行政相对人名称 江苏高济再康医药有限公司 行政相对人类别 法人及非法人组织 统一社会信用代码 91320000682977627T 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 张学绘 法定代表人证件类型 身份证 法定代表人证件号码 3****************8 证件类型 证件号码 行政处罚决定书文号 苏药监宁处罚〔2025〕21号 违法行为类型 当事人超出许可地址从事药品经营活动 违法事实 当事人超出许可地址从事药品经营活动的行为违反《药品经营和使用质量监督管理办法》第三十一条第一款的规定，依据《药品经营和使用质量监督管理办法》第六十八条第一款的规定，按照《药品管理法》第一百一十五条的规定，应予处罚 处罚依据 依据《药品经营和使用质量监督管理办法》第六十八条第一款的规定，按照《药品管理法》第一百一十五条的规定 处罚类别 罚款 处罚内容 处罚款100000元 罚款金额（万元） 10.000000 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 2025/11/19 处罚有效期 2026/05/18 公示截止期 2028/11/19 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：市场监督管理行政处罚信息公示规定。罚款金额已确认。

根据《中华人民共和国行政许可法》《医疗器械生产监督管理办法》等有关规定，依企业申请，经我局研究决定，依法注销河北德洺服装有限公司的《医疗器械生产许可证》。特此公告。《医疗器械生产许可证》注销企业名单序号企业名称许可证编号社会信用代码法定代表人企业负责人生产地址和生产范围注销原因1河北德洺服装有限公司冀药监械生产许20200051号91130533MA094CGW3B田达平田达平（2002年分类）：Ⅱ类：6864-4手术用品；6866-7手术手套（2017年分类）：Ⅱ类:14-13手术室感染控制用品；14-14医护人员防护用品企业申请河北省药品监督管理局2025年11月14日

Delivery Method:VIA UPSReference #:320-26-09Product:Drugs、Over-the-Counter DrugsRecipient:Mr. Fabian McCarthyCEODermaRite Industries, LLC7777 West Side AvenueNorth Bergen,NJ07047United StatesIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesWarning Letter320-26-09October 27, 2025Dear Mr. McCarthy:The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, DermaRite Industries, LLC, FEI 1000526900, at 7777 West Side Avenue, North Bergen, from March 26 to April 8, 2025.This warning letter summarizes significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals. See Title 21 Code of Federal Regulations (CFR), parts 210 and 211 (21 CFR parts 210 and 211).Because your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your drug products are adulterated within the meaning of section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 351(a)(2)(B).In addition, DermaSeptin OINTMENT SKIN PROTECTANT with COOLING MENTHOL, Lantiseptic Moisture Shield ORIGINALSKIN PROTECTANT, DermaMed OINTMENT SKIN PROTECTANT, DermaFungal ANTIFUNGAL CREAM with 2% MICONAZOLE NITRATE, and PeriGiene HEALTH CARE ANTISEPTIC 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). In addition, DermaMed OINTMENT SKIN PROTECTANT is misbranded under section 502(f)(1) of the FD&C Act, 21 U.S.C. 352(f)(1). Furthermore, DermaSeptin OINTMENT SKIN PROTECTANT with COOLING MENTHOL, Lantiseptic Moisture Shield ORIGINALSKIN PROTECTANT, DermaMed OINTMENT SKIN PROTECTANT, DermaFungal ANTIFUNGAL CREAM with 2% MICONAZOLE NITRATE, and PeriGiene HEALTH CARE ANTISEPTIC are misbranded under section 502(ee) of the FD&C Act, 21 U.S.C. 352(ee). These violations are described in more detail below.We reviewed your April 28, 2025 response to our Form FDA 483 in detail and acknowledge receipt of your subsequent correspondence.CGMP ViolationsDuring our inspection, our investigator observed specific violations including, but not limited to, the following.1. Your firm failed to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, whether or not the batch has already been distributed (21 CFR 211.192)Your firm manufactures over-the-counter (OTC) topical drug products for skin and wound care. Your firm failed to adequately investigate several out-of-limit (OOL) and out-of-specification (OOS) laboratory results, as well as unexplained discrepancies. For example, you failed to identify the root cause for the following:Concerning the initial failing test result for total aerobic microbial count (TAMC) of DermaKleen Lot 40375A, which showed too numerous to count, you failed to scientifically identify the root cause of the contamination. Instead of performing an investigation into the root cause of the failure, you sent a second sample to your third-party contract laboratory, obtained passing results, and subsequently released the drug product batch for distribution. This strategy of using repeated testing until a passing result is obtained, then disregarding the OOS results without scientific justification (“testing into compliance”) is unscientific and objectionable under CGMP.Concerning the initial OOS test result for the assay of the active ingredient chloroxylenol in DermaKleen Lot 9-40545, you failed to scientifically identify the root cause of the OOS. Instead of performing an investigation into the root cause of the failure, you sent a second sample to your contract laboratory. Despite this retest also producing failing results, your firm released the batch for distribution. It is noteworthy that the certificate of analysis did not reflect the actual results.You did not thoroughly investigate these unexplained discrepancies or identify failures of a drug product to meet any of its specifications. When an investigation was performed, it was inadequate because you failed to identify the root cause(s), to implement appropriate corrective action and preventive action (CAPA), and to expand the investigation to evaluate the impact on other batches or products.In your response, you indicated that you would perform a retrospective review of all OOS test results from the last two years and determine their impact on product on the market. Your response is inadequate. You did not commit to evaluating your process for investigating unexplained discrepancies or failures of batches to determine a root cause so that you could implement appropriate CAPA. Inadequate investigations can lead to unidentified root causes, ineffective CAPA, and recurring problems that compromise the ability to manufacture safe and effective drug products.We acknowledge that you initiated a voluntary recall (https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/dermarite-industries-issues-voluntary-nationwide-recall-dermakleen-dermasarra-kleenfoam-and) on July 17, 2025, for products that initially failed for TAMC and those retains that failed forBurkholderia cepacia. On August 27, 2025, you expanded the voluntary recall to include all lots of all products that contain water (https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/dermarite-industries-expands-voluntary-nationwide-recall-due-potential-burkholderia-cepacia).Microbial contamination may not be a uniformly distributed contamination. A product sample may not be representative of the type or level of contamination within the batch. Further, testing final product for microbial contamination does not ensure that you have appropriate controls in place to ensure product quality. As a manufacturer, you have a responsibility to fully investigate unexplained discrepancies, deviations, and failures to assess their impact on product quality.In response to this letter, provide:A retrospective, independent review of all invalidated OOS/OOL (including in-process and release/stability testing) results for U.S. products currently in the U.S. market and within expiry as of the date of this letter, and a report summarizing the findings of the analysis, including the following for each OOS/OOL:o Determine whether the scientific justification and evidence relating to the invalidated OOS/OOL result conclusively or inconclusively demonstrate causative laboratory error.o For investigations that conclusively establish laboratory root cause, provide rationale, and ensure that all other laboratory methods vulnerable to the same or similar root cause are identified for remediation.o For all OOS/OOL results found by the retrospective review to have an inconclusive or no root cause identified in the laboratory, include a thorough review of production (e.g., batch manufacturing records, adequacy of the manufacturing steps, suitability of equipment/facilities, variability of raw materials, process capability, deviation history, complaint history, batch failure history). Provide a summary of potential manufacturing root causes for each investigation and include any manufacturing operation improvements.A comprehensive review and remediation plan for your OOS/OOL result investigation systems. The CAPA should include but not be limited to the following:o Quality Unit (QU) oversight of laboratory investigationso Identification of adverse laboratory control trendso Resolution of laboratory variation causeso Initiation of thorough investigations of potential manufacturing causes (whenever a laboratory cause cannot be conclusively identified)o Adequate scoping of each investigation and its CAPAo Revised OOS/OOL investigation procedures with these and other remediationsThe final investigation, including the root-cause determination, into the batches affected by the voluntary recall.A comprehensive, independent assessment of your overall system for investigating deviations, discrepancies, complaints, OOS/OOL results, and failures. Provide a detailed action plan to remediate this system. Your action plan should include but not be limited to significant improvements in investigation competencies, scope determination, root-cause evaluation, CAPA effectiveness, QU oversight, and written procedures. Address how your firm will ensure that all phases of the investigations are appropriately conducted.2. Your firm failed to test samples of each component for identity and conformity with all appropriate written specifications for purity, strength, and quality. Your firm also failed to validate and establish the reliability of your component supplier’s test analyses at appropriate intervals (21 CFR 211.84(d)(1) and 211.84(d)(2)).You failed to perform adequate identity testing on each shipment of each lot of incoming components (e.g., ethanol, glycerin) used in the manufacture of your OTC drug products. In addition, you relied on your suppliers’ certificate of analysis (COA) without establishing the reliability of each of your component suppliers’ test analyses at appropriate intervals.Products Containing Ethyl AlcoholYou failed to adequately test your incoming component ethyl alcohol (ethanol), at risk of methanol contamination, for identity before using it as an active pharmaceutical ingredient (API) in manufacturing your OTC topical drug products. The use of ethanol contaminated with methanol has resulted in various lethal poisoning incidents in humans worldwide. See FDA’s guidance document Policy for Testing of Alcohol (Ethanol) and Isopropyl Alcohol for Methanol to help you meet the CGMP requirements when manufacturing drugs containing ethanol at https://www.fda.gov/media/173005/download.Products Containing Ingredients at Risk for Diethylene Glycol or Ethylene Glycol (DEG or EG) ContaminationYou also failed to adequately test your incoming components at high risk of DEG or EG contamination for identity before using them to manufacture your drug products. This includes but is not limited to testing of propylene glycol and glycerin to determine their appropriate identity, before their use in manufacturing your OTC drug products.Identity testing for propylene glycol, glycerin, and certain other high-risk drug components includes a limit test in the USP to ensure that the component meets the relevant safety limits for DEG or EG levels. Because you did not perform identity testing on each shipment of each lot using the USP identification test that detects these hazardous impurities, you failed to ensure the acceptability of these components for use in the manufacture of your drug products.The use of ingredients contaminated with DEG or EG has resulted in various lethal poisoning incidents in humans worldwide. See FDA’s guidance documentTesting of Glycerin, Propylene Glycol, Maltitol Solution, Hydrogenated Starch Hydrolysate, Sorbitol Solution, and Other High-Risk Drug Componentsto help you meet the CGMP requirements when manufacturing drugs containing ingredients at high-risk for DEG or EG contamination at https://www.fda.gov/media/167974/download.In your response, you indicated that you tested all retains of glycerin and propylene glycol for hazardous impurities and will do so for ethanol. In addition, you stated that you have identified all lots of incoming Glycerin(b)(4)and Propylene Glycol(b)(4)received from 2023 to present and used in the products manufactured during the same period. Your response is inadequate because you failed to identify and evaluate high-risk drug components that may have been received in 2022 and used in lots manufactured in 2023.Without adequate testing, you do not have scientific evidence that the components conform to appropriate specifications before their use in the manufacture of your drug products. You are responsible for sampling, testing, and examining drug components before use in production to ensure that acceptable quality parameters are met.In response to this letter, provide:A commitment to perform reconciliation of retains tested versus all lots used in production. If retain samples are unavailable, a commitment to test finished drug product batches for the presence of DEG and EG.A full risk assessment for drug products that are within expiry which contain any ingredient at risk for DEG or EG contamination (including, but not limited to, glycerin). Take prompt and appropriate actions to determine the safety of all lots of the component(s) and any related drug product that could contain DEG or EG, including customer notifications and product recalls for any contaminated lots. Identify additional appropriate CAPA that secure supply chains in the future, including, but not limited to, ensuring that all incoming raw material lots are from fully qualified manufacturers and free from unsafe impurities. Detail these actions in your response to this letter.A description of how you will test each component lot for conformity with all appropriate specifications for identity, strength, quality, and purity. If you intend to accept any results from your supplier’s COA instead of testing each component lot for strength, quality, and purity, specify how you will robustly establish the reliability of your supplier’s results through initial validation as well as periodic revalidation. In addition, include a commitment to always conduct at least one specific identity test for each incoming component lot. In the case of glycerin, propylene glycol, and certain additional high-risk components we note that this includes the performance of parts A, B, and C of the USP monograph.The chemical quality control specifications you use to test each incoming lot of high-risk drug components to determine acceptability for use in manufacturing.A comprehensive, independent review of your material system to determine whether all suppliers of components, containers, and closures, are each qualified and the materials are assigned appropriate expiration or retest dates. The review should also determine whether incoming material controls are adequate to prevent use of unsuitable components, containers, and closures.A summary of results obtained from testing all components to evaluate the reliability of the COA from each component manufacturer. Include your SOP that describes this COA validation program.3. Your firm failed to establish and follow 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)).Your firm did not have an adequate stability program to demonstrate that the chemical and microbiological properties of your drug products met established specifications and that they remain acceptable throughout their labeled shelf-life. For example, you failed to place any OTC drug products on stability in 2023 or 2024.Additionally, stability that was conducted in 2022 identified multiple failures during multiple timepoints for chemical and microbiological properties. You lack sufficient data to support your(b)(4)expiry.In your response, you indicate that you will work with a qualified laboratory to verify that the laboratory test methods are properly validated as stability-indicating methods, and that you will retest retain samples for the marketed product batches within expiry. Your response is inadequate because you failed to address product on the market that lack adequate data to support their shelf life.Without appropriate stability studies, you lack adequate scientific evidence to support whether your drug products meet established specifications and retain their quality attributes through their labeled expiry.In your response to this letter, provide:A comprehensive, independent assessment and CAPA plan to ensure the adequacy of your stability program. Your remediated program should include, but not be limited to:o Stability indicating methodso Stability studies for each drug product in its marketed container-closure system, before distribution is permittedo An ongoing program in which representative batches of each product are added each year to determine if the shelf-life claim remains valido Detailed definition of the specific attributes to be tested at each station (timepoint)All procedures that describe these and other elements of your remediated stability.Your action plan to address any product quality or patient safety risks for batches of finished product supported by failing 2022 stability batches that are in U.S. distribution, including potential customer notifications and recalls.4. Your firm’s quality control unit failed to exercise its responsibility to ensure drug products manufactured are in compliance with CGMP, and meet established specifications for identity, strength, quality, and purity (21 CFR 211.22).Your QU failed to perform adequate oversight for the manufacture and testing of