Delivery Method:VIA UPSReference #:320-26-03Product:DrugsRecipient:Mr. Walter C. JohnsenCEOAcme United Corporation1 Waterview Drive Suite 200Shelton,CT06484United StatesIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesWarning Letter320-26-03October 10, 2025Dear Mr. Johnsen:The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, Acme United Corporation, FEI 3012129555, at 301 Marianne St., Shelton, CT, from March 18 to 28, 2025.This warning letter summarizes significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals. See Title 21 Code of Federal Regulations (CFR), parts 210 and 211 (21 CFR parts 210 and 211).Because your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your drug products are adulterated within the meaning of section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 351(a)(2)(B).We reviewed your April 18, 2025 response to our Form FDA 483 in detail and acknowledge receipt of your subsequent correspondence.During our inspection, our investigator observed specific violations including, but not limited to, the following.1. Your firm failed to use equipment in the manufacture, processing, packing, or holding of drug products that is of appropriate design, adequate size, and suitably located to facilitate operations for its intended use and for its cleaning and maintenance. Your firm also failed to 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 211.63 and 21 CFR 211.192).Your firm used(b)(4)water as a component to manufacture your topical over-the-counter (OTC) drug products, such as antiseptic wipes, labeled as sterile and non-sterile. You failed to adequately design and control your(b)(4)water system to ensure that it was suitable for producing water used in the formulation of your drug products. For example, you isolated the objectionable microorganismBurkholderia cepacia (B. cepacia)on numerous occasions within the holding tank and at the point of use. You regularly sanitized your water system after recoveringB. cepacia, yet you continued to recoverB. cepaciashortly after those repeated sanitization cycles. Microbiological monitoring of your system also yielded several “too numerous to count” results at multiple points in the system. These data indicated the presence of a recalcitrant biofilm. Furthermore, your firm failed to conduct timely and comprehensive investigations into these out-of-limit (OOL) microbiological results, including documenting root cause determinations and product impact assessment.We acknowledge you recently installed a new water system. We note that this system, based on discussions during our inspection, appears to be an on-demand system without continuous circulation.In your response, you state you do not believe your products pose a safety risk to consumers. For your non-sterile drug products, you indicate that there is a low potential impact to the end user because little to no microbial contamination was recovered from batch samples. You also indicate the active ingredient has an anti-microbial effect. Your response is inadequate. Antimicrobial formulations are not a substitute for adequate CGMP. Additionally, it is important to note that microbial contamination is not uniformly distributed, and samples may not be representative of the type or level of contamination that may exist within an entire system.Your new water system continues to have deficient elements that do not assure long-term system reliability and suitable water quality. The(b)(4)water system must be adequately designed and properly maintained to minimize the potential for contamination. For example, stagnant water from an on-demand, non-recirculating system can foster the development of biofilms.(b)(4)water must be suitable for its intended use and routinely tested to ensure ongoing conformance with appropriate chemical and microbiological attributes.In response to this letter, provide:A comprehensive assessment of your water system design, control, and maintenance. Regarding system control, for example, explain whether your firm is utilizing a recirculating water system and whether heat is an element of the system. In addition, state the duration, if any, that your water system is continuously circulating, and provide your rationale for any duration less than 24 hours.A thorough independent assessment to ensure you have installed and are operating a suitable water system, accompanied by a remediation plan to address any identified deficiencies. Also, include a robust ongoing control, maintenance, and monitoring program to ensure the new system consistently produces water adhering to(b)(4)Water, USP monograph specifications, and appropriate microbial limits.Regarding the latter, ensure that your total microbial count limits and objectionable microbiological standards for water are appropriate in view of the intended use of the products produced by your firm.An updated risk assessment addressing the potential effects of the observed water system failures on the quality of all drug product lots currently in U.S. distribution. Specify actionsthat you will take in response to the risk assessment, such as customer notifications and product recalls.An action plan and timelines for conducting full microbiological testing of retain samples of your non-sterile finished drug products to determine the quality of all batches of drug product distributed to the United States that are within expiry. You should test all appropriate quality attributes including, but not limited to, microbiological quality (total counts and identification of bioburden to detect any objectionable microbes) of each batch. If testing yields an OOL result, indicate the corrective actions you will take, including notifying customers and initiating recalls.A summary of all data from all (e.g., accelerated, annual) stability studies from the last five years. Include all lots, all timepoints, and any out-of-specification (OOS) results, irrespective of whether they were later invalidated.A summary table of all individual microbial test results (total counts and identification of bioburden to detect