飞利浦医疗（苏州）有限公司报告，由于扫描架、扫描床与操作员/患者意外接触，可能出现运动按钮未松开等情况，飞利浦医疗（苏州）有限公司对其生产的X射线计算机体层摄影设备主动召回。召回级别为二级。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》

行政相对人名称安徽贵皖药业有限责任公司行政相对人类别法人及非法人组织行政相对人代码_1(统一社会信用代码)913416003487151117行政相对人代码_2(工商注册号)行政相对人代码_3(组织机构代码)行政相对人代码_4(税务登记号)行政相对人代码_5(事业单位证书号)行政相对人代码_6(社会组织登记证号)法定代表人姜祥民法定代表人证件类型法定代表人身份证号证件类型证件号码行政处罚决定书文号皖药监药处罚〔2025〕2-23号违法行为类型《中华人民共和国药品管理法》第四十三条第一款违法事实安徽贵皖药业有限责任公司生产中药饮片不符合《药品生产质量管理规范》要求。暂扣或吊销证照名称及编号处罚依据《中华人民共和国药品管理法》第一百二十六条处罚类别罚款处罚名称安徽贵皖药业有限责任公司未遵守药品生产质量管理规范生产药品案处罚内容罚款壹拾陆万元（160000元）。罚款金额(万元)16没收违法所得、没收非法财物的金额(万元)0处罚决定日期2025年06月24日处罚有效期2099年12月31日公示截止期2028年06月24日处罚行政机关安徽省药品监督管理局处罚机关统一社会信用代码11340000MB19570665数据来源单位安徽省药品监督管理局数据来源单位统一社会信用代码11340000MB19570665地方编码340000处罚状态有效备注

行政相对人名称四川一百智慧药品物流有限公司行政相对人类别法人组织行政相对人代码9151072279786928X8（统一社会信用代码）法定代表人李灵行政处罚决定书文号川药监处罚〔2024〕2013号违法行为类型未遵守药品经营质量管理规范违法事实2023年2月16日至10月10日期间，当事人未遵守《药品经营质量管理规范》，违反了《中华人民共和国药品管理法》（2019年修订，简称“《药品管理法》”）第五十三条第一款之规定。处罚依据依据《药品管理法》第一百二十六条和《中华人民共和国行政处罚法》（2021年修订）第二十八条第一款、第三十二条等规定。处罚类别罚款。处罚内容责令当事人改正违法行为，并给予以下行政处罚：罚款50万元（大写：伍拾万圆整）。罚款金额（万元）50万元没收违法所得、没收非法财物的金额（万元）处罚决定日期2025/6/23处罚机关四川省药品监督管理局处罚机关统一社会信用代码11510000MB1808933T

行政相对人名称亳州市惠康堂中药科技有限公司行政相对人类别法人及非法人组织行政相对人代码_1(统一社会信用代码)913416001519483845行政相对人代码_2(工商注册号)行政相对人代码_3(组织机构代码)行政相对人代码_4(税务登记号)行政相对人代码_5(事业单位证书号)行政相对人代码_6(社会组织登记证号)法定代表人王倩法定代表人证件类型法定代表人身份证号证件类型证件号码行政处罚决定书文号皖药监药处罚〔2025〕2-14号违法行为类型《中华人民共和国药品管理法》第四十三条第一款违法事实亳州市惠康堂中药科技有限公司生产中药饮片不符合《药品生产质量管理规范》要求。暂扣或吊销证照名称及编号处罚依据《中华人民共和国药品管理法》第一百二十六条处罚类别罚款处罚名称亳州市惠康堂中药科技有限公司未遵守药品生产质量管理规范生产药品案处罚内容罚款壹拾陆万元（160000元）。罚款金额(万元)16没收违法所得、没收非法财物的金额(万元)0处罚决定日期2025年06月24日处罚有效期2099年12月31日公示截止期2028年06月24日处罚行政机关安徽省药品监督管理局处罚机关统一社会信用代码11340000MB19570665数据来源单位安徽省药品监督管理局数据来源单位统一社会信用代码11340000MB19570665地方编码340000处罚状态有效备注

Product:DrugsRecipient:www.peacefulmeds.comUnited StatesIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesTO: www.peacefulmeds.comFROM: The United States Food and Drug AdministrationRE: Notice of Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the InternetDATE: May 5, 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.peacefulmeds.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.peacefulmeds.com introduces into interstate commerce unapproved and misbranded opioid and benzodiazepine drug products. 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. 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. FDA has also observed that www.peacefulmeds.com introduces into interstate commerce misbranded injectable semaglutide drug products. 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.peacefulmeds.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:Evidence obtained from your website establishes that certain products offered for sale by www.peacefulmeds.com are drugs intended for human use. Examples of claims that provide evidence of the intended use (as defined in 21 CFR 201.128) of these products as drugs for human use include the following:Your description of tramadol marketed as “TRAMADOL” and “Tramadol 100 mg Tabletas” includes:“it [sic] is an opioid analgesic (pain reliever) which works by blocking transmission of pain signals to the brain to lower pain perception.”Your description of diazepam marketed as “VALIUM” and “Valium Diazepam 10 mg 50 comprimidos” includes:“It is commonly used to treat a range of conditions, including anxiety, seizures, alcohol withdrawal syndrome, benzodiazepine withdrawal syndrome, muscle spasms, insomnia, and restless legs syndrome.”These products 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, www.peacefulmeds.com offers tramadol, an opioid, marketed as “TRAMADOL” and “Tramadol 100 mg Tabletas.” 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 the “TRAMADOL” and “Tramadol 100 mg Tabletas” offered by www.peacefulmeds.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. It is only available pursuant to a prescription from a licensed practitioner. FDA-approved tramadol 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 for tramadol 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 tramadol is taken in conjunction with other central nervous system depressants, including alcohol and benzodiazepines, use may result in coma or death.As another example, www.peacefulmeds.com offers diazepam, a benzodiazepine, marketed as “VALIUM” and “Valium Diazepam 10 mg 50 comprimidos.” While there are FDA-approved versions of valium 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 “VALIUM” and “Valium Diazepam 10 mg 50 comprimidos” offered by www.peacefulmeds.com. FDA-approved diazepam is indicated for the management of anxiety disorders or for the short‐term relief of the symptoms of anxiety, symptomatic relief of certain symptoms associated with acute alcohol withdrawal, and as an adjunct for the relief of certain skeletal muscle spasms and convulsive disorders. It is only available pursuant to a prescription from a licensed practitioner. FDA-approved diazepam also bears a boxed warning indicating that the drug carries a significant risk of serious or even life-threatening adverse effects. The boxed warning for diazepam address risks including abuse, misuse, addiction, dependence, and withdrawal reactions. In addition, when diazepam is taken in conjunction with opioids, 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 opioid and benzodiazepine drug products 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 product safely for the 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.peacefulmeds.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)].Furthermore, evidence obtained from your website establishes that www.peacefulmeds.com offers prescription drugs for sale without a prescription. In addition to the aforementioned opioid and benzodiazepine drug products, FDA has observed that www.peacefulmeds.com offers semaglutide drug products without requiring a prescription:Your description of semaglutide marketed as “2 Pens Ozempic 1mg,” “Ozempic 0.25 mg,” “Ozempic 0.5 mg,” and “Ozempic 1 mg” includes:“Ozempic is a brand-name injectable drug pen used to further develop glucose levels in grown-ups (explicitly type 2 diabetics).”“…Ozempic likewise lessens the gamble of major cardiovascular occasions, for example, strokes, coronary episodes, or even passing.”“…Ozempic has become progressively well known for its weight reduction capacities.”Ozempic is the brand name of an FDA-approved drug for the treatment of type 2 diabetes mellitus and established cardiovascular disease that is only available by prescription. Using the brand name of the drug product Ozempic indicates that this product is intended to treat type 2 diabetes mellitus and established cardiovascular disease. The FDA-approved product Ozempic has been approved for marketing by FDA and is limited by a new drug application to use under the supervision of a practitioner licensed to administer such drugs. Therefore, Ozempic is a prescription drug as defined in section 503(b)(1)(A) of the FD&C Act (21 U.S.C. § 353(b)(1)(A)). 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.peacefulmeds.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.peacefulmeds.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 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 Director, Office of Drug Security, Integrity, and ResponseOffice of ComplianceCenter for Drug Evaluation and Research

