellaLife VEGA Oral Care Recovery Kit” webpage https://stellalife.com/products/stellalife-vega-oral-care-recovery-kit-16oz:“IMPROVES RECOVERY: Accelerates healing naturally after dental surgeries such as extractions (including wisdom teeth), dental implants (including all-on-4, all-on-6), bone and connective tissue grafting, LANAP, osseous surgery, crown lengthening, sinus lift, ridge augmentation, and other procedures including SRP.”“FAST ACTING: Natural relief for dental surgeries . . . mouth ulcers . . . mucositis, thrush, lesions”“DIRECTIONS:3•3•3 StellaLife Program: 3 days before, 3 times per day, all 3 productsAdults and children over 6 years of age. Start 3 days before the surgery or procedure to increase therapeutic levels. Continue after the procedure.”On your “StellaLife VEGA Oral Care Peppermint Gel” webpage https://stellalife.com/products/vega-oral-gel:“StellaLife VEGA Care Gel is an innovative patented technology formulated to accelerate healing, relieve pain & reduce swelling after dental procedures. Doctors have found it effective in managing . . . mucositis”“A Product Dental Patients Need After Surgical and Non-Surgical Procedures . . . Supports healing . . . Relieves pain & swelling . . . Oral Ulcers”“When do I use StellaLife VEGA Oral Care Gel? Our natural gel has been formulated to work well in open wounds and speed up healing. Dental professionals use it for in-office application immediately after treatment or at post-operative visits. The gel has been found effective in the management of . . . mucositis, and recovery following dental surgical and non-surgical procedures.”On your “StellaLife VEGA Oral Care Spearmint Rinse” webpage https://stellalife.com/products/stellalife-vega-oral-care-sprearmint-rinse:“StellaLife Oral Rinse is a natural, microbiotic product formulated for daily use to hydrate, freshen breath, and promote healthy gums to maintain oral health. The patented rinse supports healing after dental treatment. It is part of oral hygiene to moisturize dry mouth and kill bacteria that cause periodontal disease.”“Does it help dry mouth? Yes. It has been helping patients with dry mouth symptoms, including patients who experience xerostomia caused by radiation therapy to the head and neck.”On your “StellaLife VEGA Oral Care Coconut Rinse” webpage https://stellalife.com/products/stellalife-vega-oral-care-rinse-coconut:“MICROBIOTIC THERAPY: Reduces bacteria that cause periodontal disease.Recommended by THE DENTAL ADVISOR.PROTECTIVE & HEALING: Combined use of the VEGA Oral Care Gel and Coconut Rinse (nine active ingredients) offers many additional benefits like temporary symptoms relief of dry mouth and ulcers caused by mucositis, chronic inflammatory and autoimmune conditions of the oral cavity, daily medication, chemo, and radiation treatments.”“StellaLife VEGA Oral Coconut Rinse is a natural, antimicrobial product formulated to hydrate the oral cavity, promote healthy gums, maintain oral health, and freshen your breath. The patented rinse supports healthy healing following oral surgery and periodontal treatment . . . The rinse is also uniquely designed for patients undergoing chemo and radiation treatments and with various oral cavity inflammatory conditions.”On your “StellaLife VEGA Oral Care Spearmint Rinse” and “StellaLife VEGA Oral Care Peppermint Rinse” webpages2:“StellaLife VEGA Oral Rinse is a natural, antimicrobial product formulated to hydrate the oral cavity, promote healthy gums, maintain oral health, and freshen breath. The patented rinse supports healthy healing following oral surgery and periodontal treatment for patients with xerostomia. It is recommended as part of daily oral hygiene due to its antimicrobial properties used to kill bacteria that cause tooth decay and periodontal disease.”On your “StellaLife VEGA Oral Care Spearmint Rinse,” “StellaLife VEGA Oral Care Peppermint Rinse,” and “StellaLife VEGA Oral Care Coconut Rinse” webpages3:“Clinical reports showed anti-fungal properties and effectiveness in the treatment of mucositis in conjunction with VEGA gel. Professional strength. Recommended by the Dental Advisor, dentists, and hygienists.”“How effective is StellaLife VEGA Oral Care Rinse? Independent antimicrobial studies showed the rinse efficacy against the anaerobic bacterial load in half for over 3 hours after a single application.”On your Facebook social media account at https://www.facebook.com/stellalifeheal:May 23, 2025 post: Statement in your video clip “Recover faster from Dental Surgery with Opioid-Free Pain Relief. Return to your normal life faster after dental surgery with StellaLife’s Vega Oral Care Recovery Kit 3-3-3 program . . . Many patients report faster recovery with StellaLife’s groundbreaking Intelligent Healing process . . . StellaLife is a safe and natural way to speed up recovery with less pain after dental surgery.”On your Instagram social media account at https://www.instagram.com/stellalifehealing/:July 4, 2025 post: “Their VEGA Oral Care Recovery Kit is my go-to for post-surgical healing, whether it’s after an extraction, bone graft, or even membrane placement. Natural, effective, and gentle — a must-have in recovery care!”On your YouTube social media account at www.youtube.com/@StellaLifeHealing:October 9, 2020 featured video: “In the past I would see wounds opening up, I would see membranes not only exposed but being lost, I would see bone grafts being lost . . . the use of the Oral Care program has just been really spectacular and I love the overall wound healing that I’m seeing.”Moreover, your StellaLife homeopathic drug products are “new drugs” under section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because they are not generally recognized as safe and effective for use under the above-described conditions prescribed, recommended, or suggested in their labeling. Subject to certain exceptions not applicable here, new drugs 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 applications pursuant to section 505 of the FD&C Act, 21 U.S.C. 355, are in effect for these products. Accordingly, these products are unapproved new drugs. The introduction or delivery for introduction into interstate commerce of these unapproved new drug products violates sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a).We recognize that your StellaLife homeopathic drug products are labeled as being homeopathic drugs with active ingredients measured in homeopathic strengths. Under section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1), the term “drug” includes articles recognized in the official Homeopathic Pharmacopeia of the United States (HPUS), or any supplement to it. Homeopathic drug products are subject to the same statutory requirements as other drugs; nothing in the FD&C Act exempts homeopathic drugs from any of the requirements related to adulteration, misbranding, or FDA approval.ConclusionThis letter is not intended to be an all-inclusive statement of violations that may exist in connection with your products. 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 that your firm complies with all requirements of federal law, including FDA regulations.This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address this matter may result in legal action including, without limitation, seizure and injunction.Please notify FDA in writing, within fifteen working days of receipt of this letter, of the specific steps you have taken to correct any violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. 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. If you cannot complete corrective action within fifteen working days, state the reason for the delay and the time within which you will complete the correction.Your response should be sent to U.S. Food and Drug Administration, CDER/OC/Office of Unapproved Drugs and Labeling Compliance by email to FDAADVISORY@fda.hhs.gov. Please include your firm name and the unique identifier “712804” in the subject line of the email.Sincerely,/S/Tina Smith, M.S.Captain, U.S. Public Health ServiceDirectorOffice of Unapproved Drugs and Labeling ComplianceOffice of ComplianceCenter for Drug Evaluation and ResearchU.S. Food and Drug Administration_________________________________1Your contract drug manufacturer HomeoCare Laboratories, Inc. voluntarily recalled several lots of StellaLife Homeopathic Drug products due to concerns with microbial contamination in June 2023 and June 2024. The June 2024 recall included a press release https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/homeocarelaboratories-inc-issues-voluntary-nationwide-recall-homeopathic-stella-life-oral-care.2https://stellalife.com/products/stellalife-vega-oral-care-sprearmint-rinse and https://stellalife.com/products/vega-oralcare-rinse-16oz3https://stellalife.com/products/stellalife-vega-oral-care-sprearmint-rinse; https://stellalife.com/products/vega-oralcare-rinse-16oz; and https://stellalife.com/products/stellalife-vega-oral-care-rinse-coconut.

