Delivery Method:VIA ELECTRONIC MAIL READ/DELIVERY RECEIPT REQUESTEDProduct:DrugsOver-the-Counter DrugsRecipient:RoyceDerm LLC1309 Coffeen Avenue, Ste 3000 , WYSheridan, WY 82801United States service@roycederm.comIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesOctober 1, 2026255 Primera Blvd, Ste 160Lake Mary, FL 32746WARNING LETTERReference Number: 734781To RoyceDerm LLC:This warning letter advises you of significant violations observed during a U.S. Food and Drug Administration (FDA) review of your website, https://roycederm.com/, and provides you an opportunity to address them. Promptly address any violations described herein without delay, including ensuring that appropriate resources are allocated to fully address them and prevent their recurrence. This is not intended to be an all-inclusive list of the violations that may exist in connection with your products or operations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations. Failure to adequately address any violations may result in regulatory or legal action without further notice including, without limitation, seizure and injunction.As discussed below, the “Herpes Relief Cream” product on your website is an unapproved new drug. Unapproved drug products marketed for the treatment of sexually transmitted infections (STIs) and/or their symptoms and sold directly to consumers present a serious public health concern. Individuals who rely on these products may forgo timely, appropriate medical care, increasing their risk of severe complications such as infertility, sepsis, and death. Further, a false sense of having been adequately treated may lead individuals to unknowingly transmit infections to their partners. FDA has not approved any over-the-counter (OTC) drug product for the treatment, cure, mitigation, or prevention of any STI. Effective treatment requires diagnosis and supervision by a licensed healthcare professional.FDA ReviewViolations were identified and documented during a review of your website https://roycederm.com/ in July 2026. Based on our review, “Herpes Relief Cream” is an unapproved new drug 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 this product 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).This review was conducted as part of FDA’s public health responsibility to protect the public from unsafe, ineffective, and poor-quality drugs.Violations of the Federal Food, Drug, and Cosmetic ActThe following are violations identified during our review. As a reminder, this is not an all-inclusive list of violations that may exist in connection with your products or operations.Unapproved New Drug ViolationsBased on a review of your website, “Herpes Relief Cream” is a drug under section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1), because it is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease, and/or intended to affect the structure or any function of the body. Examples from your product labeling, including on your website, that provide evidence of the intended use (as defined in 21 CFR 201.128) of this product as a drug include, but may not be limited to, the following:In the name of the product – “Herpes Relief Cream”On the product label:“RoyceDerm Herpes Relief Cream is specially formulated to help relieve the symptoms of Herpes, rashes or blisters, redness & pain.”“HELPS RELIEVE THE SYMPTOMS OF RASHES OR BLISTERS, ITCHY, REDNESS, AND PAIN.o Fights outbreakso Soothes & coolso Reduces recurrence”On the webpage https://roycederm.com/products/herpe-treatment-cream-herpe-treatment-for-women-natural-herpe-treatment-genital-gentle-cream-for-herpe-sufferers-genital-herpe-symptoms:“NATURAL GENTLE RELIEF CREAM FOR HERPES SUFFERERS” along with images of what appear to be a man and woman with their hands over their genital region and “before” and “after” images of what appears to be herpes lesions on the skin and no visible herpes lesions on the skin, respectively.“Herpes Relief Cream” is a “new drug” under 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. 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 approved applications pursuant to section 505 of the FD&C Act, 21 U.S.C. 355, are in effect for this product. Accordingly, this product is an unapproved new drug. 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).ConclusionAs previously stated, you are responsible for investigating and determining the root causes of any violations and implementing corrective and preventative measures to ensure future and sustained compliance so that these violations and any others do not occur.Send your written response to FDAAdvisory@fda.hhs.gov within fifteen (15) business days of receipt of this letter. Include the specific steps you have taken to correct any violations, an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you have information that you believe demonstrates that your products are not in violation of the FD&C Act and FDA regulations, include that information for our consideration. Identify your response with reference number “734781” in the subject line of the email.Please note FDA posts warning letters on www.fda.gov.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 Administrationcc:Everymarket Inc.2101 E Terra LnO’Fallon MO 63366cs@everymarket.com

Delivery Method:VIA ELECTRONIC MAIL READ/DELIVERY RECEIPT REQUESTEDProduct:DrugsRecipient:Alfonse J. Muto PharmDOwnerPine Pharmaceuticals, LLC355 Riverwalk ParkwayTonawanda, NY 14150-5837United StatesIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesWARNING LETTERWL # 728537August 7, 2026Dear Dr. Muto:You registered your facility with the U.S. Food and Drug Administration (FDA) as an outsourcing facility under section 503B of the Federal Food, Drug, and Cosmetic Act (FDCA) [21 U.S.C. § 353b]1 on March 9, 2018, and most recently on November 19, 2025. From November 4, 2025, to November 14, 2025, FDA investigators inspected your facility, Pine Pharmaceuticals, LLC located at 355 Riverwalk Parkway, Tonawanda, NY 14150. During the inspection, the investigators collected evidence indicating serious deficiencies in your practices for producing drug products which put patients at risk.FDA issued a Form FDA 483 to your facility on November 14, 2025. We reviewed your December 8, 2025, response to our Form FDA 483 in detail and acknowledge receipt of your subsequent correspondence. Based on this inspection, it appears you produced drugs that violate the FDCA.A. Compounded Drug Products under the FDCAUnder section 503B(b) of the FDCA, a compounder can register as an outsourcing facility with FDA. Drug products compounded by or under the direct supervision of a licensed pharmacist in an outsourcing facility qualify for exemptions from the drug approval requirements in section 505 of the FDCA [21 U.S.C. § 355(a)], the requirement in section 502(f)(1) of the FDCA [21 U.S.C. § 352(f)(1)] that labeling bear adequate directions for use and the Drug Supply Chain Security Act requirements in section 582 of the FDCA [21 U.S.C. § 360eee-1] if the conditions in section 503B of the FDCA are met.An outsourcing facility, which is defined in section 503B(d)(4) of the FDCA [21 U.S.C. § 353b(d)(4)], is a facility at one geographic location or address that — (i) is engaged in the compounding of sterile drugs; (ii) has elected to register as an outsourcing facility; and (iii) complies with all of the requirements of this section. Outsourcing facilities must comply with other applicable provisions of the FDCA, including section 501(a)(2)(B) [21 U.S.C. § 351(a)(2)(B)], regarding current good manufacturing practice (CGMP), and section 501(a)(2)(A) [21 U.S.C. § 351(a)(2)(A)], regarding insanitary conditions. Generally, CGMP requirements for the preparation of drug products are established in Title 21 of the Code of Federal Regulations (CFR) parts 210 and 211.B. Violations of the FDCAAdulterated Drug ProductsFDA investigators collected evidence indicating that drug products intended or expected to be sterile were prepared, packed, or held under insanitary conditions, whereby they may have become contaminated with filth or rendered injurious to health, causing your drug products to be adulterated under section 501(a)(2)(A) of the FDCA. For example, the investigators collected evidence indicating that:1. Your firm did not disinfect materials during transfer from the ISO 7 cleanroom into the ISO 5 hood. Specifically, operators failed to sanitize materials, equipment, and hands prior to introducing them into the ISO 5 critical area during the production of drug products intended to be sterile. Furthermore, an operator rested their sleeved arms on ergonomic support bars attached to the ISO 5 hood (located in the ISO 7 background area) and subsequently extended their sleeved arms into the ISO 5 critical area without first sanitizing their sleeves.2. Your environmental monitoring program lacks adequate routine environmental monitoring that captures data representative of aseptic production conditions. Specifically, your firm does not perform routine environmental monitoring of high-touch staging trays ((b)(4)) that are manually handled by gloved operators to stage materials, including final container closures for drug products intended to be sterile, prior to placement into the ISO 5 classified area. These trays have a difficult-to-clean (b)(4) design.FDA investigators also collected evidence indicating CGMP violations at your facility, that caused your drug products to be adulterated within the meaning of section 501(a)(2)(B) of the FDCA. The violations include, for example:1. Your firm failed to 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].2. Your firm failed to establish and follow appropriate written procedures that are designed to prevent microbiological contamination of drug products purporting to be sterile, and that include validation of all aseptic and sterilization processes [21 CFR 211.113(b)].3. Your firm failed to ensure that each person engaged in the manufacture, processing, packing, or holding of a drug product has the education, training, and experience, or any combination thereof, to enable that person to perform his or her assigned functions [21 CFR 211.25(a)].4. Your firm failed to determine actual yield and percentages of theoretical yield at the conclusion of each appropriate phase of manufacturing, processing, packaging, or holding of the drug product [21 CFR 211.103]. Specifically, in addition to the deficiencies noted in the visual inspection reject rate calculations, our review of the data collected during the inspection revealed that the acceptable yield range established in your batch records permits yields as low as (b)(4), allowing up to (b)(4) of a batch to be rejected without triggering an investigation, yet the batch can still be released for distribution. Furthermore, although (b)(4) meets the definition of particulate matter as “mobile undissolved particles, other than air bubbles, unintentionally present in solutions” in SOP-061 (Visual Inspection Finished Product, Rev. 23), it was classified as a “minor” defect in ISSUE-2025-0011, without scientific justification or a clear procedural basis in SOP-061. By classifying (b)(4) as a minor defect rather than as particulate matter, (b)(4) rejects are counted only as part of the minor reject rate limit, bypassing both the major defect category trigger and the separate particulate category trigger entirely. Additionally, certain “cosmetic” defects are allowed to be returned to the batch, despite SOP-061 containing no definition, criteria, or examples of what constitutes a “cosmetic” defect, nor does it specify which cosmetic defect may be returned to the batch and which must be rejected.5. Your firm failed to establish 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)].Outsourcing facilities must comply with CGMP requirements under section 501(a)(2)(B) of the FDCA. FDA’s regulations regarding CGMP requirements for the preparation of drug products have been established in 21 CFR parts 210 and 211. FDA intends to promulgate more specific CGMP regulations for outsourcing facilities. FDA has issued a revised draft guidance, Current Good Manufacturing Practice — Guidance for Human Drug Compounding Outsourcing Facilities under Section 503B of the FD&C Act. This draft guidance, when finalized, will describe FDA’s expectations regarding outsourcing facilities and the CGMP requirements