Delivery Method:Via EmailProduct:DrugsRecipient:Shuja ArshadFormPour50686 Scarborough RdCanton,MI48188United Statesusapak2020@gmail.comIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesWARNING LETTERMarch 31, 2026RE: 722215Shuja Arshad:This letter is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your eBay store at https://www.ebay.com/str/formpour in December 2025. The FDA has observed that your eBay store offers “SMGT-GLT-1 Nano Microneedle Patch” for sale in the United States. Based on our review, this product 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).Based on a review of your eBay store, your “SMGT-GLT-1 Nano Microneedle Patch” product is a drug as defined by 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 function of the body.Examples from your product labeling, including on your eBay store, 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:SMGT-GLT-1 Nano Microneedle PatchOn the webpage https://www.ebay.com/itm/376775334757?_skw=smgt-glp-1+nano+microneedle+patch&itmmeta=01KCKN9J0DKBD2MW9SRESK76%E2%80%A6:“The patch contains a blend of fat-burning ingredients (such as caffeine, green tea extract, or other thermogenic compounds) that work to help stimulate fat metabolism, reduce cellulite, and promote a smoother, slimmer appearance.”“For:Type 2 Diabetes TreatmentWeight LossCardiovascular Protection”“Global User Survey Results98.6% Type 2 Diabetes TreatmentWeight Loss Aid 97.5%98.1% Cardiovascular Protection”Your “SMGT-GLT-1 Nano Microneedle Patch” product 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 above-described conditions prescribed, recommended, or suggested in the 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 application pursuant to section 505 of the FD&C Act, 21 U.S.C. 355, is in effect for this product. Accordingly, this product is an unapproved new drug. The introduction or delivery for introduction into interstate commerce of this unapproved new drug product violates sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a).ConclusionThe violations cited in this letter are not intended to be an all-inclusive statement of violations that may exist in connection with your products. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations.This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address this matter may lead to regulatory or legal action including, without limitation, seizure and injunction.Please notify FDA in writing, within fifteen working days of receipt of this letter, of the specific steps you have taken to correct any violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration. If you cannot complete corrective action within fifteen working days, state the reason for the delay and the time within which you will complete the correction.Your response should be sent to U.S. Food and Drug Administration, CDER/OC/Office of Unapproved Drugs and Labeling Compliance by email to FDAAdvisory@fda.hhs.gov. Please include your firm name and the unique identifier “722215” in the subject line of the email.Sincerely,/S/Tina Smith, M.S.Captain, U.S. Public Health ServiceDirectorOffice of Unapproved Drugs and Labeling ComplianceOffice of ComplianceCenter for Drug Evaluation and ResearchFood and Drug Administrationcc:Mike CarsonRegulatory Policy Group eBay, Inc.2025 Hamilton AvenueSan Jose, California 95125

Delivery Method:Via EmailProduct:DrugsRecipient:Bernard GramlichGram PeptidesPO Box 9227Rancho Santa Fe,CA92067United Statessupport@grampeptides.comIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesWARNING LETTERMarch 31, 2026RE: 721806Bernard Gramlich:This letter is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website at https://grampeptides.com from January to March 2026. The FDA has observed that your website offers “Retatrutide” (also referred to by your firm as “GLP-1-R peptide”) and “Tirzepatide” (also referred to by your firm as “GLP-2 peptide”) and “Bacteriostatic Water for Injection” (hereinafter Gram Peptides products) for sale in the United States. Based on our review, these products are unapproved new drugs under section 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 355(a). As explained further below, introducing or delivering these products for introduction into interstate commerce violates sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a).These products are especially concerning from a public health perspective because injectable drug products can pose risks of serious harm to users. Injectable products are delivered directly into the body, sometimes directly into the bloodstream, and therefore, bypass some of the body’s key defenses against toxins and microorganisms that can lead to serious and life-threatening conditions.Despite statements on your product labeling marketing your products for “Research Use Only,” and “not intended for human consumption, medical use, or veterinary use,” evidence obtained from your website establishes that your products are intended to be drugs for human use. Your products are drugs as defined by section 201(g)(1) of the FD&C Act 21, U.S.C. 321(g)(1), because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or intended to affect the structure or function of the body.Examples from your product labeling, including on your website, that provide evidence of the intended use (as defined in 21 CFR 201.128) of these products as drugs include, but may not be limited to, the following:Retatrutide (also referred to as “GLP-1-R Peptide”)On the webpage https://grampeptides.com/product/retatrutide/:“[I]nfluences appetite suppression, insulin sensitivity, thermogenesis, and fat-oxidation models.”“[D]emonstrated significant potential for reducing body weight, improving glucose handling, and enhancing lipid metabolism.”