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桂药监流稽罚〔2025〕6号广西藤县同源堂医药有限公司销售劣药清气化痰丸案广西藤县同源堂医药有限公司91450422566788618K甘伟原销售劣药清气化痰丸的行为违反了《中华人民共和国药品管理法》第九十八条第一款的规定。行政处罚的种类：没收违法所得、没收非法财物。行政处罚的依据：《中华人民共和国药品管理法实施条例》第七十五条。履行广西壮族自治区药品监督管理局2025年07月24日

行政相对人名称 江苏宏宇医疗设备有限公司 行政相对人类别 法人及非法人组织 统一社会信用代码 91321181589959619T 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 夏叶挺 法定代表人证件类型 法定代表人证件号码 证件类型 证件号码 行政处罚决定书文号 苏药监镇处字〔2025〕2号 违法行为类型 《医疗器械监督管理条例》第三十九条第一款 违法事实 该公司生产的制氧机（产品规格：ZY-03AW，产品批号：25030015，出厂编号250300015）使用说明书中说明项中缺少“声功率级和测试流量”的说明，违反了《医疗器械监督管理条例》第三十九条第一款的规定 处罚依据 《医疗器械监督管理条例》第八十八条第一款第（二）项的规定 处罚类别 罚款 处罚内容 罚款1.5万元 罚款金额（万元） 1.5 没收违法所得没收非法财物的金额（万元） 暂扣或吊销证照名称及编号 处罚决定日期 2025/07/30 处罚有效期 2026/01/30 公示截止期 2026/07/30 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

　　为深入贯彻“四个最严”要求，持续强化医疗器械高效能监管，结合2024年全省医疗器械生产企业监督检查计划，聚焦《浙江省医疗器械生产协同监管实施细则》规定的高风险生产企业，省局对杭州亿科医疗科技有限公司等106家生产企业组织开展了108家次飞行检查，目前检查企业除杭州鸿立生物医疗科技有限公司外已基本完成整改，现将有关检查情况予以通告。2024年浙江省医疗器械生产企业飞行检查情况序号单位名称产品名称检查依据检查时间检查结论整改情况1杭州鸿立生物医疗科技有限公司同种异体骨植入材料无菌、植入2024.3.11-3.13限期整改整改中2杭州锐健马斯汀医疗器材有限公司金属带线锚钉、聚醚醚酮缝合锚钉、不可吸收带线锚钉、全缝线锚钉植入2024.3.28-3.29限期整改已完成3浙江一益医疗器械有限公司一次性使用无菌注射针、一次性使用钝末端注射针、一次性使用无菌胰岛素注射器无菌2024.3.27-3.29停产整改已完成4杭州鸿立生物医疗科技有限公司同种异体骨植入材料无菌、植入2024.4.25-4.27停产整改整改中5杭州亿科医疗科技有限公司微导管、颅内球囊无菌2024.4.10-4.12限期整改已完成6杭州启明医疗器械股份有限公司经皮介入人工心脏瓣膜系统、经导管人工肺动脉瓣膜系统、导管鞘无菌2024.5.9-5.11限期整改已完成7杭州科腾生物制品有限公司注射用交联透明质酸钠凝胶植入2024.5.14-5.16限期整改已完成8海宁市绿健医疗用品有限公司一次性使用麻醉穿刺包无菌2024.5.9-5.11限期整改已完成9泰尔茂医疗产品（杭州）有限公司一次性使用静脉留置针，一次性使用静脉输液针，一次性使用防针刺造影导管留置针、血管内造影导管、一次性使用泵用输液器无菌2024.5.23-5.24限期整改已完成10杭州民生立德医疗科技有限公司软组织水平牙种植体及附件、骨水平牙种植体及附件植入2024.5.23-5.24限期整改已完成11温州欣视界科技有限公司硬性角膜接触镜，硬性透氧性角膜接触镜其他2024.6.27-6.28限期整改已完成12杭州承诺医疗科技有限公司植入式骶神经刺激器、植入式骶神经刺激延伸导线、植入式骶神经刺激电极植入2024.7.10-7.12限期整改已完成13杭州柳叶刀机器人有限公司髋关节置换手术导航定位系统其他2024.7.10-7.12限期整改已完成21浙江康飞思医疗科技有限公司直型金属接骨板（非锁定）、金属锁定接骨板、金属骨针、金属角度固定器系统、金属锁定接骨螺钉、金属接骨螺钉（非锁定）、金属髓内钉、胸腰椎后路钉棒固定系统、椎间融合器、脊柱内固定器-钉板系统、椎板固定系统、丙烯酸树脂骨水泥植入2024.7.15-7.18限期整改已完成19宁波华科润生物科技有限公司钛合金带线锚钉、颈椎前路固定系统、椎间融合器、脊柱后路内固定系统、骨水泥及配件、丙烯酸树脂骨水泥、可弯曲椎体扩张球囊套件无菌、植入2024.7.16-7.18限期整改已完成20浙江德康医疗器械有限公司椎间融合器、钛网系统、金属锁定接骨板系统、锁定接骨板系统、手腕锁定接骨板系统、金属骨针、金属缆索系统植入2024.7.17-7.19限期整改已完成15浙江广慈医疗器械有限公司金属接骨板（解剖型）、直型金属接骨板、金属锁定接骨板钉系统、金属骨针、金属接骨螺钉、颈椎前路钉板系统、脊柱椎间融合器、脊柱后路内固定装置、人工牙种植体植入2024.7.17-7.19限期整改已完成16归创通桥医疗科技股份有限公司PTCA球囊扩张导管、药物洗脱PTA球囊扩张导管（创新产品）、药物洗脱外周血管支架系统（创新产品）、药物涂层外周球囊扩张导管、腔静脉滤器、腔静脉滤器抓捕器无菌、植入2024.7.17-7.19限期整改已完成17杭州安杰思医学科技股份有限公司一次性内镜用注射针无菌2024.7.24-7.26停产整改已完成14浙江星月生物科技股份有限公司丝素蛋白膜状敷料无菌2024.7.25-7.26限期整改已完成18杭州键嘉机器人有限公司髋关节置换手术导航定位系统其他2024.7.29-7.30限期整改已完成26杭州优思达生物技术有限公司核酸扩增检测分析仪其他2024.7.31-8.1限期整改已完成22宁波海泰科迈医疗器械有限公司一次性使用肛肠吻合器、一次性使用消化道吻合器、一次性使用直线型吻(缝)合器、一次性使用直线切割吻合器和钉仓、一次性使用痔疮套扎吻合器、一次性使用腔镜直线型切割吻合器及组件、一次性使用腔镜直线切割吻合器及一次性钉匣、一次性使用可旋转腔镜直线切割吻合器及一次性钉匣、一次性使用腔镜关节头直线切割吻合器和钉仓、一次性使用电动腔镜直线切割吻合器及组件、超声软组织切割止血设备、一次性使用单孔多通道穿刺器、一次性使用电动腔镜直线切割吻合器钉仓、一次性使用腔内闭式镜头清洗穿刺器、一次性使用电动腔镜直线切割吻合器及钉仓无菌2024.8.1-8.2停产整改已完成24宁波兆盈医疗器械有限公司椎间融合器、钛合金带线锚钉、足踝锁定接骨板系统、金属髓内针、胸腰椎后路内固定钉棒系统植入2024.8.7企业停产/28宁波菲拉尔医疗用品有限公司一次性使用贮血滤血器、一次性使用血液微栓过滤器、一次性使用人工心肺机体外循环管道包、一次性使用心脏冷停搏液灌注器无菌2024.8.7-8.9限期整改已完成29浙江欧健医用器材有限公司一次性使用输液器 带针，一次性使用无菌注射器 带针等无菌2024.8.12-8.13限期整改已完成30浙江海圣医疗器械股份有限公司一次性使用中心静脉导管及套件、一次性使用麻醉穿刺包等无菌2024.8.14-8.16限期整改已完成23浙江康德莱医疗器械股份有限公司一次性使用输血器、一次性使用静脉输液针、一次性使用无菌注射器无菌2024.8.14-8.16限期整改已完成34桐庐洲济医疗器械有限公司一次性结扎夹植入2024.8.15-8.16限期整改已完成31浙江康泰医疗器械有限公司一次性使用输液器 带针、一次性使用避光精密过滤输液器 带针、一次性使用精密过滤输液器 带针、一次性使用静脉输液针、一次性使用静脉留置针无菌2024.8.19-8.21限期整改已完成32浙江苏嘉医疗器械股份有限公司一次性使用静脉留置针，一次性使用麻醉穿刺包、一次性使用硬膜外麻醉导管及导管接头等无菌2024.8.21-8.23限期整改已完成27杭州励楷科技有限公司颅内球囊扩张导管；血管鞘无菌2024.8.21-8.23限期整改已完成35微创龙脉医疗科技（嘉兴）有限公司微导管、导引导丝无菌2024.8.27-8.29限期整改已完成25安瑞医疗器械（杭州）有限公司一次性使用止血夹无菌2024.8.28-8.30限期整改已完成36杭州康基医疗器械有限公司一次性结扎夹、一次性可吸收结扎夹无菌、植入2024.9.3-9.5限期整改已完成40浙江微度医疗器械有限公司可吸收软组织拉提整形带、牙种植体、颅骨锁、一次性使用连发施夹钳和结扎夹等无菌、植入2024.9.4-9.7限期整改已完成37杭州杰毅麦特医疗器械有限公司胎儿染色体非整倍体(T13、T18、T21)检测试剂盒（可逆末端终止测序法）体外2024.9.11-9.14限期整改已完成38杭州天诚药业有限公司陶瓷粉敷料无菌2024.9.13-9.14限期整改已完成39雪龙眼镜（宁波）有限公司软性亲水接触镜无菌2024.9.12-9.14限期整改已完成33浙江星期一生物技术有限公司壳聚糖宫颈膜无菌2024.9.12-9.14停产整改已完成41旭化成医疗器械（杭州）有限公司血液透析滤过器、一次性使用血液透析器、空心纤维透析器无菌2024.9.25-9.27限期整改已完成42大晶眼健康科技（浙江）有限公司软性亲水接触镜无菌2024.10.14企业停产/43浙江龙德医药有限公司一次性使用无菌注射器 带针无菌2024.10.10-10.12限期整改已完成44杭州协合医疗用品有限公司注射用交联透明质酸钠凝胶、可吸收胶原蛋白止血海绵、吸收性氧化再生纤维素止血材料、医用透明质酸钠凝胶、注射用修饰透明质酸钠凝胶，可吸收止血微球无菌、植入2024.10.22-10.25限期整改已完成45浙江创想医学科技有限公司一次性使用止血夹、一次性使用内窥镜注射针无菌2024.11.6-11.8停产整改已完成46宁波慈北医疗器械有限公司内固定钛板、椎板固定板系统植入2024.10.14-10.16限期整改已完成47余姚市久盛医疗用品厂硅橡胶人工鼻梁、硅橡胶充填人工乳房植入2024.10.14-10.16限期整改已完成48宁波戴维医疗器械股份有限公司婴儿培养箱其他2024.11.4-11.6限期整改已完成49宁波天益医疗器械股份有限公司一次性使用输血器、血液透析浓缩液、一次性使用血液透析管路、血液净化装置的体外循环血路、一次性使用无菌注射器 带针、一次性使用滴定管式输液器 带针、一次性使用输液器、一次性使用静脉输液针无菌2024.10.14-10.16限期整改已完成一次性使用钝型动静脉瘘穿刺针无菌2024.10.14-10.16停产整改50宁波美生医疗器材有限公司一次性使用胰岛素笔配套用针无菌2024.10.14-10.16限期整改已完成51贝普医疗科技股份有限公司一次性使用无菌注射器 带针、一次性使用输液器 带针、一次性使用无菌胰岛素注射器无菌2024.10.29-10.31限期整改已完成52浙江新德意医疗科技股份有限公司一次性使用精密过滤输液器，一次性使用输血器 带针、一次性使用输液器 带针、一次性使用注射器 带针、一次性使用避光输液器无菌2024.10.16-10.18限期整改已完成53浙江三创生物科技有限公司壳聚糖宫颈膜无菌2024.10.14-10.16限期整改已完成54浙江华福医用器材有限公司一次性使用无菌注射器 带针，一次性使用静脉输液针无菌2024.10.30-11.1限期整改已完成55浙江玉升医疗器械股份有限公司一次性使用无菌注射器 带针、一次性使用吊瓶式输液器 带针、一次性使用精密过滤输液器 带针、一次性使用输液器 带针、一次性使用自锁无菌注射器 带针无菌2024.10.21-10.23限期整改已完成56浙江京环医疗用品有限公司一次性使用精密过滤输液器 带针、一次性使用无菌注射器 带针无菌2024.10.21-10.23限期整改已完成57浙江灵洋医疗器械有限公司一次性使用无菌注射器 带针、自毁式一次性使用注射器 带针、一次性使用精密过滤输液器 带针、一次性使用疫苗注射器、自动回缩式防重复使用注射器、一次性使用精密过滤避光输液器 带针、一次性使用吊瓶式输液器 带针、一次性使用静脉留置针无菌2024.10.21-10.23限期整改已完成58浙江康泰医疗器械有限公司一次性使用无菌注射器 带针无菌2024.10.24-10.25限期整改已完成59浙江康康医疗器械股份有限公司一次性使用无菌注射器 带针、一次性使用自毁式无菌注射器 带针、一次性使用自毁式无菌注射器 带针、一次性使用精密过滤输液器 带针、一次性使用输血器带针无菌2024.10.23-10.25限期整改已完成60浙江仁翔医疗器械有限公司一次性使用无菌注射器 带针、一次性使用无菌注射针无菌2024.10.23-10.24限期整改已完成61浙江欧健保灵医疗设备有限公司一次性使用输液器 带针、一次性使用精密过滤输液器 带针、一次性使用静脉留置针、一次性使用防针刺自毁式无菌注射器 带针等无菌2024.10.24-10.24通过检查/62浙江慧勤医疗器械有限公司连续性血液净化设备其他2024.11.20-11.22停产整改已完成63杭州华迈医疗科技有限公司骨修复材料植入2024.11.13-11.15限期整改已完成64浙江景嘉医疗科技有限公司医用透明质酸钠凝胶、注射用交联透明质酸钠凝胶、透明质酸钠防粘连凝胶植入2024.11.27-11.29停产整改已完成65杭州德晋医疗科技有限公司微导管、经导管二尖瓣夹系统、球囊扩张导管无菌、植入2024.11.13-11.15限期整改已完成66浙江天松医疗器械股份有限公司一次性使用不可吸收结扎夹无菌、植入2024.11.20-11.22限期整改已完成67普昂（杭州）医疗科技股份有限公司一次性使用胰岛素注射笔用针头、一次性使用无菌胰岛素注射器、植入式给药装置专用针及附件无菌2024.11.20-11.22限期整改已完成68微泰医疗器械（杭州）股份有限公司胰岛素泵、胰岛素泵用皮下输液器、胰岛素泵用储药器组件、持续葡萄糖监测系统无菌、软件2024.11.20-11.22限期整改已完成69建德市康华医疗器材有限公司不可吸收结扎夹无菌2024.11.20-11.22限期整改已完成70宁波韦科医疗科技有限公司导引导管无菌2024.11.20-11.22停产整改已完成导引导管、外周球囊扩张导管限期整改71浙江伏尔特医疗器械股份有限公司一次性使用避光精密过滤输液器、一次性使用麻醉穿刺包等无菌2024.11.13-11.15限期整改已完成73瑞奇医疗科技（嘉兴）有限公司牙科种植体系统、牙科种植体植入2024.11.20-11.22限期整改已完成74杭州德诺脑神经医疗科技有限公司微导管无菌2024.11.20-11.22企业停产/75浙江巴泰医疗科技有限公司紫杉醇洗脱PTCA球囊扩张导管、紫杉醇涂层外周球囊扩张导管、一次性使用造影导管、一次性使用导管鞘组无菌2024.11.20-11.22限期整改已完成76浙江诺尔康神经电子科技股份有限公司人工耳蜗植入体植入2024.11.27-11.29限期整改已完成77杭州诺辉健康科技有限公司KRAS基因突变及BMP3/NDRG4基因甲基化和便隐血联合检测试剂盒（PCR荧光探针法-胶体金法）体外2024.11.20-11.22限期整改已完成86浙江润强医疗器械股份有限公司一次性使用麻醉穿刺包、一次性使用精密过滤输液器无菌2024.11.20-11.22限期整改已完成88浙江欧贝特生物材料有限公司壳聚糖止血敷料无菌2024.11.20-11.22限期整改已完成78杭州糖吉医疗科技有限公司胃转流支架系统植入2024.11.21-11.22限期整改已完成79杭州圣石科技股份有限公司可吸收止血结扎夹植入2024.11.27-11.29限期整改已完成80杭州唯强医疗科技有限公司外周球囊扩张导管、导管鞘、胸主动脉支架系统无菌、植入2024.11.20-11.22限期整改已完成81杭州九源基因工程有限公司骨修复材料植入2024.12.4-12.6限期整改已完成82杭州亚慧生物科技有限公司医用粘合剂植入2024.12.4-12.6限期整改已完成83宁波汉科医疗器械有限公司一次性使用胰岛素笔配套用针无菌2024.11.20-11.22限期整改已完成84宁波胜杰康生物科技有限公司一次性使用冷冻消融球囊导管无菌2024.11.27-11.29限期整改已完成72浙江乾合畅脉医疗科技有限公司紫杉醇药物涂层冠状动脉球囊扩张导管无菌2024.12.4-12.6限期整改已完成85鑫高益医疗设备股份有限公司磁共振成像系统其他2024.12.4-12.6限期整改已完成87浙江嘉佑医疗器械有限公司椎间融合器，颈椎前路钉板系统植入2024.12.4-12.6限期整改已完成89浙江天瞳医疗器械有限公司角膜塑形镜硬性透气接触镜其他2024.12.4-12.6限期整改已完成90浙江科惠医疗器械股份有限公司金属接骨螺钉、金属带线锚钉、椎间融合器、牙种植体系统、髋关节假体 