in 21 CFR parts 210 and 211 until more specific CGMP regulations for outsourcing facilities are promulgated.Under section 301(a) of the FDCA [21 U.S.C. § 331(a)], the introduction or delivery for introduction into interstate commerce of any drug that is adulterated is a prohibited act. Further, it is a prohibited act under section 301(k) of the FDCA [21 U.S.C. § 331(k)] to do any act with respect to a drug, if such act is done while the drug is held for sale after shipment in interstate commerce and results in the drug being adulterated.C. Corrective ActionsWe have reviewed your firm’s responses to the Form FDA 483. We are unable to fully evaluate some of your corrective actions due to lack of adequate supporting documentation:1. Your response states that you implemented post-production surface sampling of (b)(4) per FID 131 batch (PLANDEV-2025-0021) and plan to transition to (b)(4) trays by the end of Q2 2026. While these actions are intended to address the observed deficiency, we are unable to determine their adequacy due to insufficient supporting documentation and scientific justification. You did not provide data demonstrating the effectiveness of (b)(4) for cleaning the current trays (particularly the difficult-to-clean (b)(4)), a risk-based rationale for sampling only (b)(4) when (b)(4) bins are used per lot, justification for the chosen sampling site, confirmation that tray sampling will be permanently incorporated into routine procedure MWA-041, a validation protocol for the planned (b)(4) trays, or a defined plan to verify the effectiveness of the interim tray sampling program.Some of your corrective actions appear deficient:1. Your response fails to address the specific deficiencies in the cited investigations and non-conformances. For the particulate complaint (COMP-2025-0005), your firm did not determine root cause for the confirmed cellulose particles or translucent fibers found in the returned vials or the retain sample, reconcile the particulate finding in the retain sample with the multiple particulates observed in the returned vials, or implement corrective actions for the visual inspection failure that allowed particulates to reach distributed product. You classified cellulose as an “intrinsic” particle without scientific justification, despite potential sources (e.g., cleaning wipes) indicating extrinsic contamination. Your response does not clearly commit to identifying and characterizing all observed particulates (including fibers and residues) in future investigations, nor does it define when such identification is required. Additionally, although you revised POL-030 (Product Complaint Handling) and implemented a training checkpoint, you did not provide evidence that the training was completed and did not establish a defined effectiveness verification plan for these corrective actions.For the batches released despite exceeding critical defect limits, your responses rely on retrospective risk assessments, passing targeted/second 100% reinspection and (b)(4) AQL without thorough root-cause investigations or (b)(4) process corrections for recurring defects (e.g., dislodged caps, partially crimped seals, particulates). These risk assessments are outcome-based, focusing primarily on the absence of complaints or adverse events rather than evaluating the adequacy of your production and inspection controls. Furthermore, lot disposition for batches exceeding the (b)(4) critical reject rate was contingent on the outcome of a pending risk analysis (ISSUE-2025-0008) rather than on a completed investigation and upstream correction, indicating that risk assessment is being used as a substitute for corrective action rather than a complement to it. You also provided no scientific justification for limiting reinspections to preselected defect types rather than conducting a comprehensive 100% visual inspection across all potential defects, and you provided no evidence that CAPA-2025-0017 has been completed. This pattern of relying on reinspection and risk review to achieve passing results, without addressing underlying process failures, fails to demonstrate that the root causes of these defects have been identified, addressed, or controlled.2. Your response concludes that the observed aseptic technique failures were isolated to one operator and posed no product impact, with the risk declared low based primarily on passing environmental monitoring and sterility test results. However, your own batch review data (Tables 1 and 2 in ISSUE-2025-0006) demonstrates a widespread pattern of non-adherence by that operator across (b)(4) reviewed batches, with (b)(4) disinfection adherence to SOP-299 at only 11% and (b)(4) disinfection adherence at 0%.Reliance on passing environmental monitoring and sterility test results does not adequately address the significant risk created by these repeated failures to follow basic aseptic techniques, including inadequate sanitization of materials and equipment transferred from the ISO 7 area into the ISO 5 hood during production of drug products intended to be sterile. This approach is scientifically insufficient because microbial contamination does not spread uniformly, and limited environmental monitoring and finished product sterility testing cannot reliably detect low-probability contamination events from consistent (b)(4) and (b)(4) lapses. Furthermore, your claim that the process is “closed” is not supported, as aseptic operations occur in ISO 5 hoods with routine interventions, making operator technique a primary sterility assurance control.Although you stated that similar deficiencies do not exist with other operators, you provided no supporting documentation (e.g., audit reports, video reviews, or Manufacturing Quality Assurance (MQA) records) to support this claim. You also did not provide the operator removal record (AI-2025-0524), the revised SOPs under CAPA-2025-0015, or a defined effectiveness verification plan. The repeated nature of these deviations by the same operator, going undetected and uncorrected over an extended period, raises serious concerns about the effectiveness of your routine oversight, training reinforcement, and overall quality system controls.The failures to sanitize or change gloves and sleeves after contact with non-sterile ISO 7 surfaces, and the failure to sanitize materials and equipment transferred from ISO 7 into the ISO 5 area, are not minor risks. They constitute insanitary conditions which can lead to contamination of products intended to be sterile and serious adverse events. Your response also fails to explain why these deviations went undetected for so long and does not address the specific hand sanitization deficiencies noted in the observation, including incomplete coverage of the backs of the hands and interdigital spaces and failure to meet the required (b)(4) duration as per your SOP-299 (Cleanroom Behavior and Aseptic Technique Procedure, Rev. 04). This is a repeat deficiency from the FDA inspections conducted in May 2021, September 2023, and September 2024.3. Your response states that you conducted a historical review of qualification records and provided additional training for visual inspectors. However, you failed to manage the significant change to SOP-155, Training and Qualification of Qualified Visual Inspectors for Compounded Products, Rev. 09 (which introduced immediate failure of a visual inspector for missing any critical defect) through formal change control or a timely requalification plan for previously qualified inspectors that did not meet the new standard. You did not perform a root-cause analysis for why inspectors continued performing critical visual inspections for approximately three months after the SOP revision without meeting the new standard. Although you dispute the specific example with visual inspector (b)(6), (b)(7), you provided no documentation reconciling the answer key discrepancy or addressing the violation of performing (b)(4) qualification assessments in (b)(4). You also submitted no evidence that all impacted inspectors have been removed from relevant tasks or successfully requalified under the revised criteria. In addition, you have not committed to managing future significant changes to qualification procedures through formal change control. CAPA-2025-0014 remains pending with no supporting documentation.4. Your response states that you reviewed (b)(4) batches and implemented PLANDEV-2025-0027 to include all rejected units (confirmed and unconfirmed) in reject rate calculations. Although you identified six batches that would have exceeded thresholds when using actual reject rates, you did not demonstrate that formal investigations were opened for these batches. In addition, the permanent updates to SOP-061 (Visual Inspection Finished Product, Rev. 23) and the electronic batch record remain incomplete, with no firm completion dates or effectiveness verification plan. You also did not address the specific Diltiazem HCl lot 83709 example discussed during the inspection close-out. This is a repeat deficiency from the FDA inspection conducted in September 2024.5. Your response acknowledges the lack of validated mixing and (b)(4) parameters but treats full process validation (CAPA-2025-0013) as conditional, only to be prioritized if future potency variability or out of specification (OOS) events occur. You provided no root-cause analysis explaining why critical process parameters remained undefined and operator-dependent for an extended period despite a prior OOS investigation. You also submitted no supporting documentation for PLANDEV-2025-0028, no revised master production records or executed batch record examples showing the new parameters, and no completion date or detailed validation plan for CAPA-2025-0013.In addition to the issues discussed above, you should note that CGMP requires the implementation of quality oversight and controls over the manufacture of drugs, including the safety of raw materials, materials used in drug manufacturing, and finished drug products. See section 501 of the FDCA. If you choose to contract with a laboratory to perform some functions required by CGMP, it is essential that you select a qualified contractor and that you maintain sufficient oversight of the contractor’s operations to ensure that it is fully CGMP compliant.Regardless of whether you rely on a contract facility, you are responsible for assuring that drugs you produce are neither adulterated nor misbranded. [See 21 CFR 210.1(b), 21 CFR 200.10(b).]FDA strongly recommends that your management undertake a comprehensive assessment of operations, including facility design, procedures, personnel, processes, maintenance, materials, and systems. In particular, this review should assess your aseptic processing operations. A third-party consultant with relevant sterile drug manufacturing expertise should assist you in conducting this comprehensive evaluation.D. ConclusionThe violations cited in this letter are not intended to be an all-inclusive statement of violations at your facility. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations.You should take prompt action to address any violations. Failure to adequately address any violations may result in legal action without further notice, including, without limitation, seizure and injunction.Within fifteen (15) working days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to address any violations. Please include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. This letter notifies you of our concerns and provides you an opportunity to address them. If you believe your products are not in violation of the FDCA, include your reasoning and any supporting information for our consideration. If you cannot completely address this matter within fifteen (15) working days, state the reason for the delay and the time within which you will do so.All correspondence should refer to the Warning Letter Number above (# 728537) and include a subject line that clearly identifies the submission as a Response to Warning Letter. If you have questions regarding the contents of this letter, please contact compoundinginspections@fda.hhs.gov.Sincerely,/S/Matthew J. LashActing DirectorOffice of Compounding Quality and ComplianceOffice of ComplianceCenter for Drug Evaluation and Research_________________1 See Pub. L. No. 113-54, § 102(a), 127 Stat. 587, 587-588 (2013).

