Delivery Method:VIA UPS Reference #:320-26-58 Product:DrugsRecipient:Ms. Maria N. MattinaOwner/PresidentPurolea Cosmetics Lab12782 Currie Ct.Livonia,MI48150-1109United StatesIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesWarning Letter320-26-58April 2, 2026Dear Ms. Mattina:The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, Purolea Cosmetics Lab, FEI 3011669383, at 12782 Currie Ct., Livonia, from October 28 to 30, 2025.Your drug products are adulterated under section 501(a)(2)(A) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 351(a)(2)(A), in that they have been prepared, packed, or held under insanitary conditions.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 FD&C Act, 21 U.S.C. 351(a)(2)(B).In addition, the FDA reviewed the product labels for drug products manufactured at your facility, including "Dermveda Extra Strength Shingles Relief" and "Dermveda Extra Strength Ultra Genital Herpes Relief." 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 "Dermveda Extra Strength Shingles Relief" and "Dermveda Extra Strength Ultra Genital Herpes Relief" 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). These drug products are especially concerning from a public health perspective as they are intended to treat serious and/or life-threatening conditions such as shingles and genital herpes.We acknowledge receipt of your response to our Form FDA 483. Your response is inadequate because you failed to provide supportive documentation for evaluation or adequate evidence of corrective actions taken to bring your operations into compliance with CGMP.During our inspection, our investigator observed specific violations including, but not limited to, the following.Insanitary ConditionsYour drug products are adulterated under section 501(a)(2)(A) of the FD&C Act because they were prepared, packed, or held under insanitary conditions. During the inspection, our investigator observed the presence of insects, filth, leaves, and clutter in several areas within your facility.Furthermore, your facility lacked adequate separation to prevent contamination from other internal or external contaminants. For example, the facility docking bay door, when opened, would directly expose manufacturing to the outside environment.CGMP Violations1. Your firm failed to conduct, for each batch of drug product, appropriate laboratory testing, as necessary, required to be free of objectionable microorganisms (21 CFR 211.165(b)You manufacture multiple(b)(4)homeopathic drug products. Some of these products can be used to(b)(4). Additionally, some products may be used(b)(4).Your firm released your finished homeopathic drug products without testing for microbiological attributes (e.g., total count, objectionable microorganisms). Without testing each batch prior to release, you did not have scientific evidence that all drug product batches were free of objectionable microbial contamination.Your firm failed to conduct testing for(b)(4)for non-sterile(b)(4)drug products prior to release and at appropriate intervals for stability. See FDA’s guidance document,Microbiological Quality Considerations in Non-sterile Drug Manufacturing, for help minimizing the risks of harmful microbiological contamination of(b)(4)drugs at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/microbiological-quality-considerations-non-sterile-drug-manufacturing.Drug products that do not meet quality standards can pose a safety risk to the public.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. Your firm also failed to conduct microbiological testing before use of each lot of a component with potential for objectionable microbiological contamination in light of its intended use (21 CFR 211.84(d)(1) and 211.84(d)(2) and 211.84(d)(6)).You failed to perform adequate testing for purity, strength, quality, and identity for the components used in the manufacture of your(b)(4)drug products. In addition, you relied on your suppliers’ certificates of analysis (COA) without establishing the reliability of your component suppliers’ test analyses at appropriate intervals.(b)(4)You failed to test your purchased bulk(b)(4)to assure it was of acceptable quality for use in drug production. You also failed to establish the reliability of your component supplier at appropriate intervals. Your firm has not demonstrated that the(b)(4)was suitable for its intended use, tested for microbiological quality, and minimally met the United States Pharmacopeia (USP)(b)(4)monograph.(b)(4)must be suitable for its intended use. Each lot must be tested to ensure conformance with appropriate chemical and microbiological attributes. Routine monitoring of microbial counts as well as characterization and identification of contamination is integral to ensuring(b)(4)is of acceptable quality for use in manufacturing operations.Of note, you did not test the(b)(4)for(b)(4), a contamination risk in(b)(4)drug products, which has been linked to(b)(4). For further information regarding the significance of(b)(4)contamination of(b)(4)drug products, see FDA’s advisory notice at(b)(4).Ingredients at Risk for(b)(4)ContaminationYou failed to adequately test your incoming components at high risk of(b)(4)contamination for identity before using them to manufacture your drug products. This includes, but is not limited to, testing of(b)(4)to determine its appropriate identity. The identity testing of(b)(4)includes a limit test, according to the USP, to ensure that the component meets the relevant safety limits for the levels of(b)(4).The use of ingredients contaminated with(b)(4)has resulted in various lethal poisoning incidents in humans worldwide. See FDA’s guidance document,(b)(4).Without appropriate testing of components and ingredients, you cannot ensure the quality and safety of your drug products.3. Your firm’s quality control unit failed to exercise its responsibility to ensure drug products manufactured are in compliance with CGMP and meet established specifications for identity, strength, quality, and purity (21 CFR 211.22).Your quality unit (QU) did not adequately oversee your drug manufacturing operations. For example, your QU failed to ensure:Procedures were established or followed (21 CFR 211.22(d))Batch records were reviewed before drug product release (21 CFR 211.22(a))Adequate production and process controls were established (21 CFR 211.100(a))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.Inappropriate Use of Artificial Intelligence in Pharmaceutical Manufacturing.During the FDA inspection of your drug manufacturing facility, you stated to FDA investigators that you utilized artificial intelligence (AI) agents(b)(4)to help your firm comply with FDA regulations. Specifically, you used AI to create drug product specifications, procedures, and master production or control records to be in compliance with FDA requirements.If you use AI as an aid in document creation, you must review the AI generated documents to ensure they were accurate and actually compliant with CGMP. Your failure to do so is a violation of 21 CFR 211.22(c). Overreliance on artificial intelligence for your drug manufacturing operations was also documented during the inspection. For example, the FDA investigators found that you had not conducted process validation prior to distribution of your drug products, as required under 21 CFR 211.100, and informed you as such. You replied that you were not aware of the legal requirement, as the AI agent you used(b)(4), never told you it was required.We recognize that you have ceased drug production. If you plan to resume drug production, and use AI to help with CGMP activities, such as development of procedures and specifications, any output or recommendations from an AI agent must be reviewed and cleared by an authorized human representative of your firm’s QU in accordance with section 501(a)(2)(B) of the FD&C Act. See also 21 CFR 211.22; 21 CFR 211.100.Drug Production CeasedWe acknowledge your commitment to cease production and distribution of drugs at this facility.Even though you indicated your firm is no longer manufacturing products at your facility, there are still products within expiry in U.S. distribution. Data is required to support whether your components and your drug products meet established specifications (such as identity, strength, quality, and purity) and that these drug products will remain within acceptable limits and retain their quality attributes through their labeled shelf-life until expiry.In response to this letter:Specify by National Drug Code (NDC) number which