your drug products. For example, your QU failed to ensure the following:Performance of annual product reviews (21 CFR 211.180(e))Performance of adequate testing of component (e.g., water) (211.22(d))COA included all data derived from actual testing performed (211.194(a))In your response, you indicate that you have an SOP in place outlining the responsibilities of your QU and that retraining is occurring. Your response is inadequate because it does not include how you intend to structure the QU to ensure that assigned authorities and responsibilities support the production, quality, and management activities needed to produce quality products.Your firm’s quality systems are inadequate. See FDA’s guidance documentQuality Systems Approach to Pharmaceutical CGMP Regulationsfor help implementing quality systems and risk management approaches to meet the requirements of CGMP regulations 21 CFR, parts 210 and 211 at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/quality-systems-approach-pharmaceutical-current-good-manufacturing-practice-regulations.Your quality system does not adequately ensure the accuracy and integrity of data to support the safety, effectiveness, and quality of the drugs you manufacture. See FDA’s guidance documentData Integrity and Compliance with Drug CGMPfor guidance on establishing and following CGMP compliant data integrity practices at https://www.fda.gov/media/119267/download.In your response to this letter, provide:A comprehensive assessment and remediation plan to ensure your QU is given the authority and resources to effectively function. The assessment should also include, but not be limited to:o A determination of whether procedures used by your firm are robust and appropriateo Provisions for QU oversight throughout your operations to evaluate adherence to appropriate procedures and practiceso A complete and final review of each batch and its related information before the QU disposition decisiono Oversight and approval of investigations and discharging of all other QU duties to ensure identity, strength, quality, and purity of all productso A description of how top management supports quality assurance and reliable operations, including but not limited to timely provision of resources to proactively address emerging manufacturing/quality issues and to assure a continuing state of controlA comprehensive investigation into the extent of the inaccuracies in data records and reporting including results of the data review for drugs distributed to the United States. Include a detailed description of the scope and root causes of your data integrity lapses.A current risk assessment of the potential effects of the observed failures on the quality of your drugs. Your assessment should include analyses of the risks to patients caused by the release of drugs affected by a lapse of data integrity and analyses of the risks posed by ongoing operations.A management strategy for your firm that includes the details of your global CAPA plan. The detailed corrective action plan should describe how you intend to ensure the reliability and completeness of all data generated by your firm including microbiological and analytical data, manufacturing records, and all data submitted to FDA.Unapproved New Drug and Misbranded Drug ViolationsDermaSeptin OINTMENT SKIN PROTECTANT with COOLING MENTHOL, Lantiseptic Moisture Shield ORIGINALSKIN PROTECTANT, DermaFungal ANTIFUNGAL CREAM with 2% MICONAZOLE NITRATE, PeriGiene HEALTH CARE ANTISEPTIC, and DermaMed OINTMENT SKIN PROTECTANT, 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 these products’ labeling, including the DermaRite website, that provide evidence of the intended uses (as defined in 21 CFR 201.128) of the products as drugs include, but may not be limited to, the following:DermaSeptin OINTMENT SKIN PROTECTANT with COOLING MENTHOL“Drug Facts . . . Purpose: Skin Protectant . . . Uses: Dries the oozing and weeping of poison: - Ivy – Oil – Sumac – Or other skin irritations” [from the product label]“Also contains menthol to help soothe minor skin irritation and dry/manage weeping skin.” [from the DermaRite website https://dermarite.com/product/dermaseptin-ointment/]Lantiseptic Moisture Shield ORIGINALSKIN PROTECTANT“Drug Facts . . . Purpose: Skin Protectant . . . Uses: - Helps relieve and prevent rashes and irritation due to wetness from incontinence. Protects chafed skin due to irritation and helps to seal out wetness.” [from the product label]DermaFungal ANTIFUNGAL CREAM with 2% MICONAZOLE NITRATE“Drug Facts . . . Purpose: Antifungal . . . Uses: For the treatment and prevention of most – athlete’s foot – jock itch – ringworm….” [from the product label]PeriGiene HEALTH CARE ANTISEPTIC“Drug Facts . . . Purpose: Antiseptic . . . Uses: Antiseptic cleanser for use in the perineal area” [from the product label]“PeriGiene is a rinse-free non-drying perineal cleanser…Antimicrobial formula kills bacteria on contact.” [from the DermaRite website https://dermarite.com/product/perigiene/]DermaMed OINTMENT SKIN PROTECTANT“Drug Facts . . . Purpose: Skin protectant . . . Uses: Dries the oozing and weeping of poison: ivy, oak, or sumac, or other skin irritations.” [from the product label]Unapproved New Drug ViolationsOTC Skin protectantsBased on the above labeling evidence, DermaSeptin OINTMENT SKIN PROTECTANT with COOLING MENTHOL, Lantiseptic Moisture Shield ORIGINALSKIN PROTECTANT, and DermaMed OINTMENT SKIN PROTECTANT are intended for use as skin protectant 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 the drug products identified above.Under section 505G of the FD&C Act, 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 skin protectant drug products, such as your DermaSeptin OINTMENT SKIN PROTECTANT with COOLING MENTHOL, Lantiseptic Moisture Shield ORIGINALSKIN PROTECTANT, and DermaMed OINTMENT SKIN PROTECTANT products, in order to be GRASE and not new drugs, the product must, among other things, conform to the conditions in the applicable OTC monograph, here M016: Skin Protectant Drug Products for Over-the-Counter Human Use (henceforth “M016”).1However, DermaSeptin OINTMENT SKIN PROTECTANT with COOLING MENTHOL, Lantiseptic Moisture Shield ORIGINALSKIN PROTECTANT, and DermaMed OINTMENT SKIN PROTECTANT do not conform to the conditions specified in M016 for the reasons described below.DermaSeptin OINTMENT SKIN PROTECTANT with COOLING MENTHOL is formulated with an active ingredient that is not permitted for OTC skin protectant drug products under M016.10. Specifically, your DermaSeptin OINTMENT SKIN PROTECTANT with COOLING MENTHOL is formulated with the active ingredient menthol. We note that, although you identify this ingredient as an inactive ingredient in Drug Facts on the product label, other statements show that it is an active ingredient because it is intended to furnish pharmacological activity or other direct effect for the treatment of a disease or condition or to affect the structure or any function of the body of humans.2For example, the product name includes “COOLINGMENTHOL” (emphasis added), and the DermaRite website page for DermaSeptin OINTMENT SKIN PROTECTANT with COOLING MENTHOL states “Also contains menthol to help soothe minor skin irritation and dry/manage weeping skin.” Thus, menthol is an active ingredient in your DermaSeptin OINTMENT SKIN PROTECTANT with COOLING MENTHOL product, but it is not an active ingredient permitted under M016.10.Regarding Lantiseptic Moisture Shield ORIGINALSKIN PROTECTANT, the Drug Facts panel of this product’s labeling states that the product contains the active ingredient lanolin 50%, while the Uses section of that labeling states that the product “helps relieve and prevent rashes and irritation due to wetness from incontinence” and “Protects chafed skin due to irritation and helps to seal out wetness.” While lanolin up to 50% is permitted as an active ingredient under M016.10(k), these labeled uses are not permitted for products with this active ingredient under M016.50(b).Regarding DermaMed OINTMENT SKIN PROTECTANT, the Drug Facts panel of this product’s labeling states that it contains the active ingredient Aluminum hydroxide gel 2% but includes intended uses that are not permitted for products with this active ingredient in M016. Specifically, the Uses section of that labeling states, “Dries the oozing and weeping of poison: ivy, oak, or sumac,or otherskin irritations.” (emphasis added). Claims that suggest DermaMed OINTMENT SKIN PROTECTANT is intended to dry oozing and weeping or otherwise treat skin irritations that are not associated with poison ivy, oak, or sumac go beyond the allowed general intended uses for an OTC skin protectant drug product and do not conform to the uses permitted for a product with the active ingredient Aluminum hydroxide gel3as set forth in M016.50(b)(3).Thus, your DermaSeptin OINTMENT SKIN PROTECTANT with COOLING MENTHOL, Lantiseptic Moisture Shield ORIGINALSKIN PROTECTANT, and DermaMed OINTMENT SKIN PROTECTANT do not comply with the applicable conditions specified in M016. These products have not otherwise been found GRASE.4Accordingly, 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 applications in effect for these products, these products are unapproved new drugs.The introduction or delivery for introduction of these unapproved new drug products into interstate commerce violates sections 505(a) and 301(d) of the FD&C Act, 21 U.S.C. 355(a) and 331(d).OTC Topical AntifungalsBased on its labeling,5DermaFungal ANTIFUNGAL CREAM with 2% MICONAZOLE NITRATE is intended for use as a topical antifungal drug product. As described below, this drug product is an unapproved new drug 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 the drug product identified above.Under section 505G of the FD&C Act, 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 topical antifungal drug products, such as your product mentioned above, in order to be GRASE and not a new drug, the product must, among other things, conform to the conditions in the applicable OTC monograph, here M005: Topical Antifungal Drug Products for Over-the-Counter Human Use (henceforth “M005”).6However, DermaFungal ANTIFUNGAL CREAM with 2% MICONAZOLE NITRATE does not conform to the conditions specified in M005 for the reason described below.The Uses section of the Drug Facts panel for DermaFungal ANTIFUNGAL CREAM with 2% MICONAZOLE NITRATE states, “…preventionof most – athlete’s foot – jock itch – ringworm.” (emphasis added). While miconazole nitrate 2% is permitted as an active ingredient under M005.10(c), these labeled uses in prevention of athlete’s foot, jock itch, and ringworm are not permitted for products with this active ingredient under M005.50(b). Thus, DermaFungal ANTIFUNGAL CREAM with 2% MICONAZOLE NITRATE does not comply with the applicable conditions specified in M005. This product has not otherwise been found GRASE.7Accordingly, this product is a new drug 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 this product would be legally marketed without an approved application. Because there are no applications in effect for this product, this product is an unapproved new drug.The introduction or delivery for introduction of this unapproved new drug product into interstate commerce violates sections 505(a) and 301(d) of the FD&C Act, 21 U.S.C. 355(a) and 331(d).OTC Health Care AntisepticsBased on the above labeling evidence, PeriGiene HEALTH CARE ANTISEPTIC is intended for use as a healthcare topical antiseptic drug product. This product is a new drug within the meaning of section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because it is not generally recognized as safe and effective (GRASE) for use under the conditions prescribed, recommended, or suggested in its labeling. New drugs 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), unless they are lawfully marketed under section 505G of the FD&C Act (which is not the case for this product, as further described below) or other exceptions not applicable here. No FDA-approved applications pursuant to section 505 of the FD&C Act, 21 U.S.C. 355, are in effect for this drug product, nor are we aware of any adequate and well-controlled clinical studies in the published literature that support a determination that the PeriGiene HEALTH CARE ANTISEPTIC drug product is GRASE for use under the conditions suggested, recommended, or prescribed in its labeling. Accordingly, this product is an unapproved new drug marketed in violation of sections 505(a) and 301(d) of the FD&C Act, 21 U.S.C. 355(a) and 331(d).Under section 505G of the FD&C Act, 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. Under section 505G(a)(3) of the FD&C Act, drugs that (prior to enactment of section 505G) were classified as Category III8for safety or effectiveness in the preamble of a tentative final monograph (TFM) that is the most recently applicable proposal or determination for such drugs issued under 21 CFR Part 330—and that were not classified as Category II for safety or effectiveness – are not required to have an approved application under section 505 in order to be marketed, as long as they are in conformity with the relevant conditions of use outlined in the applicable TFM, including the active ingredients and indications, and comply with all other applicable requirements.Health care topical antiseptic products, such as your PeriGiene HEALTH CARE ANTISEPTIC product, were addressed in a TFM titled “Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Tentative Final Monograph for Health-Care Antiseptic Drug Products,” Proposed Rule, 59 FR 31402 (June 17, 1994) (hereinafter “1994 TFM”), as amended by “Safety and Effectiveness of Health Care Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record,” Proposed Rule, 80 FR 25166 (May 1, 2015) (hereinafter “Health Care Topical Antiseptics Proposed Rule”),9and “Safety and Effectiveness of Health Care Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use,” Final Rule, 82 FR 60474 (December 20, 2017) (hereinafter "Health Care Topical Antiseptics Final Rule”).10Over the course of these rulemakings, six active ingredients (benzalkonium chloride, benzethonium chloride, chloroxylenol—the active ingredient in your PeriGiene HEALTH CARE ANTISEPTIC product—ethyl alcohol, isopropyl alcohol, and povidone-iodine) were classified as Category III for use in healthcare OTC antiseptic products. Chloroxylenol was classified as Category III for both safety and effectiveness for use in patient antiseptic skin preparations (i.e., patient preoperative and preinjection skin preparations), health care personnel hand washes, and surgical hand scrubs.11However, for the reasons described below, PeriGiene HEALTH CARE ANTISEPTIC product does not meet the conditions under section 505G(a)(3) for legal marketing without an approved application. Specifically, PeriGiene HEALTH CARE ANTISEPTIC does not conform to the conditions applicable to topical antiseptics under the 1994 TFM, as amended by the Healthcare Topical Antiseptics Proposed and Final Rules.The product labeling for PeriGiene HEALTH CARE ANTISEPTIC states that it is an antiseptic cleanser for use in the perineal area. This is not consistent with the 1994 TFM as amended, which provides that a health care antiseptic product with the active ingredient chloroxylenol is Category III for use in patient antiseptic skin preparations (i.e., patient preoperative and preinjection skin preparations), health care personnel hand washes, and surgical hand scrubs. Thus, your PeriGiene HEALTH CARE ANTISEPTIC product does not conform to the conditions for health care topical antiseptic products described in the relevant rulemakings for such products.Accordingly, your PeriGiene HEALTH CARE ANTISEPTIC product does not meet the criteria under section 505G(a)(3) for legal marketing without an approved application and thus cannot be legally marketed as an OTC monograph drug under section 505G of the FD&C Act.The introduction or delivery for introduction of these unapproved new drug products into interstate commerce violates sections 505(a) and 301(d) of the FD&C Act, 21 U.S.C. 355(a) and 331(d).Misbranded Drug ViolationsDermaMed OINTMENT SKIN PROTECTANT is misbranded under section 502(f)(1) of the FD&C Act, 21 U.S.C. 352(f)(1), because its labeling does not bear adequate directions for use. Here, the direction set forth in M016.50(d)(4), “children under 6 months: ask a doctor.” is required for a skin protectant containing the active ingredient Aluminum hydroxide gel to be legally marketed under section 505G of the FD&C Act. This monograph labeling also falls within the scope of the directions described in section 502(f)(1) of FD&C Act. Your product’s Directions state, “Apply liberally to affected area as neededor asdirected by a physician” (emphasis added) but include no reference to children under 6 months of age.12The omission of this monograph direction from your product’s labeling renders it misbranded under section 502(f)(1).Additionally, DermaSeptin OINTMENT SKIN PROTECTANT with COOLING MENTHOL, Lantiseptic Moisture Shield ORIGINALSKIN PROTECTANT, DermaFungal ANTIFUNGAL CREAM with 2% MICONAZOLE NITRATE, PeriGiene HEALTH CARE ANTISEPTIC, and DermaMed OINTMENT SKIN PROTECTANT 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 (as described above) 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 violates section 301(a) of the FD&C Act, 21 U.S.C. 331(a).Test Results Out-of-SpecificationFor more information about handling failing, out-of-specification, out-of-trend, or other unexpected results and documentation of your investigations, see FDA’s guidance documentInvestigating Out-of-Specification (OOS) Test Results for Pharmaceutical Productionat https://www.fda.gov/regulatory-information/search-fda-guidance-documents/investigating-out-specification-oos-test-results-pharmaceutical-production-level-2-revision.CGMP Consultant RecommendedBased upon the nature of the violations we identified at your firm, you should engage a consultant qualified as set forth in 21 CFR 211.34 to assist your firm in meeting CGMP requirements.Your use of a consultant does not relieve your firm’s obligation to comply with CGMP. Your firm’s executive management remains responsible for resolving all deficiencies and systemic flaws to ensure ongoing CGMP compliance.Cosmetics Manufactured for Distribution in the United StatesIn addition, some of the products you manufacture may be regulated as cosmetics, as defined in section 201(i) of the FD&C Act [21 U.S.C. 321(i)]. Any cosmetics you manufacture must comply with applicable statutory and regulatory requirements, including the FD&C Act. We note that under section 301(a) of the FD&C Act [21 U.S.C. 331(a)], it is a prohibited act to introduce or deliver for introduction into interstate commerce a cosmetic that is adulterated or misbranded.We also note that the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) provides new requirements with which facilities that manufacture cosmetic products must comply. You may find the FD&C Act, MoCRA, and FDA’s regulations through links on FDA’s website at www.fda.gov.ConclusionThe violations cited in this letter are not intended to be an all-inclusive list of violations that exist at your facility. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations.Correct any violations promptly. Failure to promptly and adequately address this matter may result in regulatory or legal action without further notice including, without limitation, seizure and injunction. Unresolved violations may also prevent other Federal agencies from awarding contracts.Failure to address violations may also cause FDA to withhold issuance of Export Certificates. FDA may withhold approval of new applications or supplements listing your firm as a drug manufacturer until any violations are completely addressed and we confirm your compliance with CGMP. We may re-inspect to verify that you have completed corrective actions to address any violations.This letter notifies you of our findings and provides you an opportunity to address the above deficiencies. After you receive this letter, respond to this office in writing within 15 working days. Specify what you have done to address any violations and to prevent their recurrence. In response to this letter, you may provide additional information for our consideration as we continue to assess your activities and practices. If you cannot complete corrective actions within 15 working days, state your reasons for delay and your schedule for completion.Send your electronic reply to CDER-OC-OMQ-Communications@fda.hhs.gov. Identify your response with FEI 1000526900 and ATTN: Nancy Scheraga.Sincerely,/S/Francis GodwinDirectorOffice of Manufacturing QualityOffice of ComplianceCenter for Drug Evaluation and Research/S/Tina SmithCaptain, U.S. Public Health ServiceDirectorOffice of Unapproved Drugs & Labeling ComplianceOffice of ComplianceCenter for Drug Evaluation and Research_______________________1M016 reflects the conditions set forth in the relevant final order(s) established and in effect under section 505G; see Order ID OTC000005, available at FDA’s website OTC Monographs@FDA [https://dps.fda.gov/omuf]2See 21 CFR 201.66(b)(2), which defines an active ingredient as “any component that is intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body of humans.”3Aluminum hydroxide gel is an active ingredient identified in M016.10(b).4FDA is not aware of any adequate and well-controlled clinical trials in the published literature that support a determination that DermaSeptin OINTMENT SKIN PROTECTANT with COOLING MENTHOL, Lantiseptic Moisture Shield ORIGINALSKIN PROTECTANT, DermaMed OINTMENT SKIN PROTECTANT are GRASE for use under the conditions prescribed, recommended, or suggested in their labeling, nor has FDA determined these drug products to be GRASE pursuant to an order issued under section 505G(b).5In addition to labeling cited earlier in this letter, other parts of its labeling indicate in particular that your product is intended for topical application. See, e.g., Warnings: “For external use only” and various Directions in the Drug Facts panel of your product.6M005 reflects the conditions set forth in the relevant final order(s) established and in effect under section 505G; see Order ID OTC000017, available at FDA’s website OTC Monographs@FDA [https://dps.fda.gov/omuf]7FDA is not aware of any adequate and well-controlled clinical trials in the published literature that support a determination that DermaFungal ANTIFUNGAL CREAM with 2% MICONAZOLE NITRATE is GRASE for use under the conditions prescribed, recommended, or suggested in their labeling, nor has FDA determined this drug product to be GRASE pursuant to an order issued under section 505G(b).8As used under the OTC monograph system prior to enactment of section 505G, “[t]he OTC drug procedural regulations in § 330.10 use the terms ‘Category I’ (generally recognized as safe and effective and not misbranded), ‘Category II’ (not generally recognized as safe and effective or misbranded), and ‘Category III’ (available data are insufficient to classify as safe and effective, and further testing is required)”, 81 FR 42912, 42915.9As stated in the Healthcare Topical Antiseptics Proposed Rule, “The Food and Drug Administration (FDA) is issuing this proposed rule to amend the 1994 tentative final monograph or proposed rule (the 1994 TFM) for over-the-counter (OTC) antiseptic drug products. In this proposed rule, we are proposing to establish conditions under which OTC antiseptic products intended for use by health care professionals in a hospital setting or other health care situations outside the hospital are generally recognized as safe and effective”, 80 FR 25166.10As stated in the Health Care Topical Antiseptics Final Rule, “The Food and Drug Administration (FDA, the Agency, or we) is issuing this final rule establishing that certain active ingredients used in nonprescription (also known as over-the-counter or OTC) antiseptic products intended for use by health care professionals in a hospital setting or other health care situations outside the hospital are not generally recognized as safe and effective (GRAS/GRAE)”, 82 FR 60474.1182 FR 60474 at 60478; 80 FR 25166 at 25174-25175.12The only reference to seeking physician advice presented in your product’s labeling is “Stop use and ask a doctor if• condition worsens • symptoms last more than 7 days or clear up and occur again within a few days.” In context, then, the labeling suggests that after one of these events had prompted a user to “stop use and ask a doctor”, use might resume “as directed by a physician”.

Delivery Method:VIA UPSReference #:320-26-08Product:DrugsRecipient:Mr. Mark S. McKibbenPresidentUriel Pharmacy, Inc.N8464 Sterman Rd.East Troy,WI53120United StatesIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesWarning Letter320-26-08October 21, 2025Dear Mr. McKibben:The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, Uriel Pharmacy, Inc., FEI 3003813327, at N8464 Sterman Rd., East Troy, from February 25 to March 4, 2025.This warning letter summarizes significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals. See Title 21 Code of Federal Regulations (CFR), parts 210 and 211 (21 CFR parts 210 and 211).Because your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your drug products are adulterated within the meaning of section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 351(a)(2)(B).In addition, the FDA reviewed the labeling evidence collected during the inspection of your facility and observed on your website www.shopuriel.com. Based on our review, all of your products labeled as homeopathic drug products that are offered for sale in the United States and packaged in glass ampule containers, including, “Aquilinum Taraxacum Homeopathic Ampules,” “Aurum 6X Homeopathic Ampules,” “Belladonna ex herba 6X Homeopathic Ampules,” “Gelsemium Bryonia Homeopathic Ampules,” “Nux vomica Chamomilla Homeopathic Ampules,” “Symphytum Stannum Homeopathic Ampules,” and “Viscum Mali e pl. tota 4X Homeopathic Ampules” (hereinafter your Homeopathic Ampule Drug products), are unapproved new drugs introduced or delivered for introduction into interstate commerce in violation of sections 505(a) and 301(d) of the FD&C Act, 21 U.S.C. 355(a) and 331(d).As described further below, these products also present significant public health concerns because your Homeopathic Ampule Drug products are packaged in glass ampules and could be mistaken for injectable drugs. Glass ampules are container closure systems typically used for sterile injectable drug products and may create confusion regarding the intended route of administration, potentially leading to serious harm if these unapproved new drugs are injected.We reviewed your March 26, 2025 response to our Form FDA 483 in detail and acknowledge receipt of your subsequent correspondence.CGMP ViolationsDuring our inspection, our investigators observed specific violations including, but not limited to, the following.1. Your firm failed to establish and follow adequate control procedures to monitor the output and to validate the performance of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and the drug product (21 CFR 211.110(a)). Your firm also failed to have, for each batch of drug product, appropriate laboratory determination of satisfactory conformance to final specifications for the drug product, including the identity and strength of each active ingredient, prior to release (21 CFR 211.165(a)).You manufacture various drug products labeled as homeopathic including those intended for use on broken skin and scrapes, as well as drugs filled into glass ampules that are processed to be rendered sterile.You failed to conduct adequate in-process and finished product testing of active ingredients to support the dilutions or processing to substantiate the potency claims stated on your products’ labels. For example, Calendula 10%, lot(b)(4), drug product is labeled to contain 50 gm of calendula in 100 gm at 1X, which is equivalent to approximately 5% concentration; and Arnica 20%, lot(b)(4), is labeled to contain 20 gm of arnica in 100 gm at 1X, which is equivalent to approximately 2% concentration of the respective active ingredients. However, you did not conduct in-process or finished product testing to verify that the stated strengths meet established in-process and finished product specifications.1Additionally, your Viscum Mali 50 drug product is labeled to contain 1X, 500 mg of Viscum Album (Mali), specifying the finished concentration in 1 gram is, “equivalent to 50 mg fresh plant.” This results in a finished drug product concentration of 5%. This concentration is large enough to be considered a measurable therapeutic dose and well within the current scientific capabilities for conducting assay testing on constituent chemicals within the labeled active ingredient. You failed to sample and test your drug product before release to ensure that the product was within its labeled specification, a violation of CGMP as well as a potential violation of other sections of 501 (e.g., subsections (b) and (c)) of the FD&C Act.Manufacturing processes must consistently meet their parameters, and in-process materials must meet acceptance criteria or limits so that finished pharmaceutical products will meet their acceptance criteria.Your response includes your procedure for(b)(4)techniques demonstrating your(b)(4). You state that “if further validation is necessary,” you need approximately(b)(4)days for method development and validation for(b)(4)intermediates. Your response is inadequate because you did not commit to developing methods or conducting validation.As noted below, FDA is aware2that your viscum products are sometimes used as an injectable drug product where it is required to be sterile. You aseptically fill and process drugs such as Viscum Mali (and many other of your ampule drug products) through a(b)(4), using the same technology as sterile drug product manufacturers, but, as explained below, those processes are not adequate for aseptic manufacturing of a sterile injectable drug. You also conduct bacterial endotoxin and sterility testing before release, neither of which is generally required for oral medications.Of note, FDA has documented that your processes are not adequate for aseptic manufacturing of a sterile injectable drug. For example, inappropriate cleaning methods were observed. The use of a(b)(4)mop was observed deviating from established cleaning patterns for the cleaning of your cleanroom walls. It was also observed that non-sterile cleaning and disinfecting agents were used in your cleanroom with inadequate contact times.Your response states that you will update your procedures to clarify the proper cleaning method for cleaning walls, equipment, and surfaces to specify the requisite contact time for each disinfection agent used in the cleanroom, and that non-sterile cleaning agents were removed from your cleanroom.If you intend to manufacture sterile injectable drugs, you must meet full CGMP requirements for sterile injectable drugs. Failure to adhere to CGMP increases the risk for contaminated drug product, which poses an unacceptable risk to patients. You must establish and follow procedures designed to prevent contamination of drug product intended to be sterile and such procedures shall include validation of any sterilization process, in accordance with 21 CFR 211.113(b).See FDA’s guidance documentSterile Drug Products Produced by Aseptic Processing—Current Good Manufacturing Practiceto help you meet the CGMP requirements when manufacturing sterile drugs using aseptic processing at https://www.fda.gov/media/71021/download.In response to this letter, provide:A comprehensive assessment of your in-process monitoring and sampling operations, focusing on each(b)(4)process step that can introduce variability. Provide your remediation plan to improve: (1) in-process detection of variation; (2)(b)(4)controls; and (3) sampling plans.A list of chemical specifications, including test methods, used to analyze each lot of your drug products before a lot disposition decision.o An action plan and timelines for conducting full chemical testing of retain samples to determine the quality of all batches of drug product distributed to the United States that are within expiry as of the date of this letter.o A summary of all results obtained from testing retain samples from each batch. If such testing reveals substandard quality drug products, take rapid corrective actions, such as notifying customers and product recalls.2. Your firm failed to test samples of each component for identity and conformity with all appropriate written specifications for purity, strength, and quality (21 CFR 211.84(d)(1) and 211.84(d)(2)).You failed to perform adequate identity testing of each component lot used in the manufacture of your drug products and you failed to verify the reliability of your suppliers’ certificates of analysis (COAs).WaterYou purchase(b)(4)water and(b)(4)water for use as a component in your drug products, including drug products you manufacture under conditions attempting to render a drug sterile, without adequately demonstrating that your water was suitable for its intended use. Your firm failed to test the(b)(4)water or(b)(4)water to determine whether they are of adequate identity, purity, strength, and other appropriate quality attributes. Additionally, you accept the water without an accompanying COA. Without adequate testing, you have no assurance that your purchased water meets minimum microbiological and chemical standards suitable for the manufacture of your drug products. Pharmaceutical water must be suitable for its intended use (e.g., minimally(b)(4)for pharmaceutical use and(b)(4)for parenteral use products) and routinely monitored using adequate methods to ensure ongoing conformance with appropriate chemical and microbiological attributes.If your drug products are parenterally administered, water of appropriate quality must be used. Water is a primary contributor for bacterial endotoxin, and parenteral products are intended to be nonpyrogenic.GlycerinYou use glycerin as a component in the manufacturing of your drug products such as Bryophyllum Avena Homeopathic Liquid. You failed to adequately test each shipment of each lot of glycerin for identity, a component at high-risk of diethylene glycol (DEG) or ethylene glycol (EG) contamination. Identity testing for glycerin and certain other high-risk drug