Delivery Method:VIA Electronic MailProduct:Medical DevicesRecipient:David E. RadcliffeChief Information OfficerThe Richline Group, Inc.6701 Nob Hill RoadTamarac,FL33321-6402United StatesDavid.Radcliffe@richlinegroup.comIssuing Office:Center for Devices and Radiological HealthUnited StatesWARNING LETTERCMS # 712818August 25, 2025Dear Mr. Radcliffe:During an inspection of your firm located in Tamarac, FL, from March 24, 2025, through April 16, 2025, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures the Inverness Ear Care Antiseptic, Inverness Ear Care Solution, and Inverness Home Ear Piercing Kit products. The inspection of your firm identified violations of the Food, Drug, and Cosmetic Act, a number of which were repeat violations from an earlier inspection. We note that FDA has had prior communications with your firm about these products.Our inspection and review of the available information revealed that your firm markets the Inverness Ear Care Antiseptic and Inverness Ear Care Solution without marketing authorization. Wound washes containing certain chemicals, including antimicrobials (e.g., benzalkonium chloride), include several risks which necessitate the premarket review of these products prior to marketing. These risks include adverse tissue reaction, toxicity, delayed wound healing, incompatibilities with other therapies, contribution to the spread of antimicrobial resistance, infection, microbial growth within the product, product degradation during stated shelf storage, and negatively impacting the skin microbiota in the periwound area resulting in impaired wound healing. Wound washes with certain chemicals, such as antimicrobials for preservative purposes only, that are intended to irrigate a wound are generally regulated by the Center for Devices and Radiological Health (CDRH), categorized within FDA product code FRO (dressing, wound, drug), and require submission of a 510(k) for FDA review. However, please note that the claims and indications for a product can impact the regulatory pathway of the product, as well as the classification or jurisdiction of the product. Your firm appears to be making claims that go beyond the types of claims appropriate for wound washes categorized under the FRO product code. For example, the current labeling for Ear Care Antiseptic suggests that the benzalkonium chloride component is intended for use as an antiseptic rather than a preservative. The Ear Care Antiseptic labeling identifies benzalkonium chloride as the active ingredient, for the purpose of ear care antiseptic, e.g., as identified in the name of the product. If you intend to continue making such claims, we note that your products may be regulated by the Center for Drug Evaluation and Research (CDER) and require an approved new drug application, among other requirements.However, assuming that the claims for these products would be consistent with wound care products regulated by CDRH, these products would be adulterated under section 501(f)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 351(f)(1)(B), because your firm does not have an approved application for premarket approval (PMA) in effect pursuant to section 515(a) of the Act, 21 U.S.C. § 360e(a), or an approved application for an investigational device exemption under section 520(g) of the Act, 21 U.S.C. § 360j(g). These products would also be misbranded under section 502(o) of the Act, 21 U.S.C. § 352(o), because your firm did not notify the agency of its intent to introduce the products into interstate commerce for commercial distribution, as required by section 510(k) of the Act, 21 U.S.C. § 360(k). For a product 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 products 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 products may be legally marketed.Additionally, assuming that the claims for these products would be consistent with wound care products regulated by CDRH, your products would be in violation of the Act in other respects as well, as discussed further below.Quality System RegulationBased on this inspection, your products would be 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 responses from Mr. Jose A. Abrams, Jr., Director of Quality Assurance dated May 5, 2025, and June 18, 2025, 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 the responses below, in relation to each of the noted violations. These violations include, but are not limited to, the following:1. Failure to establish and maintain procedures to control the design of the device in order to ensure that specified design requirements are met, as required by 21 CFR 820.30(a).For example: Your firm has not implemented design controls for your products, including the Inverness Home Ear Piercing Kits, Ear Care Antiseptic, and Ear Care Solution. Specifically:a. Your firm defines requirements in your Design Control procedure, SOP-003, Ver. 0, 10/10/2024 for design and development planning, design input, design output, design verification, design validation, design transfer, design review, and design history for your products, but does not maintain design documents that support these established requirements, including any documentation of design control requirements from the original design of the products. During the inspection, these records were requested, and your Quality Control Manager affirmed that your firm has not established any design controls or developed design plans for your firm’s products. Accordingly, your firm has been operating without design controls since(b)(4).b. Your firm has not addressed expiration dating as part of the design controls. Although your firm’s Ear Care Antiseptic & Ear Care Solution Preparation procedure, SOP-015, Ver. 0, 01/16/2025, requires each bottle of Ear Care Antiseptic and Ear Care Solution to be printed with an expiration date(b)(4)beyond the batch mixing date, your firm maintains no supporting documentation for the current(b)(4)expiration date of such products, or for the(b)(4)expiration date of your sterile cassette containing 2-piercing cartridges. Your firm provided the report, Technique Report Ref: 1330084, Accelerated Stability Trial ((b)(4)), to demonstrate testing was conducted on the Ear Care Solution in(b)(4)but the report does not include: Testing protocol, actual testing raw data, product packaging configuration, and batch/lot number, in support of the(b)(4)expiration date for the firm’s Ear Care Solution and Ear Care Antiseptic. Also, your firm maintains no supporting documentation for testing conducted for the(b)(4)expiration date for your firm’s sterile cassette.Your firm manufactured and distributed over(b)(4)bottles of Ear Care Antiseptic and Ear Care Solution, configured in 2 oz., 4 oz., and 16 oz. bottle sizes, for your Home Ear Piercing Kits and for individual own-label and private-label sale, between June 2024 and April 2025, without proper design controls in place.We reviewed your firm’s response and concluded that it is not adequate. Your firm's response (CAPA-25-004) is inadequate because it provides only partial coverage of the design control violations and lacks implementation specifics. While the CAPA acknowledges the need for design controls, it does not comprehensively address all identified deficiencies and fails to detail how each aspect of the design control process will be implemented. Critically, your response lacks a documented plan for establishing and validating product expiration dates and does not explain how compliance with SOP-003 (Design Control) will be ensured across all design process elements for your products.Additionally, the ongoing status of CAPA-25-004, which has been extended(b)(4)per CAPA-EXT-002, raises concerns about your firm's ability to effectively implement necessary corrections. Your firm’s CAPA-25-004 should be revised to comprehensively address this design control violation, including specific implementation plans for each design control element; establish clear procedures for expiration date documentation and validation; and demonstrate how SOP-003 compliance will be achieved and maintained throughout your design processes.2. Failure to adequately ensure that when the results of a process cannot be fully verified by subsequent inspection and test that the process shall be validated with a high degree of assurance and approved according to established procedure. The validation activities and results, including the date and signature of the individual(s) approving the validation and where appropriate the major equipment validated, are to be documented, as required by 21 CFR 820.75(a).For example: Your firm has not validated the manufacturing process and equipment used to produce Inverness Ear Care Solution and Ear Care Antiseptic. Your firm has defined requirements for validations in your procedure, Production and Process Control, SOP-021, Ver. 0, 09/05/2024, but does not maintain documents that address original process validations and any subsequent re-validations, to ensure that robust, reliable, and efficiently monitored processes are used to manufacture product. Specifically:a. Equipment used to establish and to monitor critical parameters such as tank fill weight, water quality, raw material weight, mixing speed, and mixing times is not validated.b. Your firm’s procedure, SOP-021, requires determination of process variables and that they be understood and controlled through validation, e.g., batch size. However, three different batch sizes of Ear Care Antiseptic Batch (Lot #(b)(4)at(b)(4)lbs., Lot #(b)(4)at(b)(4)lbs., and Lot#(b)(4)at(b)(4)lbs.) were produced without establishing critical process parameters through validation for each batch size, to consistently meet predetermined specifications.c. Critical equipment used in the manufacture of your firm’s products, including the(b)(4)system,(b)(4), and(b)(4), is not validated. This is not consistent with your firm’s procedure, SOP-021, which requires the documentation and validation of products and equipment transferred in the(b)(4)relocation from Massachusetts to the current facility in Florida.d. Validation protocol and/or validation report is not maintained by your firm for your manufactured products.Your firm manufactured and distributed over(b)(4)bottles of Ear Care Antiseptic and Ear Care Solution, configured in 2 oz., 4 oz., and 16 oz. bottle sizes, for your Home Ear Piercing Kits and for individual own-label and private-label sale, between June 2024 and April 2025, without proper equipment and process validations in place. This is a continued and repeated violation from the previous inspection of your firm’s facility.We reviewed your firm’s response and concluded that it is not adequate. Your firm's response (CAPA-25-007) is inadequate because it lacks specificity and essential documentation. While the CAPA addresses general validation concerns, it fails to specify how critical process parameters, manufacturing equipment ((b)(4)),(b)(4),(b)(4)the(b)(4)system, and different batch sizes will be validated.Additionally, your response does not include required supporting documentation such as validation protocols, validation summary reports, equipment qualification documentation, or batch size validation studies. The implementation status remains unclear, as you have not indicated whether proposed corrective actions have been implemented, provided implementation timelines, nor described interim measures during CAPA execution.Furthermore, your CAPA inadequately addresses the repeat nature of this validation deficiency, which typically requires more comprehensive corrective actions than those proposed. While training is mentioned, the response lacks concrete validation methodologies and procedures necessary to ensure process control and product quality. The focus on training alone does not substitute for the development and implementation of actual validation processes. Your firm’s response should include a revised CAPA that includes specific validation protocols with supporting documentation, clear implementation timelines, and comprehensive measures to prevent recurrence of these validation deficiencies.