drugs have been discontinued and the last day of manufacture.Clarify your intentions for the drug products that remain on the market within expiry.o Explain how distributed drug products will be verified to ensure they meet specifications.o Confirm that if you receive any client or customer complaints and/or any results from ongoing testing or evaluation that reveal substandard quality for the drug components, active pharmaceutical ingredient (API), or distributed drug products, that rapid corrective action should be taken for products that were released for commercial distribution and that are still within expiry, such as notifying customers and product recalls.Provide commitment that if you intend to resume manufacturing drugs at this facility or any other facility in the future, that you will notify this office prior to resuming your drug manufacturing operations.If you resume CGMP activities, you are responsible for resolving all deficiencies and systemic flaws to ensure your firm is capable of ongoing CGMP compliance. In addition, based 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 all corrective action and preventive action, before you pursue resolution of your firm’s compliance status with FDA.Owner’s ResponsibilitiesDrugs 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 your drugs regardless of agreements in place with a contract facility. You are required to ensure that drugs are made in accordance with section 501(a)(2)(B) of the FD&C Act to ensure 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.Updates to the Electronic Drug Registration and Listing System (eDRLS)If your firm does not intend to engage in any further drug manufacturing activities, then you, as the owner and operator of the drug manufacturing establishment, are required to update all outdated information to avoid miscommunication or errors. Consequently, your firm will need to modify the drug product marketing status and delist each product with the last lot expiry date as the “marketing end date” on the specific product listing per 21 CFR 207.57(b)(1)(ii).Additionally, after delisting your drug products, you will need to deregister your overall drug establishment with FDA if you cease manufacturing and distributing drugs in U.S. per 21 CFR 207.29(a)(1). If you have any further registration or listing questions, please contact the EDRLS general mailbox: eDRLS@fda.hhs.gov.Unapproved New DrugsBased on a review of the product labels collected during the inspection, "Dermveda Extra Strength Shingles Relief" and "Dermveda Extra Strength Ultra Genital Herpes Relief" 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 of claims from the product labels that provide evidence of the intended uses (as defined in 21 CFR 201.128) of these products as drugs include, but are not limited to, the following:Dermveda Extra Strength Shingles Relief"SHINGLES"Dermveda Extra Strength Ultra Genital Herpes Relief"GENITAL HERPES RELIEF""Dermveda Extra Strength Shingles Relief" and "Dermveda Extra Strength Ultra Genital Herpes Relief" 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 sections 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 "Dermveda Extra Strength Shingles Relief" and "Dermveda Extra Strength Ultra Genital Herpes Relief" are labeled as homeopathic drugs. 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.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 3011669383 and ATTN: Frank Wackes.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

Delivery Method:Via Electronic Mail - Return Receipt RequestedReference #:320-26-60Product:Drugs,Over-the-Counter DrugsRecipient:Mr. Eitelberg G. Montarroyos, Sr.Chief Executive OfficerChemco Corporation4920 NW 165th StreetMiami Lakes,FL33014-6323United StatesIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesWarning Letter320-26-60April 7, 2026Dear Mr. Montarroyos:The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, Chemco Corporation, FEI 1042599, at 4920 NW 165th St., Miami Lakes, from August 11 to 22, 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, your “PRO Nail FUNGUS KILLER” drug product is an unapproved new drug introduced or delivered for introduction into interstate commerce in violation of section 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 355(a). This product is also misbranded under section 502(ee) of the FD&C Act, 21 U.S.C. 352(ee).Separately, "Eternal Spirit Beauty HAIR PRO Anti-Dandruff, Now With Stem Cells," "Eternal Spirit Beauty PAINLESS Pain relieving cream," and "Eternal Spirit Beauty FUNGI FRESH Anti-fungus Liquid for Fingers & Toes" drug products are misbranded under section 502(a) of the FD&C Act, 21 U.S.C. 352(a), while the “SPA REDI Gelle-n-Detox Massage Lotion LAVENDER & ROSEMARY,” and “SPA REDI Gelle-n-Detox Massage Lotion ICY MINT” drug products are misbranded under section 502(c) of the FD&C Act, 21 U.S.C. 352(a). Subsequently, these products are also misbranded under section 502(ee) of the FD&C Act, 21 U.S.C. 352(ee).Introduction or delivery for introduction of such products into interstate commerce is prohibited under sections 301(d) and (a) of the FD&C Act, 21 U.S.C. 331(d) and (a). These violations are described in more detail below.We reviewed your September 12, 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 clean, maintain, and, as appropriate for the nature of the drug, sanitize and/or sterilize equipment and utensils at appropriate intervals to prevent malfunctions or contamination that would alter the safety, identity, strength, quality, or purity of the drug product beyond the official or other established requirements. You also failed to establish written procedures for cleaning and maintenance of equipment (21 CFR 211.67(a) and 211.67(b)).You manufacture topical, over-the-counter (OTC), non-sterile drug products. You have not demonstrated that your cleaning practices are adequate to remove contaminants from the shared equipment used to manufacture your drug products.Inadequate Equipment CleaningDuring the inspection, our investigator observed white residue in a piece of manufacturing equipment (Tank #68) that your quality unit verified as clean according to your(b)(4)tank cleaning logbook. This equipment was previously used in the manufacture of a topical drug product containing(b)(4).Lack of Cleaning ValidationDuring the inspection, you stated that you had not conducted cleaning validation studies for your non-dedicated equipment. You use active ingredients such as(b)(4)in your drug products. You failed to demonstrate that your cleaning process is effective in preventing cross-contamination between the various drug products manufactured on the same equipment.In your response, you state that you will use(b)(4)analysis to verify the effectiveness of cleaning activities performed on your manufacturing equipment. Your response is inadequate because you did not provide evidence that your cleaning methods are appropriate and effective in removing contaminants, such as drug product residues, cleaning and sanitizing agents, and objectionable organisms. Furthermore, you did not assess the impact of your inadequate cleaning processes on drug products that are currently on the market and within expiry.In response to this letter, provide the following:A comprehensive, independent retrospective assessment of your cleaning effectiveness to evaluate the scope of cross-contamination hazards. Include the identity of residues, other manufacturing equipment that may have been improperly cleaned, and an assessment of whether cross-contaminated drug products may have been released for distribution. The assessment should identify any inadequacies of cleaning procedures and practices and encompass each piece of manufacturing equipment used to manufacture more than one drug product.A corrective action and preventive action (CAPA) plan, based on the retrospective assessment of your cleaning program, that includes appropriate remediations to your cleaning processes and practices, and timelines for completion. Provide a detailed summary of vulnerabilities in your process for lifecycle management of equipment cleaning. Describe improvements to your cleaning program, including enhancements to cleaning effectiveness; improved ongoing verification of proper cleaning execution for all drug products and equipment; and all other needed remediations.Appropriate improvements to your cleaning validation program with special emphasis on incorporating conditions identified as worst case in your drug manufacturing operation. This should include but