为加强药品流通环节安全监管，保障公众用药安全，福建省药品监督管理局于2025年8月3日至8月8日组织检查人员对12家药品经营企业开展飞行检查，现将检查结果公告如下：一、被检查企业名单序号企业名称企业类型1福建小欧医药科技有限公司批发2泉州市东南医药连锁有限公司批零一体泉州市东南医药连锁有限公司丰泽东海分店连锁门店泉州市东南医药连锁有限公司丰泽浦西分店连锁门店3福建泉安医药有限公司批发4福建泰和医药有限公司批发5国药控股泉州有限公司批发（疫苗）6华润东大(福建)医药有限公司批发（第三方物流）7福州海王星辰健康药房连锁有限公司连锁福州海王星辰健康药房连锁有限公司仓山区一品新筑分店连锁门店福州海王星辰健康药房连锁有限公司仓山区花溪南路分店连锁门店8漱玉平民医药(福建)有限公司批发9福建省圆心逸仙医药连锁有限公司连锁福建省圆心逸仙医药连锁有限公司福州第八分店连锁门店福建省圆心逸仙医药连锁有限公司福州第十六分店连锁门店10厦门康腾医药科技有限公司批发11瑞祺堂(福建)药业有限公司批发12福建健宸医药有限公司批发二、检查的主要内容根据《药品管理法》《疫苗管理法》《药品经营质量管理规范》及《药品检查管理办法（试行）》等相关法律法规，重点针对被检查企业的质量管理体系、购销渠道、计算机系统、储存与运输、资金票据往来、处方药销售等重点内容开展检查。三、检查结果检查发现，部分批发企业（含零售连锁总部）存在未依法经营，药品销售、运输环节未采取有效的控制措施，未对委托运输药品（含冷藏）的企业质保能力进行审核，有的甚至未签订委托运输协议，个别企业冷藏药品运输过程相关记录不真实，企业质量管理部门对计算机系统操作权限审核不到位，部分数据记录不完整、计算机系统质量控制功能不够完善。部分销后退回药品记录不完整，质量管理部门未对不合格药品的处理过程实施监督。温湿度自动监测系统管理不到位，室温不符合存储标准，备份数据不完整或无库房温湿度备份数据，未对温湿度监测系统进行定期验证。企业开展的质量管理体系内审不规范，内部管理制度完善不及时，对相关岗位人员培训不到位。质管部门未能有效指导监督药品储存、养护环节质量管理工作，库房存在不同药品混垛，药品到货时未核对随货同等单样式，未对启用和停用的库房制定启停制度，麻精药品未按要求进行双人验收。连锁门店存在未按药品储存要求分类陈列的现象，阴凉区温度不符合要求，个别药品进销记录不完整、不准确，未建立拆零药品销售记录，个别门店现场无法提供相关药品购进单据，执业药师未严格落实处方审核管理，处方药未凭处方销售，计算机有一键审方的操作权限，门店网销记录不完整。第三方物流企业存在与物流公司签订的运输协议中未明确药品质量责任。疫苗配送企业存在个别冷藏库制冷机组表面结霜、渗水，地面积水。四、处置措施对企业存在严重缺陷的，线索问题已按职权移交药品监管部门作进一步调查；存在主要缺陷和一般缺陷的，已依法要求企业限期整改，并由辖区药品监管部门结合日常监管跟踪企业整改落实。特此通告。福建省药品监督管理局 2025年8月20日

行政相对人名称 扬州市桂龙医疗器械有限公司 行政相对人类别 法人及非法人组织 统一社会信用代码 913210007863282428 工商注册号 组织机构代码 税务登记号 事业单位证书号 社会组织登记证号 法定代表人 王丽 法定代表人证件类型 身份证 法定代表人证件号码 3****************7 证件类型 证件号码 行政处罚决定书文号 苏药监扬处罚〔2025〕24号 违法行为类型 生产不符合经注册的产品技术要求的行为，违反了《医疗器械监督管理条例》第三十五条第一款的规定。 违法事实 扬州市桂龙医疗器械有限公司，生产不符合经注册的产品技术要求的行为，违反了《医疗器械监督管理条例》第三十五条第一款的规定，根据《中华人民共和国行政处罚法》第二十八条第二款、《医疗器械监督管理条例》第八十六条第一项规定，应予处罚。 处罚依据 根据《中华人民共和国行政处罚法》第二十八条第二款、《医疗器械监督管理条例》第八十六条第一项规定。 处罚类别 罚款;没收违法所得、没收非法财物 处罚内容 没收违法所得柒仟捌佰整；处以罚款贰万肆仟伍佰元整。 罚款金额（万元） 2.45 没收违法所得没收非法财物的金额（万元） 0.78 暂扣或吊销证照名称及编号 处罚决定日期 2025/08/19 处罚有效期 2026/02/19 公示截止期 2028/08/19 处罚机关 江苏省药品监督管理局 处罚机关统一社会信用代码 11320000014000394R 数据来源单位 江苏省药品监督管理局 数据来源单位统一社会信用代码 11320000014000394R 备注 公示截止期依据文件：市场监督管理行政处罚信息公示规定。罚款金额已确认。

信用主体名称 :包头富康医药有限责任公司统一社会信用代码 :91150202114423968X行政处罚决定书文号 :内药监处罚〔2025〕001号处罚名称 :包头富康医药有限责任公司销售劣药菠萝蛋白酶肠溶片案处罚类别 :没收违法所得、没收非法财物处罚事由 :当事人销售劣药菠萝蛋白酶肠溶片的行为，违反了《中华人民共和国药品管理法》第九十八条第一款、第三款第一项之规定处罚依据 :中华人民共和国行政处罚法,中华人民共和国药品管理法实施条例处罚结果 :没收违法所得人民币叁万壹仟贰佰伍拾捌元叁角肆分（¥31258.34），免除其他行政处罚。处罚决定日期 :2025-08-19处罚机关 :内蒙古自治区药品监督管理局

行政相对人名称 江苏华东医疗器械实业有限公司 行政相对人类别 法人及非法人组织 统一社会信用代码 91321000731168333G 工商注册号 组织机构代码 税务登记号 事业单位证书号 社会组织登记证号 法定代表人 刘银 法定代表人证件类型 身份证 法定代表人证件号码 3****************7 证件类型 证件号码 行政处罚决定书文号 苏药监扬处罚〔2025〕23号 违法行为类型 生产不符合经注册的产品技术要求的行为，违反了《医疗器械监督管理条例》第三十五条第一款的规定。 违法事实 江苏华东医疗器械实业有限公司，生产不符合经注册的产品技术要求的行为，违反了《医疗器械监督管理条例》第三十五条第一款的规定，根据《中华人民共和国行政处罚法》第二十八条第二款、《医疗器械监督管理条例》第八十六条第一项规定，应予处罚。 处罚依据 根据《中华人民共和国行政处罚法》第二十八条第二款、《医疗器械监督管理条例》第八十六条第一项规定。 处罚类别 罚款;没收违法所得、没收非法财物 处罚内容 没收违法所得壹仟肆佰捌拾元整；处以罚款叁万伍仟元整。 罚款金额（万元） 3.5 没收违法所得没收非法财物的金额（万元） 0.148 暂扣或吊销证照名称及编号 处罚决定日期 2025/08/19 处罚有效期 2026/02/19 公示截止期 2028/08/19 处罚机关 江苏省药品监督管理局 处罚机关统一社会信用代码 11320000014000394R 数据来源单位 江苏省药品监督管理局 数据来源单位统一社会信用代码 11320000014000394R 备注 公示截止期依据文件：市场监督管理行政处罚信息公示规定。罚款金额已确认。

信用主体名称 :乌兰察布市集宁区盛康医药有限责任公司统一社会信用代码 :911509021164818701行政处罚决定书文号 :内药监处罚〔2025〕002号处罚名称 :乌兰察布市集宁区盛康医药有限责任公司销售劣药红参（红参片）案处罚类别 :没收违法所得、没收非法财物处罚事由 :当事人销售劣药红参（红参片）的行为，违反了《中华人民共和国药品管理法》第九十八条第一款、第三款第七项之规定。处罚依据 :中华人民共和国行政处罚法、中华人民共和国药品管理法实施条例处罚结果 :1.没收劣药红参（红参片）(批号：426220601)1.5kg；2.没收违法所得人民币叁佰玖拾贰元伍角（¥392.5）；免除其他行政处罚。处罚决定日期 :2025-08-19处罚机关 :内蒙古自治区药品监督管理局

Delivery Method:VIA Electronic MailProduct:Medical DevicesRecipient:Stacey R. ReynoldsCEOLes Encres LLC149 Kelsey Ln Ste 200 BLenoir City,TN37772United Statessreynolds@lesencres.comIssuing Office:Center for Devices and Radiological HealthUnited StatesWARNING LETTERCMS 709263July 30, 2025Dear Ms. Reynolds:During an inspection of your firm Les Encres LLC, FEI 3014822674 located at 149 Kelsey Ln Ste 200 B in Lenoir City, Tennessee, on March 14, 2025, through April 1, 2025, an investigator from the United States Food and Drug Administration (FDA) determined that your firm is a specification developer of Les Encres absorbable polydioxanone (PDO) surgical suture devices (“Les Encres threads”). Under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 321(h), these products are devices because they are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body.Quality System Regulation ViolationsThis inspection revealed that these devices are adulterated within the meaning of section 501(h) of the Act, 21 U.S.C. § 351(h), in that the methods used in, or the facilities or controls used for, their manufacture, packing, storage, or installation are not in conformity with the current good manufacturing practice requirements of the Quality System regulation found at Title 21, Code of Federal Regulations (CFR), Part 820. These violations include, but are not limited to, the following:1. Failure to maintain complaint files and to adequately maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit, to review and evaluate all complaints to determine whether an investigation is necessary, and to review, evaluate, and investigate any complaint involving the possible failure of the device, labeling, or packaging, as required by 21 CFR 820.198. Specifically, you failed to document, review, and evaluate complaints as required by your procedure “Complaint Handling,” MD34, Rev A, dated 05/01/2023. For example, you received e-mails with alleged deficiencies potentially related to the identity, quality, durability, reliability, safety, effectiveness, or performance of your absorbable PDO surgical suture devices. These complaints were not logged, assigned a complaint number, assessed for complaint category type, investigated, reviewed for reportability, evaluated to determine if your device met all specifications and claims, nor evaluated to determine if corrective and preventive actions were needed as required by your procedure MD34.2. Failure to adequately maintain procedures for implementing corrective and preventive action, and to document all activities required under the procedures, as required by 21 CFR 820.100(a) and (b). Specifically, you failed to implement your procedure “Corrective and Preventive Action,” MD30, Rev A, dated 05/01/2023, which requires your firm to document corrective and preventive actions (CAPA), and to verify or validate that CAPAs are effective. Your procedure MD30 Section 7.2 requires CAPAs to be documented on form “Corrective and Preventive Action Report,” MD30-RF1, and to be logged on the “Corrective and Preventive Action Report Log,” MD30-LB1. In your written response to FDA on 05/31/2023, responding to your previous inspection, you detailed your activities performed in response to your FDA Inspectional Observations that included opening CAPA 23-001, CAPA 23-002, CAPA 23-003, and CAPA 23-004. However, this inspection found that your CAPA Log MD30-LB1 has no entries, and you have no documented CAPA records.3. Failure to establish and maintain procedures to ensure that all purchased or otherwise