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).For example: Your firm has not implemented your(b)(4)System procedure, SOP-034, Ver. 0, 01/16/2025, to maintain records for the conduct of required(b)(4)and(b)(4)monitoring of your(b)(4)system. Records requested during the inspection for eight(b)(4)of monitoring show your firm did not maintain water monitoring records for three of the eight(b)(4)in January, February, and March 2025, which is not consistent with the requirements of your procedure. Five(b)(4)monitoring records in January, February, March, and April 2025, reviewed during the inspection, similarly showed(b)(4)weekly monitoring records are incomplete, where(b)(4)monitoring is not recorded as required by procedure.Your Quality Control Manager stated that(b)(4). However, your firm has not demonstrated that this sampling plan adequately represents the microbiological quality of your(b)(4)system monitoring and is sufficient to detect microbial contamination. Additionally, your procedure SOP-034 lacks essential requirements including testing frequency, sample quantities, identification of viable organisms in the manufacturing process, and microbial count action levels. This is a continued and repeated violation from the previous inspection of your firm’s facility.We reviewed your firm’s response and concluded that it is not adequate. While CAPA-25-004 was initiated to address(b)(4)system monitoring and records were provided demonstrating(b)(4)and(b)(4)monitoring activities, the response fails to identify the root cause of previous monitoring failures or provide a comprehensive plan to prevent recurrence. Your firm attributes the issue to training deficiencies but does not explain why training was inadequate or demonstrate that additional training will effectively address the underlying problem.Your firm’s response should provide for establishing microbiological sampling requirements at appropriate frequencies, update SOP-034 to include comprehensive monitoring requirements (the current version remains unchanged from the inspection and still lacks microbiological testing requirements), ensure consistent performance and documentation of all required monitoring, and address the recurring nature of this observation with more urgent corrective actions. CAPA-25-004 remains ongoing and has been extended 60 days per CAPA-EXT-002, as of your June 18, 2025, response.4. Failure to validate computer software for its intended use according to an established protocol when computers or automated data processing systems are used as part of production or the quality system, as required by 21 CFR 820.70(i).For example: Your firm has not validated the Excel spreadsheet for its intended use of calculating the final concentration of benzalkonium chloride in your manufactured, finished products, Inverness Ear Care Solution (0.09%) and Inverness Ear Care Antiseptic (0.12%). Not validating the formulation software for each different batch size can result in super-potent or sub-potent finished products that may present a risk to health for the users of the product, including adverse tissue reactions, immunological reactions, transmission of pathogens and parasites, toxicity, delayed wound healing, infection, microbial growth or product degradation during storage, and inability to remove wound debris and foreign materials. Scaling batch size up or down can have an intrinsic effect on the finished product chemical and physical properties. This is a continued and repeated deficiency from previous inspection of your firm’s facility.The adequacy of your firm's response cannot be determined at this time. While CAPA-25-007 was provided to include Excel Validation Protocol (TP-25-001) and Excel Validation Report (TP-25-001-TR) under SOP-021-B, to address the Excel software and formula spreadsheet, your response is incomplete. Although the Excel Validation Report demonstrates that your firm initiated software validation of the Excel formula spreadsheet, you have not provided confirmatory testing (assay) data to verify that the Inverness Ear Care Solution (0.09%) and Inverness Ear Care Antiseptic (0.12%) products manufactured using the newly validated Excel formula spreadsheet meet the established specifications outlined in SOP-021-B, Section 2, Product Characteristics.5. Failure to ensure that all inspection, measuring, and test equipment, including mechanical, automated, or electronic inspection and test equipment, is suitable for its intended purposes and is capable of producing valid results, as required by 21 CFR 820.72(a).For example: Your firm has not adequately implemented SOP-017 (Control of Measuring and Monitoring Devices, Ver. 0, 09/05/2024) to ensure scales used for weighing water in mixing Tanks C and D are calibrated within the appropriate working range. The last(b)(4)batches of Ear Care Solution produced in these tanks had a final batch size of(b)(4)lbs., yet calibration records show the scales were only calibrated for a weight range of(b)(4)lbs. This inadequate calibration range may result in super-potent or sub-potent finished products, presenting health risks to users.We reviewed your firm’s response and concluded that it is not adequate. While CAPA-25-008 was provided to address scale calibration for(b)(4)and(b)(4)under SOP-017, and your firm acknowledges the importance of ensuring correct calibration ranges for tank weights, you have not provided evidence that the scales are calibrated within the batch size working range. Your firm’s response also lacks a documented rationale demonstrating that calibrating the scales for(b)(4)and(b)(4)up to only(b)(4)lbs. is acceptable for(b)(4)lb. batches. It is also concerning that your firm did not evaluate the potential that the use of the scale outside the calibrated range could have resulted in distribution of nonconforming product. The response merely states that calibration certificates were located, and calibration status was confirmed for all equipment, without addressing the fundamental calibration range deficiency.6. Failure to establish procedures to control product that does not conform to specified requirements, as required by 21 CFR 820.90(a).For example: During the investigator’s walk-through of your firm’s finished-goods, inventory area, multiple examples of non-conforming product, i.e., mis-labeled, non-labeled, expired, and leaking products were observed held for sale and ready for shipment to customers. Your firm failed to implement your Control of Nonconformances procedure, SOP-022, to properly quarantine and control the affected products because your firm has no identified and dedicated quarantine area to segregate and maintain nonconforming product from finished product inventory for determining product final disposition.We reviewed your firm’s response and concluded that it is not adequate. CAPA-25-009 was provided to address control of non-conforming product. While this CAPA acknowledges the lack of a quarantine area and product non-conformance issues and proposes establishing a dedicated quarantine area with personnel retraining on SOP-022 (Control of Nonconformances), it lacks essential elements including specific corrective actions for each non-conformance type (i.e., unlabeled bottles, expired products, incorrect components, leaking bottles), preventive measures to avoid recurrence, and how ongoing compliance with SOP-022 will be ensured, including specific actions for implementing and maintaining the quarantine area, and establishing a plan for measuring corrective action effectiveness.UDI LabelingThe inspection revealed that your products would be misbranded within the meaning of section 502(c) of the Act, 21 U.S.C. § 352(c), because a word, statement, or other information required by or under authority of section 519 of the Act, 21 U.S.C. § 360i, to appear on the label or labeling of the products was not prominently placed thereon with such conspicuousness (as compared with other words, statements, designs, or devices, in the labeling) and in such terms as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use. In particular, 21 CFR 801.20(a) – which was promulgated under authority of section 519 of the Act, among other provisions – requires, with exceptions not relevant here, that the label and package bear a unique device identifier (UDI) that meets the requirements of 21 CFR Part 801, subpart B, and 21 CFR Part 830. The labels of the Inverness Home Ear Piercing Kit, Inverness Ear Care Solution (0.09%), and Inverness Ear Care Antiseptic (0.12%) products do not bear such a UDI.Specifically, the labels for the Inverness Home Ear Piercing Kit, Inverness Ear Care Solution (0.09%), and Inverness Ear Care Antiseptic (0.12%) products do not include a device identifier within the meaning of 21 CFR 801.3 or 830.3, and there is no UDI presented in easily readable plain-text on the label (see 21 CFR 801.40(a)(1)), and there is no UDI presented in machine-readable form that uses automatic identification and data capture (AIDC) technology on the label (see 21 CFR 801.40(a)(2)).We reviewed your firm’s response and concluded that it is not adequate. Your firm provided CAPA-25-014, which promises to establish UDIs and update all labels by June 13, 2025. In addition, your firm provided evidence of acquiring DIs for Ear Care Solution, Ear Care Antiseptic, Inverness Disposable Nose Piercing Instrument, and Inverness Reusable Ear Piercing Instruct from GS1. However, your firm has not provided information about the design of the new labels and examples that include valid UDIs.Submitting Required Information to GUDIDIn addition, the Inverness Home Ear Piercing Kit, Inverness Ear Care Solution (0.09%), and Inverness Ear Care Antiseptic (0.12%) products are 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 these products. In particular, 21 CFR 830.300(a) and 830.320(b) – both of which were promulgated under section 519 of the Act, among other provisions – require that the labeler 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 these products with the intent that they be commercially distributed without any subsequent replacement or modification of the label. Richline Group, Inc. is therefore a “labeler” within the meaning of 21 CFR 830.3 and has not submitted to GUDID any information required by 21 CFR Part 830, subpart E, respecting these products.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).We reviewed your firm’s response and concluded that it is not adequate. Though CAPA-25-014 mentions FDA 483 Observation 16 regarding GUDID reporting, the analysis, root cause, and solution do not address the need for GUDID reporting.Medical Device Reporting (MDR)We recommend that your firm establish an active Electronic Submissions Gateway (ESG) production account for the electronic submission of MDR reports, so that your firm can comply with 21 CFR 803.12(a). FDA verified that, as of June 11, 2025, your firm does not have such an account. Information about the ESG can be found at: How to Enroll in eMDR Program | 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 devices will not be approved until the violations have been addressed. Should FDA determine that your products or facilities do not meet the requirements of the Act, requests for Certificates to Foreign Governments (CFG) may not be granted.Please notify this office in writing within fifteen business days from the date you receive this letter of the specific steps your firm has taken to address the noted violations, as well as an explanation of how your firm plans to prevent these violations, or similar violations, from occurring again. Include documentation of the corrections and/or corrective actions (which must address systemic problems) that your firm has taken. If your firm’s planned corrections and/or corrective actions will occur over time, please include a timetable for implementation of those activities. If corrections and/or corrective actions cannot be completed within fifteen business days, state the reason for the delay and the time within which these activities will be completed. Your firm’s response should be comprehensive and address any violations included in this Warning Letter. If you believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration as part of your response.Your firm’s response should be sent to: Melissa Michurski, Assistant Director, at CDRHEnforcement@fda.hhs.gov. Refer to CMS # 712818 when replying. If you have any questions about the contents of this letter, please contact Salvatore Randazzo, Compliance Officer, at 407-475-4712 or salvatore.randazzo@fda.hhs.gov.Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your firm’s facility. It is your firm’s responsibility to ensure compliance with applicable laws and regulations administered by FDA. The specific violations noted in this letter and in the Inspectional Observations, FDA 483, issued at the close of the inspection may be symptomatic of serious problems in your firm’s manufacturing and quality management systems. Your firm should investigate and determine the causes of any violations and take prompt actions to address any violations and bring the products into compliance.Sincerely,/S/Matthew G. HillebrennerDeputy DirectorOffice of Product Evaluation and QualityCenter for Devices and Radiological Health

行政处罚案件信息摘要行政处罚决定书文号湘药监药罚〔2025〕44号当事人湖南**医药有限公司组织机构代码91430111682820734A法定代表人方荣国违法行为类型销售劣药二十五味珊瑚丸案行政处罚内容依据《中华人民共和国药品管理法》第一百一十七条第一款及《中华人民共和国药品管理法实施条例》第七十五条的规定，对当事人给予如下行政处罚：没收违法所得4318.9元。作出行政处罚决定的行政机关湖南省药品监督管理局作出行政处罚决定的日期2025年9月18日行政处罚履行方式和期限收到本行政处罚决定书立即执行备注

