Product:Drugs、Over-the-Counter DrugsRecipient:TKTX USAUnited Statesadmin@tktxusa.comIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesWARNING LETTERFebruary 25, 2025RE: 698435Dear Sir/Madam:This letter concerns your firm’s distribution of the drug products “TKTX Blue Numbing Cream 40%,” “TKTX Green Numbing Cream 40%,” “TKTX Black Numbing Cream 40%,” “TKTX Gold Numbing Cream 40%,” and “TKTX Yellow Numbing Cream 40%” (hereinafter collectively referred to as “TKTX Numbing Creams”) for use as external analgesics prior to sensitive cosmetic procedures. The United States Food and Drug Administration (FDA) reviewed your product labeling, including your website at the internet address www.tktxusa.com, where your products are available for purchase in the United States without a prescription. We also reviewed your social media handles, “TKTX Numbing Cream USA” on Facebook and “tktx.numbingcream” on Instagram, which direct consumers to your website to purchase the products.“TKTX 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). “TKTX Numbing Creams” 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 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, these drug products include lidocaine concentrations that exceed what is permissible for over-the-counter (OTC) external analgesic drug products marketed without an approved application and/or include combinations of active ingredients that do not conform to the conditions of marketing in the external analgesics final administrative order issued under section 505G.1FDA 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 advisories2and a recent news release3about the use of similar lidocaine and other “-caine” type ingredient products when applied over large areas of skin, particularly on irritated or broken skin, for prolonged periods of time, and when the skin is covered after application. These uses increase the amount of active ingredient that passes into the bloodstream and, if used improperly, may cause serious injury.Unapproved New Drug and Misbranded Drug Violations“TKTX 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 “TKTX Numbing Creams” 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 Blue Numbing Cream 40%”“What is TKTX Blue Numbing Cream?Blue TKTX Numbing Cream is a topical anesthetic designed to numb the skin surface, effectively reducing pain and discomfort associated with dermal procedures. It is widely used in various cosmetic and medical applications to provide temporary relief from pain and itching.” [from the product website]“Ingredients of TKTX Blue Numbing CreamThe primary ingredients typically found in Blue TKTX Numbing Cream include: ∙Lidocaine: An anesthetic that numbs tissue in a specific area. ∙Prilocaine: Another anesthetic that works in conjunction with Lidocaine to increase numbness. ∙ Epinephrine: Helps to reduce bleeding and prolong the duration of the anesthetic effect…” [from the product website]“Blue TKTX Numbing Cream is used during: ∙Tattoo application and removal. ∙Body piercing. ∙Cosmetic procedures like microblading and lip fillers. ∙Laser hair removal and other laser treatments. ∙Minor surgical procedures and injections…To use Blue TKTX Numbing Cream…2. Apply a generous amount of cream to the skin and spread it evenly. 3. Cover the area with a plastic wrap to enhance absorption. 4. Leave the cream on the skin for approximately 25 to 30 minutes before the procedure. 5. Remove the wrap and wipe away any excess cream before starting the procedure.” [from the product website]“TKTX Green Numbing Cream 40%”“What is TKTX Green Numbing Cream 40%?TKTX Green Numbing Cream 40% is a topical anesthetic with a potent formula designed to numb the skin effectively. The “40%” indicates the strength of active agents in the cream, which is formulated to provide maximum pain relief for skin procedures that may otherwise be quite painful.” [from the product website]“Ingredients of Green TKTX Numbing CreamThe Green TKTX Numbing Cream is composed of several active ingredients, which may include: ∙Lidocaine: A local anesthetic that helps to reduce pain and discomfort. ∙Prilocaine: Another anesthetic that increases the numbing effect when combined with Lidocaine. ∙Epinephrine: Helps to prolong the numbing effect and decrease bleeding and swelling…” [from the product website]“Green TKTX Numbing Cream is commonly used for: Tattoo application, especially in areas with dense nerve endings. ∙Body piercing procedures. ∙Cosmetic procedures such as microblading and dermal fillers. ∙Laser hair removal and other laser-based skin treatments. ∙Minor surgical procedures that can be performed without deep anesthesia…” [from the product website]“TKTX Numbing Cream VariantsTKTX Numbing Cream comes in four different variants, each with its unique color and potency level. They are: ∙ Green: This variant has a 40% concentration of lidocaine and is recommended for use on sensitive areas such as the face, neck, and genitals…” [from the product website]“TKTX Black Numbing Cream 40%”“TKTX Black Numbing Cream 40%Introducing the powerful TKTX Black Numbing Cream, a trusted ally in pain management since its inception. Specially formulated for maximum efficiency, this cream is an ideal solution for easing discomfort associated with a wide range of skin procedures such as tattoos, cosmetic treatments, and laser hair removal. Recognized for its exceptional quality, TKTX Black sets the standard in pain relief, providing a numbing effect that lasts for a full four hours when applied correctly.” [from the product website]“TKTX Numbing Cream VariantsTKTX Numbing Cream comes in four different variants, each with its unique color and potency level. They are…∙ Black: The black variant contains 25% lidocaine and is ideal for use on smaller areas, such as the fingers and toes…” [from the product website]“TKTX Gold Numbing Cream 40%”“What is TKTX Gold Numbing Cream 40%?Gold TKTX Numbing Cream 40% is a highly concentrated topical anesthetic cream that provides significant numbing effects for skin procedures. The “40%” indicates a potent blend of active ingredients designed to deliver an intense level of numbness for an extended period of time, making it suitable for more painful procedures where deep numbing is essential.” [from the product website]“Ingredients of TKTX Gold Numbing CreamThe key ingredients in Gold TKTX Numbing Cream usually include: ∙Lidocaine: A numbing agent that provides pain relief by blocking nerve signals in the skin. ∙Prilocaine: Works synergistically with Lidocaine to enhance the numbing effect. ∙Epinephrine: Constricts blood vessels to reduce swelling and bleeding, and prolongs the duration of the anesthetic.” [from the product website]“Gold TKTX Numbing Cream is typically utilized for: ∙Extensive tattooing sessions. ∙Piercings in sensitive areas. ∙Cosmetic procedures that may cause significant discomfort, such as deep laser treatments and extensive waxing. ∙Minor surgical interventions that do not require injectable anesthesia….” [from the product website]“TKTX Numbing Cream VariantsTKTX Numbing Cream comes in four different variants, each with its unique color and potency level. They are… ∙Gold: This variant has the lowest concentration of lidocaine at 20% and is recommended for use on thicker skin, such as the palms and soles of the feet.” [from the product website]“TKTX Yellow Numbing Cream 40%”“TKTX Yellow Numbing Cream 40%…This cream, known for its authentic quality, skillfully alleviates pain and discomfort linked to various skin procedures, including cosmetic treatments, tattoo applications, and laser hair removal. With a standing as a top choice in the realm of pain relief, its effectiveness and quality are evident. When applied as directed, it maintains its numbing effect for up to 04 hours.” [from the product website]“TKTX Numbing Cream VariantsTKTX Numbing Cream comes in four different variants, each with its unique color and potency level. They are…∙Yellow: With a 35% concentration of lidocaine, this variant is suitable for use on larger areas of the body, such as the arms and legs…” [from the product website]Unapproved New Drug ViolationsBased on the above labeling evidence “TKTX Numbing Creams” are 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 “TKTX 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, here