received product and services conform to specified requirements, as required by 21 CFR 820.50. Specifically, you do not have a procedure that describes the process by which suppliers, contractors, or consultants are evaluated and how their approval status is documented. You did not document the results of any evaluation performed by you that qualifies your supplier of absorbable PDO surgical sutures.4. Failure to adequately ensure that all personnel are trained to adequately perform their assigned responsibilities, and document training, as required by 21 CFR 820.25(b). Specifically,a. Your procedure “Complaint Handling” MD34, Rev A. dated 05/01/2023 details the responsibilities of all employees on how complaints are to be handled. Your statements, together with this procedure and the “Clinical Specialist Job Description,” indicate your Clinical Specialist is responsible for complaint investigations. However, you have confirmed that the Clinical Specialist has not been trained on your current complaint handling procedure. At least five complaints concerning absorbable PDO surgical sutures, received between(b)(4)and(b)(4), were not documented, investigated, or handled as complaint records as required by your procedure MD34.b. Your procedure “Complaint Handling” MD34, Rev A. dated 05/01/2023, Section 5.5 identifies that sales and marketing personnel are responsible for assisting in performing and documenting complaint investigation activities. In addition, you stated that sales representatives are responsible for intake of complaint data and fill in as needed for complaint investigation activities. You indicated your salespeople have been trained on your procedure MD34; however, there is no documented evidence that shows this training was completed.Medical Device ReportingFailure to adequately develop, maintain, and implement written MDR procedures as required by 21 CFR 803.17. For example, your firm presented the document titled “Medical Device Reporting”, MD33, Rev A, DCO: 23-002, dated 05/01/2023, as your MDR procedure. Upon review, we concluded that your MDR procedure does not establish internal systems that provide for a standardized review process or procedure to determine when an event meets the criteria for reporting under this part, as required by 21 CFR 803.17(a)(2). For example, although Sections 6.2-6.3 of your procedure MD33 include a requirement to conduct investigations of MDR reportable events, your procedure lacks the instructions on how to perform the investigation and evaluate the cause of such events.Additionally, your firm is recommended to establish an active Electronic Submissions Gateway (ESG) production account for the electronic submission of MDR reports. FDA verified that, as of June 9, 2025, your firm does not have such an account. Information about the ESG can be found at: How to Enroll in eMDR Program | FDA.Unapproved Device Violation(s)FDA has reviewed information during the inspection and on your website and determined that your Les Encres threads are adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B), because your firm does not have an approved application for premarket approval (PMA) in effect pursuant to section 515(a) of the Act, 21 U.S.C. § 360e(a), or an approved application for an investigational device exemption under section 520(g) of the Act, 21 U.S.C. § 360j(g) for the device as described and marketed. The device is also misbranded under section 502(o) of the Act, 21 U.S.C. § 352(o), because your firm introduced or delivered for introduction into interstate commerce for commercial distribution these devices with major changes or modifications to the intended use without submitting a new premarket notification to FDA as required by section 510(k) of the Act, 21 U.S.C. § 360(k) and 21 CFR 807.81(a)(3)(ii).Specifically, your Les Encres threads were cleared under K190264 with the following indications: “barbed suture comprised of dyed polydioxanone (PDO) is indicated for use in soft tissue approximation where use of absorbable suture is appropriate.” However, your firm’s promotion of the devices (as noted in the examples below) provides evidence that the devices are intended for specific cosmetic uses, which would constitute a major change or modification to their intended use, for which your firm lacks clearance or approval.One example can be found on your Les Encres website (https://lesencres.com/company/faqpage/ reviewed on 07/23/2025):“Using Les Encres Threads, we can lift, tighten and add volume where needed, all in the time it takes you to eat lunch.”Another example is your Les Encres Product Listing titled “les encres Threads – Les Encres Product Request” (collected during FDA inspection 03/14/2025 – 04/01/2025):“Ideal for Light cheek lift, Jawline lift, Neck lift, Brow lift and Lower Face treatments.”We discussed these issues with you in 2024 regarding promotion of your devices with statements beyond the scope of the cleared 510(k). FDA is currently unaware of any evidence you have submitted that could support the above intended uses of your devices. The above intended uses of tightening and adding volume raise safety and effectiveness concerns that are different from those normally associated with the cleared use of the devices. Use of the devices for cosmetic purposes presents additional risks such as migration, extrusion, asymmetry, visible scarring, and poor cosmetic outcomes that generally require clinical data to demonstrate safety in superficial dermal/subdermal use and to confirm the durability and predictability of cosmetic results before such statements can be made. Your barbed sutures have not been cleared for such indications and you have not submitted data demonstrating safety and effectiveness for such use. We strongly recommended that you conduct the performance testing appropriate for barbed sutures and submit a new 510(k) notification, including identifying a suitable predicate device to the Agency. This submission is necessary to obtain clearance for marketing of your Les Encres threads for the above intended uses, which carry clinical implications not normally associated with the cleared use of the device. Furthermore, we emphasize that for any cosmetic use related to sutures, the Agency has required comprehensive performance testing, including clinical evidence, to establish substantial equivalence to a legally marketed predicate device. This information must be submitted as part of a new 510(k) submission.For a device requiring premarket approval, the notification required by section 510(k) of the Act, 21 U.S.C. § 360(k), is deemed satisfied when a PMA is pending before the agency. The kind of information that your firm needs to submit in order to obtain approval or clearance for the device is described on the Internet at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/default.htm. The FDA will evaluate the information that