行政相对人名称黑龙江亿美医疗美容管理有限公司行政相对人代码(统一社会信用代码)91230607MA1CNAK42J法定代表人秦远行政处罚决定书文号庆市监处罚〔2025〕181号违法行为类型化妆品经营者擅自配制化妆品，或者经营变质、超过使用期限的化妆品的行为违法事实经查，1、自2021年7月6日至2025年1月8日，当事人实施了未执行化妆品进货查验记录制度的行为。2、自2023年7月1日至2025年1月8日实施了使用过期化妆品的行为，货值金额210元，违法所得无法计算。处罚依据《化妆品监督管理条例》 / 第六十条 / 第五项有下列情形之一的，由负责药品监督管理的部门没收违法所得、违法生产经营的化妆品和专门用于违法生产经营的原料、包装材料、工具、设备等物品；违法生产经营的化妆品货值金额不足1万元的，并处1万元以上5万元以下罚款；货值金额1万元以上的，并处货值金额5倍以上20倍以下罚款；情节严重的，责令停产停业、由备案部门取消备案或者由原发证部门吊销化妆品许可证件，对违法单位的法定代表人或者主要负责人、直接负责的主管人员和其他直接责任人员处以其上一年度从本单位取得收入的1倍以上3倍以下罚款，10年内禁止其从事化妆品生产经营活动；构成犯罪的，依法追究刑事责任：（五）化妆品经营者擅自配制化妆品，或者经营变质、超过使用期限的化妆品；;《化妆品监督管理条例》 / 第六十二条 / 第一款 / 第二项有下列情形之一的，由负责药品监督管理的部门责令改正，给予警告，并处1万元以上3万元以下罚款；情节严重的，责令停产停业，并处3万元以上5万元以下罚款，对违法单位的法定代表人或者主要负责人、直接负责的主管人员和其他直接责任人员处1万元以上3万元以下罚款：（二）未依照本条例规定建立并执行进货查验记录制度、产品销售记录制度；处罚类别警告;罚款;没收非法财物处罚内容1、警告，2、处罚款3000元，3、没收违法使用的超过使用期限的化妆品。罚款金额（万元）0.3没收违法所得没收非法财物的金额（万元）0.021处罚决定日期2025-04-03处罚有效期2099-12-31公示截止期2025-07-03处罚机关大庆市市场监督管理局相关推荐CIO提供以下相关文库下载、合规服务以及线上培训课程学习。

主体名称杭州建辰医疗器械有限公司处罚决定书文号杭拱市监处罚﹝2025﹞150号处罚类别罚款处罚决定时间2025-04-03处罚内容当事人发布便隐血(FOB)检测试剂(胶体金法)具有大肠癌筛查、肠胃疾病风险筛查功能的广告的行为,违反了《医疗器械监督管理条例》第六十条第一款“医疗器械广告的内容应当真实合法,以经负责药品监督管理的部门注册或者备案的医疗器械说明书为准,不得含有虚假、夸大、误导性的内容”之规定,属于发布虚假医疗器械广告之违法行为。对当事人发布虚假医疗器械广告的违法行为,根据《医疗器械监督管理条例》第九十七条“违反本条例有关医疗器械广告管理规定的,依照《中华人民共和国广告法》的规定给予处罚”和《中华人民共和国广告法》第五十五条第一款“违反本法规定,发布虚假广告的,由市场监督管理部门责令停止发布广告,责令广告主在相应范围内消除影响,处广告费用三倍以上五倍以下的罚款,广告费用无法计算或者明显偏低的,处二十万元以上一百万元以下的罚款;两年内有三次以上违法行为或者有其他严重情节的,处广告费用五倍以上十倍以下的罚款,广告费用无法计算或者明显偏低的,处一百万元以上二百万元以下的罚款,可以吊销营业执照,并由广告审查机关撤销广告审查批准文件、一年内不受理其广告审查申请”之规定量罚。鉴于当事人积极配合案件调查,如实陈述违法事实并主动提供证据材料,决定对当事人责令停止发布虚假广告,并处罚如下:1、罚款人民币1925元(壹仟玖佰贰拾伍圆整),上缴国库。罚款金额（万元）0.192500没收违法所得0.000000暂扣或吊销证照名称及编号-违法行为类型杭州建辰医疗器械有限公司其它违法行为案处罚依据《医疗器械监督管理条例》第九十七条;违法事实主要违法事实:经查明,杭州建辰医疗器械有限公司是一家主要从事医疗器械销售的企业。2024年3月11日,当事人在其淘宝天猫平台开设的“建辰医疗器械专营店”店铺销售了第一单商品名称为“艾博便隐血检测试纸粪便隐血检测家用筛查自检大肠癌筛查试纸医用”的便隐血(FOB)检测试剂(胶体金法),至2024年12月30日期间,该商品共计销售87单,共计2570.69元。上述商品为第二类医疗器械,注册证号为浙械注准201*****0472,说明书标明预期用途为消化道出血的早期诊断。2024年3月11日至2024年12月30日期间,当事人在上述商品的商品图片中一直使用“肠胃疾病风险筛查”用语。上述商品的广告内容由当事人委托中视美冠(杭州)文化传播有限公司制作,涉案广告制作费用为550元。2024年12月30日被举报后,当事人在上述商品名称及商品图片里删除了“大肠癌筛查”、“肠胃疾病风险筛查”用语。行政处罚种类、依据、内容:当事人发布便隐血(FOB)检测试剂(胶体金法)具有大肠癌筛查、肠胃疾病风险筛查功能的广告的行为,违反了《医疗器械监督管理条例》第六十条第一款“医疗器械广告的内容应当真实合法,以经负责药品监督管理的部门注册或者备案的医疗器械说明书为准,不得含有虚假、夸大、误导性的内容”之规定,属于发布虚假医疗器械广告之违法行为。对当事人发布虚假医疗器械广告的违法行为,根据《医疗器械监督管理条例》第九十七条“违反本条例有关医疗器械广告管理规定的,依照《中华人民共和国广告法》的规定给予处罚”和《中华人民共和国广告法》第五十五条第一款“违反本法规定,发布虚假广告的,由市场监督管理部门责令停止发布广告,责令广告主在相应范围内消除影响,处广告费用三倍以上五倍以下的罚款,广告费用无法计算或者明显偏低的,处二十万元以上一百万元以下的罚款;两年内有三次以上违法行为或者有其他严重情节的,处广告费用五倍以上十倍以下的罚款,广告费用无法计算或者明显偏低的,处一百万元以上二百万元以下的罚款,可以吊销营业执照,并由广告审查机关撤销广告审查批准文件、一年内不受理其广告审查申请”之规定量罚。鉴于当事人积极配合案件调查,如实陈述违法事实并主动提供证据材料,决定对当事人责令停止发布虚假广告,并处罚如下:1、罚款人民币1925元(壹仟玖佰贰拾伍圆整),上缴国库。行政处罚履行方式和期限:当事人自收到行政处罚决定书之日起十五日内,按照行政处罚决定书载明的履行方式履行。处罚机关杭州市拱墅区市场监督管理局处罚机关统一社会信用代码1133010539649777XY数据来源单位省市场监管局数据来源单位统一社会信用代码11330000MB19062420主体名称杭州建辰医疗器械有限公司处罚决定书文号杭拱市监处罚﹝2025﹞150号处罚类别罚款处罚决定时间2025-04-03处罚内容当事人发布便隐血(FOB)检测试剂(胶体金法)具有大肠癌筛查、肠胃疾病风险筛查功能的广告的行为,违反了《医疗器械监督管理条例》第六十条第一款“医疗器械广告的内容应当真实合法,以经负责药品监督管理的部门注册或者备案的医疗器械说明书为准,不得含有虚假、夸大、误导性的内容”之规定,属于发布虚假医疗器械广告之违法行为。对当事人发布虚假医疗器械广告的违法行为,根据《医疗器械监督管理条例》第九十七条“违反本条例有关医疗器械广告管理规定的,依照《中华人民共和国广告法》的规定给予处罚”和《中华人民共和国广告法》第五十五条第一款“违反本法规定,发布虚假广告的,由市场监督管理部门责令停止发布广告,责令广告主在相应范围内消除影响,处广告费用三倍以上五倍以下的罚款,广告费用无法计算或者明显偏低的,处二十万元以上一百万元以下的罚款;两年内有三次以上违法行为或者有其他严重情节的,处广告费用五倍以上十倍以下的罚款,广告费用无法计算或者明显偏低的,处一百万元以上二百万元以下的罚款,可以吊销营业执照,并由广告审查机关撤销广告审查批准文件、一年内不受理其广告审查申请”之规定量罚。鉴于当事人积极配合案件调查,如实陈述违法事实并主动提供证据材料,决定对当事人责令停止发布虚假广告,并处罚如下:1、罚款人民币1925元(壹仟玖佰贰拾伍圆整),上缴国库。罚款金额（万元）0.192500没收违法所得0.000000暂扣或吊销证照名称及编号-违法行为类型杭州建辰医疗器械有限公司其它违法行为案处罚依据《医疗器械监督管理条例》第九十七条;违法事实主要违法事实:经查明,杭州建辰医疗器械有限公司是一家主要从事医疗器械销售的企业。2024年3月11日,当事人在其淘宝天猫平台开设的“建辰医疗器械专营店”店铺销售了第一单商品名称为“艾博便隐血检测试纸粪便隐血检测家用筛查自检大肠癌筛查试纸医用”的便隐血(FOB)检测试剂(胶体金法),至2024年12月30日期间,该商品共计销售87单,共计2570.69元。上述商品为第二类医疗器械,注册证号为浙械注准201*****0472,说明书标明预期用途为消化道出血的早期诊断。2024年3月11日至2024年12月30日期间,当事人在上述商品的商品图片中一直使用“肠胃疾病风险筛查”用语。上述商品的广告内容由当事人委托中视美冠(杭州)文化传播有限公司制作,涉案广告制作费用为550元。2024年12月30日被举报后,当事人在上述商品名称及商品图片里删除了“大肠癌筛查”、“肠胃疾病风险筛查”用语。行政处罚种类、依据、内容:当事人发布便隐血(FOB)检测试剂(胶体金法)具有大肠癌筛查、肠胃疾病风险筛查功能的广告的行为,违反了《医疗器械监督管理条例》第六十条第一款“医疗器械广告的内容应当真实合法,以经负责药品监督管理的部门注册或者备案的医疗器械说明书为准,不得含有虚假、夸大、误导性的内容”之规定,属于发布虚假医疗器械广告之违法行为。对当事人发布虚假医疗器械广告的违法行为,根据《医疗器械监督管理条例》第九十七条“违反本条例有关医疗器械广告管理规定的,依照《中华人民共和国广告法》的规定给予处罚”和《中华人民共和国广告法》第五十五条第一款“违反本法规定,发布虚假广告的,由市场监督管理部门责令停止发布广告,责令广告主在相应范围内消除影响,处广告费用三倍以上五倍以下的罚款,广告费用无法计算或者明显偏低的,处二十万元以上一百万元以下的罚款;两年内有三次以上违法行为或者有其他严重情节的,处广告费用五倍以上十倍以下的罚款,广告费用无法计算或者明显偏低的,处一百万元以上二百万元以下的罚款,可以吊销营业执照,并由广告审查机关撤销广告审查批准文件、一年内不受理其广告审查申请”之规定量罚。鉴于当事人积极配合案件调查,如实陈述违法事实并主动提供证据材料,决定对当事人责令停止发布虚假广告,并处罚如下:1、罚款人民币1925元(壹仟玖佰贰拾伍圆整),上缴国库。行政处罚履行方式和期限:当事人自收到行政处罚决定书之日起十五日内,按照行政处罚决定书载明的履行方式履行。处罚机关杭州市拱墅区市场监督管理局处罚机关统一社会信用代码1133010539649777XY数据来源单位省市场监管局数据来源单位统一社会信用代码11330000MB19062420相关推荐CIO提供以下相关文库下载、合规服务以及线上培训课程学习。