“GLP-1-R peptide acts through coordinated activation of: GLP-1 receptors – improving glucose response, slowing gastric emptying, and reducing appetite.”Tirzepatide (also referred to as “GLP-2 Peptide”)On the webpage https://grampeptides.com/product/tirzepatide/:“Benefits of GLP-2 Peptide . . .o Metabolic Regulation – Studied for its ability to lower glucose and support balanced insulin levels.o Weight Management – Associated with significant decreases in body weight in both animal and human studies.o Improved Lipid Profiles – Research shows reductions in triglycerides and improved cholesterol ratios.”Bacteriostatic Water for InjectionYour firm offers “Bacteriostatic Water for Injection” for sale alongside peptide products, which are drugs intended for injection and require reconstitution, including the two above-mentioned GLP products. The sale of these products together demonstrates that you intend for your “Bacteriostatic Water for Injection” to be used in combination for injection. Therefore, your “Bacteriostatic Water for Injection” is a drug.Your Gram Peptides products are “new drugs” under section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because they are not generally recognized as safe and effective (GRASE) for use under the above-described conditions prescribed, recommended, or suggested in their labeling. With certain exceptions not applicable here, 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).ConclusionThe violations cited in this letter are not intended to be an all-inclusive statement of violations that may exist in connection with your products. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations.This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address this matter may lead to regulatory or legal action including, without limitation, seizure and injunction.Please notify FDA in writing, within fifteen working days of receipt of this letter, of the specific steps you have taken to correct any violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration. If you cannot complete corrective action within fifteen working days, state the reason for the delay and the time within which you will complete the correction.Your response should be sent to U.S. Food and Drug Administration, CDER/OC/Office of Unapproved Drugs and Labeling Compliance by email to FDAAdvisory@fda.hhs.gov. Please include your firm name and the unique identifier “721806” in the subject line of the email.Sincerely,/S/Tina Smith, M.S.Captain, U.S. Public Health ServiceDirectorOffice of Unapproved Drugs and Labeling ComplianceOffice of ComplianceCenter for Drug Evaluation and ResearchFood and Drug Administration

Delivery Method:Via EmailProduct:DrugsRecipient:Susan VegaLovega LLC dba Pink Pony Peptides9314 Forest Hill Blvd 902Wellington,FL33411United Stateshelp@pinkponypeptides.comIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesWARNING LETTERMarch 31, 2026RE: 721088Susan Vega:This letter is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website at https://pinkponypeptides.com/ in December 2025. The FDA has observed that your website offers “GLP-2 TZ,” “GLP-3 RT,” and “Bacteriostatic Water” (hereinafter Pink Pony Peptides products) for sale in the United States. Based on our review, these products are unapproved new drugs under section 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 355(a). As explained further below, introducing or delivering these products for introduction into interstate commerce violates sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a).These products are especially concerning from a public health perspective because injectable drug products can pose risks of serious harm to users. Injectable products are delivered directly into the body, sometimes directly into the bloodstream, and therefore, bypass some of the body’s key defenses against toxins and microorganisms that can lead to serious and life-threatening conditions.Despite statements on your product labeling marketing your products for “laboratory research purposes only” and “[n]ot for human consumption,” evidence obtained from your website establishes that your products are intended to be drugs for human use. Your products are drugs as defined by section 201(g)(1) of the FD&C Act 21, U.S.C. 321(g)(1) because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or intended to affect the structure or function of the body.Examples from your product labeling, including on your website, that provide evidence of the intended use (as defined in 21 CFR 201.128) of these products as drugs include, but may not be limited to, the following:GLP-2 TZOn the webpage https://pinkponypeptides.com/product/glp2/:“As a dual GIP and GLP-1 receptor agonist, Tirzepatide helps:o . . . Reduce appetite and increase satietyo . . . Enhance insulin sensitivity and glucose controlo . . . Curb cravings without harsh stimulantso . . . Support fat loss over time with clinical precisionOriginally developed for type 2 diabetes, Tirzepatide has rapidly become a favorite among physicians and wellness experts for its dramatic body recomposition results and long-lasting appetite regulation.”GLP-3 RTOn the webpage https://pinkponypeptides.com/product/glp3/:“As a GIP, GLP-1, and glucagon receptor agonist, Retatrutide offers three times the fat-fighting horsepower in one clean, clinical ride. This cutting-edge peptide has shown jaw-dropping results in clinical trials — helping the body torch fat, suppress appetite, regulate blood sugar, and even improve metabolic function better than its single-pathway competitors.”Bacteriostatic WaterYour firm offers “Bacteriostatic Water” for sale alongside peptide products, which are drugs intended for injection and require reconstitution, including the two above-mentioned GLP products. The sale of these products together demonstrates that you intend for your “Bacteriostatic Water” to be used in combination for injection. Therefore, your “Bacteriostatic Water” is a drug.Your Pink Pony Peptides products are “new drugs” under section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because they are not generally recognized as safe and effective (GRASE) for use under the above-described conditions prescribed, recommended, or suggested in their labeling. With certain exceptions not applicable here, 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).ConclusionThe violations cited in this letter are not intended to be an all-inclusive statement of violations that may exist in connection with your products. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations.This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address this matter may lead to regulatory or legal action including, without limitation, seizure and injunction.Please notify FDA in writing, within fifteen working days of receipt of this letter, of the specific steps you have taken to correct any violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration. If you cannot complete corrective action within fifteen working days, state the reason for the delay and the time within which you will complete the correction.Your response should be sent to U.S. Food and Drug Administration, CDER/OC/Office of Unapproved Drugs and Labeling Compliance by email to FDAAdvisory@fda.hhs.gov. Please include your firm name and the unique identifier “721088” in the subject line of the email.Sincerely,/S/Tina Smith, M.S.Captain, U.S. Public Health ServiceDirectorOffice of Unapproved Drugs and Labeling ComplianceOffice of ComplianceCenter for Drug Evaluation and ResearchFood and Drug Administration

Delivery Method:VIA UNITED PARCEL SERVICE AND VIA E-MAILReference #:26-HFD-45-03-03Product:DrugsRecipient:Ehsan Sadri, M.D.361 Hospital Road, Suite 324Newport Beach,CA92663-3524United StatesIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesWARNING LETTERFDA Ref. No.: 26-HFD-45-03-03Dear Dr. Sadri:This Warning Letter informs you of objectionable conditions observed during the U.S. Food and Drug Administration (FDA) inspection conducted at your clinical site between March 27 and April 16, 2025. The investigators representing FDA reviewed your conduct of the following clinical investigations:Protocol(b)(4), “(b)(4),” of the investigational drug(b)(4)(preservative-free(b)(4)), performed for(b)(4)Protocol(b)(4), “(b)(4),” of the investigational drug(b)(4), performed for(b)(4)This inspection was conducted as a part of FDA’s Bioresearch Monitoring Program, which includes inspections designed to evaluate the conduct of research and to help ensure that the rights, safety, and welfare of human subjects have been protected.At the conclusion of the inspection, the FDA investigators presented and discussed with you the Form FDA 483, Inspectional Observations. We acknowledge receipt of your April 17, 2025, written response to the Form FDA 483.From our review of the FDA Establishment Inspection Report, the documents submitted with that report, and your written response dated April 17, 2025, it appears that you did not adhere to the applicable statutory requirements in the Federal Food, Drug, and Cosmetic Act (FD&C Act) and applicable regulations contained in Title 21 of the Code of Federal Regulations, part 312 (21 CFR 312), governing the conduct of clinical investigations and the protection of human subjects. We wish to emphasize the following:You failed to ensure that the investigation was conducted according to the investigational plan [21 CFR 312.60].As a clinical investigator, you are required to ensure that your clinical investigations are conducted in accordance with the investigational plan. The investigational plan for Protocol(b)(4)required you to ensure that all subjects met all eligibility criteria before enrollment in the study. For example, the protocol required the following inclusion criteria to be eligible for enrollment in the study:Central corneal endothelial cells (CEC) density of at least 2000 cells/mm in each eye at Visit 1 (Screening)Intraocular pressure (IOP) ≥ 21 mmHg in at least one eye at 8:00 a.m. at Visit 2 (Randomization)You failed to adhere to these requirements. Specifically:1. Subject(b)(6)’s central CEC density measurement was not completed at Visit 1 (Screening) on August 27, 2024, as required by the protocol. However, this subject was enrolled and received study drug on September 23, 2024.2. Subject(b)(6)’s IOP measurement at Visit 2 (Randomization) on September 23, 2024, at 8:00 a.m., was 16 mmHg in each eye, which was outside the protocol-specified range for eligibility. However, this subject was enrolled and received study drug on September 23, 2024.We acknowledge that the finding discussed above regarding Subject(b)(6)’s IOP measurement at Visit 2 (Randomization) at 8:00 a.m. was not included on the Form FDA 483 you received, and therefore your written response does not specifically address this finding.In your April 17, 2025, written response to the FDA 483, you acknowledged the observation and stated that the root cause was the repeated delay of site activation and the abrupt shortening of the enrollment period, which caused significant challenges, added pressure, and ultimately led to mistakes. As part of your corrective and preventive action plan, your written response stated that a checklist detailing the required assessments for each visit according to the protocol was created as part of your standard operating procedure (SOP). You stated that this checklist is reviewed by the subinvestigator during the visit and by the principal investigator at the conclusion of the visit, which provides a two-step review system to confirm eligibility and to verify that all required assessments are completed. You also stated that, upon site activation, each visit must have its checklist created, and it is the clinical research coordinator’s responsibility to ensure that each checklist and its source documents are reviewed by both investigators in a timely manner. Your response further stated that your site plans to revise its SOPs to include weekly team meetings, when you will review study status and progression.Your written response also outlined the following ongoing efforts to address systemic issues at the site: (1) comprehensive training programs for your clinical research coordinators, to manage multiple large-scale projects