Delivery Method:VIA UPSProduct:DrugsRecipient:Mr. Dean BerryPresidentSterling Distributors4381 NW 124th AveCoral Springs,FL33065-7634United Statesdberry@sterlingdistributors.netIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesWarning Letter706508June 5, 2025FEI: 3007309337Dear Mr. Berry:The U.S. Food and Drug Administration (FDA) inspected your wholesale distribution facility, Sterling Distributors (Sterling), FEI 3007309337, 4381 NW 124th Ave, Coral Springs, FL 33065-7634, from March 4, 2025, to March 6, 2025.The Drug Supply Chain Security Act (DSCSA) (Title II of Public Law 113-54), enacted by Congress on November 27, 2013, added section 582 to the Federal Food, Drug, and Cosmetic Act (FD&C Act). Section 582 of the FD&C Act (21 U.S.C. 360eee-1) specifies the requirements that certain entities in the pharmaceutical distribution supply chain (including wholesale drug distributors, as defined by the DSCSA) must follow related to product tracing, product identification, verification, and authorized trading partners. This warning letter summarizes significant violations by your firm of requirements in section 503(e) and 582(c) of the FD&C Act. These requirements are intended to help preserve the security of the supply chain for certain prescription drug products, thereby protecting patients from exposure to drugs that may be counterfeit, stolen, contaminated, or otherwise harmful.FDA issued a Form FDA 483 to Sterling at its Coral Springs, FL headquarters location on March 6, 2025. FDA reviewed Sterling’s response submitted on March 26, 2025.DSCSA ViolationsDuring FDA’s inspection, our investigators observed that your firm failed to comply with various requirements of the DSCSA. Specific violations include, but may not be limited to, the following:1. Your firm engaged in wholesale distribution of prescription drug products without being appropriately licensed (FD&C Act Section 503(e)).Under section 503(e)(1)(A) of the FD&C Act, no person may engage in wholesale distribution of a prescription drug unless such person is (i) licensed by the State from which the drug is distributed, or if the State from which the drug is distributed has not established a licensure requirement, is licensed by the Secretary, and (ii) licensed by the State into which the drug is distributed if that State requires licensure of a person that distributes drugs into the State.Between August 29, 2024, and February 4, 2025, your firm received(b)(4)prescription drug products from(b)(4). Between August 29, 2024, and February 5, 2025, your firm distributed these prescription drug units from its Florida facility to customers all over the U.S.For example, your firm conducted the following distributions of prescription drug products without the required licensure in Florida, Arkansas or Mississippi in violation of section 503(e) of the FD&C Act:On 11/5/2024, distribution of(b)(4)units of(b)(4)with lot #s(b)(4).(b)(4)units were shipped under the same tracking number(b)(4)to a pharmacy in Arkansas.On 12/09/2024, distribution of(b)(4)unit of(b)(4), with lot #(b)(4)under shipment tracking number(b)(4)to a pharmacy in Arkansas.On 12/10/2024, distribution of(b)(4)units of(b)(4), lot #s(b)(4), and(b)(4)units of(b)(4), lot #s(b)(4)under the shipment tracking number(b)(4)to a pharmacy in Mississippi.Your firm was not able to demonstrate that Sterling held a prescription drug wholesale distribution license from Florida, where Sterling is located and from where Sterling distributes drugs. In addition, while both Arkansas and Mississippi require licensure of a person that distributes drugs into their states, Sterling was not licensed in either state at the time these prescription drugs were distributed to customers in these states.2. Your firm conducted transactions with trading partners that were not authorized (FD&C Act Section 582(c)(3)).Under section 582(c)(3) of the FD&C Act, trading partners of wholesale drug distributors must be authorized trading partners. Under section 581(2)(B) of the FD&C Act, to be authorized, a wholesale drug distributor must have a valid license under state law or section 583 of the FD&C Act, in accordance with section 582(a)(6) of the FD&C Act, and comply with the licensure reporting requirements of section 503(e) of the FD&C Act. Under section 503(e)(2)(A) of the FD&C Act, wholesale distributors must report to FDA, on an annual basis, “each State by which the person is licensed and the appropriate identification number of each such license; the name, address, and contact information of each facility at which, and all trade names under which, the person conducts business;” and “any significant disciplinary actions.”Sterling purchased product from a trading partner that was not authorized. Specifically, between August 29, 2024, and February 4, 2025, your firm purchased prescription(b)(4)products from(b)(4), another wholesale drug distributor. FDA has no record of(b)(4)ever submitting the required annual reports to FDA regarding state licensure as required by section 503(e) of the FD&C Act, and there is no evidence that(b)(4)held the appropriate state licensure. Further, Sterling could not demonstrate that it took any action to verify the licensure or reporting status of its direct trading partner,(b)(4).13. Your firm failed to respond to requests for information from Federal and State Officials (FD&C Act Section 582(c)(1)(C)).As required by section 582(c)(1)(C) of the FD&C Act, upon a request from Federal or State officials investigating a suspect product or illegitimate product, wholesale drug distributors must respond, within one (1) business day to such a request with the applicable transaction statement and transaction information for the product.As part of its investigation into suspect or illegitimate product identified at a pharmacy in Arkansas, the Arkansas Board of Pharmacy (BoP) sent Sterling a subpoena for records, dated November 19, 2024, via certified mail commanding Sterling to produce records showing purchase information for all products Sterling sold and/or shipped into Arkansas since November 19, 2022. Sterling was not able to demonstrate that it responded to the inquiry, or that it responded to the Arkansas BoP’s follow-up subpoena dated January 14, 2025. After Sterling’s non-response, the Arkansas BoP suspended Sterling’s Arkansas medical gas license. Sterling was notified of this decision in a February 14, 2025, letter sent via certified mail. In addition, the Mississippi BoP first reached out to Sterling via phone call on or around January 8, 2025, seeking information as part of its investigation into suspect or illegitimate product identified at a pharmacy in Mississippi. On January 23, 2025, the Mississippi BoP followed up via email and certified mail requesting invoices for any medications Sterling shipped to Mississippi since January 1, 2022. During the inspection, Sterling acknowledged that it had been contacted by the Arkansas and Mississippi BoP. Sterling was unable to demonstrate that it responded to the Mississippi BoP.Additionally, when FDA presented Sterling with a 582(c)(1)(C) request for information letter on March 4, 2025, your firm did not provide FDA with the applicable transaction information and transaction statement for the products subject to the request. In fact, in response to this request by FDA, you stated, by letter dated March 5, 2025, that Sterling “does not maintain such records in the ordinary course.”4. Your firm failed to identify suspect product in its possession or control (FD&C Act section 582(c)(4)(A)(i)), promptly conduct an investigation with trading partners to determine whether the suspect product was an illegitimate product (FD&C Act Section 582(c)(4)(A)(i)(II)), determine, in coordination with the manufacturer, whether product in its possession or control is illegitimate (FD&C Act Section 582(c)(4)(B)), respond to notifications of illegitimate product from trading partners (FD&C Act Section 582(c)(4)(B)(iii)), and make notifications of illegitimate product to FDA and trading partners (FD&C Act Section 582(c)(4)(B)(ii)).Under section 582(c)(4)(A) of the FD&C Act, wholesale drug distributors must determine whether product in its possession or control is suspect product. Under section 582(c)(4)(A)(i)(II), upon making a determination that a