M017: External Analgesic Drug Products for Over-the-Counter Human Use (hereinafter “M017” or the “external analgesics monograph”).4However, “TKTX Numbing Creams” do not conform to the conditions of use specified in the external analgesics monograph for the reasons described below.The combinations and/or concentrations for the active ingredients identified in the labeling for the “TKTX Numbing Creams” do not conform to the conditions of use set forth in M017. Specifically, your labeling purports that “TKTX Green Numbing Cream 40%,” “TKTX Yellow Numbing Cream 40%,” “TKTX Black Numbing Cream 40%,” and “TKTX Gold Numbing Cream 40%” have a concentration of lidocaine at 40%, 35%, 25%, and 20%, respectively. These concentrations are above the 0.5% to 4% concentration range of lidocaine permitted in M017. Additionally, these drug products also include lidocaine in combination with other active ingredients that are not permitted in M017. As noted above, your labeling states that “TKTX Blue Numbing Cream 40%,” “TKTX Green Numbing Cream 40%,” and “TKTX Gold Numbing Cream 40%,” are typically composed of lidocaine, prilocaine, and epinephrine. Neither epinephrine nor prilocaine are permitted as active ingredients in M017. Moreover, prilocaine is not a permitted active ingredient in any final administrative order issued in accordance with section 505G.Furthermore, labeling for all of the “TKTX Numbing Creams” include indications that are not consistent with the indications for external analgesic 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.Thus, “TKTX Numbing Creams” do not comply with the applicable conditions specified in M017 and have not otherwise been found GRASE.5Accordingly, these products are new drugs within the meaning of section 201(p) of the FD&C Act, 21 U.S.C. 321(p), and there is no basis under section 505G of the FD&C Act under which these products would be legally marketed without 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 Violations“TKTX 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 these 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 these 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__________________1Section 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).2Refer 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.3Refer 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,” see https://www.fda.gov/news-events/press-announcements/fda-warns-consumers-avoid-certain-topical-pain-relief-products-due-potential-dangerous-health4M017 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).5FDA is not aware of any adequate and well-controlled clinical studies in the published literature that support a determination that “TKTX Blue Numbing Cream 40%,” “TKTX Green Numbing Cream 40%,” “TKTX Black Numbing Cream 40%,” “TKTX Gold Numbing Cream 40%,” and “TKTX Yellow Numbing Cream 40%” are GRASE for use under the conditions prescribed, recommended, or suggested in their labeling.

Product:Drugs、Over-the-Counter DrugsRecipient:TKTX Numb StoreUnited Statesservice@tktxnumbstore.comIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesWARNING LETTERFebruary 25, 2025RE: 697051Dear Sir/Madam:This letter concerns your firm’s distribution of the drug products “TKTX TOPICAL ANESTHETIC CREAM 5% Lidocaine [TKTX Tub],” “TKTX plus 200% More Volume,” and “TKTX RAPID NUMB & LONG LASTING” indicated for use as external analgesics prior to sensitive cosmetic procedures. The United States Food and Drug Administration (FDA) reviewed your product labeling, including your website at the internet address www.tktxnumbstore.com where the products are available for purchase in the United States without a prescription.“TKTX TOPICAL ANESTHETIC CREAM 5% Lidocaine [TKTX Tub],” “TKTX plus 200% More Volume,” and “TKTX RAPID NUMB & LONG LASTING” 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). “TKTX TOPICAL ANESTHETIC CREAM 5% Lidocaine [TKTX Tub],” “TKTX plus 200% More Volume,” and “TKTX RAPID NUMB & LONG LASTING” 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 as external analgesics, among other things,1to be used before and/or during various sensitive cosmetic procedures such as tattooing, piercing, laser cosmetic procedures, 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, these drug products include lidocaine concentrations that exceed what is permissible for over-the-counter (OTC) external analgesic drug products marketed without an approved application and/or include combinations of active ingredients that do not conform with the conditions of marketing in the external analgesics final administrative order issued under section 505G.2FDA has safety concerns about these 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 advisories3and a recent news release4about the use of similar lidocaine and other “-caine” type ingredient products when applied over large areas of skin, particularly on irritated or broken skin, for prolonged periods of time, and when the skin is covered after application. These uses increase the amount of active ingredient that passes into the bloodstream and, if used improperly, may cause serious injury.Unapproved New Drug and Misbranded Drug Violations“TKTX TOPICAL ANESTHETIC CREAM 5% Lidocaine [TKTX Tub],” “TKTX plus 200% More Volume,” and “TKTX RAPID NUMB & LONG LASTING” 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 TOPICAL ANESTHETIC CREAM 5% Lidocaine [TKTX Tub]”“TOPICAL ANESTHETIC CREAM” [from the product website]“DRUG FACTS…Active Ingredient…Lidocaine 5%, Prilocaine, Epinephrine…Local Anesthetic…Uses:For the temporary relief of ■ TATTOOING ■ PIERCING ■ PERMANENT MAKEUP ■ LASER TREATMENTS ■ WAXING ■ MESO PROCEDURES” [from the product website]“TKTX plus 200% More Volume”“Active ingredients- Lido5%,Prilo, Epine…Uses– For the temporary relief the discomfort of ∙ TATTOOING ∙ PIERCING ∙ PERMANENT MAKEUP ∙ LASER TREATMENTS ∙ WAXING ∙ MESO PROCEDURES” [from the product website]“…Best for minor cuts, minor scrapes, minor burns, insect bites, anorectal disorder” [from the product website]“Helps Reduce Inflammation- Enriched with Vitamin E, your TKTX topical helps relieve swelling. your TKTX topical helps relieve swelling…”[from the product website]“TKTX RAPID NUMB & LONG LASTING”“FAST PAIN RELIEF” [from the product website]“Topical Anesthetic Cream” [from the product website]“5% LIDO TOPICAL CREAM MAXIMUM STRENGTH…APPLY-Great for tattoos, tattoo removals, piercings and laser waxing” [from the product website]Unapproved New Drug ViolationsBased on the above labeling evidence “TKTX TOPICAL ANESTHETIC CREAM 5% Lidocaine [TKTX Tub],” “TKTX plus 200% More Volume,” and “TKTX RAPID NUMB & LONG LASTING” are 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 sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 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 “TKTX TOPICAL ANESTHETIC CREAM 5% Lidocaine [TKTX Tub],” “TKTX plus 200% More Volume,” and “TKTX RAPID NUMB & LONG LASTING” in order to be GRASE and not new drugs, the products must, among other things, conform to the conditions in the applicable OTC monograph, here M017: External Analgesic Drug Products for Over-the-Counter Human Use (hereinafter “M017” or the “external analgesic monograph”).5However, “TKTX TOPICAL ANESTHETIC CREAM 5% Lidocaine [TKTX Tub],” “TKTX plus 200% More Volume,” and “TKTX RAPID NUMB & LONG LASTING” do not conform to the conditions of use specified in the external analgesic monograph for the reasons described below.The combinations and/or concentrations of the active ingredients identified in the product labeling for “TKTX TOPICAL ANESTHETIC CREAM 5% Lidocaine [TKTX Tub],” “TKTX plus 200% More Volume,” and “TKTX RAPID NUMB & LONG LASTING” do not conform to the conditions of use set forth in M017. Specifically, lidocaine, the active ingredient in all of these products is at a concentration of 5%. These concentrations are above the 0.5% to 4% concentration range of lidocaine permitted by M017.Additionally, these drug products also include lidocaine in combination with other active ingredients that are not permitted by M017. Specifically, “TKTX TOPICAL ANESTHETIC CREAM 5% Lidocaine [TKTX Tub]” and “TKTX plus 200% More Volume,” contain lidocaine 5%, prilocaine, and epinephrine as active ingredients. Neither epinephrine nor prilocaine are permitted as active ingredients by M017. Moreover, prilocaine is not a permitted active ingredient in any final administrative order issued in accordance with section 505G.Furthermore, the labeling for TKTX TOPICAL ANESTHETIC CREAM 5% Lidocaine [TKTX Tub],” “TKTX plus 200% More Volume,” and “TKTX RAPID NUMB & LONG LASTING” include indications that are not consistent with the indications for external analgesic 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 procedures are not included in M017 or any other final administrative order in accordance with section 505G.We note that “TKTX plus 200% More Volume” also appears 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. 