better; (2) revision of your resource-allocation strategies to ensure adequate support for all ongoing studies; (3) establishment of clearer communication channels with contract research organizations and clinical research associates to prevent inconsistencies; and (4) regular internal audits and monitoring.While we acknowledge your response that an abrupt shortening of the enrollment period led to challenges and mistakes, your response is inadequate because, regardless of the length of the enrollment period, you are still responsible for ensuring that subjects meet protocolspecified eligibility criteria before you enroll them into the study. Further, while we acknowledge the corrective and preventive actions that your site has taken or plans to take, your written response is inadequate because it does not provide sufficient details about how you, as a clinical investigator, will ensure adequate oversight of the study procedures (for example, adherence to eligibility requirements). In addition, your response is inadequate because you did not provide sufficient details about proposed changes to policies and procedures being implemented at your site to prevent similar violations in the future. Without this information, we are unable to determine whether your corrective action plan is adequate to prevent similar violations in the future.We emphasize that as the clinical investigator, it is your responsibility to ensure that studies are conducted in accordance with the investigational plan, both to protect the rights, safety, and welfare of subjects and to ensure the integrity of study data. Specifically, two of the nine subjects who were randomized and treated with investigational product at your site were ineligible for enrollment in the study. Your failure to ensure that subjects met all protocolrequired eligibility criteria before their enrollment in the study raises significant concerns about the safety of study subjects enrolled at your site, and raises concerns about the reliability of the data collected at your site.This letter is not intended to be an all-inclusive list of deficiencies with your clinical study of an investigational drug. It is your responsibility to ensure adherence to each requirement of the law and relevant FDA regulations. You should address any deficiencies and establish procedures to ensure that any ongoing or future studies comply with FDA regulations.This letter notifies you of our findings and provides you with an opportunity to address the deficiencies noted above. Within 15 business days of your receipt of this letter, you should notify this office in writing of the actions you have taken to prevent similar violations in the future. Failure to address this matter adequately may lead to regulatory action without further notice to you. If you believe that you have complied with the FD&C Act and relevant regulations, please include your reasoning and any supporting information for our consideration.Should you have any questions or concerns about this letter or the inspection, please email FDA at CDER-OSI-Communications@fda.hhs.gov. Your written response and any pertinent documentation should be addressed to:Brittany L. Garr, MPHBranch ChiefCompliance Enforcement BranchDivision of Enforcement and Postmarketing SafetyOffice of Scientific InvestigationsOffice of ComplianceCenter for Drug Evaluation and ResearchU.S. Food and Drug AdministrationBuilding 51, Room 535210903 New Hampshire AvenueSilver Spring, MD 20993Sincerely yours,{See appended electronic signature page}David C. Burrow, Pharm.D., J.D.DirectorOffice of Scientific InvestigationsOffice of ComplianceCenter for Drug Evaluation and ResearchU.S. Food and Drug Administration--------------------------------------------------------------------------------------------This is a representation of an electronic record that was signed electronically. Following this are manifestations of any and all electronic signatures for this electronic record.--------------------------------------------------------------------------------------------/s/------------------------------------------------------------DAVID C BURROW03/27/2026 11:07:26 AM

Delivery Method:Via EmailProduct:DrugsRecipient:Prime Sciences14500 N. Northsight Blvd, STE 100Scottsdale,AZ85260United Statesinfo@prime-sciences.comsupport@prime-sciences.comIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesWARNING LETTERMarch 31, 2026RE: 721805Prime Sciences:This letter is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website at https://prime-sciences.com/ from January to March 2026. The FDA has observed that your website offers “Cagrilintide,” “GLP1-R,” “GLP1-S,” “GLP1-T,” “Mazdutide,” and “BAC water” (hereinafter Prime Sciences products) for sale in the United States. Based on our review, these products are unapproved new drugs under section 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 355(a). As explained further below, introducing or delivering these products for introduction into interstate commerce violates sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a).These products are especially concerning from a public health perspective because injectable drug products can pose risks of serious harm to users. Injectable products are delivered directly into the body, sometimes directly into the bloodstream, and therefore, bypass some of the body’s key defenses against toxins and microorganisms that can lead to serious and life-threatening conditions.Despite statements on your product labeling marketing your products for “laboratory research purposes only” and “not for human consumption, medical use or veterinary use,” evidence obtained from your website establishes that your products are intended to be drugs for human use. Your products are drugs as defined by section 201(g)(1) of the FD&C Act 21, U.S.C. 321(g)(1), because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or intended to affect the structure or function of the body.Examples from your product labeling, including on your website, that provide evidence of the intended use (as defined in 21 CFR 201.128) of these products as drugs include, but may not be limited to, the following:CagrilintideOn the webpage https://prime-sciences.com/product/cagrilintide:“In one study, weight loss of 25% or more was achieved in 40.4% of patients receiving Cagri compared to 16.2% with semaglutide alone.”