your firm submits and decide whether the product may be legally marketed.Our office requests that Les Encres cease any activities that result in the misbranding or adulteration of the Les Encres threads, such as the commercial distribution of the devices for the uses discussed above.Your firm should take prompt action to address any violations identified in this letter. Failure to adequately address this matter may result in regulatory action being initiated by the FDA without further notice. These actions include, but are not limited to, seizure, injunction, and civil money penalties. Other federal agencies may take your compliance with the FD&C Act and its implementing regulations into account when considering the award of federal contracts. Additionally, should FDA determine that you have Quality System regulation violations that are reasonably related to premarket approval applications for Class III devices, such devices will not be approved until the violations have been addressed. Should FDA determine that your devices or facilities do not meet the requirements of the Act, requests for Certificates to Foreign Governments (CFG) may not be granted.Please notify this office in writing within fifteen business days from the date you receive this letter of the specific steps your firm has taken to address the noted violations, as well as an explanation of how your firm plans to prevent these violations, or similar violations, from occurring again. Include documentation of the corrections and/or corrective actions (which must address systemic problems) that your firm has taken. If your firm’s planned corrections and/or corrective actions will occur over time, please include a timetable for implementation of those activities. If corrections and/or corrective actions cannot be completed within fifteen business days, state the reason for the delay and the time within which these activities will be completed. Your firm’s response should be comprehensive and address any violations included in this Warning Letter. If you believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration as part of your response.Your firm’s response should be sent to Melissa Michurski, Assistant Director, via email to cdrhenforcement@fda.hhs.gov. Please include in the subject line, CMS Case 709263 when replying. If you have any questions about the contents of this letter, please contact Demetria Lueneburg, Compliance Officer, at Demetria.Lueneburg@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

信用主体名称 :上药控股(内蒙古)有限公司统一社会信用代码 :91150602733251261T行政处罚决定书文号 :内药监处罚〔2025〕003号处罚名称 :上药控股(内蒙古)有限公司销售劣药辅酶Q10注射液案处罚类别 :没收违法所得、没收非法财物处罚事由 :当事人销售劣药辅酶Q10注射液的行为，违反了《中华人民共和国药品管理法》第九十八条第一款、第三款第七项的规定处罚依据 :中华人民共和国行政处罚法、中华人民共和国药品管理法实施条例处罚结果 :没收违法所得人民币叁仟捌佰肆拾元（¥3840.00），免除其他行政处罚。处罚决定日期 :2025-08-19处罚机关 :内蒙古自治区药品监督管理局

Delivery Method:VIA UPSReference #:320-25-99Product:DrugsRecipient:Ms. Rosy AtwalFounder and CEOEverlaan Organics, Inc. dba Maple Organics17220 Heather Dr, Unit 106SurreyBCV3S 8G6CanadaIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesWarning Letter320-25-99August 11, 2025Dear Ms. Atwal:Your facility was registered with the United States Food and Drug Administration (FDA) as a manufacturer of over-the-counter (OTC) drug products. FDA has reviewed the records you submitted in response to our September 4, 2024 request and subsequent correspondence, 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, Everlaan Organics, Inc., dba Maple Organics, FEI 3025798567, 17220 Heather Dr, Unit 106, Surrey, British Columbia, Canada.This warning letter summarizes significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals. See Title 21 Code of Federal Regulations, parts 210 and 211 (21 CFR, parts 210 and 211).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 drug products are adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act (21 U.S.C. 351(a)(2)(B)).In addition, “maple organics Joint Pain Relief” and “maple organics Muscle Pain Relief” are unapproved new drugs introduced or delivered for introduction into interstate commerce in violation of section 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 355(a). Furthermore, “maple organics Joint Pain Relief,” “maple organics Muscle Pain Relief,” “maple organics Cough & Cold Relief for Kids,” and “maple organics Cough & Cold Relief” are misbranded under 502(a) of the FD&C Act, 21 U.S.C. 352(a). Additionally, “maple organics Cough & Cold Relief” is further misbranded under 502(f)(1) of the FD&C Act, 21 U.S.C. 352(f)(1) and “maple organics Joint Pain Relief,” “maple organics Muscle Pain Relief,” and “maple organics Cough & Cold Relief” are misbranded under section 502(ee) of the FD&C Act, 21 U.S.C. 352(ee). Introduction or delivery for introduction of a misbranded product into interstate commerce is prohibited under section 301(a) of the FD&C Act, 21 U.S.C. 331(a). These violations are described in more detail below.Following review of records and other information provided pursuant to section 704(a)(4) of the FD&C Act, significant violations were observed including, but not limited to, the following:CGMP Violations1. Your firm failed to have, for each batch of drug product, appropriate laboratory determination of satisfactory conformance to final specifications for the drug product, including the identity and strength of each active ingredient, prior to release (21 CFR 211.165(a)).You manufacture OTC drug products, including(b)(4)products for(b)(4). Based on the records and information you provided, you did not demonstrate that you adequately test your OTC finished drug products prior to release for distribution to the United States.In your initial response, you state that you test each batch of your finished drug products before release. However, when FDA requested you to provide the test data, you failed to provide any records demonstrating that you tested your finished products prior to release. You do not appear to be performing release testing on finished products.Full release testing, including for identity, strength, and impurities, must be performed prior to drug release and distribution. Without adequate testing, there is no scientific evidence to assure that your drug products conform to appropriate specifications before release.In response to this letter, provide:A list of chemical and microbial specifications, including adequate test methods, used to analyze each batch of your drug products before a batch disposition decision.o An action plan and timelines for conducting full chemical and microbiological testing of retain samples to determine the quality of all batches of drug product distributed to the United States that are within expiry as of the date of this letter.o A summary of all results obtained from testing retain samples from each batch. If such testing reveals substandard quality drug products, take rapid corrective actions, such as notifying customers