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, “TKTX TOPICAL ANESTHETIC CREAM 5% Lidocaine [TKTX Tub],” “TKTX plus 200% More Volume,” and “TKTX RAPID NUMB & LONG LASTING” do not comply with the applicable conditions specified in M017 and have not otherwise been found GRASE.6Accordingly, 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 ViolationsFurther, “TKTX TOPICAL ANESTHETIC CREAM 5% Lidocaine [TKTX Tub],” “TKTX plus 200% More Volume,” and “TKTX RAPID NUMB & LONG LASTING” 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 these 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 these 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______________________1We note that “TKTX plus 200% More Volume” also appears to be indicated to relieve pain associated with anorectal disorders. OTC anorectal drug products are deemed to be generally recognized as safe and effective (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. This product does not conform to the conditions set forth in this monograph. “TKTX plus 200% More Volume” is labeled as both an external analgesic and anorectal drug product. This product cannot meet the requirements of both M017 and M015 with lidocaine or lidocaine HCl as an active ingredient at or above a concentration of 5% nor with a combination of active ingredients of lidocaine, prilocaine, and epinephrine. Moreover, prilocaine is not a permitted active ingredient in any final administrative order issued in accordance with section 505G.2Section 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).3Refer to FDA public health advisories Life-Threatening Side Effects with the Use of Skin Products Containing Numbing Ingredients for Cosmetic Procedures, Potential Hazards of Skin Products Containing Numbing Ingredients for Relieving Pain from Mammography and Other Medical Tests and Conditions, and Improper Use of Skin Numbing Products Can Be Deadly.4Refer 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,” see https://www.fda.gov/news-events/press-announcements/fda-warns-consumers-avoid-certain-topical-pain-relief-products-due-potential-dangerous-health.5M017 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).6FDA is not aware of any adequate and well-controlled clinical studies in the published literature that support a determination “TKTX TOPICAL ANESTHETIC CREAM 5% Lidocaine [TKTX Tub],” “TKTX plus 200% More Volume,” and “TKTX RAPID NUMB & LONG LASTING” are GRASE for use under the conditions prescribed, recommended, or suggested in their labeling.

Product:Drugs、Over-the-Counter DrugsRecipient:TKTX Numbing Cream USA7831 20th StWestminster,CA92683United Statescontact@tktxnumbingcreamusa.comIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesWARNING LETTERFebruary 25, 2025RE: 702106Dear Sir/Madam:This letter concerns your firm’s distribution of the drug products, “Yellow TKTX Numbing Cream 40%,” “White TKTX Numbing Cream 40%,” “Gold TKTX Numbing Cream 40%,” and “Black TKTX Numbing Cream 40%” (hereinafter collectively referred to as “TKTX Numbing Creams”), for use as external analgesics prior to sensitive cosmetic procedures. The United States Food and Drug Administration (FDA) reviewed your product labeling, including your website at the internet address www.tktxnumbingcreamusa.com, where your products are available for purchase in the United States without a prescription.“TKTX 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). “TKTX Numbing Creams” 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 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, these drug products include lidocaine concentrations that exceed what is permissible for over-the-counter (OTC) external analgesic drug products marketed without an approved application and/or include a combination of active ingredients that does not conform to the conditions of marketing in the external analgesics final administrative order issued under section 505G.1FDA 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 advisories2and a recent news release3about the use of similar lidocaine and other “-caine” type ingredient products when applied over large areas of skin, particularly on irritated or broken skin, for prolonged periods of time, and when the skin is covered after application. These uses increase the amount of active ingredient that passes into the bloodstream and, if used improperly, may cause serious injury.Unapproved New Drug and Misbranded Drug Violations“TKTX 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 “TKTX Numbing Creams” products’ 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:“Yellow TKTX Numbing Cream 40%”“Yellow TKTX Numbing Cream 40% takes the edge off tattoos, piercings, and cosmetic treatments so you can focus on the results you love.” [from the product website]“Are you ready to experience a tattoo session that’s more about the art and less about the ouch? At TKTX Numbing Cream USA, we introduce Yellow TKTX Numbing Cream, your go-to solution for a smooth and comfortable tattooing journey.” [from the product website]“Yellow TKTX Numbing Cream is crafted with high-quality ingredients, including 5% lidocaine, a proven anesthetic, ensuring a safe and effective numbing experience.” [from the product website]“Simply cleanse the area, apply a generous layer, and cover with plastic wrap for 40-60 minutes, and you’re all set for a comfortable tattoo session.” [from the product website]“Can I use it for other procedures besides tattoos?While primarily designed for tattoos, Yellow TKTX can also be used for other minor procedures such as piercings and laser hair removal.” [from the product website]“White TKTX Numbing Cream 40%”“White TKTX Numbing Cream 40% takes the edge off tattoos, piercings, and cosmetic treatments so you can focus on the results you love.” [from the product website]“Ready to embrace the artistry of tattoos without the sting? At TKTX Numbing Cream USA, we present White TKTX Numbing Cream, your ultimate solution for a comfortable and enjoyable tattoo session.” [from the product website]“White TKTX Numbing Cream is formulated with high-quality ingredients, including 5% lidocaine, a proven anesthetic.” [from the product website]“Simply cleanse the area, apply a thick layer, and cover with plastic wrap for 40-60 minutes, and you’re ready for a pain-free tattoo session.” [from the product website]“Can I use it for other procedures besides tattoos?While primarily designed for tattoos, White TKTX Numbing Cream can also be used for other minor procedures like piercings and laser hair removal.” [from the product website]“Gold TKTX Numbing Cream 40%”“Gold TKTX Numbing Cream 40% takes the edge off tattoos, piercings, and cosmetic treatments so you can focus on the results you love.” [from the product website]“Are you ready to indulge in a luxurious tattoo experience where pain is a distant memory? At TKTX Numbing Cream USA, we present Gold TKTX Numbing Cream…This premium topical anesthetic is meticulously formulated to provide deep and lasting numbing, ensuring a comfortable and enjoyable tattoo session that feels nothing short of extraordinary.” [from the product website]“Gold TKTX Numbing Cream is crafted with the finest ingredients, including a powerful blend of 5% lidocaine and prilocaine, ensuring a safe and effective numbing experience.” [from the product website]“Simply cleanse the area, apply a generous layer, cover with plastic wrap for 40-60 minutes, and you’re all set for a comfortable tattoo session.” [from the product website]“Can I use it for other procedures besides tattoos?While primarily designed for tattoos, Gold TKTX Numbing Cream can also be used for