“Mechanism of action: Cagrilintide promotes weight loss through various mechanisms: Slowing gastric emptying. Reducing food intake. Modulating postprandial glucose spikes. Inducing satiety (feeling of fullness).”“Application: Research peptide with potential in diabetes management and obesity treatment.”GLP1-R (10MG) (identified as Retatrutide)On the webpage https://prime-sciences.com/product/glp1-r:“Retatrutide has shown higher weight loss results in clinical trials, with an average of up to 28% body weight reduction, compared to around 15% with semaglutide or Tirzapeptide.”“Retatrutide is a drug that works similarly to semaglutide and tirzepatide, but works in three different ways. Semaglutide targets your receptor of the GLP-1 hormone, which stabilizes your blood sugar, helping to reduce cravings while helping you to eat less, as well as slowing down your digestive system to help you feel fuller longer.”GLP1-S (10MG) (identified as Semaglutide)On the webpage https://prime-sciences.com/product/glp1-s:“Ozempic – Weight Loss Supplement.”“Semaglutide peptide therapy benefits include:o Participants taking semaglutide lost an average of 15.2% of their initial body weight . . .o Stimulates the pancreas to produce insulin and reduces the hunger hormone ghrelino Reduces blood sugar levels to promote weight loss”“Application: Research peptide with potential in diabetes management and obesity treatment.”GLP1-T (10MG) (identified as Tirzepatide)On the webpage https://prime-sciences.com/product/glp1-t:“Tirzepatide therapy benefits include:o A phase 3 randomized, controlled clinical trial demonstrated that Tirzepatide led to a 20 percent reduction in body weighto Stimulates the production of insulin to lower blood sugaro Reduces appetite by slowing the time it takes the stomach to empty”“Application: Functionally, Tirzepatide stimulates insulin release from the pancreas and reduces hyperglycemia.”MAZDUTIDE (10MG)On the webpage https://prime-sciences.com/product/mazdutide:“Mazdutide peptide therapy benefits include:o Weight Management???? Significant weight loss: In a phase 3 trial (GLORY-1), once-weekly mazdutide led to an average body weight reduction of up to 14.8%.”“Improved metabolic healtho Enhanced glycemic control: In patients with type 2 diabetes, mazdutide has been shown to significantly reduce blood glucose levels (HbA1c) and improve insulin sensitivity.o Reduced liver fat . . . some participants in a phase 3 trial achieving up to an 80% reduction.”o Lowered cardiometabolic risk factors: . . . Reduced blood pressure . . . Decreased total cholesterol and LDL . . . Lowered triglycerides”BAC waterYour firm offers a “Reconstitution Kit” for sale, which contains “BAC water” and a syringe. This kit is offered for sale alongside peptide products, which are drugs intended for injection and require reconstitution, including the above-mentioned products. The sale of a kit containing the “BAC water” and a means of injection (a syringe) with these peptide drugs demonstrates that you intend for the “BAC water” to be used in combination for injection. Therefore, your “BAC water” is a drug.Your Prime Sciences products are “new drugs” under section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because they are not generally recognized as safe and effective (GRASE) for use under the above-described conditions prescribed, recommended, or suggested in their labeling. With certain exceptions not applicable here, 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).ConclusionThe violations cited in this letter are not intended to be an all-inclusive statement of violations that may exist in connection with your products. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations.This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address this matter may lead to regulatory or legal action including, without limitation, seizure and injunction.Please notify FDA in writing, within fifteen working days of receipt of this letter, of the specific steps you have taken to correct any violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration. If you cannot complete corrective action within fifteen working days, state the reason for the delay and the time within which you will complete the correction.Your response should be sent to U.S. Food and Drug Administration, CDER/OC/Office of Unapproved Drugs and Labeling Compliance by email to FDAAdvisory@fda.hhs.gov. Please include your firm name and the unique identifier “721805” in the subject line of the email.Sincerely,/S/Tina Smith, M.S.Captain, U.S. Public Health ServiceDirectorOffice of Unapproved Drugs and Labeling ComplianceOffice of ComplianceCenter for Drug Evaluation and ResearchFood and Drug Administration

Delivery Method: VIA Electronic Mail Product: Medical DevicesRecipient:Jim BoyleCEOMedline Industries, LP3 Lakes DriveNorthfield,IL60093United StatesJBoyle@medline.comIssuing Office:Center for Devices and Radiological HealthUnited StatesWARNING LETTERCMS # 723866March 25, 2026Dear Mr. Boyle:During an inspection of your firm, Medline Industries, LP (NAMIC Division), located at 10 Glens Falls Tech Park, Glen Falls, NY 12801, from December 1, 2025 through December 12, 2025, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures and assembles numerous medical devices into Cardiovascular Procedure Kits to include (but not limited to) NAMIC brand Angiographic Control Syringes and manifolds intended to be used for the intra-arterial or intravenous administration of radiographic contrast media. 