any objectionable microbes) obtained from testing samples from your new water system. Also, include all physical and chemical test results (total organic carbon, conductivity, etc.)A retrospective review of all invalidated OOL water test results, including the following for each OOL:• For all OOL results found by the retrospective review to have an inconclusive or no root cause identified in the laboratory, include a thorough review of production (e.g., batch manufacturing records, adequacy of the manufacturing steps, suitability of equipment/facilities, variability of raw materials, process capability, deviation history, complaint history, batch failure history). Provide a summary of potential manufacturing root causes for each investigation, and any manufacturing operation improvements.A comprehensive review and remediation plan for your OOS/OOL result investigation systems. The corrective action and preventative action (CAPA) should include but not be limited to addressing the following:• Quality unit oversight of laboratory investigations• Identification of adverse laboratory control trends• Resolution of causes of laboratory variation• Initiation of thorough investigations of potential manufacturing causes whenever a laboratory cause cannot be conclusively identified• Adequately scoping of each investigation and its CAPA• Revised OOS/OOL investigation procedures with these and other remediations2. 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. Your firm also failed to follow appropriate written procedures that are designed to prevent microbiological contamination of drug products purporting to be sterile, and that include validation of all sterilization processes (21 CFR 211.100(a) and 21 CFR 211.113(b)).You failed to adequately validate your production and process controls used in the manufacture of your drug products. Additionally, you failed to conduct adequate qualification activities for equipment used to manufacture your drug products.Furthermore, your firm failed to follow appropriate written procedures that are designed to prevent microbiological contamination of drug products purporting to be sterile, and that included validation of all sterilization processes. For example, your firm has not performed quarterly dose audit studies to monitor the(b)(4)dose to ensure that it remains effective for the(b)(4)sterilization of your drug products intended to be sterile.In your response, you state that you will develop and implement enhanced process controls and complete process validation studies. Your response is inadequate as it did not provide a timeframe for completion of process validation activities for each of your drug products. In addition, your response did not include your interim plan for any drugs distributed before validation activities are completed to ensure you produce drug products of acceptable quality.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 and assure the quality of raw material inputs, in-process materials, and finished drugs. Process qualification studies include intensive monitoring and testing throughout each significant process stage to characterize intra-batch variation and evaluate batches to determine whether an initial state of control has been established.Successful process qualification studies are necessary before commercial distribution. Thereafter, ongoing vigilant oversight of process performance and product quality is necessary to ensure you maintain a stable manufacturing operation throughout the product lifecycle. See FDA’s guidance for industry,Process Validation: General Principles and Practices, for general principles and approaches that the FDA considers appropriate elements of process validation athttps://www.fda.gov/regulatory-information/search-fda-guidance-documents/process-validation-general-principles-and-practices.In response to this letter, provide:A detailed summary of your validation program for ensuring a state of control throughout the product lifecycle, along with associated procedures. Describe your program for process performance qualification, and ongoing monitoring of both intra-batch and inter-batch variation to ensure a continuing state of control.A timeline for performing process performance qualification for each of your marketed drug products. Also provide a risk assessment and any follow-up actions to be taken for the distributed drug products produced without performing any process validation studies.A detailed program for designing, validating, maintaining, controlling and monitoring each of your manufacturing processes that includes vigilant monitoring of intra-batch and inter-batch variation to ensure an ongoing state of control. As part of your response, explain how you handle changes throughout the lifecycle, including determining whether any changes (e.g., materials, manufacturing process, atypical bioburden) adversely impact the effectiveness of your(b)(4)sterilization process. Finally, include your program for qualification of your equipment and facility.A list of all quality complaints for the past five years. Include the batch number, name of product, lot size, whether a complaint sample was received (if not, explain why), and description of any associated CAPA.3. Your firm failed to conduct appropriate laboratory testing to determine whether each batch of drug product purporting to be sterile conforms to such requirements (21 CFR 211.167(a)).Your firm released your finished OTC drug products to the U.S. market without testing each batch for all appropriate quality attributes. For example, your firm distributed multiple batches of purportedly sterile finished drug products without conducting sterility testing. Without testing all appropriate physical and microbiological quality attributes of your drug products, your quality unit lacks essential safety information required to make suitable batch release decisions.In your response, you acknowledge that you did not begin sterility testing on your drug products until the end of 2024. You indicate that you will test the retains, per USP