other minor procedures such as piercings and laser hair removal.” [from the product website]“Black TKTX Numbing Cream 40%”“Black TKTX Numbing Cream 40% takes the edge off tattoos, piercings, and cosmetic treatments so you can focus on the results you love.” [from the product website]“Are you ready to transform your tattoo experience from daunting to delightful? At TKTX Numbing Cream USA, we present Black TKTX Numbing Cream….” [from the product website]“Black TKTX Numbing Cream is crafted with high-quality ingredients, including 5% lidocaine and prilocaine, ensuring a safe and effective numbing experience.” [from the product website]“Simply cleanse the area, apply a generous layer, and cover with plastic wrap for 40-60 minutes, and you’re ready for a virtually pain-free tattoo session.” [from the product website]“Can I use it for other procedures besides tattoos?While primarily intended for tattoos, Black TKTX can also be used for other minor procedures such as piercings and laser hair removal.” [from the product website]Unapproved New Drug ViolationsBased on the above labeling evidence “TKTX Numbing Creams” are 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 “TKTX 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”).4However, “TKTX Numbing Creams” do not conform to the conditions of use specified in the external analgesics monograph for the reasons described below.As formulated, the concentration of active ingredient in your “TKTX Numbing Creams” does not conform to the conditions of use set forth in M017. Specifically, your labeling purports that “Yellow TKTX Numbing Cream 40%,” “White TKTX Numbing Cream 40%,” “Gold TKTX Numbing Cream 40%,” and “Black TKTX Numbing Cream 40%” have a concentration of lidocaine at 5%. This concentration is above the 0.5% to 4% concentration range of lidocaine permitted in M017.Additionally, your labeling purports that “Gold TKTX Numbing Cream 40%” and “Black TKTX Numbing Cream 40%” contain lidocaine in combination with prilocaine. Prilocaine is not permitted as an active ingredient in M017 or any other OTC drug monograph issued in accordance with section 505G.Furthermore, the labeling for your “TKTX Numbing Creams” includes indications that are not consistent with the indications for external analgesic drug products. For example, 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 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.Thus, “TKTX Numbing Creams” do not comply with the applicable conditions specified in M017 and have not otherwise been found GRASE.5Accordingly, these products are new drugs within the meaning of section 201(p) of the FD&C Act, 21 U.S.C. 321(p), and there is no basis under section 505G of the FD&C Act under which these products would be legally marketed without an approved application. Because there are no approved applications in effect for these products, 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 Violations“TKTX 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 these 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 these 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____________________1Section 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).2Refer 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.3Refer 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,” see https://www.fda.gov/news-events/press-announcements/fda-warns-consumers-avoid-certain-topical-pain-relief-products-due-potential-dangerous-health.4M017 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).5FDA is not aware of any adequate and well-controlled clinical studies in the published literature that support a determination that “Yellow TKTX Numbing Cream 40%,” “White TKTX Numbing Cream 40%,” “Gold TKTX Numbing Cream 40%,” and “Black TKTX Numbing Cream 40%” are GRASE for use under the conditions prescribed, recommended, or suggested in their labeling.

Delivery Method:Via Electronic Mail - Delivery and Read Receipt RequestedProduct:DrugsRecipient:Mr. Mark L’HommedieuManaging PartnerProRx, LLC619 Jeffers CircleExton,PA19341-2540United StatesIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesAMENDED1WARNING LETTERWL # 696742March 4, 2025Dear Mr. L’Hommedieu:You registered your facility with the U.S. Food and Drug Administration (FDA) as an outsourcing facility under section 503B of the Federal Food, Drug, and Cosmetic Act (FDCA) [21 U.S.C. § 353b]2on April 27, 2022, and most recently on November 22, 2024. From July 15, 2024, to August 2, 2024, FDA investigators inspected your facility, ProRx, LLC, located at 619 Jeffers Circle, Exton, Pennsylvania 19341. During the inspection, the investigators collected evidence that drug products you produced failed to meet the conditions of section 503B of the FDCA necessary for drugs produced by an outsourcing facility to qualify for exemptions from certain provisions of the FDCA. In addition, the investigators noted serious deficiencies in your practices for producing drug products intended or expected to be sterile, which put patients at risk.FDA issued a Form FDA 483 to your facility on August 2, 2024. FDA acknowledges receipt of your facility’s responses, dated August 7, 2024, August 23, 2024, and September 18, 2024. FDA acknowledges that your firm ceased sterile drug production as of August 7, 2024, and notified FDA, on November 11, 2024, of an intent to resume sterile drug production. FDA also acknowledges that on August 22, 2024, your firm initiated a voluntary recall of drug products intended or expected to be sterile, within expiry, due to lack of sterility assurance. Based on this inspection, it appears you produced drugs that violate the FDCA.A. Compounded Drug Products under the FDCAUnder section 503B(b) of the FDCA, a compounder can register as an outsourcing facility with FDA. Drug products compounded by or under the direct supervision of a licensed pharmacist in an outsourcing facility qualify for exemptions from the drug approval requirements in section 505 of the FDCA [21 U.S.C. § 355(a)], the requirement in section 502(f)(1) of the FDCA [21 U.S.C. § 352(f)(1)] that labeling bear adequate directions for use and the Drug Supply Chain Security Act requirements in section 582 of the FDCA [21 U.S.C. § 360eee-1] if the conditions in section 503B of the FDCA are met.3An outsourcing facility, which is defined in section 503B(d)(4) of the FDCA [21 U.S.C. § 353b(d)(4)], is a facility at one geographic location or address that — (i) is engaged in the compounding of sterile drugs; (ii) has elected to register as an outsourcing facility; and (iii) complies with all of the requirements of this section. Outsourcing facilities must comply with other applicable provisions of the FDCA, including section 501(a)(2)(B) [21 U.S.C. § 351(a)(2)(B)], regarding current good manufacturing practice (CGMP), and section 501(a)(2)(A) [21 U.S.C. § 351(a)(2)(A)], regarding insanitary conditions. Generally, CGMP requirements for the preparation of drug products are established in Title 21 of the Code of Federal Regulations (CFR) parts 210 and 211.In addition, for a drug product compounded using bulk drug substances to qualify for exemptions under section 503B, each bulk drug substance used to compound a drug product must be manufactured by an establishment that is registered under section 510 of the FDCA [21 U.S.C § 360] (section 503B(a)(2)(C) of the FDCA [21 U.S.C. § 353b(a)(2)(C)]).In addition, for a compounded drug product to qualify for the exemptions under section 503B, the labeling of the drug must include certain information (section 503B(a)(10) of the FDCA [21 U.S.C. §353b(a)(10)]).Furthermore, for a compounded drug product to qualify for the exemptions under section 503B, it must be compounded in an outsourcing facility that is in compliance with the registration and reporting requirements in section 503B(b), including the requirement to submit adverse event reports to FDA “in accordance with the content and format requirements established through guidance or regulation under section 310.305 of title 21, Code of Federal Regulations (or any successor regulations)” (section 503B(a)(1), (b)(5) of the FDCA [21 U.S.C. § 353b(a)(1), (b)(5)]).B. Failure to Meet the Conditions of Section 503BDuring the inspection, FDA investigators noted that drug products produced by your facility