product in its possession or control is a suspect product, a wholesale drug distributor must promptly conduct an investigation in coordination with trading partners, where applicable, to determine whether the product is an illegitimate product. This determination must be made in coordination with the product’s manufacturer (see FD&C Act section 582(c)(4)(B)(i)). In addition, under section 582(c)(4)(B)(iii) of the FD&C Act, wholesale drug distributors must respond to a notification of illegitimate product from a trading partner by identifying all illegitimate product subject to the notification in the wholesale drug distributor’s possession or control, including any product that is subsequently received, and performing the activities specified in section 582(c)(4)(A) of the FD&C Act, including, but not limited to, quarantining and dispositioning any product within the possession or control of the wholesale distributor. Further, under section 582(c)(4)(B)(ii) of the FD&C Act, not later than 24 hours upon determining that a product in its possession or control is an illegitimate product, a wholesale drug distributor must notify FDA, and all immediate trading partners that the wholesale drug distributor has reason to believe may have received the illegitimate product, that the product is illegitimate.On December 4, 2024, Sterling was notified by one of its trading partners, a dispenser, that the dispenser was concerned it had received “mispackaged”(b)(4)from Sterling after product was returned to the dispenser by a patient. At that point, Sterling was obligated to promptly conduct the investigation specified in 582(c)(4)(A)(i)(II) of the FD&C Act; yet Sterling failed to do so. Based on photos of the returned product, the product’s manufacturer,(b)(4), later determined that the product was counterfeit and an illegitimate product. The product was not a genuine unit of(b)(4)but rather a unit of(b)(4)with falsified(b)(4)labeling. The dispenser returned the product to Sterling on December 5, 2024. This further obligated Sterling to promptly conduct the investigation specified in 582(c)(4)(A)(i)(II); yet Sterling again failed to do so. Instead, Sterling returned the product to its supplier,(b)(4), without conducting its own investigation.On December 17, 2024,(b)(4)contacted Sterling about the unit of(b)(4)with falsified(b)(4)labeling as a part of their investigation into the counterfeit and illegitimate product. This again obligated Sterling to promptly conduct the investigation specified in 582(c)(4)(A)(i)(II); yet Sterling again failed to do so.(b)(4)followed-up with Sterling via voice message and email on December 19, 2024, and January 3, 2025. Sterling could not provide any evidence during the inspection that it cooperated with the manufacturer’s investigation into this product. Sterling also could not provide any evidence that it coordinated with the manufacturer to identify illegitimate product in Sterling’s possession or control, including product subsequently received. Evidence collected during the inspection indicates that Sterling continued to receive product with the same lot number as the product subject to the notification of illegitimate product, obtained through the same distributor,(b)(4), until January 28, 2025. Your firm failed to quarantine such product and otherwise investigate. Your firm continued distributing product with the same lot number until February 3, 2025, nearly two months after you were first made aware of having distributed illegitimate product from this supplier labeled with this lot number.Sterling did not notify FDA of the illegitimate product and was not able to demonstrate that it notified immediate trading partners that Sterling had reason to believe may have also received the illegitimate product. Invoices collected during the inspection indicate that Sterling knew or should have known that it distributed illegitimate product obtained from(b)(4)to other dispenser customers. Sterling nevertheless continued to receive product from(b)(4)containing the same lot number that was the subject of the notification of illegitimate product until January 28, 2024, and Sterling continued distributing product containing that lot number until February 3, 2025.Sterling’s actions are especially concerning because certain(b)(4)products, like those Sterling purchased from(b)(4),(b)(4)2(b)(4)3. In addition, counterfeit(b)(4)has been the subject of multiple FDA4and(b)(4)consumer alerts5, 6over the past several years.FDA has provided some specific transaction scenarios that could significantly increase the risk of suspect product entering the drug supply chain, and has recommended that trading partners be particularly diligent when engaging in such transactions.7Such scenarios include:Purchasing product that is generally in high demand in the U.S. market;Purchasing product that has been or is the subject of a public alert or announcement related to drug quality issued by a trading partner or FDA;Purchasing product that has been or is the subject of an FDA counterfeit alert;Purchasing product from a trading partner that has been involved in business transactions where they sold or delivered illegitimate product; andPurchasing product where the finished dosage form seems questionable (e.g., it has a different shape or color from the FDA-approved product, a different or unusual imprint, an unusual odor, or there are signs of poor quality like chips or cracks in tablet coatings or smeared or unclear ink imprints).Nevertheless, Sterling failed to comply with its verification obligations to ensure that the(b)(4)products purchased from(b)(4)were legitimate product. In addition, Sterling continued to distribute product it purchased from(b)(4)through February 5, 2025, well after your firm first became aware that(b)(4)may have distributed illegitimate product. And, as discussed above, in addition to failing to identify such product as suspect product, your firm was not able to demonstrate that Sterling conducted an investigation in coordination with trading partners after receiving a returned unit of counterfeit(b)(4)from a pharmacy to whom your firm distributed product, responded to notifications of illegitimate product from trading partners, or made notifications of illegitimate product to trading partners.5. Your firm failed to collect and maintain transaction information and transaction statements (FD&C Act Section 582(c)(1)).Under section 582(c)(1) of the FD&C Act, wholesale drug distributors must not accept ownership of a product unless the previous owner provides the transaction information and transaction statement for the product, and must provide subsequent purchasers the transaction information and a transaction statement for the product. Under section 582(c)(1)(A)(v), a wholesale distributor must capture the transaction information and transaction statement for each transaction and maintain such information for not less than 6 years.Sterling could not demonstrate that your firm collected and maintained transaction information and transaction statements that should have been received from(b)(4). Sterling could not demonstrate that your firm shared transaction information and transaction statements with Sterling’s downstream trading partners.6. Your firm failed to have systems in place to enable compliance with the verification requirements of the DSCSA. (FD&C Act Sections 582(c)(4)(A) and (B)).Under sections 582(c)(4)(A) and (B) of the FD&C Act, wholesale drug distributors must have systems in place to enable the wholesale distributor to comply with the verification requirements of the DSCSA, including but not limited to:Identifying and determining whether a product in its possession or control is a suspect product;Promptly conducting an investigation in coordination with trading