Delivery Method:Via EmailProduct:DrugsRecipient:Joseph YoungCEOPico IV Inc.1610 R St. Ste 300Sacramento,CA95811United StatesSupport@picoiv.comIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesWARNING LETTERMarch 6, 2024RE: 700591Dear Joseph Young:This letter is to advise you that the United States Food and Drug Administration (FDA) reviewed your website at the internet address www.picoiv.com in January 2024 and has observed that your website offers “Pico IV,” an intravenous form of cannabidiol (CBD). We have also reviewed your social media websites at www.facebook.com/profile.php?id=100094470687041 and www.instagram.com/picoivcbd/. Your social media websites direct consumers to your www.picoiv.com website to purchase your products. As described below, your “Pico IV” product is an unapproved new drug introduced or delivered for introduction into interstate commerce in violation of sections 505(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 355(a) and 331(d).Your “Pico IV” product is especially concerning from a public health perspective because injectable drug products can pose risks of serious harm to users. Injectable products are delivered directly into the body and therefore bypass some of the body’s key defenses against toxins and microorganisms that can lead to serious and life-threatening conditions.You appear to be marketing your “Pico IV” as a dietary supplement. For example, marketing material found on your website states that “CBD, and other cannabinoids, are considered dietary supplements by the FDA . . . even if they’re administered intravenously.” The FD&C Act defines the term “dietary supplement” in section 201(ff)(2)(A)(i), 21 U.S.C. 321(ff)(2)(A)(i), as a product that is “intended for ingestion.” Your “Pico IV” (or any intravenously administered product) is not intended for ingestion. For this reason, among others, your “Pico IV” product does not meet the definition of a dietary supplement under the FD&C Act. Based on our review of your social media websites and website (www.picoiv.com), your “Pico IV” is a drug as defined by section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1), because it is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease, and/or intended to affect the structure or any function of the body. Examples of claims observed on your social media websites and website (www.picoiv.com) that establish the intended use of “Pico IV” as a drug include, but may not be limited to, the following:On your social media websites at www.facebook.com/profile.php?id=100094470687041 and www.instagram.com/picoivcbd/:January 22, 2025 post: “PICO IV CBD IV’s may be a game-changer for active lifestyles. Intravenous delivery allows for rapid absorption, potentially aiding in faster muscle recover, reduced inflammation, and pain relief after intense workouts. CBD interacts with the body’s endocannabinoid system, influencing pain perception, inflammation, and mood. This may translate to improved sleep, reduced anxiety, and overall better recovery.”January 13, 2025 post: On your graphic visual, it reads, “PICOIV 6 CANNABINOIDS MAKE UP OUR CBD BROAD SPECTRUM . . . CBD [p]otentially reduce anxiety and inflammation. CBG [c]an support bone health and neuroprotection. CBN [m]ay promote relax.ation [sic] and sleep. CBC [p]otentially have anti-inflammatory properties. CBDa [m]ay have anti-inflammatory and neuroprotective effects. CBGa [c]an have antibacterial properties.”January 6, 2025 post: “Potential Benefits of PICO IV CBD Infusions:Pain Relief: CBD may help reduce chronic pain by interacting with the body’s endocannabinoid system, which plays a role in pain perception.Sleep Improvement: CBD may enhance sleep quality by promoting relaxation and reducing anxiety, which can interfere with sleep.Neurodegenerative Diseases: CBD has shown potential in supporting brain health and potentially slowing the progression of neurodegenerative diseases.Anti-inflammatory Effects: CBD may possess anti-inflammatory properties, which could benefit conditions associated with inflammation.Anxiety Relief: CBD may offer potential benefits for managing anxiety disorders by interacting with neurotransmitters that regulate mood and stress.If you’re looking for a more effective and efficient way to experience the potential benefits of CBD, consider PICO IV.”July 18, 2024 post: “‘Living with Crohn’s has never felt easier.’ If you have a Crohn’s diagnosis, PICO IV might be your next step toward trying to manage your symptoms. As the world’s first sterile CBD IV for infusions, it offers targeted relief, potentially reducing inflammation and easing discomfort. Discover the potential benefits of PICO IV and take control of your health journey. #CBD #PICOIV #Health #Wellness #Hemp #HolisticHealth #IV #CBDIV #CBDInfusion #Intravenous #CBDResearch #CBDBroadSpectrum”Your webpage https://www.picoiv.com/testimonials contains evidence of intended use in the form of personal testimonials recommending or describing the use of your product for the cure or treatment of disease and/or to affect the structure or function of the body. Examples of such testimonials include:“I had a motorcycle accident about 6 months ago and shattered my foot. I have pins and plates in my heel and throughout my recovery process doing these infusions I have had less inflammation and less pain in my foot and with a high threshold of pain comes stress and the CBD has helped relieve some of that stress giving me better sleep. I also love the staff at PicoIV and my experience has been very positive.”“I have learned to manage my emotions, but I still suffered from anxiety and was heavily reliant on benzodiazepines to control it. While reading numerous medical journals on the negative long-term effects of Xanax, I realized I had to stop the destructive cycle and search for another way to manage my anxiety . . . I have now completed two PICO CBD infusions (each 14 days apart) and have had no need to take any Xanax. It's been years since I have been able to go 30+ days without an anti-anxiety pill.”Your “Pico IV” product is not generally recognized as safe and effective for the above referenced uses and, therefore, is a “new drug” under section 201(p) of the FD&C Act, 21 U.S.C. 321(p). Subject to certain exceptions not applicable here, new drugs may not be legally introduced or delivered for introduction into interstate commerce without an approved application from FDA in effect, as described in sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a). No approved application pursuant to section 505 of the FD&C Act, 21 U.S.C. 355 is in effect for your product. Accordingly, the introduction or delivery for introduction into interstate commerce of “Pico IV” violates sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a).ConclusionThis letter is not intended to be an all-inclusive statement of violations that may exist in connection with your product. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations.This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address this matter may result in legal action including, without limitation, seizure and injunction.Please notify FDA in writing, within fifteen working days of receipt of this letter, of the specific steps you have taken to correct any violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you believe that your product is not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration. If you cannot complete corrective action within fifteen working days, state the reason for the delay and the time within which you will complete the correction.Your response should be sent to U.S. Food and Drug Administration, CDER/OC/Office of Unapproved Drugs and Labeling Compliance by email to FDAADVISORY@fda.hhs.gov. Please include your firm name and the unique identifier “CMS 700591” in the subject line of the email.Sincerely,/S/Tina Smith, M.S.Captain, U.S. Public Health ServiceDirectorOffice of Unapproved Drugs and Labeling ComplianceOffice of ComplianceCenter for Drug Evaluation and ResearchU.S. Food and Drug Administration