附件2025年监督检查结果通报（第一期）序号企业名称地市检查结果及采取监管措施备 注1国药集团贵州生物制药有限公司黔东南州符合集采药品检查、GMP符合性检查2贵州科伦药业有限公司贵阳市符合集采药品检查、GMP符合性检查3贵州肾元制药有限公司黔南州符合常规检查4贵州健兴药业有限公司贵阳市符合集采药品检查、常规检查5贵州双壶堂药业有限公司贵阳市符合常规检查6贵州汉方药业有限公司贵阳市符合麻醉药品检查7双鹤天安药业（贵州）股份有限公司贵阳市符合集采药品检查8贵阳宇顺气体有限公司贵阳市不符合。暂停生产、销售常规检查9贵州盛世龙方制药股份有限公司黔南州符合常规检查相关推荐CIO提供以下相关文库下载、合规服务以及线上培训课程学习。

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名称违法企业组织机构代码证/ 统一社会信用代码法定代表人/负责人姓名主要违法事实行政处罚内容决定机关名称处罚决定日期公示日期备注1渝药监药处罚〔2024〕41号重庆灏宇医药有限公司出借药品经营许可证案重庆灏宇医药有限公司91500115MAC2FG9A59        彭兵 当事人向他人出借药品经营许可证。当事人的行为违反了《药品经营和使用质量监督管理办法》第二十九条的规定，依据《中华人民共和国药品管理法》第一百二十二条和《中华人民共和国行政处罚法》第二十八条第一款的规定，责令当时人改正违法行为，并决定给予行政处罚如下：1.没收违法所得35000元；2.罚款100000元。重庆市药品监督管理局2025.03.282025.04.03相关推荐CIO提供以下相关文库下载、合规服务以及线上培训课程学习。

广西壮族自治区药品监督管理局行政处罚案件信息公开表（6月）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组织机构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钦分械罚〔2025〕1号广西凯尔医疗科技有限公司涉嫌生产销售不符合规定的血氧检测仪（批号：KE600220221231）广西凯尔医疗科技有限公司91450706MA5Q9YD395田国辉当事人生产销售的血氧检测仪（批号：KE600220221231）“检验项目：设备或设备部件的外部标记”不符合要求，其违反了《医疗器械监督管理条例》第三十九条第二款第（五）项的规定。依据《中华人民共和国行政处罚法》第二十八条和《医疗器械监督管理条例》第八十八条的规定，责令当事人立即停止生产销售说明书或标签未标明其他需要警示或者提示的内容的血氧检测仪的违法行为，并给予当事人以下行政处罚：1、没收违法所得人民币贰仟柒佰陆拾捌元整（¥2768.00元）；2、并处罚款人民币贰万贰仟元整（¥22000.00元）；主动履行2025年3月24日广西壮族自治区药品监督管理局2025年3月24日相关附件：钦分械罚〔2024〕4号行政处罚决定书--广西凯尔医疗科技有限公司公示版.pdf

主体名称舟山芝林大药房零售连锁有限公司沥港店处罚决定书文号舟金市监处罚﹝2025﹞17号处罚类别罚款处罚决定时间2025-04-01处罚内容当事人未经依法经资格认定的药师或其它药学技术人员审核销售处方药的行为违反了《药品经营和使用质量监督管理办法》第四十二条第五款之规定,依据《药品经营和使用质量监督管理办法》第七十二条之规定,本局决定对当事人作如下处理:罚款人民币6500元整。罚款金额（万元）0.650000没收违法所得0.000000暂扣或吊销证照名称及编号-违法行为类型舟山芝林大药房零售连锁有限公司沥港店未经依法经资格认定的药师或其它药学技术人员审核销售处方药案处罚依据《药品经营和使用质量监督管理办法》第七十二条第一款“药品零售企业有以下情形之一的,由药品监督管理部门责令限期改正;逾期不改正的,处五千元以上五万元以下罚款;造成危害后果的,处五万元以上二十万元以下罚款:(一)未按规定凭处方销售处方药的;”;违法事实主要违法事实:2025年1月3日至2025年1月9日,被处罚人舟山芝林大药房零售连锁有限公司沥港店在浙江省舟山市定海区沥港欣港路未经依法经资格认定的药师或其它药学技术人员审核销售处方药。行政处罚种类、依据、内容:当事人未经依法经资格认定的药师或其它药学技术人员审核销售处方药的行为违反了《药品经营和使用质量监督管理办法》第四十二条第五款之规定,依据《药品经营和使用质量监督管理办法》第七十二条之规定,本局决定对当事人作如下处理:罚款人民币6500元整。行政处罚履行方式和期限:当事人自收到行政处罚决定书之日起十五日内,按照行政处罚决定书载明的履行方式履行。处罚机关舟山市市场监督管理局金塘分局处罚机关统一社会信用代码113309000909950478数据来源单位省市场监管局数据来源单位统一社会信用代码11330000MB19062420相关推荐CIO提供以下相关文库下载、合规服务以及线上培训课程学习。

主体名称嘉善县干窑药店处罚决定书文号善市监处罚﹝2025﹞72号处罚类别罚款;没收违法所得处罚决定时间2025-04-01处罚内容对当事人未从药品上市许可持有人或者具有药品生产、经营资格的企业购进药品的违法行为,根据《中华人民共和国药品管理法》第一百二十九条规定,责令当事人改正,决定对当事人作如下处罚:1、没收未从药品上市许可持有人或者具有药品生产、经营资格的企业购进的药品:福牌阿胶(批准文号:国药准字Z37021269,批号:2010057)2盒;2、没收违法所得700元;3、处罚款人民币101000元。对当事人购销药品未按照规定进行记录的违法行为,根据《中华人民共和国药品管理法》第一百三十条的规定,责令当事人改正,决定对当事人作如下处罚:警告。罚款金额（万元）10.100000没收违法所得0.070000暂扣或吊销证照名称及编号-违法行为类型嘉善县干窑药店从非法渠道购进药品案处罚依据《中华人民共和国药品管理法》第七十九条;违法事实主要违法事实:2024年12月16日,本局查获当事人从非法渠道购进福牌阿胶4盒。行政处罚种类、依据、内容:对当事人未从药品上市许可持有人或者具有药品生产、经营资格的企业购进药品的违法行为,根据《中华人民共和国药品管理法》第一百二十九条规定,责令当事人改正,决定对当事人作如下处罚:1、没收未从药品上市许可持有人或者具有药品生产、经营资格的企业购进的药品:福牌阿胶(批准文号:国药准字Z37021269,批号:2010057)2盒;2、没收违法所得700元;3、处罚款人民币101000元。对当事人购销药品未按照规定进行记录的违法行为,根据《中华人民共和国药品管理法》第一百三十条的规定,责令当事人改正,决定对当事人作如下处罚:警告。行政处罚履行方式和期限:当事人自收到行政处罚决定书之日起十五日内,按照行政处罚决定书载明的履行方式履行。处罚机关嘉善县市场监督管理局处罚机关统一社会信用代码113304210974966033数据来源单位省市场监管局数据来源单位统一社会信用代码11330000MB19062420相关推荐CIO提供以下相关文库下载、合规服务以及线上培训课程学习。

主体名称龙港科智妍医疗美容诊所有限公司处罚决定书文号龙市监处罚﹝2025﹞82号处罚类别罚款处罚决定时间2025-04-01处罚内容当事人使用未取得药品注册证书的进口药品行为,违反了《中华人民共和国药品管理法》第二十四条第一款规定,构成使用未取得药品批准证明文件进口药品行为;当事人从未具有药品经营资格的企业购进药品行为,违反了《中华人民共和国药品管理法》第五十五条规定,构成从未具有药品经营资格企业购进药品的违法行为。根据《中华人民共和国行政处罚法》第二十八条第一款和《中华人民共和国药品管理法》第一百二十四条第一款第一项规定,本局决定责令改正违法行为,并作如下处罚:没收案涉麻舒痛乳膏药品1瓶和LIPORASEInj(音译:溶解酶)药品1盒;二、处以罚款30000元,上缴财政。罚款金额（万元）3.000000没收违法所得0.000000暂扣或吊销证照名称及编号-违法行为类型龙港科智妍医疗美容诊所有限公司使用从非法渠道购进未取得药品注册证书的进口药品（使用环节）案处罚依据《中华人民共和国药品管理法》第一百二十四条第一款第(一)项、第三款没收违法生产、进口、销售的药品和违法所得以及专门用于违法生产的原料、辅料、包装材料和生产设备,责令停产停业整顿,并处违法生产、进口、销售的药品货值金额十五倍以上三十倍以下的罚款;货值金额不足十万元的,按十万元计算;情节严重的,吊销药品批准证明文件直至吊销药品生产许可证、药品经营许可证或者医疗机构制剂许可证,对法定代表人、主要负责人、直接负责的主管人员和其他责任人员,没收违法行为发生期间自本单位所获收入,并处所获收入百分之三十以上三倍以下的罚款,十年直至终身禁止从事药品生产经营活动,并可以由公安机关处五日以上十五日以下的拘留。未经批准进口少量境外已合法上市的药品,情节较轻的,可以依法减轻或者免予处罚。;《中华人民共和国药品管理法》第一百二十九条;违法事实主要违法事实:2025年1月27日,本局执法人员在浙江省温州市龙港市鑫浦豪庭**室龙港科智妍医疗美容诊所有限公司实施检查,在其治疗室里的柜台上查获未取得药品批准的进口药品的麻舒痛乳膏药品1瓶和LIPORASEInj(音译:溶解酶)药品1盒。行政处罚种类、依据、内容:当事人使用未取得药品注册证书的进口药品行为,违反了《中华人民共和国药品管理法》第二十四条第一款规定,构成使用未取得药品批准证明文件进口药品行为;当事人从未具有药品经营资格的企业购进药品行为,违反了《中华人民共和国药品管理法》第五十五条规定,构成从未具有药品经营资格企业购进药品的违法行为。根据《中华人民共和国行政处罚法》第二十八条第一款和《中华人民共和国药品管理法》第一百二十四条第一款第一项规定,本局决定责令改正违法行为,并作如下处罚:没收案涉麻舒痛乳膏药品1瓶和LIPORASEInj(音译:溶解酶)药品1盒;二、处以罚款30000元,上缴财政。行政处罚履行方式和期限:当事人自收到行政处罚决定书之日起十五日内,按照行政处罚决定书载明的履行方式履行。处罚机关龙港市市场监督管理局处罚机关统一社会信用代码11330383MB1D79277F数据来源单位省市场监管局数据来源单位统一社会信用代码11330000MB19062420相关推荐CIO提供以下相关文库下载、合规服务以及线上培训课程学习。

