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  • 福建昇达医药有限公司药品经营案(闽药监厦稽办处罚〔2026〕004、004-1号)

    福建省药品监督管理局行政处罚信息公开表序号行政处罚决定书文号案件名称违法企业名称或违法自然人姓名违法企业社会信用代码法定代表人姓名主要违法事实行政处罚的种类和依据行政处罚的履行方式和期限做出处罚的机关名称和日期备注1闽药监厦稽办处罚〔2026〕004、004-1号福建昇达医药有限公司未遵守药品经营质量管理规范案福建昇达医药有限公司、许*勇91350600689360363E许*勇 经查,当事人从事药品经营活动未遵守药品经营质量管理规范。违法行为发生期间,许*勇为福建昇达医药有限公司的法定代表人兼企业负责人,同时负责该公司的采购和销售工作,为直接责任人。当事人违反了《中华人民共和国药品管理法》第五十三条第一款、第五十七条的规定,构成未遵守药品经营质量管理规范的行为且情节严重。依据《药品管理法》第一百二十六条、《福建省药品监管行政处罚裁量适用细则》第十一条第一款第二项和第八项、第二十八条的规定,责令福建昇达改正上述违法行为,并作出处罚如下:1.处罚款700000元(柒拾万元整)。2.责令停产停业10天。3.没收许*勇自2023年8月15日至2023年11月1日从福建昇达医药有限公司所获收入15000元,并处所获收入百分之二十的罚款3000元,十年禁止从事药品生产经营等活动。当事人应当自接到本行政处罚决定之日起十五日内,缴纳上述罚没款。当事人根据《福建省非税收收入缴款通知书》,自行选择缴款方式。到期不缴纳罚款的,依据《中华人民共和国行政处罚法》第七十二条的规定,本办将每日按罚款数额的百分之三加处罚款,并依法申请人民法院强制执行。福建省药品监督管理局,2026年3月10日。附件:福建省药品监督管理局行政处罚决定书(闽药监厦稽办处罚〔2026〕004、004-1号)

    监管 / 行政处罚 / 药品 江西省
  • 安徽省药品监督管理局第七分局药品流通监督检查信息通告(2026年3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结果1马鞍山市长江医药有限公司马鞍山市雨山区磁山路488号深马华东工业科技产业园13栋药品批发企业2026年3月13日基本符合要求2国药控股铜陵有限公司安徽省铜陵市经济技术开发区泰山大道951号药品批发企业2026年3月18日基本符合要求3芜湖康奇医药销售有限责任公司中国(安徽)自由贸易试验区芜湖片区九华北路116号8号楼(芜湖市鸠江区医药物流科技园C地块)药品批发企业2026年3月17日基本符合要求4芜湖司辰昱霄医药有限公司芜湖市弋江区芜湖高新技术产业开发区南区杨河路口5#厂房药品批发企业2026年3月4日基本符合要求

    监管 / 其它 / 药品 安徽省
  • 安徽省药品监督管理局第七分局化妆品生产监督检查信息通告(2026年1期)

    序号检查时间企业名称生产地址检查依据检查范围检查结论处理措施备注12026.3.17可美科丝化妆品(马鞍山)有限公司安徽马鞍山慈湖高新技术产业开发区慈湖河路4556号《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。一般液态单元(啫喱类);蜡基单元(蜡基类)企业目前处于停产状态

    监管 / 产品质量公告 / 化妆品 安徽省
  • 辽宁省鞍山市新药特大药房连锁有限公司药品经营检查(2026年第36期)

    企业名称鞍山市新药特大药房连锁有限公司企业类型药品零售连锁总部检查时间2026年3月5日-2026年3月6日所在地市鞍山市检查依据《药品管理法》《药品经营和使用质量监督管理办法》《药品经营质量管理规范》等法律、法规、规范性文件检查事项药品经营检查检查方式常规检查检查内容执行GSP情况存在问题在质量管理体系方面存在更换计算机医药管理系统未组织专项内审的问题;在验证校准方面存在未根据验证结论修订操作规程的问题;在人员与培训方面存在未将2026年5月15日实施的《药品管理法实施条例》列入本年度培训计划的问题。处理措施责令限期整改整改情况已按要求完成整改