and product recalls.A comprehensive, independent assessment of your laboratory practices, procedures, methods, equipment, documentation, and analyst competencies. Based on this review, provide a detailed plan to remediate and evaluate the effectiveness of your laboratory system.2. Your firm failed to conduct at least one test to verify the identity of each component of a drug product (21 CFR 211.84(d)(1)).Based on the records and information you provided about the manufacture of your OTC drug products, you did not demonstrate that you are adequately testing each shipment of each lot of incoming components.In response to our initial request, you state that you “identify all items via receiving practices” and provided a receiving procedure. However, the procedure did not specify chemical identity testing for incoming components. You also did not provide your incoming component testing data for the most recent batches shipped to the United States when asked by FDA subsequently.Without adequate testing, you do not have scientific evidence that incoming materials conform to appropriate specifications prior to use in the manufacture of your drugs. As a manufacturer, you have a responsibility to sample, test, and examine incoming materials before use in production to assure adequate quality.In response to this letter, provide:A comprehensive, independent review of your material system to determine whether all suppliers of incoming materials 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 materials.The chemical and microbiological quality control specifications you use to test and release each incoming lot of components for use in manufacturing.A description of how you will test each incoming material lot for conformity with all appropriate specifications for identity. If you intend to accept any results from your supplier’s certificate of analysis (COA) instead of testing each incoming material lot for other tests, specify how you will ensure that you have adequate evidence to establish that the supplier consistently provides material meeting specifications. In addition, include a commitment to always conduct at least one specific identity test for each incoming material lot.A summary of results obtained from testing all incoming materials to evaluate the reliability of the COA from each incoming materials manufacturer. Include your standard operating procedure that describes this COA validation program.A summary of your program for qualifying and overseeing contract facilities that test the drugs you manufacture.3. Your firm failed to establish and follow an adequate written testing program designed to assess the stability characteristics of drug products (21 CFR 211.166(a)).The records and information you provided did not demonstrate that you have an adequate stability program for the OTC drug products you manufacture. You provided a stability test procedure that only discussed accelerated stability testing but did not include long-term stability testing. In lieu of stability data, you provided a cost estimate from a contract testing laboratory outlining the various stability tests to be performed. We note that one of your microbiological test references USP , which is intended for evaluating nutritional supplements, and not drug products.Without appropriate stability studies, you do not have scientific evidence to support whether your drug products meet established specifications and retain their quality attributes through their labeled expiry.In response to this letter, provide:A comprehensive, independent assessment and CAPA plan to ensure the adequacy of your stability program. Your remediated program should include, but not be limited to:o Stability indicating methods.o Stability studies for each drug product in its marketed container-closure system before distribution is permitted.o An ongoing program in which representative batches of each product are added each year to the program to determine if the shelf-life claim remains valid.o Detailed definition of the specific attributes to be tested at each station (timepoint).All procedures that describe these and other elements of your remediated stability program.4. Your firm failed to prepare batch production and control records that include documentation of the accomplishment of each significant step in the manufacture, processing, packing, or holding of the batch, for each batch of drug product (21 CFR 211.188(b)).The batch records you provided in response to our request for records lacked adequate production details regarding significant manufacturing steps, including, but not limited to, identity of major equipment and lines, in-process controls, yield, and container closures. This documentation is necessary to establish that manufacturing processes were consistently followed and are reproducible. Having incomplete records deprives you of traceability of actions necessary for investigational purposes.In response to this letter, provide:• Your master production and control records for your drug products, to demonstrate that they fully document each significant and validated manufacturing step.• A complete assessment of documentation systems used throughout your manufacturing operations, to determine where documentation practices are insufficient. Include a detailed corrective action and preventive action (CAPA) plan that comprehensively remediates your firm’s documentation practices, to ensure you retain attributable, legible, complete, original, accurate, and contemporaneous records throughout your operation.5. Your firm failed to establish an adequate quality control unit with the responsibility and authority to approve or reject all components, drug product containers, closures, in-process materials, packaging materials, labeling, and drug products (21 CFR 211.22(a)).The records and information you provided demonstrate that your quality unit (QU) did not effectively exercise its responsibilities to oversee the quality of your drug manufacturing operations. Specifically, your QU did not adequately exercise its authority in the approval or rejection of components, approval or rejection of finished drug products, batch record review, establishment and implementation of an adequate stability study program, and performance of adequate process validation.Your procedures did not define your QU structure and delineation of QU roles and responsibilities. We acknowledge that you plan to cease production and seek a contract manufacturing organization (CMO),(b)(4), to manufacture your drug products.In response to this letter, provide:A comprehensive assessment and remediation plan to ensure your QU is given the authority and resources to effectively function. The assessment should also include, but not be limited to:o A determination of whether procedures used by your firm are robust and appropriate.o Provisions for QU oversight throughout your