Sterility Tests, of lots for which you have retains.Your response is inadequate because you have not provided proof of method suitability of the sterility test performed by your contract laboratory to ensure its capability to detect microbes in your finished drug product. Additionally, you have failed to indicate if there are batches for which you lack retains and are therefore unable to test for sterility.In response to this letter, provide:A comprehensive, independent assessment of your laboratory practices, procedures, methods, documentation, supervision, and analyst competencies. Based on this review, provide a detailed CAPA plan to remediate your laboratory system. If a contract facility performs any laboratory functions on your behalf, conduct an equivalent comprehensive assessment of their practices, implement an appropriate supplier CAPA, monitor the remediations at the contractor, and provide a summary of these planned CAPA activities.A summary of all test results obtained from testing your batch retains, including any OOS/OOL results obtained (irrespective of whether later invalidated). Also include a list of batches for which you have no retains and are unable to test for sterility.A list of microbial test methods and specifications used to analyze each batch of your drug product before making a batch disposition decision, and the associated written procedures.Method suitability tests performed for each of your formulations.Quality SystemsYour firm’s quality systems are inadequate. For guidance on establishing and maintaining CGMP-compliant quality systems, see these FDA guidance documents:Q8(R2) Pharmaceutical Developmentat https://www.fda.gov/regulatory-information/search-fda-guidance-documents/q8r2-pharmaceutical-developmentQ9 Quality Risk Managementat https://www.fda.gov/regulatory-information/search-fda-guidance-documents/q9r1-quality-risk-managementQ10 Pharmaceutical Quality Systemat https://www.fda.gov/regulatory-information/search-fda-guidance-documents/q10-pharmaceutical-quality-systemConclusionThe violations cited in this letter are not intended to be an all-inclusive list of violations that exist at your facility. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations.Correct any violations promptly. Failure to promptly and adequately address this matter may result in regulatory or legal action without further notice including, without limitation, seizure and injunction. Unresolved violations may also prevent other Federal agencies from awarding contracts.Failure to address violations also cause FDA to withhold issuance of Export Certificates. FDA may withhold approval of new applications or supplements listing your firm as a drug manufacturer until any violations are completely addressed and we confirm your compliance with CGMP. We may re-inspect to verify that you have completed corrective actions to address any violations.This letter notifies you of our findings and provides you an opportunity to address the above deficiencies. After you receive this letter, respond to this office in writing within 15 working days. Specify what you have done to address any violations and to prevent their recurrence. In response to this letter, you may provide additional information for our consideration as we continue to assess your activities and practices. If you cannot complete corrective actions within 15 working days, state your reasons for delay and your schedule for completion.After you receive this letter, respond to this office in writing within 15 working days. In response to this letter, you may provide additional information for our consideration as we continue to assess your activities and practices, and/or submit a request to schedule an FDA inspection.Send your electronic reply to CDER-OC-OMQ-Communications@fda.hhs.gov. Identify your response with FEI 3012129555 and ATTN: Nancy Scheraga.Sincerely,/S/Francis GodwinDirectorOffice of Manufacturing QualityOffice of ComplianceCenter for Drug Evaluation and Research

Product:DrugsRecipient:www.usmedschoice.comUnited StatesIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesFROM: The United States Food and Drug AdministrationRE: Notice of Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the InternetDATE: October 6, 2025WARNING LETTERThis is to advise you that the United States (U.S.) Food and Drug Administration (FDA) recently reviewed your website at the Internet address www.usmedschoice.com and has observed that your website introduces into interstate commerce misbranded and unapproved new drugs in violation of sections 301(a), 301(d), 301(k), 503(b), and 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) [21 U.S.C. §§ 331(a), 331(d), 331(k), 353(b), and 355(a)].As discussed below, FDA has observed that www.usmedschoice.com introduces into interstate commerce unapproved and misbranded opioids. Opioid addiction and abuse have created an immense public health crisis, and the death toll is staggering. Given the severity of the opioid epidemic, the easy availability of opioids via the Internet poses significant risks to U.S. consumers.FDA has also observed that www.usmedschoice.com introduces into interstate commerce unapproved and misbranded benzodiazepines. Benzodiazepines are drug products with an acknowledged potential for abuse, and it is important to address the public health impact of their nonmedical use. Benzodiazepine nonmedical use is widespread, and individuals frequently co‐use benzodiazepines with alcohol, prescription opioids, and illicit drugs. Associated harms of benzodiazepine nonmedical use are substantial but occur primarily when people use benzodiazepines in combination with other drugs. Further, in cases where benzodiazepines were co‐used with other substances, medical outcomes are typically more severe than in cases involving benzodiazepines alone.Polysubstance overdose deaths account for the vast majority of overdose deaths documenting involvement of benzodiazepines.Finally, FDA has observed that www.usmedschoice.com introduces into interstate commerce unapproved and misbranded Schedule II