partners, as applicable, to determine whether the product is an illegitimate product, which must include, among other things, investigating to determine whether the product is an illegitimate product and verifying the product at the package level;Quarantining and disposing of any illegitimate product in the wholesale distributor’s possession or control;Taking reasonable and appropriate steps to assist a trading partner with disposition of an illegitimate product not in the possession or control of the wholesale distributor; andMaintaining records of the investigation of a suspect product and disposition of illegitimate product for not less than 6 years.Your firm was not able to produce complete and accurate standard operating procedures (SOPs), or other systems related to compliance with the verification requirements of the DSCSA, that would enable Sterling to comply with the verification requirements under sections 582(c)(4)(A) and (B) of the FD&C Act. Sterling provided the FDA investigators with(b)(4)policy documents and standard operating procedures; none address the verification requirements of the DSCSA.Your Response to the FDA Form 483FDA has reviewed your March 26, 2025, response to our Form FDA 483 in detail. FDA acknowledges the corrective actions Sterling has taken and committed to, but FDA finds Sterling’s response to be inadequate. Sterling’s response does not provide adequate information about how Sterling will ensure compliance with the FD&C Act moving forward. In addition, Sterling’s response does not acknowledge that, as early as November 2024, your firm knew or should have known that it was distributing prescription drugs without a wholesale distributor of prescription drugs license, and that by December 2024, your firm was distributing suspect and illegitimate product. Nevertheless, Sterling chose not to follow-up on those notifications.In your firm’s response, you state that you were not alerted to the fact the products at issue were potentially counterfeit, and therefore suspect and illegitimate.During the course of their investigations,(b)(4)and the Arkansas and Mississippi BoP made multiple attempts to contact Sterling.(b)(4)tried to contact your firm on at least three (3) occasions regarding product it was investigating that had been distributed by your firm. You did not respond to assist in(b)(4)investigation. As a result of your lack of cooperation with(b)(4)investigation,(b)(4)was unable to provide you with additional information. Similarly, if Sterling had responded to the requests for information from the Mississippi and Arkansas State BoP, including the subpoena your firm received from Arkansas BoP, even to seek clarity about the requests, Sterling would have better understood the scope of the respective investigations. Instead, Sterling did not respond to the requests or the subpoena and did not participate in these investigations, in violation of the DSCSA requirements as outlined extensively above. The lack of specific language in these notifications and requests for information does not absolve Sterling of its obligations under the DSCSA. Sterling had significant notice and reason to know that(b)(4), the manufacturer of the products distributed by Sterling, and multiple state BoP were investigating Sterling’s distribution of prescription drug products, and your firm did not act.Sterling’s response does not explain how your firm will process notifications of illegitimate product and requests for information moving forward. It does not address how Sterling will ensure it is responsive and cooperative, as required by DSCSA, when contacted about suspect and illegitimate product investigations in the future.Other reasons Sterling’s response is insufficient include, but are not limited to, the following:Sterling’s response explains that your firm is updating its policies and procedures for reviewing the credentials of vendors. Sterling has not yet explained what these policies and procedures will entail, nor provided a timeline for submitting these revised policies to FDA.In its response, Sterling explains that its vendor purchase order requires vendors to verify that all products sold to Sterling Distributors “have been stored following manufacturer recommendations and have never been previously distributed to any entity,” and that products “are legitimate products purchased from FDA approved manufacturers.” The response does not otherwise explain how Sterling plans to audit its vendors and ensure that product it receives is legitimate product from authorized sources.Given your firm’s confusion over the prescription status of drugs you have previously distributed, Sterling’s response does not explain how your firm will identify drugs as either an over-the-counter drug or a prescription drug.DSCSA ResourcesAs explained above, your firm has failed to comply with a number of DSCSA provisions. Please see FDA’s guidance documents,8including those listed below, for additional information about the DSCSA requirements noted above:Verification Systems Under the Drug Supply Chain Security Act for Certain Prescription Drugs, Final Guidance for Industry, December 2023, https://www.fda.gov/media/117950/download.Definitions of Suspect Product and Illegitimate Product for Verification Obligations Under the Drug Supply Chain Security Act, Final Guidance for Industry, March 2023, https://www.fda.gov/media/111468/download.Drug Supply Chain Security Act Implementation: Identification of Suspect Product and Notification, Final Guidance, June 2021, https://www.fda.gov/media/88790/download.ConclusionSterling’s response to FDA Form 483 does not indicate that sufficient remediation efforts have been taken. FDA is sending this compliance letter to Sterling because of the inherent risk to the supply chain when firms do not comply with the provisions of the DSCSA.The violations cited in this letter are not intended to be an all-inclusive list of violations that exist at your facility. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations.Correct any violations promptly. Failure to promptly and adequately address the violations described herein may result in regulatory or legal action without further notice, including seizure and injunction.Within fifteen (15) working days of your receipt of this letter, please notify this office in writing of the specific steps that you have taken to correct the violations identified in this warning letter. Please include an explanation of each step being taken to prevent the recurrence of violations and include copies of related documentation. If you disagree with the characterization of the violations of the FD&C Act in this warning letter, include your reasoning and any supporting information for our consideration. If you cannot complete corrective actions within fifteen (15) working days, state the reason for the delay and the time within which you will complete the corrections.Please send your electronic reply, or any questions regarding the contents of this letter, to: DSCSAInspections@fda.hhs.gov.Please identify your responses with the unique identifier: CMS 706508.Sincerely,/S/Sangeeta Vaswani Chatterjee, Pharm.D.Acting DirectorOffice of Drug Security, Integrity, and ResponseOffice of ComplianceCenter for Drug Evaluation and Research_________________________1FDA maintains a reporting database that contains information submitted by wholesale drug distributors. Please note that reporting by a wholesale drug distributor provider does not mean the facility is licensed or approved by FDA or the facility is in compliance with applicable state and federal regulations. Check licensure of wholesale drug distributors and third-party logistics providers for more information.2(b)(4)3(b)(4)4(b)(4)5(b)(4)6(b)(4)7See FDA’sDrug Supply Chain Security Act Implementation: Identification of Suspect Product and Notification, Final Guidance, June 2021, https://www.fda.gov/media/88790/download.8FDA guidance documents can be found on our website: Drug Supply Chain Security Act Law and Policies | FDA