Delivery Method:VIA ELECTRONIC MAIL READ/DELIVERY RECEIPT REQUESTEDReference #:320-26-122Product:DrugsOver-the-Counter DrugsRecipient:Vincent LinChief Executive OfficerTCI Co., Ltd BioCosme PABP BRANCH8F, No. 187, Gangqian Rd.Neihu District, Taipei City 11494Taiwan vincent@tci-bio.comIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesSeptember 2, 2026WARNING LETTERReference number: 320-26-122To Vincent Lin:This warning letter advises you of significant violations identified during a U.S. Food and Drug Administration (FDA) inspection of your facility. Promptly address the violations described herein without delay, including ensuring that appropriate resources are allocated to fully address the violations and prevent their recurrence. This is not intended to be an all-inclusive list of the violations that exist at your facility. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations. Failure to adequately address violations may result in regulatory action without further notice.FDA InspectionViolations were identified and documented during an inspection of your drug manufacturing facility, TCI Co., Ltd. - BioCosme PABP BRANCH, FDA Establishment Identifier (FEI) 3014217121, at No. 21 Nongke Rd., Changzhi Township, Pingtung County, Taiwan, from March 9 to March 13, 2026. This inspection was conducted under FDA’s statutory authority and public health responsibilities to protect the public from unsafe, ineffective, and poor quality drugs.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 you tested are adulterated within the meaning of section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 351(a)(2)(B).We reviewed your April 2, 2026, response to our Form FDA 483 in detail. 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.Violations of the Federal Food, Drug, and Cosmetic ActThe following are violations identified during our review. As a reminder, this is not an all-inclusive list of violations at your facility.1. Your firm failed to have, for each batch of drug product, appropriate laboratory determination of satisfactory conformance to final specifications for the drug product, including the identity and strength of each active ingredient, prior to release (21 CFR 211.165(a)).Your firm failed to adequately test your OTC drug products prior to release and distribution to the U.S. market. For example, your firm did not perform assay testing of the API as part of finished product release testing of your (b)(4) product (b)(4) batches (b)(4). These batches were released and distributed to the U.S. market without appropriate testing.Without adequate testing, you do not have adequate scientific evidence to assure that drug product batches conform to appropriate specifications before release.In your response you state you will confirm the definitions of raw material and product specification standards with your customer and explicitly verify whether the assay test is included.Your response is inadequate. Your firm’s quality system does not ensure that all required tests are identified, documented, and performed before product is released to your customers. You do not have a written procedure or a quality agreement describing the roles and responsibilities between you, as the contract manufacturing organization, and your customer regarding testing requirements and established product specifications.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/downloads/drugs/guidances/ucm353925.pdf.In response to this letter, provide the following:A comprehensive quality agreement describing the responsibilities of each party regarding drug products testing and release, establishing drug product specifications, initiating investigations, and batch disposition. The quality agreement should define the manufacturing responsibilities and communication processes for quality related activities.A list of chemical and microbial test methods and specifications used to analyze each lot of your drug product before making a lot disposition decisions.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 manufactured over-the-counter (OTC) drug products without adequate identity testing of incoming active pharmaceutical ingredients (APIs) and raw materials including, but not limited to, (b)(4) before use in your OTC drug products. Additionally, you relied on your suppliers’ certificates of analysis (COA) for these components without verifying your suppliers’ test results at appropriate intervals.Your firm failed to ensure components met United States Pharmacopeia (USP) monograph identity requirements and were suitable for use in manufacturing your (b)(4) drug products. For example:You did not perform all identity testing on components you used to manufacture (b)(4), batches (b)(4), including (b)(4).You did not perform all identity testing on components you used to manufacture (b)(4), batch (b)(4), including (b)(4).You failed to test incoming lots of (b)(4) used in the manufacturing of the drug products intended for the US market for (b)(4) and (b)(4) in each shipment of each lot of (b)(4) before determining acceptability for use.The identity testing of (b)(4) includes a limit test per the USP monograph to ensure it 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), to help you meet CGMP requirements when manufacturing drugs containing ingredients at high-risk for (b)(4) contamination.Your quality control laboratory failed to perform all identity testing of (b)(4) per USP monograph requirements. Additionally, your Ingredients and Raw Material Standard Guidelines do not require these raw materials be tested for identity.Our investigator documented that you do not test your components in conformance with the USP monograph. For example, your supplier’s COA for (b)(4) lacks Identification Test A, Impurities - Lead test, Iron and Other Heavy Metals test, Alkalinity test, and Carbonate and Color of Solution test. In addition, for (b)(4) the supplier COA lacks Identification Test A, Residue on Ignition test, Limit of Lead test, and Limit of Organic Impurities test; for (b)(4) the supplier’s COA lacks Identification Test A, Composition of Fatty Acid test, Residue on Ignition test, and Limit of (b)(4) test.You failed to provide records indicating that you established the reliability of your supplier’s analyses through appropriate validation of the supplier’s test results. Although 21 CFR 211.84(d)(2) provides for some reliance on a COA from the supplier of the component, such reliance is permissible only if the drug product manufacturer establishes the reliability of the supplier’s test results through appropriate validation of the test results at appropriate intervals.In your response you state, your laboratory has not performed identification testing for certain raw materials due to the lack of appropriate instrumentation. Further, you state for certain raw materials, you did not perform identity testing because the USP methods do not specify such tests. It is your responsibility to ensure that the appropriate USP monographs are used for the testing of all ingredients used in the manufacture of your drug products.We acknowledge that you commit to outsourcing testing for certain raw materials for which USP does not specify an identity testing method. 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 adequately sample, test, and examine drug components before use in production to assure quality.In response to this letter, provide the following:Identify additional appropriate corrective actions and preventive actions (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.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 qualification as well as periodic requalification.3. Your firm failed to establish adequate written procedures for production and process controls designed to assure that the drug products have the identity, strength, purity, and quality that they are purported or represented to possess (21 CFR 211.100(a)).Inadequate Process Validation for DrugsYour firm did not adequately validate the manufacturing processes you used to manufacture your (b)(4) drug products to demonstrate that your processes are reproducible and controlled to consistently yield drugs of uniform character and quality.Your Process Validation for Cosmetic Products document indicates that you use it to validate your manufacturing process for your OTC (b)(4)mL bottle. During the inspection, your firm confirmed that this process validation is intended to support the manufacture of (b)(4). However, our investigator confirmed that the (b)(4) is not manufactured in accordance with the validated process. For example, the process validation includes a (b)(4) step that is absent from the (b)(4) batch record.Furthermore, you failed to conduct process validation for your (b)(4). Your firm confirmed during the inspection that your firm relies on the process validation performed for (b)(4) to support the manufacturing of (b)(4). However, the manufacturing processes for these products differ.We acknowledge your commitment to perform process validation for all your products moving forward. It remains your responsibility to maintain all supporting documentation, including your defined critical manufacturing process parameters.Process validation evaluates the soundness of design and state of control of a process throughout its lifecycle. Each significant stage of a manufacturing process must be designed appropriately to ensure the quality of raw material inputs, in-process materials, and finished drugs.Your validation program should identify sources of process variability and assure that manufacturing operations meet appropriate parameters and quality standards. This includes, but is not limited to, evaluating suitability of equipment for its intended use, ensuring quality of input materials, determining the capability and reliability of each manufacturing process step with ongoing monitoring of process performance and product quality.Inadequate Validation of (b)(4)You used (b)(4) as a component to manufacture multiple batches of OTC (b)(4) drug products and distributed these batches to the U.S. market. However, your firm failed to adequately qualify your (b)(4) to ensure it produces (b)(4) that meets appropriate chemical and microbial attributes and meets the (b)(4) monograph. Specifically, your (b)(4) qualification protocol and report lacked total organic carbon (TOC) testing, conductivity, or microbial content to ensure the (b)(4) is fit for its intended use. Additionally, you use this (b)(4) for cleaning drug manufacturing equipment.