Product:Drugs、Over-the-Counter DrugsRecipient:Kelly ChanTKTX Store391 Sutter StreetSan Francisco,CA94108United Stateskelly@tktxstore.comIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesWARNING LETTERFebruary 25, 2025RE: 698371Dear Ms. Chan:This letter concerns your firm’s distribution of “Mithra+ 10% Lidocaine,” “J-PRO Cream” and all your TKTX branded numbing products,1for use as external analgesics, among other things,2prior to sensitive cosmetic procedures. The United States Food and Drug Administration (FDA) reviewed your product labeling, including your website at the internet address https://www.tktxstore.com, where your products are available for purchase in the United States without a prescription. We also reviewed your social media website at “Instagram.com/tktxstore,” which includes a link to your website to purchase the products.Your “Mithra+ 10% Lidocaine,” “J-PRO Cream,” and TKTX branded numbing creams are unapproved new drugs introduced or delivered for introduction into interstate commerce in violation of sections 505(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 355(a) and 331(d). These products are also misbranded under section 502(ee) of the FD&C Act, 21 U.S.C. 352(ee). Introduction or delivery for introduction of such products into interstate commerce is prohibited under sections 301(a) and (d) of the FD&C Act, 21 U.S.C. 331(a) and (d).Your firm markets the above listed drug products primarily as external analgesics to be used before and/or during various sensitive cosmetic procedures such as tattooing, laser cosmetic procedures, microblading, and others. These products are marketed without an approved application under section 505 of the FD&C Act for indications that are not included in a final administrative order issued under section 505G of the FD&C Act, 21 U.S.C. 355h, which governs nonprescription drugs marketed without an approved application. Furthermore, the “J-PRO Cream” and the “Mithra+ 10% Lidocaine” drug products include lidocaine concentrations that exceed what is permissible for over-the-counter (OTC) external analgesic and anorectal drug products marketed without an approved application and/or include a combination of active ingredients that does not conform with the conditions of marketing in the external analgesics final administrative order issued under section 505G.3FDA has safety concerns about your external analgesic drug products, which include certain active ingredients at concentrations that exceed levels currently permitted in such nonprescription drug products, because they are intended to be used before or during certain cosmetic procedures that could lead to increased absorption of the drug product through the skin. FDA is aware that use of these products before and/or during a cosmetic procedure may not be supervised by trained health professionals. Without this supervision, large amounts of topical analgesics may be applied to a person’s skin. FDA has specifically warned in multiple public health advisories4and a recent news release5about the use of similar lidocaine and other “-caine” type ingredient products when applied over large areas of skin, particularly on irritated or broken skin, for prolonged periods of time, and when the skin is covered after application. These uses increase the amount of active ingredient that passes into the bloodstream and, if used improperly, may cause serious injury.Unapproved New Drug and Misbranded Drug ViolationsYour “Mithra+ 10% Lidocaine,” “J-PRO Cream,” and TKTX branded numbing creams are drugs as defined by section 201(g)(1)(B) of the FD&C Act, 21 U.S.C. 321(g)(1)(B), because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or under section 201(g)(1)(C) of the FD&C Act, 21 U.S.C. 321(g)(1)(C), because they are intended to affect the structure or any function of the body.Examples from the product labeling, including the website listed above, that provide evidence of the intended uses (as defined in 21 CFR 201.128) of the products include, but may not limited to, the following:TKTX branded numbing creams6“Which to select TKTX numbing cream?. . . Big Size Tattoo Green 40% Lasting 5-8 Hours…Medium Size Tattoo … Yellow 40%, Black 40%, Gold 40% Lasting 4 Hours…Small Size Tattoo…White 39%, Red 38%, Blue 39% Lasting 3-4 Hours” [from website blog at https://www.tktxstore.com/blogs/news/how-to-select-tktx-numbing-cream]“How Do TKTX Numbing Creams Work? One of the main reasons people avoid getting tattoos is the pain. No one likes pain, but also, many say that beauty is pain, so at the