Delivery Method:VIA Electronic MailProduct:Medical DevicesRecipient:Jon E. SwansonCOONext Science LLC10550 Deerwood Park Blvd. Ste 300Jacksonville,FL32256United States(b)(6)@nextscience.com(b)(6)@nextscience.comIssuing Office:Center for Devices and Radiological HealthUnited StatesWARNING LETTERCMS # 698114February 21, 2025Dear Mr. Swanson:During an inspection of your firm located in Jacksonville, Florida on August 12 through September 5, 2024, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures wound gels under the brand names SURGX® and BLASTX®, and wound irrigation solutions under the brand names XPERIENCE® and Bactisure®. These products include devices under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 321(h), because they are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body.Lack of Marketing AuthorizationOur inspection and review of your firm’s website (https://www.nextscience.com/) determined that the XPERIENCE®, BLASTX® and SURGX® products are adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B), because your firm does not have an approved application for premarket approval (PMA) in effect pursuant to section 515(a) of the Act, 21 U.S.C. § 360e(a), or an approved application for an investigational device exemption under section 520(g) of the Act, 21 U.S.C. § 360j(g) for the products, as described and marketed. These products are also misbranded under section 502(o) of the Act, 21 U.S.C. § 352(o), because your firm did not notify the agency of its intent to introduce the products into interstate commerce for commercial distribution, as required by section 510(k) of the Act, 21 U.S.C. § 360(k). For a product requiring premarket approval, the notification required by section 510(k) is deemed satisfied when a PMA is pending before the agency. 21 CFR 807.81(b).The kind of information that your firm needs to submit in order to obtain approval or clearance for a device is described on the Internet at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/default.htm. The FDA will evaluate the information that your firm submits and decide whether the product may be legally marketed. Our office requests that your firm cease any activities that result in the misbranding or adulteration of the products.XPERIENCE®Your XPERIENCE® product was cleared under K203835 as MIS Solution with the following indications for use: “MIS Solution is indicated for use in cleansing and removal of debris, including microorganisms, from wounds.” However, based on our inspection and review of your firm’s website, FDA is aware that you are marketing these products without clearance or approval for the following uses in your marketing materials and website (https://www.nextscience.com/xperience/), including but not limited to:“XPERIENCE rinses away debris and microorganisms from the surgical wound site.”“XPERIENCE does not have cytotoxic effects on osteoblasts. Cell viability and bone growth and healing were shown to be more favorable compared to 10% Betadine.”“XPERIENCE is cleared for use in a variety of orthopedic surgeries, including arthroplasty, orthopedic trauma, spine, podiatric, and plastics.”“XPERIENCE is compatible with most commonly used implants, including hydroxyapatite (HA) coated implants, and closure methods.”“XPERIENCE compatibility with surgical implants and closure methods (316 Stainless Steel, Chrome Alloy, Nylon Sutures, Polyethylene Sutures, Polyethylene, Polydimethylsulfoxide, Polyethylene Sutures, Polysulphone, Silk Sutures, Titanium, Tivanium and Hydroxyapatit Implants).”“5+ hours of ongoing, broad-spectrum efficacy.”These claims were not reviewed as part of your premarket notification materials submitted to FDA and do not appear to be within the scope of the clearance issued under K203835. These claims also appear to constitute major changes or modifications in the intended use and could significantly affect the safety or effectiveness of the product that would require submission of a new marketing application. We also note that some of the claims raise jurisdictional issues, and if you intend to continue making such claims, the product may be regulated by the Center for Drug Evaluation and Research (CDER) and subject to drug requirements. Please note that the claims and indications for a product can impact the regulatory pathway of the product, as well as the classification of or jurisdiction of FDA over the product.The agency previously expressed concerns with the use of XPERIENCE® in deep (surgical) wounds. However, you continue to market XPERIENCE® with the cited claims. For example:On March 3, 2019, the FDA provided feedback in K203835, Additional Information Letter which stated that the intended use of your device is for use on breached or compromised skin. Any claims regarding the use of the XPERIENCE® product for deep wound cavities, fissures and wound pockets are not cleared under product code FRO (dressing, wound, drug), and require submission of a 510(k) for FDA review.