not be limited to identification and evaluation of all worst-case:o drugs with higher toxicitieso drugs with higher drug potencieso drugs of lower solubility in their cleaning solventso drugs with characteristics that make them difficult to cleano swabbing locations for areas that are most difficult to cleano maximum hold times before cleaningIn addition, describe the steps that must be taken in your change management system before introduction of new manufacturing equipment or a new product.A summary of updated SOPs that ensure an appropriate program is in place for verification and validation of cleaning procedures for products, processes, and equipment.2. Your firm failed to conduct at least one test to verify the identity of each component of a drug product. Your firm also failed to validate and establish the reliability of your component supplier’s test analyses at appropriate intervals (21 CFR 211.84(d)(1) and 211.84(d)(2)).You failed to perform adequate identity testing of each component lot used in the manufacture of your drug products, such as(b)(4).Identity testing of high-risk drug components (e.g.,(b)(4)) includes a limit test in the United States Pharmacopeia (USP) to ensure the component meets the relevant safety limits for(b)(4)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 this component for use in the manufacture of your drug products.In addition, you relied on your suppliers’ certificates of analysis (COA) without establishing the reliability of your component suppliers’ test analyses at appropriate intervals.(b)(4)You failed to adequately test each shipment of each lot of(b)(4)for(b)(4)contamination.The use of ingredients contaminated with(b)(4)has resulted in various lethal poisoning incidents in humans worldwide. See FDA’s guidance document(b)(4)to help you meet the CGMP requirements when manufacturing drugs containing ingredients at high-risk for(b)(4)contamination at(b)(4).(b)(4)You failed to adequately test your incoming(b)(4)for(b)(4). The use of(b)(4)contaminated with(b)(4)has resulted in various lethal poisoning incidents in humans worldwide. See FDA’s guidance document(b)(4).In your response, you state that you will install and qualify new laboratory equipment to perform all required testing and will send components to a third-party laboratory for analysis in the interim. Your response is inadequate because you did not consider retrospective identity testing, or assessment by other methods, of reserve samples of the components used in your drug products that remain in the market and are within expiry. Additionally, your response lacks details on the remediation of your supplier qualification program.Without adequate testing, you do not have scientific evidence that components conform to appropriate specifications prior to use in the manufacture of your drug products. As a manufacturer, you have a responsibility to sample, test, and examine drug components before use in production to assure adequate quality.In response to this letter, provide the following:A comprehensive, independent review of your material system, including but not limited to:o evaluating all suppliers of materials (components, containers, and closures) to determine if they are reliable and appropriately qualified;o an assessment of all materials to determine whether they are consistently of acceptable quality;o a review to ensure assigned expiration or retest dates are appropriate (supported by data)o adequacy of the supplier qualification program, and its selection, qualification, and disqualification provisions.Based on a thorough review, provide a summary of your systemic CAPA to remediate the vendor qualification program and prevent use of unsuitable components, containers, and closures.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 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 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.A summary of your program for qualifying and overseeing contract facilities that test the drug products you manufacture.A commitment to provide(b)(4)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, test retain samples of all implicated finished drug product batches for the presence of(b)(4).A full risk assessment for drug products that are within expiry which contain any ingredient at risk for(b)(4)contamination (including, but not limited to,(b)(4)). Take prompt and appropriate actions to determine the safety of all lots of the component(s) and any related drug product that could contain(b)(4)including customer notifications and product recalls for any contaminated lots. Identify additional appropriate 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.3. Your firm’s quality control unit failed to exercise its responsibility to ensure drug products manufactured are in compliance with CGMP, and meet established specifications for identity, strength, quality, and purity (21 CFR 211.22).Your quality unit (QU) did not provide adequate oversight for the manufacture of your drug products. For example, your QU failed to ensure the following:Adequate investigations into out-of-specification (OOS) results that include scientific justification for the purported root cause and an assessment of impact to other batches and drug products.Adequate written procedures for production and process control (e.g., process validation).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.In your response, you state that for process validation you will establish a robust validation program and will validate the manufacturing processes used in the production of your drug products. However, you did not address the issue of inadequate investigations.Your response is inadequate because it does not address remediation to your investigation procedures. Additionally, your response does not provide a timeframe for completion of process validation activities for each of your drug products, nor does it provide your interim plan for any drugs distributed before validation activities are completed to ensure you produce drug products of acceptable quality.In response to this letter, provide:A comprehensive, independent assessment of your overall system for investigating deviations, 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 assurance 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 assurance decisions, and is fully supported by executive management.A detailed summary of your validation program for ensuring a state of control throughout the product lifecycle along with associated procedures. Describe your program for process performance qualification and ongoing monitoring of both intra-batch and inter-batch variation to ensure a continuing state of control.A timeline for performing process performance qualification for each of your marketed drug products. Also provide a risk assessment and any follow-up actions to be taken for the distributed drug products produced without performing any process validation studies.Process performance protocol(s), and written procedures for qualification of equipment and facilities.A detailed program for designing, validating, maintaining, controlling and monitoring each of your manufacturing processes that includes vigilant monitoring of intra-batch and inter-batch variation to ensure an ongoing state of control. Also, include your program for qualification of your equipment and facility.Repeat Violations at FacilityIn a previous inspection, conducted in October 2022, FDA cited similar CGMP violations. You proposed specific remediation for these violations in your responses. Repeated failures demonstrate that executive management oversight and control over the manufacture of drugs is inadequate. For example, during the regulatory meeting held with your firm on June 16, 2023, we discussed that you failed to adequately validate the manufacturing processes used in the production of your drug products. After the meeting, you committed to correcting this deficiency. However, during the current inspection, the same deficiency was observed.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.