(b)(4) is an ingredient in your drug products. (b)(4) must be suitable for its intended use and routinely tested to ensure ongoing conformance with appropriate chemical and microbiological attributes.In your response, you state you increased microbial sampling frequency to (b)(4), revised the (b)(4) facility inspection record form to include TOC for routine monitoring, and established a trend analysis mechanism.Your response is inadequate because it fails to include the current action and alert limits for total counts and objectionable microorganisms used for your (b)(4). Without defined limits, increased sampling frequency alone does not constitute a robust monitoring mechanism.See FDA's guidance for industry, Process Validation: General Principles and Practices at https://www.fda.gov/downloads/drugs/guidances/ucm070336.pdf for general principles and approaches that FDA considers appropriate elements of process validation.In response to this letter, provide the following: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 vigilant monitoring of both intra-batch and inter-batch variation to ensure a continuing state of control. Also, describe your equipment and facility qualification program.A procedure for your (b)(4) monitoring that specifies routine microbial testing of (b)(4) 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). Ensure that the total count limits for your (b)(4) are appropriately stringent in view of the intended use of each of the drug products produced by your firm.A procedure governing your program for ongoing control, maintenance, and monitoring that ensures the remediated system consistently produces (b)(4) that meets (b)(4) specifications and appropriate microbial limits.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 quality unit (QU) lacked adequate control over your OTC drug product manufacturing operations and failed to ensure that you had adequate procedures. Your firm made changes to your manufacturing process parameters in the batch manufacturing instructions without following your Procedure for Change Management and Operational Procedures for Handling of Abnormal Situations. For example:During the manufacture of your product (b)(4), batch (b)(4), you changed your (b)(4) without documented justification.During the manufacture of your product (b)(4), batches (b)(4), you changed a (b)(4) without documented justification.Your response states that a retrospective investigation revealed that your research and development team made on-site adjustments to process parameters without following the established change procedure. In your response you commit to following the required change procedure.Your response is inadequate because your retrospective review did not include a comprehensive assessment of other possible incidents of the change procedure not being followed.Additionally, the following are examples of poor QU oversight:The batch production and control records are deficient in that they do not include documentation of the accomplishment of each significant step in manufacturing. 21 CFR 211.188(b)There is no written testing program designed to assess the stability characteristics of drug products. 21 CFR 211.166(a)An adequate QU overseeing all manufacturing operations is necessary to consistently ensure drug quality. See FDA’s guidance document Quality Systems Approach to Pharmaceutical CGMP Regulations at https://www.fda.gov/downloads/drugs/guidances/ucm353925.pdf for help implementing quality systems and risk management approaches to meet the requirements of CGMP regulations 21 CFR parts 210 and 211. In response to this letter, provide the following:A copy of your revised SOP, Operational Procedures for Handling of Abnormal SituationsA 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 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 products.Procedures to ensure if your manufacturing process parameters change your quality approves before all commercial manufacturing.Training records to confirm that all relevant personnel, including research and development staff have been trained in the change management requirements.Drug Production SuspendedDuring the inspection you communicated your decision to allow your drug registration with the FDA to expire. Your firm stated that you will renew the drug registration if a U.S. (b)(4) order is received.If you plan to resume any manufacturing operations regulated under the FD&C Act, notify this office before 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 actions and preventive actions 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.In your notification to the Agency, provide a summary of your remediations to demonstrate that you have appropriately completed all corrective action and preventive action (CAPA).ConclusionAs previously stated, you are responsible for investigating and determining the root causes of any violations and implementing corrective and preventative measures to ensure future and sustained compliance so that these violations and any others do not occur.Failure to address any violations may also result in the FDA refusing admission of articles manufactured at TCI Co., Ltd. - BioCosme PABP BRANCH, located at No. 21 Nongke Rd., Changzhi Township, Pingtung County, Taiwan, 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).Send your written response to CDER-OC-OMQ-Communications@fda.hhs.gov within fifteen (15) business days of receipt of this letter. Identify your written response with FEI 3014217121 and ATTN: Compliance officer Sneha Patel in the subject line of the email.If you have information that you believe demonstrates that your products are not in violation of the FD&C Act and FDA regulations, include that information for our consideration.Please note FDA posts warning letters on www.FDA.gov.Sincerely,/S/Francis GodwinDirectorOffice of Manufacturing QualityOffice of ComplianceCenter for Drug Evaluation and ResearchU.S. Food and Drug Administrationcc: regulatory.usa@tci-bio.com

Delivery Method:VIA Electronic MailProduct:Medical DevicesRecipient:Shui WongCEOO.N. Diagnostics, LLC1936 University Ave, Ste 280Berkley, CA 94704United States (b)(6), (b)(7)(C)Issuing Office:Center for Devices and Radiological HealthUnited StatesWARNING LETTERCMS 7303019/1/2026Dear Ms. Wong,During an inspection of your firm located in Berkley, CA, from March 12-17, 2026, investigators from the United States Food and Drug Administration (FDA) determined that your firm manufactures (or markets) the VirtuOst and VirtuOst Vertebral Fracture Assessment (VFA) software products. Under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 321(h), these products are devices because they are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body. The VirtuOst and VirtuOst VFA software products are device software functions because they analyze medical images for use in the diagnosis of existing vertebral fractures and the management of osteoporosis. As such, your firm has responsibility for maintaining full compliance with all applicable pre- and post-market requirements associated with these device software functions.Unapproved Device Violation(s)Our inspection revealed that the VirtuOst VFA 3.0.0 is adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B), because your firm does not have an approved application for premarket approval (PMA) in effect pursuant to section 515(a) of the Act, 21 U.S.C. § 360e(a), or an approved application for an investigational device exemption (IDE) under section 520(g) of the Act, 21 U.S.C. § 360j(g) for the device as described and marketed. The VirtuOst VFA 3.0.0 is also misbranded under section 502(o) of the Act, 21 U.S.C. § 352(o), because your firm introduced or delivered for introduction into interstate commerce for commercial distribution this device with changes or modifications in the device that could significantly affect the safety or effectiveness of the device without submitting a new premarket notification to FDA as required by section 510(k) of the Act, 21 U.S.C. § 360(k), and 21 CFR 807.81(a)(3)(i).Specifically, the VirtuOst VFA was cleared under K171435 with the following indications: VirtuOst VFA uses sagittal sections from a spine-containing CT scan, with or without contrast enhancement, to visualize and measure vertebral deformities, classify the type and grade of any existing vertebral fracture, and from this identify patients at high risk of a future osteoporosis-related fracture. This information can be interpreted by a physician to diagnose existing vertebral fractures and to manage patients for osteoporosis.A review of the Software Version Control Log and “3.0.0 Release Notes” dated June 11, 2024, shows that a new machine learning algorithm was introduced for vertebral landmarking. A new model trained on different data, with different architecture, or optimized for a different objective may perform differently across patient populations, imaging equipment types, or clinical settings. This new feature fundamentally changes how the device performs, fails, and affects patients in ways that go beyond what was originally cleared and therefore the feature must be adequately validated. Inadequate validation of this new feature may lead to a device that is unable to perform clinically as expected, which may result in patient harm such as missed or inadequate diagnosis, absence or delay of results, leading to missing, inaccurate, or delayed patient assessment. It can also lead to incorrect patient management due to misinterpretation of device output or overreliance on device output for radiological image interpretation. Thus, a new premarket notification is required.Additionally, the VirtuOst VFA 3.0.0 version involves two other changes that each independently raise significant regulatory concerns. First, the device has migrated from a desktop application to a web-based architecture, which introduces network-exposed attack surfaces, authentication vulnerabilities, and other cybersecurity risks inherent to internet-accessible platforms. As your firm acknowledged during the inspection, the change from a desktop application to a web-based architecture expanded the “cyberattack surface area.” Second, the technology platform has been migrated from (b)(4) to (b)(4) only, which necessitates comprehensive re-verification and re-validation of the entire software codebase, including changes to third-party libraries and dependencies. FDA has not reviewed your device's Software Bill of Materials (SBOM) or documentation of third-party components affected by this migration.Each of these changes could significantly affect the safety or effectiveness of the device by introducing new software and cybersecurity risks. Furthermore, these changes require a new premarket notification pursuant to 21 CFR 807.81(a)(3)(i).For a device requiring premarket approval, the notification required by section 510(k) of the Act, 21 U.S.C. § 360(k), is deemed satisfied when a PMA is pending before the agency. 