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.Quality System Regulation ViolationsThis inspection 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 System regulation found at Title 21,Code of Federal Regulations(CFR), Part 820.We received a response from Mr. Richard Kalita, Senior Manager of Quality Assurance, dated January 13, 2026, and February 27, 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 establish and maintain procedures for implementing corrective and preventive action, as required by 21 CFR 820.100(a).Specifically:A. Your firm failed to implement section 5.8.4 of your “Internal Corrective-Preventive Action Procedure (CAPA)” (SOP-00022; Rev. 40), which states “***[the] degree of corrective and preventive action taken to eliminate or minimize actual or potential nonconformities must be appropriate to the magnitude of the problem and commensurate with the risks encountered***”, in that your firm did not take actions commensurate with risk for NAMIC Angiographic Control Syringes in the field for which CAPA-01872 was opened due to an increase in complaints in June 2023 regarding disconnection from manifolds you attributed to the presence of excess silicone. Your Health Hazard Evaluation (HHE) Qual-124366 dated June 11, 2024, determined the risk was low, which is inconsistent with your design failure modes and effectiveness analysis (dFMEA) (RA2022047; Rev. 4) which identified "air embolism" as the highest severity issue for loose connections. Your firm’s corrective actions only included scrapping devices in inventory and increasing the cleaning frequency of the(b)(4)machine to prevent excess silicone from migrating to the luer connector, despite receiving 221 complaints and filing 177 MDRs for the disconnection of the NAMIC Angiographic Control Syringes from manifolds which impact patients and clinicians, including one (1) MDR # 3015910259-2025-00109 involving the injection of air into a patient (Complaint #(b)(4)dated(b)(4)) and one (1) MDR # 3015910259-2024-00045 involving biohazard exposure of a clinician (Complaint #(b)(4)dated(b)(4)).B. Your firm failed to implement section 5.19 of your “Internal Corrective-Preventive Action Procedure (CAPA)” (SOP-00022; Rev. 47; Effective: 11/1/25), in that “***while in the effectiveness check stage and either the effectiveness check failed or additional root causes or problems are identified; the CAPA may be routed back to a previous phase or an additional CAPA may be opened at the discretion of the CRB [CAPA Review Board]. Risk and containment activities must be considered when moving the CAPA to a previous phase***”. Your firm did not execute any of the above actions for CAPA-01872 when trending data revealed, as early as Quarter 1 of 2025, that the complaints per million (CPM) of NAMIC Angiographic Control Syringes manufactured post-corrective action was at 16.90 CPM followed by 16.44 CPM in Quarter 2 and 26.81 CPM in Quarter 3, all of which was above the 15.98 CPM threshold for complaints received for disconnections established in the verification of effectiveness plan (VOE AI#(b)(4)to start 1/15/25; Updated 8/1/25). Moreover, the total rate of complaints, including devices manufactured before and after the implementation of the corrective action (starting January 15, 2025) and for product where the manufacturing date is unknown, was 39.95 CPM, 31.62 CPM, and 59.27 CPM for Quarters 1, 2 and 3 of 2025, respectively.We reviewed your firm’s response and conclude that it is not adequate. In your January 13, 2026, response, your firm acknowledged that the corrective action was not effective, closed CAPA-01872, and opened a new CAPA-02612 to further investigate the issue. You also communicate a plan to issue a field correction with a safety notice to all customers who have received or will receive NAMIC Angiographic Control Syringes, based on a HHE (Qual-156459) of post-market data from June 2023 to December 2025, to alert them about the unwinding issue and provide reinforced instructions and additional guidance. You further state that you plan to develop(b)(4)syringe solution currently undergoing verification with production targeted to begin in(b)(4)and proposed that a field notice rather than a full product removal was appropriate given the effectiveness of prior communications, the upcoming alternative solution, and prevention of a market shortage.In your latest response on February 27, 2026, you state that you updated your HHE (Qual-156459; Approved 2/26/26) to reflect your revised plan to conduct a removal of NAMIC Angiographic Control Syringes based on multiple discussions with the agency regarding your recall strategy. This HHE reports a total CPM for the syringe/ manifold disconnection issue from June 2023 to February 19, 2026, as 62.62 CPM (250 complaints out of(b)(4)syringes manufactured ending(b)(4)). On March 13, 2026, an 806 Report was submitted to the agency for the removal of these devices ((b)(4)).You also indicate that you initiated an additional CAPA-02627 under which you conducted a systemic review of all open CAPAs and trained personnel on an updated CAPA procedure (SOP-00022) which requires more frequent post-market data reviews per established guidance. The targeted completion date for CAPA-02627 is June 30, 2026.With regards to CAPA-02612, no information was provided on when you anticipate a new investigation will be completed to determine the cause(s) of the disconnections between the syringes and manifolds to assure your actions are timely and commensurate with risk of this issue. Furthermore, no assurance was provided that the scope of the product removal will include affected devices manufactured both before and after the corrective action (April 17, 2024) since the corrective action was found to be ineffective. Furthermore, the manufacturing quantities documented in your updated HHE fall short of the nearly(b)(4)syringes your Senior Director of Quality stated were manufactured (approximately(b)(4)devices from(b)(4)to(b)(4)and nearly(b)(4)devices from(b)(4)to(b)(4)) in that it states that only(b)(4)syringes were manufactured through(b)(4), resulting