operations to evaluate adherence to appropriate practices.o A complete and final review of each batch and its related information before the QU disposition decision.o Oversight and approval of investigations and discharging of all other QU duties to ensure identity, strength, quality, and purity of all products.Use of Contract ManufacturersWe note that your prospective contract manufacturing facility,(b)(4), was placed on Import Alert 66-40 on(b)(4)for failure to comply with CGMP requirements. Drugs manufactured at your prospective CMO are considered adulterated and thus should not be used for the manufacture of drugs for the United States market. It is your responsibility to perform adequate due diligence to ensure that your CMO is in full compliance with CGMPs, the applicable requirements in the FD&C Act, PHS Act, and all applicable regulations.Drugs must be manufactured in conformance with CGMP. FDA is aware that many drug manufacturers use independent contractors, such as production facilities, testing laboratories, packagers, and labelers. FDA regards contractors as extensions of the manufacturer.You are responsible for the quality of your drugs regardless of agreements in place with your contract facilities. You are required to ensure that drugs are made in accordance with section 501(a)(2)(B) of the FD&C Act to ensure safety, identity, strength, quality, and purity. See FDA’s guidance documentContract Manufacturing Arrangements for Drugs: Quality Agreementsat https://www.fda.gov/media/86193/download.Quality SystemsYour firm’s quality systems are inadequate. See FDA’s guidance documentQuality Systems Approach to Pharmaceutical CGMP Regulationsfor help implementing quality systems and risk management approaches to meet the requirements of CGMP regulations 21 CFR, parts 210 and 211 at https://www.fda.gov/media/71023/download.CGMP Consultant RecommendedBased upon the nature of the violations we identified at your firm, you should engage a consultant qualified as set forth in 21 CFR 211.34 to evaluate your operations and to assist your firm in meeting CGMP requirements if your firm intends to resume manufacturing drugs for the U.S. market. The qualified consultant should also perform a comprehensive six-system audit1of your entire operation for CGMP compliance and evaluate the completion and efficacy of your CAPA before you pursue resolution of your firm’s compliance status with FDA.Your use of a consultant does not relieve your firm’s obligation to comply with CGMP. Your firm’s executive management remains responsible for resolving all deficiencies and systemic flaws to ensure ongoing CGMP compliance.Unapproved New Drug and Misbranding Violations“maple organics Joint Pain Relief,” “maple organics Muscle Pain Relief,” “maple organics Cough & Cold Relief for Kids,” and “maple organics Cough & Cold Relief” are drugs as defined by section 201(g)(1)(B) of the FD&C Act, 21 U.S.C. 321(g)(1)(B) because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease, and/or under section 201(g)(1)(C) of the FD&C Act, 21 U.S.C. 321(g)(1)(C) because they are intended to affect the structure or any function of the body.Examples of claims observed on the product labels and labeling from your website listed above that provide evidence of the intended uses (as defined in 21 CFR 201.128) of the products include, but may not be limited to, the following:“maple organics Joint Pain Relief”• “DRUG FACTS . . . Uses:Temporarily relieves joint pain.” [from the product label]• “Maple Organics Joint Therapy is an FDA-approved, all-natural formula designed to relieve pain, stiffness, and inflammation.” [from the product website www.mapleorganics.com]• “Made with organic Arnica Montana, known for its anti-inflammatory and analgesic properties, this balm provides fast-acting, long-lasting relief from discomfort caused by osteoarthritis, tendonitis, and rheumatoid arthritis.” [from the product website www.mapleorganics.com]• “Unlike conventional ointments, our steroid-free formula helps reduce muscle damage, so you can feel better without the harsh side effects.” [from the product website www.mapleorganics.com]• “A remedy for pain and inflammation due to osteoarthritis, tendonitis and rheumatoid arthritis.” [from the product website www.mapleorganics.com]“maple organics Muscle Pain Relief”• “DRUG FACTS . . . Uses:Temporarily relieves minor aches and pains of muscles and joints associated with simple backache, strains and bruises.” [from the product label]• “This is not an icy hot product but will increase circulation to remove lapsed blood while giving a numbness in your muscles to help reduce pain.” [from the product website www.mapleorganics.com]“maple organics Cough & Cold Relief for Kids”• “DRUG FACTS . . . Uses:Temporarily relieves cough associated with the common cold.” [from the product label]“maple organics Cough & Cold Relief”• “DRUG FACTS…Uses:Temporarily relieves cough associated with the common cold.” [from the product label]Unapproved New Drug ViolationsBased on the above labeling evidence, “maple organics Joint Pain Relief” and “maple organics Muscle Pain Relief” are intended for use as external analgesic drug products. As described below, these drug products are unapproved new drugs marketed in violation of sections 505(a) and 301(d) of the FD&C Act, 21 U.S.C 355(a) and 331(d).A drug product is a “new drug” within the meaning of section 201(p) of the FD&C Act, 21 U.S.C. 321(p), if it is not generally recognized as safe and effective (GRASE) for use under the conditions prescribed, recommended, or suggested in its labeling. With certain exceptions not applicable here, a new drug may not be introduced or delivered for introduction into interstate commerce without an approved application from FDA in effect, as described in section 505(a) of the FD&C Act, 21 U.S.C. 355(a). No FDA-approved applications pursuant to section 505 of the FD&C Act, 21 U.S.C. 355, are in effect for these drug products identified above.Under section 505G of the FD&C Act, certain nonprescription drugs marketed without an approved application —commonly referred to as "OTC monograph drugs"—may be legally marketed if they meet applicable requirements. With respect to external analgesic drug products, such as your “maple organics Joint Pain Relief” and “maple organics Muscle Pain Relief,” in order to be GRASE and not new drugs, the products must, among other things, conform to the conditions in the applicable OTC monograph, here the External Analgesic Drug Products for Over-the-Counter Human Use (M017).2However, “maple organics Joint Pain Relief” and “maple organics Muscle Pain Relief” do not conform to the conditions specified in M017 for the reasons described belowSpecifically, “maple organics Joint Pain Relief” contains the active ingredient arnica, which is not a permitted active ingredient under M017. 