安徽省药品监督管理局第四分局药品流通监督检查信息通告（2025年4月）序号企业名称经营地址 /仓库地址企业类型检查时间检查人员检查结果1安徽相王医药有限公司安徽省淮北市杜集区石台镇乡村振兴产业园4号厂房西侧1-3层/ 安徽省淮北市杜集区石台镇乡村振兴产业园4号厂房东侧1-2层药品批发企业2025.4.16-17闫培、许珊珊待整改后评定

安徽省中药饮片（含中药配方颗粒）生产第四分局日常监督检查信息通告（2025年4月）序号检查时间企业名称生产地址检查范围检查结论处理措施备注12025年3月4日-5日上海赛睿宿州药业有限公司安徽省宿州市经济开发区金海五路东侧中药饮片（净制、切制、炒制、炙制、蒸制、发酵）整改后符合告诫22025年3月24日-25日安徽省佑森中药饮片有限公司淮北市经济开发区龙湖高新区云龙路西，开渠路以南中药饮片（净制、切制、蒸制、煮制、炒制、炙制、净制）整改后符合告诫32025年4月14日-15日安徽华智生物制药有限公司安徽省淮北市杜集区龙言路18号中药饮片（其他类：胆固醇、胆酸、牛胆粉、猪胆粉、胆红素、猪去氧胆酸）符合/

序号企业名称经营地址/ 仓库地址企业类型检查时间检查人员检查结果1安徽华洲医药贸易有限公司经营地址：安徽省淮南市寿县经济开发区(原工业园区)寿蔡西路寿县清雅环保材料科技有限公司综合厂房3楼仓库地址：安徽省淮南市寿县寿春镇寿蔡西路1号厂房第三层批发企业2025年4月3日李多福、吴旭娟、张普基本符合要求2淮南三和世纪医药有限公司经营地址：淮南市大通区工业新区二期九号办公楼一、二两层仓库地址：淮南市大通区工业新区二期九号1号仓库一层批发企业2025年4月25日吴旭娟、张普基本符合要求

安徽省药品监督管理局第五分局化妆品生产监督检查信息通告（2025年1期）序号检查时间企业名称生产地址检查范围检查依据检查结论处理措施备注12025年4月24日-25日蚌埠天泽家用化学品有限公司安徽省蚌埠市高新开发区兴旺路529号膏霜乳液单元（护肤清洁类）；气雾剂及有机溶剂单元（有机溶剂类）；蜡基单元（蜡基类）《化妆品监督管理条例》《化妆品生产质量管理规范》《化妆品生产质量管理规范检查要点及判定原则》《化妆品检查管理办法》等。基本符合（生产质量管理体系存在缺陷）限期整改无

序号行政处罚决定书文号违法企业名称或自然人姓名法定代表人姓名违法企业组织机构代码违法行为类型主要违法事实行政处罚的内容行政处罚的依据履行方式和期限作出处罚决定的行政机关和日期1鄂药监襄阳药处罚〔2025〕1号湖北药昇中药科技有限公司陈晓91420683MA490XA06W生产、销售劣药该公司生产销售药品性状不符合《中国药典》(2020年版一部)的“海螵蛸”，违反了《药品管理法》第九十八条第一款、第三款第（七）项的规定。1.没收违法产品；2.没收违法所得；3.罚款。《中华人民共和国行政处罚法》第三十二条第（一）项、《中华人民共和国药品管理法》第一百一十七条第一款规定主动履行，当事人收到行政处罚决定书之日起十五日内湖北省药品监督管理局2025年03月24日