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.Unapproved New Drugs and Misbranded Drug Violations“PRO Nail FUNGUS KILLER,” “SPA REDI Gelle-n-Detox Massage Lotion LAVENDER & ROSEMARY,” “SPA REDI Gelle-n-Detox Massage Lotion ICY MINT,” “Eternal Spirit Beauty HAIR PRO Anti-Dandruff, Now With Stem Cells,” “Eternal Spirit Beauty PAINLESS Pain relieving cream,” and “Eternal Spirit Beauty FUNGI FRESH Anti-fungus Liquid for Fingers & Toes” 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 product labeling, including your websites, www.echemco.com and www.beautymarketonline.com, that provide evidence of intended uses (as defined in 21 CFR 201.128) of these products as drugs include, but may not be limited to, the following:PRO Nail FUNGUS KILLER “maximum strength Antifungal Solution with Undecylenic Acid 25%, Eliminates fungus on fingers & toes” [from principal display panel on product label] “Helps stop and eliminate fungal infections on cuticles, skin around nail edges and under nail tips where accessible with applicator drops.” [from side panel on product label] “Uses▪ Cures most athlete’s foot (tinea pedis) and ringworm (tinea corporis). ▪ Relieves itching, scaling, cracking, burning and redness.” [from drug facts panel on product label] “Maximum Strength Fungus Killer Liquid – Antifungal Treatmentwith Undecylenic Acid, Vitamin E & Tea Tree – Treats Toe Nail Fungi, Athlete’s Foot, Ringworm, and Jock Itch” [from sidebar ad on product website page at https://beautymarketonline.com/products/pronail-maximum-strength-fungus-killer?variant=45535349440739]SPA REDI Gelle-n-Detox Massage Lotion LAVENDER & ROSEMARY and ICY MINT “…ANTISEPTIC Protects Against Bacteria Reducing the Risk of Skin Infection with Each Use…” [from principal display panel on product label] “UsesFirst aid to help protect against bacterial contamination.” [from drug facts panel on product label]Eternal Spirit Beauty HAIR PRO Anti-Dandruff, Now With Stem Cells “UseHelp prevent recurrence of flaking and itching associated with dandruff.” [from drug facts panel on product label]Eternal Spirit Beauty PAINLESS Pain relieving cream “UsesFor the temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, sprains and strains.” [from drug facts panel on product label]Eternal Spirit Beauty FUNGI FRESH Anti-fungus Liquid for Fingers & Toes “Uses▪ Cures most athlete’s foot (tinea pedis) and ringworm (tinea corporis). ▪ Relieves itching, scaling, cracking, burning and redness.” [from drug facts panel on product label]Unapproved New Drug ViolationsBased on the above labeling evidence, “PRO Nail FUNGUS KILLER” is intended for use as an over-the-counter (OTC) topical antifungal drug product. As described below, this OTC 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 application pursuant to section 505 of the FD&C Act, 21 U.S.C. 355, is in effect for this drug product.1Under 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.PRO Nail FUNGUS KILLERYour “PRO Nail FUNGUS KILLER” is a topical antifungal drug product subject to section 505G of the FD&C Act, 21 U.S.C. 355h, which governs nonprescription drugs marketed without an approved application. Specifically, this product falls under section 505G(a)(5) of the FD&C Act, 21 U.S.C. 355h(a)(5), because FDA has concluded, in a final determination issued under 21 CFR part 330, that topical antifungal drug products labeled with claims or directions for use on the scalp or nails are not GRASE.2This is evidenced by the product labeling that states “helps stop and eliminate fungal infections . . . under nail tips where accessible with applicator drops” and the image on the principal display panel (PDP) of the dropper dispensing the drug directly on the nail. Thus, this product is a new drug within the meaning of section 201(p) of the FD&C Act, 21 U.S.C. 321(p), for which no FDA-approved application pursuant to section 505 of the FD&C Act is in effect. Therefore, 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).Misbranded Drug ViolationsYour “Eternal Spirit Beauty HAIR PRO Anti-Dandruff, Now With Stem Cells,” “Eternal Spirit Beauty PAINLESS Pain relieving cream,” and “Eternal Spirit Beauty FUNGI FRESH Anti-fungus Liquid for Fingers & Toes” drug products are misbranded under section 502(a) of the FD&C Act, 21 U.S.C. 352(a), because the product labeling includes statements that misleadingly suggest that the drug products are approved or endorsed by FDA in some way. For example, all three product labels include the statement “made in an FDA registered facility.” FDA’s regulations provide that “[r]egistration of an establishment or listing of a drug does not denote approval of the establishment, the drug, or other drugs of the establishment, nor does it mean that a product may be legally marketed” (21 CFR 207.77(a)). However, the general public is not likely to be familiar with the details of FDA’s regulations. The above assertions misleadingly suggest that the above-mentioned drug products are approved or endorsed by FDA in some way. Your “Eternal Spirit Beauty HAIR PRO Anti-Dandruff, Now With Stem Cells,” “Eternal Spirit Beauty PAINLESS Pain relieving cream,” and “Eternal Spirit Beauty FUNGI FRESH Anti-fungus Liquid for Fingers & Toes” drug products are not the subjects of an FDA-approved application. Therefore, these products are misbranded under section 502(a) of the FD&C Act, 21 U.S.C. 352(a), because their labeling is false or misleading.Additionally, "Eternal Spirit Beauty HAIR PRO Anti-Dandruff, Now With Stem Cells" is further misbranded under section 502(a) because it prominently features "Now With Stem Cells" on the label’s PDP. Under 21 CFR 201.10(c)(4), "[t]he labeling of a drug may be misleading by reason ... [of] [t]he featuring in the labeling of inert or inactive ingredients in a manner that creates an impression of value greater than their true functional role in the formulation." The labeling for "Eternal Spirit Beauty HAIR PRO Anti-Dandruff, Now With Stem Cells" prominently features stem cells on the PDP including within the product name. Featuring this inactive ingredient prominently on the PDP creates an impression of value greater than its functional role in the formulation and thus causes this product to be misbranded under section 502(a) of the FD&C Act, 21 U.S.C. 352(a).The product labels for "SPA REDI Gelle-n-Detox Massage Lotion LAVENDER & ROSEMARY" and "SPA REDI Gelle-n-Detox Massage Lotion ICY MINT" are not labeled in accordance with the “Drug Facts” labeling requirements described in 21 CFR 201.66. Specifically, the products’ labels fail to include the statement “in minor cuts, scrapes, and burns” within the Uses section of Drug Facts as required under M003.50(b) within the Over-the-Counter Monograph M003: First Aid Antiseptic Drug Products for OTC Human Use. Therefore, these products are misbranded under section 502(c) of the FD&C Act, 21 U.S.C. 352(c), because the information that is required to appear on the labeling is not prominently placed thereon with such conspicuousness and in such terms as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use.Subsequently, “PRO Nail FUNGUS KILLER,” “SPA REDI Gelle-n-Detox Massage Lotion LAVENDER & ROSEMARY,” “SPA REDI Gelle-n-Detox Massage Lotion ICY MINT,” “Eternal Spirit Beauty HAIR PRO Anti-Dandruff, Now With Stem Cells,” “Eternal Spirit Beauty PAINLESS Pain relieving cream,” and “Eternal Spirit Beauty FUNGI FRESH Anti-fungus Liquid for Fingers & Toes” are also 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/or 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).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 1042599 and ATTN: CDR Frank Verni.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_________________1FDA is not aware of any adequate and well-controlled clinical trials in the published literature that support a determination that your “PRO Nail FUNGUS KILLER” drug product is GRASE for use under the conditions prescribed, recommended, or suggested in its labeling.2On September 2, 1993, FDA issued a final rule establishing that certain labeling claims for OTC topical antifungal drug products, including for use on scalp or on the nails, are not generally recognized as safe and effective. 58 Fed. Reg. 46744. FDA’s final determination was codified in regulations at 21 CFR 310.545(a)(22)(iii). 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/).Section 505G(a)(1) of the FD&C Act specifies criteria under which certain nonprescription drugs without an approved application are deemed GRASE and not "new drugs;" notably, conformance with conditions detailed in applicable OTC monograph documents issued by FDA under 21 CFR 330 prior to enactment of the CARES Act. In the case of first aid antiseptic drug products, relevant documents were deemed under section 505G to be a final administrative order, Over-the-Counter Monograph M003: First Aid Antiseptic Drug Products for OTC Human Use. See Order ID OTC000030, available at FDA’s website OTC Monographs@FDA, https://www.accessdata.fda.gov/scripts/cder/omuf/.)