    监管 / 其它 / 药品 辽宁省
  • 重庆市药品监督管理局关于对重庆叁壹医药有限公司采取风险防控措施的通告

      经监督检查,重庆叁壹医药有限公司存在安全隐患。为防控药品质量安全风险,依据《中华人民共和国药品管理法》第九十九条的规定,重庆市药品监督管理局依法对企业采取暂停销售的风险防控措施,停业期间不得擅自开展药品经营活动。现予以公布。序号企业名称许可证编号经营地址仓库地址经营范围1重庆叁壹医药有限公司渝AA023000650重庆市经开区长生桥镇玉马路18号11幢2-2委托重庆康哲医药有限责任公司储存中成药、化学药、生物制品  企业应当严格落实主体责任,排除质量安全隐患后,向重庆市药品监督管理局提交整改报告,经复查符合条件后予以解除风险防控措施。  特此通告。                                                         重庆市药品监督管理局                                                          2026年3月31日

    监管 / 产品销售公告 / 药品 重庆市
  • 广东省药品监督管理局关于化妆品抽样检验信息的通告(2026年第2期)

    广东省药品监督管理局通 告2026年 第30号  为加强化妆品监管,保障公众用妆安全,根据2025年广东省化妆品抽检计划,广东省药品监督管理局组织对全省化妆品生产经营环节进行化妆品抽样检验,现将化妆品抽样检验信息予以通告(见附件)。  对抽检不符合规定化妆品,广东省药品监督管理局已要求相关企业和单位采取暂停销售、召回等风险控制措施,对不符合规定原因开展调查并切实进行整改。  广东省药品监督管理局要求相关地市药品监督管理部门依据《化妆品监督管理条例》《化妆品生产经营监督管理办法》等法规,组织对相关企业和单位存在的涉嫌违法行为立案调查,严厉打击提供虚假信息或者隐瞒真实情况否认生产的违法行为,并按规定公开查处结果。  附件:广东省化妆品抽样检验信息(2026年第2期)广东省药品监督管理局2026年4月2日

    监管 / 产品质量公告 / 化妆品 广东省
  • Guangzhou Huli Technology Co., Ltd. dba Fantasy Face(RE: 722228)

    Delivery Method:Via Email Product:DrugsRecipient:Haijie LongGuangzhou Huli Technology Co., Ltd. dba Fantasy Face933 W 32nd StChicago,IL60608United Stateslsj20250509@163.comIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesWARNING LETTERMarch 31, 2026RE: 722228Haijie Long:This letter is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your eBay store at https://www.ebay.com/str/fantasyface in December 2025. The FDA has observed that your eBay store offers “Googeer GLP-1 Weight Control Oral Solution” for sale in the United States. Based on our review, this product is an unapproved new drug under section 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 355(a). As explained further below, introducing or delivering this product for introduction into interstate commerce violates sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a).Based on a review of your eBay store, your “Googeer GLP-1 Weight Control Oral Solution” is a drug under section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1), because it is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease, and/or intended to affect the structure or any function of the body.Examples from your product labeling, including on your eBay store, that provide evidence of the intended use (as defined in 21 CFR 201.128) of this product as a drug include, but may not be limited to, the following:Googeer GLP-1 Weight Control Oral SolutionOn the your eBay store webpage https://www.ebay.com/itm/357972658414?itmmeta=01KBR20V0X11QS0M7FX9DMNAJ9&hash=item5358d548ee:g:XG0AAeSwfq5osANH:“Metabolism Support . . . Weight management Blood Sugar Balance”“Ideal Body Shaping helps to shape a slim body.”Your “Googeer GLP-1 Weight Control Oral Solution” product is a “new drug” under section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because it is not generally recognized as safe and effective (GRASE) for use under the above-described conditions prescribed, recommended, or suggested in the labeling. With certain exceptions not applicable here, a new drug may not be introduced or delivered for introduction into interstate commerce without an approved application from FDA in effect, as described in section 505(a) of the FD&C Act, 21 U.S.C. 355(a). No approved application pursuant to section 505 of the FD&C Act, 21 U.S.C. 355, is in effect for this product. Accordingly, this product is an unapproved new drug. The introduction or delivery for introduction into interstate commerce of this unapproved new drug product violates sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a).ConclusionThe violations cited in this letter are not intended to be an all-inclusive statement of violations that may exist in connection with your products. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations.This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address this matter may lead to regulatory or legal action including, without limitation, seizure and injunction.Please notify FDA in writing, within fifteen working days of receipt of this letter, of the specific steps you have taken to correct any violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration. If you cannot complete corrective action within fifteen working days, state the reason for the delay and the time within which you will complete the correction.Your response should be sent to U.S. Food and Drug Administration, CDER/OC/Office of Unapproved Drugs and Labeling Compliance by email to FDAAdvisory@fda.hhs.gov. Please include your firm name and the unique identifier “722228” in the subject line of the email.Sincerely,/S/Tina Smith, M.S.Captain, U.S. Public Health ServiceDirectorOffice of Unapproved Drugs and Labeling ComplianceOffice of ComplianceCenter for Drug Evaluation and ResearchFood and Drug Administrationcc:Mike CarsonRegulatory Policy GroupeBay, Inc.2025 Hamilton AvenueSan Jose, California 95125