Delivery Method:VIA UPS and Electronic MailReference #:CBER 25-713252Product:BiologicsRecipient:George KaltnerChief Executive Officer and PresidentCellebration LLC(b)(6)San Juan00909Puerto Ricogeorge@cellebration.comIssuing Office:Center for Biologics Evaluation and Research (CBER)United StatesWARNING LETTERSeptember 12, 2025CBER 25-713252Dear Mr. Kaltner:The United States Food and Drug Administration (FDA) reviewed your company’s website, https://www.cellebration.com/conditions (last visited September 2025), through which your company offers cellular products derived from cord blood for use in the treatment or prevention of various diseases or conditions, such as autism, cerebral palsy, chronic pain, colitis, Crohn’s disease, degenerative disease, gout, liver cirrhosis, multiple sclerosis, neurological disorders, Parkinson’s disease, spine and disc conditions, sports injuries, and arthritis. As a result, your products are drugs as defined in section 201(g)(1) of the FD&C Act, 21 U.S.C. § 321(g)(1), and biological products as defined in section 351(i) of the PHS Act, 42 U.S.C. § 262(i).It is a prohibited act under section 301(e) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. § 331(e), to refuse to permit access to or copying of any record as required by section 704(a) of the FD&C Act, 21 U.S.C. § 374(a).Under section 704(a)(4) of the FD&C Act, 21 U.S.C. § 374(a)(4), you are required to provide within a reasonable timeframe, within reasonable limits, and in a reasonable manner, requested records or information that FDA may inspect under section 704. However, your firm failed to comply with this requirement.Specifically, on October 18, 2024, FDA sent an electronic request for records and other information pursuant to section 704(a)(4) of the FD&C Act to the above address. On November 5, 2024, you requested a 30-day extension to the submission deadline. You noted the additional time would allow your firm to “work closely with legal counsel to meet all standards and respond comprehensively.” On November 13, 2024, FDA approved your extension request. On January 3, 2025, your firm requested a second 30-day extension due to the holidays and an unexpected illness. FDA approved this request on January 10, 2025. As you failed to answer our initial request for records, we sent a second request via e-mail on April 23, 2025. You indicated on April 28, 2025, that you had sent your response weeks earlier; however, our records reflect that no such response was received. On May 19, 2025, FDA requested that you resend the response referenced in your email. In response, you stated that you were unclear about what we were seeking. On May 21 and May 28, 2025, we sent additional follow-up emails again asking you to provide the requested records.FDA has not received a response to its request to date even though FDA’s request and follow-up communications sufficiently and clearly described the records sought. Your refusal to permit access to or copying of any record required by section 704(a), 21 U.S.C. § 374(a), violates section 301(e) of the FD&C Act, 21 U.S.C. § 331(e).In response to this letter, we again ask you to provide the information and records requested by FDA pertaining to Cellebration, located at(b)(6)San Juan, PR, 00909, and your cellular products derived from cord blood.Your firm should take prompt action to address this matter. This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address this matter may result in legal action being initiated by FDA without further notice, including, without limitation, seizure and/or injunction.We request that you respond in writing within fifteen (15) working days from your receipt of this letter. If you cannot address this matter within fifteen (15) working days, please explain the reason for your delay and the timeframe for completion. If you do not believe your products are 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 CBERDCMRecommendations@fda.hhs.gov.Sincerely,/S/Melissa J. MendozaDirectorOffice of Compliance and Biologics QualityCenter for Biologics Evaluation and ResearchCc:George KaltnerCellebration Regeneration Limited Liability Company15 Ave. Munoz Rivera, Suite 103Paseo Caribe, San Juan, PR 00901

Delivery Method:VIA EMAIL WITH READ RECEIPTProduct:DrugsRecipient:Mr. John YiGeneral ManagerJanssen Vaccines Corp., A Johnson & Johnson Company23, Harmony-ro 303beon-gilYeonsu-guIncheon22014South KoreaIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesWarning Letter320-25-95July 18, 2025Dear Mr. Yi:The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, Janssen Vaccines Corp., A Johnson & Johnson Company (Janssen), FEI 3012637764, at 23, Harmony-ro 303beon-gil, Yeonsu-gu, Incheon, from November 11 to 19, 2024.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 product is adulterated within the meaning of section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 351(a)(2)(B).We reviewed your December 10, 2024, response to our Form FDA 483 in detail and acknowledge receipt of your subsequent correspondence.During our inspection, our investigator observed specific violations including, but not limited to, the following.1. Your firm failed to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, whether or not the batch has already been distributed (21 CFR 211.192).You failed to conduct adequate investigations of recurring complaints received between November 13, 2023, and November 8, 2024, for(b)(4)stopper(b)(4)associated with(b)(4)injection,(b)(4)mg/(b)(4)mL. Several complaints included reports of stopper(b)(4)events associated with two or more vials, including one complaint that reported stopper(b)(4)in four vials from the same batch.Your investigations, which included review of batch records, did not identify any “… relevant issue recorded which might have impacted the product quality and could lead to the investigated defect…,” and you add that “The manufacturing process is in a validated state of control and is capable to consistently meet specifications.”However, the investigations did not include a comprehensive assessment of human use, manufacturing, and stability factors that could increase the risk of stopper(b)(4)during use. In addition, you did not always sufficiently pursue collection of relevant samples of vials from complainants.In response to the stopper(b)(4)reports, you submitted a(b)(4)that included language instructing(b)(4)to “…(b)(4)…”Your firm had performed an assessment that identified several human use factors that may contribute to stopper(b)(4), including(b)(4). The assessment concluded “…(b)(4).”The(b)(4)revisions also included instructions to(b)(4).”Your response is inadequate. You did not adequately investigate other human use factors, such as the effect of(b)(4). You also lacked investigation of the potential effects of manufacturing factors including your stopper processing methods (e.g., assembly steps for the container-closure system).We acknowledge that your firm indicates plans to undertake further risk assessment activities.Revised(b)(4)cannot substitute for ensuring drugs products meet all required quality attributes and remain suitable for their intended use through their labeled expiry.In response to this letter, provide:A comprehensive assessment of your overall system for investigating deviations, discrepancies, and complaints. 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, corrective action, and preventive action (CAPA) effectiveness, quality unit (QU) oversight, and written procedures including those associated with identifying the existence of, obtaining, and evaluating relevant samples. Address how your firm will ensure all phases of investigations are appropriately conducted.Provide your detailed plan to further assess the repeated reports of stopper(b)(4)associated with(b)(4). The plan should explain how you will assess(b)(4)over the labeled expiry period and include, but not be limited to, the following:o An analysis of the comparative effect(s) of the stopper sterilization processes employed at the Janssen facility and the(b)(4)facility where the drug is manufactured.o An analysis of the comparative effect(s) of container closure system assembly processes ((b)(4)), including equipment and operating parameters, employed at the Janssen facility and the(b)(4)facility.o An analysis of the relative risk(s) of(b)(4)associated with various human use factors, including the effect of(b)(4).o An analysis of any other raw material, processing, or use factors that may contribute to stopper(b)(4).A retrospective review of all stopper(b)(4)complaints for the last 3 years and a report summarizing the review’s findings, including for each stopper(b)(4)complaint:o Determine whether the scientific justification and evidence relating to the identified root cause(s) of each stopper(b)(4)report were adequately documented.o Determine whether relevant complaint samples were available, and if insufficient attempts were made for their return to Janssen for investigation, the root cause(s) for not adequately pursuing their return.o For all complaint investigations found by the retrospective review to be deficient, 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 identified CAPA.An independent, comprehensive review of your company’s complaint handling program that identifies any deficiencies and corresponding CAPA.2. Your firm’s quality unit failed to exercise its responsibility to ensure drug products manufactured are in compliance with CGMP, and meet established specifications for identity, strength, quality, and purity (21 CFR 211.22).Your quality unit does not consistently follow your procedures for the submission of regulatory notification of product quality defects. For example, your procedure for the preparation of “Advisory Notice” documents, including Biological Product Deviation Reports (BPDRs), includes instructions for your quality unit to “[e]scalate and/or report quality and compliance issues that may require Regulatory Body notification to Segment Management and ensure that quality issue management process is followed for decisions regarding issues that have potential to lead to an Advisory Notice.”You received two or more stopper(b)(4)complaints for each of(b)(4)batches of(b)(4), between November 13, 2023, and November 8, 2024. Responsible officials did not adequately discharge their duties to ensure escalation and sufficient action on these complaints in accordance with your procedure.Timely submission of BPDRs to regulatory authorities facilitates awareness and evaluation of potentially hazardous product defects. Notably, your comparable procedure for Field Alert Reports (FARs) requires the submission of a FAR upon receipt of “[t]wo or more complaints with the same confirmed defect… with or without a signal.” Additionally, your procedure “Advisory Notice US FDA Form 3911 (Drug Notification and Health Authority (HA) Communication-Reportable Events Procedure” requires the submission of a BPDR “… as soon as possible, but no more than(b)(4)from the date that information is acquired reasonably suggesting that a reportable incident occurred.”We acknowledge that your firm ultimately submitted a BPDR for the stopper(b)(4)complaints, dated December 10, 2024, and your subsequent updates of that BDPR. We also acknowledge your commitment to update procedures associated with the submission of BPDRs.Your response is inadequate. You identified a root cause for failing to submit a BPDR in accordance with your procedures as “…the recurring complaints were not considered reportable under the current procedure… because the definition of confirmed is related only to cases where the product quality is determined not meeting manufacturing standards or specifications.” Although you proposed multiple CAPA to address this root cause and to assess other products in your corporate portfolio for stopper(b)(4)complaints, you did not propose a retrospective review of complaints implicating marketed product quality to identify additional instances in which a BPDR should have been submitted.In response to this letter, provide:A retrospective review of product quality complaints received within the last 3 years for all Janssen products to identify any circumstances in which your firm did not submit a FAR or BPDR, as applicable, when such a report should have been submitted.A comprehensive assessment and remediation plan to ensure your QU is given the authority and resources to effectively function. The assessment should also include, but not be limited to:o A determination of whether procedures used by your firm are robust and appropriateo Provisions for QU oversight throughout your operations to evaluate adherence to appropriate practiceso A complete and final review of each batch and its related information before the QU disposition decisiono Oversight and approval of investigations and discharging of all other QU duties to ensure identity, strength, quality, and purity of all productsConclusionThe violations cited in this letter are not intended to be an all-inclusive list of violations that exist at your facility. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations.If you are considering an action that is likely to lead to a disruption in the supply of drugs produced at your facility, FDA requests that you contact CDER’s Drug Shortages Staff immediately, at drugshortages@fda.hhs.gov, so that FDA can work with you on the most effective way to bring your operations into compliance with the law. Contacting the Drug Shortages Staff also allows you to meet any obligations you may have to report discontinuances or interruptions in your drug manufacture under 21 U.S.C. 356C(b). This also allows FDA to consider, as soon as possible, what actions, if any, may be needed to avoid shortages and protect the health of patients who depend on your products.Correct any violations promptly. FDA may withhold approval of new applications or supplements listing your firm as a drug manufacturer until any violations are completely addressed and we confirm your compliance with CGMP. We may re-inspect to verify that you have completed corrective actions to any violations.Failure to address any violations may also result in the FDA refusing admission of articles manufactured at Janssen Vaccines Corp., A Johnson & Johnson Company, 23, Harmony-ro 303beon-gil, Yeonsu-gu, Incheon, into the United States under section 801(a)(3) of the FD&C Act, 21 U.S.C. 381(a)(3). Articles under this authority that appear to be adulterated may be detained or refused admission, in that the methods and controls used in their manufacture do not appear to conform to CGMP within the meaning of section 501(a)(2)(B) of the FD&C Act, 21 U.S.C. 351(a)(2)(B).This letter notifies you of our findings and provides you an opportunity to address the above deficiencies. After you receive this letter, respond to this office in writing within 15 working days. Specify what you have done to address any violations and to prevent their recurrence. In response to this letter, you may provide additional information for our consideration as we continue to assess your activities and practices. If you cannot complete corrective actions within 15 working days, state your reasons for delay and your schedule for completion.Send your electronic reply to CDER-OC-OMQ-Communications@fda.hhs.gov. Identify your response with FEI 3012637764 and ATTN: Jason F. Chancey.Sincerely,/S/Francis Godwin DirectorOffice of Manufacturing Quality Office of ComplianceCenter for Drug Evaluation and ResearchCc: Christopher Milano, Vice President, Supply Chain Quality Johnson & Johnson Innovative Medicines