Product:DrugsRecipient:RxgoodusaUnited StatesIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesWARNING LETTERApril 1, 2026MARCS-CMS 723622Rxgoodusa:This is to advise you that the United States (U.S.) Food and Drug Administration (FDA) recently reviewed your website at the Internet address www.rxgoodusa.com and has observed that your website introduces into interstate commerce misbranded and unapproved new drugs in violation of sections 301(a), 301(d), 301(k), 502(f)(1), 503(b)(1), and 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) [21 U.S.C. §§ 331(a), 331(d), 331(k), 352(f)(1), 353(b)(1), and 355(a)]. FDA previously issued a Warning Letter to you on August 1, 2025, addressing similar violations while you were operating under www.usaquickmeds.com.1Your continued introduction into interstate commerce of misbranded and unapproved new drugs after receipt of that Warning Letter raises significant concerns regarding your compliance with the FD&C Act.As discussed below, FDA has observed that www.rxgoodusa.com introduces into interstate commerce unapproved and misbranded opioids. Opioid addiction and abuse have created an immense public health crisis, and the death toll is staggering. Given the severity of the opioid epidemic, the easy availability of opioids via the Internet poses significant risks to U.S. consumers.FDA has also observed that www.rxgoodusa.com introduces into interstate commerce unapproved and misbranded benzodiazepines. Benzodiazepines are drug products with an acknowledged potential for abuse, and it is important to address the public health impact of their nonmedical use. Benzodiazepine nonmedical use is widespread, and individuals frequently co‐use benzodiazepines with alcohol, prescription opioids, and illicit drugs. Associated harms of benzodiazepine nonmedical use are substantial but occur primarily when people use benzodiazepines in combination with other drugs. Further, in cases where benzodiazepines were co‐used with other substances, medical outcomes are typically more severe than in cases involving benzodiazepines alone. Polysubstance overdose deaths account for the vast majority of overdose deaths documenting involvement of benzodiazepines.There are inherent risks to consumers who purchase unapproved new drugs and misbranded drugs. Unapproved new drugs do not carry the same assurances of safety and effectiveness as those drugs subject to FDA oversight. Drugs that have circumvented regulatory safeguards may be contaminated, counterfeit, contain varying amounts of active ingredients, or contain different ingredients altogether. Accordingly, FDA requests that www.rxgoodusa.com cease offering any unapproved and misbranded drugs for sale to U.S. consumers. This is critical to shielding the American public from harm.Unapproved New Drugs:Certain products offered for sale by www.rxgoodusa.com are drugs within the meaning of section 201(g) of the FD&C Act [21 U.S.C. § 321(g)] because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or because they are intended to affect the structure or function of the body. These drugs are also new drugs as defined by section 201(p) of the FD&C Act [21 U.S.C. § 321(p)], because they are not generally recognized as safe and effective for their labeled uses. With certain exceptions not applicable here, new drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from FDA, as described in section 505(a) of the FD&C Act [21 U.S.C. § 355(a)]. No approved applications pursuant to section 505 of the FD&C Act are in effect for these products. Accordingly, their introduction or delivery for introduction into interstate commerce violates sections 301(d) and 505(a) of the FD&C Act [21 U.S.C. §§ 331(d) and 355(a)].An example of an unapproved opioid you offer for sale on www.rxgoodusa.com is tramadol marketed as “Citra 100mg (Loose Pills) – US TO US Tramadol”. Evidence obtained from your website establishing that this product is a drug intended for human use (as defined in 21 CFR 201.128) includes the claims “Citra Tramadol (Loose Pills)is used to deal with moderate to severe pain. It is an opioid analgesic medicine used for the short term to feel relieved from different painful conditions.” While there are FDA-approved versions of tramadol on the market in the U.S., there are no approved drug applications pursuant to section 505 of the FD&C Act in effect for “Citra 100mg (Loose Pills) – US TO US Tramadol” offered by www.rxgoodusa.com. FDA-approved tramadol is indicated in adults for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.FDA-approved tramadol is only available pursuant to a prescription from a licensed practitioner. Furthermore, this drug product bears a boxed warning, commonly referred to as a “black box warning,” which is the strongest warning FDA requires, indicating that the drug carries a significant risk of serious or even life-threatening adverse effects. This boxed warning addresses risks including addiction, abuse, misuse, life-threatening respiratory depression (breathing problems), neonatal opioid withdrawal syndrome (withdrawal symptoms in newborn baby), and accidental exposure resulting in death. In addition, when these drug products are taken in conjunction with other central nervous system depressants, including alcohol and benzodiazepines, use may result in coma or death.An example of unapproved benzodiazepine you offer for sale on www.rxgoodusa.com is diazepam marketed as “Diazepam 10mg US to US”. Evidence obtained from your website establishing that this product is a drug intended for human use (as defined in 21 CFR 201.128) includes the claims “DIAZEPAM (dye AZ e pam) treats seizures, muscle spasms or twitches. It may also be used to treat anxiety, including before a procedure.” While there are FDA-approved versions of diazepam on the market in the U.S., there are no approved drug applications pursuant to section 505 of the FD&C Act in effect for “Diazepam 10mg US to US” offered by www.rxgoodusa.com. FDA-approved diazepam (VALIUM®) is indicated for the management of anxiety disorders, acute alcohol withdrawal symptom relief, as adjunctive therapy for skeletal muscle spasm relief, and as adjunctive therapy in convulsive disorders.FDA-approved diazepam is only available pursuant to a prescription from a licensed practitioner. Furthermore, this drug product bears a boxed warning, addressing risks including abuse, misuse, addiction, and physical dependence. In addition, the concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death.Misbranded Drugs:A drug is misbranded under section 502(f)(1) of the FD&C Act [21 U.S.C. § 352(f)(1)] if its labeling fails to bear adequate directions for use. “Adequate directions