    监管 / 其它 / 药品 全国
  • FormPour(RE: 722215)

    Delivery Method:Via EmailProduct:DrugsRecipient:Shuja ArshadFormPour50686 Scarborough RdCanton,MI48188United Statesusapak2020@gmail.comIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesWARNING LETTERMarch 31, 2026RE: 722215Shuja Arshad:This letter is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your eBay store at https://www.ebay.com/str/formpour in December 2025. The FDA has observed that your eBay store offers “SMGT-GLT-1 Nano Microneedle Patch” for sale in the United States. Based on our review, this product is an unapproved new drug under section 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 355(a). As explained further below, introducing or delivering this product for introduction into interstate commerce violates sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a).Based on a review of your eBay store, your “SMGT-GLT-1 Nano Microneedle Patch” product is a drug as defined by section 201(g)(1) of the FD&C Act 21, U.S.C. 321(g)(1) because it is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or intended to affect the structure or function of the body.Examples from your product labeling, including on your eBay store, that provide evidence of the intended use (as defined in 21 CFR 201.128) of this product as a drug include, but may not be limited to, the following:SMGT-GLT-1 Nano Microneedle PatchOn the webpage https://www.ebay.com/itm/376775334757?_skw=smgt-glp-1+nano+microneedle+patch&itmmeta=01KCKN9J0DKBD2MW9SRESK76%E2%80%A6:“The patch contains a blend of fat-burning ingredients (such as caffeine, green tea extract, or other thermogenic compounds) that work to help stimulate fat metabolism, reduce cellulite, and promote a smoother, slimmer appearance.”“For:Type 2 Diabetes TreatmentWeight LossCardiovascular Protection”“Global User Survey Results98.6% Type 2 Diabetes TreatmentWeight Loss Aid 97.5%98.1% Cardiovascular Protection”Your “SMGT-GLT-1 Nano Microneedle Patch” product is a “new drug” under section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because it is not generally recognized as safe and effective (GRASE) for use under the above-described conditions prescribed, recommended, or suggested in the labeling. With certain exceptions not applicable here, a new drug may not be introduced or delivered for introduction into interstate commerce without an approved application from FDA in effect, as described in section 505(a) of the FD&C Act, 21 U.S.C. 355(a). No approved application pursuant to section 505 of the FD&C Act, 21 U.S.C. 355, is in effect for this product. Accordingly, this product is an unapproved new drug. The introduction or delivery for introduction into interstate commerce of this unapproved new drug product violates sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a).ConclusionThe violations cited in this letter are not intended to be an all-inclusive statement of violations that may exist in connection with your products. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations.This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address this matter may lead to regulatory or legal action including, without limitation, seizure and injunction.Please notify FDA in writing, within fifteen working days of receipt of this letter, of the specific steps you have taken to correct any violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration. If you cannot complete corrective action within fifteen working days, state the reason for the delay and the time within which you will complete the correction.Your response should be sent to U.S. Food and Drug Administration, CDER/OC/Office of Unapproved Drugs and Labeling Compliance by email to FDAAdvisory@fda.hhs.gov. Please include your firm name and the unique identifier “722215” in the subject line of the email.Sincerely,/S/Tina Smith, M.S.Captain, U.S. Public Health ServiceDirectorOffice of Unapproved Drugs and Labeling ComplianceOffice of ComplianceCenter for Drug Evaluation and ResearchFood and Drug Administrationcc:Mike CarsonRegulatory Policy Group eBay, Inc.2025 Hamilton AvenueSan Jose, California 95125

    监管 / 其它 / 药品 全国
  • Gram Peptides(RE: 721806)