Product:DrugsRecipient:www.soma4ever.comSingaporeIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesTO: www.soma4ever.comFROM: The United States Food and Drug AdministrationRE: Notice of Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the InternetDATE: June 13, 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.soma4ever.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.soma4ever.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.soma4ever.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 are 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.Finally, FDA has observed that www.soma4ever.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.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.soma4ever.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.soma4ever.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.Evidence obtained from your website www.soma4ever.com establishing that the products you offer for sale are drugs intended for human use (as defined in 21 CFR 201.128) includes the claims “The medicines sold on our website are 100% genuine and safe to use. We only sell FDA-approved medications that will make you feel better. Our website sells anxiety medications, including Xanax, Ativan, Valium, and Klonopin; insomnia medications, including Ambien; and ADHD medications, including Adderall and Rivotril,” and “We also deal in different kinds of pain medications, both opioids, and non-opioids.”One example of an unapproved opioid you offer for sale on www.soma4ever.com is tapentadol, marketed as “Tapentadol 100mg” and “Aspadol® Tab.” 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 “Tapentadol 100mg” and “Aspadol® Tab” offered by www.soma4ever.com. 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.Additional examples of unapproved opioids you offer for sale on www.soma4ever.com are oxycodone, marketed as “Percocet 10mg/325mg,” and tramadol, marketed as “Tramadol 50mg” “Tramadol 50 mg Tabletas,” “Tramadol 100mg,” “Trakem-100,” “Tramadol 100mg (Citra),” “Citra Tabletas,” “Oltram 100mg,” “OL-TRAM® TABLETS 100mg,” “Tramadol 225mg Royal,” and “Royal - 225.” While there are FDA-approved versions of oxycodone and 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 “Buy Percocet 10mg online,” “Tramadol 50mg” “Tramadol 50 mg Tabletas,” “Tramadol 100mg,” “Trakem-100,” “Tramadol 100mg (Citra),” “Citra Tabletas,” “Oltram 100mg,” “OL-TRAM® TABLETS 100mg,” “Tramadol 225mg Royal,” and “Royal - 225” offered by www.soma4ever.com. FDA-approved oxycodone, including the brand name PERCOCET, and tramadol are each indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.FDA-approved tapentadol, oxycodone, PERCOCET, and tramadol are opioid drug products only available pursuant to a prescription from a licensed practitioner. Furthermore, FDA-approved tapentadol, oxycodone, PERCOCET, 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, oxycodone, PERCOCET, 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.An example of an unapproved benzodiazepine you offer for sale on www.soma4ever.com is alprazolam, marketed as “Xanax 1mg,” “Xanax 2mg,” “Ksalol 1mg,” and “Ksalol® 1mg 30 tableta oralna upotreba.” 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 “Xanax 1mg,” “Xanax 2mg,” “Ksalol 1mg,” and “Ksalol® 1mg 30 tableta oralna upotreba” offered by www.soma4ever.com. FDA-approved alprazolam, including the brand name XANAX, is indicated for the acute treatment of generalized anxiety disorder and panic disorder with or without agoraphobia.Additional examples of unapproved benzodiazepines you offer for sale on www.soma4ever.com include:Clonazepam marketed as “Klonopin 2mg,” “NOZIM-2,” “Rivotril 2mg” and “Rivotril® Clonazepam 2 mg 60 comprimidos birranurados.” While there are FDA-approved versions of clonazepam 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 “Klonopin 2mg,” “NOZIM-2,” “Rivotril 2mg” and “Rivotril® Clonazepam 2 mg 60 comprimidos birranurados” offered by www.soma4ever.com. FDA-approved clonazepam, including the brand name KLONOPIN, is indicated for the treatment of certain seizures and of panic disorder, with or without agoraphobia, as defined in DSM-V.Diazepam marketed as “Valium 5mg,” “Valium 10mg,” and “ELIPAM-10.” While there are FDA-approved versions of diazepam 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 “Valium 5mg,” “Valium 10mg,” and “ELIPAM-10” offered by www.soma4ever.com. FDA-approved diazepam, including the brand name VALIUM, is indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety and acute alcohol withdrawal.Lorazepam marketed as “Ativan 1mg,” “Ativan 2mg,” and “LOR-2.” 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 “Ativan 1mg,” “Ativan 2mg,” and “LOR-2” offered by www.soma4ever.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, clonazepam, diazepam, and lorazepam are benzodiazepine drug products only available pursuant to a prescription from a licensed practitioner. Furthermore, FDA-approved alprazolam, clonazepam, diazepam, 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.An example of an unapproved Schedule II stimulant you offer for sale on www.soma4ever.com is amphetamine, marketed as “Adderall 30mg.” While there are FDA-approved versions of amphetamine 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 “Adderall 30mg” offered by www.soma4ever.com. ADDERALL is the brand name for FDA-approved drug indicated for the treatment of attention deficit hyperactivity disorder and narcolepsy. It is only available pursuant to a prescription from a licensed practitioner. Using the brand name of the drug product ADDERALL indicates that this product is intended to treat attention deficit hyperactivity disorder and narcolepsy. Furthermore, FDA-approved ADDERALL bears a boxed warning, addressing risks including abuse, misuse, and addiction. In addition, ADDERALL can be diverted for non-medical use into illicit channels or distribution. Misuse and abuse of CNS stimulants, including ADDERALL, can result in overdose and death, and this risk is increased with higher doses or unapproved methods of administration.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.soma4ever.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.soma4ever.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.soma4ever.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.soma4ever.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 V. Chatterjee, Pharm.D.Acting Director, Office of Drug Security, Integrity, and ResponseOffice of ComplianceCenter for Drug Evaluation and Research