陶瓷球头植入2024.12.4-12.6限期整改已完成91浙江天使医疗器械有限公司一次性使用全麻包无菌2024.11.20-11.22限期整改已完成92杭州深睿博联科技有限公司肺结节CT影像辅助检测软件软件2024.11.27-11.29限期整改已完成93浙江归创医疗科技有限公司外周血管灌注导管无菌2024.12.4-12.6限期整改已完成94杭州爱晶伦科技有限公司有晶体眼后房屈光晶体植入2024.12.4-12.6限期整改已完成95杭州迈瑞医疗科技有限公司一次性结扎夹植入2024.12.9-12.12限期整改已完成96杭州创心医学科技有限公司牛心包心脏外科补片植入2024.12.17-12.19限期整改整改中97杭州艾力康医药科技有限公司聚乙烯醇颗粒栓塞剂，明胶海绵颗粒栓塞剂植入2024.12.18-12.20限期整改已完成98杭州德心医疗科技有限公司介入引导导丝无菌2024.12.17-12.20限期整改已完成99杭州迪诺医疗器械有限公司一次性使用钝末端注射针无菌2024.12.18-12.20限期整改已完成100浙江首鼎医学科技有限公司一次性使用内窥镜注射针无菌2024.12.18-12.20限期整改已完成101杭州德诺电生理医疗科技有限公司左心耳封堵器系统植入2024.12.25-12.27限期整改已完成102浙江东一医疗科技有限公司一次性使用血液透析管路无菌2024.12.18-12.20限期整改已完成103杭州亨泰视觉科技有限公司硬性透气角膜接触镜其他2025.1.2-2025.1.3限期整改已完成104杭州瑞维特医疗科技有限公司一次性使用导引导丝、药物涂层PTCA球囊扩张导管、一次性使用微导管、一次性使用导管鞘组无菌2025.1.8-2025.1.10限期整改已完成一次性使用外周血管导引导管停产整改105嘉兴市舒福特生物科技有限公司壳聚糖抑菌膜无菌2025.1.2-2025.1.3限期整改因厂房搬迁停产中106诸暨市鹏天医疗器械有限公司一次性内镜用注射针无菌2025.1.2-2025.1.3停产整改已完成107浙江科瑞医药科技有限公司生物流体敷料膜无菌2025.1.8-2025.1.10限期整改已完成108济民健康管理股份有限公司预充式导管冲洗器无菌2025.1.8-2025.1.10限期整改已完成

黑龙江七号医药连锁有限公司经营劣药环孢素软胶囊（批号：20230326）的行为违反了《中华人民共和国药品管理法》第九十八条第一款、第三款第（七）项规定,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》第二十八条第一款的规定给予处罚。

鹤岗市济世堂医药连锁零售有限公司销售劣药醋氯芬酸胶囊案（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、第三款第（七）项规定,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》第二十八条第一款的规定给予处罚。

Delivery Method:VIA EMAIL WITH READ RECEIPTReference #:320-25-96Product:DrugsRecipient:Mr. Nagaraj RanganathanChief Executive Officer (CEO)Shiva Analyticals Private LimitedPlot 24D (P) and 34D KIADB Industrial AreaHoskote, Bangaluru562114KarnatakaIndiaIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesWarning Letter320-25-96July 23, 2025Dear Mr. Nagaraj Ranganathan:The United States Food and Drug Administration (FDA) inspected your contract testing laboratory, Shiva Analyticals (India) Private Limited, FEI 3006192929, located at Plot 24D (P) and 34D KIADB Industrial Area, Hoskote, Bangaluru, Karnataka State, 562114, India, from January 20 to 24, 2025.This warning letter summarizes significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals. See Title 21 Code of Federal Regulations (CFR), parts 210 and 211 (21 CFR parts 210 and 211).Because your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, the drug products you tested are adulterated within the meaning of section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 351(a)(2)(B).We reviewed your February 13, 2025, response to our Form FDA 483 in detail and acknowledge receipt of your subsequent correspondence.During our inspection, our investigators observed specific violations including, but not limited to, the following:1. Your firm failed to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications whether or not the batch has already been distributed (21 CFR 211.192).Your firm did not adequately investigate out-of-specification (OOS) results. Your investigations into laboratory incidents and OOS results lacked adequate scientific rationale to support root cause determinations and did not extend into previously analyzed batches. New test results were used as the basis for invalidating OOS results without also performing an adequate root cause investigation.In addition, our inspection found that your firm did not take adequate effective corrective action and preventive action (CAPA) to reduce specific recurring human errors that have contributed significantly to the number of laboratory incidents and OOS investigations in the past 3 years.In your response, you acknowledge that standard operating procedures (SOPs) for handling OOS results and laboratory incidents are inadequate to effectively evaluate trends, identify causes, and enable implementation of suitable holistic CAPA. You also acknowledge that there was no procedure to assess human errors and that had contributed to significant trends not being assessed by your quality unit (QU). You commit to improve CAPA effectiveness based on your newly implemented trend evaluation program.Your response is inadequate because you do not adequately address how you will ensure that laboratory OOS results are adequately investigated using scientifically sound and appropriate procedures for retesting, hypothesis testing, re-sampling, and root cause analyses.For more information about handling failing, out-of-specification, out-of-trend, or other unexpected results and documentation of your investigations, see FDA’s guidance documentInvestigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production, at https://www.fda.gov/media/158416/download.As a contract laboratory, you must comply with the CGMP regulations that apply to operations you perform, including but not limited to, those that address the operations of your quality control unit, laboratory, investigation system, and documentation system.FDA considers contractors as extensions of manufacturer’s own facility. Your failure to comply with CGMP may affect the quality, safety, and efficacy of the products you test for your clients. It is essential that you understand your responsibility to operate in full compliance with CGMP, and to inform all your customers or clients of significant problems encountered during the testing of their drugs. Your clients (e.g., drug manufacturers, application sponsors), in turn, must provide you with all the scientific data and information needed to support reliable testing and method implementation.For additional information refer to FDA Guidance for IndustryContract Manufacturing Arrangements for Drugs: Quality Agreements(https://www.fda.gov/media/86193/download).In response to this letter, provide:A retrospective, independent review of all laboratory incident investigations and OOS results for all finished product tests. Identify any products which may be intended for the United States for the last 3 years and a report summarizing the findings of the analysis, including the following for each OOS:o Determine whether the scientific justification and evidence relating to the invalidated OOS result conclusively or inconclusively demonstrates causative laboratory error.o For investigations that conclusively establish laboratory root cause, provide rationale and ensure that all other laboratory methods vulnerable to the same or similar root cause are identified for remediation.o For all OOS results found by the retrospective review, identify any potential root cause and indicate if your customer was notified of the failure. Include the original test, date of test, testing result, customer, and reason for initiating an investigation.o The written response from your customers following notification of the testing failure(s).An independent assessment of your overall system for investigating deviations, incidents, complaints, OOS results, and failures. Provide a detailed action plan to remediate this system. Your action plan should include, but not be limited