in 62.62 CPM (250 complaints), without defining the manufacturing start date of affected products. The HHE also incorrectly specifies a corrective action start date of June 2024 instead of April 16, 2024, as specified in CAPA-01872.With regards to CAPA-02627, you did not identify actions that assure that employees will follow your corrective action procedure to route the CAPA back to a previous phase or open an additional CAPA as soon as it is evident that corrective actions are not effective, as was the case in(b)(4)of 2025 when your complaint analysis data showed that the CPM for syringe and manifold disconnections was above the established CPM thresholds.Please provide a response on how you plan to address the above deficiencies. In addition, please continue to provide updates on the progress of your corrections and/or corrective actions, including any supporting evidence.2. Failure to establish and maintain schedules for the adjustment, cleaning, and other maintenance of equipment to ensure that manufacturing specifications are met, as required by 21 CFR 820.70(g)(1).Specifically, your firm failed to implement sections 6.2.2 ((b)(4)Cleaning) and 6.3 (General Requirements) of your “GN 010 - Manufacturing Cleaning Procedure” (NMC-00228; Rev. 7; Effective: 5/2/25) which state “a top-to-bottom cleaning of the controlled environments will be conducted, at minimum,(b)(4)***The cleaning shall also include all equipment not routinely cleaned by operators***” and “***Always clean the(b)(4)first and work toward the(b)(4)of cleaning with the(b)(4)being last***,” respectively, of controlled environments such as the clean rooms where you manufacture various Angiographic and Radiology Syringes. In addition, the corresponding forms titled “(b)(4)Cleaning Schedule and Sign-off Sheet” form (NMC-00228-F-00001; Rev. 2) and “(b)(4)Cleaning Schedule and Sign-off Sheet” (NMC-00228-F-00002; Rev.1) are inadequate because they fail to ensure consistent implementation of sections 6.2.2 and 6.3 of NMC-00228 due to absence of specific instructions requiring the cleaning of top of manufacturing equipment as is included for the cleaning of vents, ceiling lights, walls, benches, cabinets, fixtures, etc. For example, on December 1, 2025, the investigator observed a visible accumulation of particulate on the top of manufacturing equipment in cleanrooms including the(b)(4)syringe manufacturing machine (ID # 90303527),(b)(4)machine (ID # 90306846),(b)(4)manufacturing machine (ID # 90308616), and(b)(4)machine (Asset # 8974). There have been approximately 114 complaints regarding foreign matter or hair in the package or device from December 2023 to at least December 1, 2025.We reviewed your firm’s response and conclude that it is not adequate. In your January 13, 2026, response, you state you performed immediate ad-hoc cleaning of all equipment to remove observed particulate matter, established preventative maintenance schedules based on(b)(4)of monitoring data, and updated the cleaning and preventative maintenance procedures (NMC-00228 and NMC-00171) to formalize these requirements followed by training under CAPA-02518. Additionally, you state you developed an ad-hoc cleaning procedure (NMC-01120) and addressed air filtration concerns by installing(b)(4)indicators around all cleanroom(b)(4)vents to ensure proper clearance, repaired damaged vents, and updated your environmental control procedure (NMC-00233) to include inspection and clearance requirements. You also determined that validation of the cleaning process was not required.In your latest response on February 27, 2026, you state you conducted a comprehensive review of the cleanroom manufacturing environments and identified improvement opportunities but not any risks. The target completion for these additional actions is April 30, 2026, and the target completion date of CAPA-02518 is July 17, 2026.However, there were no corrective actions identified to assess the impact of products in the field and inventory for products which have been manufactured in these cleanrooms since the last documented cleaning of equipment tops on November 26, 2023, including review of the manufacturing dates of products referenced in the 114 complaints received for foreign matter or hair since this date as a part of the respective complaint investigations. Please provide a response on how you plan to address the above deficiencies. In addition, please continue to provide updates on the progress of your corrections and/or corrective actions, including any supporting evidence.3. Failure to establish and maintain procedures for verifying the device design. Design verification shall confirm that the design output meets the design input requirements, as required by 21 CFR 820.30(f).Specifically, your firm’s design verification conducted under “Design Verification Protocol Polycarbonate Female Luer ISO 80369-7” (P017333; Rev. B; Approved: 10/7/20) with resulting “Design Verification Report Polycarbonate Female Luer ISO 80369-7” (P017334; Rev. A; Approved: 6/30/20) fails to demonstrate that the polycarbonate female luer connector components of your Fluid Management product lines (e.g., stopcock product family, manifold product family, disposable transducer product family, Y adaptor, etc.), which underwent changes to their threads and taper dimensions to become BS EN ISO 80369-7 compliant, meet the dimensional and functional testing requirements specified in this standard. For example, there was no documentation in the protocol (or elsewhere) on why design verification testing was only performed on a single female luer connector (Part # 24644210) and not any of the other(b)(4)connectors listed in the “Scope” section of this protocol which were also impacted by this design change. Moreover, this solely tested connector is not included in the final version of your “Design Change Analysis Form (DCAF) for ISO 80369-7 Compliance for Male and Female Luer Connectors (P017104) QUAL-66717 Rev. 4” (Approved: 9/7/22) which