    Delivery Method:Via EmailProduct:DrugsRecipient:Bernard GramlichGram PeptidesPO Box 9227Rancho Santa Fe,CA92067United Statessupport@grampeptides.comIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesWARNING LETTERMarch 31, 2026RE: 721806Bernard Gramlich:This letter is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website at https://grampeptides.com from January to March 2026. The FDA has observed that your website offers “Retatrutide” (also referred to by your firm as “GLP-1-R peptide”) and “Tirzepatide” (also referred to by your firm as “GLP-2 peptide”) and “Bacteriostatic Water for Injection” (hereinafter Gram Peptides products) for sale in the United States. Based on our review, these products are unapproved new drugs under section 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 355(a). As explained further below, introducing or delivering these products for introduction into interstate commerce violates sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a).These products are especially concerning from a public health perspective because injectable drug products can pose risks of serious harm to users. Injectable products are delivered directly into the body, sometimes directly into the bloodstream, and therefore, bypass some of the body’s key defenses against toxins and microorganisms that can lead to serious and life-threatening conditions.Despite statements on your product labeling marketing your products for “Research Use Only,” and “not intended for human consumption, medical use, or veterinary use,” evidence obtained from your website establishes that your products are intended to be drugs for human use. Your products are drugs as defined by section 201(g)(1) of the FD&C Act 21, U.S.C. 321(g)(1), because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or intended to affect the structure or function of the body.Examples from your product labeling, including on your website, that provide evidence of the intended use (as defined in 21 CFR 201.128) of these products as drugs include, but may not be limited to, the following:Retatrutide (also referred to as “GLP-1-R Peptide”)On the webpage https://grampeptides.com/product/retatrutide/:“[I]nfluences appetite suppression, insulin sensitivity, thermogenesis, and fat-oxidation models.”“[D]emonstrated significant potential for reducing body weight, improving glucose handling, and enhancing lipid metabolism.”“GLP-1-R peptide acts through coordinated activation of: GLP-1 receptors – improving glucose response, slowing gastric emptying, and reducing appetite.”Tirzepatide (also referred to as “GLP-2 Peptide”)On the webpage https://grampeptides.com/product/tirzepatide/:“Benefits of GLP-2 Peptide . . .o Metabolic Regulation – Studied for its ability to lower glucose and support balanced insulin levels.o Weight Management – Associated with significant decreases in body weight in both animal and human studies.o Improved Lipid Profiles – Research shows reductions in triglycerides and improved cholesterol ratios.”Bacteriostatic Water for InjectionYour firm offers “Bacteriostatic Water for Injection” for sale alongside peptide products, which are drugs intended for injection and require reconstitution, including the two above-mentioned GLP products. The sale of these products together demonstrates that you intend for your “Bacteriostatic Water for Injection” to be used in combination for injection. Therefore, your “Bacteriostatic Water for Injection” is a drug.Your Gram Peptides products are “new drugs” under section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because they are not generally recognized as safe and effective (GRASE) for use under the above-described conditions prescribed, recommended, or suggested in their labeling. With certain exceptions not applicable here, a new drug may not be introduced or delivered for introduction into interstate commerce without an approved application from FDA in effect, as described in section 505(a) of the FD&C Act, 21 U.S.C. 355(a). No approved applications pursuant to section 505 of the FD&C Act, 21 U.S.C. 355, are in effect for these products. Accordingly, these products are unapproved new drugs. The introduction or delivery for introduction into interstate commerce of these unapproved new drug products violates sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a).ConclusionThe violations cited in this letter are not intended to be an all-inclusive statement of violations that may exist in connection with your products. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations.This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address this matter may lead to regulatory or legal action including, without limitation, seizure and injunction.Please notify FDA in writing, within fifteen working days of receipt of this letter, of the specific steps you have taken to correct any violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration. If you cannot complete corrective action within fifteen working days, state the reason for the delay and the time within which you will complete the correction.Your response should be sent to U.S. Food and Drug Administration, CDER/OC/Office of Unapproved Drugs and Labeling Compliance by email to FDAAdvisory@fda.hhs.gov. Please include your firm name and the unique identifier “721806” in the subject line of the email.Sincerely,/S/Tina Smith, M.S.Captain, U.S. Public Health ServiceDirectorOffice of Unapproved Drugs and Labeling ComplianceOffice of ComplianceCenter for Drug Evaluation and ResearchFood and Drug Administration