to:o Significant improvements in investigation competencies, scope determination, root cause evaluation, CAPA effectiveness, QU oversight, and written procedures.o Address how your firm will ensure all phases of investigations are appropriately conducted.o Revised OOS investigation procedures with these and other remediations.o Informing clients of batches for which the invalidation of an OOS result may not be adequately supported by your investigation.2. Your firm failed to establish adequate written responsibilities and procedures applicable to the quality control unit and to follow such written procedures applicable to the quality control unit (21 CFR 211.22(d)).Your QU failed to ensure the reliability and integrity of analytical testing data. For example, our investigators observed many torn and discarded original CGMP documents inside your main waste disposal area. These discarded original documents included, but were not limited to, analytical balance weighing printouts, pH meter printouts, and analytical method verification records. The discarded balance printouts were observed containing test weights that were different from those weights documented in testing of raw materials and finished products (including those intended for the U.S. market).Additionally, during the evaluation of audit trail review for your MassLynx software, our investigator documented that your laboratory analysts performed hundreds of entries related to “Add/Modify/Delete peaks,” and “Alter existing file on disk” user privileges between January 16, 2022, and January 23, 2025.Data integrity is critical throughout the CGMP data lifecycle, including in the creation, modification, processing, maintenance, archival, retrieval, and transmission of data. Customers rely on the integrity of the laboratory data that you generate to make decisions regarding drug quality.It is important to maintain strict control over electronic data to ensure that any additions, deletions, or modifications of information in your electronic records are authorized and appropriately documented.In your response, you identify lack of quality oversight and lack of procedures for the proper control of CGMP documents as root causes for these deficiencies. You state that you are performing a protocol-based study to review the sample and system audit trails.Your response is inadequate. You do not provide a scientific evaluation of whether discarded data may have caused reported test results to fail drug product specifications.Your firm’s quality systems are inadequate. See FDA’s guidance documentQuality Systems Approach to Pharmaceutical CGMP Regulationsfor help in implementing adequate Quality Unit (QU) in your laboratory operation to meet the requirements of CGMP regulations 21 CFR, parts 210 and 211 at https://www.fda.gov/media/71023/download.In response to this letter, provide:A comprehensive assessment and remediation plan to ensure your QU is given the authority and resources to effectively function. The assessment should also include, but not be limited to:o A determination of whether procedures used by your firm are robust and appropriate.o Provisions for QU oversight throughout your operations to evaluate adherence to appropriate practices.o Oversight and approval of investigations.A complete and independent assessment of documentation systems used throughout your laboratory operations to determine where documentation practices are insufficient. Include a detailed CAPA plan that comprehensively remediates your firm’s documentation practices ensuring you retain attributable, legible, complete, original, accurate, contemporaneous records throughout your operation.An independent assessment of your laboratory practices, procedures, methods, equipment, documentation, and analyst competencies. Based on this review, provide a detailed plan to remediate and evaluate the effectiveness of your laboratory system.CGMP Consultant RecommendedBased upon the nature of the violations we identified at your firm, we strongly recommend that your firm engage a consultant qualified as set forth in 21 CFR 211.34 to assist your firm in meeting CGMP requirements. Your use of a consultant does not relieve your firm’s obligation to comply with CGMP. Your firm’s executive management remains responsible for resolving all deficiencies and systemic flaws to ensure ongoing CGMP compliance.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 these violations and for preventing their recurrence or the occurrence of other violations.Correct any violations promptly. FDA may withhold approval of new applications or supplements listing your firm as a drug contract testing laboratory until any violations completely addressed and we confirm your compliance with CGMP. We may re-inspect to verify that you have completed corrective actions to address any violations.Failure to address any violations may also result in the FDA refusing admission of articles manufactured by your clients and tested at Shiva Analyticals (India) Private Limited, 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 appears 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 3006192929 and ATTN: Joan Johnson.Sincerely,/S/Francis GodwinDirectorOffice of Manufacturing QualityOffice of ComplianceCenter for Drug Evaluation and Research

Delivery Method:VIA EMAIL WITH READ RECEIPTReference #:320-25-94Product:DrugsRecipient:Mr. Erik L. KreiderCEOKabana Skin Care LLC685 S Arthur Ave Unit 9bLouisville,CO80027-3141United StatesIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesWarning Letter320-25-94July 18, 2025Dear Mr. Kreider:The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, Kabana Skin Care LLC, FEI 3015118914, at 685 S Arthur Ave Unit 9b, Louisville, CO 80027-3141, from February 19 to 20, 2025.This warning letter summarizes significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals. See Title 21 Code of Federal Regulations (CFR), parts 210 and 211 (21 CFR parts 210 and 211).Because your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your drug products are adulterated within the meaning of section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 351(a)(2)(B).We reviewed your March 3, 2025, response to our Form FDA 483 in detail and acknowledge receipt of your subsequent correspondence. Your response is inadequate because you failed to provide supportive documentation for evaluation or adequate evidence of corrective actions taken to bring your operations into compliance with CGMP.During our inspection, our investigator observed specific violations including, but not limited to, the following.1. Your firm failed to test samples of each component for identity and conformity with all appropriate written specifications for purity, strength, and quality. Your firm also failed to validate and establish the reliability of your component supplier’s test analyses at appropriate intervals (21 CFR 211.84(d)(1) and 211.84(d)(2)).Your firm manufactures over the counter (OTC) drug