failed to meet the conditions of section 503B. For example, the investigators collected evidence that:1. Your facility compounded drug products using a bulk drug substance from(b)(4), which is not a registered establishment under section 510 of the FDCA.2. Your facility’s drug products, such as Semaglutide 5mg/2ml (2.5mg/ml) 2ml, Tirzepatide 60mg/3ml (20mg/ml) 3ml, and Vancomycin 25mg/ml 10ml, did not include the following on the label: the statement “This is a compounded drug”; the name, address, and phone number of the applicable outsourcing facility; the established name of the drug; the dosage form; the statement “Office Use Only”; and a list of active and inactive ingredients, identified by established name and the quantity and proportion of each ingredient.3. Your facility’s drug products, such as Vancomycin 25mg/ml 10ml, and Tobramycin 14mg/ml 10ml, did not include the following information on the container: 1) information to facilitate adverse event reporting: www.fda.gov/medwatch and 1-800-FDA-1088 and 2) directions for use, including, as appropriate, dosage and administration.4. Your facility did not submit adverse event reports to FDA in accordance with the content and format requirements established through guidance or regulation under section 310.305 of title 21, Code of Federal Regulations (or any successor regulations). Specifically, your facility’s procedures for reporting adverse events are inadequate. For example, your documented procedures for reporting adverse events (1) do not include a definition of what constitutes a “serious” and “unexpected” adverse event (21 CFR 310.305(b)); (2) do not include a requirement to report each adverse drug experience received or otherwise obtained that is both serious and unexpected as soon as possible, but in no case later than 15 calendar days of initial receipt of the information (21 CFR 310.305(c)(1)(i)); (3) do not include a requirement to promptly investigate and submit a follow-up report regarding a serious, unexpected adverse event within 15 calendar days of receipt of new information or as requested by FDA (21 CFR 310.305(c)(2)); (4) do not include a requirement that the firm investigate four data elements when an adverse event report is received – Identifiable Patient, Identifiable Reporter, Suspect Drug Product, Serious Adverse Event (21 CFR 310.305(d)); and (5) do not provide that adverse events should be reported utilizing FDA’s Safety Reporting Portal (SRP) or Electronic Submission Gateway (ESG) (21 CFR 310.305(e)).4Because your compounded drug products have not met all of the conditions of section 503B, they are not eligible for the exemptions in that section from the FDA approval requirements of section 505, the requirement under section 502(f)(1) that labeling bear adequate directions for use, and the Drug Supply Chain Security Act requirements described in section 582 of the FDCA.Specific violations are described below.C. Violations of the FDCAAdulterated Drug ProductsFDA investigators noted that drug products intended or expected to be sterile were prepared, packed, or held under insanitary conditions, whereby they may have become contaminated with filth or rendered injurious to health, causing your drug products to be adulterated under section 501(a)(2)(A) of the FDCA. For example, the investigators observed that:1. Your firm’s operator was observed filling drug product intended to be sterile in a manner that directly blocked first pass air over uncapped filled vials.2. Your firm’s Pharmacist in Charge (PIC) was observed rapidly prodding a pile of sterilized rubber caps with forceps, in an attempt to dislodge them, inside of the ISO 5 Biosafety Cabinet (BSC), near uncapped filled vials of drug product intended to be sterile. This practice, moving quickly in a critical area, may disrupt airflow and increases the risk of bringing lesser quality air into the ISO 5 area.3. An operator exposed their bare hands within the ISO 5 work area while donning gloves in preparation for aseptic production.4. Your firm’s PIC put on gowning apparel in a way that may cause the gowning apparel to become contaminated. Specifically, your firm’s PIC was observed bending down on the floor, on their hands and knees, inside of the ISO 7 Anteroom. Your firm’s PIC then only sprayed their gloves with(b)(4)and proceeded to produce drug products intended to be sterile.5. Your firm’s ISO 5 BSC is powered off when not in use and during the cleaning and disinfection process prior to aseptic drug production. There is no assurance that contamination is not introduced when the BSC is powered off as it may allow for the influx of lesser quality air into a higher quality air area.6. Your firm used non-sterile wipes within the ISO 5 aseptic processing area.7. Your media fills were not performed under the most challenging or stressful conditions. Therefore, there is a lack of assurance that your firm can aseptically produce drug products within your facility.8. Your firm has never performed environmental monitoring in the ISO 5 area.9. Your firm failed to perform adequate smoke studies under dynamic conditions to demonstrate unidirectional airflow within the ISO 5 area. Therefore, your products intended to be sterile are produced in an environment that may not provide adequate protection against the risk of contamination.10. A flying insect was observed on the walls and ceilings of the ISO 7 Anteroom and on the door inside of the ISO 7 Buffer Room, approximately 10 feet from the ISO 5 BSC used for sterile drug processing.FDA investigators also noted CGMP violations at your facility, that caused your drug product(s) to be adulterated within the meaning of section 501(a)(2)(B) of the FDCA. The violations include, for example:1. Your firm failed to establish and follow appropriate written procedures that are designed to prevent microbiological contamination of drug products purporting to be sterile, and that include validation of all aseptic and sterilization processes (21 CFR 211.113(b)).2. Your firm failed to establish an adequate system for monitoring environmental conditions in aseptic processing areas (21 CFR 211.42(c)(10)(iv)).3. Your firm failed to establish an adequate quality unit and the responsibilities and procedures applicable to the quality control unit are not in writing and fully followed (21 CFR 211.22(a) and 211.22(d)).4. 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).5. Your firm failed to ensure that manufacturing personnel wear clothing appropriate to protect drug product from contamination (21 CFR 211.28(a)).6. Your firm failed to establish an adequate system for cleaning and disinfecting the room and equipment to produce aseptic conditions (21 CFR 211.42(c)(10)(v)).7. Your firm failed to maintain the buildings used in the manufacture, processing, packing, or holding of a drug product in a clean and sanitary condition (21 CFR 211.56(a)).8. Your firm failed to use equipment in the manufacture, processing, packing, or holding of drug products that is of appropriate design, adequate size, and suitably located to facilitate operations for its intended use and for its cleaning and maintenance (21 CFR 211.63).9. Your firm failed to establish an adequate written testing program designed to assess the stability characteristics of drug products and to use results of stability testing to determine appropriate storage conditions and expiration dates (21 CFR 211.166(a)).10. Your firm failed to conduct at least one test to verify the identity of each component of a drug product. 