(b)(4)to conduct an Investigational Device Exemption Study to expand the use of the XPERIENCE® product for the use in colorectal surgical wounds.(b)(4), the FDA communicated our concern regarding the hemocompatibility of XPERIENCE® product, indicating that it is likely hemolytic. The FDA raised concern that hemocompatibility testing or scientific rationale is needed to evaluate the risk of using the XPERIENCE® product in surgical wounds. You have not provided any additional hemocompatibility report and have not been granted clearance for use of XPERIENCE® in deep (surgical) wounds.BLASTX®Your BLASTX® product was cleared under K150792 as Next ScienceTM Wound Gel for Over-The-Counter Use with the following indications for use: “Next ScienceTM Wound Gel is indicated for the management of skin abrasions, lacerations, minor irritations, cuts, exit sites and intact skin.” However, based on our inspection and review of your firm’s website, FDA is aware that your firm is marketing this product without clearance or approval for the following uses in your marketing materials and website (https://www.nextscience.com/blastx-wound-gel/), including but not limited to:“BLASTX® can be applied once daily for up to 30 days.”“BLASTX® has been shown to suppress inflammation and repair the skin’s barrier function.”“BLASTX® inactivates matrix Metalloproteases (MMPs), leading to stopping the cytokine cascade. Also, BLASTX® inactivates proteases production by the bacteria, which prevents tissue destruction and inflammation by the same mechanism.”“Lowers inflammation allowing transition to proliferative stage.”“BLASTX® Results in Fewer Days with Wounds, Fewer Amputations.”These claims were not reviewed as part of your premarket notification materials submitted to FDA and are outside the scope of the clearance issued under K150792. These claims also appear to constitute major changes or modifications in the intended use of the product that require submission of a new marketing application. We also note that some of the claims raise jurisdictional issues, and if you intend to continue making such claims, the product may be regulated by CDER. Please note that the claims and indications for a product can impact the regulatory pathway of the product, as well as the classification of or jurisdiction of FDA over the product.SURGX®Your SURGX® product was cleared under K163188 as Next Science nonsterile wound gel for Prescription Use and with the following indications for use: “Next Science Wound Gel (Rx) is indicated for the management of wounds such as Stage I-IV pressure ulcers, partial and full thickness wounds, diabetic foot and leg ulcers, post-surgical wounds, first- and second-degree burns, grafted and donor sites.” However, based on our inspection and review of your firm’s website, FDA is aware that your firm is marketing this product without clearance or approval for the following uses in your marketing materials and website, including but not limited to:“SURGX® Sterile Antimicrobial Gel as sterilized by gamma radiation for one time use.”“SURGX® is designed to reduce surgical site and post-surgical infections by destroying planktonic and biofilm-encased bacteria within the gel. The proprietary, non-toxic formulation conforms to the postoperative wound to provide proven broad spectrum and sustained effectiveness for up to 5 days.”These claims were not reviewed as part of your premarket notification materials submitted to FDA and are outside the scope of the clearance issued under K163188. These claims also appear to constitute major changes or modifications in the intended use of the product that require submission of a new marketing application. We also note that some of the claims raise jurisdictional issues, and if you intend to continue making such claims, the product may be regulated by CDER. Please note that the claims and indications for a product can impact the regulatory pathway of the product, as well as the classification of or jurisdiction of FDA over the product.Additionally, your firm is currently marketing the XPERIENCE®, BLASTX® and SURGX® products as powered by XBIO® Technology. Our inspection and the review of your website (https://www.nextscience.com/) indicates you are making the following claims for XBIO® Technology:“Since 2012, Next Science has been developing revolutionary material science-based technology that is non-toxic with proven efficacy against bacteria and microorganisms. This technology is called XBIO®.”