products, including sunscreens and antibacterial hand sanitizers. You failed to adequately test incoming components, such as ethanol and glycerin, for identity before using them in the manufacture of your drug products.Identity testing for high-risk drug components ethanol and glycerin include a limit test in the United States Pharmacopeia (USP) to ensure the component meets the relevant safety limits for methanol or DEG or EG levels, respectively. Because you did not perform identity testing on each shipment of each lot using the USP identification test that detects these hazardous impurities, you failed to assure the acceptability of these components for use in the manufacture of your drug products.In addition, you did not adequately establish the reliability of each of your suppliers’ analyses at appropriate intervals.EthanolYou failed to adequately test each shipment of each lot of ethanol, used as an active pharmaceutical ingredient, for methanol. The use of ethanol contaminated with methanol has resulted in various lethal poisoning incidents in humans worldwide. See FDA’s guidance document,Policy for Testing of Alcohol (Ethanol) and Isopropyl Alcohol for Methanol, at https://www.fda.gov/media/173005/download.GlycerinYou failed to adequately test each shipment of each lot of glycerin, used as an inactive ingredient, for diethylene glycol (DEG) or ethylene glycol (EG) contamination.The use of ingredients contaminated with DEG or EG has resulted in various lethal poisoning incidents in humans worldwide. See FDA’s guidance document,Testing of Glycerin, Propylene Glycol, Maltitol Solution, Hydrogenated Starch Hydrolysate, Sorbitol Solution, and Other High-Risk Drug Components for Diethylene Glycol and Ethylene Glycol, to help you meet the CGMP requirements when manufacturing drugs containing ingredients at high-risk for DEG or EG contamination at https://www.fda.gov/media/167974/download.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. As a manufacturer, you have the responsibility to sample, test, and examine drug components before use in production to assure adequate quality.In response to this letter, provide:A commitment to provide methanol or DEG and EG test results, as applicable, no later than 30 calendar days from the date of this letter, from testing retains for all lots of high-risk drug components used in the manufacture of drug products. Alternatively, if a retain of a component lot is unavailable, perform retain sample testing of all implicated, marketed finished drug product batches for the presence of methanol or DEG and EG, as applicable.A full risk assessment for drug products that are within expiry which contain any ingredient at risk for methanol or DEG and EG contamination (including, but not limited to, ethanol and glycerin). Take prompt and appropriate actions to determine the safety of all lots of the component(s) and any related marketed drug product that could contain methanol or DEG and EG, including customer notifications and product recalls for any contaminated lots. Identify additional appropriate corrective action and preventive action that secure supply chains in the future, including, but not limited to, ensuring that all incoming raw material lots are from fully qualified manufacturers and free from unsafe impurities. Detail these actions in your response to this letter.2. Your firm failed to have, for each batch of drug product, appropriate laboratory determination of satisfactory conformance to final specifications for the drug product, including the identity and strength of each active ingredient, prior to release (21 CFR 211.165(a)).You failed to adequately test batches of your drug products before release and distribution. For example, you stated during the inspection that you did not perform chemical or microbiological tests on your finished drug products prior to release and distribution into the U.S. market.Appropriate release testing, including identity and strength testing of the active ingredient, must be performed before drug product release and distribution. Without adequate testing, you do not have scientific evidence to support whether your drug products conform to appropriate specifications before release.3. Your firm’s quality control unit failed to exercise its responsibility to ensure drug products manufactured are in compliance with CGMP, and meet established specifications for identity, strength, quality, and purity (21 CFR 211.22).You lacked adequate quality oversight for the manufacture of your drug products. For example, you failed to ensure:Establishment of suitable quality oversight procedures (e.g., raw material handling, review of production records, investigations, complaints, recalls) (21 CFR 211.22(a) and 211.22(d)).Establishment of an adequate stability program to support the labeled expiration dates (21 CFR 211.137 and 211.166).Establishment of appropriate written procedures for production and process controls (21 CFR 211.100(a)).Establishment of adequate equipment cleaning and maintenance procedures (21 CFR 211.67(a) and 211.67(b)).Your firm’s quality systems are inadequate. 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.Drug RecallOn March 12, 2025, you communicated your commitment to permanently cease manufacturing and distribution of all drugs for the U.S. market and agreed to a voluntary recall of all drugs in current distribution in the United States.Drug Production CeasedWe acknowledge your commitment to cease production of all OTC drugs and that you deregistered your facility as a drug manufacturer.If you plan to resume any drug manufacturing operations regulated under the FD&C Act, notify this office before resuming your operations. If your firm intends to resume manufacturing drugs, you should engage a consultant qualified to evaluate your operations to assist your firm in meeting CGMP requirements. Your use of a consultant does not relieve your firm’s obligation to comply with CGMP. Your firm’s executive management remains responsible for resolving all deficiencies and systemic flaws to ensure ongoing CGMP compliance.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.ConclusionThe violations cited in this letter are not intended to be an all-inclusive list of violations that exist at your facility. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations.Correct any violations promptly. Failure to promptly and adequately address this matter may result in regulatory or legal action without further notice including, without limitation, seizure and injunction. Unresolved violations may also prevent other Federal agencies from awarding contracts.Failure to address violations may also cause FDA to withhold issuance of Export Certificates. FDA may withhold approval of new applications or supplements listing your firm as a drug manufacturer until any violations are completely addressed and we confirm your compliance with CGMP. We may re-inspect to verify that you have completed corrective actions to address any violations.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 3015118914 and ATTN: Carlos Gonzalez.Sincerely,/S/Francis GodwinDirectorOffice of Manufacturing QualityOffice of ComplianceCenter for Drug Evaluation and Research