行政相对人名称江苏迪赛诺制药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91320481792322090C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祝大勇法定代表人证件类型身份证法定代表人证件号码2****************8证件类型证件号码行政处罚决定书文号苏药监常处字〔2024〕21号违法行为类型《中华人民共和国药品管理法》第九十八条第一款违法事实该单位生产的一批炉甘石洗剂（批号：47240704）产品经监督抽检和复验，不符合标准规定。该单位生产销售该批产品行为，违反《中华人民共和国药品管理法》第九十八条第一款规定，构成生产销售劣药。处罚依据《中华人民共和国药品管理法》第一百一十七条第一款处罚类别罚款;没收违法所得、没收非法财物处罚内容1、没收不符合标准规定的炉甘石洗剂11495瓶；2、没收违法所得28745.96元，罚款1100000元，罚没款合计人民币壹佰壹拾贰万捌仟柒佰肆拾伍元玖角陆分（1128745.96元）。罚款金额（万元）110没收违法所得没收非法财物的金额（万元）2.874596暂扣或吊销证照名称及编号处罚决定日期2025/05/06处罚有效期2025/11/06公示截止期2028/05/06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

序号企业名称经营地址/ 仓库地址企业类型检查时间检查人员检查结果1安徽九天医药有限公司歙县徽城镇旸村工业园1幢药品批发企业2025.4.17-4.18吕春华、、汪浩亮、汪巍基本符合要求

安徽省药品监督管理局第八分局中药饮片生产日常监督检查信息通告（2025年4月）序号检查时间企业名称生产地址企业关键人员检查人员检查结论处理措施备注法定代表人或企业负责人质量负责人生产负责人12025/4/28-4/29安徽祥云谷现代中药有限公司安徽省宣城市旌德县经济开发区篁嘉园区篁嘉大道周俊蒋亦农叶宗荣鲍必卫、武艳艳符合GMP要求限期整改

行政相对人名称安徽健康源医药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91340111MA2N1EJL84法定代表人哈继文行政处罚决定书文号皖药监药处罚﹝2025﹞1-8号处罚类别罚款处罚决定日期2025-04-30处罚内容罚款罚款金额（万元）6.000000没收违法所得、没收非法财物的金额（万元）0.000000暂扣或吊销证照名称及编号-违法行为类型《药品网络销售监督管理办法》第八条第二款、第十一条第一款违法事实当事人于2025年1月22日通过自建微信小程序“安徽健康源医药自营”（小程序管理网址：root.ahjky.cn）销售5盒血液制品人血白蛋白;当事人自2024年12月18日通过该自建微信小程序开始销售药品，截至2025年3月25日检查当日，未向省级药品监督管理部门报告企业名称、网站名称、应用程序名称、IP地址、域名、药品经营许可证等信息。处罚依据《中华人民共和国行政处罚法》第二十八条第一款、《药品网络销售监督管理办法》第三十三条、第三十五条处罚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