“XBIO™ Technology deconstructs biofilm by removing the metal ions holding it together.”“XBIO Technology takes an innovative approach to solving the problem of bacterial biofilms. The unique, non-toxic technology attacks and deconstructs the structure of the biofilm by removing the metal ions that hold the EPS together. This exposes the bacteria within the biofilm, making them more vulnerable to eradication. Bacteria that are enveloped within the XBIO Technology are then destroyed by the combination of a surfactant and high osmotic imbalance across the bacterial cell wall. XBIO Technology’s broad-spectrum efficacy helps defend from biofilm reformation, reducing the rate of reoccurrence by over 100X. Due to this unique mechanism of action there is no known resistance to XBIO Technology.”“XBIO gives physicians the transformational technology to help improve surgical outcomes for even their most at-risk patients.”“Through our anti-biofilm solutions, it is our purpose to help reduce infections and combat the rising problem of antimicrobial resistance.”“At Next Science, we are leading a paradigm shift with a unique approach to eradicating both biofilm bacteria and planktonic bacteria with our XBIO Technology. XBIO disrupts the biofilm’s extracellular polymeric substance and exposes the bacteria, once protected by the biofilm, leaving it more vulnerable to attack.”From the review of your marketing material, you claim XBIO® Technology deconstructs biofilm by removing the metal ions holding biofilm together. The claims indicate that XBIO® Technology has effect on biofilm. XPERIENCE®, BLASTX® and SURGX® have not been evaluated for safety and effectiveness against biofilm. As communicated to you during the regulatory meeting held on May 5, 2022, the antimicrobial component found in your 510(k) cleared products are intended to function as a preservative that inhibits growth of microorganisms in the products and claims of effectiveness against biofilm are outside the clearance of XPERIENCE®, BLASTX® and SURGX®. Additionally, the claims found in our inspection and review of your website go beyond the types of claims appropriate for wound dressings and wound washes categorized under the FRO product code. Further, the claims raise jurisdictional issues, and if you intend to continue making such claims, we note that the products may be regulated by CDER and subject to drug requirements.Quality System Regulation (QSR) ViolationsThis inspection also revealed that these products 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.We received your responses dated September 26, 2024, November 21, 2024, and January 15, 2025, concerning our investigator’s observations noted on the Form FDA 483 (FDA 483), List of Inspectional Observations, that was issued to your firm. We address this response below, in relation to each of the noted violations. These violations include, but are not limited to, the following:1. Failure to establish and maintain procedures for validating the device design to ensure that devices conform to defined user needs and intended uses and include testing of production units under actual or simulated use conditions, and include risk analysis where appropriate, as required by, 21 CFR 820.30(g). Specifically,a. Your firm did not provide evidence to demonstrate that the design of XPERIENCE® was validated for the uses claimed in the product labeling and marketing material. Design validation activities for XPERIENCE® (MIS Solution FDA 510(k) K203835) were conducted for cleansing and removal of debris, including microorganisms, from external topical wounds, but your firm markets the solution as “cleared for use in a variety of orthopedic surgeries, including arthroplasty, orthopedic trauma, spine, podiatric, and plastics,” areas that may pose a greater risk and potential adverse effects because of the access to blood vessels and bone. Your firm did not conduct additional blood compatibility studies when establishing the biocompatibility assessment of XPERIENCE® that would be relevant for the uses marketed by your firm. Without this information, there are outstanding questions related to hemolysis risks from the use of this product as marketed by your firm.b. Your firm did not present design validation studies to support the biofilm disruption mechanism of action currently promoted on your products’ labeling and marketing material. Specifically, your