Product:DrugsRecipient:www.d-pharmacy.comSingaporeIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesFROM: The United States Food and Drug AdministrationRE: Notice of Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the InternetDATE: July 16, 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.d-pharmacy.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.d-pharmacy.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.d-pharmacy.com introduces into interstate commerce unapproved and misbranded benzodiazepines. Benzodiazepines are drug products with an acknowledged potential for abuse, and it is important to address the public health impact of their nonmedical use. Benzodiazepine nonmedical use is widespread, and individuals frequently co‐use benzodiazepines with alcohol, prescription opioids, and illicit drugs. Associated harms of benzodiazepine nonmedical use are substantial but occur primarily when people use benzodiazepines in combination with other drugs. Further, in cases where benzodiazepines were co‐used with other substances, medical outcomes are typically more severe than in cases involving benzodiazepines alone. Polysubstance overdose deaths account for the vast majority of overdose deaths documenting involvement of benzodiazepines.Finally, FDA has observed that www.d-pharmacy.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.d-pharmacy.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.d-pharmacy.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.An example of an unapproved opioid you offer for sale on www.d-pharmacy.com is tapentadol, marketed as “Aspadol (Tapentadol) 100mg,” “Aspadol® Tab,” “Nucynta,” “Tapentadol (Nucynta) 200mg”, “Tofrodol-XX,” and “Tapentadol Tablets 225 mg.” Evidence obtained from your website establishing that these products are drugs intended for human use (as defined in 21 CFR 201.128) includes the claim “used to treat chronic pain,” the category “Pain Killer,” and the tags “Muscle Relaxant,” “Pain Killer,” and “Pain Reliever.” 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 “Aspadol (Tapentadol) 100mg,” “Aspadol® Tab,” “Nucynta,” “Tapentadol (Nucynta) 200mg,” “Tofrodol-XX,” and “Tapentadol Tablets 225 mg” offered by www. d-pharmacy.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.Other examples of unapproved opioids you offer for sale on www.d-pharmacy.com are:Hydrocodone marketed as “Hydrocodone 10/325mg,” “Watson 853,” “M367,” and “Hydrocodone 10/500mg (Watson 540).” Evidence obtained from your website establishing that these products are drugs intended for human use (as defined in 21 CFR 201.128) includes the claim “used to treat severe or chronic pain,” the category “Pain Killer,” and the tags “Muscle Relaxant,” “Pain Killer,” and “Pain Reliever.” While there are FDA-approved versions of hydrocodone 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 “Hydrocodone 10/325mg,” “Watson 853,” “M367,” and “Hydrocodone 10/500mg (Watson 540)” offered by www.d-pharmacy.com.Tramadol marketed as “Tramadol 50mg,” “Ultram,” “ALKALOID®,” “Tramal (Tramadol HCL) 100mg,” “TOP DOL 100 mg,” “TRAMADOL,” “Citra Tabletas,” “TRAMOL-100 SR”, “Trakem 100,” “OL-TRAM,” “Trakem Elikem,” and “Oltram.” Evidence obtained from your website establishing that these products are drugs intended for human use (as defined in 21 CFR 201.128) includes the category “Pain Killer” and the tags “Anti Anxiety,” “Anti Depressant,” “Insomnia,” “Muscle Relaxant,” “Pain Killer,” “Pain Reliever,” and “Sleeping Pills.” While there are FDA-approved versions of tramadol on the market in the U.S., there are no approved drug applications pursuant to section 505 of the FD&C Act in effect for “Tramadol 50mg,” “Ultram,” “ALKALOID®,” “Tramal (Tramadol HCL) 100mg,” “TOP DOL 100 mg,” “TRAMADOL,” “Citra Tabletas,” “TRAMOL-100 SR”, “Trakem 100,” “OL-TRAM,” “Trakem Elikem,” and “Oltram” offered by www.d-pharmacy.com.Oxycodone marketed as “Oxycodone 30mg (M30),” “Roxicodone,” “Oxycodone 60mg (OP 60),” and “OxyContin 80mg (OC 80).” Evidence obtained from your website establishing that these products are drugs intended for human use (as defined in 21 CFR 201.128) includes the claims “used to treat severe and chronic pain” and “used to treat chronic pain,” the category “Pain Killer,” and the tags “Muscle Relaxant,” “Pain Killer,” and “Pain Reliever.” While there are FDA-approved versions of oxycodone 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 “Oxycodone 30mg (M30),” “Roxicodone,” “Oxycodone 60mg (OP60),” and “OxyContin 80mg (OC80)” offered by www.d-pharmacy.com.Oxycodone and acetaminophen marketed as “Percocet 10/325mg” and “E712.” Evidence obtained from your website establishing that these products are drugs intended for human use (as defined in 21 CFR 201.128) includes the claim “used to treat chronic pain,” the category “Pain Killer,” and the tags “Muscle Relaxant,” “Pain Killer,” and “Pain Reliever.” While there are FDA-approved versions of oxycodone and acetaminophen 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 “Percocet 10/325mg” and “E712” offered by www.d-pharmacy.com.Hydromorphone marketed as “Dilaudid 8mg (Hydromorphone).” Evidence obtained from your website establishing that this product is a drug intended for human use (as defined in 21 CFR 201.128) includes the claim “used to treat chronic pain,” the category “Pain Killer,” and the tags “Muscle Relaxant,” “Pain Killer,” and “Pain Reliever.” While there are FDA-approved versions of hydromorphone 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 “Dilaudid 8mg (Hydromorphone)” offered by www.d-pharmacy.com.FDA-approved hydrocodone, tramadol, oxycodone, and brand names OXYCONTIN, PERCOCET, and DILAUDID 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, hydrocodone, tramadol, oxycodone, and brand names NUCYNTA, OXYCONTIN, PERCOCET, and DILAUDID are only available pursuant to a prescription from a licensed practitioner. Furthermore, FDA-approved tapentadol, hydrocodone, tramadol, oxycodone, NUCYNTA, OXYCONTIN, PERCOCET, and DILAUDID each 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. This boxed warning addresses risks including addiction, abuse, misuse, life-threatening respiratory depression (breathing problems), neonatal opioid withdrawal syndrome (withdrawal symptoms in newborn baby), and accidental exposure resulting in death. In addition, when tapentadol, hydrocodone, tramadol, oxycodone, NUCYNTA, OXYCONTIN, PERCOCET, or DILAUDID is 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.d-pharmacy.com is alprazolam, marketed as “Xanax (Alprazolam) 0.5mg,” “XANAX 0,5 MG tableta,” “Xanax (Alprazolam) 1mg,” “Helex® 1 mg” “Ksalol® 1 mg,” “Rlam-1,” “Xanax 2mg (Alprazolam Bars),” “Green Bars,” and “White Bars.” Evidence obtained from your website establishing that these products are drugs intended for human use (as defined in 21 CFR 201.128) includes the claims “used to treat Anxiety and Panic Disorders” and “used to treat Anxiety disorder and Panic disorder,” the category “Benzodiazepine,” and the tags “Anti Anxiety,” “Anti Depressant,” “Benzodiazepines,” “Insomnia” and “Sleeping Pills.” 