for use” means directions under which a layperson can use a drug safely and for the purposes for which it is intended (see 21 CFR 201.5). Prescription drugs, as defined in section 503(b)(1) of the FD&C Act [21 U.S.C. § 353(b)(1)] include those that, because of their toxicity or other potentiality for harmful effect, and/or the method of their use, and/or the collateral measures necessary for their use, are not safe for use except under supervision of a practitioner licensed by law to administer them. Prescription drugs, as defined in section 503(b)(1)(A) of the FD&C Act [21 U.S.C. § 353(b)(1)(A)], can be used safely only at the direction, and under the supervision, of a licensed practitioner.Because the aforementioned drugs are prescription drugs intended for conditions that are not amenable to self-diagnosis and treatment by a layperson, adequate directions cannot be written such that a layperson can use the products safely for their intended use. Consequently, the labeling for these drug products fail to bear adequate directions for use, causing them to be misbranded under section 502(f)(1) of the FD&C Act [21 U.S.C. § 352(f)(1)]. In addition, because these drugs are not approved in the U.S., they are also not exempt under 21 CFR 201.115(a) from the requirements of section 502(f)(1) of the FD&C Act [21 U.S.C. § 352(f)(1)]. By offering these drugs for sale to U.S. consumers, www.rxgoodusa.com is causing the introduction of misbranded drugs into interstate commerce in violation of section 301(a) of the FD&C Act [21 U.S.C. § 331(a)].Furthermore, under U.S. law, prescription drugs can be dispensed only pursuant to a prescription from a healthcare practitioner licensed by law to administer prescription drugs. By offering the aforementioned drug products without requiring a prescription, www.rxgoodusa.com jeopardizes patient safety and misbrands the drug products under section 503(b)(1) of the FD&C Act [21 U.S.C. § 353(b)(1)]. Dispensing a prescription drug without a prescription is an act which results in the drug being misbranded while held for sale, in violation of section 301(k) of the FD&C Act [21 U.S.C. § 331(k)].FDA is sending this warning letter to www.rxgoodusa.com because of the inherent risks to consumers who purchase misbranded and unapproved new drugs. This letter is not intended to identify all the ways in which your products or operations might be in violation of the law. It is your responsibility to ensure that all products you offer for sale are in compliance with the FD&C Act and its implementing regulations. You should take prompt action to address any violations of the FD&C Act (which may include the offer for sale of similarly misbranded and/or unapproved new drugs other than the drug products noted above). We advise you to review your websites, product labels, and other labeling and promotional materials to ensure that you are not misleadingly representing your products as safe and effective for a use for which they have not been approved by FDA and that you are not distributing misbranded and unapproved drug products in violation of the FD&C Act.Please notify this office in writing within 15 working days describing the specific steps you have taken to address any violations and to prevent their recurrence. Include an explanation of each step being taken to remedy and prevent the recurrence of any violations, as well as copies of related documentation. Failure to adequately address this matter may result in legal action, including, without limitation, seizure, and injunction, without further notice. If you cannot complete corrective action within 15 working days, state the reason for the delay and the time within which you will complete the corrections. This letter notifies you of our concerns and provides you with an opportunity to address them. If you believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration within 15 working days.If you are not located in the U.S., please note that products that appear to be misbranded or unapproved new drugs may be detained or refused admission. We may advise the appropriate regulatory officials in the country from which you operate that your products referenced above appear to be unapproved and misbranded products that cannot be legally sold to consumers in the U.S.Please direct your response and any inquiries to FDA at FDAInternetPharmacyTaskForce-CDER@fda.hhs.gov.Sincerely,/S/Sangeeta Vaswani Chatterjee, Pharm.D.DirectorOffice of Drug Security, Integrity, and ResponseOffice of ComplianceCenter for Drug Evaluation and Research_______________1Warning Letter to www.usaquickmeds.com (Aug. 1, 2025), available at https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/wwwusaquickmedscom-713312-08012025

Product:DrugsRecipient:Online Rx MedzUnited StatesIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesWARNING LETTERApril 1, 2026MARCS-CMS 723472Online Rx Medz:This is to advise you that the United States (U.S.) Food and Drug Administration (FDA) recently reviewed your website at the Internet address www.onlinerxmedz.com and has observed that your website introduces into interstate commerce misbranded and unapproved new drugs in violation of sections 301(a), 301(d), 301(k), 502(f)(1), 503(b)(1), and 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) [21 U.S.C. §§ 331(a), 331(d), 331(k), 352(f)(1), 353(b)(1), and 355(a)].As discussed below, FDA has observed that www.onlinerxmedz.com introduces into interstate commerce unapproved and misbranded opioids. Opioid addiction and abuse have created an immense public health crisis, and the death toll is staggering. Given the severity of the opioid epidemic, the easy availability of opioids via the Internet poses significant risks to U.S. consumers.FDA has also observed that www.onlinerxmedz.com introduces into interstate commerce unapproved and misbranded benzodiazepines. Benzodiazepines are drug products with an acknowledged potential for abuse, and it is important to address the public health impact of their nonmedical use. Benzodiazepine nonmedical use is widespread, and individuals frequently co‐use benzodiazepines with alcohol, prescription opioids, and illicit drugs. Associated harms of benzodiazepine nonmedical use are substantial but occur primarily when people use benzodiazepines in combination with other drugs. Further, in cases where benzodiazepines were co‐used with other substances, medical outcomes are typically more severe than in cases involving benzodiazepines alone. Polysubstance overdose deaths account for the vast majority of overdose deaths documenting involvement of benzodiazepines.Finally, FDA has observed that www.onlinerxmedz.com introduces into interstate commerce