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)).Outsourcing facilities must comply with CGMP requirements under section 501(a)(2)(B) of the FDCA. FDA’s regulations regarding CGMP requirements for the preparation of drug products have been established in 21 CFR parts 210 and 211. FDA intends to promulgate more specific CGMP regulations for outsourcing facilities. FDA has issued a revised draft guidance,Current Good Manufacturing Practice — Guidance for Human Drug Compounding Outsourcing Facilities under Section 503B of the FD&C Act. This draft guidance, when finalized, will describe FDA’s expectations regarding outsourcing facilities and the CGMP requirements in 21 CFR parts 210 and 211 until more specific CGMP regulations for outsourcing facilities are promulgated.Under section 301(a) of the FDCA [21 U.S.C. § 331(a)], the introduction or delivery for introduction into interstate commerce of any drug that is adulterated is a prohibited act. Further, it is a prohibited act under section 301(k) of the FDCA [21 U.S.C. § 331(k)] to do any act with respect to a drug, if such act is done while the drug is held for sale after shipment in interstate commerce and results in the drug being adulterated.Unapproved New Drug ProductsYou do not have any FDA-approved applications on file for drug products that you compound.5Under sections 505(a) and 301(d) of the FDCA [21 U.S.C. §§ 331(d)] a new drug may not be introduced into or delivered for introduction into interstate commerce unless an application approved by FDA under section 505 of the FDCA is in effect for the drug. Marketing of these products, or other applicable products, without an approved application violates these provisions of the FDCA.Misbranded Drug ProductsYou compound drug products that are intended for conditions not amenable to self-diagnosis and treatment by individuals who are not medical practitioners; therefore, adequate directions for use cannot be written so that a layman can use these products safely for their intended uses. Consequently, their labeling fails to bear adequate directions for their intended uses causing them to be misbranded under section 502(f)(1) of the FDCA.6The introduction or delivery for introduction into interstate commerce of these products therefore violates section 301(a) of the FDCA. Further, it is also a prohibited act under section 301(k) of the FDCA to do any act with respect to a drug, if such act is done while the drug is held for sale after shipment in interstate commerce and results in the drug being misbranded.D. Corrective ActionsWe have reviewed your facility’s responses to the Form FDA 483. FDA acknowledges that your firm ceased sterile drug production as of August 7, 2024, and notified FDA, on November 11, 2024, of an intent to resume sterile drug production. FDA also acknowledges your voluntary recall, on August 22, 2024, of drug products intended or expected to be sterile, within expiry, due to lack of sterility assurance.We are unable to fully evaluate some of your corrective actions due to lack of adequate supporting documentation:1. Regarding your media fills, we acknowledge your commitments described in your response, including that you have revised your media fill SOP and that, “Going forward, the size and scope of media fill will be(b)(4).” However, to date, you have not submitted the revised media fill SOP, training records, or any other supporting documentation to demonstrate that the corrective actions were implemented. You have submitted two blank documents that appear to be your media fill batch record templates with no specific details reflecting the commitments written in your response. Moreover, your firm has provided no justification for failing to conduct an investigation and implement corrective and preventive actions (CAPA) related to your failed media fill. Any contaminated unit should be considered objectionable and investigated. Whenever contamination exists in a media fill batch, it should be considered indicative of a potential sterility assurance problem.2. Regarding your failure to establish a pest control program, you stated that you have instituted a formalized pest control policy and have signed a contract with(b)(4)to assist with(b)(4)monitoring of the perimeter of your facility and inside areas as needed. However, it appears your firm has not conducted any investigation to identify the root cause, specifically, where and how these insects enter the facility, or taken appropriate action to eliminate these points of ingress.Some of your corrective actions appear deficient:1. The process outlined in your SOP #: ProSOP-B094 Rev.00, allows for the use of a sterile(b)(4)to cover unfilled sterile vials and directs operators to move the(b)(4)during filling. This practice puts the product at risk for contamination and may also disrupt unidirectional airflow to the exposed product.2. The process outlined in your SOP #: ProSOP-B088, Rev. 00, instructs operators to don their(b)(4)of sterile gloves after donning not only their hair net, facemask, and shoe covers, but also the sterile garment using their bare hands. While the procedure requires your operator to wash and clean their hands with antiseptic before gowning, gowning with bare hands compromises the sterile garment and represents a contamination risk to your aseptic production environment. Additionally, your gowning procedure permits the reuse of gowning multiple times after entry and exit of the cleanroom within the same compounding day, which also represents a contamination risk.3. The procedure outlined in your SOP #: ProSOP-B090, Rev. 00, appears contradictory. Step 7.1.4 within the SOP, states that the BSC(b)(4). However, the instruction in step 7.1.5 states to turn off the blower prior to and during the sanitization of the BSC. You did not provide any scientific justification or data to support this practice.4. The supporting document you provided in your response does not adequately demonstrate that your cleanrooms were certified under dynamic conditions. For example, on page 8 of 12, the certification report indicates the room’s status as “At Rest” and the number of people in room is “(b)(4).” This does not appear to represent dynamic conditions at your facility. Review of the evidence collected during the inspection notes that your production process for sterile filling requires(b)(4)operators in the BSC during filling and capping.5. In your response, you stated that you, “purchased media that came with a valid Certificate of Analysis (COA)” and that “the COA lists all the organisms that the media supports.” Your response is not adequate as the media your firm uses is not a ready-to-use media; it comes in(b)(4)form that requires additional preparation at your facility before it can be used as intended. You did not commit to conducting growth promotion testing after media preparation to ensure that the media was prepared correctly prior to use. Growth promotion testing should be performed on all lots of prepared media.6. Regarding your Environmental Monitoring (EM) and Personnel Monitoring (PM), we acknowledge your commitment to include EM/PM for all your future batches and to also incubate your sampling plates at(b)(4)temperatures. However, you have not provided sufficient details regarding your planned corrective actions.In addition, you did not commit to revising the action level (“(b)(4)”) for viable surface sampling within the ISO 5 environment. Any microbial contamination within the ISO 5 area is a serious concern, and upon recovery, your firm should immediately assess the impact on drug products produced. This assessment should include a thorough evaluation of how contamination could have entered this critical area, and the time period over which the contamination could have existed, as well as an evaluation of drug products that remain on the market that could be affected.7. In response to our concerns with your smoke studies, you provided a new smoke study conducted on August 13, 2024. However, this smoke study does not appear to be a simulation of operational conditions at your facility. For example, it does not include all materials and equipment your firm uses during production, such as IV bag setup and aseptic filling.8. Regarding the lack of a defined minimum pressure differential between classified and non-classified spaces, you stated that you have revised your SOP to define the pressure differential from the ISO 7 space to the non-classified area to(b)(4). However, you did not provide scientific justification for utilizing this specification. A positive pressure differential of at least 0.04-0.06 inches of water gauge (10-15 Pascals (Pa)) should be maintained between adjacent rooms of differing classification (with doors closed).9. Regarding our concerns noted with your visual inspection program, we acknowledge you established a written procedure for your visual inspection process, SOP #: ProSOP-B069, Rev. 00. However, your SOP lacks key procedures and processes required for a visual inspection program. For example, there was no mention of 