stimulants. Schedule II stimulants have an acknowledged high potential for abuse, and it is important to address the public health impact of their diversion and nonmedical use. Diversion is the primary source of prescription stimulants for nonmedical use, and nonmedical use is most frequent among young adults and college students. Polysubstance use is common among those who use prescription stimulants nonmedically, with individuals frequently co‐using illicit drugs and/or prescription opioids. These concerns come against a backdrop of rising mortality from psychostimulant‐involved overdoses, which involve illicit stimulants the vast majority of the time, but sometimes involve prescription stimulants. The easy availability of benzodiazepines and Schedule II stimulants via the Internet poses additional significant risks to U.S. consumers.There are inherent risks to consumers who purchase unapproved new drugs and misbranded drugs. Unapproved new drugs do not carry the same assurances of safety and effectiveness as those drugs subject to FDA oversight. Drugs that have circumvented regulatory safeguards may be contaminated, counterfeit, contain varying amounts of active ingredients, or contain different ingredients altogether. Accordingly, FDA requests that www.usmedschoice.com cease offering any unapproved and misbranded drugs for sale to U.S. consumers. This is critical to shielding the American public from harm.Unapproved New Drugs:Certain products offered for sale by www.usmedschoice.com are drugs within the meaning of section 201(g) of the FD&C Act [21 U.S.C. § 321(g)] because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or because they are intended to affect the structure or function of the body. These drugs are also new drugs as defined by section 201(p) of the FD&C Act [21 U.S.C. § 321(p)], because they are not generally recognized as safe and effective for their labeled uses. With certain exceptions not applicable here, new drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from FDA, as described in section 505(a) of the FD&C Act [21 U.S.C. § 355(a)]. No approved applications pursuant to section 505 of the FD&C Act are in effect for these products. Accordingly, their introduction or delivery for introduction into interstate commerce violates sections 301(d) [21 U.S.C. § 331(d)] and 505(a) of the FD&C Act.Examples of unapproved opioids you offer for sale on www.usmedschoice.com, including how these products are marketed on your website and evidence obtained from your website establishing that these products are drugs intended for human use (as defined in 21 CFR 201.128), are listed below:Unapproved opioid:Marketed as:Evidence includes the claim(s):hydrocodone bitartrate"Hydrocodone 10/325mg,""Zohydro ER""Hydrocodone 10/325mg is an opioid relief medication for coping with moderate to intense pain and discomfort. It belongs to the opioid analgesic, which is indicated for mild to severe pain. Buy Hydrocodone 10/325mg online; it’s a semi‐artificial opioid for coping with mild to excessive pain."hydromorphonehydrochloride (HCl)"Dilaudid 8 mg,""DILAUDID ® HYDROMORPHONEHYDROCHLORIDE 8 mg""CONTROLLED DRUG"oxycodone HCl"Oxycodone 30mg,""Oxycodone 80mg,""NDC 57664‐224‐88 OxycodoneHydrochloride Tablets, USP C II 30 mg,""Oxycontin,""Oxycontin 30mg,""NDC 50419‐430‐20 OxyContin ®(oxycodone hydrochloridecontrolled‐release) tablets 30 mg,""Roxicodone,""Oxycontin 80mg,""OxyContin ® (Controlled‐releaseoxycodone) 80 mg,""Oxycontin OC 80mg,""Oxycontin OP 40mg,""Oxycontin OP 60mg,""Oxycontin OP 80mg""Oxycodone is a semisynthetic, orally available opioid drug with analgesic effects. This drug is used to help relieve you of moderate to severe pain. It works in the brain by changing how your body responds and feels about the pain. It is used in an immediate release form for moderate to severe form and an extended-release form for chronic moderate to severe pain. You can order Oxycodone online both as a brand name and as a generic drug. Its immediate‐release tablets are available in brand‐name drugs Oxaydo, Roxycodone, and Roxybond, and extended‐release tablets are available in brand name Oxycontin."tapentadol HCl"Tapentadol 100mg,""Aspadol,""Aspadol ® Tab""Tapentadol 100mg from USMedsChoice offers effective pain relief without harsh side effects. Fast‐acting and reliable, it’s a great choice for managing moderate to severe pain. The prompt delivery and excellent customer service make the experience even better!"tramadol"Ol‐Tram 100mg,""OL‐TRAM ® TABLETS 100 mg,""Trakem 100mg,""Trakem‐100,""Ultram, ""Tramadol 100mg,""TMD‐100 SR,""Clovidol‐100 SR,""Tramadol 100mg (Citra),""Citra ® Tramadol Tabletas,""Tramadol 225mg (Royal),""Royal‐225,""We can regard Tramadol is a narcotic‐like pain reliever that is mainly used to treat moderate to severe pain that you are facing. People use this drug for the round‐the‐clock treatment of depression."While there are FDA‐approved versions of hydrocodone bitartrate extended release, hydromorphone HCl (brand name DILAUDID), oxycodone HCl (brand name OXYCONTIN), tapentadol HCl (brand names NUCYNTA and NUCYNTA ER), and tramadol HCl on the market in the U.S., there are no approved drug applications pursuant to section 505 of the FD&C Act in effect for these drug products offered by www.usmedschoice.com. Brand names ZOHYDRO ER (hydrocodone bitartrate extended release), ULTRAM (tramadol HCl), and ULTRAM ER (tramadol HCl extended release) are discontinued. FDA‐approved hydrocodone bitartrate extended‐release is indicated for the management of severe and persistent pain that requires an extended treatment period with a daily opioid analgesic and for which alternative treatment options are inadequate. FDA‐approved hydromorphone HCl (brand name DILAUDID), oxycodone HCl (brand name OXYCONTIN), and tramadol HCl are each indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. FDAapproved tapentadol HCl (brand name NUCYNTA) is indicated for the management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. FDA‐approved tapentadol HCl extended release (brand name NUCYNTA ER) is indicated