unapproved and misbranded Schedule II stimulants. Schedule II stimulants have an acknowledged high potential for abuse, and it is important to address the public health impact of their diversion and nonmedical use. Diversion is the primary source of prescription stimulants for nonmedical use, and nonmedical use is most frequent among young adults and college students. Polysubstance use is common among those who use prescription stimulants nonmedically, with individuals frequently co-using illicit drugs and/or prescription opioids. These concerns come against a backdrop of rising mortality from psychostimulant-involved overdoses, which involve illicit stimulants the vast majority of the time, but sometimes involve prescription stimulants. The easy availability of benzodiazepines and Schedule II stimulants via the Internet poses additional significant risks to U.S. consumers.There are inherent risks to consumers who purchase unapproved new drugs and misbranded drugs. Unapproved new drugs do not carry the same assurances of safety and effectiveness as those drugs subject to FDA oversight. Drugs that have circumvented regulatory safeguards may be contaminated, counterfeit, contain varying amounts of active ingredients, or contain different ingredients altogether. Accordingly, FDA requests that www.onlinerxmedz.com cease offering any unapproved and misbranded drugs for sale to U.S. consumers. This is critical to shielding the American public from harm.Unapproved New Drugs:Certain products offered for sale by www.onlinerxmedz.com are drugs within the meaning of section 201(g) of the FD&C Act [21 U.S.C. § 321(g)] because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or because they are intended to affect the structure or function of the body. These drugs are also new drugs as defined by section 201(p) of the FD&C Act [21 U.S.C. § 321(p)], because they are not generally recognized as safe and effective for their labeled uses. With certain exceptions not applicable here, new drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from FDA, as described in section 505(a) of the FD&C Act [21 U.S.C. § 355(a)]. No approved applications pursuant to section 505 of the FD&C Act are in effect for these products. Accordingly, their introduction or delivery for introduction into interstate commerce violates sections 301(d) and 505(a) of the FD&C Act [21 U.S.C. §§ 331(d) and 355(a)].An example of an unapproved opioid you offer for sale on www.onlinerxmedz.com is oxycodone marketed as “Oxycodone 80mg”. Evidence obtained from your website establishing that this product is a drug intended for human use (as defined in 21 CFR 201.128) includes the claim “Oxycodone belongs to a class of drugs known as opioids. It works by changing how the brain and nervous system respond to pain.” While there are FDA-approved versions of oxycodone on the market in the U.S., there are no approved drug applications pursuant to section 505 of the FD&C Act in effect for “Oxycodone 80mg” offered by www.onlinerxmedz.com. FDA-approved oxycodone is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.FDA-approved oxycodone is only available pursuant to a prescription from a licensed practitioner. Furthermore, this drug product bears a boxed warning, commonly referred to as a “black box warning,” which is the strongest warning FDA requires, indicating that the drug carries a significant risk of serious or even life-threatening adverse effects. This boxed warning addresses risks including addiction, abuse, misuse, life-threatening respiratory depression (breathing problems), neonatal opioid withdrawal syndrome (withdrawal symptoms in newborn baby), and accidental exposure resulting in death. In addition, when these drug products are taken in conjunction with other central nervous system (CNS) depressants, including alcohol and benzodiazepines, use may result in coma or death.An example of an unapproved benzodiazepine you offer for sale on www.onlinerxmedz.com is alprazolam marketed as “Xanax 2mg”. Evidence obtained from your website establishing that this product is a drug intended for human use (as defined in 21 CFR 201.128) includes the claim “Xanax 2mg offers powerful relief for severe anxiety and panic disorders, helping to quickly calm intense symptoms.” While there are FDA-approved versions of alprazolam on the market in the U.S., there are no approved drug applications pursuant to section 505 of the FD&C Act in effect for “Xanax 2mg” offered by www.onlinerxmedz.com. FDA-approved alprazolam (XANAX®) is indicated for the acute treatment of generalized anxiety disorder and panic disorder with or without agoraphobia.FDA-approved alprazolam is only available pursuant to a prescription from a licensed practitioner. Furthermore, this drug product bears a boxed warning, addressing risks including abuse, misuse, addiction, and physical dependence. In addition, the concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death.An example of unapproved Schedule II stimulant you offer for sale on www.onlinerxmedz.com is amphetamine (MAS) (dextroamphetamine sulfate, dextroamphetamine saccharate, amphetamine sulfate and amphetamine aspartate tablets) marketed as “Adderall 30mg”. Evidence obtained from your website establishing that this product is a drug intended for human use (as defined in 21 CFR 201.128) includes the claim “Adderall is a prescription medication used to treat Attention Deficit Hyperactivity Disorder (ADHD) and Narcolepsy, a condition that causes excessive daytime sleepiness.” While there are FDA-approved versions of amphetamine (MAS) on the market in the U.S., there are no approved drug applications pursuant to section 505 of the FD&C Act in effect for “Adderall 30mg” offered by www.onlinerxmedz.com. FDA-approved amphetamine (MAS) (ADDERALL®) is indicated for the treatment of attention deficit hyperactivity disorder (ADHD) and narcolepsy. Using the brand name of the drug product ADDERALL indicates that this product is intended to treat ADHD and narcolepsy.FDA-approved amphetamine (MAS) is only available pursuant to a prescription from a licensed practitioner. Furthermore, this drug product bears a boxed warning, addressing risks including abuse, misuse, and addiction. In addition, this drug product can be diverted for non-medical use into illicit channels or distribution. Misuse and abuse of CNS stimulants, including this drug product, can result in overdose and death, and this risk is increased with higher doses or unapproved methods of administration.Misbranded Drugs:A drug is misbranded under section 502(f)(1) of the FD&C Act [21 U.S.C. § 352(f)(1)] if its labeling fails to bear adequate directions for use. “Adequate directions