100% inspection, Acceptance Quality Limit (AQL) inspection, operator qualification, classification of defects, or the testing environment. Additionally, there is no scientific justification for how your PIC is going to assess, “the integrity and quality of the preparation” with respect to your new SOP stating to notify the PIC if there was a discrepancy observed during visual inspection and the PIC will, “decide on the integrity and quality of the preparation.”10. Regarding your failure to perform a disinfectant efficacy study, your responses focus on purchasing ready to use pharmaceutical grade germicidal detergents, disinfectants, and(b)(4)sporicidal solutions and a commitment to use them per the manufacturer’s instructions. While your firm may rely on this information when initially determining the effectiveness of agents used to clean and disinfect, your firm still needs to conduct an evaluation of the suitability and efficacy of the cleaning agents and cleaning methods with applicable work surfaces within your facility.11. Your responses related to your equipment qualification studies are not adequate. For example, you did not perform an adequate load study on any of the listed units within this observation. All the units were tested via a mapping study on “empty shelves.” You did not test these units under the load comparable to that expected during routine production. There was no information describing the different type of materials (e.g., vials, caps, rubber stoppers) that were loaded inside these units to represent routine production. You did not establish any preventative maintenance requirements for any of the equipment listed within this observation with the exception of the(b)(4)unit. You did not provide any scientific justification for your statement that these units, that are used for testing and storage of your sterile drug products, are all “maintenance free except when poor temperature control is observed” then an investigation will be open and “rectified by appropriate repair.”In addition to the issues discussed above, you should note that CGMP requires the implementation of quality oversight and controls over the manufacture of drugs, including the safety of raw materials, materials used in drug manufacturing, and finished drug products. See section 501 of the FDCA. If you choose to contract with a laboratory to perform some functions required by CGMP, it is essential that you select a qualified contractor and that you maintain sufficient oversight of the contractor’s operations to ensure that it is fully CGMP compliant. Regardless of whether you rely on a contract facility, you are responsible for assuring that drugs you produce are neither adulterated nor misbranded. [See 21 CFR 210.1(b), 21 CFR 200.10(b).]Regarding observations related to the conditions of section 503B of the FDCA, your corrective actions appear deficient:1. The information that you submitted, including the SOP for Product Labeling and the Label Template, does not adequately address the labeling deficiencies. Specifically, the label template does not provide for a list of active ingredients, identified by established name and the quantity or proportion of each ingredient.2. Your revised documented procedures for reporting adverse events do not adequately address adverse event reporting. For example:a. Your procedures do not adequately define what constitutes a “serious” and “unexpected” adverse event;b. Your procedures do not include a requirement to report each adverse drug experience received or otherwise obtained that is both serious and unexpected as soon as possible, but in no case later than 15 calendar days of initial receipt of the information;c. Your procedures do not include a requirement to promptly investigate and submit a follow-up report regarding a serious, unexpected adverse event within 15 calendar days of receipt of new information or as requested by FDA;d. Your procedures do not include a requirement that the firm investigate four data elements when an adverse event report is received – Identifiable Patient, Identifiable Reporter, Suspect Drug Product, Serious Adverse Event; ande. Your procedures do not provide that adverse events should be reported utilizing the Safety Reporting Portal (SRP) or Electronic Submission Gateway (ESG).Furthermore, you have not addressed the compounding of drug products using bulk drug substances manufactured by establishments which are not registered establishments under section 510 of the FDCA.Should you continue to compound and distribute drug products that do not meet the conditions of section 503B, the compounding and distribution of your drugs would be subject to the new drug approval requirement, the requirement to label drug products with adequate directions for use, and the Drug Supply Chain Security Act requirements.FDA strongly recommends that your management undertake a comprehensive assessment of operations, including facility design, procedures, personnel, processes, maintenance, materials, and systems. In particular, this review should assess your aseptic processing operations and CGMP compliance. A third-party consultant with relevant sterile drug manufacturing expertise should assist you in conducting this comprehensive evaluation.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.E. ConclusionThe violations cited in this letter are not intended to be an all-inclusive statement of violations 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. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations.You should take prompt action to address any violations. Failure to adequately address any violations may result in legal action without further notice, including, without limitation, seizure and injunction.Within fifteen (15) working days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to address any violations. Please include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. This letter notifies you of our concerns and provides you an opportunity to address them. If you believe your products are not in violation of the FDCA, include your reasoning and any supporting information for our consideration. If you cannot completely address this matter within fifteen (15) working days, state the reason for the delay and the time within which you will do so.Your response and any questions regarding the contents of this letter should be sent to compoundinginspections@fda.hhs.gov. In your response, refer to the Warning Letter Number above (#696742) and include a subject line that clearly identifies the submission as a Response to Warning Letter.Sincerely,/S/F. Gail Bormel, JD, RPhDirectorOffice of Compounding Quality and ComplianceOffice of ComplianceCenter for Drug Evaluation and Research___________1The Amended Warning Letter includes changes to the date of the letter and the named addressee as well as to the title of the letter. The original Warning Letter was issued to an individual who was no longer employed by the firm at the time of issuance, and a new responsible individual has been identified. No other material changes were made to the amended letter. For FDA tracking purposes, the original Warning Letter date of December 20, 2024, continues to serve as the date of issuance.2SeePub. L. No. 113-54, § 102(a), 127 Stat. 587, 587-588 (2013).3We remind you that there are conditions, other than those discussed in this letter, that must be satisfied to qualify for the exemptions in section 503B of the FDCA.4For more information, see, FDA’s guidance, “Adverse Event Reporting for Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act,” which can be found at https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM434188.pdf.5The specific products made by your firm are drugs within the meaning of section 201(g) of the FDCA [21 U.S.C. § 321(g)] because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of diseases and/or because they are intended to affect the structure or any function of the body. Further, they are “new drugs” within the meaning of section 201(p) of the FDCA [21 U.S.C. § 321(p)] because they are not generally recognized as safe and effective for their labeled uses.6Your compounded drug products are not exempted from the requirements of section 502(f)(1) of the FDCA by regulations issued by the FDA (see, e.g., 21 CFR 201.115).