21 CFR 807.81(b). The kind of information that your firm needs to submit in order to obtain approval or clearance for the device is described on the Internet at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/default.htm. The FDA will evaluate the information that your firm submits and decide whether the product may be legally marketed.Our office requests that O.N. Diagnostics cease any activities that result in the misbranding or adulteration of the VirtuOst VFA 3.0.0, such as the commercial distribution of the device for the uses discussed above.Quality Management System Regulation Violation(s)This inspection also revealed that these devices are adulterated within the meaning of section 501(h) of the Act, 21 U.S.C. § 351(h), in that the methods used in, or the facilities or controls used for, their manufacture, packing, storage, or installation are not in conformity with the current good manufacturing practice requirements of the Quality Management System Regulation found at Title 21, Code of Federal Regulations (CFR), Part 820. We received a response from Dr. Kopperdahl, Director of Research and Development, dated April 1, 2026, concerning our investigator’s observations noted on the Form FDA 483 (FDA 483), List of Inspectional Observations, that was issued to your firm. We address this response below, in relation to each of the noted violations. These violations include, but are not limited to, the following:1. Failure to document procedures for corrective actions and take action to eliminate the cause of nonconformities in order to prevent recurrence, as required by ISO 13485:2016, Clause 8.5.2.Review of your CAPA procedure, DOC: SOP-017, and related records found:A. Failure to take necessary corrective actions without undue delay. For example:i. Within CAPA-0080, procedural updates from four other CAPA records identified as necessary to eliminate the cause of nonconformities and prevent their recurrence were not made for over a year and a half.ii. Additionally, your organization was made aware of the underlying issue related to the need to update your (b)(4) software three times over three years. Although CAPA-0088 was opened the day before our inspection began to address this three yearlong software issue, it was unsigned (even to demonstrate opening a new record) and no corrective actions had been identified or initiated within the record.B. Failure to clearly define the requirements to evaluate the need for action to ensure that nonconformities do not recur. For example:i. Your procedure allows use of a (b)(4) ticket instead of a corrective action when there are “Individual and sporadic instances of issues that need correction do not require a CAPA”. This is one reason for some of the untimely corrective actions discussed in item A above. The procedure needs to more clearly define when a (b)(4) ticket may be used vs. opening a CAPA to ensure corrective action is taken appropriately.ii. Your organization has changed the requirements used to evaluate the need for action / determine when a corrective action is necessary. CAPA-0083 included a corrective action to update to your CAPA procedure. Your findings stated the language governing when a CAPA should be opened was too broad and did not include the potential for process based CAPAs to be opened. The language targeted for update stated, “In general, a CAPA investigation will be initiated for any quality problem that is a non-conformance with respect to medical device requirements that has an associated safety hazard.”Therefore, in revision 11 released 10/2/2024, your organization implemented a change to “narrow the CAPA triggers and place more emphasis on systemic or recurring issues”. This update also included allowance to document other issues as a (b)(4) ticket, as previously mentioned above. These changes altered the threshold of when to open a CAPA from a safety hazard focus to systemic issues and allowed more flexibility to handle “individual and sporadic instances” through the (b)(4) system. In doing so, it appears your procedure now lacks clarity for when it is necessary to open a corrective action, based on risk.Additionally, the impact of these changes was not evaluated prior to implementation. To maintain the integrity of the QMS, all changes must be evaluated to determine their potential impact on it. This evaluation must be conducted before implementing the change.C. Failure to require documentation of verification of effectiveness following corrective action implementation.The procedure allows closure after “A failure investigation has been completed, a corrective action has been defined and implemented, and the effectiveness of the implemented action has been evaluated.”Within CAPA-0080, the record includes verification of implementation, but not of effectiveness. There is no developed plan to determine how to verify effectiveness or a place to do so within the form, only a yes / no checkbox.We reviewed your firm’s response regarding items 1A and C above and conclude that it is not adequate. We understand your intent is to update the CAPA procedure to “strengthen requirements for effectiveness verification, including predefined acceptance criteria and sufficient prospective evidence, to ensure nonconformities do not recur”, as well as train staff, conduct a retrospective review to include performing additional analysis where necessary, and document findings. You anticipate an overall timeline of 90 days to complete all these steps (early August 2026). The CAPA documenting these actions will be closed when 100% of CAPAs over a six-month period and at least three CAPAs have demonstrated correct implementation of the revised procedure. This overall approach seems reasonable, however your response is inadequate because the requirement of ensuring necessary corrective actions are taken without undue delay has not been addressed to complete necessary procedural updates, and no records were provided for evidence of implementation of corrective actions.Your response related to item 1B states you intend to require documented risk assessments prior to implementation as part of change control procedures, establish criteria for when a change is ‘critical’ or ALARP, create a new form for this assessment following ISO 14971, train staff, perform a retrospective review of QMS changes over the last six months and act on those that meet new criteria, and summarize findings. You estimate all these actions to take about 90 days (early August 2026) and state this CAPA will be closed if no recurrence over a six-month period defined as failure to identify critical process changes or perform risk assessments of those changes. The adequacy of your response to item 1B cannot be determined as no records were provided for evidence of implementation of corrective actions.2. Failure to adequately document procedures to ensure that purchased product conforms to specified purchasing information and plan the monitoring and re-evaluation of suppliers, as required by 21 CFR 820, ISO 13485: 2016 Clause 7.4.1.For example: the procedural requirements in your organization’s Purchasing Controls procedure, rev 11, concerning how your firm will re-evaluate and conduct monitoring and trending of suppliers / vendors is vague. Specifically, none of these give details of when action should be taken. For example, the procedure mentions re-evaluation frequency will be every (b)(4) which maybe increased based on the criticality, but gives no specific criteria or examples of when this should occur. Regarding monitoring the procedure, it discusses “periodic progress reports and incremental deliverables” but doesn’t explain when they should be run or how those will be assessed. The extent of monitoring should be commensurate with the risk of the device, or impact on the device or QMS. The procedure also mentions trending of vendor performance but contains no limits or criteria stating when action might be necessary.This was discussed during your recent inspection, but as it was not cited in the 483, your response did not address this violation.Medical Device Reporting (MDR) Violation(s)Our inspection (also) revealed that your firm has failed to adequately develop, maintain, and implement written MDR procedures as required by 21 CFR 803.17.For example, during the inspection, your organization presented the document titled “Complaint Management Procedure”, SOP-014, Revision 15, dated January 15, 2026, as its guidance for MDR reporting. Specifically, the purpose and scope of the procedure highlights that the SOP is intended to address the requirements of 21 CFR 803. However, after reviewing the procedure, the following deficiencies were noted:1. Your procedure does not establish internal systems that provide for timely and effective identification, communication, and evaluation of events that may be subject to MDR requirements, as required by 21 CFR 803.17(a)(1).a. Your procedure does not include adequate definitions of what constitutes a reportable event under 21 CFR Part 803. The fact that the procedure does not include definitions from 21 CFR 803.3 for the terms “become aware” and “caused or contributed”, and the definition described in 21 CFR 803.20(c)(1) for the term “reasonably suggests”, may lead your firm to make an incorrect reportability decision when evaluating a complaint that may meet the criteria for reporting under 21 CFR 803.50(a).b. Your procedure’s definition of “serious injury” is not consistent with 21 CFR 803.3(w) and will not allow you to correctly identify complaints as reportable events.Specifically, DC03055, MDR Reportability Review Memorandum 4 the regulatory definition includes both injury and illness, whereas the procedure limits the definition to injury only.2. Your procedure does not establish internal systems that provide for timely transmission of complete medical device reports, as required by 21 CFR 803.17(a)(3). Specifically, the procedure does not include:a. Instructions for submitting information that corresponds generally to the format of Form FDA 3500A, including how you will ensure that all information reasonably known to you is submitted for each event. Specifically, which types of information corresponding generally to the format of Form 3500A will need to be submitted, including the information in your firm’s possession when the initial report is filed and any required information later obtained that was not available when the initial report is filed.b. Instructions for complying with the 21 CFR 803.12(a) requirement to submit reports to FDA in an electronic format that the FDA can process, review, and archive.3. Your organization’s MDR event files do not contain all documentation of its deliberations and decision-making processes used to determine if a device-related death, serious injury, or malfunction was or was not reportable under 21 CFR Part 803, as required under 21 CFR 803.18(b)(1)(i). Specifically, although Sections 2.2 and 2.3 of the procedure describe documentation requirements, your firm’s ONG-FRM-007 Event Report reviewed for Event 0047 did not demonstrate implementation of these requirements for reportability determination.A device is deemed to be misbranded under section 501(t)(2) of the Act, 21 U.S.C. § 352(t)(2), if there was a failure or refusal to furnish any material or information respecting a device required by or under section 519 of the Act, 21 U.S.C. § 360i, including adverse event reports required under CFR Part 803.Your firm’s response dated April 1, 2026, does not address the procedural deficiencies, given that such deficiencies were not cited on the FDA 483.We also note your organization’s SOP-014 procedure includes references to baseline reports in Section 4.4. Baseline reports are no longer required, and we recommend that all references to a Baseline Report be removed from your firm’s MDR procedure; see: 73 Federal Register Notice 53686, dated September 17, 2008.Additionally, we recommend your organization establish an active Electronic Submission Gateway Next Generation (ESG NextGen) production account for