for use” means directions under which a layperson can use a drug safely and for the purposes for which it is intended (see 21 CFR 201.5). Prescription drugs, as defined in section 503(b)(1) of the FD&C Act [21 U.S.C. § 353(b)(1)] include those that, because of their toxicity or other potentiality for harmful effect, and/or the method of their use, and/or the collateral measures necessary for their use, are not safe for use except under supervision of a practitioner licensed by law to administer them. Prescription drugs, as defined in section 503(b)(1)(A) of the FD&C Act [21 U.S.C. § 353(b)(1)(A)], can be used safely only at the direction, and under the supervision, of a licensed practitioner.Because the aforementioned drugs are prescription drugs intended for conditions that are not amenable to self-diagnosis and treatment by a layperson, adequate directions cannot be written such that a layperson can use the products safely for their intended use. Consequently, the labeling for these drug products fail to bear adequate directions for use, causing them to be misbranded under section 502(f)(1) of the FD&C Act [21 U.S.C. § 352(f)(1)]. In addition, because these drugs are not approved in the U.S., they are also not exempt under 21 CFR 201.115(a) from the requirements of section 502(f)(1) of the FD&C Act [21 U.S.C. § 352(f)(1)]. By offering these drugs for sale to U.S. consumers, www.onlinerxmedz.com is causing the introduction of misbranded drugs into interstate commerce in violation of section 301(a) of the FD&C Act [21 U.S.C. § 331(a)].Furthermore, under U.S. law, prescription drugs can be dispensed only pursuant to a prescription from a healthcare practitioner licensed by law to administer prescription drugs. By offering the aforementioned drug products without requiring a prescription, www.onlinerxmedz.com jeopardizes patient safety and misbrands the drug products under section 503(b)(1) of the FD&C Act [21 U.S.C. § 353(b)(1)]. Dispensing a prescription drug without a prescription is an act which results in the drug being misbranded while held for sale, in violation of section 301(k) of the FD&C Act [21 U.S.C. § 331(k)].FDA is sending this warning letter to www.onlinerxmedz.com because of the inherent risks to consumers who purchase misbranded and unapproved new drugs. This letter is not intended to identify all the ways in which your products or operations might be in violation of the law. It is your responsibility to ensure that all products you offer for sale are in compliance with the FD&C Act and its implementing regulations. You should take prompt action to address any violations of the FD&C Act (which may include the offer for sale of similarly misbranded and/or unapproved new drugs other than the drug products noted above). We advise you to review your websites, product labels, and other labeling and promotional materials to ensure that you are not misleadingly representing your products as safe and effective for a use for which they have not been approved by FDA and that you are not distributing misbranded and unapproved drug products in violation of the FD&C Act.Please notify this office in writing within 15 working days describing the specific steps you have taken to address any violations and to prevent their recurrence. Include an explanation of each step being taken to remedy and prevent the recurrence of any violations, as well as copies of related documentation. Failure to adequately address this matter may result in legal action, including, without limitation, seizure, and injunction, without further notice. If you cannot complete corrective action within 15 working days, state the reason for the delay and the time within which you will complete the corrections. This letter notifies you of our concerns and provides you with an opportunity to address them. If you believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration within 15 working days.If you are not located in the U.S., please note that products that appear to be misbranded or unapproved new drugs may be detained or refused admission. We may advise the appropriate regulatory officials in the country from which you operate that your products referenced above appear to be unapproved and misbranded products that cannot be legally sold to consumers in the U.S.Please direct your response and any inquiries to FDA at FDAInternetPharmacyTaskForce-CDER@fda.hhs.gov.Sincerely,/S/Sangeeta Vaswani Chatterjee, Pharm.D.DirectorOffice of Drug Security, Integrity, and ResponseOffice of ComplianceCenter for Drug Evaluation and Research

经徐州、苏州市市场监管局调查，发现执业药师李攀等人注册单位和实际工作单位不符，存在“挂证”行为，现已依照规定注销其执业药师注册证。省局按规定将其“挂证”不良信用信息录入全国执业药师注册管理信息系统“奖惩记录”栏，现予公告：序号执业药师资格证号受处罚原因注册证号注册单位1李攀ZY00381001存在“挂证”行为321225031588logout江苏振远同康医药连锁有限公司凌城五店2张金华20231002634000000568存在“挂证”行为321225031538logout江苏振远同康医药连锁有限公司凌城店3丁志芬02620241055000000005存在“挂证”行为322225032195logout江苏振远同康医药连锁有限公司李集祥瑞店4惠杰ZY00351475存在“挂证”行为323225032278logout江苏振远同康医药连锁有限公司邱集二店5闫丽ZY00390853存在“挂证”行为ZY00390853常熟市民康药房江苏省药品监督管理局2026年4月13日

柯惠医疗器材国际贸易（上海）有限公司报告，柯惠识别到三个批号的微导管产品存在器械推进/导航至目标病变过程中可能出现阻力，以及与外层涂层相关的缺陷风险。截至2026年3月25日，柯惠已收到针对上述三个批号相关的32起投诉。目前，柯惠尚未收到任何因该问题导致患者伤害的报告。柯惠医疗器材国际贸易（上海）有限公司对其生产的微导管（注册证号：国械注进20173037171）主动召回。召回级别为二级。涉及产品的型号、规格及批次等详细信息见《医疗器械召回事件报告表》。附件：医疗器械召回事件报告表2026年04月13日

附件：安徽省药品生产监督检查信息通告（2026年3月）

依据《国家药监局农业农村部国家林草局国家中医药局关于发布的公告》（2022年第22号）和《国家药监局综合司关于印发〈中药材生产质量管理规范〉监督实施示范建设方案的通知》（药监综药管函〔2023〕313号）有关要求，我局组织对浙江天皇药业有限公司、浙江培元堂中药饮片有限公司、宁波市中药饮片有限公司、浙江中医药大学中药饮片有限公司相关中药产品的中药材种植基地开展了《中药材生产质量管理规范》（中药材GAP）延伸检查，经综合评定符合中药材GAP要求。现予以公告。附件：浙江省中药材GAP延伸检查结果信息表浙江省药品监督管理局2026年4月13日 附件浙江省中药材GAP延伸检查结果信息表序号中药生产企业名称中药材品种中药材生产企业名称基地地址基 地面 积检 查结 果1浙江天皇药业有限公司铁皮石斛天台县中药药物研究所浙江省台州市天台县坦头镇西方洋村（地理坐标：N29°7′3.31″,E121°6′26.33″）；浙江省台州市天台县街头镇后洋村（地理坐标：N29°7′23.49″,E120°47′59.53″）；浙江省台州市天台县街头镇叶宅村（地理坐标：N29°6′37.78″,E120°47′19.45″）；浙江省台州市天台县街头镇明堂村（地理坐标：N29°1′19.09″,E120°50′34.54″）；浙江省台州市天台县平桥镇山头庞村（地理坐标：N29°8′46.48″，E120°54′36.11″）；浙江省台州市天台县赤城街道田洋陈村（地理坐标：N29°8′41.42″,E121°3′52.12″）；浙江省台州市天台县始丰街道济公大道1098号（地理坐标：N29°10′32.30″,E120°59′1.70″）4035亩符合要求2浙江培元堂中药饮片有限公司延胡索浙江大成药业有限公司浙江省台州市仙居县白塔镇前塘村（地理坐标：地块1:N28°43'14.57",E120°38′05.91";地块2：N28°42'17.09",E120°38'08 .22"）;浙江省台州市仙居县白塔镇上邵村（地理坐标:地块1：N28°43'47.33",E120°37'55.78";地块2：N28°43'51.05",E120°38'14.50"）233亩符合要求3宁波市中药饮片有限公司浙贝母宁波小贝农农业科技有限公司浙江省宁波市海曙区章水镇章溪村（地理坐标：N29°47′36.25″,E121°19′24.08″）171亩符合要求4浙江中医药大学中药饮片有限公司枳壳（代代花）浙江中医药大学中药饮片有限公司浙江省衢州市江山市张村乡秀峰村（地理坐标：N28°33′41.04″,E118°39′59.42″）100亩符合要求

江西康堡堂中药饮片有限公司：根据江西康堡堂中药饮片有限公司申请，我局依据《中华人民共和国药品管理法》《药品生产监督管理办法》有关规定，经现场检查和综合评定，认为本次检查符合《药品生产质量管理规范（2010年修订）》及相关附录的要求。检查具体信息如下：企业名称生产地址检查范围检查日期检查结论江西康堡堂中药饮片有限公司江西省宜春市樟树市中医药产业园创新大道8号中药饮片（净制、切制、炮炙（炒制、炙制、制炭、煅制、蒸制、煮制、炖制）、其他（燀制）；含毒性饮片：净制、切制、炮炙（煮制））2026年3月4日-3月6日本次检查符合药品GMP要求。 江西省药品监督管理局2026年4月10日