21 CFR 201.66(b)(2) defines “active ingredient” to mean “any component that is intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body of humans.” Although your firm does not specifically list arnica as an active ingredient, your labeling of “maple organics Joint Pain Relief,” such as your website, includes statements that claim arnica is intended as an anti-inflammatory and analgesic, and “…provides fast-acting, long-lasting relief from discomfort caused by osteoarthritis, tendonitis, and rheumatoid arthritis.” Such statements demonstrate that arnica is an “active ingredient” in your “maple organics Joint Pain Relief” because it is intended to furnish pharmacological activity or other direct effect to affect the structure or any function of the body of humans. Because arnica is not an active ingredient permitted under M017, your “maple organics Joint Pain Relief” does not conform with the conditions set forth in M017.Furthermore, the labeling for “maple organics Joint Pain Relief” and “maple organics Muscle Pain Relief” include intended uses that are not permitted in M017. For example, you claim that “maple organic Joint Pain Relief” will “help reduce muscle damage” and it can be used as “a remedy for pain and inflammation due to osteoarthritis, tendonitis and rheumatoid arthritis.” In addition, you claim that “maple organic Muscle Pain Relief” “…will increase circulation to remove lapsed blood while giving a numbness in your muscles to help reduce pain.” Such intended uses do not conform with M017.50(b).Thus, as formulated and labeled, your “maple organics Joint Pain Relief” and “maple organics Muscle Pain Relief” products do not comply with the applicable final administrative order described above or any other final order.3Moreover, there is no evident basis under the FD&C Act under which these products would be legally marketed without an approved application. Thus, these products are new drugs within the meaning of section 201(p) of the FD&C Act, 21 U.S.C. 321(p). Accordingly, these products are unapproved new drugs marketed in violation of section 505(a) of the FD&C Act, 21 U.S.C. 355(a).The introduction or delivery for introduction of these unapproved new drug products into interstate commerce violates sections 505(a) and 301(d) of the FD&C Act, 21 U.S.C. 355(a) and 331(d).Misbranded Drug ViolationsYour “maple organics Joint Pain Relief” product is misbranded under section 502(a) because the website labeling claims the product is “…an FDA-approved, all-natural formula….” This claim suggests that the drug is approved or legally marketable (see 21 CFR 207.77(b)). However, your product is not subject to an FDA-approved application. Therefore, your labeling representation suggesting that your product is FDA-approved is false or misleading.Further, “maple organics Joint Pain Relief,” “maple organics Muscle Pain Relief,” “maple organics Cough & Cold Relief for Kids,” and “maple organics Cough & Cold Relief” are misbranded under 502(a) because your products’ labels claim ”At Maple Organics, we scientifically validate natural remedies to FDA standards, ensuring their efficacy….” This claim misleadingly suggests that your products are validated to FDA-standards when such is not the case.We note that, based on the labeling evidence described above, “maple organics Cough & Cold Relief” is intended for use as topical antitussives under M012 (Cold, Cough Allergy, Bronchodilator, and Antiasthmatic Drug Products for Over-the-Counter Human Use). Your “maple organics Cough & Cold Relief” product is misbranded under section 502(f)(1) because the product label is missing adequate directions for use specified in M012.74(d)(2)(i) and M012.74(d)(2)(ii). Specifically, the directions on the product label are missing the following statement, “Children under 2 years of age: Ask a doctor.”Additionally, “maple organics Joint Pain Relief,” “maple organics Muscle Pain Relief,” and “maple organics Cough & Cold Relief” are misbranded under section 502(ee) of the FD&C Act, 21 U.S.C. 352(ee), because these products are nonprescription drugs subject to section 505G of the FD&C Act, 21 U.S.C. 355h, but do not comply with the requirements for marketing under that section and are not the subject of an application approved under section 505 of the FD&C Act, 21 U.S.C. 355.The introduction or delivery for introduction of a misbranded drug into interstate commerce violates section 301(a) of the FD&C Act, 21 U.S.C. 331(a).ConclusionThe violations cited in this letter are not intended to be an all-inclusive list of violations that exist at your facility. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations.FDA placed all drugs and drug products offered for import into the United States from your firm on Import Alert 66-40 on May 23, 2025. Additionally, FDA placed your “maple organics Joint Pain Relief” and “maple organics Muscle Pain Relief” drug products on Import Alert 66-41 on June 30, 2025.Correct any violations promptly. FDA may withhold approval of new applications or supplements listing your firm as a drug manufacturer until any violations are completely addressed and we confirm your compliance with CGMP. We may re-inspect to verify that you have completed corrective actions to any violations.Failure to address any violations may also result in the FDA continuing to refuse admission of articles manufactured at Everlaan Organics, Inc., dba Maple Organics, 17220 Heather Dr, Unit 106 Surrey, British Columbia, Canada, 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 or misbranded 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) and are misbranded under section 502 of the FD&C Act, respectively.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 3025798567 and ATTN: William Yang.Sincerely,/S/Francis GodwinDirectorOffice of Manufacturing QualityOffice of ComplianceCenter for Drug Evaluation and Research/S/Tina SmithCaptain, U.S. Public Health ServiceDirectorOffice of Unapproved Drugs & Labeling ComplianceOffice of ComplianceCenter for Drug Evaluation and Research_____________________1i.e., Quality System, Facilities & Equipment System, Materials System, Production System, Packaging & Labeling System, and Laboratory Control System per FDA’s guidance document Quality Systems Approach to Pharmaceutical CGMP Regulations.2M017 reflects the conditions in the relevant final order established and in effect under Section 505G of the FD&C Act; see Order ID OTC000033, available at FDA’s website OTC Monographs@FDA, https://dps.fda.gov/omuf/ordersearch/order_otc000033.3FDA is not aware of any adequate and well-controlled clinical trials in the published literature that support a determination that “maple organics Joint Pain Relief” and “maple organics Muscle Pain Relief” are GRASE for use under the conditions prescribed, recommended, or suggested in their labeling, nor has FDA determined these drug products to be GRASE pursuant to an order issued under section 505G(b).