    监管 / 其它 / 药品 全国
  • Lovega LLC dba Pink Pony Peptides(RE: 721088)

    Delivery Method:Via EmailProduct:DrugsRecipient:Susan VegaLovega LLC dba Pink Pony Peptides9314 Forest Hill Blvd 902Wellington,FL33411United Stateshelp@pinkponypeptides.comIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesWARNING LETTERMarch 31, 2026RE: 721088Susan Vega:This letter is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website at https://pinkponypeptides.com/ in December 2025. The FDA has observed that your website offers “GLP-2 TZ,” “GLP-3 RT,” and “Bacteriostatic Water” (hereinafter Pink Pony Peptides products) for sale in the United States. Based on our review, these products are unapproved new drugs under section 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 355(a). As explained further below, introducing or delivering these products for introduction into interstate commerce violates sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a).These products are especially concerning from a public health perspective because injectable drug products can pose risks of serious harm to users. Injectable products are delivered directly into the body, sometimes directly into the bloodstream, and therefore, bypass some of the body’s key defenses against toxins and microorganisms that can lead to serious and life-threatening conditions.Despite statements on your product labeling marketing your products for “laboratory research purposes only” and “[n]ot for human consumption,” evidence obtained from your website establishes that your products are intended to be drugs for human use. Your products are drugs as defined by section 201(g)(1) of the FD&C Act 21, U.S.C. 321(g)(1) because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or intended to affect the structure or function of the body.Examples from your product labeling, including on your website, that provide evidence of the intended use (as defined in 21 CFR 201.128) of these products as drugs include, but may not be limited to, the following:GLP-2 TZOn the webpage https://pinkponypeptides.com/product/glp2/:“As a dual GIP and GLP-1 receptor agonist, Tirzepatide helps:o . . . Reduce appetite and increase satietyo . . . Enhance insulin sensitivity and glucose controlo . . . Curb cravings without harsh stimulantso . . . Support fat loss over time with clinical precisionOriginally developed for type 2 diabetes, Tirzepatide has rapidly become a favorite among physicians and wellness experts for its dramatic body recomposition results and long-lasting appetite regulation.”GLP-3 RTOn the webpage https://pinkponypeptides.com/product/glp3/:“As a GIP, GLP-1, and glucagon receptor agonist, Retatrutide offers three times the fat-fighting horsepower in one clean, clinical ride. This cutting-edge peptide has shown jaw-dropping results in clinical trials — helping the body torch fat, suppress appetite, regulate blood sugar, and even improve metabolic function better than its single-pathway competitors.”Bacteriostatic WaterYour firm offers “Bacteriostatic Water” for sale alongside peptide products, which are drugs intended for injection and require reconstitution, including the two above-mentioned GLP products. The sale of these products together demonstrates that you intend for your “Bacteriostatic Water” to be used in combination for injection. Therefore, your “Bacteriostatic Water” is a drug.Your Pink Pony Peptides products are “new drugs” under section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because they are not generally recognized as safe and effective (GRASE) for use under the above-described conditions prescribed, recommended, or suggested in their labeling. With certain exceptions not applicable here, a new drug may not be introduced or delivered for introduction into interstate commerce without an approved application from FDA in effect, as described in section 505(a) of the FD&C Act, 21 U.S.C. 355(a). No approved applications pursuant to section 505 of the FD&C Act, 21 U.S.C. 355, are in effect for these products. Accordingly, these products are unapproved new drugs. The introduction or delivery for introduction into interstate commerce of these unapproved new drug products violates sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a).ConclusionThe violations cited in this letter are not intended to be an all-inclusive statement of violations that may exist in connection with your products. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations.This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address this matter may lead to regulatory or legal action including, without limitation, seizure and injunction.Please notify FDA in writing, within fifteen working days of receipt of this letter, of the specific steps you have taken to correct any violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration. If you cannot complete corrective action within fifteen working days, state the reason for the delay and the time within which you will complete the correction.Your response should be sent to U.S. Food and Drug Administration, CDER/OC/Office of Unapproved Drugs and Labeling Compliance by email to FDAAdvisory@fda.hhs.gov. Please include your firm name and the unique identifier “721088” in the subject line of the email.Sincerely,/S/Tina Smith, M.S.Captain, U.S. Public Health ServiceDirectorOffice of Unapproved Drugs and Labeling ComplianceOffice of ComplianceCenter for Drug Evaluation and ResearchFood and Drug Administration

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