end of the day we’re all just very confused about this concept. However, what if we told you there is a way you can go through the whole tattooing process with the minimum pain and discomfort possible.” [from website blog at https://www.tktxstore.com/blogs/news/why-tktx-doesnt-work-well-to-me]“Mithra+ 10 Lidocaine”“Purple 10% Color . . . Mithra numbing cream is used for temporary relief of pain which available (sic) without a prescription. Tattooing without pain anymore. . . Helps to relieve the pain experienced during tattooing, laser hair removal, body piercing, body waxing, bikini waxing, cosmetic tattooing and permanent make up.” [from the product website]“Usage:. . . 1.Wash the area receiving tattoo or lasers treatment with soap and water. . . . 2.Cover Hot towel (sic) in 5 minutes or Apply with alcohol. . . 3.Dry area completely. . . . 4.Cover 2-3 mm thickness (not good effective (sic) if too thin) . . . 5.Seal with Film (Canon plastic wrap) in 45-60 minutes . . . 6.Clean the skin and start tattooing.” [from the product website]“25 minutes super fast deep numbs, and it will last for 3-5 hours tattooing with no pain.” [from the product website]“J-PRO Cream”“Lidocaine Pricaine (sic) Local anesthetics . . . Lidocaine 25 mg+Prilcaine (sic) 25mg . . . 39.9% More Numbing” [from the product website]“39.9% 10g . . . JRPO Numbing Cream Tattoo Body Deep Anesthetic Fast Numb Cream Semi Permanent Skin Body”“Used for Eyebrow (sic), eyeliner, lips, face tattoo; permanent cosmetics; tattooing; micro needle pain; body piercing;laser (sic) tattoo removal;laser (sic) hair; removal;waxing;IPL (sic) treatment;electrocautery (sic)” [from the product website]“Usage: . . . For temporary relief of pain and itching due to anorectal disorders or a local anesthetic for minor surgery or cosmetic procedures. . . . *tattooing & body piercing . . . *body waxing & bikini waxing . . . *laser hair removal . . . *cosmetic tattooing . . . *Micro needle pain, body piercing,(sic) laser tattoo removal,laser hair removal,waxing,permanent (sic) cosmetics,IPL (sic) treatment, electrocautery and so on.” [from the product website]“How to Use TKTX: . . . 1.Wash (sic) the area receiving tattoo or laser treatment with soap and water. . . . 2.Cover a Hot (sic) Towel (sic) on skin for 5 Minutes ,(sic) Dry area completely. . . . 3.Apply a thick amount of TKTX numbing cream to the area and rub in thoroughly. . . . 4.After rubbing into the skin, apply a 2nd heavy layer of TKTX cream (1/8” or 2-3 mm thick) over the area. . . . 5.Cover the TKTX cream with plastic wrap (saran wrap) and keep warm. The heat under the plastic wrap helps activate the cream and keeps the cream from drying out. . . . 6.Leave TKTX cream (sic) and wrap in place for 25-50 Minutes (sic) before tattoo. For long procedures lasting hours . . . over large areas; apply numbing cream over the entire work area, then remove in sections as procedure progresses. . . . 7.Skin typically remains numb for 3 – 5 hours once cream is removed from numbed skin depending on . . . skin type and location on body.” [from the product website]Unapproved New Drug ViolationsBased on the above labeling evidence your “Mithra+ 10% Lidocaine,” “J-PRO Cream,” and TKTX branded numbing creams are primarily intended for use as external analgesic drug products. As described below, these drug products are unapproved new drugs marketed in violation of sections 505(a) and 301(d) of the FD&C Act, 21 U.S.C 355(a) and 331(d).A drug product is a “new drug” within the meaning of section 201(p) of the FD&C Act, 21 U.S.C. 321(p), if it is not generally recognized as safe and effective (GRASE) for use under the conditions prescribed, recommended, or suggested in its labeling. With certain exceptions not applicable here, a new drug may not be introduced or delivered for introduction into interstate commerce without an approved application from FDA in effect, as described in section 505(a) of the FD&C Act, 21 U.S.C. 355(a). No FDA-approved applications pursuant to section 505 of the FD&C Act, 21 U.S.C. 355, are in effect for these drug products identified above.Under section 505G of the FD&C Act, 21 U.S.C. 355h, certain nonprescription drugs marketed without an