Product:DrugsRecipient:cheaptrustedpharmacy.comTurks & Caicos IslandsIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesFROM: The United States Food and Drug AdministrationRE: Notice of Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the InternetDATE: July 29, 2025WARNING LETTERThis is to advise you that the United States (U.S.) Food and Drug Administration (FDA) recently reviewed your website at the Internet address www.cheaptrustedpharmacy.com and has observed that your website introduces into interstate commerce misbranded and unapproved new drugs in violation of sections 301(a), 301(d), 503(b), and 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) [21 U.S.C. §§ 331(a), 331(d), 353(b), and 355(a)]. FDA has observed that www.cheaptrustedpharmacy.com introduces into interstate commerce certain drugs for which the FDA-approved version is subject to a Risk Evaluation and Mitigation Strategy (REMS)1program, is an opioid, semaglutide, an injectable, and/or is indicated to treat serious conditions such as HIV/AIDS or cancer.There are inherent risks to consumers who purchase unapproved new drugs and misbranded drugs. Unapproved new drugs do not carry the same assurances of safety and effectiveness as those drugs subject to FDA oversight. Drugs that have circumvented regulatory safeguards may be contaminated, counterfeit, contain varying amounts of active ingredients, or contain different ingredients altogether.Opioid addiction and abuse have created an immense public health crisis, and the death toll is staggering. Given the severity of the opioid epidemic, the easy availability of opioids via the Internet poses significant risks to U.S. consumers. Furthermore, injectable drug products can pose a serious risk of harm to users because they bypass many of the body’s natural defenses against toxic ingredients, toxins, or dangerous organisms that can lead to serious and life-threatening conditions such as septicemia or sepsis. Accordingly, FDA requests that www.cheaptrustedpharmacy.com cease offering any unapproved and misbranded drugs for sale to U.S. consumers. This is critical to shielding the American public from harm.Unapproved New Drugs:Certain products offered for sale by www.cheaptrustedpharmacy.com are drugs within the meaning of section 201(g) of the FD&C Act [21 U.S.C. § 321(g)] because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or because they are intended to affect the structure or function of the body. These drugs are also new drugs as defined by section 201(p) of the FD&C Act [21 U.S.C. § 321(p)], because they are not generally recognized as safe and effective for their labeled uses. With certain exceptions not applicable here, new drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from FDA, as described in section 505(a) of the FD&C Act [21 U.S.C. § 355(a)]. No approved applications pursuant to section 505 of the FD&C Act are in effect for these products. Accordingly, their introduction or delivery for introduction into interstate commerce violates sections 301(d) [21 U.S.C. § 331(d)] and 505(a) of the FD&C Act.On www.cheaptrustedpharmacy.com you offer for sale lenalidomide marketed as “Evermide 10 (Lenalidomide)” and “Evermide 25 (Lenalidomide)”. Evidence obtained from your website establishing that these products are drugs intended for human use (as defined in 21 CFR 201.128) includes the claim “Indication: Multiple myeloma, Lepra reaction” and categorization “Life Saving Drugs / Anti Cancer”. While there are FDA-approved versions of lenalidomide on the market in the U.S., there are no approved drug applications pursuant to section 505 of the FD&C Act in effect for “Evermide 10 (Lenalidomide)” and “Evermide 25 (Lenalidomide)” offered by www.cheaptrustedpharmacy.com. Currently there are lenalidomide products that are FDA-approved for the U.S. market and they are only available pursuant to a prescription from a licensed practitioner. FDA-approved lenalidomide, including products marketed under the brand name REVLIMID, are indicated for the treatment of certain adult patients with multiple myeloma and myelodysplastic syndromes. Certain FDA-approved lenalidomide products are also approved for the treatment of mantle cell lymphoma, follicular lymphoma, and marginal zone lymphoma. FDA-approved lenalidomide bears a boxed warning, commonly referred to as a “black box warning,” which is the strongest warning FDA requires, indicating that the drug carries a significant risk of serious or even life-threatening adverse effects. The boxed warning addresses the risk of embryo-fetal toxicity (including birth defects and embryo-fetal death), hematologic toxicity (neutropenia and thrombocytopenia), and venous and arterial thromboembolism (deep vein thrombosis and pulmonary embolism).On www.cheaptrustedpharmacy.com you offer for sale combination abacavir, dolutegravir, and lamivudine marketed as “Inbec (Abacavir/Dolutegravir/Lamivudine)”. Evidence obtained from your website establishing that this product is a drug intended for human use (as defined in 21 CFR 201.128) includes the claim “Indication: HIV infection” and categorization “Life Saving Drugs / HIV-Aids [sic]”. While there are FDA-approved versions of combination abacavir, dolutegravir, and lamivudine drug products on the market in the U.S., there are no approved drug applications pursuant to section 505 of the FD&C Act in effect for “Inbec (Abacavir/Dolutegravir/Lamivudine)” offered by www.cheaptrustedpharmacy.com. Currently there are two combination abacavir, dolutegravir, and lamivudine products that are FDA-approved for the U.S. market and these products are only available pursuant to a prescription from a licensed practitioner. FDA-approved combination abacavir, dolutegravir, and lamivudine marketed under the brand names TRIUMEQ and TRIUMEQ PD are indicated for the treatment of HIV-1 infection in adults and in certain pediatric patients. FDA-approved TRIUMEQ and TRIUMEQ PD bear a boxed warning addressing the risks of serious and sometimes fatal hypersensitivity reactions and severe acute exacerbations of Hepatitis B.On www.cheaptrustedpharmacy.com you offer for sale injectable semaglutide marketed as “Semaglutide 0.5mg,” “Semaglutide 1mg,” “Semanize 4 Mg (Semaglutide),” and “Semanize 8 Mg (Semaglutide).” Evidence obtained from your website establishing that these products are drugs intended for human use (as defined in 21 CFR 201.128) includes the claim “Indication: Type 2 diabetes” and categorization “Diabetes Care / Diabetes Type 2”. While there are FDA-approved versions of semaglutide on the market in the U.S., there are no approved drug applications pursuant to section 505 of the FD&C Act in effect for the “Semaglutide 0.5mg,” “Semaglutide 1mg,” “Semanize 4Mg (Semaglutide),” and “Semanize 8 Mg (Semaglutide)” offered by www.cheaptrustedpharmacy.com. Currently there are three semaglutide products that are FDA-approved for the U.S. market and these products are only available pursuant to a prescription from a licensed practitioner. FDA-approved semaglutide injection marketed under the brand name OZEMPIC is indicated as an adjunct to diet and exercise to improve glycemic control in individuals with type 2 diabetes mellitus and to reduce the risk of major adverse cardiovascular events in adults with type 2 diabetes mellitus and established cardiovascular disease. FDA-approved semaglutide injection marketed under the brand name WEGOVY is indicated as an adjunct to a reduced calorie diet and increased physical activity for chronic weight management in certain adult and pediatric patients. FDA-approved semaglutide tablets marketed under the brand name RYBELSUS are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. FDA-approved semaglutide products bear a boxed warning addressing the risk of thyroid C-cell tumors.On www.cheaptrustedpharmacy.com you offer for sale tapentadol, an opioid, marketed as “Noosanta 100Mg (Tapentadol),” “Noosanta 200Mg (Tapentadol),” and “Noosanta 250mg (Tapentadol).” Evidence obtained from your website establishing that these products are drugs intended for human use (as defined in 21 CFR 201.128) includes the claim “Indication: Pain Reliever” and categorization under “Pain / Tapentadol”. While there are FDA-approved versions of tapentadol on the market in the U.S., there are no approved drug applications pursuant to section 505 of the FD&C Act in effect for the “Noosanta 100Mg (Tapentadol),” “Noosanta 200Mg (Tapentadol),” and “Noosanta 250mg (Tapentadol)” offered by www.cheaptrustedpharmacy.com. Currently, there are two tapentadol products that are FDA-approved for the U.S. market and these products are only available pursuant to a prescription from a licensed practitioner. FDA-approved tapentadol marketed under the brand name NUCYNTA is indicated for the management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. FDA-approved tapentadol marketed under the brand name NUCYNTA ER is indicated for the management of severe and persistent pain, including neuropathic pain associated with diabetic peripheral neuropathy, that requires an extended treatment period with a daily opioid analgesic and for which alternative treatment options are inadequate. FDA-approved tapentadol products bear a boxed warning addressing risks including addiction, abuse, misuse, life-threatening respiratory depression (breathing problems), and neonatal opioid withdrawal syndrome (withdrawal symptoms in newborn baby). In addition, when tapentadol is taken in conjunction with other central nervous system depressants, including alcohol and benzodiazepines, use may result in coma or death.Misbranded Drugs:A drug is misbranded under section 502(f)(1) of the FD&C Act [21 U.S.C. § 352(f)(1)] if its labeling fails to bear adequate directions for use. “Adequate directions for use” means directions under which a layperson can use a drug safely and for the purposes for which it is intended (see 21 CFR 201.5). Prescription drugs, as defined in section 503(b)(1) of the FD&C Act [21 U.S.C. § 353(b)(1)] include those that, because of their toxicity or other potentiality for harmful effect, and/or the method of their use, and/or the collateral measures necessary for their use, are not safe for use except under supervision of a practitioner licensed by law to administer them. Prescription drugs, as defined in section 503(b)(1)(A) of the FD&C Act, can be used safely only at the direction, and under the supervision, of a licensed practitioner.Because the aforementioned drugs are prescription drugs intended for conditions that are not amenable to self-diagnosis and treatment by a layperson, adequate directions cannot be written such that a layperson can use the products safely for their intended use. Consequently, the labeling for these drugs fail to bear adequate directions for use, causing them to be misbranded under section 502(f)(1) of the FD&C Act. In addition, because these drugs are not approved in the U.S., they are also not exempt under 21 CFR 201.115(a) from the requirements of section 502(f)(1) of the FD&C Act. By offering these drugs for sale to U.S. consumers, www.cheaptrustedpharmacy.com is causing the introduction of misbranded drugs into interstate commerce in violation of section 301(a) of the FD&C Act [21 U.S.C. § 331(a)].FDA is sending this warning letter to www.cheaptrustedpharmacy.com because of the inherent risks to consumers who purchase misbranded and unapproved new drugs. This letter is not intended to identify all the ways in which your products or operations might be in violation of the law. It is your responsibility to ensure that all products you offer for sale are in compliance with the FD&C Act and its implementing regulations. You should take prompt action to address any violations of the FD&C Act (which may include the offer for sale of similarly misbranded and/or unapproved new drugs other than the drugs noted above). We advise you to review your websites, product labels, and other labeling and promotional materials to ensure that you are not misleadingly representing your products as safe and effective for a use for which they have not been approved by FDA and that you are not distributing misbranded and unapproved drug products in violation of the FD&C Act.Please notify this office in writing within 15 working days describing the specific steps you have taken to address any violations and to prevent their recurrence. Include an explanation of each step being taken to remedy and prevent the recurrence of any violations, as well as copies of related documentation. Failure to adequately address this matter may result in legal action, including, without limitation, seizure, and injunction, without further notice. If you cannot complete corrective action within 15 working days, state the reason for the delay and the time within which you will complete the corrections. This letter notifies you of our concerns and provides you with an opportunity to address them. 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 within 15 working days.If you are not located in the U.S., please note that products that appear to be misbranded or unapproved new drugs may be detained or refused admission. We may advise the appropriate regulatory officials in the country from which you operate that your products referenced above appear to be unapproved and misbranded productsthat cannot be legally sold to consumers in the U.S.Please direct your response and any inquiries to FDA at FDAInternetPharmacyTaskForce-CDER@fda.hhs.gov.Sincerely,/S/Sangeeta Vaswani Chatterjee, Pharm.D.Acting DirectorOffice of Drug Security, Integrity, and ResponseOffice of ComplianceCenter for Drug Evaluation and Research___________________1REMS is a drug safety program that FDA can require for certain medications with serious safety concerns to help ensure the benefits of the medication outweigh its risks.