Product:Medical DevicesRecipient:Tae Hoon KimPresident and CEOAju Pharm Co., Ltd.Room 201, Room 207, Bl A Bundangtekeunopakeu697 Pangyo-RoBundang-guSeongnam-siGyeonggi-do13511South KoreaIssuing Office:Center for Devices and Radiological HealthUnited StatesWARNING LETTERMay 21, 2025Dear Tae Hoon Kim:During an inspection of your firm located in Seongnam-Si, Gyeonggi, South Korea on January 20, 2025, through January 23, 2025, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures the Class II Fixone Hybrid Knotless Anchor and the Class II Fixone Biocomposite Anchor. Under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 321(h), these products are devices because they are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or to affect the structure or function of the body.This inspection revealed that 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. The inspection also revealed that your firm failed to adequately establish and maintain medical device report procedures, as required by 21 C.F.R. § 803.17.We received a response from Lee Seung Hoon, Quality Manager dated February 12, 2025 (received by the FDA on February 11, 2025) concerning our investigator’s observations noted on the Form FDA 483 (FDA 483), List of Inspectional Observations, which was issued to your firm. We address this response below, in relation to each of the noted violations. These violations include, but are not limited to, the following:1. Failure to adequately establish procedures for validating the device design, as required by 21 CFR 820.30(g).For example, although you have been distributing the Fixone Hybrid Knotless Anchor in the United States since 2023, your firm has not followed your Design and Development Procedure, Document # AJP-OP-702, and has not performed design validation activities to ensure that the device conforms to defined user needs and intended uses, including testing of production units under actual or simulated use conditions.We reviewed your firm’s response and concluded that it is not adequate. Your response acknowledged absence of design validation. You also state that your planned actions are expected to be completed by April 30, 2025. As part of your actions, your firm has opened a corrective and preventative action (CAPA) and you plan to conduct a comparative evaluation during the validation stage and to train your staff. Your response is not adequate because it is unclear how the comparative evaluation will assess operative conditions and if the comparator product you will use has undergone adequate design validation. Additionally, your corrective action plan does not include a systemic approach to address the adequacy of all applicable procedures or other devices distributed by your firm. Furthermore, you have not assessed if the distributed devices meet their specifications and if any additional action is necessary to minimize risk to patients.2. Failure to adequately establish and maintain procedures for implementing corrective and preventive action, as required by 21 CFR 820.100(a).For example, a review of your firm’s 2022 and 2023 analysis of complaint data revealed that the firm has yet to initiate CAPAs to address the following identified suture anchor issues:a) For 2022i.(b)(4)ii.(b)(4)iii.(b)(4)b) For 2023i.(b)(4)ii.(b)(4)iii.(b)(4)iv.(b)(4)v.(b)(4)vi.(b)(4)We reviewed your firm’s response and concluded that it is not adequate. Your response acknowledged the absence of CAPA implementation for these nonconformities. You plan to conduct CAPA for nonconformities and take corrective actions based on the results of your data analysis. Your response is not adequate because your corrective action plan does not include a systemic approach to address any applicable CAPA procedures or to retrospectively review other issues identified to date by your firm to determine if additional CAPA activities are necessary. Per your Annual Complaint Handling Trend Analysis Reports for 2022 and 2023, corrective actions were proposed to address the device issues cited above. However, you have not implemented corrective actions in compliance with 21 CFR 820.100 because there was no evidence that your firm adequately investigated the cause of these nonconformities. Additionally, you have not provided any information to evaluate if distributed devices meet their specifications and if any additional action is necessary to minimize risk to patients. We recommend that your response include a thorough investigation of the cause of these nonconformities and identification of any actions necessary to correct and prevent their recurrence. Additionally, we recommend that you verify or validate that any actions taken because of CAPA are effective at addressing the root cause of these issues without adversely affecting the device specifications. And you state that your planned actions are expected to be completed by April 30, 2025.3. Failure to adequately establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit, as required by 21 CFR 820.198(a).For example, twenty (20) complaint files from 2022 to 2024 were reviewed during the inspection. Our inspection revealed that all 20 complaint files randomly selected for review during the inspection did not include sufficient event information on complaint evaluation for MDR reportability.We reviewed your firm’s response and concluded that it is not adequate. Your response acknowledged absence of complaint review for MDR reportability during the complaint handling process. As part of your actions, your firm has opened a CAPA and you plan to document the reporting criteria in the customer complaint handling procedure. Your response is not adequate as your corrective action plan does not include a systemic approach to address this observation such as performing a retrospective evaluation of all past complaints to determine MDR reportability. We recommend that your response addresses the specific complaints identified during our inspection and that all other complaints have been procedurally processed, and if applicable, that investigation of the issues has been initiated. And you state that your planned actions are expected to be completed by April 30, 2025.4. Failure to adequately 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.a) For example, the following suppliers and contractors were not evaluated based on their ability to meet specified requirements, including quality requirements:i.(b)(4)ii.(b)(4)iii.(b)(4)iv.(b)(4)v.(b)(4)We reviewed your firm’s response and concluded that it is not adequate. You acknowledged the absence of supplier evaluations. As part of your actions, your firm has opened a CAPA and plan to re-evaluate your current suppliers to identify approved suppliers. You also plan to document supplier requirements and register key facilities in accordance with FDA regulations. Your response is not adequate because your corrective actions do not include a systemic approach to address all purchasing control procedures. Additionally, you did not conduct a retrospective evaluation of all products and services received and whether those products and services met predetermined specifications and quality requirements. We recommend that your corrective actions also evaluate whether any additional action is necessary for distributed devices to minimize risk to patients. And you state that your planned actions are expected to be completed by April 30, 2025.b) As another example, your firm is currently using the poly(lactic-co-glycolic) acid (PLGA) and β-tricalcium phosphate (β-TCP) to manufacture biocomposite anchors for the Fixone Anchor System. However, the product label for the β-TCP states that this product is “For R&D use only.” Your firm has not evaluated this material from the supplier to ensure it meets predetermined specifications.We reviewed your firm’s response and concluded that it is not adequate. As part of your actions, your firm opened a CAPA and you reached out to the supplier of this manufacturing material to clarify its use in routine manufacturing. Per your response, the supplier ((b)(4)) confirmed that this raw material (β-TCP) can be used in research, synthesis, and processing. You also noted that this raw material was purchased through an(b)(4)((b)(4)),(b)(4)than being(b)(4)from(b)(4). You noted that you have(b)(4)with(b)(4), and you plan to conduct a quality evaluation for this(b)(4)supplier.Your response is not adequate because you have not provided an evaluation of the monitoring and control of component characteristics that confirms the suitability of this β-TCP, and it is unclear if the chemical composition of this manufacturing material meets predetermined specifications. This is critically important considering what appears to be, in comparison to sales data, a high rate of device defects (ascertained via complaints), such as broken suture anchors