for the management of severe and persistent pain, including neuropathic pain associated with diabetic peripheral neuropathy, that requires an extended treatment period with a daily opioid analgesic and for which alternative treatment options are inadequate.FDA‐approved hydrocodone bitartrate, hydromorphone HCl (brand name DILAUDID), oxycodone HCl (brand name OXYCONTIN), tapentadol HCl (brand names NUCYNTA and NUCYNTA ER), and tramadol HCl are only available pursuant to a prescription from a licensed practitioner. Furthermore, these drug products each 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. This boxed warning addresses risks including addiction, abuse, misuse, life‐threatening respiratory depression (breathing problems), neonatal opioid withdrawal syndrome (withdrawal symptoms in newborn baby), and accidental exposure resulting in death. In addition, when these drug products are taken in conjunction with other central nervous system (CNS) depressants, including alcohol and benzodiazepines, use may result in coma or death.Examples of unapproved benzodiazepines you offer for sale on www.usmedschoice.com, including how these products are marketed on your website and evidence obtained from your website establishing that these products are drugs intended for human use (as defined in 21 CFR 201.128), are listed below:Unapproved benzodiazepine:Marketed as:Evidence includes the claim(s):alprazolam"Xanax,""Xanax bars,""Green Xanax S 90 3,""Ksalol 1mg,""Ksalol ® 1 mg (alprazolam) 30 tableta,""Xanax 1mg,""Xanax 2mg""Xanax is an anti‐anxiety drug, which is also known as Alprazolam that mainly affects the chemicals in the brain that makes the people unbalanced with anxiety. The drug is used to treat anxiety disorders, panic disorders, and depression, as well.""Ksalol 1mg is an oral prescription medicine for handling tension, phobia, panic disorder and insomnia."clonazepam"Clonazepam 2mg,""Clonazepam Tableta,""Klonopin 2mg,""Lonazep,""Rnaze‐2,""Rivotril 2mg,""Rivotril ® (Clonazepam)""Clonazepam is an antiepileptic drug used in the treatment of seizures, panic disorder, and the movement disorder known as akathisia. It is a tranquilizer belonging to the benzodiazepine class and works by calming the nerves in your brain.""Klonopin 2mg is a medicine used for treating seizure disorders in adults and kids. Buy Klonopin 2mg online as a benzodiazepine that improves the hobby of neurotransmitters within the mind."diazepam"Diazepam 10mg,""Diazepam Tableta,""Valium 5mg,""Valium 10mg""Valium has a genic name that is benzodiazepine, which is a drug that is mainly used to kill the anxiety problem. The drug affects the chemicals in the brain that may unbalance in people due to anxiety.""Valium comes under the class of benzodiazepines. The generic version of the drug is known as Diazepam."While there are FDA‐approved versions of alprazolam (brand name XANAX), clonazepam (brand name KLONOPIN), and diazepam (brand name VALIUM) on the market in the U.S., there are no approved drug applications pursuant to section 505 of the FD&C Act in effect for these drug products offered by www.usmedschoice.com. FDA‐approved alprazolam (brand name XANAX) is indicated for the acute treatment of generalized anxiety disorder and panic disorder with or without agoraphobia. FDA‐approved clonazepam (brand name KLONOPIN) is indicated for the treatment of certain seizure disorders and panic disorder with or without agoraphobia. FDA‐approved diazepam (brand name VALIUM) is indicated for anxiety disorders, acute alcohol withdrawal symptoms, skeletal muscle spasm relief, and as adjunctive therapy in convulsive disorders.FDA‐approved alprazolam (brand name XANAX), clonazepam (brand name KLONOPIN), and diazepam (brand name VALIUM) are only available pursuant to a prescription from a licensed practitioner. Furthermore, these drug products each bear a boxed warning addressing risks including abuse, misuse, addiction, and physical dependence. In addition, the concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death.Examples of unapproved Schedule II stimulants you offer for sale on www.usmedschoice.com, including how these products are marketed on your website and evidence obtained from your website establishing that these products are drugs intended for human use (as defined in 21 CFR 201.128), are listed below:Unapproved Schedule II stimulant:Marketed as:Evidence includes the claim(s):amphetamine"Adderall 30mg,""Adderall XR""In the United States, Adderall is said to be one of the most commonly prescribed medications. It is a combinational drug that contains Amphetamine and Dextroamphetamine. Both these substances work inside a human body as a CNS stimulant. They affect the chemicals of the brains that travel through the nerves causing impulsivity and hyperactivity."While there are FDA‐approved versions of amphetamine on the market in the U.S., there are no approved drug applications pursuant to section 505 of the FD&C Act in effect for these drug products offered by www.usmedschoice.com. FDA‐approved amphetamine (brand name ADDERALL) is indicated for the treatment of attention deficit hyperactivity disorder (ADHD) and narcolepsy. Using the brand name of the drug product ADDERALL indicates that this product is intended to treat ADHD and narcolepsy. FDA‐approved amphetamine extended release (brand name ADDERALL XR) is indicated for the treatment of ADHD in adults and pediatric patients 6 years and older.FDA‐approved amphetamine (brand names ADDERALL, ADDERALL XR) is only available pursuant to a prescription from a licensed practitioner. Furthermore, FDA‐approved amphetamine (brand names ADDERALL, ADDERALL XR) bears a boxed warning, addressing risks including abuse, misuse, and addiction. In addition, this drug product can be diverted for non‐medical use into illicit channels or distribution. Misuse and abuse of CNS stimulants, including these drug products, can result in overdose and death, and this risk is increased with higher doses or unapproved methods of administration.Misbranded Drugs:A drug is misbranded under section 