the electronic submission of MDR reports. FDA verified that, as of April 24, 2026, your firm does not have such an account. Information about the ESG NextGen can be found at: Electronic Submissions Gateway Next Generation (ESG NextGen) | FDA.Your firm should take prompt action to address any violations identified in this letter. Failure to adequately address this matter may result in regulatory action being initiated by the FDA without further notice. These actions include, but are not limited to, seizure, injunction, and civil money penalties.Other federal agencies may take your compliance with the Act and its implementing regulations into account when considering the award of federal contracts. Additionally, should FDA determine that you have Quality Management System Regulation violations that are reasonably related to premarket approval applications for Class III devices, such devices will not be approved until the violations have been addressed. Should FDA determine that your devices or facilities do not meet the requirements of the Act, requests for Certificates to Foreign Governments (CFG) may not be granted.Please notify this office in writing within fifteen business days from the date you receive this letter of the specific steps your firm has taken to address the noted violations, as well as an explanation of how your firm plans to prevent these violations, or similar violations, from occurring again. Include documentation of the corrections and/or corrective actions (which must address systemic problems) that your firm has taken. If your firm’s planned corrections and/or corrective actions will occur over time, please include a timetable for implementation of those activities. If corrections and/or corrective actions cannot be completed within fifteen business days, state the reason for the delay and the time within which these activities will be completed. Your firm’s response should be comprehensive and address any violations included in this Warning Letter. If you believe that your products are not in violation of the Act, include your reasoning and any supporting information for our consideration as part of your response.Your firm’s response should be sent via email to Jeff Wooley at CDRHEnforcement@fda.hhs.gov. Please include in the subject line, “CMS Case 730301” when replying. If you have any questions about the contents of this letter, please contact: Lauren Priest at Lauren.Priest@fda.hhs.gov.Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your firm’s facility. It is your firm’s responsibility to ensure compliance with applicable laws and regulations administered by FDA. The specific violations noted in this letter and in the Inspectional Observations, FDA 483, issued at the close of the inspection may be symptomatic of serious problems in your firm’s manufacturing and quality management systems. Your firm should investigate and determine the causes of any violations and take prompt actions to address any violations and bring the products into compliance.Sincerely,/S/Barbara C. MarsdenDirectorOffice of Regulatory ProgramsOffice of Product Evaluation and QualityCenter for Devices and Radiological Health

Delivery Method:VIA ELECTRONIC MAIL READ/DELIVERY RECEIPT REQUESTEDProduct:DrugsOver-the-Counter DrugsRecipient:John FurnerPresident and CEOWalmart, Inc.702 SW 8th StreetBentonville, AR 72716-6299United States HWSCSAFETY@wal-mart.comIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesOctober 1, 2026WARNING LETTERReference Number: 736557To John Furner:This warning letter advises you of significant violations observed during a U.S. Food and Drug Administration (FDA) review of drug products that were purchased on your website, www.walmart.com, and provides you an opportunity to address them. Promptly address any violations described herein without delay, including ensuring that appropriate resources are allocated to fully address them and prevent their recurrence. This is not intended to be an all-inclusive list of the violations that may exist in connection with your products or operations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations. Failure to adequately address any violations may result in regulatory or legal action without further notice including, without limitation, seizure and injunction.As discussed below, the “HClear for him,” “Herstat GST,” and “Terragen HG Formula” products available for purchase on your website are unapproved new drugs. Unapproved drug products marketed for the treatment of sexually transmitted infections (STIs) and/or their symptoms and sold directly to consumers present a serious public health concern. Individuals who rely on these products may forgo timely, appropriate medical care, increasing their risk of severe complications such as infertility, sepsis, and death. Further, a false sense of having been adequately treated may lead individuals to unknowingly transmit infections to their partners. FDA has not approved any over-the-counter (OTC) drug product for the treatment, cure, mitigation, or prevention of any STI. Effective treatment requires diagnosis and supervision by a licensed healthcare professional.FDA ReviewViolations were identified and documented during review of the product labeling of products purchased on your website www.walmart.com in July 2026. FDA purchased, “HClear for him,” “Herstat GST,” and “Terragen HG Formula” through your website, and these products were introduced or delivered for introduction into interstate commerce by Walmart via your Walmart Fulfillment Services.1 Based on our review, “HClear for him,” “Herstat GST,” and “Terragen HG Formula” 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).This review was conducted as part of FDA’s public health responsibility to protect the public from unsafe, ineffective, and poor-quality drugs.Violations of the Federal Food, Drug, and Cosmetic ActThe following are violations identified during our review. As a reminder, this is not an all-inclusive list of violations that may exist in connection with your products or operations.Unapproved New Drug ViolationsBased on a review of your website, “HClear for him,” “Herstat GST,”2 and “Terragen HG Formula” 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 observed on the product labeling 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:HClear for him“GENITAL HERPES SYMPTOMS”“>90 of USERS REPORTED LESS SEVERE OUTBREAKS”“FAST-ACTING OUTBREAK SYMPTOM RELIEF ITCHING, TINGLING, PAIN & BURNING”“[I]ntended to relieve symptoms associated with diagnosed genital herpes, including itching, burning and/or pain.”“[B]est used at first sign of outbreak. Early use ensures the best results.”Herstat GST“Genital Sore Treatment”“Soothes and calms genital sores”“[R]elieves pain and itching associated with genital sores.”Terragen HG Formula“Uses . . . relief of swelling and pain associated with genital sores.”“HClear for him,” “Herstat GST,” and “Terragen HG Formula” 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 conditions prescribed, recommended, or suggested in their 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 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 the “Terragen HG Formula” product available for purchase on your website is labeled as a homeopathic drug 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.3ConclusionAs previously stated, you are responsible for investigating and determining the root causes of any violations and implementing corrective and preventative measures to ensure future and sustained compliance so that these violations and any others do not occur.Send your written response to FDAAdvisory@fda.hhs.gov within fifteen (15) business days of receipt of this letter. Include the specific steps you have taken to correct any violations, an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you have information that you believe demonstrates that your products are not in violation of the FD&C Act and FDA regulations, include that information for our consideration. Identify your response with reference number “760337” in the subject line of the email.Please note FDA posts warning letters on www.fda.gov.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______________________1 Walmart distributed each of the products directly to individual U.S. consumers on behalf of third parties. Each of the products discussed below were “fulfilled” by Walmart; your website states, “Walmart Fulfillment Services (WFS) allows Marketplace sellers to leverage Walmart’s end-to-end logistics services, from imports to storage to 2-day fulfillment[] and beyond. When a customer places an order on Walmart.com, we’ll pick, pack and ship the item to the customer on the seller’s behalf. WFS also handles all customer support and returns for these orders.” (See https://marketplacelearn.walmart.com/guides/Walmart%20Fulfillment%20Services%20(WFS)/WFS%20basics/walmart-fulfillment-services-wfs-overview).2 The permitted indications under OTC Monograph M017: External Analgesic Drug Products for OTC Human Use (M017) are for the treatment of pain, itching, and minor skin irritation generally and for the prevention of premature ejaculation. The “Herstat GST” product available for purchase on your website is intended to provide relief from genital sores and their associated symptoms, which goes beyond the permissible indications under M017. “Herstat GST” therefore does not conform to M017 or any other final OTC administrative order. Accordingly, there is no basis under section 505G of the FD&C Act under which “Herstat GST” could be legally marketed without an approved application. (see https://www.accessdata.fda.gov/drugsatfdadocs/omuf/monographs/OTC%20MonographM017-External%20Analgesic%20Drug%20Products%20for%20OTC%20Human%20Use%2005.02.2023.pdf).3 We recognize that the “HClear for him” product available for purchase on your website is also labeled as being “homeopathic.” FDA issued a guidance in December 2022 that describes how the Agency intends to prioritize enforcement and regulatory actions for certain categories of homeopathic drug products that potentially pose a higher risk to public health. (See Homeopathic Drug Products: Guidance for FDA Staff and Industry, available at https://www.fda.gov/media/163755/download). For purposes of this guidance, FDA defines a “homeopathic drug product” as “a drug product that is labeled as ‘homeopathic,’ and is labeled as containing only active ingredients and dilutions (e.g., 10X, 20X) listed for those active ingredients in the Homeopathic Pharmacopeia of the United States (HPUS).” “Hclear for him” does not meet the definition of a “homeopathic drug product” because it includes “lemongrass 2X HPUS,” which is not listed in the HPUS as an active ingredient. Therefore, this product falls outside the scope of products addressed in this guidance.Notwithstanding, even if the above listed product is considered a “homeopathic drug product" under this guidance, this product would fall under the guidance’s category of homeopathic drug products marketed without the required FDA approval that FDA views as potentially posing higher risks to public health and thus intends to prioritize for enforcement and regulatory actions.