approved application —commonly referred to as “over-the-counter (OTC) monograph drugs”— may be legally marketed if they meet applicable requirements. With respect to nonprescription external analgesic drug products, such as “Mithra+ 10% Lidocaine,” “J-PRO Cream,” and TKTX branded numbing creams, in order to be GRASE and not new drugs, the products must, among other things, conform to the conditions in the applicable OTC monograph M017: External Analgesic Drug Products for Over-the-Counter Human Use (hereinafter “M017” or the “external analgesics monograph”).7However, “Mithra+ 10% Lidocaine,” “J-PRO Cream,” and TKTX branded numbing creams do not conform to the conditions of use specified in the external analgesics monograph for the reasons described below.Labeling for the distributed “Mithra+ 10% Lidocaine,” “J-PRO Cream,” and TKTX branded numbing creams include indications that are not consistent with the indications for external analgesic or anorectal drug products. Claims from the product labeling described above related to tattooing, piercing, and laser cosmetic procedures go beyond merely describing the general intended uses for an external analgesic drug product. Indications related to tattooing, piercing, and laser cosmetic or surgical procedures are not included in M017 or any other final administrative order in accordance with section 505G. As stated in the introduction to this letter, we have safety concerns related to the use of these products for these indications due to the potential for greater absorption of the active ingredients through irritated or broken skin.Furthermore, the concentration of active ingredients purported in the product formulation identified in the website labeling for the “Mithra+ 10% Lidocaine” drug product includes a lidocaine concentration that is not permitted by M017. In addition, the “J-PRO Cream” drug product includes lidocaine in combination with prilocaine, which is not permitted in M017 or any final administrative order issued in accordance with section 505G. Your TKTX branded numbing creams are labeled to contain the active ingredients lidocaine, prilocaine, and epinephrine at various strengths. No OTC drug monograph includes prilocaine as an acceptable active ingredient and epinephrine is only permitted in Over-the-Counter Monograph M015: Anorectal Drug Products for Over-the-Counter Human Use at concentrations between 0.005 to 0.01 percent.We note that your TKTX branded numbing creams also appear to be indicated to relieve pain associated with anorectal disorders. OTC anorectal drug products are deemed to be GRASE and not new drugs if, among other things, they conform to the conditions of use set forth in the M015. Indications related to tattooing and piercing are not included in M015. As stated in the introduction to this letter, we have safety concerns related to the use of these products for these indications due to the potential for greater absorption of the active ingredients through irritated or broken skin.Thus, “Mithra+ 10% Lidocaine,” “J-PRO Cream,” and your TKTX branded numbing creams do not comply with the applicable conditions specified in M017 and have not otherwise been found GRASE.8Accordingly, these products are new drugs within the meaning of section 201(p) of the FD&C Act, 21 U.S.C. 321(p), and there is no basis under section 505G of the FD&C Act under which these products would be legally marketed without and approved application. Because there are no approved applications in effect for these products, they are unapproved new drugs. The introduction or delivery for introduction of such products into interstate commerce is prohibited under section 301(d) of the FD&C Act, 21 U.S.C. 331(d).Misbranded Drug ViolationsYour “Mithra+ 10% Lidocaine,” “J-PRO Cream,” and TKTX branded numbing creams are misbranded under section 502(ee) of the FD&C Act, 21 U.S.C. 352(ee), because these products are nonprescription drugs subject to section 505G of the FD&C Act, 21 U.S.C. 355h, but do not comply with the requirements for marketing under that section and are not the subject of an application approved under section 505 of the FD&C Act, 21 U.S.C. 355.The introduction or delivery for introduction of a misbranded drug into interstate commerce is prohibited under section 301(a) of the FD&C Act, 21 U.S.C. 331(a).ConclusionThe violations cited in this letter are not intended to be an all-inclusive list of violations that may exist in connection with your products. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations.This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address this matter may result in legal action including, without limitation, seizure and injunction.Please notify FDA in writing, within 15 working days of receipt of this letter, of the specific steps you have taken to address any violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration. If you cannot complete corrective action within 15 working days, state the reason for the delay and the time within which you will complete the correction. Your response should be sent to U.S. Food and Drug Administration, CDER/OC/Office of Unapproved Drugs and Labeling Compliance by email to FDAADVISORY@fda.hhs.gov and include your firm name in the subject line of your email.Sincerely,/S/Tina Smith, M.S.Captain, U.S. Public Health ServiceDirectorOffice of Unapproved Drugs & Labeling ComplianceOffice of ComplianceCenter for Drug Evaluation and ResearchU.S. Food and Drug Administration________________________1Your TKTX numbing products include “Deep Numbs TKTX 40% More Numbing” (Green Color), “TKTX 40% More Numbing” (Black Color),” “TKTX 40% More Numbing” (Gold Color),” “Deep Numbs TKTX 40% More Numbing” (Yellow Color), “TKTX 40% More Numbing” (Red Color), “TKTX 39% More Numbing” (Blue Color),” “TKTX 39% More Numbing” (White Color), “TKTX 38% More Numbing” (Red Color), and “TKTX 38% More Numbing” (Gold Color).2We note that your TKTX Numbing Creams also appear to be indicated to relieve pain associated with anorectal disorders. OTC anorectal drug products are deemed to be GRASE and not new drugs if, among other things, they conform to the conditions of use set forth in the final administrative order, Over-the-Counter Monograph M015: Anorectal Drug Products for Over-the-Counter Human Use. Your TKTX Numbing Creams do not conform to the conditions set forth in this monograph. Your TKTX Numbing Creams are labeled as both external analgesics and anorectal products. Your products cannot meet the requirements of both M017 and M015 for the intended use to numb the skin prior to sensitive cosmetic procedures. In addition, according to labeling for your “J-PRO Cream” and “Mithra+ 10% Lidocaine,” both products contain lidocaine as an active ingredient at or above a concentration of 5% and thus cannot meet the requirements of both M017 and M015.3Section 505G(a)(1) of the FD&C Act specifies criteria under which certain nonprescription drugs without an approved application are deemed GRASE and not "new drugs," notably, conformance with conditions detailed in applicable OTC monograph documents issued by FDA under 21 CFR part 330 prior to enactment of the CARES Act. In the case of OTC external analgesic drug products, relevant documents were deemed under section 505G to be a final administrative order, Over-the-Counter Monograph M017: External Analgesic Drug Products for Over-the-Counter Human Use. (See Order ID OTC000033, available at FDA’s website OTC Monographs@FDA,https://dps.fda.gov/omuf).4Refer to FDA public health advisories Life-Threatening Side Effects with the Use of Skin Products Containing Numbing Ingredients for Cosmetic Procedures, Potential Hazards of Skin Products Containing Numbing Ingredients for Relieving Pain from Mammography and Other Medical Tests and Conditions, and Improper Use of Skin Numbing Products Can Be Deadly.5Refer to the March 26, 2024 news release titled, “FDA Warns Consumers to Avoid Certain Topical Pain Relief Products Due to Potential for Dangerous Health Effects,” seehttps://www.fda.gov/news-events/press-announcements/fda-warns-consumers-avoid-certain-topical-pain-relief-products-due-potential-dangerous-health6The cited claims are attributable to all your TKTX branded numbing creams that are listed in footnote 1.7M017 reflects the conditions as set forth in the relevant final order established and in effect under section 505G; see Order ID