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 (Alprazolam) 0.5mg,” “XANAX 0,5 MG tableta,” “Xanax (Alprazolam) 1mg,” “Helex® 1 mg” “Ksalol® 1 mg,” “Rlam-1,” “Xanax 2mg (Alprazolam Bars),” “Green Bars,” and “White Bars” offered by www.d-pharmacy.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.d-pharmacy.com include:Clonazepam marketed as “Rivotril (Clonazepam) 2mg,” “Rivotril® tableta,” “AKLONIL® 2mg,” and “Clona Nozim.” Evidence obtained from your website establishing that these products are drugs intended for human use (as defined in 21 CFR 201.128) includes the claim “classified as Anti-Anxiety, Anti-Depressant, Benzodiazepine, Stress Relief, Sleeping Pills, Insomnia Treatment medication,” the category “Benzodiazepine,” and the tags “Anti Anxiety,” “Anti Depressant,” “Benzodiazepines,” “Insomnia,” and “Sleeping Pills.” 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 “Rivotril (Clonazepam) 2mg,” “Rivotril® tableta,” “AKLONIL® 2mg,” and “Clona Nozim” offered by www.d-pharmacy.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 (Diazepam) 5mg,” “Valium (Diazepam) 10mg,” “Apaurin® 10 mg,” “Bensedin® 10 mg tableta,” and “Stancam-10.” Evidence obtained from your website establishing that these products are drugs intended for human use (as defined in 21 CFR 201.128) includes the claim “used to treat Anxiety, Depression, Seizures and Alcohol withdrawal,” the category “Benzodiazepine,” and the tags “Anti Anxiety,” “Anti Depressant,” “Benzodiazepines,” “Insomnia,” and “Sleeping Pills.” 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 (Diazepam) 5mg,” “Valium (Diazepam) 10mg,” “Apaurin® 10 mg,” “Bensedin® 10 mg tableta,” and “Stancam-10” offered by www.d-pharmacy.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 (Lorazepam) 2mg,” “Arivan®,” “Arrivan,” “Arsopal®,” and “LOR-2.” Evidence obtained from your website establishing that these products are drugs intended for human use (as defined in 21 CFR 201.128) includes the claim “used to treat Anxiety, Insomnia (trouble sleeping) and status epilepticus (a type of severe seizure),” the category “Benzodiazepine,” and the tags “Anti Anxiety,” “Anti Depressant,” “Benzodiazepines,” “Insomnia,” and “Sleeping Pills.” 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 (Lorazepam) 2mg,” “Arivan®,” “Arrivan,” “Arsopal®,” and “LOR-2” offered by www.d-pharmacy.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.Temazepam marketed as “Restoril (Temazepam) 30 mg.” Evidence obtained from your website establishing that these products are drugs intended for human use (as defined in 21 CFR 201.128) includes the claim “used to treat sleeplessness, insomnia, anxiety and depression” and the tags “Anti Anxiety,” “Anti Depressant,” “Benzodiazepines,” “Insomnia,” and “Sleeping Pills.” While there are FDA-approved versions of temazepam 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 “Restoril (Temazepam) 30 mg” offered by www.d-pharmacy.com. FDA-approved temazepam, including the brand name RESTORIL, is indicated for the short-term treatment of insomnia (generally 7 to10 days).Bromazepam marketed as “Lexotanil (Bromazepam) 3mg,” “Lexotanil (Bromazepam) 6mg,” and “LEXILIUM.” Evidence obtained from your website establishing that these products are drugs intended for human use (as defined in 21 CFR 201.128) includes the category “Benzodiazepine” and the tags “Anti Anxiety,” “Anti Depressant,” “Benzodiazepines,” “Insomnia,” and “Sleeping Pills.” There are no FDA-approved versions of bromazepam on the market in the U.S., and there are no approved drug applications pursuant to section 505 of the FD&C Act in effect for “Lexotanil (Bromazepam) 3mg,” “Lexotanil (Bromazepam) 6mg,” and “LEXILIUM” offered by www.d-pharmacy.com.FDA-approved alprazolam, clonazepam, diazepam, lorazepam, temazepam, and brand name RESTORIL are benzodiazepine drug products only available pursuant to a prescription from a licensed practitioner. Furthermore, FDA-approved alprazolam, clonazepam, diazepam, lorazepam, temazepam, and RESTORIL 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.Two examples of unapproved Schedule II stimulants you offer for sale on www.d-pharmacy.com are:Amphetamine marketed as “Adderall 30mg,” “AD 30,” “B974.” Evidence obtained from your website establishing that these products are drugs intended for human use (as defined in 21 CFR 201.128) includes the claim “used to treat ADHD (Attention-Deficit / Hyperactivity Disorder),” the category “ADD/ADHD,” and the tag “ADHD.” 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,” “AD 30,” “B974” offered by www.d-pharmacy.com.Methylphenidate marketed as “Ritalin (Methylphenidate) 10mg,” “Ritalin 10mg,” “Addranil,” and “Ciba.” Evidence obtained from your website establishing that this product is a drug intended for human use (as defined in 21 CFR 201.128) includes the claim “used to treat ADHD (Attention-Deficit / Hyperactivity Disorder),” the category “ADD/ADHD,” and the tag “ADHD.” While there are FDA-approved versions of methylphenidate 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 “Ritalin (Methylphenidate) 10mg,” “Ritalin 10mg,” “Addranil,” and “Ciba” offered by www.d-pharmacy.com.ADDERALL and RITALIN are brand names for FDA-approved drugs indicated for the treatment of attention deficit hyperactivity disorders and narcolepsy. Using the brand name of the drug products ADDERALL and RITALIN indicates that these products are intended to treat attention deficit hyperactivity disorder and narcolepsy. FDA-approved ADDERALL and RITALIN are only available pursuant to a prescription from a licensed practitioner. Furthermore, FDA-approved ADDERALL and RITALIN each bear a boxed warning, addressing risks including abuse, misuse, and addiction. In addition, ADDERALL and RITALIN can be diverted for non-medical use into illicit channels or distribution. Misuse and abuse of CNS stimulants, including ADDERALL and RITALIN, 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.d-pharmacy.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 the www.d-pharmacy.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.d-pharmacy.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.d-pharmacy.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 Vaswani Chatterjee, Pharm.D.Acting DirectorOffice of Drug Security, Integrity, and ResponseOffice of ComplianceCenter for Drug Evaluation and Research