components includes a limit test in the United States Pharmacopeia (USP) to ensure the component meets the relevant safety limits for levels of DEG or EG. Because you did not perform identity testing on each shipment of each lot using the USP identification test that detects these hazardous impurities, you failed to assure the acceptability of these components for use in the manufacture of your drug products.The use of ingredients contaminated with DEG or EG has resulted in various lethal poisoning incidents in humans worldwide. See FDA’s guidance documentTesting of Glycerin, Propylene Glycol, Maltitol Solution, Hydrogenated Starch Hydrolysate, Sorbitol Solution, and Other High-Risk Drug Components for Diethylene Glycol and Ethylene Glycolto help you meet the CGMP requirements when manufacturing drugs containing ingredients at high-risk for DEG or EG contamination at https://www.fda.gov/media/167974/download.Without adequate testing, you do not have scientific evidence that the components conform to appropriate specifications prior to use in the manufacture of your drug products.Your response states that you will update your procedures, develop a plan to test your purchased water to meet water for pharmaceutical purposes by December 31, 2025, and that you engaged a third-party laboratory for identity testing of glycerin for DEG and EG testing for current inventory and going forward.Your response is inadequate because your corrective action for your water is not timely, and your interim plans are unclear (e.g., accept/reject, test inventory, pause production). In addition, it does not address potential impact to drug products manufactured using water of unknown quality, including drugs that may be injected. You also do not discuss your plans regarding obtaining potential failing results of glycerin obtained from current inventory for released product. Further, you did not commit to reviewing all your components to determine whether adequate identity testing is conducted and conformity with all appropriate written specifications.In response to this letter, provide:The chemical and microbiological quality control specifications you use to test and release each incoming lot of components for use in manufacturing.A summary of results obtained from testing all components to evaluate the reliability of the COA from each component manufacturer. Include your standard operating procedure that describes this COA validation program.A summary of your program for qualifying and overseeing contract facilities that test the drug products you manufacture.A comprehensive review of your material system to determine whether all suppliers of components, containers, and closures, are each qualified and the materials are assigned appropriate expiration or retest dates. The review should also determine whether incoming material controls are adequate to prevent use of unsuitable components, containers, and closures.A commitment to provide DEG and EG test results, no later than 30 calendar days from the date of this letter, from testing retains for all lots of high-risk drug components used in the manufacture of drug products. Alternatively, if a retain of a component lot is unavailable, perform retain sample testing of all implicated finished drug product batches for the presence of DEG and EG.A full risk assessment for drug products that are within expiry which contain any ingredient at risk for DEG or EG contamination (including, but not limited to, glycerin). Take prompt and appropriate actions to determine the safety of all lots of the component(s) and any related drug product that could contain DEG or EG, including customer notifications and product recalls for any contaminated lots. Identify additional appropriate corrective actions and preventive actions (CAPAs) that secure supply chains in the future, including, but not limited to, ensuring that all incoming raw material lots are from fully qualified manufacturers and free from unsafe impurities. Detail these actions in your response to this letter.A description of how you will test each component lot for conformity with all appropriate specifications for identity, strength, quality, and purity. If you intend to accept any results from your supplier’s COA instead of testing each component lot for strength, quality, and purity, specify how you will robustly establish the reliability of your supplier’s results through initial validation as well as periodic revalidation. In addition, include a commitment to always conduct at least one specific identity test for each incoming component lot. In the case of glycerin, propylene glycol, and certain additional high-risk components we note that this includes the performance of parts A, B, and C of the United States Pharmacopeia (USP) monograph.The chemical quality control specifications you use to test each incoming lot of high-risk drug components to determine acceptability for use in manufacturing.3. Your firm failed to establish laboratory controls that include scientifically sound and appropriate specifications, standards, sampling plans, and test procedures designed to assure that components, drug product containers, closures, in-process materials, labeling, and drug products conform to appropriate standards of identity, strength, quality, and purity (21 CFR 211.160(b)).Your drugs include those intended for application to broken skin and scrapes. You failed to establish laboratory controls that include scientifically sound methods to assure that drug products conform to appropriate standards of identity, strength, quality, and purity.You failed to adequately validate your alternative microbiological test methods. For example, you use the(b)(4)microbiological analyzer for(b)(4)microbiological testing of your non-sterile drug products. You stated this system was validated by the manufacturer, but you did not demonstrate the system adequately quantifies and identifies objectionable microbes, and you failed to demonstrate it was scientifically sound.You also failed to establish scientifically sound and adequate specifications for microbial limits for your non-sterile drug products. For example, your established microbiological limits for your non-sterile dosage forms are set(b)(4)times greater than limits for similar dosage forms with the same route of administration. Furthermore, you failed to conduct adequate testing of your aqueous based non-sterile drug products for objectionable organisms such asBurkholderia cepacia.Additionally, you failed to conduct Antimicrobial Effectiveness Testing (AET) on all of your non-sterile drug products.The ability of microbial testing methods to detect objectionable microorganisms in the presence of each drug product to be tested must be established and validated.Your response states the(b)(4)microbiological analyzer was validated by the manufacturer, that you will test products with “higher water activity” forBurkholderia cepacia, and will perform AET if needed. Your response is inadequate because it lacks adequate scientific justification, and your interim plans remain unclear. For example, the(b)(4)Microbiology System validation report is incomplete and was not reviewed and approved by your firm. You only evaluated(b)(4)of your approximate(b)(4)products, which contain differing components and preservatives. In addition, your plans do not include testing of all aqueous dugs forBurkholderia cepaciaor testing of all drugs for preservative effectiveness. Your response also did not consider a retrospective evaluation of impact to product on the market.In response to this letter, provide a comprehensive assessment of your laboratory practices, procedures, methods, equipment, documentation, and analyst competencies. Based on this review, provide a detailed plan to remediate and evaluate the effectiveness of your laboratory system.4. Your firm failed to establish an adequate quality control unit with the responsibility and authority to approve or reject all components, drug product containers, closures, in-process materials, packaging materials, labeling, and drug products (21 CFR 211.22(a)).Your quality unit (QU) did not effectively exercise its responsibilities to oversee the quality of your drug manufacturing operations. Specifically, your QU failed to ensure adequate written procedures were in place governing manufacturing and quality oversight.You failed to establish and follow adequate change control procedures, including labeling changes made by production personnel and not reviewed and approved by your QU (21 CFR 211.125(a)).You failed to establish and follow procedures for Annual Production Review (21 CFR 211.180(e)) and Adverse Events Reporting (21 CFR 211.198(a)).Your batch records do not include all critical steps and verifications (21 CFR 211.188(b)).Further, you manufacture active ingredients for drug products using batch records with inadequate instructions. Critical in-process controls and critical process monitoring, including control points and methods, should be stated in writing and approved by the QU. For example, your batch record for Aquavit Liquid, lot(b)(4), lacks documented time and temperatures for(b)(4)herbs,(b)(4)and(b)(4), collecting the(b)(4)and using a(b)(4)to(b)(4)for further processing. A lack of adequate documentation for critical steps and parameters doubts whether processes are in control and consistency between batches.Complete and accurate batch production and control records are necessary to ensure that manufacturing processes are consistently followed and reproducible. Additionally, incomplete manufacturing records deprive you of the ability to reliably conduct batch record review, adequately investigate deviations and batch failures, and to ensure a continued state of validation processes.Your QU is not fully exercising its authority and/or responsibilities. Your firm must provide the QU with the appropriate authority and sufficient resources to carry out its responsibilities and consistently ensure drug quality and safety.Your response indicates that you will improve your change control processes, update your procedures, and commit to corrective action to address gaps in your batch record documentation. Your response is inadequate because you did not conduct a retrospective evaluation of access controls for all computerized systems and did not commit to investigate whether other labels were altered without QU approvals. Additionally, you did not commit to systemic evaluation of similar gaps for missing procedures.Your firm’s quality systems are inadequate. See FDA’s guidance documentQuality Systems Approach to Pharmaceutical CGMP Regulationsfor help implementing quality systems and risk management approaches to meet the requirements of CGMP regulations 21 CFR, parts 210 and 211 at https://www.fda.gov/media/71023/download.In response to this letter, provide:A comprehensive assessment of your change management system. This assessment should include, but not be limited to, your procedure(s) to ensure changes are justified, reviewed, and approved by your QU. Your change management program should also include provisions for determining change effectiveness.A comprehensive assessment and remediation plan to ensure your QU is given the authority and resources to effectively function. The assessment should also include, but not be limited to:o A determination of whether procedures used by your firm are robust and appropriate.o Provisions for QU oversight throughout your operations to evaluate adherence to appropriate practices.o A complete and final review of each batch and its related information before the QU disposition decision.o Oversight and approval of investigations and discharging of all other QU duties to ensure identity, strength, quality, and purity of all products.Unapproved New DrugsBased on our review of the product labeling, your Homeopathic Ampule Drug products are drugs as defined by section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1), because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or intended to affect the structure or any function of the body. Examples from your product labeling that provide evidence of the intended use (as defined in 21 CFR 201.128) of your products as drugs include, but may not be limited to, the following:“Aquilinum Taraxacum Homeopathic Ampules”• “Use: Temporary relief of digestive upset.”“Aurum 6X Homeopathic Ampules,” “Belladonna ex herba 6X Homeopathic Ampules,” and “Viscum Mali e pl. tota 4X Homeopathic Ampules”• “Use: Temporary relief of headache.”“Gelsemium Bryonia Homeopathic Ampules”• “Use: Temporary relief of flu symptoms.”“Nux vomica Chamomilla Homeopathic Ampules”• “Use: Temporary relief of upset stomach.”“Symphytum Stannum Homeopathic Ampules”• “Use: Promotes healing of broken bones.”Your Homeopathic Ampule Drug products are “new drugs” under section 201(p) of the FD&C Act, 21 U.S.C. 321(p) because they are not generally recognized as safe and effective for use under the above-described conditions prescribed, recommended, or suggested in their labeling. With certain exceptions not applicable here, new drugs may not be introduced or delivered for introduction into interstate commerce without an approved application from FDA in effect, as described in section 505(a) of the FD&C Act, 21 U.S.C. 355(a). No approved applications pursuant to section 505 of the FD&C Act, 21 U.S.C. 355, are in effect for these products. Accordingly, these products are unapproved new drugs. The introduction or delivery for introduction into interstate commerce of these unapproved new drug products violates sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a).We recognize that your Homeopathic Ampule Drug products are labeled as being homeopathic drugs with active ingredients measured in homeopathic strengths. Under section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1), the term “drug” includes articles recognized in the official Homeopathic Pharmacopeia of the United States (HPUS), or any supplement to it. Homeopathic drug products are subject to the same statutory requirements as other drugs; nothing in the FD&C Act exempts homeopathic drugs from any of the requirements related to adulteration, misbranding, or FDA approval.In addition to the above-described violations, your Homeopathic Ampule Drug products present significant public health concerns because, although they are labeled for oral use, these products are packaged in glass ampules, a type of container closure system which is typically intended for packaging of sterile injectable drug products. Accordingly, these products could be mistaken for or inappropriately used as injectable drugs. We note that drug products similar to your viscum products are known to be administered parenterally in other markets (see https://www.mistletoe-therapy.org/scientific-information and https://www.cancer.gov/about-cancer/treatment/cam/hp/mistletoe-pdq), and online your viscum products are being recommended by a purported physician for injection despite being labeled for oral use.3We have also noted that another variation of your drug product (i.e., “Viscum Abietis Series 1 Homeopathic Ampules”) is shown being injected on social media by a purported medical clinician.4As mentioned above, FDA has documented that your manufacturing processes are not adequate for aseptic manufacturing of a sterile injectable drug, and there is a serious risk of harm if your Homeopathic Ampule Drug products are injected, including the risk of glass particles being injected intravenously.Additionally, we are concerned that your labeling of liquid drugs in glass ampules for “oral use” will result in oral ingestion of the product from ampules broken open by the user with possible glass contamination, which could result in direct injury by ingesting glass fragments, e.g., lacerations to the mouth and gastrointestinal tract, and associated bleeding.CGMP Consultant RecommendedBased upon the nature of the violations we identified at your firm, you should engage a consultant qualified as set forth in 21 CFR 211.34 to assist your firm in meeting CGMP requirements. The qualified consultant should also perform a comprehensive six-system audit of your entire operation for CGMP compliance and evaluate the completion and efficacy of your CAPAs before you pursue resolution of your firm’s compliance status with FDA.Your use of a consultant does not relieve your firm’s obligation to comply with CGMP. Your firm’s executive management remains responsible for resolving all deficiencies and systemic flaws to ensure ongoing CGMP compliance.ConclusionThe violations cited in this letter are not intended to be an all-inclusive list of violations that exist at your facility. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations.Correct any violations promptly. Failure to adequately address this matter may lead to regulatory or legal action without further notice including, without limitation, seizure and injunction. Other Federal agencies may take your compliance history into account when considering the award of contracts.Failure to address violations may be cause for FDA to withhold issuance of Export Certificates. Any violations of CGMP requirements may also be cause for FDA to withhold approval of new applications or supplements listing your firm as a drug manufacturer. We may re-inspect to verify that you have completed corrective actions to address any violations.This letter notifies you of our findings and provides you an opportunity to address the above deficiencies. After you receive this letter, respond to this office in writing within 15 working days. Specify what you have done to address any violations and to prevent their recurrence. In response to this letter, you may provide additional information for our consideration as we continue to assess your activities and practices. If you cannot complete corrective actions within 15 working days, state your reasons for delay and your schedule for completion.Send your electronic reply to CDER-OC-OMQ-Communications@fda.hhs.gov. Identify your response with FEI 3003813327 and ATTN: Michael Klapal.Sincerely,/S/Jill P. Furman, J.D.DirectorOffice of ComplianceCenter for Drug Evaluation and Research_____________________1Such testing is required under 21 CFR 211.110 and 21 CFR 211.165(a). Homeopathic drugs are subject to these same requirements like other drug products; there is no exemption for homeopathic drug products from compliance with these regulations (i.e., 21 CFR 211.110(a) or 211.165(a)). Further, advances in analytical testing technology have improved the ability to detect and measure(b)(4)active ingredients, making testing feasible in the case of homeopathic drug products using contemporary, commonly available assay methods.2See website describing your mistletoe (or viscum) products as “injectables” that come labeled for oral use https://holistic-einstein.com/wp-content/uploads/2020/10/InstructionsForInjections-1.pdf3See website describing your mistletoe (or viscum) products as “injectables” that come labeled for oral use https://holistic-einstein.com/wp-content/uploads/2020/10/InstructionsForInjections-1.pdf4Video of a purported medical clinician injecting Uriel drug product - https://www.youtube.com/watch?v=1r_u0iID7ck