Product:DrugsRecipient:motionpharmacy.comUnited StatesIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesFROM: The United States Food and Drug AdministrationRE: Notice of Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the InternetDATE: September 10, 2025WARNING LETTERThis is to advise you that the United States (U.S.) Food and Drug Administration (FDA) recently reviewed your website at the Internet address www.motionpharmacy.com and has observed that your website introduces into interstate commerce misbranded and unapproved new drugs in violation of sections 301(a), 301(d), 301(k), 503(b), and 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) [21 U.S.C. §§ 331(a), 331(d), 331(k), 353(b), and 355(a)].As discussed below, FDA has observed that www.motionpharmacy.com introduces into interstate commerce unapproved and misbranded opioids. Opioid addiction and abuse have created an immense public health crisis, and the death toll is staggering. Given the severity of the opioid epidemic, the easy availability of opioids via the Internet poses significant risks to U.S. consumers.FDA has also observed that www.motionpharmacy.com introduces into interstate commerce unapproved and misbranded benzodiazepines. Benzodiazepines are drug products with an acknowledged potential for abuse, and it is important to address the public health impact of their nonmedical use. Benzodiazepine nonmedical use is widespread, and individuals frequently co‐use benzodiazepines with alcohol, prescription opioids, and illicit drugs. Associated harms of benzodiazepine nonmedical use are substantial but occur primarily when people use benzodiazepines in combination with other drugs. Further, in cases where benzodiazepines were co‐used with other substances, medical outcomes are typically more severe than in cases involving benzodiazepines alone. Polysubstance overdose deaths account for the vast majority of overdose deaths documenting involvement of benzodiazepines.Additionally, FDA has observed that www.motionpharmacy.com introduces into interstate commerce unapproved and misbranded Schedule II stimulants. Schedule II stimulants have an acknowledged high potential for abuse, and it is important to address the public health impact of their diversion and nonmedical use. Diversion is the primary source of prescription stimulants for nonmedical use, and nonmedical use is most frequent among young adults and college students. Polysubstance use is common among those who use prescription stimulants nonmedically, with individuals frequently co-using illicit drugs and/or prescription opioids. These concerns come against a backdrop of rising mortality from psychostimulant-involved overdoses, which involve illicit stimulants the vast majority of the time, but sometimes involve prescription stimulants. The easy availability of benzodiazepines and Schedule II stimulants via the Internet poses additional significant risks to U.S. consumers.Finally, FDA has observed that www.motionpharmacy.com introduces into interstate commerce unapproved and misbranded semaglutide drug products, including injectable versions. Injectable drug products can pose a serious risk of harm to users because they bypass many of the body’s natural defenses against toxic ingredients, toxins, or dangerous organisms that can lead to serious and life-threatening conditions such as septicemia or sepsis.There are inherent risks to consumers who purchase unapproved new drugs and misbranded drugs. Unapproved new drugs do not carry the same assurances of safety and effectiveness as those drugs subject to FDA oversight. Drugs that have circumvented regulatory safeguards may be contaminated, counterfeit, contain varying amounts of active ingredients, or contain different ingredients altogether. Accordingly, FDA requests that www.motionpharmacy.com cease offering any unapproved and misbranded drugs for sale to U.S. consumers. This is critical to shielding the American public from harm.Unapproved New Drugs:Certain products offered for sale by www.motionpharmacy.com are drugs within the meaning of section 201(g) of the FD&C Act [21 U.S.C. § 321(g)] because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or because they are intended to affect the structure or function of the body. These drugs are also new drugs as defined by section 201(p) of the FD&C Act [21 U.S.C. § 321(p)], because they are not generally recognized as safe and effective for their labeled uses. With certain exceptions not applicable here, new drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from FDA, as described in section 505(a) of the FD&C Act [21 U.S.C. § 355(a)]. No approved applications pursuant to section 505 of the FD&C Act are in effect for these products. Accordingly, their introduction or delivery for introduction into interstate commerce violates sections 301(d) [21 U.S.C. § 331(d)] and 505(a) of the FD&C Act.Examples of unapproved opioids you offer for sale on www.motionpharmacy.com, including how these products are marketed on your website and evidence obtained from your website establishing that these products are drugs intended for human use (as defined in 21 CFR 201.128), are listed below:Unapproved opioid:Marketed as:Evidence includes the claim(s):hydrocodone bitartrate and acetaminophen“Hydrocodone”“Vicodine (Hydrocodone)”“Hydrocodone Bitartrate and Acetaminophen Tablets USP NDC 0591-0540-01”“Hydrocodone is a prescription medication at Motion Pharmacy classified as an opioid analgesic, primarily used to manage moderate to severe pain and to relieve coughing when combined with other medications.”hydromorphone hydrochloride (HCl)“Dilaudid”“Hydromorphone (Dilaudid)”“® pms-HYDROmorphone 4 mg”“® HYDROMORPH CONTIN® 4.5 mg”“® HYDROMORPH CONTIN® 8 mg”“® pms-HYDROmorphone 8 mg DIN 00885428”“Dilaudid is the brand name for hydromorphone, a powerful prescription opioid medication at Motion Pharmacy used to treat moderate to severe pain. It is often prescribed for patients who require relief from acute pain, such as post-surgical pain, or for chronic pain when other treatments are ineffective.”oxycodone HCl“Oxycontin”“Oxycontin (Oxycodone ER)”“OxyContin® 10 mg prolonged release tablets”“Oxycodone IR”“Oxycodone Immediate Release”“OxyContin is a prescription opioid pain medication at Motion Pharmacy. It is an extended-release formulation designed to manage severe, ongoing pain that requires around-the-clock treatment. It works by altering how the brain and nervous system perceive pain.”“Oxycodone IR (Immediate Release) at Motion Pharmacy is a potent prescription opioid medication used to relieve moderate to severe pain. It is a short-acting form of oxycodone, designed to provide quick relief from pain by releasing the active ingredient into the bloodstream rapidly.”oxycodone HCl and acetaminophen“Percocets”“DEPALGOS® 20 mg / 325 mg”“Percocet is commonly used to manage acute or chronic pain that cannot be controlled by non-opioid medications alone.”oxymorphone HCl“Oxymorphone”“Opana (Oxymorphone)”“Opana® ER (oxymorphone hydrochloride) Extended-Release Tablets”“Oxymorphone is a powerful prescription opioid analgesic used for the treatment of moderate to severe pain.”promethazine HCl“Promethazine”“Promethazine Syrop”“Promethazine Hydrochloride and Codeine Phosphate Oral Solution”“Promethazine with Codeine Oral Solution”“Wockhardt”“Akorn”“Tris”“Promethazine is an antihistamine commonly used for various medical purposes. It belongs to a class of drugs known as first-generation antihistamines, and it works by blocking the effects of histamine, a substance in the body involved in allergic reactions. It is often prescribed for allergy relief, but it has several other uses due to its sedative, anti-nausea, and anti-motion sickness properties.”While there are FDA-approved versions of hydrocodone bitartrate and acetaminophen, hydromorphone HCl (brand name DILAUDID), oxycodone HCl (brand name OXYCONTIN), oxycodone HCl and acetaminophen (brand name PERCOCET), oxymorphone HCl, and promethazine HCl and codeine phosphate oral solution on the market in the U.S., there are no approved drug applications pursuant to section 505 of the FD&C Act in effect for these drug products offered by www.motionpharmacy.com. Brand names VICODIN (hydrocodone bitartrate and acetaminophen), OPANA (oxymorphone HCl), and OPANA ER (oxymorphone HCl extended release) are discontinued.FDA-approved hydrocodone bitartrate and acetaminophen, hydromorphone HCl (brand name DILAUDID), oxycodone HCl, and oxycodone HCl and acetaminophen (brand name PERCOCET) are each indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. FDA-approved oxycodone HCl extended release (brand name OXYCONTIN) is indicated for the management of severe and persistent pain that requires an extended treatment period with a daily opioid analgesic and for which alternative treatment options are inadequate. FDA-approved oxymorphone HCl is indicated for the management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. FDA-approved oxymorphone HCl extended release is indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. FDA-approved promethazine HCl and codeine phosphate oral solution is indicated for the temporary relief of cough and upper respiratory symptoms associated with allergy or the common cold in patients 18 years of age and older.FDA-approved hydrocodone bitartrate and acetaminophen, hydromorphone HCl (brand name DILAUDID), oxycodone HCl (brand name OXYCONTIN), oxycodone HCl and acetaminophen (brand name PERCOCET), oxymorphone HCl, and promethazine HCl and codeine phosphate oral solution are only available pursuant to a prescription from a licensed practitioner. Furthermore, these drug products each bear a boxed warning, commonly referred to as a “black box warning,” which is the strongest warning FDA requires, indicating that the drug carries a significant risk of serious or even life-threatening adverse effects. This boxed warning addresses risks including addiction, abuse, misuse, life-threatening respiratory depression (breathing problems), neonatal opioid withdrawal syndrome (withdrawal symptoms in newborn baby), and accidental exposure resulting in death. In addition, when these drug products are taken in conjunction with other central nervous system (CNS) depressants, including alcohol and benzodiazepines, use may result in coma or death.Examples of unapproved benzodiazepines you offer for sale on www.motionpharmacy.com, including how these products are marketed