during insertion, anchor bending, and fix suture loosening. Additionally, your response is not adequate because your corrective action plan does not include a systemic approach to address this observation such as performing an assessment of monitoring and control of component characteristics. We recommend that you perform a risk assessment that evaluates if distributed devices are non-conforming to their specifications and if any additional actions are necessary to minimize risk to patients. Additionally, we recommend that additional training be performed for any changes to production and process control procedures. And you state that your planned actions are expected to be completed by April 30, 2025.5. Failure to adequately establish and maintain process control procedures that describe any process controls necessary to ensure conformance to specifications, where deviations from device specifications could occur because of the manufacturing process, per 21 CFR 820 70(a).For example, your firm's mixing procedure (for the biocomposite anchors), Document #AJP-WS-02, is incomplete in that it fails to include the thawing requirements/procedures of the frozen poly (lactic-co-glycolic acid) (PLGA) prior to mixing. The product label for the PLGA states that the “content must be at room temperature before opening.”We reviewed your firm’s response and concluded that it is not adequate. You acknowledged that the procedure for adequate handling of this critical raw material (PLGA) during the mixing process was not documented. As part of your actions, your firm has opened a CAPA and you plan to revise the relevant procedures for processing this raw material. You state that your planned actions are expected to be completed by April 30, 2025.Your response is not adequate because it did not include plans for training on the revised procedures and it did not include a retrospective evaluation to determine if inappropriate handling of this manufacturing material may have led to the distribution of non-conforming product. Additionally, your corrective actions do not include a systemic approach to address all other process controls used in the manufacturing of your medical devices. As inappropriate manufacturing of the PLGA could lead to changes in the device function and degradation, we recommend that you perform a risk assessment that evaluates if devices distributed are non-conforming to their specifications and if any additional actions is necessary to minimize risk to patients. In comparison to sales data, there appears to be a high rate of device defects (ascertained via complaints), such as broken suture anchors during insertion, anchor bending, and fix suture loosening.6. Failure to adequately establish and maintain procedures to ensure that sampling methods are adequate for their intended use and to ensure that when changes occur the sampling plans are reviewed, as required by 21 CFR 820.250(b).For example, your firm’s in-process testing (after injection) of the bone anchors of the Fixone Hybrid Anchor system are limited to only a few samples and is not based on a valid statistical rationale.We reviewed your firm’s response and concluded that it is not adequate. You acknowledged that your “sampling plan had no statistical basis in the process test at the semi-finished product (injection) stage.” You also state that the planned actions are expected to be completed by April 30, 2025. As part of your actions, your firm has opened a CAPA and you plan to change the injection process sampling criteria to conform to a valid statistical plan.Your firm’s response is not adequate because your corrective actions do not include a systemic approach and do not include an assessment of sampling methods used for all other devices manufactured by your firm. Additionally, you do not include procedural updates to prevent the recurrence of this issue, and do not include any staff training. We recommend that your response includes a statistically justified sampling plan for in-process testing for all manufactured devices.Our inspection also revealed that your firm failed to establish or maintain a record or report required under section 519 of the Act, 21 U.S.C. § 360i, and 21 CFR Part 803 - Medical Device Reporting. Failing to maintain a record or report required under section 519 of the Act is a prohibited act under section 301(e) of the Act. Specifically, your firm failed to adequately develop, maintain, and implement written MDR procedures as required by 21 CFR 803.17.During the inspection, your firm presented a document titled “Safety Information Report”, Doc. No. AJP-OP-807, Ver. No. 4, dated 2024-04-19, where Section 6 is defined as their FDA Medical Device Reporting procedure. After reviewing the procedure, the following deficiencies were noted:a) The procedure does not establish internal systems that provide for timely and effective identification, communication, and evaluation of events that may be subject to MDR requirements, as required by 21 CFR 803.17(a)(1). For example, the instructions for how your firm will evaluate information about an event to make MDR reportability determinations in a timely manner are inadequate because although Section 6.1 references the criteria for report submission and Section 6.3 clarifies what information must be included in the report, the procedure does not define the steps and timeframes the firm will follow to evaluate information received, determine whether certain information is reportable and submit the report accordingly].b) The procedure does not establish internal systems that provide for a standardized review process to determine when an event meets the criteria for reporting under this part, as required by 21 CFR 803.17(a)(2). For example:i. There are no instructions for conducting an investigation of each MDR reportable event and evaluating the cause of the event.ii. The procedure, as written, does not specify who makes the decision for reporting events to FDA.c) The procedure does not establish internal systems that provide for timely transmission of complete medical device reports, as required by 21 CFR 803.17(a)(3). Specifically:i. The procedure does not contain instructions for how your firm will comply with 21 C.F.R. § 803.12(a)’s requirement to submit reports to FDA in an electronic format that the FDA can process, review, and archive. Although Section 6.3 states that the FDA 3500A form much be submitted electronically, it does not identify how employees are to ensure that the form will be submitted to FDA in a format that FDA can process, review, and archive.ii. The procedure does not include a description of the steps for how the firm will ensure that electronic reports are adequately processed and submitted to FDA within the required timeframe.d) The procedure does not describe how your firm will address documentation and recordkeeping requirements, as required by 21 CFR 803.17(b), including:\i. Documentation of adverse event related information maintained as MDR event files.ii. Information that was evaluated to determine if an event was reportable.iii. Documentation of the deliberations and decision-making processes used to determine if a device-related death, serious injury, or malfunction was or was not reportable, as required under 21 CFR 803.18(b)(1)(i).In your response, you state that the planned actions are expected to be completed by April 30, 2025. As part of your actions, you plan to implement corrective actions to adhere to MDR reporting requirements. A device is deemed to be misbranded under section 502(t)(2) of the Act, 21 U.S.C. § 352(t)(2), if there was a failure or refusal to furnish any material or information required by or under section 519 of the Act, 21 U.S.C. § 360i, which includes adverse event reports required under 21 CFR Part 803, respecting the device.”The adequacy of your response cannot be determined at this time. Although your response indicates that actions are expected to be completed by April 30, 2025, your firm has not yet provided a revised procedure as evidence of implementing the above listed issues.Given the serious nature of the violations of the Act by your firm, the Fixone Hybrid Knotless Anchor and the Fixone Biocomposite Anchors that your firm manufactures are subject to refusal of admission under section 801(a) of the Act, 21 U.S.C. § 381(a), in that they appear to be adulterated. As a result, FDA is taking steps to refuse entry of these devices into the United States, known as “detention without physical examination,” until these violations are addressed. To remove the devices from detention, your firm should provide a written response to this Warning Letter as described below and address the violations described in this letter. We will notify you regarding the adequacy of your firm’s response and the need to re-inspect your firm’s facility to verify that the appropriate corrections and/or corrective actions have been made.