Delivery Method:VIA UPSReference #:320-26-10Product:DrugsRecipient:Ms. Ivania S. GutierrezPresidentWorld Perfumes Inc.2360 NW 150th StreetOpa-Locka,FL33054-2706United StatesIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesWarning Letter320-26-10October 29, 2025Dear Ms. Gutierrez:The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, World Perfumes Inc., FEI 3009971047, at 2360 NW 150th Street, Opa-Locka, from May 5 to 9, 2025.This warning letter summarizes significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals. See Title 21 Code of Federal Regulations (CFR), parts 210 and 211 (21 CFR parts 210 and 211).Because your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your drug products are adulterated within the meaning of section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 351(a)(2)(B).We reviewed your May 29, 2025, response to our Form FDA 483 in detail and acknowledge receipt of your subsequent correspondence.During our inspection, our investigator observed specific violations including, but not limited to, the following.1. Your firm failed to conduct at least one test to verify the identity of each component of a drug product (21 CFR 211.84(d)(1)).Your firm manufactures over-the-counter (OTC) oral and topical drug products. You failed to perform adequate identity testing on each shipment of each lot of incoming components (e.g., ethanol, glycerin) used in the manufacture of your OTC oral and topical drug products.Products Contain EthanolYou manufacture multiple drugs that contain ethanol (e.g., ethanol, ethyl alcohol, alcohol). You failed to adequately test your incoming component ethanol for methanol. The use of ethanol contaminated with methanol has resulted in various lethal poisoning incidents in humans worldwide. See FDA’s guidance documentPolicy for Testing of Alcohol (Ethanol) and Isopropyl Alcohol for Methanolat https://www.fda.gov/media/173005/download.Additionally, you failed to demonstrate that the component alcohol, used to manufacture your drug products, met United States Pharmacopoeia (USP) monograph specifications including those for impurities (e.g., acetaldehyde, acetal, benzene). For example, when we reviewed your raw material specification for your component alcohol, we noted that the specifications failed to demonstrate performance of the USP monograph identification part C, and reference incorrect acceptance ranges for part A, the specific gravity test. Furthermore, you used nonpharmaceutical-grade ethanol to manufacture your drug products.In your response, you state that you will test current samples of the nonpharmaceutical-grade ethanol. Your response is inadequate because you do not provide adequate details to demonstrate that your identity testing meets all compendial requirements, and how you will ensure that appropriate incoming testing will be performed for each component. Additionally, you do not propose testing retain samples or otherwise conduct an analysis of previously used drug product components to ensure that all quality attributes were met.Products Contain Ingredients at Risk for Diethylene Glycol or Ethylene Glycol (DEG or EG) ContaminationYou also failed to adequately test your incoming components at high risk of DEG or EG contamination for identity before using them to manufacture your drug products. This includes, but is not limited to, testing of glycerin to determine its appropriate identity before using it in manufacturing your OTC oral and topical drug products.The use of ingredients contaminated with DEG or EG has resulted in various lethal poisoning incidents in humans worldwide. See FDA’s guidance documentTesting of Glycerin, Propylene Glycol, Maltitol Solution, Hydrogenated Starch Hydrolysate, Sorbitol Solution, and Other High-Risk Drug Components for Diethylene Glycol and Ethylene Glycolto help you meet the CGMP requirements when manufacturing drugs containing ingredients at high-risk for DEG or EG contamination at https://www.fda.gov/media/167974/download.Identity testing for glycerin and certain other high-risk drug components includes a limit test in the USP to ensure that the component meets the relevant safety limits for DEG or EG levels. Because you did not perform identity testing on each shipment of each lot using the USP identification test that detects these hazardous impurities, you failed to ensure the acceptability of these components for use in the manufacture of your drug products.In your response, you state that you will test excipients in the future to determine if they are within expected specifications and free from “high-risk contaminants.” Again, your response is inadequate because you do not provide adequate details to demonstrate that your components meet all compendial requirements or impact to product on the market.Without adequate testing, you do not have scientific evidence that the components conform to the appropriate specifications before their use in the manufacture of your drug products. You are responsible for sampling, testing, and examining drug components before their use in production to ensure that acceptable quality parameters are met.In response to this letter, provide:A comprehensive, independent review of your material system to determine whether all suppliers of components, containers, and closures, are each qualified and the materials are assigned appropriate expiration or retest dates. The review should also determine whether incoming material controls are adequate to prevent use of unsuitable components, containers, and closures.A summary of your program for qualifying and overseeing contract facilities that test the drug products you manufacture.The chemical quality control specifications you use to test each incoming lot of high-risk drug components to determine acceptability for use in manufacturing.A description of how you will test each component lot for conformity with all appropriate specifications for identity, strength, quality, and purity. If you intend to accept any results from your supplier’s certificate of analysis (COA) instead of testing each component lot for strength, quality, and purity, specify how you will robustly establish the reliability of your supplier’s results through initial validation as well as periodic revalidation. In addition, include a commitment to always conduct at least one specific identity test for each incoming component lot. In the case of glycerin, propylene glycol, and certain additional high-risk components we note that this includes the performance of parts A, B. and C of the USP monograph.A summary of results obtained from testing all components to evaluate the reliability of the COA from each component manufacturer. Include your standard operating procedure (SOP) that describes this COA validation program.A commitment to provide methanol test results, no later than 30 calendar days from the date of this letter, from testing retains for all lots of components within expiry of manufactured drug products. Alternatively, if a retain of a component lot is unavailable, perform retain sample testing of all implicated finished drug product batches for the presence of methanol.A commitment to provide DEG and EG test results, no later than 30 calendar days from the date of this letter, from testing retains for all lots of high-risk drug components used in the manufacture of drug products. Alternatively, if a retain of a component lot is unavailable, perform retain sample testing of all implicated finished drug product batches for the presence of DEG and EG.A full risk assessment for drug products that are within expiry which contain any ingredient at risk for DEG or EG contamination (including, but not limited to, glycerin). Take prompt and appropriate actions to determine the safety of all lots of the component(s) and any related drug product that could contain DEG or EG, including customer notifications and product recalls for any contaminated lots. Identify additional appropriate corrective action and preventive action (CAPA) that secure supply chains in the future, including, but not limited to, ensuring that all incoming raw material lots are from fully qualified manufacturers and free from unsafe impurities. Detail these actions in your response to this letter.2. Your firm failed to 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. Your firm also failed to establish adequate written procedures for production and process control designed to assure that the drug products you manufacture have the identity, strength, quality, and purity they purport or are represented to possess (21 CFR 211.63 and 21 CFR 211.100(a)).Your firm uses water as a component to manufacture your OTC oral and topical drug products. You failed to adequately design your water system to ensure that it was suitable for producing the water used in the formulation of your drug products. For example, your water system is(b)(4)and has dead-legs located at each point-of-use in the production area. Stagnant water can foster the development of biofilms. Moreover, your water system cannot be adequately sanitized because of the(b)(4)piping in its design.In addition, you failed to demonstrate that your water system is adequately monitored to ensure that it consistently produces water that meets appropriate microbial limits. You lacked appropriate testing and representative sampling to ensure that the(b)(4)water used as a component in your drug products is suitable for the intended use. Specifically, you did not perform adequate testing for objectionable microorganisms in your(b)(4)water (e.g.,Burkholderia cepaciacomplex (BCC)) or sample your manufacturing points-of-use.In your response, you state that you will update your SOP regarding water system sampling locations with the addition of another sampling port, maintenance of hoses, and additional testing for chemical and microbial attributes. Your response is inadequate because it did not demonstrate that your water system is of adequate design, control, maintenance, and monitoring to consistently produce water suitable for its intended use as a component in your drug products. You also did not assess the impact of using water from your water system on the quality of drug products you manufactured.Your(b)(4)water system must be adequately designed and properly maintained to minimize and control the potential for contamination.(b)(4)water must be suitable for its intended use and routinely tested at an adequate frequency to ensure ongoing conformance with appropriate chemical and microbiological attributes.Inadequate design, control, and/or maintenance of(b)(4)water systems have led to contamination with BCC and other water-borne opportunistic pathogens. For further information regarding the significance of BCC contamination of non-sterile, water-based drug products, see FDA’s advisory notice at https://www.fda.gov/drugs/drug-safety-and-availability/fda-advises-drug-manufacturers-burkholderia-cepacia-complex-poses-contamination-risk-non-sterile.Moreover, your firm has failed to adequately validate your alternative(b)(4)microbiological test method for water samples. For example, you use the(b)(4)Microbiology System to test your drug products and water samples. You did not perform a suitability study of your water samples to demonstrate that the chosen test media and incubation conditions are appropriate for bioburden recovery of your water system’s microbiome.Your response is inadequate because you did not provide test data to support your alternative test method or commit to performing a suitability study; instead, you are performing a trend analysis.A complete method validation of alternative microbiological methods includes the validation of the alternative technology, method suitability, and a determination of the test method’s ability to produce equivalent or better results than the compendial method. This complete method validation should be completed for the alternative test method performed on both finished drug products and water samples.Routine and representative monitoring of microbial counts and identification of contamination in the system are integral to maintaining a state of control and the suitability of water used in manufacturing operations.In response to this letter, provide:A comprehensive, independent assessment of your water system design, control, and maintenance. A third-party consultant with relevant expertise in water systems for(b)(4)use should assist you in conducting this comprehensive evaluation.A thorough remediation plan to install and operate a suitable water system. Include a robust ongoing control, maintenance, and monitoring program to ensure the remediated system design consistently produces water adhering to(b)(4)Water,(b)(4)monograph specifications and appropriate microbial limits.Regarding the latter, ensure that your total microbial count limit for water is appropriate in view of the intended use of the products produced by your firm.A detailed risk assessment addressing the potential effects of the observed water system failures on the quality of all drug product lots currently in U.S. distribution. Specify actions that you will take in response to the risk assessment, such as customer notifications and product recalls.A procedure for your water system monitoring that specifies routine microbial testing of water to ensure its acceptability for use in each batch of drug products produced by your firm.The current action/alert limits for total counts and objectionable organisms used for your(b)(4)Water system. Ensure that the total count limits for your(b)(4)water are appropriately stringent in view of the intended use of each of the products produced by your firm.A procedure governing your program for ongoing control, maintenance, and monitoring that ensures the remediated system consistently produces water that meets(b)(4)Water,(b)(4)monograph specifications and appropriate microbial limits.A(b)(4)water system validation protocol and report.Validation of your microbiological test methods, including growth promotion testing, demonstrating that these test methods are equivalent to or better than USP compendial methods and are suitable for their intended use.Cosmetics Manufactured for Distribution in the United StatesIn addition, some of the products you manufacture may be regulated as cosmetics, as defined in section 201(i) of the FD&C Act [21 U.S.C. 321(i)]. Any cosmetics you manufacture must comply with applicable statutory and regulatory requirements, including the FD&C Act. We note that under section 301(a) of the FD&C Act [21 U.S.C. 331(a)], it is a prohibited act to introduce or deliver for introduction into interstate commerce a cosmetic that is adulterated or misbranded.We also note that the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) provides new requirements with which facilities that manufacture cosmetic products must comply. You may find the FD&C Act, MoCRA, and FDA’s regulations through links on FDA’s website at www.fda.gov.Quality SystemsSignificant findings in this letter demonstrate that your firm does not operate an effective quality system in accord with CGMP. In addition to the lack of effective management oversight of your production operations, we found your quality unit is not enabled to exercise proper authority and/or has insufficiently implemented its responsibilities. Executive management should immediately and comprehensively assess your company’s global manufacturing operations to ensure that your systems, processes, and products conform to FDA requirements.Your firm’s quality systems are inadequate. See FDA’s guidance document Quality Systems Approach to Pharmaceutical CGMP Regulations for help implementing quality systems and risk management approaches to meet the requirements of CGMP regulations 21 CFR, parts 210 and 211 at https://www.fda.gov/media/71023/download.Responsibilities as a ContractorDrugs must be manufactured in conformance with CGMP. FDA is aware that many drug manufacturers use independent contractors such as production facilities, testing laboratories, packagers, and labelers. FDA regards contractors as extensions of the manufacturer.You are responsible for the quality of drugs you produce as a contract facility regardless of agreements in place with product owners. You are required to ensure that drugs are made in accordance with section 501(a)(2)(B) of the FD&C Act for safety, identity, strength, quality, and purity. See FDA’s guidance document Contract Manufacturing Arrangements for Drugs: Quality Agreements at https://www.fda.gov/media/86193/download.CGMP Consultant RecommendedBased upon the nature of the violations we identified at your firm, you should engage a consultant qualified as set forth in 21 CFR 211.34 to assist your firm in meeting CGMP requirements. Your use of a consultant does not relieve your firm’s obligation to comply with CGMP. Your firm’s executive management remains responsible for resolving all deficiencies and systemic flaws to ensure ongoing CGMP compliance.ConclusionThe violations cited in this letter are not intended to be an all-inclusive list of violations that exist at your facility. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations.Correct any violations promptly. Failure to promptly and adequately address this matter may result in regulatory or legal action without further notice including, without limitation, seizure and injunction. Unresolved violations may also prevent other Federal agencies from awarding contracts.Failure to address violations may also cause FDA to withhold issuance of Export Certificates. FDA may withhold approval of new applications or supplements listing your firm as a drug manufacturer until any violations are completely addressed and we confirm your compliance with CGMP. We may re-inspect to verify that you have completed corrective actions to address any violations.This letter notifies you of our findings and provides you an opportunity to address the above deficiencies. After you receive this letter, respond to this office in writing within 15 working days. Specify what you have done to address any violations and to prevent their recurrence. In response to this letter, you may provide additional information for our consideration as we continue to assess your activities and practices. If you cannot complete corrective actions within 15 working days, state your reasons for delay and your schedule for completion.Send your electronic reply to CDER-OC-OMQ-Communications@fda.hhs.gov. Identify your response with FEI 3009971047 and ATTN: Sena G. Dissmeyer.Sincerely,/S/Francis GodwinDirectorOffice of Manufacturing QualityOffice of ComplianceCenter for Drug Evaluation and Research

Delivery Method:VIA UPSReference #:320-26-05Product:DrugsRecipient:Ms. Yvonne E. GrosePresident and OwnerRNA Bio/Pharma, Incorporated19470 Navarre Coulee RoadChelan,WA98816-9394United StatesIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesWarning Letter320-26-05October 10, 2025Dear Ms. Yvonne E. Grose:The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, RNA Bio/Pharma, Incorporated, FEI 3023116, at 19470 Navarre Coulee Road, Chelan, Washington, from April 9 to April 11, 2025.This warning letter summarizes significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals. See Title 21, Code of Federal Regulations (CFR), parts 210 and 211 (21 CFR parts 210 and 211).Because your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your drug products are adulterated within the meaning of section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 351(a)(2)(B).We have not received a response from your firm stating the actions you are taking to address the deficiencies identified during the inspection and cited on our Form FDA 483. As of the date of this letter, you have not responded to the Form FDA 483, Inspectional Observations, despite two inquiries from the Agency regarding your intent to do so.During our inspection, our investigator observed specific violations, including but not limited to the following:1. Your firm failed to test samples of each component for conformity with all appropriate written specifications for purity, strength, and quality. Your firm also failed to validate and establish the reliability of your component supplier’s test analyses at appropriate intervals (21 CFR 211.84(d)(1) and 211.84(d)(2)).You manufacture oral liquid homeopathic drug products, including drug products intended for children. You failed to perform adequate testing for purity, strength, quality, and identity for the components used in the manufacture of your oral drug products. In addition, you relied on your suppliers’ certificate of analysis (COA) without establishing the reliability of your component suppliers’ test analyses at appropriate intervals.Ingredients at Risk for Diethylene Glycol (DEG) or Ethylene Glycol (EG) ContaminationYou failed to adequately test your incoming components at high risk of DEG and EG contamination for identity before using them to manufacture your drug products. This includes but is not limited to testing of glycerin to determine its appropriate identity. The identity testing of glycerin includes a limit test, according to the United States Pharmacopeia (USP), to ensure that the component meets the relevant safety limits for the levels of DEG or EG.The use of ingredients contaminated with DEG or EG has resulted in various lethal poisoning incidents in humans worldwide. See FDA’s guidance documentTesting of Glycerin, Propylene Glycol, Maltitol Solution, Hydrogenated Starch Hydrolysate, Sorbitol Solution, and Other High-Risk Drug Components for Diethylene Glycol and Ethylene Glycol to help you meet the CGMP requirements when manufacturing drugs containing ingredients at risk for DEG or EG contamination, at https://www.fda.gov/media/167974/download.Products Containing Ethyl AlcoholYou relied on your suppliers’ COA without establishing the reliability of your component suppliers’ test analyses at appropriate intervals. For example, you failed to adequately test your incoming(b)(4)ethanol, used as an inactive ingredient in your formulations, for impurities, such as benzene. You also failed to adequately perform identity testing of your ethanol for methanol. The use of ethanol contaminated with methanol has resulted in various lethal poisoning incidents in humans worldwide. See FDA’s guidance documentPolicy for Testing of Alcohol (Ethanol) and Isopropyl Alcohol for Methanolat https://www.fda.gov/media/173005/download to help you meet the CGMP requirements when manufacturing drugs containing ethanol.Alcohol used as a component in homeopathic drugs must meet the specifications in the USP monograph for alcohol (ethanol or ethyl alcohol). These specifications establish acceptance criteria for impurities for methanol, acetaldehyde and acetal, benzene, and the sum of all other impurities, and the identity test for alcohol specifies a limit test for methanol to prevent methanol contamination. Alcohol that does not meet the USP monograph is adulterated under section 501(b) of the FD&C Act. We note that your finished drug product formulations indicate that they contain(b)(4)% alcohol in the formulation.Products containing Potentially Toxic or Harmful IngredientsYou failed to adequately test your incoming components to confirm their identification, purity, strength (e.g., dilution), and quality before using them to manufacture your drug products. For example,(b)(4)testing, primarily for(b)(4), was not performed on(b)(4)(more commonly known as(b)(4)). You also failed to perform testing of(b)(4)to detect the levels of(b)(4)(a highly toxic, well-studied poison that is used as a rodenticide). We note that(b)(4)is an ingredient used in your “(b)(4)” drug product, and(b)(4)is an ingredient used in your “(b)(4)” drug product.Furthermore, you utilize homeopathic active pharmaceutical ingredients (mother tinctures) in your finished drug product production. During the inspection, you stated that testing was not performed on the mother tinctures.Without appropriate testing of components and ingredients, you cannot ensure the quality and safety of your drug products. Drug products that do not meet quality standards can pose a safety risk to the public. Potentially toxic or harmful substances (including substances derived from animal venom and from botanical flowers and plants) are routinely used in your formulations and at your facility, and caution should be taken when they are used for children, with vulnerable populations, or with frequent dosing or extended use of the drug product.In response to this letter, provide:A commitment to provide DEG and EG test results, no later than 30 calendar days from the date of this letter, from testing retains for all lots of high-risk drug components used in the manufacture of drug products. Alternatively, if a retain of a component lot is unavailable, perform retain sample testing of all implicated finished drug product batches for the presence of DEG and EG.A full risk assessment for drug products that are within expiry which contain any ingredient at risk for DEG or EG contamination (including but not limited to glycerin). Take prompt and appropriate actions to determine the safety of all lots of the component(s) and any related drug product that could contain DEG or EG, including customer notifications and product recalls for any contaminated lots. Identify additional appropriate corrective action and preventive action (CAPA) to secure supply chains in the future, including but not limited to ensuring that all incoming raw material lots are from fully qualified manufacturers and are free from unsafe impurities. Detail these actions in your response to this letter.A risk assessment for biologic substances (including(b)(4)) that will ensure and address whether these substances have been rendered sterile or have not been adulterated by pathogens or other deleterious substances.The chemical and microbiological quality control specifications you use to test and release each incoming lot of component for use in manufacturing.A description of how you will test each component lot for conformity with all appropriate specifications for identity, strength, quality, and purity. If you intend to accept any results from your suppliers’ COA instead of testing each component lot for strength, quality, and purity, specify how you will robustly establish the reliability of your suppliers’ results through initial validation, as well as periodic revalidation. In addition, include a commitment to always conduct at least one specific identity test for each incoming component lot. In the case of glycerin, propylene glycol, and certain additional high-risk components, we note that this includes the performance of parts A, B, and C of the USP monograph.A summary of results obtained from testing all components to evaluate the reliability of the COA from each component manufacturer. Include your SOP that describes this COA validation program.A comprehensive, independent review of your material system to determine whether all suppliers of components, containers, and closures are individually qualified and whether the materials are assigned appropriate expiration or retest dates. The review should also determine whether incoming material controls are adequate to prevent the use of unsuitable components, containers, and closures.2. Your firm failed to establish adequate written procedures for production and process control designed to assure that the drug products you manufacture have the identity, strength, quality, and purity they purport or are represented to possess (21 CFR 211.100(a)).Water is the major component of your drug products. However, you did not demonstrate that your water system was designed, validated, or maintained adequately for its intended use in drug manufacturing. For example, your water system consists of a(b)(4)located underneath a sink. It was not continuously circulating, which could foster the development of biofilms. Additionally, you dispensed the water from your system into separate(b)(4)storage containers for future use and assigned them lot numbers. However, you failed to monitor the quality of the water at the point of use or from the individual containers for appropriate chemical and microbiological limits over time, including but not limited to microbial enumeration and the presence of objectionable microorganisms.You did not adequately demonstrate that your water, at a minimum, meets the(b)(4)Water USP monograph and appropriate chemical and microbiological limits.A well-designed water(b)(4)system with procedures for monitoring, cleaning, and maintenance is an important part of ensuring that water used as a component is of appropriate quality. Water must be suitable for its intended use and routinely tested to ensure ongoing conformance with appropriate chemical and microbiological attributes. Monitoring of water quality is critical to ensuring that microbial counts are below established limits and that the water is free of objectionable microorganisms. Identification of contamination in the system is integral to ensuring oversight of ongoing state of control and suitability of water for use in pharmaceutical manufacturing operations.In response to this letter, provide:A comprehensive remediation plan for the design, control, and maintenance of the water system.o Include a(b)(4)water system validation report.o Include a summary of any improvements made to the system design and to the program for ongoing control and maintenance.A comprehensive remediation plan for the design, control, and maintenance of the water system.A procedure for your water system monitoring that specifies routine microbial testing of water to ensure its acceptability for use in each batch of drug products produced by your firm.The current action/alert limits for total counts and objectionable organisms used for your water system. Ensure that the total count limits for your water are appropriate for the intended use of the products produced by your firm.A procedure governing your program for ongoing control, maintenance, and monitoring that ensures the system consistently produces water that meets the(b)(4)Water USP monograph specifications and appropriate microbial limits.Scientific justification to demonstrate that the water you use is suitable for use in drug manufacturing operations. If you determine that the water you used to manufacture drugs was not suitable, provide a detailed risk assessment addressing the potential effects on the quality of all drug product lots currently in U.S. distribution and within expiry. Specify actions you will take in response to the risk assessment.Concerns Regarding Process ValidationFDA documented during the inspection that you utilized ingredients with potentially dangerous effects that are marketed for use in children. For instance, one of your products contains minute levels of ethylene glycol (also known as “(b)(4)”) and is labeled to assist with detoxification. Given the nature of your ingredients, dilution control is paramount to ensure safety of your homeopathic drug products. In response to this letter, provide scientific data that your manufacturing processes ensure that the dilutions of your ingredients are reproducible and supported by scientific evidence.CGMP Consultant RecommendedBased upon the nature of the violations we identified at your firm, you should engage a consultant qualified as set forth in 21 CFR 211.34 to evaluate your operations and to assist your firm in meeting CGMP requirements. The qualified consultant should also perform a comprehensive six-system audit of your entire operation for CGMP compliance and evaluate the completion and efficacy of your CAPA before you pursue resolution of your firm’s compliance status with FDA. See FDA’s guidance for industryQuality Systems Approach to Pharmaceutical CGMP Regulationsat https://www.fda.gov/media/71023/download.Your use of a consultant does not relieve your firm’s obligation to comply with CGMP. Your firm’s executive management remains responsible for resolving all deficiencies and systemic flaws to ensure ongoing CGMP compliance.ConclusionThe violations cited in this letter are not intended to be an all-inclusive list of violations that exist at your facility. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations.Correct any violations promptly. Failure to promptly and adequately address this matter may result in regulatory or legal action without further notice, including, without limitation, seizure and injunction. Unresolved violations may also prevent other Federal agencies from awarding contracts.Failure to address violations may also cause FDA to withhold issuance of Export Certificates. FDA may withhold approval of new applications or supplements listing your firm as a drug manufacturer until any violations are completely addressed and we confirm your compliance with CGMP. We may re-inspect to verify that you have completed corrective actions to address any violations.This letter notifies you of our findings and provides you with an opportunity to address the above deficiencies. After you receive this letter, respond to this office in writing within 15 working days. Specify what you have done to address any violations and to prevent their recurrence. In response to this letter, you may provide additional information for our consideration as we continue to assess your activities and practices. If you cannot complete corrective actions within 15 working days, state your reasons for delay and your schedule for completion.Send your electronic reply to CDER-OC-OMQ-Communications@fda.hhs.gov. Identify your response with FEI 3023116 and ATTN: Frank Wackes.Sincerely,/S/Francis GodwinDirectorOffice of Manufacturing QualityOffice of ComplianceCenter for Drug Evaluation and Research