on your website and evidence obtained from your website establishing that these products are drugs intended for human use (as defined in 21 CFR 201.128), are listed below:Unapproved benzodiazepine:Marketed as:Evidence includes the claim(s):clonazepam“Clonazepam”“Rivotril (Clonazepam)”“Rivotril® 2 mg tabletta clonazepam 30 db”“Rivotril® tablet”“Rivotril is a brand name for the drug clonazepam, which is a benzodiazepine medication at Motion Pharmacy. It is primarily used to treat seizure disorders, anxiety disorders, and panic attacks. Rivotril works by calming the brain and nerves, which helps to reduce the frequency and severity of seizures and manage symptoms of anxiety.”diazepam“Diazepam”“Valium”“Valium® 10 mg comprimidos”“Diazepam is a medication belonging to the benzodiazepine class, commonly prescribed to treat a range of conditions by calming the central nervous system (CNS). It works by enhancing the effects of gamma-aminobutyric acid (GABA), a neurotransmitter that inhibits brain activity, resulting in a calming and relaxing effect.”estazolam“Estazolam”“Estazolam TZF”“Estazolam is a prescription medication belonging to the benzodiazepine class, commonly used to treat insomnia. It works by enhancing the effects of a neurotransmitter called gamma-aminobutyric acid (GABA) in the brain, which helps to produce a calming effect.”lorazepam“Lorazepam”“Ativan”“Ativan® (Lorazepam) 2 mg”“Lorazepam enhances the effects of gamma-aminobutyric acid (GABA), a neurotransmitter that calms the brain and nervous system. By increasing GABA activity, lorazepam reduces excessive nerve activity, leading to a calming effect”bromazepam“Bromazepam”“BROMAZÉPAM BIOGARAN® 6 mg”“Bromazepam 6 – 1 A Pharma® 6 mg Tabletten”“Bromazepam is a prescription medication belonging to the benzodiazepine class. It is primarily used for the short-term treatment of anxiety disorders, including excessive worry, agitation, and tension.”bromazolam“Bromazolam”“Bromazolam is a benzodiazepine medication that is chemically related to alprazolam (Xanax). It is primarily used for its anxiolytic (anxiety-reducing) and sedative properties. Bromazolam is not widely approved for medical use in many countries, but it has been available in some regions or online markets as a research chemical.”While there are FDA-approved versions of clonazepam (brand name KLONOPIN), diazepam (brand name VALIUM), estazolam, and lorazepam (brand name ATIVAN) on the market in the U.S., there are no approved drug applications pursuant to section 505 of the FD&C Act in effect for these drug products offered by www.motionpharmacy.com. Brand name PROSOM (estazolam) is discontinued. FDA-approved clonazepam (brand name KLONOPIN) is indicated for the treatment of certain seizure disorders and panic disorder with or without agoraphobia as defined in DSM-5. FDA-approved diazepam (brand name VALIUM) is indicated for anxiety disorders, acute alcohol withdrawal symptoms, skeletal muscle spasm relief, and as adjunctive therapy in convulsive disorders. FDA-approved estazolam is indicated for the short-term management of insomnia characterized by difficulty in falling asleep, frequent nocturnal awakenings, and/or early morning awakenings. FDA-approved lorazepam (brand name ATIVAN) is indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety or anxiety associated with depressive symptoms. There are no FDA-approved versions of bromazepam nor bromazolam on the market in the U.S., and there are no approved drug applications pursuant to section 505 of the FD&C Act in effect for bromazepam nor bromazolam offered by www.motionpharmacy.com.FDA-approved clonazepam (brand name KLONOPIN), diazepam (brand name VALIUM), estazolam, and lorazepam (brand name ATIVAN) are only available pursuant to a prescription from a licensed practitioner. Furthermore, these drug products each bear a boxed warning addressing risks including abuse, misuse, addiction, and physical dependence. In addition, the concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death.Examples of unapproved Schedule II stimulants you offer for sale on www.motionpharmacy.com, including how these products are marketed on your website and evidence obtained from your website establishing that these products are drugs intended for human use (as defined in 21 CFR 201.128), are listed below:Unapproved Schedule II stimulant:Marketed as:Evidence includes the claim(s):lisdexamfetamine dimesylate“Vyvanse”“Lisdexamphetamine”“Vyvanse® 50 mg Lisdexamfetamine dimesilate 50 mg”“Vyvanse (generic name: lisdexamfetamine dimesylate) is a prescription medication used to treat Attention Deficit Hyperactivity Disorder (ADHD) in adults and children aged six and older.”methylphenidate HCl“Concerta”“methylphenidate”“methylphenidate hydrochloride”“Concerta (Metilfenidato Clorhidrato) 36 mg”“Concerta XL 36 mg PL 00432/0373”“Ritalin”“Ritalin® LA Methylphenidate hydrochloride AUST R 82958”“Concerta is a prescription medication containing methylphenidate hydrochloride, a stimulant that affects chemicals in the brain and nerves that contribute to hyperactivity and impulse control.”“Ritalin is a prescription medication at Motion Pharmacy is primarily used to treat attention deficit hyperactivity disorder (ADHD) and narcolepsy, a sleep disorder. The active ingredient in Ritalin is methylphenidate, a stimulant that works by affecting certain chemicals in the brain that contribute to impulse control and hyperactivity.”While there are FDA-approved versions of lisdexamfetamine dimesylate and methylphenidate HCl on the market in the U.S., there are no approved drug applications pursuant to section 505 of the FD&C Act in effect for these drug products offered by www.motionpharmacy.com. FDA-approved lisdexamfetamine dimesylate (brand name VYVANSE) is indicated for the treatment of attention deficit hyperactivity disorder (ADHD) in adults and pediatric patients 6 years and older and moderate to severe binge eating disorder in adults. FDA-approved methylphenidate HCl (brand name RITALIN) is indicated for the treatment of ADHD in pediatric patients 6 years and older and adults and narcolepsy. Using the brand name of the drug product RITALIN indicates that this product is intended to treat ADHD and narcolepsy. FDA-approved methylphenidate HCl extended release is indicated for the treatment of ADHD, in pediatric patients 6 to 12 years of age (brand name RITALIN LA) and indicated for the treatment of ADHD in children 6 years of age and older, adolescents, and adults up to the age of 65 (brand name CONCERTA).FDA-approved lisdexamfetamine dimesylate (brand name VYVANSE) and methylphenidate HCl (brand names RITALIN, RITALIN LA, and CONCERTA) are only available pursuant to a prescription from a licensed practitioner. Furthermore, FDA-approved lisdexamfetamine dimesylate (brand name VYVANSE) and methylphenidate HCl (brand names RITALIN, RITALIN LA, and CONCERTA) each bear a boxed warning, addressing risks including abuse, misuse, and addiction. In addition, these drug products can be diverted for non-medical use into illicit channels or distribution. Misuse and abuse of CNS stimulants, including these drug products, can result in overdose and death, and this risk is increased with higher doses or unapproved methods of administration.An example of unapproved semaglutide you offer for sale on www.motionpharmacy.com, including how this product is marketed on your website and evidence obtained from your website establishing that this product is a drug intended for human use (as defined in 21 CFR 201.128), is listed below:Unapproved semaglutide:Marketed as:Evidence includes the claim(s):semaglutide“Ozempic”“OZEMPIC 1 mg”“OZEMPIC® 1 mg Injektionslösung im Fertigpen Semaglutid Subkutane Anwendung”“Increases insulin production: Helps regulate blood sugar after meals.”“Reduces glucagon secretion: Lowers blood sugar levels by preventing excessive sugar release from the liver.”While there are FDA-approved versions of semaglutide on the market in the U.S., there are no approved drug applications pursuant to section 505 of the FD&C Act in effect for semaglutide offered by www.motionpharmacy.com. Currently there are three semaglutide products that are FDA-approved for the U.S. market and these products are only available pursuant to a prescription from a licensed practitioner. FDA-approved semaglutide tablets (brand name RYBELSUS) are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. FDA-approved semaglutide injection (brand name OZEMPIC) is indicated as an adjunct to diet and exercise to improve glycemic control in individuals with type 2 diabetes mellitus and to reduce the risk of major adverse cardiovascular events in adults with type 2 diabetes mellitus and established cardiovascular disease. FDA-approved semaglutide injection (brand name WEGOVY) is indicated as an adjunct to a reduced calorie diet and increased physical activity for chronic weight management in certain adult and pediatric patients. FDA-approved semaglutide products also bear a boxed warning, which again, is the strongest warning FDA requires, indicating that the drug carries a significant risk of serious or even life-threatening adverse effects. The boxed warning addresses the risk of thyroid C-cell tumors.Misbranded Drugs:A drug is misbranded under section 502(f)(1) of the FD&C Act [21 U.S.C. § 352(f)(1)] if its labeling fails to bear adequate directions for use. “Adequate directions for use” means directions under which a layperson can use a drug safely and for the purposes for which it is intended (see 21 CFR 201.5). Prescription drugs, as defined in section 503(b)(1) of the FD&C Act [21 U.S.C. § 353(b)(1)] include those that, because of their toxicity or other potentiality for harmful effect, and/or the method of their use, and/or the collateral measures necessary for their use, are not safe for use except under supervision of a practitioner licensed by law to administer them. Prescriptiondrugs, as defined in section 503(b)(1)(A) of the FD&C Act, can be used safely only at the direction, and under the supervision, of a licensed practitioner.Because the aforementioned drugs are prescription drugs intended for conditions that are not amenable to self-diagnosis and treatment by a layperson, adequate directions cannot be written such that a layperson can use the products safely for their intended use. Consequently, the labeling for these drugs fail to bear adequate directions for use, causing them to be misbranded under section 