502(f)(1) of the FD&C Act [21 U.S.C. § 352(f)(1)] if its labeling fails to bear adequate directions for use. “Adequate directions for use” means directions under which a layperson can use a drug safely and for the purposes for which it is intended (see 21 CFR 201.5). Prescription drugs, as defined in section 503(b)(1) of the FD&C Act [21 U.S.C. § 353(b)(1)] include those that, because of their toxicity or other potentiality for harmful effect, and/or the method of their use, and/or the collateral measures necessary for their use, are not safe for use except under supervision of a practitioner licensed by law to administer them. Prescription drugs, as defined in section 503(b)(1)(A) of the FD&C Act, can be used safely only at the direction, and under the supervision, of a licensed practitioner.Because the aforementioned drugs are prescription drugs intended for conditions that are not amenable to self-diagnosis and treatment by a layperson, adequate directions cannot be written such that a layperson can use the products safely for their intended use. Consequently, the labeling for these drugs fail to bear adequate directions for use, causing them to be misbranded under section 502(f)(1) of the FD&C Act. In addition, because these drugs are not approved in the U.S., they are also not exempt under 21 CFR 201.115(a) from the requirements of section 502(f)(1) of the FD&C Act. By offering these drugs for sale to U.S. consumers, www.usmedschoice.com is causing the introduction of misbranded drugs into interstate commerce in violation of section 301(a) of the FD&C Act [21 U.S.C. § 331(a)].FDA has also observed that the www.usmedschoice.com offers prescription drugs for sale without a prescription. In addition to the aforementioned drugs, examples of misbranded opioids you offer for sale on www.usmedschoice.com, including how these products are marketed on your website and evidence obtained from your website establishing that these products are drugs intended for human use (as defined in 21 CFR 201.128), are listed below:Misbranded opioid:Marketed as:Evidence includes the claim(s):oxycodone HCl and acetaminophen"Percocet 10mg/325mg,""Percocet,""NDC 63481‐623‐70 Percocet ®(oxycodone and acetaminophentablets, USP) 5 mg / 325 mg""Percocet 10/325mg is a mixture of acetaminophen and oxycodone. It is a synthetic opioid pain medicine; you can buying Percocet 10/325mg online without problems from our certified medical pharmacy to reduce pain and discomfort."FDA‐approved oxycodone HCl and acetaminophen (brand name PERCOCET) is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. It is only available pursuant to a prescription from a licensed practitioner. Furthermore, FDA‐approved oxycodone HCl and acetaminophen (brand name PERCOCET) bears a boxed warning addressing risks including addiction, abuse, misuse, life‐threatening respiratory depression, neonatal opioid withdrawal syndrome, and accidental exposure resulting in death. In addition, when this drug product is taken in conjunction with other CNS depressants, including alcohol and benzodiazepines, use may result in coma or death.Under U.S. law, prescription drugs can be dispensed only pursuant to a prescription from a healthcare practitioner licensed by law to administer prescription drugs. By offering the aforementioned drugs without requiring a prescription, www.usmedschoice.com jeopardizes patient safety and misbrands the drugs 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 [21 U.S.C. § 331(k)].FDA is sending this warning letter to www.usmedschoice.com because of the inherent risks to consumers who purchase misbranded and unapproved new drugs. This letter is not intended to identify all the ways in which your products or operations might be in violation of the law. It is your responsibility to ensure that all products you offer for sale are in compliance with the FD&C Act and its implementing regulations. You should take prompt action to address any violations of the FD&C Act (which may include the offer for sale of similarly misbranded and/or unapproved new drugs other than the drugs noted above). We advise you to review your websites, product labels, and other labeling and promotional materials to ensure that you are not misleadingly representing your products as safe and effective for a use for which they have not been approved by FDA and that you are not distributing misbranded and unapproved drug products in violation of the FD&C Act.Please notify this office in writing within 15 working days describing the specific steps you have taken to address any violations and to prevent their recurrence. Include an explanation of each step being taken to remedy and prevent the recurrence of any violations, as well as copies of related documentation. Failure to adequately address this matter may result in legal action, including, without limitation, seizure, and injunction, without further notice. If you cannot complete corrective action within 15 working days, state the reason for the delay and the time within which you will complete the corrections. This letter notifies you of our concerns and provides you with an opportunity to address them. If you believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration within 15 working days.If you are not located in the U.S., please note that products that appear to be misbranded or unapproved new drugs may be detained or refused admission. We may advise the appropriate regulatory officials in the country from which you operate that your products referenced above appear to be unapproved and misbranded products that cannot be legally sold to consumers in the U.S.Please direct your response and any inquiries to FDA at FDAInternetPharmacyTaskForce-CDER@fda.hhs.gov.Sincerely,/S/Sangeeta Vaswani Chatterjee, Pharm.D.Acting DirectorOffice of Drug Security, Integrity, and ResponseOffice of ComplianceCenter for Drug Evaluation and Research