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.Please notify this office in writing within fifteen business days from the date you receive this letter of the specific steps your firm has taken to address the noted violations, including an explanation of how your firm plans to prevent these violations, or similar violations, from occurring again. Include documentation of the corrections and/or corrective 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. Please provide a translation of documentation not in English to facilitate our review. 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 by email to CDRHWarningLetterResponses@fda.hhs.gov or by mail to Food and Drug Administration, Center for Devices and Radiological Health, Office of Regulatory Programs, Division of Regulatory Programs 2: Establishment Support, Regulatory Inspections and Audits Team, White Oak Building 66, 10903 New Hampshire Avenue, Silver Spring, MD 20993. Refer to CMS case #704823 when replying. If you have any questions about the contents of this letter, please contact: Christopher Ferreira atchristopher.ferreira@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/RDML Raquel Peat, Ph.D., M.P.H., USPHSDirectorOHT 6: Office of Orthopedic DevicesOffice of Product Evaluation and QualityCenter for Devices and Radiological HealthCC:Peter Chung300 Atwood StreetPittsburgh, Pennsylvania 15213Phone: 412-512-8802Email: peterchung210@gmail.com

Delivery Method:VIA Electronic MailReference #:320-25-82Product:DrugsRecipient:Mr. Sinan GundoganCEOPushclean Technology Plastik Sanayi Ve Ticaret Ltd. SirketiErbay Center IC Kapi No.11No.4 Mahmutbey Mahallesi Haci Bostan Caddesi Bagcilar34200/İstanbulTurkeyIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesWarning Letter320-25-82June 16, 2025Dear Mr. Gundogan:Your facility is 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 for records and other information pursuant to section 704(a)(4) of the Federal Food, Drug, and Cosmetic (FD&C) Act for your facility, Pushclean Technology Plastik Sanayi Ve Ticaret Ltd. Sirketi, FEI 3021033904, at Erbay Center IC Kapi No. 11, No.4 Mahmutbey Mahallesi Haci Bostan Caddesi Bagcilar, Istanbul.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)).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:1. Your firm failed to have, for each batch of drug product, appropriate laboratory determination of satisfactory conformance to final specifications for the drug product, including the identity and strength of each active ingredient, prior to release (21 CFR 211.165(a)).Your firm manufactures OTC drug products, such as(b)(4)wipes. Based on the records and information you provided, you did not demonstrate that you adequately tested your finished drug products prior to release and distribution. For example, the test reports that you provided in your response do not demonstrate that you tested for identity and assay testing for your active ingredient(b)(4).Testing is an essential part of CGMP to ensure that the drug products you manufacture conform to all pre-determined quality attributes appropriate for their intended use. Drug products must be tested for identity and strength of the active ingredient, prior to release and distribution. Without adequate testing, you do not have scientific evidence to assure that your drug products conform to appropriate specifications before release.2. Your firm failed to test samples of each component for identity and conformity with all appropriate written specifications for purity, strength, and quality (21 CFR 211.84(d)(1) and 211.84(d)(2).Based on the records and information you provided, you did not demonstrate that you adequately tested the identity of incoming components used in the manufacture of your drug products. Specifically, you failed to conduct identity and component testing for(b)(4), and you failed to conduct conductivity and total organic carbon testing on your(b)(4)used to manufacture your drug products.Without adequate testing, you do not have scientific evidence that your components conform to appropriate specifications prior to use in the manufacture of your drug products.3. 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. For example, your QU failed to establish an adequately validated manufacturing process and to adequately ensure that the stability data supported the expiry of your drug products.Your QU is responsible for fully exercising its authority and responsibilities. FDA is concerned that your QU may not be conducting appropriate oversight regarding CGMP operations.See FDA’s guidance document Quality Systems Approach to Pharmaceutical CGMP Regulations for help implementing quality systems and risk management approaches to meet the requirements of CGMP regulations 21 CFR, parts 210 and 211 at https://www.fda.gov/media/71023/download.Cosmetics Manufactured for Distribution in the United StatesIn addition, some of the products you manufacture may be regulated as cosmetics, as defined in section 201(i) of the FD&C Act (21 U.S.C. 321(i)). Any cosmetics you manufacture must comply with applicable statutory and regulatory requirements, including the FD&C Act. We note that under section 301(a) of the FD&C Act (21 U.S.C. 331(a)), it is a prohibited act to introduce or deliver for introduction into interstate commerce a cosmetic that is adulterated or misbranded. We also note that the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) provides new requirements with which facilities that manufacture cosmetic products must comply. You may find the FD&C Act, MoCRA, and FDA’s regulations through links on FDA’s website at www.fda.gov.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 audit of your entire operation for CGMP compliance and evaluate the completion and efficacy of your corrective actions and preventive actions before you pursue resolution of your firm’s compliance status with FDA.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 June 5, 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 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 Pushclean Technology Plastik Sanayi Ve Ticaret Ltd. Sirketi, FEI 3021033904, at Erbay Center IC Kapi No. 11, No.4 Mahmutbey Mahallesi Haci Bostan Caddesi Bagcilar, Istanbul 34200, Turkey, 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 3021033904 and ATTN: Yvette Johnson.Sincerely,/S/Francis GodwinDirectorOffice of Manufacturing QualityOffice of ComplianceCenter for Drug Evaluation and ResearchCc: Registered U.S. AgentMs. Lili Vainstoklili@pushclean.us

黑龙江诚信阳光大药房连锁有限公司销售劣药醋氯芬酸胶囊（批号：230201）的行为，违反了《中华人民共和国药品管理法》第九十八条第一款之规定，依据《中华人民共和国药品管理法》第一百一十七条第一款、《中华人民共和国药品管理法实施条例》第七十五条、《中华人民共和国行政处罚法》第二十八条，应予以行政处罚。