Product:DrugsRecipient:www.portmeds.comUnited StatesIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesFROM: The United States Food and Drug AdministrationRE: Notice of Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the InternetDATE: July 16, 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.portmeds.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.portmeds.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.portmeds.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.portmeds.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. consumersThere 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.portmeds.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.portmeds.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.One example of an unapproved opioid you offer for sale on www.portmeds.com is tapentadol, marketed as “Tapentadol 100mg” and “Actep-100.” Evidence obtained from your website establishing that this product is a drug intended for human use (as defined in 21 CFR 201.128) includes the claims “a trusted opioid analgesic that offers effective pain relief” and “its ability to target pain receptors in the brain,” and the categories “Muscle Relaxant” and “Pain Relief.” 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 “Actep-100” offered by www.portmeds.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.portmeds.com include:Hydrocodone marketed as “Hydrocodone 10/325mg” and “Watson 780.” Evidence obtained from your website establishing that these products are drugs intended for human use (as defined in 21 CFR 201.128) includes the claim “alleviating chronic pain,” the category “Pain Relief.” While there are FDA-approved versions of hydrocodone 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 “Hydrocodone 10/325mg” and “Watson 780” offered by www. portmeds.com.Oxycodone marketed as “Oxycodone 30mg,” “Oxycodone 80mg,” and “Oxycontin 80mg.” Evidence obtained from your website establishing that these products are drugs intended for human use (as defined in 21 CFR 201.128) includes the claims “prescribed to individuals experiencing moderate to severe pain” and “altering how the brain perceives and responds to pain,” and the category “Pain Relief.” While there are FDA-approved versions of oxycodone 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 “Oxycodone 30mg,” “Oxycodone 80mg,” and “Oxycontin 80mg” offered by www.portmeds.com.Tramadol marketed as “Tramadol 100mg” and “Tramadol 100 mg Tabletas.” Evidence obtained from your website establishing that this product is a drug intended for human use (as defined in 21 CFR 201.128) includes the claims “a trusted opioid analgesic that offers effective pain relief” and “its ability to target pain receptors in the brain,” and the categories “Muscle Relaxant” and “Pain Relief.” While there are FDA-approved versions of tramadol on the market in the U.S., there are no approved drug applications pursuant to section 505 of the FD&C Act in effect for “Tramadol 100mg,” and “Tramadol 100 mg Tabletas” offered by www.portmeds.com.FDA-approved hydrocodone, oxycodone, 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, hydrocodone, oxycodone, and tramadol are opioid drug products only available pursuant to a prescription from a licensed practitioner. Furthermore, FDA-approved tapentadol, hydrocodone, oxycodone, 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, hydrocodone, oxycodone, 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.portmeds.com is alprazolam, marketed as “Alprazolam or Xanax 2mg Tablets.” Evidence obtained from your website establishing that this product is a drug intended for human use (as defined in 21 CFR 201.128) includes the claim “designed to help individuals suffering from anxiety disorders” and the categories “Anti Anxiety” and “Sleeping Aids.” While there are FDA-approved versions of alprazolam on the market in the U.S., there are no approved drug applications pursuant to section 505 of the FD&C Act in effect for “Alprazolam or Xanax 2mg Tablets” offered by www.portmeds.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.portmeds.com include:Clonazepam marketed as “Clonazepam 2mg” and “Klonopin 2mg.” Evidence obtained from your website establishing that this product is a drug intended for human use (as defined in 21 CFR 201.128) includes the claim “prescribed to alleviate the symptoms of anxiety and prevent seizures” and the categories “Anti Anxiety” and “Sleeping Aids.” 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 “Clonazepam 2mg” and “Klonopin 2mg” offered by www.portmeds.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 “Diazepam 10mg” and “Valium 10mg.” Evidence obtained from your website establishing that this product is a drug intended for human use (as defined in 21 CFR 201.128) includes the claim “commonly prescribed for anxiety, muscle spasms, and sleep disorders,” and the categories “Anti Anxiety” and “Sleeping Aids.” 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 “Diazepam 10mg” and “Valium 10mg” offered by www.portmeds.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 “Lorazepam 2mg,” “Ativan 2mg,” and “Lorazepam EG 2,5 Tabletten Comprimés.” Evidence obtained from your website establishing that this product is a drug intended for human use (as defined in 21 CFR 201.128) includes the claims “for the treatment of anxiety disorders” and “acts on the central nervous system,” and the categories “Anti Anxiety” and “Sleeping Aids.” 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 “Lorazepam 2mg,” “Ativan 2mg,” and “Lorazepam EG 2,5 Tabletten Comprimés” offered by www.portmeds.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.portmeds.com is amphetamine, marketed as “Adderall 30mg.” Evidence obtained from your website establishing that this product is a drug intended for human use (as defined in 21 CFR 201.128) includes the claim “used to treat ADHD, helping individuals improve their focus, concentration, and impulse control,” and the category “ADHD.” 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.portmeds.com. ADDERALL is the trade 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 trade 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.portmeds.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.portmeds.com offers prescription drugs for sale without a prescription. In addition to the unapproved drug products aforementioned, on www.portmeds.com you offer for sale oxycodone, marketed as “Percocet 10mg/325mg” and “Percocet® (oxycodone and acetaminophen tablets, USP).” FDA-approved oxycodone, including the brand name PERCOCET, is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. FDA-approved PERCOCET is only available pursuant to a prescription from a licensed practitioner. Furthermore, FDA-approved PERCOCET bears a boxed warning, addressing risks including addiction, abuse, misuse, life-threatening respiratory depression, and neonatal opioid withdrawal syndrome. In addition, PERCOCET is taken in conjunction with other CNS depressants, including alcohol and benzodiazepines, use may result in coma or death.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.portmeds.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.portmeds.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 DirectorOffice of Drug Security, Integrity, and ResponseOffice of ComplianceCenter for Drug Evaluation and Research