firm’s wound gels and irrigation solutions are labeled as “Powered by XBio®.” Your firm’s website explains that XBio® is a proprietary non-toxic technology platform that disrupts the biofilm’s EPS matrix by removing the metal ions holding it together without inhibiting new tissue growth, offers no known opportunity for bacteria resistance, and removes bacteria from the treated surface and defends against biofilm recurrence.c. Your firm failed to conduct design validation studies to support the website claim that SURGX® provides broad-spectrum efficacy and multi-log reduction within the gel for fungusC. albicans and A. brasiliensis.Your responses indicate that you have opened CAPA 0029 in response to this observation and that the marketing materials were placed on your firm’s website by a marketing associate without going through the formal review and approval process. Your responses indicate that your firm did not intend to plan and promote these products for the uses described above. Your responses also indicate that you have corrected your website and that your firm will review all currently approved marketing materials to verify that there is supporting evidence for each claim and will remove any claims without such evidence. Your responses indicate that you have hired a Director of Marketing with experience related to medical devices. In addition, your responses stated that you have reopened your Risk Management Plan and initiated a comprehensive reevaluation of risk management activities in accordance with ISO 14971 to better evaluate potential harms associated with known conditions of use. Your responses also indicated that you will update your firm’s website to clearly differentiate the use of XBIO® Technology in non-FDA regulated applications. In addition, your January 15, 2025, response indicates that your firm has updated several applicable procedures. However, at this time, the adequacy of your corrections cannot be determined at this time. Your corrections are ongoing, and a follow-up inspection will verify the effectiveness of your corrective actions.2. Failure to 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:Your firm’s procedure QOP-85-03, Customer Complaints, assigns responsibilities and provides a system and instructions for receiving and processing customer complaints relating to the product. This procedure was not adequately established in that:a. Information collected by your company from February 2022 through January 2023 regarding excessive bleeding caused by XPERIENCE® was not comprehensively evaluated to determine its relationship to the product and to understand the underlying potential mode or mechanism of failure when using the product on breast soft tissue. Specifically, your firm’s Medical Science Liaison Manager informed a clinical site on January 24, 2023, the following about the bleeding reports: “The fluid action coupled with the surfactant and citrates may loosen micro-clots. Moreover, a cleaner space than you usually see with just N/S may make any extant bleeders more obvious. The general approach seems to be to simply slow down and allow those clots to stabilize before commencing aggressive irrigation.” There is no evidence that this information was further investigated to identify failure mode, risk of using the product on breast soft tissue, and any corrective action needed to preclude the bleeding and oozing adverse events.b. Complaints reporting several events under one report are entered in your complaint system as one complaint, limiting the extent of the investigation to be conducted for each individual case. Specifically, complaints received for XPERIENCE® reporting excessive bleeding did not include the nature and details of each individual case. In addition, data for complaint trending may be artificially lowered by grouping several events under one complaint, for example:i. Complaint # 00265- a surgeon reported three cases of bleeding he encountered at two different surgery centers.ii. Complaint # 00266- a surgeon reported two cases of increase in bleeding within the first five minutes after irrigating on capsulectomy cases.iii. Complaint # 00274- a surgeon reported three cases of oozing and bleeding and one case of hematoma.iv. Complaint # 00278- a surgeon reported three cases of diffuse bleeding and oozing.v. Complaint # 00299- a surgeon reported two cases of diffuse bleeding and one hematoma requiring drainage.Your responses indicate that you have opened CAPA 0033 and that you have updated your complaint handling module to ask whether new information has