Delivery Method:VIA ELECTRONIC MAIL READ/DELIVERY RECEIPT REQUESTEDProduct:DrugsRecipient:Online Generic Medicine/www.onlinegenericmedicine.comUnited StatesIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesSeptember 23, 2026info@onlinegenericmedicine.comWARNING LETTERReference Number: MARCS-CMS 737806To Online Generic Medicine:This warning letter advises you of significant violations identified during a U.S. Food and Drug Administration (FDA) review of your website www.onlinegenericmedicine.com. Promptly address the violations described herein without delay, including ensuring that appropriate resources are allocated to fully address the violations and prevent their recurrence. This is not intended to be an all-inclusive list of the violations that may exist in connection with your products or operations. It is your responsibility to ensure that you comply with all requirements of federal law, including FDA regulations. Failure to adequately address violations may result in regulatory or legal action without further notice including, without limitation, seizure and injunction.As discussed below, FDA has observed that www.onlinegenericmedicine.com introduces into interstate commerce unapproved and misbranded injectable semaglutide drug products. There are inherent risks to consumers who purchase unapproved and misbranded drug products. 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. Furthermore, injectable drug products can pose a serious risk of harm to users because they bypass many of the body's natural defenses against toxic ingredients, toxins, or dangerous organisms that can lead to serious and life-threatening conditions such as septicemia or sepsis.Accordingly, FDA requests that www.onlinegenericmedicine.com cease offering any unapproved and misbranded drugs for sale to U.S. consumers. This is critical to shielding the American public from harm.FDA ReviewViolations were identified and documented during a review of your website www.onlinegenericmedicine.com, FDA Establishment Identifier (FEI) 3048678145, on August 26, 2026, and September 2, 2026.Violations of the Federal Food, Drug, and Cosmetic ActOn your website at internet address www.onlinegenericmedicine.com, you introduce 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)).The following are violations identified during our review. As a reminder, this is not an all-inclusive list of violations that may exist in connection with your products or operations.Unapproved New Drug ViolationsCertain products offered for sale by www.onlinegenericmedicine.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.You failed to obtain approved applications pursuant to section 505 of the FD&C Act (21 U.S.C. 355) for these products that you have introduced into interstate commerce. Accordingly, their introduction or delivery for introduction into interstate commerce violates sections 301(d) and 505(a) of the FD&C Act.An example of an unapproved semaglutide drug product you offer for sale on www.onlinegenericmedicine.com is semaglutide marketed as "Semanat Injection (Semaglutide)." Evidence obtained from your website establishing that this product is a drug intended for human use (as defined in 21 Code of Federal Regulations (CFR) 201.128) includes the claim "Semanat Injection, [sic] is a potent glucagon-like peptide-1 (GLP-1) receptor agonist wich [sic] is designed to help manage blood sugar levels in type 2 diabetes and support weight management."While there are FDA-approved versions of semaglutide drug products on the market in the United States, there are no approved drug applications pursuant to section 505 of the FD&C Act in effect for "Semanat Injection (Semaglutide)” offered by www.onlinegenericmedicine.com. Currently there are several semaglutide products FDA-approved for the U.S. market, and these products are only available pursuant to a prescription from a licensed practitioner.FDA-approved semaglutide injection marketed under the brand name OZEMPIC is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus; to reduce the risk of major adverse cardiovascular (CV) events in adults with type 2 diabetes mellitus and established CV disease; and to reduce the risk of sustained eGFR decline, end-stage kidney disease, and CV death in adults with type 2 diabetes mellitus and chronic kidney disease.FDA-approved semaglutide injection marketed under the brand name WEGOVY is indicated as an adjunct to a reduced calorie diet and increased physical activity to reduce the risk of major adverse CV events in adults with established CV disease and either obesity or overweight, to reduce excess body weight and maintain weight reduction long term in certain adult and pediatric patients, and for the treatment of noncirrhotic metabolic dysfunction-associated steatohepatitis with moderate to advanced liver fibrosis in adults.Furthermore, FDA-approved semaglutide products bear a boxed warning, commonly referred to as a “black box warning,” which is the strongest warning FDA requires, indicating that the drug carries a significant risk of serious or even life-threatening adverse effects. The boxed warning addresses the risk of thyroid C-cell tumors.Misbranded Drug ViolationsA drug is misbranded under section 502(f)(1) of the FD&C Act 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 include those that, because of their toxicity or other potentiality for harmful effect, or the method of their use, 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.You failed to bear adequate directions for use on the labeling for this drug product that you have introduced into interstate commerce. Because the aforementioned drug is a prescription drug 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 product safely for their intended use. Consequently, the labeling for this drug product fails to bear adequate directions for use, causing it to be misbranded under section 502(f)(1) of the FD&C Act. Because this drug is not approved in the United States, it is also not exempt under 21 CFR 201.115(a) from the requirements of section 502(f)(1) of the FD&C Act. By offering this drug for sale to U.S. consumers, www.onlinegenericmedicine.com is causing the introduction of misbranded drugs into interstate commerce in violation of section 301(a) of the FD&C Act.Furthermore, under U.S. law, prescription drugs can be dispensed only pursuant to a prescription from a health care practitioner licensed by law to administer prescription drugs. By offering the aforementioned drug product without requiring a prescription, www.onlinegenericmedicine.com jeopardizes patient safety and misbrands the drug product under section 503(b)(1) of the FD&C Act. Dispensing a prescription drug without a prescription is an act which results in the drug being misbranded while held for sale, in violation of section 301(k) of the FD&C Act.ConclusionAs previously stated, you are responsible for investigating and determining the root causes of any violations and implementing corrective and preventative measures to ensure future and sustained compliance so that these violations and any others do not occur.Send your written response to FDAInternetPharmacyTaskForce-CDER@fda.hhs.gov within 15 business days of receipt of this letter. Include the specific steps you have taken to correct any violations, an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. Identify your written response with reference number “MARCS-CMS 737806” in the subject line of the email.If you have information that you believe demonstrates that your products are not in violation of the FD&C Act and FDA regulations, include that information for our consideration.If you are not located in the United States, 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 United States.Please note FDA posts warning letters on www.fda.gov.Sincerely,/S/Sangeeta Vaswani Chatterjee, PharmDDirectorOffice of Drug Security, Integrity, and ResponseOffice of ComplianceCenter for Drug Evaluation and ResearchU.S. Food and Drug Administration