Delivery Method:Via EmailProduct:Drugs\Over-the-Counter DrugsRecipient:Andrew R. JassyCEOAmazon.com, Inc.410 Terry Ave. NSeattle,WA98109-5210United StatesRegulatory-inquiries@amazon.comIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesWARNING LETTERApril 17, 2025RE: 689355Dear Mr. Jassy:This letter concerns your firm’s distribution of products that violate the Federal Food, Drug, and Cosmetic Act (the “FD&C Act”). The United States Food and Drug Administration (FDA) purchased on your website, www.amazon.com, external analgesic drug products intended to be used prior to sensitive cosmetic procedures. As discussed further below, your firm is responsible for introducing or delivering for introduction into interstate commerce these products, which are unapproved new drugs under section 505(a) of the FD&C Act, 21 U.S.C. 355(a). These products are also misbranded under section 502(ee) of the FD&C Act, 21 U.S.C. 352(ee). As explained further below, introducing or delivering these products for introduction into interstate commerce is prohibited under sections 301(a) and (d) of the FD&C Act, 21 U.S.C. 331(a) and (d).FDA purchased “Painless Tattoo: Tattoo Numbing Cream,” “Ink Scribd: Numbing Cream,” “Nupharmisto: Tattoo Numbing Cream,” “QWP: Painless Tattoo,” “Kaisasa: Tattoo Numbing Cream,” “Painless Tattoo: Tattoo Triple Numb,” and “TKTX 40%” through your website, www.amazon.com.These products, which are drugs as defined by section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1), were introduced or delivered for introduction into interstate commerce by Amazon via your Fulfillment by Amazon service.1These products are marketed as, among other things,2external analgesics to be used before, during, and/or after various sensitive cosmetic procedures such as tattooing, piercing, and laser hair removal. FDA has safety concerns about external analgesic drug products formulated with active ingredients at concentrations that exceed levels currently permitted for nonprescription external analgesic products, because they are intended to be used before or during certain cosmetic procedures in ways that could lead to increased absorption of the drug product through the skin. FDA is aware that use of these products before and/or during a cosmetic procedure may not be supervised by trained health professionals. Without this supervision, large amounts of topical analgesics may be applied to a person’s skin. FDA has specifically warned in multiple public health advisories3about the use of similar lidocaine and other “-caine” type ingredient products when applied over large areas of skin, particularly on irritated or broken skin, for prolonged periods of time, and when the skin is covered after application. These uses increase the amount of active ingredient that passes into the bloodstream and, if used improperly, may cause serious injury.Unapproved New Drug and Misbranded Drug Violations“Painless Tattoo: Tattoo Numbing Cream,” “Ink Scribd: Numbing Cream,” “Nupharmisto: Tattoo Numbing Cream,” “QWP: Painless Tattoo,” “Kaisasa: Tattoo Numbing Cream,” “Painless Tattoo: Tattoo Triple Numb,” and “TKTX 40%” 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. Specifically, these products are primarily intended for use as external analgesic drug products for pain-sensitive cosmetic procedures.Examples of claims from the product labeling 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:Painless Tattoo: Tattoo Numbing Cream:“PAINLESS TATTOO: TATTOO NUMBING CREAM ALL GAIN NO PAIN TOPICAL ANESTHETIC . . . Drug Facts . . . Active Ingredients . . . Lidocaine 5% . . . Prilocaine 5% . . . Epinephrine 1% . . . Suggested Use . . . For the temporary relief of pain associated with itching, swelling, inflammation or discomfort . . . WE NUMB ???? YOU RELAX ???? ART HAPPENS” [from the product label]Ink Scribd: Numbing Cream:“INK SCRIBD . . . NUMBING CREAM . . . 