been received on a previously closed investigation that would warrant further investigation. Your responses also indicate that you have created a new procedure for Issue Impact Assessments QOP 85-05, and that training was conducted. In addition, your responses indicate that a retrospective review of complaints for all product families and new individual complaint events was opened. Also, your January 15, 2025, response indicates that your firm has updated QOP-82-01 to redefine the process, roles, and responsibilities for the act of reviewing publications, articles, literature reviews and opening complaint report records. We cannot determine the adequacy of your corrective actions at this time. A follow-up inspection will need to be conducted to evaluate the adequacy of the implementation and the effectiveness of your corrective actions.3. Failure to adequately establish and maintain procedures for implementing corrective and preventive action, as required by 21 CFR 820.100(a). Specifically, per your Corrective and Preventive Action procedure QOP-85-004, a reported failure that may pose a significant patient safety risk and/or presents an upward trend of reported events are to be considered sources of corrective and preventive actions. Your firm did not follow this procedure for the XPERIENCE® bleeding complaints in that a CAPA was not opened after receiving at least twenty reports of excessive bleeding after using XPERIENCE® to rinse the breast pocket in breast surgery cases.Your responses indicate that you have opened CAPA 0036 and determined that the failure occurred because the relevant procedures did not properly trigger CAPA escalation. Your responses indicate that you have modified your procedures and conducted a retrospective review of complaints based on the updated procedures to determine if CAPAs need to be initiated for certain failures. Your January 15, 2025, response indicated that your firm concluded that no new issues required escalation to CAPA when compared against updated Customer Complaints procedure QOP-85-03. Your responses also indicate that you have developed a new procedure QOP-85-05 Issue Impact Assessment in order to have a documented determination for elevation to CAPA. Your responses indicate that the new procedure will require the Issue Impact Assessment be revisited (including CAPA determinations) when failure modes of a similar nature are detected. Your responses also indicate that you have developed a new work instruction that requires the reporting of trending of failure modes for adverse/reportable/IIA events. We cannot determine the adequacy of your corrective actions at this time. A follow-up inspection will need to be conducted to evaluate the implementation and the effectiveness of your corrective actions.Medical Device Reporting (MDR) ViolationsOur inspection also revealed that your firm’s XPERIENCE® solution is misbranded under section 502(t)(2) of the Act, 21 U.S.C. § 352(t)(2), in that your firm failed or refused to furnish material or information respecting the product that is required by or under section 519 of the Act, 21 U.S.C. § 360i, and 21 CFR Part 803 - Medical Device Reporting. Significant violations include, but are not limited to, the following:Failure to submit a report to FDA no later than 30 calendar days after the day that your firm received or otherwise became aware of information, from any source, that reasonably suggests that a device that your firm markets may have caused or contributed to a death or serious injury, as required by 21 CFR 803.50(a)(1). For example:a. The information included for Complaint# 0299 reasonably suggests that a patient sustained an injury (hematoma) following the breast reduction surgery involving your firm’s XPERIENCE® solution, which required percutaneous aspiration. There is no information included in the complaint that rules out that your firm’s XPERIENCE® solution may not have caused or contributed to the referenced injury. Further, the information described in the complaint meets the definition of serious injury under 21 CFR 803.3(w) because medical intervention was necessary to preclude permanent impairment of a body function or permanent damage to a body structure. Your firm became aware of the event on January 26, 2023, yet the corresponding MDR# 3012271775-2024-00002 was not received by the FDA until October 31, 2024, exceeding the required 30-calendar-day reporting timeframe.b. The information included for Complaint# 0276 reasonably suggests that a patient sustained an injury (diffuse bleeding) on one breast pocket