OTC000033, available at FDA’s website OTC Monographs@FDA,https://dps.fda.gov/omuf).8FDA is not aware of any adequate and well-controlled clinical studies in the published literature that support a determination that “Deep Numbs TKTX 40% More Numbing” (Green Color), “Mithra+ 10% Lidocaine” (Black Color), “TKTX 40% More Numbing” (Black Color), “TKTX 40% More Numbing” (Gold Color), “Deep Numbs TKTX 40% More Numbing” (Yellow Color), “TKTX 40% More Numbing” (Red Color), “J-PRO Cream” “TKTX 39% More Numbing” (Blue Color), “TKTX 39% More Numbing” (White Color), “TKTX 38% More Numbing” (Red Color), and “TKTX 38% More Numbing” (Gold Color) are GRASE for use under the conditions prescribed, recommended, or suggested in their labeling.

福建省药品监督管理局行政处罚信息公开表序号行政处罚决定书文号案件名称违法企业名称或违法自然人姓名违法企业社会信用代码法定代表人姓名主要违法事实行政处罚的种类和依据行政处罚的履行方式和期限做出处罚的机关名称和日期备注1闽药监明稽办处罚〔2025〕4号建瓯市博睿医疗器械有限公司未主动维护国家医疗器械不良事件监测信息系统用户信息且拒不改正案建瓯市博睿医疗器械有限公司91350783MA8ULJH89K蔡善儒自2023年5月9日至2024年12月24日案发期间，当事人未在国家医疗器械不良事件监测信息系统中录入在产产品定制式固定义齿的注册信息。另查，因当事人应当注册而未注册为国家医疗器械不良事件监测信息系统用户、未主动维护国家医疗器械不良事件监测信息系统用户信息等未按规定开展医疗器械不良事件监测的行为，本局于2024年3月6日责令当事人改正违法行为，并对当事人作出警告的行政处罚（闽明药稽当罚〔2024〕2号）。后当事人虽注册了国家医疗器械不良事件监测信息系统用户，但至案发时仍未录入在产产品定制式固定义齿的注册信息。依据《医疗器械不良事件监测和再评价管理办法》第七十三条第（五）项、《福建省药品监管行政处罚裁量适用细则》第十一条第一款第（二）项以及《福建省医疗器械行政处罚裁量基准（试行）》第QX-97项的规定，现责令当事人改正上述违法行为，并决定处罚如下：1.警告；2.罚款5000元（伍仟元整）。当事人应当自接到本行政处罚决定之日起十五日内，缴纳上述罚没款。当事人根据福建省药品监督管理局开具的《福建省非税收收入缴款通知书》，自行选择缴款方式。到期不缴纳罚款的，依据《中华人民共和国行政处罚法》第七十二条的规定，本局将每日按罚款数额的百分之三加处罚款，并依法申请人民法院强制执行。福建省药品监督管理局，2025年2月28日。2闽药监明稽办处罚〔2025〕5号福建省安康医疗器械有限公司生产不符合强制性标准的医用外科口罩案福建省安康医疗器械有限公司91350104574704146N廖赟远福建省安康医疗器械有限公司生产的批号为20240801、型号规格为17cm*9cm-3P的医用外科口罩经检验结果为不符合YY 0469-2011《医用外科口罩》标准要求，属不符合强制性标准的医用外科口罩。福建省安康医疗器械有限公司生产不符合强制性标准的医用外科口罩的行为，违反了《医疗器械监督管理条例》第七条、第三十五条第一款的规定。依据《中华人民共和国行政处罚法》第二十八条第二款、《医疗器械监督管理条例》第八十六条第（一）项、《福建省药品监管行政处罚裁量适用细则》第十一条第一款第（二）项、第（十）项以及《福建省医疗器械行政处罚裁量基准（试行）》第QX-11项的规定，本局责令当事人改正上述违法行为，并决定处罚如下：1.没收违法所得7216元；2.罚款20000元。上述罚没款合计27216元（贰万柒仟贰佰壹拾陆元整）。当事人应当自接到本行政处罚决定之日起十五日内，缴纳上述罚没款。当事人根据福建省药品监督管理局开具的《福建省非税收收入缴款通知书》，自行选择缴款方式。到期不缴纳罚款的，依据《中华人民共和国行政处罚法》第七十二条的规定，本局将每日按罚款数额的百分之三加处罚款，并依法申请人民法院强制执行。福建省药品监督管理局，2025年2月28日。相关单位或者个人转载或引用药品监管部门公布的信息时，应当遵守《中华人民共和国药品管理法》等法律法规的要求，对有关药品的宣传报道应当全面、科学、客观、公正，否则将依法承担相应责任。如对信息作进一步解读，应作必要的核实。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。

行政执法案件信息公开表（2025年第7期，总第165期）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渝药监械处罚〔2024〕17号重庆鑫亿医疗器械有限公司生产不符合注册的产品技术要求的医疗器械案重庆鑫亿医疗器械有限公司915001087659379629王贵兰当事人生产的特定电磁波治疗器（型号：TDP-XY-8X，生产批号：2304045），经山东省医疗器械和药品包装检验研究院检验，不符合标准规定。    当事人的行为违反了医疗器械监督管理条例》（2021年修订版）第三十五条第一款的规定。依据《医疗器械监督管理条例》（2021年修订版）第八十六条第一项和《中华人民共和国行政处罚法》（2021年修订版）第二十八条第二款的规定，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5280元；2.罚款2万元。重庆市药品监督管理局2025.03.102025.03.11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。

行政相对人名称尚志市王辉大药房有限公司行政相对人代码(统一社会信用代码)91230183MA1CH7220M法定代表人王辉行政处罚决定书文号尚志市监处罚{2025}12号违法行为类型违反《中华人民共和国药品管理法》违法事实未凭处方销售处方药处罚依据《中华人民共和国药品管理法》处罚类别罚款处罚内容罚款5000元罚款金额（万元）0.5处罚决定日期2025-03-10处罚有效期2099-12-31公示截止期2028-03-10处罚机关尚志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。

依据《化妆品监督管理条例》《化妆品生产质量管理规范》《化妆品生产质量管理规范检查要点及判定原则》等法规规章文件，广东省药品监督管理局前期对139家化妆品生产企业进行现场监督检查，经检查23家企业“生产质量管理体系存在严重缺陷”。广东省药品监督管理局已要求属地负责药品监督管理的部门对上述企业依法采取责令暂停生产、经营等紧急控制措施，及时控制产品风险。　　特此通告。　　附件：生产质量管理体系存在严重缺陷的化妆品生产企业名单广东省药品监督管理局2025年3月6日　　附件生产质量管理体系存在严重缺陷的化妆品生产企业名单序号企业名称许可证编号1名采日用品（佛山）有限公司粤妆202202672广东妙莲化妆品有限公司粤妆202101203广州市博卡利生物科技有限公司粤妆201602754暨研医药生物科技（广州）有限公司粤妆201802325中山市泛华精细化学品有限公司粤妆201614276广州市麦谷生物科技有限公司粤妆202200697广州市香蒙诗生物科技有限公司粤妆201802238广州迪丽生物科技有限公司粤妆201601649广州悠莱化妆品有限公司粤妆2016052710广州浩美药业有限公司粤妆2021036911广州家亿生物科技有限公司粤妆2022001012广州纳薇美容生物科技有限公司粤妆2021029213广州欧芭化妆品有限公司粤妆2018006314广州市露韩饰化妆品科技有限公司粤妆2016095515广州市露琪化妆品有限公司粤妆2017020216东莞市国丰化妆品有限公司粤妆2016179517广东粤美蒂化妆品有限公司粤妆2022023618广州优蓓生物科技有限公司粤妆2021032619广州舟捷生物科技有限公司粤妆2019028820康润美化妆品（佛山）有限公司粤妆2019028121广东润肽生物医药科技有限公司粤妆2024001322广州亮诗日用化工有限公司粤妆2017023723广州宇佳化妆品有限公司粤妆20180237

菏泽华佗国药大药房有限公司违反《药品经营质量管理规范》的规定，存在质量安全隐患。为防控药品质量风险，依据《中华人民共和国药品管理法》第九十九条的规定，决定对该企业采取暂停销售药品的风险控制措施。特此通告。附件：菏泽华佗国药大药房有限公司《药品经营许可证》有关信息山东省药品监督管理局2025年3月7日附件：企业名称许可证编号法定代表人质量负责人注册地址经营范围有效期至备注菏泽华佗国药大药房有限公司鲁BA530100027郭永革薛莲山东省菏泽市单县园艺场六队1号院化学药,中成药,中药饮片,生物制品,以上经营范围不含冷藏冷冻药品2029年6月24日相关推荐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。