Delivery Method:VIA Electronic MailReference #:320-26-04Product:Drugs、Over-the-Counter DrugsRecipient:Mr. Veblen LiangGeneral ManagerFoshan Yiying Hygiene Products Co., Ltd.Industrial Building No. 3, Ruichang Industrial Park, No. 1, Honggang SectionLishui TownNanhai QuFoshan ShiGuangdong Sheng,528244ChinaIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesWarning Letter320-26-04October 10, 2025Dear Mr. Liang:Your facility is registered with the United States Food and Drug Administration (FDA) as a manufacturer of over-the-counter (OTC) drug products. FDA has reviewed the records you submitted in response to our February 10, 2025, request for records and other information pursuant to section 704(a)(4) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) for your facility, Foshan Yiying Hygiene Products Co., Ltd, FEI 3017706051, at Industrial Building No. 3, Ruichang Industrial Park, No. 1, Honggang Section, Lishui Town, Nanhai District, Foshan, Guangdong, China.This warning letter summarizes significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals. See Title 21 Code of Federal Regulations, parts 210 and 211 (21 CFR, parts 210 and 211).Because your methods, facilities, or controls for manufacturing, processing, packing, or holding of drugs as described in your response to our 704(a)(4) request do not conform to CGMP, your drug products are adulterated within the meaning of section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 351(a)(2)(B)).Following review of records and other information provided pursuant to section 704(a)(4) of the FD&C Act, significant violations were observed including, but not limited to, the following: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 manufactures OTC drug products, including(b)(4). Your response to our request for records and other information under section 704(a)(4) indicated that you did not conduct adequate finished product testing on drug products shipped to the United States market.Testing is an essential part of CGMP to ensure that the drug products you manufacture conform to all pre-determined quality attributes appropriate for their intended use. Drug products must be tested for identity and strength of the active ingredient, prior to release and distribution. Without adequate testing, you do not have adequate scientific evidence to assure that your drug products conform to appropriate specifications before release.2. Your firm failed to assure that the drug product bore an expiration date that was supported by appropriate stability testing (21 CFR 211.137(a)).Your response to our request for records and other information under section 704(a)(4) indicated that you did not perform stability testing. Therefore, you have not demonstrated that the active ingredient in your drug products is stable throughout its shelf life.Without appropriate stability data, you cannot ensure your drug products meet established specifications and all pre-determined quality criteria throughout their assigned shelf-life.3. Your firm failed to conduct at least one test to verify the identity of each component of a drug product. Your firm also failed to validate and establish the reliability of your component supplier’s test analyses at appropriate intervals (21 CFR 211.84(d)(1) and 211.84(d)(2)).Your response to our request for records and other information under section 704(a)(4) indicated that you did not adequately test the identity of incoming components used in the manufacture of your drug products. You also did not demonstrate that you are testing your active ingredient(b)(4)for(b)(4).Without adequate testing you do not have scientific evidence that your raw materials conform to appropriate specifications prior to use in the manufacture of your drug products. As a manufacturer, you have a responsibility to sample, test, and examine drug components before use in production to assure adequate quality, including testing for the presence of(b)(4)in(b)(4).The use of(b)(4)contaminated with(b)(4)has resulted in various lethal poisoning incidents in humans worldwide. See FDA’s guidance document(b)(4).4. Your firm failed to establish adequate written procedures for production and process control designed to assure that the drug products you manufacture have the identity, strength, quality, and purity they purport or are represented to possess (21 CFR 211.100(a)).Your response to our request for records and other information under section 704(a)(4) indicated that you did not ensure that your manufacturing processes are reproducible and controlled to yield a product of uniform character and quality. For example, we requested the manufacturing process validation reports for your drug products. In response, you stated you have not validated the manufacturing process for your drug products. In addition, you distributed your drug products to the U.S. market prior to performing process validations.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 and assure the quality of raw material inputs, in-process materials, and finished drugs. Process qualification studies include intensive monitoring and testing throughout each significant process stage to characterize intra-batch variation and evaluate batches to determine whether an initial state of control has been established.Successful process qualification studies are necessary before commercial distribution. Thereafter, ongoing vigilant oversight of process performance and product quality is necessary to ensure you maintain a stable manufacturing operation throughout the product lifecycle.We also note that your quality unit did not ensure that your manufacturing processes were adequately validated and in a state of control before releasing your OTC products for distribution to the U.S. market.5. Your firm failed to prepare batch production and control records with complete information relating to the production and control of each batch of drug product produced (21 CFR 211.188).Your response to our request for records and other information under section 704(a)(4) indicated that you did not document all important steps in your manufacturing process. For example, in your response, you stated “…this site does not prepare batch production records for every batch of our listed