5% LIDOCAINE . . . TATTOOING . . . HAIR REMOVAL . . . BODY PIERCING . . .” [from the product label]Nupharmisto: Tattoo Numbing Cream:“Nupharmisto . . . TATTOO NUMBING CREAM . . . DRUG FACTS . . . Active Ingredient . . . Lidocaine 5% . . . Uses: For the temporary alleviation of localized discomfort, pruritus, pain, or burning sensation in the perianal area associated with anorectal disorders. . .. Apply a thick layer of numbing cream to the treatment area, making sure to cover both the tattooed area and its surroundings.” [from the product label]QWP: Painless Tattoo:“PAINLESS TATTOO . . . NO PAIN FOREVER, JUST RELAX NOW! . . . Drug Facts . . . Active ingredient . . . Lidocaine 5% . . . Uses: For temporary relief of local discomfort, itching, pain, soreness or burning in the perianal area associated with anorectal disorders. . . For the best numbing effect, follow the application steps, apply the cream thickly and wrap the area with a tattoo film. . .” [from the product label]Kaisasa: Tattoo Numbing Cream:“KAISASA . . . TATTOO NUMBING CREAM . . . Drug Facts . . . Active Ingredient . . . Lidocaine 5% . . . Purpose . . . For temporary relief of local discomfort, itching, pain, soreness or burning related to the tattoo process.” [from the product label]Painless Tattoo: Tattoo Triple Numb:“PAINLESS TATTOO . . . Tattoo Triple Numb . . . TATTOOS . . . BURNS . . . FIRST AID . . . COSMETICS . . . BENZOCAINE 20% . . . LIDOCAINE 4% . . . TETRACAINE 2%” [from the product label]TKTX 40%:“Deep Numb . . . TKTX . . . 40% More Numbing . . . Ingredients . . . Lidocaine 5%, Prilccaine 5% [sic], Epinephrine 1%, Cream Base and so on. . .. Usable Range . . . Mcro [sic] Needle Pain Tattooing Body Piercing, Laser Tattoo Removal, Laser Hair Removal, Waxing, Permanent Cosmetics.” [from the product label]Unapproved New Drug ViolationsBased on the above labeling, “Painless Tattoo: Tattoo Numbing Cream,” “Ink Scribd: Numbing Cream,” “Nupharmisto: Tattoo Numbing Cream,” “QWP: Painless Tattoo,” “Kaisasa: Tattoo Numbing Cream,” “Painless Tattoo: Tattoo Triple Numb,” and “TKTX 40%” are intended for use as external analgesic drugs, among other intended uses. As described below, these drugs 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 “over-the-counter (OTC) monograph drugs”—may be legally marketed if they meet applicable requirements. With respect to nonprescription external analgesic drug products, in order to be GRASE and not new drugs, the products must, among other things, conform to the conditions in the applicable OTC monograph(s), here Over-the-Counter Monograph M017: External Analgesic Drug Products for Over-the-Counter Human Use (hereinafter “M017” or the “external analgesics monograph”).4However, the products your firm distributed do not conform to the conditions specified in M017 for the reasons described below.The labeled concentrations and/or combinations for the active ingredients identified in product labeling for “Painless Tattoo: Numbing Cream,” “Ink Scribd: Numbing Cream,” “Nupharmisto: Tattoo Numbing Cream,” “QWP: Painless Tattoo,” “Kaisasa: Tattoo Numbing Cream,” “Painless Tattoo: Tattoo Triple Numb,” and “TKTX 40%” do not conform to the conditions of use set forth in M017. Specifically, lidocaine, an active ingredient labeled to be in all these products, is listed as lidocaine 5% or lidocaine hydrochloride 5% in all of these products except for “Painless Tattoo: Tattoo Triple Numb.” This concentration is above the 0.5% to 4% concentration range of lidocaine or lidocaine hydrochloride permitted by M017.10(a). Furthermore, “Painless Tattoo: Numbing Cream” includes a combination of lidocaine, prilocaine, and epinephrine as active ingredients in the same drug product; “Painless Tattoo: Tattoo Triple Numb” includes a combination of lidocaine, tetracaine, and benzocaine as active ingredients in the same drug product; and “TKTX 40%” includes a combination of lidocaine, prilocaine, and epinephrine as active ingredients in the same drug product. These combinations of active ingredients in a single external analgesic drug product are not permitted under M017.20.Additionally, labeling for “Painless Tattoo: Tattoo Numbing Cream,” “Ink Scribd: Numbing Cream,” “Nupharmisto: Tattoo Numbing Cream,” “QWP: Painless Tattoo,” “Kaisasa: Tattoo Numbing Cream,” “Painless Tattoo: Tattoo Triple Numb,” and “TKTX 40%” includes indications that are not permitted indications for external analgesic drug products under M017.50(b). Indications related to tattooing and piercing are not included in M017 or any other final administrative order in accordance with section 505G. As stated in the introduction to this letter, we have safety concerns related to the use of these products for these indications due to the potential for greater absorption of the active ingredients through irritated or broken skin.Thus, “Painless Tattoo: Tattoo Numbing Cream,” “Ink Scribd: Numbing Cream,” “Nupharmisto: Tattoo Numbing Cream,” “QWP: Painless Tattoo,” “Kaisasa: Tattoo Numbing Cream,” “Painless Tattoo: Tattoo Triple Numb,” and “TKTX 40%” do not comply with the applicable conditions specified in M017 and have not otherwise been found GRASE.5Accordingly, these products are new drugs within the meaning of section 