Delivery Method:Via EmailProduct:DrugsRecipient:Hyun Kwang DanSenior Managing DirectorSinsin Pharmaceutical Co., Ltd.9 Sojeongsandandong-RoSojeong-myeonSejong30002South Koreahktan@sinsin.comIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesWARNING LETTERNovember 12, 2025RE: 718720Hyun-Kwang Dan:This letter is to advise you that on April 15, 2025, the U.S. Food and Drug Administration (FDA) reviewed your product labeling, including your website at www.sinsinpas.us/, which directs consumers to your Amazon storefront where your SINSINPAS AREX INSTANT PAIN RELIEF and SINSINPAS Pain Relieving Liquid MULPAS drug products are available for purchase in the United States without a prescription. We also reviewed your social media on Facebook and Instagram at https://www.facebook.com/search/top?q=sinsinpas_us and https://www.instagram.com/sinsinpas_us, which also direct consumers to your Amazon storefront.SINSINPAS AREX INSTANT PAIN RELIEF and SINSINPAS Pain Relieving Liquid MULPAS 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), 331(d). In addition, these products are misbranded under section 502(ee) of the FD&C Act, 21 U.S.C. 352(ee). Introduction or delivery for introduction of misbranded products into interstate commerce is prohibited under section 301(a) of the FD&C Act, 21 U.S.C. 331(a). These violations are described in more detail below.Unapproved New Drug and Misbranded Drug ViolationsSINSINPAS AREX INSTANT PAIN RELIEF and SINSINPAS Pain Relieving Liquid MULPAS 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 SINSINPAS AREX INSTANT PAIN RELIEF and SINSINPAS Pain Relieving Liquid MULPAS product labeling, including your website listed above, that provide evidence of the intended uses (as defined in 21 CFR 201.128) of the product as a drug include, but may not be limited to, the following:SINSINPAS AREX INSTANT PAIN RELIEF“Drug Facts. . . Purpose: Topical Analgesic . . .UsesFor temporary relief of minor aches and pains of muscles and joints associated with: ■ Arthritis ■ Simple Backache ■ Strains ■ Bruises ■ Sprains,” “- Joint Pain – Muscle pain – Sprains – Backache” [from the product label]SINSINPAS Pain Relieving Liquid MULPAS“Drug Facts. . . Purpose: Topical Analgesic . . .UsesFor temporary relief of minor aches and pains associated with: ■ arthritis ■ simple backache ■ sprains ■ strains ■ bruises” ; “Muscle Pain Arthritis Strains Insect Bites” [from the product label]Unapproved New Drug ViolationsBased on the above labeling evidence SINSINPAS AREX INSTANT PAIN RELIEF and SINSINPAS Pain Relieving Liquid MULPAS 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, 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 your SINSINPAS AREX INSTANT PAIN RELIEF and SINSINPAS Pain Relieving Liquid MULPAS, 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 External Analgesic Drug Products for Over-the-Counter Human Use (hereafter M017).1However, SINSINPAS AREX INSTANT PAIN RELIEF and SINSINPAS Pain Relieving Liquid MULPAS do not conform to the conditions specified in M017 for the reasons described below.Your SINSINPAS AREX INSTANT PAIN RELIEF and SINSINPAS Pain Relieving Liquid MULPAS are formulated with active ingredients that are not permitted for OTC external analgesic drug products under M017.12. Specifically, according to your product’s labeling, your SINSINPAS AREX INSTANT PAIN RELIEF product is formulated with the active ingredients zinc oxide and mentha oil. However, zinc oxide and mentha oil are not permitted active ingredients under M017.12 when used in combination, or as sole ingredients, for any OTC external analgesic drug product.In addition, your SINSINPAS Pain Relieving Liquid MULPAS is formulated with the active ingredients chlorpheniramine maleate and thymol. However, chlorpheniramine maleate and thymol are not permitted active ingredients under M017.12 when used in combination, or as sole ingredients, for any OTC external analgesic drug product. Furthermore, FDA has also determined that OTC external analgesic and anesthetic drug products with the active ingredient thymol are not generally recognized as safe and effective (GRASE) under a final determination issued under 21 CFR par 330.2Thus, your SINSINPAS AREX INSTANT PAIN RELIEF and SINSINPAS Pain Relieving Liquid MULPAS products do not comply with the applicable conditions specified in M017 and have not otherwise been found GRASE.3Accordingly, 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, these products are unapproved new drugs. The introduction or delivery for introduction into interstate commerce of these unapproved new drug products violates sections 505(a) and 301(d) of the FD&C Act, 21 U.S.C. 355(a) and 331(d).Misbranded Drug ViolationsAdditionally, SINSINPAS AREX INSTANT PAIN RELIEF and SINSINPAS Pain Relieving Liquid MULPAS 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 violates 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 correct any violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration. If you cannot complete corrective action within 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. Please include your firm name and the unique identifier “718720” 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____________________1M017 reflects the conditions as set forth in the relevant final orders established and in effect under section 505G; see Order OTC000033, available at FDA’s website OTC Monographs@FDA https://dps.fda.gov/omuf.2Non-Monograph Conditions NM900: Drug Products Containing Certain Active Ingredients Offered Over-the-Counter for Certain Uses. See Order ID OTC000007, available at FDA’s website OTC Monographs@FDA, https://dps.fda.gov/omuf.3FDA is not aware of any adequate and well-controlled clinical trials in the published literature that support a determination that SINSINPAS AREX INSTANT PAIN RELIEF and SINSINPAS Pain Relieving Liquid MULPAS are GRASE for use under the conditions prescribed, recommended, or suggested in their labeling, nor has FDA determined these drug products to be GRASE pursuant to an order issued under section 505G(b).

Delivery Method:Via EmailProduct:DrugsRecipient:Anthony Trinh123Herbals7214 Berne StRosemead,CA91770United Stateshello@123herbals.comIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesWARNING LETTERNovember 13, 2025RE: 719198Anthony Trinh:This letter is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website at the Internet address www.123herbals.com from July 2025 to November 2025. The FDA has observed that your website offers various products including, “SILINTAN,” “Ganoderma Huo Luo Dan,” “Hong Kong Vail Bon Tong,” “SAM NHUNG BO THAN,” “TDCARE,” and “Vall Boon Antacid” for sale in the United States. In addition, FDA has obtained a sample of your “SILINTAN” product. Based on our review, these products are unapproved new drugs under section 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 355(a). As explained further below, introducing or delivering these products for introduction into interstate commerce violates sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a). Furthermore, your “SILINTAN” product is a misbranded drug under section 502 of the FD&C Act, 21 U.S.C. 352, and introduced or delivered for introduction into interstate commerce in violation of section 301(a) of the FD&C Act, 21 U.S.C. 331(a).FDA confirmed through laboratory analysis that a sample of your “SILINTAN” product contains the undeclared active pharmaceutical ingredient meloxicam. Meloxicam is a non-steroidal anti-inflammatory drug (NSAID). NSAIDs may cause increased risk of cardiovascular events, such as heart attack and stroke, as well as serious gastrointestinal damage, including bleeding, ulceration, and fatal perforation of the stomach and intestines. This hidden drug ingredient may also interact with other medications and significantly increase the risk of adverse events, particularly when consumers use multiple NSAID-containing products.Unapproved New DrugsBased on a review of your website, your “SILINTAN,” “Ganoderma Huo Luo Dan,” “Hong Kong Vail Bon Tong,” “SAM NHUNG BO THAN,” “TDCARE,” and “Vall Boon Antacid” products are drugs under section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1), because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease, and/or intended to affect the structure or any function of the body. Examples from your product labeling, including on your website, that provide evidence of the intended use (as defined in 21 CFR 201.128) of these products as drugs include, but may not be limited to, the following:SILINTANOn the webpage https://123herbals.com/collections/frontpage/products/silantin-gout-joint-arthritis-supplements?variant=48198515425580:• “SILINTAN 100% natural herbal to relief gout, joint, arthritis body aches [sic].”Ganoderma Huo Luo DanOn the webpage https://123herbals.com/collections/frontpage/products/ganoderma-huo-luo-dan-arthritis-stiff-joints-gout-hot-item:• “Ganoderma Huo Luo Dan for relief of Rheumatism, Gout, Arthritis, Stiff Joints, Back Pains.”Hong Kong Vail Bon TongOn the webpage https://123herbals.com/collections/frontpage/products/hong-kong-vail-bon-tong-cough-herbals-capsules:• “Non Drowsy Treatment of acute or chronic bronchitis, Coughs due to colds, chronic coughs, sore throats, excessive sputum or phlegm.”SAM NHUNG BO THANOn the webpage https://123herbals.com/collections/frontpage/products/kian-pee-wan-appetite-stimulant:• “SAM NHUNG BO THAN herbal supports kidney tonic to nourish blood to improve physiological functions. Improve the symptoms of numb limbs, back pains, relief knee pain due to kidney failure. Relief of Urinary Tract Infection(UTI) symptoms. Support kidney health and limit urged to urinate at night.”TDCAREOn the webpage https://123herbals.com/collections/frontpage/products/korean-red-ginseng-made-in-korea-buy3-get1-more-free-plus-free-shipping:• “TDCARE helps to lower blood glucose and cholesterol. Prevents diabetic complications by lowering blood glucose. Lowers cholesterol to prevent cardiovascular disease.”Vall Boon AntacidOn the webpage https://123herbals.com/collections/frontpage/products/antacid-tablets-606:• “VALL BOON ANTACID herbals For Use: Gastric pain, Dyspepsia, Bloating, Flatulence, Heartburn, Indigestion.”Your “SILINTAN,” “Ganoderma Huo Luo Dan,” “Hong Kong Vail Bon Tong,” “SAM NHUNG BO THAN,” “TDCARE,” and “Vall Boon Antacid” products are “new drugs” under section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because they are not generally recognized as safe and effective (GRASE) for use under the above-described conditions prescribed, recommended, or suggested in their labeling. With certain exceptions not applicable here, new drugs may not be introduced or delivered for introduction into interstate commerce without an approved application from FDA in effect, as described in section 505(a) of the FD&C Act, 21 U.S.C. 355(a). No approved applications pursuant to section 505 of the FD&C Act, 21 U.S.C. 355, are in effect for these products. Accordingly, these products are unapproved new drugs.The introduction or delivery for introduction into interstate commerce of these unapproved new drug products violates sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a).Misbranded DrugYour “SILINTAN” product is misbranded under section 502(a) of the FD&C Act, 21 U.S.C. 352(a). Under section 502(a) of the FD&C Act, 21 U.S.C. 352(a), a drug is misbranded if its labeling is false or misleading in any particular. Section 201(n) of the FD&C Act, 21 U.S.C. 321(n), provides that, in determining whether an article’s labeling or advertising “is misleading there shall be taken into account . . . not only representations made or suggested . . . but also the extent to which the labeling or advertising fails to reveal facts material in light of such representations.” The labeling for your “SILINTAN” product does not declare that the product contains meloxicam. As previously mentioned, this undeclared ingredient in your “SILINTAN” product may pose serious health risks because consumers with underlying medical issues may take the product without knowing that it can cause serious harm or interact in dangerous ways with other drugs they may be taking. The failure to disclose this ingredient in the product labeling renders your “SILINTAN” product misbranded under section 502(a) of the FD&C Act, 21 U.S.C. 352(a).Your “SILINTAN” product is not the first product found by FDA to contain hidden ingredients. You previously sold the product “Vail-Bon Jie Yang Wan,” which FDA laboratory testing identified as containing undeclared dexamethasone and chlorpheniramine.1In addition, you market other products on your website that are intended for pain relief, similar to “SILINTAN.” While the Agency has not sampled and tested these products from your inventory to date, this letter is to emphasize that it is your legal responsibility under federal law to ensure that products you sell do not contain any undeclared or potentially harmful ingredients, and that they are marketed in compliance with applicable laws.ConclusionThe violations cited in this letter are not intended to be an all-inclusive statement of violations that may exist in connection with your products. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations.This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address this matter may lead to regulatory or legal action including, without limitation, seizure and injunction.Please notify FDA in writing, within fifteen working days of receipt of this letter, of the specific steps you have taken to correct any violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration. If you cannot complete corrective action within fifteen working days, state the reason for the delay and the time within which you will complete the correction.Your response should be sent to U.S. Food and Drug Administration, CDER/OC/Office of Unapproved Drugs and Labeling Compliance by email to FDAAdvisory@fda.hhs.gov. Please include your firm name and the unique identifier “719198” in the subject line of the email.Sincerely,/S/Tina Smith, M.S.Captain, U.S. Public Health ServiceDirectorOffice of Unapproved Drugs and Labeling ComplianceOffice of ComplianceCenter for Drug Evaluation and ResearchFood and Drug Administration____________________1https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/123herbals-llc-123herbalscom-issues-voluntary-nationwide-recall-vail-bon-jie-yang-wan-capsules-due