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。

当事人：天津泰康阳光科技发展有限公司主体资格证照名称：营业执照统一社会信用代码：911202233007133600住所（住址）：天津市静海区杨成庄乡静霸公路联络线东延长线8号北洋工业园区法定代表人（负责人、经营者）：刘泽伟身份证件号码：***2024年12月2日我局接到河南省药品监督管理局《关于对不合格医疗器械核查处置的函》（豫药监抽检核查函〔2024〕2105号）称“在2024年河南省医疗器械监督抽检中，安阳市市场监督管理局在***抽样的，标示天津泰康阳光科技发展有限公司生产的电动轮椅车，经河南省药品医疗器械检验院检验，结论为不合格”，随函所附《检验报告》（报告编号：QX202403096）显示“设备或设备部件的外部标记”不符合技术要求6.1“j)输入功率”的要求，检验结果为“输入功率标记与技术要求不一致”，以及“6.8.2 a）--设备上的图形、符号、警告性声明和缩写，应在使用说明书中说明”的规定，检验结论为“说明书中无II类设备符号说明”，检验结果判定为不符合要求。2024年12月5日执法人员将以上检验报告送达当事人，当事人确认检验报告中的产品为当事人生产的产品。2024年12月20日我局对当事人立案调查。经查现场无相关产品，故无行政强制措施。当事人生产、检验、销售等记录显示，当事人生产的批号为221115的电动轮椅车，生产日期为2022年11月26日，共计生产了5台，其中3台以***元每台的价格销售给***，共计***元；其中1台以***元每台的价格销售给***；其中1台以***元每台的价格销售给***。当事人提供了该批次产品的生产记录、检验记录及放行记录，符合生产及检验要求。当事人于2024年12月16日将销售的电动轮椅车召回4台，另一台已被抽检故无法召回。综上，当事人涉案产品货值金额为***元，违法所得为***元。经确认，该批次产品的生产记录、检验记录等记录齐全，且《检验报告》（报告编号：QX202403096）中不符合项目属于医疗器械标签不规范情形，未对产品的性能产生直接影响。上述事实，主要有以下证据证明：1.天津泰康阳光科技发展有限公司《营业执照》复印件、《医疗器械生产许可证》复印件、《电动轮椅车医疗器械注册证》复印件、法定代表人身份证明、被授权人身份证复印件、授权委托书原件，证明当事人主体资格；2.河南省药品监督管理局《关于对不合格医疗器械核查处置的函》（豫药监抽检核查函〔2024〕2105号）及随函所附《检验报告》（报告编号：QX202403096），证明当事人生产的电动轮椅车抽样情况、检验情况；3. 现场检查笔录一份、询问笔录一份，证明当事人生产电动轮椅车的生产、销售等情况；4.生产记录、检验记录、销售记录、销售价格说明等复印件各一份，证明当事人的生产、销售以及货值金额等情况。我局执法人员已于2025年2月27日对当事人送达《行政处罚告知书》，当事人未提出陈述、申辩意见。本局认为，当事人生产标签不符合要求的电动轮椅车的行为违反了《医疗器械监督管理条例》第三十九条第二款：“医疗器械的说明书、标签应当标明下列事项：（四）产品性能、主要结构、适用范围；（八）产品技术要求规定应当标明的其他内容。”的规定。依据《医疗器械生产监督管理办法》第八十八条第一款第二项：“有下列情形之一的，由负责药品监督管理的部门责令改正，处1万元以上5万元以下罚款；拒不改正的，处5万元以上10万元以下罚款；情节严重的，责令停产停业，直至由原发证部门吊销医疗器械生产许可证、医疗器械经营许可证，对违法单位的法定代表人、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30%以上2倍以下罚款，5年内禁止其从事医疗器械生产经营活动：（二）生产、经营说明书、标签不符合本条例规定的医疗器械；”的规定予以处罚。鉴于当事人生产标签不符合要求的第二类医疗器械电动轮椅车的行为无从轻从重情节，给予一般处罚。综上，当事人上述行为违反了《医疗器械监督管理条例》第三十九条第二款的规定，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，现责令当事人立即改正生产标签不符合要求的第二类医疗器械电动轮椅车的违法行为，并决定处罚如下:处罚款30000元。当事人应当自收到本行政处罚决定书之日起十五日内，将罚没款缴至银行（代收机构名称：见缴款通知书；地址：见缴款通知书），或者通过电子支付系统缴纳（缴纳方式为：见缴款通知书）。到期不缴纳罚款的，依据《中华人民共和国行政处罚法》第七十二条的规定，本局将每日按罚款数额的百分之三加处罚款，并依法申请人民法院强制执行。如当事人不服本行政处罚决定，可以在收到本行政处罚决定书之日起六十日内向天津市人民政府申请行政复议；也可以在六个月内依法向天津市红桥区人民法院申请行政诉讼。申请行政复议或者提起行政诉讼期间，行政处罚不停止执行。天津市药品监督管理局（印章）2025年3月7日相关推荐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。

当事人：海龙马（天津）科技有限公司主体资格证照名称：营业执照统一社会信用代码：91120112MA06JFLU6E住所（住址）：天津市津南区咸水沽镇金浩园17号楼底商1西侧法定代表人（负责人、经营者）：王锡海身份证件号码：***我局执法人员按照2024年天津市医疗器械抽检计划，于2024年10月17日对海龙马（天津）科技有限公司生产的超声治疗仪进行监督抽检，抽检一批次超声治疗仪（注册证号：津械注准20202090935，批号：20241008，型号：TOKO 900）；2024年12月2日我局接到天津市医疗器械质量监督检验中心的天津市医疗器械抽检结果通知书（编号：2024-SC1-0024）及《检验报告》（报告编号：2024-SC1-0024）显示不符合GB9706.205-2020标准中201.7.2.101的“c）治疗头上应标注以W为单位的额定输出功率，以cm2为单位的有效辐射面积，波束不均匀性系数，波束类型，预期的治疗头与设备特定发生器的匹配（若适用，见201.7.9.2.1的最后一项）和其唯一性的序列号”的要求。2024年12月4日执法人员将以上通知书及检验报告送达当事人。2024年12月20日我局对当事人立案调查。经查现场无相关产品，故无行政强制措施。当事人生产、检验、销售等记录显示，超声治疗仪共计生产2台，其中编号为T100279的产品用于抽检外，剩余的1台编号为T100280的产品于2024年10月24日以***元的价格销售给***。当事人于2024年12月20日将销售的超声治疗仪进行三级召回，在客户处进行粘贴标识完毕。综上，当事人涉案产品货值金额为***元，违法所得为***元。经确认，该批次产品的生产记录、检验记录等记录齐全，且《检验报告》（报告编号：2024-SC1-0024）中不符合项目属于医疗器械标签不规范情形，未对产品的性能产生直接影响。上述事实，主要有以下证据证明：1.海龙马（天津）科技有限公司《营业执照》复印件、《医疗器械生产许可证》复印件、《超声治疗仪注册证》复印件、企业法定代表人身份证复印件，证明当事人主体资格及产品资质情况。2.天津市医疗器械质量监督检验中心的天津市医疗器械抽检结果通知书（编号：2024-SC1-0024）及《检验报告》（报告编号：2024-SC1-0024），证明当事人生产的超声治疗仪抽样情况、检验情况。3.现场检查笔录一份、询问笔录一份，证明当事人生产超声治疗仪的生产、销售等情况。4.生产记录、检验记录、销售记录、销售价格说明等复印件各一份，证明当事人的生产、销售以及货值金额等情况。我局执法人员已于2025年2月26日对当事人送达《行政处罚告知书》，当事人未提出陈述、申辩意见。本局认为，当事人生产标签不符合要求的超声治疗仪的行为违反了《医疗器械监督管理条例》第三十九条第二款：“医疗器械的说明书、标签应当标明下列事项：（四）产品性能、主要结构、适用范围；（八）产品技术要求规定应当标明的其他内容。”的规定。依据《医疗器械生产监督管理办法》第八十八条第一款第二项：“有下列情形之一的，由负责药品监督管理的部门责令改正，处1万元以上5万元以下罚款；拒不改正的，处5万元以上10万元以下罚款；情节严重的，责令停产停业，直至由原发证部门吊销医疗器械生产许可证、医疗器械经营许可证，对违法单位的法定代表人、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30%以上2倍以下罚款，5年内禁止其从事医疗器械生产经营活动：（二）生产、经营说明书、标签不符合本条例规定的医疗器械；”的规定予以处罚。鉴于当事人生产标签不符合要求的第二类医疗器械超声治疗仪的行为无从轻从重情节，给予一般处罚。综上，当事人上述行为违反了《医疗器械监督管理条例》第三十九条第二款的规定，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，现责令当事人立即改正生产标签不符合要求的第二类医疗器械超声治疗仪的违法行为，并决定处罚如下:处罚款30000元。当事人应当自收到本行政处罚决定书之日起十五日内，将罚没款缴至银行（代收机构名称：见缴款通知书；地址：见缴款通知书），或者通过电子支付系统缴纳（缴纳方式为：见缴款通知书）。到期不缴纳罚款的，依据《中华人民共和国行政处罚法》第七十二条的规定，本局将每日按罚款数额的百分之三加处罚款，并依法申请人民法院强制执行。如当事人不服本行政处罚决定，可以在收到本行政处罚决定书之日起六十日内向天津市人民政府申请行政复议；也可以在六个月内依法向天津市红桥区人民法院申请行政诉讼。申请行政复议或者提起行政诉讼期间，行政处罚不停止执行。天津市药品监督管理局（印章）2025年3月7日相关推荐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。