drug…”. This documentation is necessary to establish that manufacturing processes were consistently followed and are reproducible. Lack of complete records also deprives you of traceability of actions necessary for investigational purposes of any quality signals related to your products.CGMP Consultant RecommendedBased upon the nature of the violations we identified at your firm, you should engage a consultant qualified as set forth in 21 CFR 211.34 to evaluate your operations and to assist your firm in meeting CGMP requirements. The qualified consultant should also perform a comprehensive six-system audit1of your entire operation for CGMP compliance and evaluate the completion and efficacy of your corrective actions and preventive actions before you pursue resolution of your firm’s compliance status with FDA.ConclusionThe violations cited in this letter are not intended to be an all-inclusive list of violations that exist at your facility. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations.FDA placed all drugs and drug products offered for import into the United States from your firm on Import Alert 66-40 on August 27, 2025.Correct any violations promptly. FDA may withhold approval of new applications or supplements listing your firm as a drug manufacturer until any violations are completely addressed and we confirm your compliance with CGMP. We may inspect to verify that you have completed corrective actions to any violations.Failure to address any violations may also result in the FDA continuing to refuse admission of articles manufactured at Foshan Yiying Hygiene Products Co., Ltd., Industrial Building No. 3, Ruichang Industrial Park, No. 1, Honggang Section, Lishui Town, Nanhai District, Foshan, Guangdong, China, into the United States under section 801(a)(3) of the FD&C Act, 21 U.S.C. 381(a)(3). Articles under this authority that appear to be adulterated may be detained or refused admission, in that the methods and controls used in their manufacture do not appear to conform to CGMP within the meaning of section 501(a)(2)(B) of the FD&C Act, 21 U.S.C. 351(a)(2)(B).This letter notifies you of our findings and provides you an opportunity to address the above deficiencies. After you receive this letter, respond to this office in writing within 15 working days. Specify what you have done to address any violations and to prevent their recurrence. In response to this letter, you may provide additional information for our consideration as we continue to assess your activities and practices. If you cannot complete corrective actions within 15 working days, state your reasons for delay and your schedule for completion.Send your electronic reply to CDER-OC-OMQ-Communications@fda.hhs.gov. Identify your response with FEI 3017706051 and ATTN: Carlos Gonzalez.Sincerely,/S/Francis GodwinDirectorOffice of Manufacturing QualityOffice of ComplianceCenter for Drug Evaluation and Research_________________________1i.e. Quality System, Facilities & Equipment System, Materials System, Production System, Packaging & Labeling System, and Laboratory Control System per FDA’s guidance document Quality Systems Approach to Pharmaceutical CGMP Regulations.

近期，太原市万柏林区市场监督管理局执法人员查实，注册单位为太原市同智祥国大药房有限公司、太原市万德堂医药有限责任公司的执业药师（具体名单附后）与实际工作单位不一致，不能保证在岗执业，不能履行执业药师法定职责。依据《执业药师注册管理办法》第三十四条规定，撤销该2 人《执业药师注册证》。特此通告附件：拟撤销《执业药师注册证》人员名单山西省药品监督管理局2025年10月17日 序号姓  名执业药师注册单位执业药师注册证号1刘  静太原市同智祥国大药房有限公司1412250103652张健祺太原市万德堂医药有限责任公司142222010703

案件名称美信药业（辽宁）有限公司未经许可从事化妆品生产案处罚决定文书号辽药监(稽一)罚〔2025〕20号被处罚企业名称美信药业（辽宁）有限公司统一社会信用代码91210113MA10C5F89Q法定代表人杨之凯主要违法事实当事人未经许可从事化妆品生产共计货值金额4292.5元，违法所得共计629.3元。行政处罚种类和依据没收违法生产的化妆品和违法所得；罚款。依据《化妆品监督管理条例》第五十九条第一款第(一)项。处罚结果1.没收违法所得629.3元；2.没收“盛医生®卸妆湿巾”4521袋、“美药师®卸妆湿巾”2664袋；3.处10000元罚款。行政处罚履行方式和期限主动履行；当事人已于2025年10月17日履行完毕。作出处罚的日期2025-10-16

案件名称沈阳市天龙化妆品有限公司生产不符合技术规范的化妆品案处罚决定文书号辽药监(稽一)罚〔2025〕19号被处罚企业名称沈阳市天龙化妆品有限公司统一社会信用代码91210104243355148T法定代表人胡晓丹主要违法事实 当事人违法生产化妆品货值金额345元，违法所得345元。行政处罚种类和依据 没收违法生产的化妆品和违法所得；罚款。依据《化妆品监督管理条例》第六十条第一款第（二）项。 处罚结果 1.没收违法所得345元；2.没收不符合规定的涉案批次花彩爽滑营养护发素3瓶；3.处罚款2000元；行政处罚履行方式和期限主动履行；当事人已于2025年10月17日履行完毕。作出处罚的日期2025-10-15

江西3L医用制品集团股份（柬埔寨）有限公司报告，由于被抽检产品检验尺寸不符合要求等原因，江西3L医用制品集团股份（柬埔寨）有限公司对其生产的医用手术薄膜(注册备案号:国械注进20192140195)主动召回，召回级别为三级,涉及产品的型号、规格及批次等详细信息见《医疗器械召回事件报告表》。附件：医疗器械召回事件报告表2025-10-20

江西康嗯呗佳医疗科技有限公司报告，由于PH值超标、氟离子含量不达标等原因，江西康嗯呗佳医疗科技有限公司对其生产的牙齿脱敏凝胶(注册备案号:赣械注准20212170279)主动召回，召回级别为三级,涉及产品的型号、规格及批次等详细信息见《医疗器械召回事件报告表》。附件：医疗器械召回事件报告表2025-10-20

　　近期，国家药监局对甘肃大手印玫瑰科技有限公司进行飞行检查。经查，发现该企业违反《化妆品监督管理条例》《化妆品生产质量管理规范》等有关规定，企业生产质量管理体系存在严重缺陷。为保障公众用妆安全，国家药监局要求甘肃省药品监督管理局对该企业涉嫌违法行为依法查处。目前，甘肃省药品监督管理局已对该企业立案调查，并责令该企业暂停生产、经营，对存在的问题进行整改。飞行检查结果具体情况详见附件。　　特此通告。　　附件：甘肃大手印玫瑰科技有限公司飞行检查结果　国家药监局2025年10月15日企业名称甘肃大手印玫瑰科技有限公司化妆品生产许可证编号甘妆20220009社会信用代码（组织机构代码）91620121MA74GTR280企业地址甘肃省兰州市永登县苦水镇新屯川村十一社1号检查单位国家药监局食品药品审核查验中心检查依据《化妆品监督管理条例》《化妆品生产质量管理规范》《化妆品生产质量管理规范检查要点及判定原则》等检查发现缺陷和问题该企业在机构与人员方面存在质量安全负责人未按规定履职等问题；在质量保证与控制方面存在未有效执行记录管理制度、自查制度等问题；在物料与产品管理方面存在未有效执行物料放行管理制度等问题；在生产过程管理方面存在未按备案资料载明的技术要求生产产品、未按规定执行产品放行管理制度等问题。处理措施1.国家药监局要求甘肃省药监局对该企业涉嫌违法的行为依法立案调查，并评估相关产品安全风险，必要时依法采取紧急控制措施。有关查处结果及时报告国家药监局。2.对检查中发现的不符合规定项目和问题，甘肃省药监局已责令该企业暂停生产、经营，并进行整改。该企业完成全面整改并经甘肃省药监局检查确认前不得恢复生产。有关整改和复产情况及时报告国家药监局。发布日期2025年10月15日

内蒙古自治区各级药品监管部门，各药品经营企业：为加强网络销售药品监管，进一步明确网络销售药品配送环节监管要求和企业合规要求，保障公众用药安全，为行业健康发展划定红线，现发布如下风险提示。一是聚焦法规适用，严管配送风险。准确把握网络销售药品配送环节法规适用标准，严格按照《药品经营质量管理规范》及《药品经营质量管理规范附录6》开展监管工作。对冷藏、冷冻药品，必须要求经营企业通过专业冷链运输，确保药品全程处于规定温度环境，不得出现温度超标情况；对阴凉药品，需督促经营企业使用隔温、防潮、避光的包装材料，并采取有效措施避免药品在配送中遭受雨淋、高温、严寒、阳光直射等外界不良环境影响。各药品经营企业委托配送阴凉药品时，须按上述要求采取隔温、避光等防护措施。若未采取任何防护措施，即属于违反《规范》及《附录 6》的行为，药品监管部门应依据《药品管理法》相关规定，责令企业限期改正，给予警告；逾期未改正的，依法予以查处。二是压实监管责任，筑牢配送防线。各级药品监管部门要强化法规宣贯指导，通过专题培训、政策解读、实地走访等形式，明确阴凉药品配送合规标准，避免企业因认知不清违规；要加强配送环节检查，重点核查第三方配送企业资质、质量协议签订情况，以及配送车辆（封闭式、独立存放区），配送箱（隔温、防潮）是否达标；要规范违规处置流程，对未落实防护措施的企业责令限期整改、警告，跟踪整改进度，对拒不整改者严肃查处。三是明确企业义务，落实主体责任。指导药品经营企业作为药品质量第一责任人从四维度强化管理，即严审配送企业资质，优先选择具备合法经营资质、质量管理体系完善的第三方配送企业，签订质量协议并纳入自身质量管理体系；合理配备运输工具，B2B/B2C模式用封闭式车辆并物理隔离药品区，O2O模式用保温配送箱并做好安全防护；加强包装标识管理，阴凉药品用隔温防潮避光材料封装，外贴配送单标注企业信息、储存要求等，确保可追溯；建立健全应急机制，针对高温严寒等极端天气制定调整配送时段、加厚包装等方案，定期检修温控设备，培训配送人员防护知识。各级监管部门需切实履行监管职责，各药品经营企业需严格落实合规要求，共同推动药品网络销售行业规范、健康发展，为公众提供安全、便捷的购药服务。