502(f)(1) of the FD&C Act. In addition, because these drugs are not approved in the U.S., they are also not exempt under 21 CFR 201.115(a) from the requirements of section 502(f)(1) of the FD&C Act. By offering these drugs for sale to U.S. consumers, www.motionpharmacy.com is causing the introduction of misbranded drugs into interstate commerce in violation of section 301(a) of the FD&C Act [21 U.S.C. § 331(a)].FDA has also observed that the www.motionpharmacy.com offers prescription drugs for sale without a prescription. In addition to the aforementioned drugs, examples of misbranded opioids you offer for sale on www.motionpharmacy.com, including how these products are marketed on your website and evidence obtained from your website establishing that these products are drugs intended for human use (as defined in 21 CFR 201.128), are listed below:Misbranded opioid:Marketed as:Evidence includes the claim(s):buprenorphine HCl“Buprenorphine”“Buprenorphine Sublingual Tablets NDC 0054-0177-13”“Buprenorphine is a prescription medication used primarily for the treatment of opioid use disorder (OUD) and for managing moderate to severe pain. It is classified as a partial opioid agonist, meaning it activates opioid receptors in the brain to a lesser extent than full agonists like heroin or oxycodone.”buprenorphine HCl and naloxone HCl“Suboxone”“Suboxone (Buprenorphine and Naloxone)”“Suboxone® (buprenorphine and naloxone) sublingual film 8 mg/2 mg NDC 12496-1208-3”“Suboxone is a prescription medication used in the treatment of opioid dependence and addiction. It is a combination of two active ingredients: buprenorphine, a partial opioid agonist, and naloxone, an opioid antagonist. Together, these ingredients help reduce withdrawal symptoms and cravings while discouraging misuse.”morphine sulfate“Morphine“Morphine Sulphate“Morphine Sulphate Oral Solution NDC 0406-8003-30”“Morphine Sulphate Extended-Release Capsule NDC 0228-3090-11”“Morphine sulfate is a powerful opioid medication commonly prescribed to manage moderate to severe pain. It belongs to a class of drugs called opioid analgesics, which work by binding to opioid receptors in the brain and spinal cord.”FDA-approved buprenorphine HCl is indicated for the treatment of opioid dependence and is preferred for induction. FDA-approved buprenorphine HCl and naloxone HCl (brand name SUBOXONE) is indicated for treatment of opioid dependence. Both drug products are indicated to be used as part of a complete treatment plan to include counseling and psychosocial support. FDA-approved morphine sulfate is indicated for the management of acute or chronic pain severe enough to require an opioid analgesic. FDA-approved morphine sulfate extended release is indicated for the management of severe and persistent pain that requires an extended treatment period with a daily opioid analgesic. Both drug products are indicated for which alternative treatment options are inadequate.FDA-approved buprenorphine HCl, buprenorphine HCl and naloxone HCl (brand name SUBOXONE), and morphine sulfate are only available pursuant to a prescription from a licensed practitioner. Furthermore, FDA-approved buprenorphine HCl, buprenorphine HCl and naloxone HCl (brand name SUBOXONE), and morphine sulfate each bear a boxed warning addressing risks including addiction, abuse, misuse, life-threatening respiratory depression, neonatal opioid withdrawal syndrome, and accidental exposure resulting in death. In addition, when these drug products are taken in conjunction with other CNS depressants, including alcohol and benzodiazepines, use may result in coma or death.An example of a misbranded benzodiazepine you offer for sale on www.motionpharmacy.com, including how this product is marketed on your website and evidence obtained from your website establishing that this product is a drug intended for human use (as defined in 21 CFR 201.128), is listed below:Misbranded benzodiazepine:Marketed as:Evidence includes the claim(s):alprazolam“Alprazolam”“Xanax”“alprazolam tablets, USP 1 mg NDC 59762-3721-1”“alprazolam XR, extended-release tablets, 3 mg NDC 59762-0068-1”“Alprazolam Tablets, USP 2 mg NDC 51991-707-05”“Xanax is a brand name for alprazolam, a medication in the benzodiazepine class. It is used primarily to treat anxiety disorders, including generalized anxiety disorder (GAD) and panic disorder. Alprazolam works by enhancing the effects of gamma-aminobutyric acid (GABA), a neurotransmitter that reduces brain activity and has a calming effect on the nervous system.”FDA-approved alprazolam (brand name XANAX) is indicated for the acute treatment of generalized anxiety disorder and panic disorder with or without agoraphobia. FDA-approved alprazolam (brand name XANAX) is only available pursuant to a prescription from a licensed practitioner. Furthermore, this drug product bears a boxed warning addressing risks including abuse, misuse, addiction, and physical dependence. In addition, the concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death.Examples of misbranded Schedule II stimulants you offer for sale on www.motionpharmacy.com, including how these products are marketed on your website and evidence obtained from your website establishing that these products are drugs intended for human use (as defined in 21 CFR 201.128), are listed below:Misbranded Schedule II stimulant:Marketed as:Evidence includes the claim(s):amphetamine“Adderall”“Adderall (Dextroamphetamine/amphetamine)”“ADDERALL XR® NDC 54092-383-01”“Adderall is a prescription medication at Motion Pharmacy that contains a combination of two stimulant drugs: amphetamine and dextroamphetamine. It is primarily used to treat Attention Deficit Hyperactivity Disorder (ADHD) and narcolepsy (a sleep disorder).”dextroamphetamine sulfate“Dextroamphetamine”“Dextroamphetamine Sulphate”“Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets NDC 0555-0973-02”“Dextroamphetamine Sulphate Tablets, USP NDC 52536-500-03”“Dextroamphetamine sulfate is a stimulant medication commonly used to treat Attention Deficit Hyperactivity Disorder (ADHD) and narcolepsy.”“Dextroamphetamine sulfate works by increasing the levels of certain chemicals (neurotransmitters) in the brain, particularly dopamine and norepinephrine, which help improve focus, attention, and impulse control in people with ADHD.”FDA-approved amphetamine (brand name ADDERALL) is indicated for the treatment of ADHD and narcolepsy. Using the brand name of the drug product ADDERALL indicates that this product is intended to treat ADHD and narcolepsy. FDA-approved amphetamine extended release (brand name ADDERALL XR) is indicated for the treatment of ADHD in adults and pediatric patients 6 years and older. FDA-approved dextroamphetamine sulfate is indicated for narcolepsy and ADHD in patients ages 3 to 16 years.FDA-approved amphetamine (brand name ADDERALL), amphetamine extended release (brand name ADDERALL XR), and dextroamphetamine sulfate are only available pursuant to a prescription from a licensed practitioner. Furthermore, FDA-approved amphetamine (brand name ADDERALL), amphetamine extended release (brand name ADDERALL XR), and dextroamphetamine sulfate each bear a boxed warning, addressing risks including abuse, misuse, and addiction. In addition, these drug products can be diverted for non-medical use into illicit channels or distribution. Misuse and abuse of CNS stimulants, including these drug products, can result in overdose and death, and this risk is increased with higher doses or unapproved methods of administration.Under U.S. law, prescription drugs can be dispensed only pursuant to a prescription from a healthcare practitioner licensed by law to administer prescription drugs. By offering the aforementioned drugs without requiring a prescription, www.motionpharmacy.com jeopardizes patient safety and misbrands the drugs under section 503(b)(1) of the FD&C Act. Dispensing a prescription drug without a prescription is an act which results in the drug being misbranded while held for sale, in violation of section 301(k) of the FD&C Act [21 U.S.C. § 331(k)].FDA is sending this warning letter to www.motionpharmacy.com because of the inherent risks to consumers who purchase misbranded and unapproved new drugs. This letter is not intended to identify all the ways in which your products or operations might be in violation of the law. It is your responsibility to ensure that all products you offer for sale are in compliance with the FD&C Act and its implementing regulations. You should take prompt action to address any violations of the FD&C Act (which may include the offer for sale of similarly misbranded and/or unapproved new drugs other than the drugs noted above). We advise you to review your websites, product labels, and other labeling and promotional materials to ensure that you are not misleadingly representing your products as safe and effective for a use for which they have not been approved by FDA and that you are not distributing misbranded and unapproved drug products in violation of the FD&C Act.Please notify this office in writing within 15 working days describing the specific steps you have taken to address any violations and to prevent their recurrence. Include an explanation of each step being taken to remedy and prevent the recurrence of any violations, as well as copies of related documentation. Failure to adequately address this matter may result in legal action, including, without limitation, seizure, and injunction, without further notice. If you cannot complete corrective action within 15 working days, state the reason for the delay and the time within which you will complete the corrections. This letter notifies you of our concerns and provides you with an opportunity to address them. 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 within 15 working days.If you are not located in the U.S., please note that products that appear to be misbranded or unapproved new drugs may be detained or refused admission. We may advise the appropriate regulatory officials in the country from which you operate that your products referenced above appear to be unapproved and misbranded products that cannot be legally sold to consumers in the U.S.Please direct your response and any inquiries to FDA at FDAInternetPharmacyTaskForce-CDER@fda.hhs.gov.Sincerely,/S/Sangeeta Vaswani Chatterjee, Pharm.D.Acting DirectorOffice of Drug Security, Integrity, and ResponseOffice of ComplianceCenter for Drug Evaluation and Research