Delivery Method:VIA Electronic MailReference #:320-26-18Product:DrugsRecipient:Ms. Manorama AvinashExecutive DirectorCdymax India Pharma Private Limited77d & 116/117, KIADB Industrial AreaJiganiBangalore560105KarnatakaIndiamanorama@cdymax.inIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesWarning Letter320-26-18November 13, 2025Dear Ms. Avinash:The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, Cdymax (India) Pharma Private Limited, FEI 3009882550, at 77d & 116/117, KIADB Industrial Area, Jigani, Bangalore, Karnataka, from April 21 to 25, 2025.This warning letter summarizes significant deviations from Current Good Manufacturing Practice (CGMP) for active pharmaceutical ingredients (APIs).Because your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your APIs are adulterated within the meaning of section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 351(a)(2)(B).We reviewed your May 15, 2025, response to our Form FDA 483 in detail and acknowledge receipt of your subsequent correspondence.During our inspection, our investigator observed specific deviations including, but not limited to, the following.1. Failure to adequately investigate and document out-of-specification results and implement appropriate corrective actions.Your firm manufactures APIs for incorporation into application drug products, including those intended for use in(b)(4)drug products for parenteral administration. You failed to adequately investigate multiple out-of-specification (OOS) results and laboratory incidents during the testing of various samples, including raw materials, starting materials, and stability samples.Since 2023, your firm has experienced approximately 1,500 laboratory incidents involving OOS results and other significant analytical events (e.g., equipment failures). There were numerous examples where your investigations were inadequate, and often lacked thorough root cause analysis, and appropriate corrective actions and preventive actions (CAPAs). In addition, your firm frequently failed to investigate these laboratory incidents as “OOS results,” as specified by your own procedures. Several laboratory incidents without conclusive laboratory root causes lacked sufficient or no manufacturing investigations.For example, your firm initiated a laboratory incident in which test results from two sample preparations of a stability sample for(b)(4)crude failed to meet specification limits for an “unknown peak.” Your firm retested these sample preparations in their original vials and in new sample vials. The results of all four retests were also OOS for an “unknown peak.” Subsequently, you performed a third test with fresh sample preparations and after receiving passing results, your firm invalidated all earlier test results.Your investigation concluded that the unknown peaks “could be due to sample solution contamination during preparation.” However, the investigation lacked scientific and thorough root cause analysis, failing to identify the contaminant, its origin, or the cause of its presence within your samples. Because you did not determine a definitive laboratory error, your investigation should have included a manufacturing investigation. Additionally, your corrective action of providing “refresher training for personnel on good laboratory practice” contradicted the investigation’s own initial finding that the analyst was trained and qualified to perform the HPLC test according to your procedure.We note that this batch of(b)(4)remains within U.S. distribution and is only one example out of numerous inadequate investigations observed during our inspection.In your response, you provided updated procedures and a risk assessment regarding the investigations identified by our investigator, concluding that the laboratory incidents posed no risk to patients and had no impact on product quality. However, your response contains inconsistencies. For example, you state that you reviewed the incidents and concluded that “none of the batches were released to market by repeating the analysis using a new sample solution preparation.” However, you also provided summarized data tables with column headers labeled “justification for repeat analysis using new sample solution preparation.” Your response is inadequate. Your response lacked evidence that your firm has remediated your systems to better evaluate whether suspected laboratory causes are valid and investigate potential manufacturing causes where laboratory errors have not been clearly established.Inadequate investigations can result in unidentified root causes, ineffective CAPAs, and recurring problems that compromise your ability to manufacture safe and effective APIs.In response to this letter, provide:A comprehensive, independent assessment of your overall system for investigating deviations, laboratory incidents, discrepancies, complaints, OOS results, and failures. Provide a detailed action plan to remediate this system. Your action plan should include but not be limited to, significant improvements in investigation competencies, scope determination, root cause evaluation, CAPA effectiveness, quality unit oversight, and written procedures. Address how your firm will ensure all phases of investigations are appropriately conducted.An independent assessment and remediation plan for your CAPA program. Provide a report that evaluates whether the program includes effective root cause analysis, ensures CAPA effectiveness, analyzes investigations trends, improves the CAPA program when needed, implements final quality unit decisions, and is fully supported by executive management.A retrospective, independent review of all laboratory incidents and OOS results (including in-process and release/stability testing) for U.S. products irrespective of whether the batch was ultimately distributed in the United States for the last four years from the initial date of inspection and a report summarizing the findings of the analysis, including the following for each laboratory incident and OOS:o Determine whether the scientific justification and evidence relating to the laboratory incident and OOS result conclusively or inconclusively demonstrates causative laboratory error.o For investigations that conclusively establish laboratory root cause, provide rationale and ensure that all other laboratory methods vulnerable to the same or similar root cause are identified for remediation.o For all laboratory incident and OOS results found by the retrospective review to have an inconclusive or no root cause identified in the laboratory, include a thorough review of production (e.g., batch manufacturing records, adequacy of the manufacturing steps, suitability of equipment/facilities, variability of raw materials, process capability, deviation history, complaint history, batch failure history). Provide a summary of potential manufacturing root causes for each investigation, and any manufacturing operation improvements.A comprehensive review and remediation plan for your OOS result investigation systems. The CAPA should include but not be limited to addressing the following:o Quality unit oversight of laboratory investigationso Identification of adverse laboratory control trendso Resolution of causes of laboratory variationo Initiation of thorough investigations of potential manufacturing causes whenever a laboratory cause cannot be conclusively identifiedo Adequately scoping of each investigation and its CAPAo Revised OOS investigation procedures with these and other remediationsFor more information about handling failing, out-of-specification, out-of-trend, or other unexpected results and documentation of your investigations, see FDA’s guidance documentInvestigating Out-of-Specification (OOS) Test Results for Pharmaceutical Productionat https://www.fda.gov/media/158416/download. A possible laboratory error is insufficient to close an investigation at Phase 1. Whenever an investigation lacks conclusive evidence of laboratory error, a thorough investigation of potential manufacturing causes must be performed.2. Failure to ensure that all specifications, sampling plans, test procedures are scientifically sound and appropriate to ensure that your raw materials, intermediate and API, conform to established standards of quality and purity.Your firm tests your raw materials, starting materials, and finished APIs using methods developed in-house. However, your firm failed to validate (or verify if compendial testing is used) multiple test methods that you use.In your response, you commit to validating and/or verifying your test methods. You provided an example of a newly completed method validation for a starting material used in the production of(b)(4)API. However, the validation report lacks adequate data to demonstrate that the method is appropriately validated for its intended use, including insufficient robustness, precision, suitability, and other testing parameter studies.Test methods must be validated to show they are suitable for their intended use or verified to show at least equivalence with United States Pharmacopeia (USP) compendial methods.In response to this letter, provide:A comprehensive, independent assessment of your laboratory practices, procedures, methods, equipment, documentation, and analyst competencies. Based on this review, provide a detailed plan to remediate and evaluate the effectiveness of your laboratory system.The chemical and microbiological quality control specifications you use to test and release each incoming lot of component for use in manufacturing.A description of how you will test each component lot for conformity with all appropriate specifications for identity, strength, quality, and purity. If you intend to accept any results from your suppliers’ Certificates of Analysis (COA) instead of testing each component lot for strength, quality, and purity, specify how you will robustly establish the reliability of your suppliers’ results through initial validation as well as periodic re-validation. In addition, include a commitment to always conduct at least one specific identity test for each incoming component lot.A summary of results obtained from testing all components to evaluate the reliability of the COA from each component manufacturer. Include your SOP that describes this COA validation program.CGMP ConsultantWe acknowledge that you engaged a consultant to evaluate your operations and to assist your firm in meeting CGMP requirements.Your use of a consultant does not relieve your firm’s obligation to comply with CGMP. Your firm’s executive management remains responsible for resolving all deficiencies and systemic flaws to ensure ongoing CGMP compliance.ConclusionThe deviations cited in this letter are not intended to be an all-inclusive list of deviations that exist at your facility. You are responsible for investigating and determining the causes of any deviations and for preventing their recurrence or the occurrence of other deviations.If you are considering an action that is likely to lead to a disruption in the supply of drugs produced at your facility, FDA requests that you contact CDER’s Drug Shortages Staff immediately, at drugshortages@fda.hhs.gov, so that FDA can work with you on the most effective way to bring your operations into compliance with the law. Contacting the Drug Shortages Staff may also allow you to meet obligations you may have to report permanent discontinuances or interruptions in your drug manufacture under 21 U.S.C. 356C(a). This also allows FDA to consider, as soon as possible, what actions, if any, may be needed to avoid shortages and protect the health of patients who depend on your products.Correct any deviations promptly. FDA may withhold approval of new applications or supplements listing your firm as a drug manufacturer until any deviations are completely addressed and we confirm your compliance with CGMP. We may re-inspect to verify that you have completed corrective actions to address any deviations.Failure to address any deviations may also result in the FDA refusing admission of articles manufactured at Cdymax (India) Pharma Private Limited, at 77d & 116/117, KIADB Industrial Area, Jigani, Bangalore, Karnataka, into the United States under section 801(a)(3) of the FD&C Act, 21 U.S.C. 381(a)(3). Articles under this authority that appear to be adulterated may be detained or refused admission, in that the methods and controls used in their manufacture do not appear to conform to CGMP within the meaning of section 501(a)(2)(B) of the FD&C Act, 21 U.S.C. 351(a)(2)(B).This letter notifies you of our findings and provides you an opportunity to address the above deficiencies. After you receive this letter, respond to this office in writing within 15 working days.1Specify what you have done to address any deviations and to prevent their recurrence. In response to this letter, you may provide additional information for our consideration as we continue to assess your activities and practices. If you cannot complete corrective actions within 15 working days, state your reasons for delay and your schedule for completion.Send your electronic reply to CDER-OC-OMQ-Communications@fda.hhs.gov. Identify your response with FEI 3009882550 and ATTN: Bryce Hammer.Sincerely,/S/Francis GodwinDirectorOffice of Manufacturing QualityOffice of ComplianceCenter for Drug Evaluation and Research___________________1Under program enhancements for the Generic Drug User Fee Amendments (GDUFA) reauthorization for fiscal years (FYs) 2023-2027, also known as the GDUFA III Commitment Letter, your facility may be eligible for a Post-Warning Letter Meeting to obtain preliminary feedback from FDA on the adequacy and completeness of your corrective action plans.

Delivery Method:Via EmailProduct:DrugsRecipient:Tony EllisonCEOShoplet39 Broadway 20th FloorNew York,NY10038United Statescustomerservice@shoplet.comIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesWARNING LETTERNovember 13, 2025RE: 717846Tony Ellison:This letter is to advise you that the United States Food and Drug Administration (FDA) reviewed your website at the internet address https://www.shoplet.com/. The FDA has observed that your website offers the following triclosan-containing consumer and health care antiseptic nonprescription drug products: “Ameriderm AmeriWash Antimicrobial Lotion Soap with Triclosan 800 mL,” “Ameriderm AmeriWash Antimicrobial Lotion Soap with Triclosan 1 Gallon,” and “Ameriderm AmeriWash Antimicrobial Lotion Soap with Triclosan 1000 mL” (hereinafter Ameriderm AmeriWash Antimicrobial Lotion Soaps with Triclosan) for sale in the United States. Based on our review, these products 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). In addition, these products are misbranded under section 502(ee) of the FD&C Act, 21 U.S.C. 352(ee). Introduction or delivery for introduction of misbranded products into interstate commerce is prohibited under section 301 (d) and (a) of the FD&C Act, 21 U.S.C. 331(d) and (a). These violations are described in more detail below.Unapproved New Drug and Misbranded Drug Violations“Ameriderm AmeriWash Antimicrobial Lotion Soaps with Triclosan” 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 “Ameriderm AmeriWash Antimicrobial Lotion Soaps with Triclosan” product labeling, including your website, https://www.shoplet.com, that provide evidence of the intended use (as defined in 21 CFR 201.128) of the products as drugs include, but may not be limited to, the following:“…Anti-Microbial. . . Kills bacteria on contact..” [from your https://www.shoplet.com/Ameriderm-AmeriWash-Antimicrobial-Lotion-Soap-with-Triclosan-1-Gallon/ADM210EA/spdv product page]Based on the above labeling evidence, “Ameriderm AmeriWash Antimicrobial Lotion Soaps with Triclosan” are intended for use as triclosan-containing consumer and health care antiseptic nonprescription 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; and in general, 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), unless it is lawfully marketed under section 505G of the FD&C Act. No FDA-approved applications pursuant to section 505 of the FD&C Act, 21 U.S.C. 355, are in effect for the drug products identified above.With respect to triclosan-containing consumer and health care antiseptic nonprescription drug products, such as the “Ameriderm AmeriWash Antimicrobial Lotion Soaps with Triclosan,” such products are subject to section 505G of the FD&C Act, 21 U.S.C. 355h, which governs nonprescription drugs marketed without an approved application. Specifically, these products fall under section 505G(a)(5) of the FD&C Act, 21 U.S.C. 355h(a)(5), because FDA has determined that topical consumer and health care antiseptic nonprescription drug products containing triclosan are not GRASE under a final determination issued under 21 CFR part 330.1Therefore, these products are new drugs within the meaning of section 201(p) of the FD&C Act, 21 U.S.C. 321(p). No FDA-approved applications pursuant to section 505 of the FD&C Act are in effect for these drug products. Accordingly, these products are unapproved new drugs marketed in violation of section 505(a) of the FD&C Act, 21 U.S.C. 355(a). 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).In addition, the “Ameriderm AmeriWash Antimicrobial Lotion Soaps with Triclosan” 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 violates 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 correct any violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration. If you cannot complete corrective action within 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, please include your firm name and the unique identifier “717846” 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________________1On September 6, 2017, FDA issued a final rule establishing that certain ingredients for OTC topical consumer antiseptic wash nonprescription drug products, including triclosan, are not generally recognized as safe and effective (81 FR 61106). FDA’s final determination was codified in regulations at 21 CFR 310.545(a)(27)(iii). On December 20, 2018, FDA issued a final rule establishing that certain ingredients for OTC health care hand wash nonprescription drug products, including triclosan, are not generally recognized as safe and effective (82 FR 60474). FDA’s final determination was codified in regulations at 21 CFR 310.545(a)(27)(vi). Under section 505G(k)(2)(A) of the FD&C Act, the non-monograph conditions in 21 CFR 310.545 in effect on the day before the date of enactment of the CARES Act (i.e., March 26, 2020) were deemed to be a final administrative order. The final administrative order is entitled “Non-Monograph Conditions NM900: Drug Products Containing Certain Active Ingredients Offered Over-the-Counter for Certain Uses” (See Order ID OTC 000007, available at OTC Monographs@FDA, https://www.accessdata.fda.gov/scripts/cder/omuf/).