Delivery Method:VIA ELECTRONIC MAIL READ/DELIVERY RECEIPT REQUESTEDProduct:DrugsRecipient:Cheap Medicine Shop/www.cheapmedicineshop.comIndia ana@cheapmedicineshop.comIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesSeptember 24, 2026WARNING LETTERReference Number: MARCS-CMS 737810To Cheap Medicine shop:This warning letter advises you of significant violations identified during a U.S. Food and Drug Administration (FDA) review of your website www.cheapmedicineshop.com. Promptly address the violations described herein without delay, including ensuring that appropriate resources are allocated to fully address the violations and prevent their recurrence. This is not intended to be an all-inclusive list of the violations that may exist in connection with your products or operations. It is your responsibility to ensure that you comply with all requirements of federal law, including FDA regulations. Failure to adequately address violations may result in regulatory or legal action without further notice including, without limitation, seizure and injunction.As discussed below, FDA has observed that www.cheapmedicineshop.com introduces into interstate commerce unapproved and misbranded injectable semaglutide drug products. There are inherent risks to consumers who purchase unapproved and misbranded drug products. 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. Furthermore, injectable drug products can pose a serious risk of harm to users because they bypass many of the body's natural defenses against toxic ingredients, toxins, or dangerous organisms that can lead to serious and life-threatening conditions such as septicemia or sepsis.Accordingly, FDA requests that www.cheapmedicineshop.com cease offering any unapproved and misbranded drugs for sale to U.S. consumers. This is critical to shielding the American public from harm.FDA ReviewViolations were identified and documented during a review of your website www.cheapmedicineshop.com, FDA Establishment Identifier (FEI) 3041109073, on August 26, 2026, and September 2, 2026.Violations of the Federal Food, Drug, and Cosmetic ActOn your website at internet address www.cheapmedicineshop.com, you introduce into interstate commerce misbranded and unapproved new drugs in violation of sections 301(a), 301(d), 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), 352(f)(1), 353(b)(1), and 355(a)).The following are violations identified during our review. As a reminder, this is not an all-inclusive list of violations that may exist in connection with your products or operations.Unapproved New Drug ViolationsCertain products offered for sale by www.cheapmedicineshop.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.You failed to obtain approved applications pursuant to section 505 of the FD&C Act (21 U.S.C. 355) for these products that you have introduced into interstate commerce. Accordingly, their introduction or delivery for introduction into interstate commerce violates sections 301(d) and 505(a) of the FD&C Act.An example of an unapproved semaglutide drug product you offer for sale on www.cheapmedicineshop.com is semaglutide marketed as "Semanext Injection." Evidence obtained from your website establishing that this product is a drug intended for human use (as defined in 21 Code of Federal Regulations (CFR) 201.128) includes the claim "Semanext Injection is a weekly injectable medicine used for controlling blood sugar in adults. It also supports weight loss and obesity management in individuals with weight-related health conditions."While there are FDA-approved versions of semaglutide drug products on the market in the United States, there are no approved drug applications pursuant to section 505 of the FD&C Act in effect for "Semanext Injection” offered by www.cheapmedicineshop.com. Currently there are several semaglutide products FDA-approved for the U.S. market, and these products are only available pursuant to a prescription from a licensed practitioner.FDA-approved semaglutide injection marketed under the brand name OZEMPIC is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus; to reduce the risk of major adverse cardiovascular (CV) events in adults with type 2 diabetes mellitus and established CV disease; and to reduce the risk of sustained eGFR decline, end-stage kidney disease, and CV death in adults with type 2 diabetes mellitus and chronic kidney disease.FDA-approved semaglutide injection marketed under the brand name WEGOVY is indicated as an adjunct to a reduced calorie diet and increased physical activity to reduce the risk of major adverse CV events in adults with established CV disease and either obesity or overweight, to reduce excess body weight and maintain weight reduction long term in certain adult and pediatric patients, and for the treatment of noncirrhotic metabolic dysfunction-associated steatohepatitis with moderate to advanced liver fibrosis in adults.Furthermore, FDA-approved semaglutide products bear a boxed warning, commonly referred to as a “black box warning,” which is the strongest warning FDA requires, indicating that the drug carries a significant risk of serious or even life-threatening adverse effects. The boxed warning addresses the risk of thyroid C-cell tumors.Misbranded Drug ViolationsA drug is misbranded under section 502(f)(1) of the FD&C Act 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 include those that, because of their toxicity or other potentiality for harmful effect, or the method of their use, 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.You failed to bear adequate directions for use on the labeling for this drug product that you have introduced into interstate commerce. Because the aforementioned drug is a prescription drug 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 product safely for their intended use. Consequently, the labeling for this drug product fails to bear adequate directions for use, causing it to be misbranded under section 502(f)(1) of the FD&C Act. Because this drug is not approved in the United States, it is also not exempt under 21 CFR 201.115(a) from the requirements of section 502(f)(1) of the FD&C Act. By offering this drug for sale to U.S. consumers, www.cheapmedicineshop.com is causing the introduction of misbranded drugs into interstate commerce in violation of section 301(a) of the FD&C Act.ConclusionAs previously stated, you are responsible for investigating and determining the root causes of any violations and implementing corrective and preventative measures to ensure future and sustained compliance so that these violations and any others do not occur.Send your written response to FDAInternetPharmacyTaskForce-CDER@fda.hhs.gov within 15 business days of receipt of this letter. Include the specific steps you have taken to correct any violations, an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. Identify your written response with reference number “MARCS-CMS 737810” in the subject line of the email.If you have information that you believe demonstrates that your products are not in violation of the FD&C Act and FDA regulations, include that information for our consideration.If you are not located in the United States, 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 United States.Please note FDA posts warning letters on www.fda.gov.Sincerely,/S/Sangeeta Vaswani Chatterjee, PharmDDirectorOffice of Drug Security, Integrity, and ResponseOffice of ComplianceCenter for Drug Evaluation and ResearchU.S. Food and Drug Administration

为推动建立全国统一的长期护理服务管理标准，提升经办服务和协议管理规范化水平，助力长期护理保险经办高质量发展，国家医保局制定《长期护理保险服务管理文书（2026版）》。为规范文书使用，引导机构准确规范填写相关内容，我们组织对国家版文书进行系列解读。《长期护理服务月度汇总表》是定点长护服务机构按月汇总护理服务执行情况的制式文书，用于系统记录失能人员每月接受护理服务情况，形成可追溯的服务过程链。本表由定点长护服务机构根据汇总月的每日服务记录填写本表，与《长期护理保险护理服务计划表》《长期护理保险服务记录单》相互衔接，配套使用，是核对定点长护服务机构服务履约的资料。表格具体说明如下：《长期护理服务月度汇总表》主要分为三个部分：表头信息、服务项目登记栏、签字确认栏。表头信息用于登记服务机构、参保人与服务月份信息。服务项目登记栏按日期列示全部服务项目，每日服务完成后对应位置标记。签字确认栏由护理人员、护士签字确认。登记内容应以汇总当月服务记录单为依据，服务机构应如实填写，做到日清月结，不得事后补填、虚报服务项目。请您按如下操作：一、表头信息表头信息用于明确服务主体、服务对象与核算周期。机构名称应填写定点长护服务机构全称。参保人姓名、身份证号码、性别应据实填写。日期应填写汇总的对应年月。二、服务项目登记栏服务项目登记栏用于登记汇总当月每日的服务项目，纵向列明服务计划表内36项服务项目，横向数字对应汇总当月日期。护理执行者每天应按实际服务情况，在相应的服务项目栏内打“√”并签字，登记标记应当清晰可辨，不得随意涂改。不得登记并未实际提供的服务项目。三、签字确认栏签字确认栏用于确认当月汇总内容的真实性与完整性。每月汇总完成后，由护理人员或护士分别在对应位置签字确认。月度汇总表不得代签。无签字确认的记录单无效。《长期护理服务月度汇总表》作为服务管理台账，定点长护服务机构应按月整理归档本表，与每日服务记录单一并留存，确保服务全程可追溯。相关事宜可咨询参保地医保经办机构，或关注当地医保部门官方发布渠道。

为推动建立全国统一的长期护理服务管理标准，提升经办服务和协议管理规范化水平，助力长期护理保险经办高质量发展，国家医保局制定《长期护理保险服务管理文书（2026版）》。为规范文书使用，引导长期护理保险待遇享受人员准确规范填写相关内容，我们组织对国家版文书进行系列解读。《长期护理服务满意度评价表》是开展长期护理服务满意度调查的制式问卷，适用于居家、社区、机构三类照护场景，旨在调查长期护理保险待遇享受人员对长护服务的感受与评价，以便后续服务工作的开展与优化。本表由统筹地区医疗保障经办机构工作人员或其授权的人员负责实施，面向享受长护服务的参保人员或家属开展调查。表格具体说明如下：《长期护理保险服务满意度评价表》分为四个部分：基本信息、问卷内容、其他意见、签名栏。基本信息用于登记被评价服务机构、参保对象及评价基础信息。问卷内容设置10个问题，采用分级评分方式开展满意度调查。其他意见栏用于收集补充建议，签名栏用于签字确认。评价工作应当客观公正，充分尊重受访人员真实意愿，不得诱导、干扰评价结果。请您按如下操作：这一部分用于明确评价对象与受访人员相关信息。定点长护服务机构名称、参保人姓名、身份证号、联系方式、评价地点应据实填写。家属参与评价的，同步填写家属姓名及与参保人关系。请您按如下操作：这一部分为评价核心内容，共设置10个问题，涵盖总体印象、服务态度、服务及时性、服务满意度、服务规范性、服务管理安全性、政策宣传咨询、服务项目知晓度、服务效果、投诉响应十个方面。每项评价设置五级评分选项，对应不同分值，由受访人员根据实际感受在对应选项前的□内打“√”。对服务有不满意或十分不满意的，可在对应说明栏注明具体情况。最后根据每题所选选项标注的分值进行总分核算。填写提醒：受访人员根据实际感受自主评价，工作人员不得引导或干预。不满意说明应当客观具体，便于后续核实整改。请您按如下操作：受访人员有其他意见建议的，可在对应栏目补充填写。受访人员确认评价内容无误后，在签名栏签字并填写评价日期。《长期护理服务满意度评价表》是展开服务满意度调查的制式文书，是服务质量监管的重要工具。评价结果应当据实记录、规范归档，作为定点长护服务机构服务质量评价的重要依据，并与费用支付、协议续签等挂钩，引导相关机构规范服务行为。通过常态化满意度调查，提升服务质量，推动长护服务市场规范有序竞争，切实保障参保人员合法权益。相关事宜可咨询参保地医保经办机构，或关注当地医保部门官方发布渠道。

近日，国家药品监督管理局通过优先审评审批程序，附条件批准Bristol-Myers Squibb Pharma EEIG公司申报的1类创新药盐酸艾泊度胺胶囊（商品名称：赞赋）上市，该药联合达雷妥尤单抗和地塞米松适用于治疗既往接受过至少一线治疗（包括一种蛋白酶体抑制剂和一种免疫调节剂）的多发性骨髓瘤成人患者。该药品上市为患者提供了新的治疗选择。