Delivery Method:VIA EMAIL WITH READ RECEIPTReference #:320-25-51Product:DrugsRecipient:Mr. Achal AgrawalCEOMacsen DrugsF-261, 262, 263 Riico Industrial Area, GudliTehsil Mavli, Udaipur313024RajasthanIndiaIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesWarning Letter320-25-51March 5, 2025Dear Mr. Agrawal:The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Macsen Drugs, FEI 3015794560, at F-261, 262, 263 Riico Industrial Area Gudli, Tehsil Mavli, Udaipur, Rajasthan, India, from September 2 to 6, 2024.This warning letter summarizes significant deviations from Current Good Manufacturing Practice (CGMP) for active pharmaceutical ingredients (APIs).Because your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your APIs are adulterated within the meaning of section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 351(a)(2)(B).We reviewed your September 27, 2024 response to our Form FDA 483 in detail and acknowledge receipt of your subsequent correspondence.During our inspection, our investigator observed specific deviations including, but not limited to, the following.1. Failure of your quality unit to exercise its responsibility to ensure the API manufactured at your facility are in compliance with CGMP.Your facility is subdivided into “Blocks” sharing walls and hallways. Your facility experienced a significant fire in Block(b)(4)on December 5, 2022. Additional areas affected included Block(b)(4), where your firm stored(b)(4)finished API lots. You moved your APIs after they were exposed to improper storage conditions and identified(b)(4)lots of(b)(4)API and(b)(4)lots of(b)(4)API as impacted by the fire in your incident report. Although these lots were impacted by the fire, your quality unit (QU) released(b)(4)lots of(b)(4)API and(b)(4)lot of(b)(4)API for distribution to the U.S. market.In your response, you propose to update your procedure for handling of incidents and deviations. You also attempt to recreate the worst-case condition for finished drugs stored in Block(b)(4)at the time of the fire by placing(b)(4), and you conclude there was no product impact.Your response is inadequate. Your response attempts to justify that your drugs, exposed to improper conditions, are acceptable. Drugs that have been subjected to improper storage conditions, including extremes in temperatures and smoke, are considered adulterated and are not suitable for distribution in the U.S. supply chain. Further, you do not commit to initiate a market action against the lots your incident report identifies as “impacted and degraded”.For more information regarding drugs exposed to conditions resulting from a fire, please refer toQuestions and Answers on Current Good Manufacturing Practice Requirements | Returned and Salvaged Drug Productsat https://www.fda.gov/drugs/pharmaceutical-quality-resources/questions-and-answers-current-good-manufacturing-practice-requirements-returned-and-salvaged-drug.In response to this letter, provide:A comprehensive assessment and remediation plan to ensure your QU is given the authority and resources to effectively function. The assessment should also include, but not be limited to:o Your revised procedures to ensure that unexpected events that may pose a risk to your products are adequately managed.o Provisions for QU oversight throughout your operations to evaluate adherence to appropriate practices.o A complete and final review of each lot and its related information before the QU disposition decision.o Oversight and approval of investigations and discharging of all other QU duties to ensure identity, strength, quality, and purity of all products.Your action plan to address any product quality or patient safety risks for all lots of(b)(4)API in U.S. distribution you identified as impacted by the December 2022 fire, including customer notifications and recalls.2. Failure of your quality unit to ensure that there is stability data to support retest or expiry dates and storage conditions of API.Based on the records and information provided for stability, you did not demonstrate the quality attributes of your API lots remain acceptable throughout the labeled expiry period.You experienced numerous power failures in your stability chambers over the past two years. These failures extended for up to 40 hours. You also lack data loggers to monitor and document actual conditions in the event of a failure or power loss.Your response is inadequate. You acknowledge your stability program is inadequate. You commit to update your stability procedure regarding power failures and conduct a study to “determine the trend of temperature and humidity in the powered-off condition and make it part of equipment qualification.” You do not provide your study protocol or risk assessment “regarding electrical connection, power supply, power surge & voltage disruption.”In response to this letter, provide:A comprehensive, independent assessment and corrective action and preventive action plan to ensure the adequacy of your stability program. Your remediated program should include, but not be limited to:o Stability indicating methods.o Stability studies for each drug product in its marketed container-closure system before distribution is permitted.o An ongoing program in which representative batches of each product are added each year to the program to determine if the shelf-life claim remains valid.o Detailed definition of the specific attributes to be tested at each station (timepoint).All procedures that describe these and other elements of your remediated stability program.ConclusionThe deviations cited in this letter are not intended to be an all-inclusive list of deviations that exist at your facility. You are responsible for investigating and determining the causes of any deviations and for preventing their recurrence or the occurrence of other deviations.Correct any deviations promptly. FDA may withhold approval of new applications or supplements listing your firm as a drug manufacturer until any deviations are completely addressed and we confirm your compliance with CGMP. We may re-inspect to verify that you have completed corrective actions to any deviations.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 days1. Specify what you have done to address any deviations 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 3015794560 and ATTN: Carlos Gonzalez.Sincerely,/S/Francis GodwinDirectorOffice of Manufacturing QualityOffice of ComplianceCenter for Drug Evaluation and Research_______________1Under program enhancements for the Generic Drug User Fee Amendments (GDUFA) reauthorization for fiscal years (FYs) 2023-2027, also known as the GDUFA III Commitment Letter, your facility may be eligible for a Post-Warning Letter Meeting to obtain preliminary feedback from FDA on the adequacy and completeness of your corrective action plans.