行政相对人名称xxx公司行政相对人类别法人及非法人组织行政相对人代码_1(统一社会信用代码)xxx法定代表人xxx行政处罚决定书文号粤药监药罚〔2025〕5001号违法行为类型1.编造生产、检验记录；2.严重违反药品GMP。违法事实1.2023年7月至8月，当事人将委托试制的复方丹参片包衣片直接分装，作为其申请复方丹参片恢复生产备案的3个验证批次，并编造了上述3个批次复方丹参片生产、检验记录，进而骗取了复方丹参片恢复生产备案。2.2024年5月至6月，本局组织本局药品检查中心对当事人先后开展了4次有因检查。综合以上4次检查情况，出具技术审评意见为:当事人属于严重违反药品GMP。处罚依据《中华人民共和国药品管理法》第一百二十四条第一款第六项、第一百二十六条处罚类别罚款;没收违法所得、没收非法财物;责令停产停业处罚内容1.对当事人：没收违法生产的药品以及专门用于违法生产的原料、辅料，罚款360万元，责令停产停业整顿3个月。2.对当事人法定代表人xxx：没收违法行为发生期间从当事人所获收入72010.10元，并处所获收入40%的罚款28804.04元。3.对当事人企业负责人、总经理xxx：没收违法行为发生期间从当事人所获收入153337.76元，并处所获收入40%的罚款61335.10元。4.对当事人质量负责人、质量受权人xxx：没收违法行为发生期间从当事人所获收入92581.85元，并处所获收入40%的罚款37032.74元。5.对当事人生产负责人xxx：没收违法行为发生期间从当事人所获收入65464.41元，并处所获收入45%的罚款29458.98元。6.对当事人质量部经理xxx：没收违法行为发生期间从当事人所获收入66454.35元，并处所获收入45%的罚款29904.45元。罚款金额（万元）378.65没收违法所得、没收非法财物的金额（万元）45.08处罚决定日期2025年2月27日处罚有效期3年处罚机关广东省药品监督管理局处罚机关统一社会信用代码11440000MB2D034421数据来源单位广东省药品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。

行政相对人名称昆山热映广电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91320583765135927L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周至元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（苏）械罚〔2024〕024号违法行为类型违反了《医疗器械监督管理条例》第86条违法事实昆山热映广电有限公司涉嫌生产销售不符合经注册的产品技术要求的医疗器械的行为，违反了医疗器械相关法律法规，应立案调查。处罚依据《医疗器械监督管理条例》处罚类别罚款处罚内容罚款20000元罚款金额（万元）2.000000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2025/03/04处罚有效期2025/03/19公示截止期2026/03/04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。

行政相对人名称苏州新区明基高分子医疗器械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91320506734413277Y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许锋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（苏）械罚〔2025〕001号违法行为类型违反了《医疗器械监督管理条例》第86条违法事实苏州新区明基高分子医疗器械有限公司涉嫌生产销售不符合经注册的产品技术要求的医疗器械的行为，违反了医疗器械相关法律法规，应立案调查。处罚依据《医疗器械监督管理条例》处罚类别罚款处罚内容罚款20000元罚款金额（万元）2.000000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2025/03/04处罚有效期2025/03/19公示截止期2026/03/04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×××公司，陈××行政相对人类别法人及非法人组织，自然人行政相对人代码_1(统一社会信用代码)×××法定代表人×××法定代表人证件类型身份证法定代表人证件号码×××行政处罚决定书文号粤药监妆罚〔2025〕2001号违法行为类型未按照化妆品生产质量管理规范的要求组织生产化妆品违法事实经查，2024年5月15日，本局对当事人生产现场进行检查，发现当事人化妆品生产质量管理体系存在产品留样数量不足、产品成品放行审核栏非质量安全负责人签名等6项不内容符合规范要求（其中1项为关键项目、2项为重点项目、3项为一般项目），检查结果为生产质量管理体系存在严重缺陷。2024年9月19日，属地化妆品监管部门对当事人未按照化妆品生产质量管理规范的要求组织生产化妆品的违法行为已作出没收违法所得、罚款等行政处罚。2023年6月21日，属地化妆品监管部门对当事人生产现场进行检查，发现当事人化妆品生产质量管理体系存在实验室试剂品类不满足检验需要、部分半成品存在昆虫污染源等8项不符合规定（其中6项为重点项目、2项为一般项目），检查结果为生产质量管理体系存在严重缺陷。属地化妆品监管部门作出《暂停生产经营通知书》，责令当事人限期改正。6月28日，当事人完成整改并申请复工复产。经审核，7月26日当事人恢复生产。2023年12月1日，当事人因未按照化妆品生产质量管理规范的要求组织生产化妆品的违法行为受到属地化妆品监管部门行政处罚。陈XX为当事人上述两次违法行为发生时的法定代表人，全面负责公司的生产管理，为该案的主要责任人。2023年陈XX从当事人处取得收入×××元。处罚依据《化妆品监督管理条例》第六十条第三项处罚类别罚款，责令停产停业，吊销化妆品生产许可证，限制从业，其他。处罚内容（一）对当事人的处罚：1.责令停止化妆品经营6个月；2.吊销化妆品生产许可证（编号：粤妆20161518）。（二）对当事人法定代表人陈XX的处罚：1.罚款46920元；2.10年内禁止其从事化妆品生产经营活动。罚款金额（万元）4.692没收违法所得、没收非法财物的金额（万元）0暂扣或吊销证照名称及编号化妆品生产许可证（编号：粤妆20161518）处罚决定日期2025年3月3日处罚有效期3年处罚机关广东省药品监督管理局处罚机关统一社会信用代码11440000MB2D034421数据来源单位广东省药品监督管理局数据来源单位统一社会信用代码11440000MB2D034421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。

行政相对人名称江苏丞飞医药有限公司行政相对人类别法人及非法人组织统一社会信用代码91320214MA7JBKBM16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钱莉娜法定代表人证件类型身份证法定代表人证件号码3****************1证件类型证件号码行政处罚决定书文号苏药监（锡）处〔2025〕1号违法行为类型销售劣药违法事实当事人销售的蜜款冬花经检验不合格，依据《中华人民共和国药品管理法》第九十八条第三款第一项的规定，涉案药品为劣药。当事人涉案药品销售金额共计24292.00元，违法所得为24292.00。处罚依据依据《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》第七十五条规定处罚类别没收违法所得处罚内容没收违法违法所得24292.00元罚款金额（万元）没收违法所得没收非法财物的金额（万元）2.429200暂扣或吊销证照名称及编号处罚决定日期2025/03/03处罚有效期2025/12/03公示截止期2028/03/03处罚机关江苏省药品监督管理局处罚机关统一社会信用代码11320000014000394R数据来源单位江苏省药品监督管理局数据来源单位统一社会信用代码11320000014000394R备注公示截止期依据文件：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。

为加强化妆品产品质量监督管理，保障化妆品产品使用安全有效，江西省药品监督管理局按照2024年全省化妆品监督抽检工作方案，持续对全省生产、流通环节化妆品实施监督抽样检验，本期对已核实的16批次不合格化妆品进行公告，具体抽检信息详见附件。附件：江西省抽不符合规定化妆品（2025年第1期）                                                    江西省药品监督管理局 2025年3月3日