Delivery Method:VIA Electronic MailReference #:320-25-100Product:DrugsRecipient:Mr. Alex LiCEOAnhui Hanbon Daily Chemical Co., Ltd.No.55 Chuangye AvenueXinqiao International Industrial ParkHuainan ShiAnhui Sheng,232221ChinaIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesWarning Letter320-25-100August 11, 2025Dear Mr. Li:The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, Anhui Hanbon Daily Chemical Co., Ltd., FEI 3017153258, at No. 55 Chuangye Avenue, Xinqiao International Industrial Park, Huainan, Anhui, 232221, from February 24 to 28, 2025.This warning letter summarizes significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals. See Title 21 Code of Federal Regulations (CFR), parts 210 and 211 (21 CFR parts 210 and 211).Because your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your drug 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 March 11, 2025 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 test samples of each component for specific identity and conformity with all appropriate written specifications for purity, strength, and quality (21 CFR 211.84(d)(1) and 211.84(d)(2)).Your firm manufactures over-the-counter (OTC) drug products, such as(b)(4). You failed to perform adequate identity testing on each incoming component lot used in the manufacture of your drug products, including for(b)(4)and the active ingredient(b)(4).(b)(4)Your firm’s incoming component testing for(b)(4)consists of evaluating appearance and microbiological attributes but does not include adequate identity tests, such as spectroscopic identification, limits for(b)(4), and chromatographic comparison to the retention time of a standard. You did not test the incoming component,(b)(4), for the presence of(b)(4)contamination prior to using in your drug products. Additionally, based on documentation you provided during the inspection, your firm accepted and used several lots of an incorrect excipient,(b)(4), instead of the specified(b)(4)as described in your formulation, and subsequently used these(b)(4)lots in the manufacture of your drug products. Adequate incoming material controls should have identified the incorrect excipient, so that your quality unit could have prevented its use in the drug products.The use of ingredients contaminated with(b)(4)has resulted in various lethal poisoning incidents in humans worldwide. See FDA’s guidance document(b)(4)to help you meet the CGMP requirements when manufacturing drugs containing ingredients at high-risk for(b)(4)contamination at(b)(4).(b)(4)The United States Pharmacopeia (USP) monograph describes(b)(4)as a(b)(4). You received and used(b)(4)that contained greater than(b)(4)based on the supplier’s certificate of analysis (COA) and your own internal specification for the manufacture of your drug product. This material does not conform with the USP monograph.In response to this letter, provide:The chemical and microbiological quality control specifications you use to test and release each incoming lot of components 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 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 comprehensive, independent review of your material system to determine whether all suppliers of components, containers, and closures, are each qualified and the materials are assigned appropriate expiration or retest dates. The review should also determine whether incoming material controls are adequate to prevent use of unsuitable components, containers, and closures.A commitment to provide(b)(4)test results, no later than 30 calendar days from the date of this letter, from testing retains for all lots of high-risk drug components used in the manufacture of drug products. Alternatively, if a retain of a component lot is unavailable, perform retain sample testing of all implicated finished drug product batches for the presence of(b)(4).A full risk assessment for drug products that are within expiry which contain any ingredient at risk for(b)(4)contamination (including, but not limited to,(b)(4)). Take prompt and appropriate actions to determine the safety of all lots of the component(s) and any related drug product that could contain(b)(4), including customer notifications and product recalls for any contaminated lots. Identify additional appropriate corrective actions and preventive actions (CAPAs) that secure supply chains in the future, including, but not limited to, ensuring that all incoming raw material lots are from fully qualified manufacturers and free from unsafe impurities. Detail these actions in your response to this letter.2. Your firm failed to establish and document the accuracy, sensitivity, specificity, and reproducibility of its test methods (21 CFR 211.165(e)).You failed to establish the adequacy of release testing procedures, and you released batches of drug products for distribution without conducting adequate testing to confirm critical quality attributes. For example, you did not use USP chemical and microbiological methods to test incoming drug substance or to test and release finished drug product, nor did you show equivalency or superiority for your alternate in-house methods.Your response is inadequate. You committed to validate your analytical methods and retest affected batches. However, you did not provide sufficient evidence to demonstrate in-house methods are equivalent or superior to the USP methods. Therefore, your commitment to retest affected batches may not yield reliable and valid results.Test methods must be validated to show they are suitable for their intended use, and equivalent or better than applicable USP compendial methods. The reproducibility of your test methods is essential to determine if your drug products meet established specifications for assay and microbial attributes.In response to this letter, provide:A comprehensive, independent assessment of your laboratory practices, procedures, methods, equipment, documentation, and analyst competencies. Based on this review, provide a detailed plan to remediate and evaluate the effectiveness of your laboratory system.A list of chemical and microbial test methods and specifications used to analyze each batch of your drug product before making a batch disposition decision, and the associated written procedures.3. Your firm failed to establish and follow a written testing program designed to assess the stability characteristics of drug products and to use results of stability testing to determine appropriate storage conditions and expiration dates (21 CFR 211.166(a)).Your firm failed to establish an adequate stability program, which includes data from long-term or accelerated storage conditions to demonstrate that your product remains acceptable throughout its labeled expiry period. Without appropriate stability studies, there is no scientific evidence to support that your drug product retains its quality attributes throughout the labeled(b)(4)expiry period.In your response, you state that you will begin stability studies. Your response is inadequate because it lacks sufficient detail describing your stability program procedures and protocols, or equipment for these studies.For products without appropriate stability studies, there is insufficient scientific evidence to support that drug products will meet established specifications and retain their quality attributes through their labeled expiry.In response to this letter, provide:A comprehensive, independent assessment and CAPA plan to ensure the adequacy of your stability program. Your remediated program should include, but not be limited to:o Stability-indicating methods.o Stability studies for each drug product in its marketed container-closure system before distribution is permitted.o An ongoing program in which representative batches of each product are added each year to the program to determine if the shelf-life claim remains valid.o Detailed definition of the specific attributes to be tested at each station (timepoint).All procedures that describe these and other elements of your remediated stability program.4. Your firm failed to establish written procedures for production and process control designed to assure that the drug products you manufacture have the identity, strength, quality, and purity they purport or are represented to possess (21 CFR 211.100(a)).Your firm failed to adequately validate the manufacturing process for your drug product. You do not have assurance that you are capable of consistently manufacturing your drug product with defined quality attributes. Your firm lacks process qualification and data to support fundamental process parameters.In your response, you commit to completing