during a bilateral breast augmentation procedure involving the application of your firm’s XPERIENCE® solution, which required a saline wash and cauterization of the bleeding tissue to manage the situation. There is no information included in the complaint that rules out that your firm’s XPERIENCE® solution may not have caused or contributed to the referenced injury. Further, the information described in the complaint meets the definition of serious injury under 21 CFR 803.3(w) because medical intervention was necessary to preclude permanent impairment of a body function or permanent damage to a body structure. Your firm became aware of the event on May 12, 2022, yet the corresponding MDR# 3012271775-2024-00004 was not received by the FDA until November 8, 2024, exceeding the required 30-calendar-day reporting timeframe.We received your responses dated September 26, 2024, November 21, 2024, and January 15, 2025. Your firm’s responses indicate that corrective actions have been taken to address this observation. These actions include streamlining the MDR reporting process by incorporating an MDR decision tree and conducting a retrospective review of XPERIENCE® complaints related to bleeding for MDR reportability. As a result, we acknowledge receipt of six newly identified MDRs. Additionally, your firm has completed a retrospective review of all complaints from the past three years and confirmed that no additional reportable events were identified. Please note that future FDA inspections or regulatory activities will assess the implementation and effectiveness of your corrective actions.Your firm should take prompt action to address any violations identified in this letter. Failure to adequately address this matter may result in regulatory action being initiated by the FDA without further notice. These actions include, but are not limited to, seizure, injunction, and civil money penalties.Other federal agencies may take your compliance with the FD&C Act and its implementing regulations into account when considering the award of federal contracts. Additionally, should FDA determine that you have Quality System regulation violations that are reasonably related to premarket approval applications for Class III devices, such devices will not be approved until the violations have been addressed. Should FDA determine that your products or facilities do not meet the requirements of the Act, requests for Certificates to Foreign Governments (CFG) may not be granted.Please notify this office in writing within fifteen business days from the date you receive this letter of the specific steps your firm has taken to address the noted violations, as well as an explanation of how your firm plans to prevent these violations, or similar violations, from occurring again. Include documentation of the corrections and/or corrective actions (which must address systemic problems) that your firm has taken. If your firm’s planned corrections and/or corrective actions will occur over time, please include a timetable for implementation of those activities. If corrections and/or corrective actions cannot be completed within fifteen business days, state the reason for the delay and the time within which these activities will be completed. Your firm’s response should be comprehensive and address any violations included in this Warning Letter. If you believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration as part of your response.Your firm’s response should be sent to: Melissa Michurski, Assistant Director at CDRHenforcement@fda.hhs.gov. Please include in the subject line, CMS case # 698114 when replying. If you have any questions about the contents of this letter, please contact: Demetria Lueneburg, Compliance Officer at Demetria.Lueneburg@fda.hhs.gov.Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your firm’s facility. It is your firm’s responsibility to ensure compliance with applicable laws and regulations administered by FDA. The specific violations noted in this letter and in the Inspectional Observations, FDA 483, issued at the close of the inspection may be symptomatic of serious problems in your firm’s manufacturing and quality management systems. Your firm should investigate and determine the causes of any violations and take prompt actions to address any violations and bring the products into compliance.Sincerely yours,/S/RDML Sean M. Boyd, MPH, USPHSDirectorOffice of Regulatory ProgramsOffice of Product Evaluation and QualityCenter for Devices and Radiological Health

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