201(p) of the FD&C Act, 21 U.S.C. 321(p), and there is no basis under section 505G of the FD&C Act under which these products would be legally marketed without an approved application. Because there are no approved applications in effect for these products, these products are unapproved new drugs. The introduction or delivery for introduction into interstate commerce of these unapproved new drug products violates sections 505(a) and 301(d) of the FD&C Act, 21 U.S.C. 355(a) and 331(d).Misbranded Drug Violations“Painless Tattoo: Numbing Cream,” “Ink Scribd: Numbing Cream,” “Nupharmisto: Tattoo Numbing Cream,” “QWP: Painless Tattoo,” “Kaisasa: Tattoo Numbing Cream,” “Painless Tattoo: Tattoo Triple Numb,” and “TKTX 40%” are misbranded under section 502(ee) of the FD&C Act, 21 U.S.C. 352(ee), because they 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 applications 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 is prohibited under 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 statement of past or present violations that may exist in connection with the products you distribute. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations.This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address this matter may result in legal action including, without limitation, seizure and/or injunction. Please notify FDA in writing, within 15 working days of receipt of this letter, of the specific steps you have taken to correct any violations. Include an explanation of each step being taken to prevent the recurrence of violations, including steps you will take to ensure that Amazon will no longer introduce, deliver, or cause the introduction or delivery for introduction into interstate commerce of unapproved external analgesic drug products intended to be used prior to sensitive cosmetic procedures, as well as copies of related documentation. If you believe that the products you distribute are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration.Your response should be sent to U.S. Food and Drug Administration, CDER/OC/Office of Unapproved Drugs and Labeling Compliance by email to FDAAdvisory@fda.hhs.gov. Please include your firm name and the unique identifier “689355” in the subject line of the email.Sincerely,/S/Tina Smith, M.SCaptain, U.S Public Health ServiceDirectorOffice of Unapproved Drugs and Labeling ComplianceOffice of ComplianceCenter for Drug Evaluation and ResearchFood and Drug Administration_______________________1Amazon distributed each of the products directly to individual U.S. consumers on behalf of third parties. Each of the products was “fulfilled” by Amazon; your website states, “Fulfillment by Amazon (FBA) is a program that lets you outsource order fulfillment to Amazon and offer customers free, two-day shipping through Prime. By enrolling in FBA, you can send your products into Amazon’s global network of fulfillment centers, and we’ll pick, pack, and ship orders . . .” (See https://sell.amazon.com/fulfillment-by-amazon.html).2We note that the “Ink Scribd: Numbing Cream,” “Nupharmisto: Tattoo Numbing Cream,” and “QWP: Painless Tattoo” products also appear to be indicated to relieve pain associated with anorectal disorders. OTC anorectal drug products are deemed to be GRASE and not new drugs if, among other things, they conform to the conditions of use set forth in the final administrative order, Over-the-Counter Monograph M015: Anorectal Drug Products for Over-the-Counter Human Use. (See Order ID OTC000009, available at FDA’s website OTC Monographs @ FDA). These products do not conform to the conditions set forth in this monograph.3Refer to FDA public health advisories Life-Threatening Side Effects with the Use of Skin Products Containing Numbing Ingredients for Cosmetic Procedures, Potential Hazards of Skin Products Containing Numbing Ingredients for Relieving Pain from Mammography and Other Medical Tests and Conditions, and Improper Use of Skin Numbing Products Can Be Deadly.4M017 reflects the conditions in the relevant final order established and in effect under section 505G; see Order ID OTC00003333, available at FDA’s website OTC Monographs @ FDA, https://dps.fda.gov/omuf.5FDA is not aware of any adequate and well-controlled clinical studies in the published literature that support a determination that “Painless Tattoo: Numbing Cream,” “Ink Scribd: Numbing Cream,” “Nupharmisto: Tattoo Numbing Cream,” “QWP: Painless Tattoo,” “Kaisasa: Tattoo Numbing Cream,” “Painless Tattoo: Tattoo Triple Numb,” and “TKTX 40%” 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).