process validation studies. However, your response is inadequate because you did not provide details on completing process performance qualification (PPQ) studies for your drug product, including but not limited to, a PPQ protocol and timeline. Likewise, you did not provide product impact assessments for distributed drug products and ongoing manufacturing.Process validation evaluates the soundness of design and state of control of a process throughout its lifecycle. Each significant stage of a manufacturing process must be designed appropriately and assure the quality of raw material inputs, in-process materials, and finished drugs. Process qualification studies include intensive monitoring and testing throughout each significant process stage to characterize intra-batch variation and evaluate batches to determine whether an initial state of control has been established.Successful process qualification studies are necessary before commercial distribution. Thereafter, ongoing vigilant oversight of process performance and product quality is necessary to ensure you maintain a stable manufacturing operation throughout the product lifecycle. Without adequate process qualification, incorporating all manufacturing inputs and parameters that can affect product quality, your firm lacks basic assurance that you can reproducibly deliver products that meet specifications. See FDA's Guidance for Industry,Process Validation: General Principles and Practicesfor general principles and approaches that the FDA considers appropriate elements of process validation at https://www.fda.gov/media/71021/download.In response to this letter, provide:A detailed summary of your validation program for ensuring a state of control throughout the product lifecycle, along with associated procedures. Describe your program for 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.CGMP Consultant RecommendedBased upon the nature of the violations we identified at your firm, you should engage a consultant qualified as set forth in 21 CFR 211.34 to evaluate your operations and to assist your firm in meeting CGMP requirements. The qualified consultant should also perform a comprehensive six-system audit of your entire operation for CGMP compliance and evaluate the completion and efficacy of your CAPAs before you pursue resolution of your firm’s compliance status with FDA.Your use of a consultant does not relieve your firm’s obligation to comply with CGMP. Your firm’s executive management remains responsible for resolving all deficiencies and systemic flaws to ensure ongoing CGMP compliance.See FDA’s guidance documentQuality Systems Approach to Pharmaceutical CGMP Regulationsfor help implementing quality systems and risk management approaches to meet the requirements of CGMP regulations 21 CFR, parts 210 and 211 at https://www.fda.gov/media/71023/download.ConclusionThe violations cited in this letter are not intended to be an all-inclusive list of violations that exist at your facility. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations.Correct any violations promptly. 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 No.55 Chuangye Avenue, Xinqiao International Industrial Park, Huainan, Anhui, 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 3017153258 and ATTN: Christina Capacci-Daniel.Sincerely,/S/Francis GodwinDirectorOffice of Manufacturing QualityOffice of ComplianceCenter for Drug Evaluation and Researchcc: U.S. AgentMr. Mark M. Yesil, CEODelta Brands Inc.mark@deltabrands.com

Product:DrugsRecipient:www.usaquickmeds.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: August 1, 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.usaquickmeds.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.usaquickmeds.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.usaquickmeds.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. The easy availability of benzodiazepines via the Internet poses additional significant risks to U.S. consumers.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.usaquickmeds.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.usaquickmeds.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.For example, on www.usaquickmeds.com you offer for sale tapentadol, an opioid marketed as:“Aspadol 100mg”“Aspadol® Tab”“Etadol 100mg (Tapentadol) US TO US”“ETADOL 100”“Noosanta 200”“Noosanta 200mg”“Tapentadol”“TAPENTADOL TABLET 100 MG”“TAPENTADOL TABLET 100 mg.”“Tapentadol Tablets 200 mg”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 tapentadol offered for sale by www.usaquickmeds.com. 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 claims:“Aspadol 100mg is a highly potent medication categorized as an analgesic drug.”“Tapentadol is the main ingredient in Aspadol 100mg that helps treat severe pain. This medication is used when other mild pain medications are ineffective or have been tolerated satisfactorily.”“Etadol 100mg is a highly potent medication categorized as an analgesic drug.”“The drug works well to treat moderate to severe levels of pain. You can use the medication to treat both acute and chronic musculoskeletal pain.”“Noosanta 200MG is typically used when other pain drugs fail to provide considerable relief from chronic pain. Tapentadol, the active ingredient in Noosanta 200 mg tablets, is a narcotic pain medication useful for managing moderate to severe pain of various origins.”Currently, there are two tapentadol products that are FDA-approved for the U.S. market. 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.As another example, on www.usaquickmeds.com you offer for sale tramadol, an opioid marketed as “Celcidale P (Tramadol) 100Mg - US to US,” “Celcidale P 100Mg,” and “Tramadol 100 Mg”. 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 descriptions “Brand Name: Celcidale P 100Mg” and “Generic Name: Tramadol 100 Mg”. While there are FDA-approved versions of tramadol 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 tramadol offered for sale by www.usaquickmeds.com. FDA-approved tramadol is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.FDA-approved tapentadol and tramadol are opioid drug products only available pursuant to a prescription from a licensed practitioner. Furthermore, FDA-approved tapentadol and tramadol 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. The boxed warning addresses 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 and tramadol products are taken in conjunction with other central nervous system (CNS) depressants, including alcohol and benzodiazepines, use may result in coma or death.On www.usaquickmeds.com you also offer for sale alprazolam, a benzodiazepine marketed as:“Alprx 1mg (Alprazolam) US TO US”“Alprazolam 1mg”“Alprazolam Tablets IP 1 mg”“Alprx 1mg”“ALPRX-1”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 “Alprazolam tablets are used to treat panic attacks and anxiety disorders that cause symptoms such as flushing, difficulty breathing, sweating, restlessness, insomnia, palpitations, and trembling.” While there are FDA-approved versions of alprazolam 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 alprazolam offered for sale by www.usaquickmeds.com. FDA-approved alprazolam, including the brand name XANAX, is a benzodiazepine indicated for the acute treatment of generalized anxiety disorder and panic disorder with or without agoraphobia.As another example, on www.usaquickmeds.com you offer for sale lorazepam, a benzodiazepine marketed as:“Lorakem-2 (Lorazepam) US TO US”“Lorakem 2mg”“Lorakem-2”“Lorazepam”“Lorazepam Tablets I.P.”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 description “Drug Classes: Anticonvulsants, Anxiolytic, Benzodiazepine”. While there are FDA-approved versions of lorazepam 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 benzodiazepine offered for sale by www.usaquickmeds.com. FDA-approved lorazepam, including the 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.FDA-approved alprazolam and lorazepam are benzodiazepine drug products only available pursuant to a prescription from a licensed practitioner. Furthermore, FDA-approved alprazolam and lorazepam 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.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.usaquickmeds.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)].Additionally, FDA has observed that www.usaquickmeds.com offers prescription drugs for sale without a prescription. 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.usaquickmeds.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.usaquickmeds.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 yourproducts 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