captures all luer connectors affected by this design change.We reviewed your firm’s response and conclude that it is not adequate. In your January 13, 2026 response, you state you revised the design verification procedure (NMC-00155) to require documentation of part selection rationale, added product configuration tables and guidance for recording representative SKU selection and rationale for selection in the Design Verification Protocol Template (NMC-00155-F-00001), and amended design change file QUAL-66717 to include the missing justification for part selection under CAPA-02610.In your latest response on February 27, 2026, you state you conducted a comprehensive review of all design changes from(b)(4)to present that required design verification testing and uncovered four (4) instances of insufficient documentation of part rationale which will require protocol updates with appropriate justification. The target completion of CAPA-02610 is June 1, 2026.However, review of the “Unit Rationale” provided revealed that it fails to explain how design verification testing of part number 41338202 covers anything beyond the manifold product family, such as the stopcock product family, disposable transducer product family, and Y adaptor of the Fluid Management product lines which were in the scope of the Design Verification. Moreover, this rationale does not explain why this part number was not listed in the final version of your “Design Change Analysis Form (DCAF) for ISO 80369-7 Compliance for Male and Female Luer Connectors (P017104) QUAL-66717 Rev. 4” (Approved: 9/7/22) meant to capture all the luer connectors affected by this design change. Please provide a response on how you plan to address the above deficiencies. In addition, please continue to provide updates on the progress of your corrections and/or corrective actions, including any supporting evidence.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 FD&C Act and its implementing regulations into account when considering the award of federal contracts. Additionally, should FDA determine that you have Quality 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.On February 2, 2024, the FDA issued afinal ruleamending the device current good manufacturing practice (CGMP) requirements of the Quality System (QS) Regulation under 21 CFR 820 to align more closely with the international consensus standard for Quality Management Systems for medical devices used by many other regulatory authorities around the world. The revised part 820, referred to as the Quality Management System Regulation (QMSR), became effective on February 2, 2026. Your most recent inspection on December 1, 2025 to December 12, 2025 was conducted pursuant to the QS Regulation, which was in effect at the time of the inspection. However, any corrective actions you propose or implement must be pursuant to the QMSR requirements in effect as of February 2, 2026. For more information on the QMSR please refer to our frequently asked questions webpage: https://www.fda.gov/medical-devices/quality-system-qs-regulationmedical-device-current-good-manufacturing-practices-cgmp/quality-management-system-regulation-final-rule-amending-quality-system-regulation-frequently-asked.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 FD&C 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 Gina Brackett, Establishment Assessment Team 1 Assistant Director at CDRHEnforcement@fda.hhs.gov. Please include in the subject line, “CMS Case 723866” when replying. If you have any questions about the contents of this letter, please contact: Sargum C. Morgan, Compliance Officer at sargum.morgan@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 A. MarsdenDirectorOffice of Regulatory ProgramsOffice of Product Evaluation and QualityCenter for Devices and Radiological HealthCC: Bradley R. Pratt, Sr. Director of Manufacturing Operations, BPratt@medline.com

Delivery Method:Via Email Product:DrugsRecipient:Max RadovanicMile High Compounds LLC490 Aspen Grove Dr.Clifton,CO81520United Statessupport@milehighcompounds.isIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesWARNING LETTERMarch 31, 2026RE: 721600Max Radovanic:This letter is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website at https://milehighcompounds.is, which links to your community forum www.skool.com/milehighcompoundsofficial/, from January to March 2026. The FDA has observed that your website offers “GLP-1 SM,” “GLP-2 TRZ,” “GLP-3 RT” and “BAC Water” (hereinafter Mile High Compounds products) for sale in the United States. Based on our review, these products are unapproved new drugs under section 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 355(a). As explained further below, introducing or delivering these products for introduction into interstate commerce violates sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a).These products are especially concerning from a public health perspective because injectable drug products can pose risks of serious harm to users. Injectable products are delivered directly into the body, sometimes directly into the bloodstream, and therefore, bypass some of the body’s key defenses against toxins and microorganisms that can lead to serious and life-threatening conditions.Despite statements on your product labeling marketing your products for “in vitro research and educational purposes only” and “not for human or veterinary consumption,” evidence obtained from your website establishes that your products are intended to be drugs for human use. Your products are drugs as defined by section 201(g)(1) of the FD&C Act 21, U.S.C. 321(g)(1), because they are intended to prevent, treat, or cure disease conditions and/or affect the structure or function of the body.Examples from your product labeling, including on your website, that provide evidence of the intended use (as defined in 21 CFR 201.128) of these products as drugs include, but may not be limited to, the following:GLP-3 RTOn the webpage https://milehighcompounds.is/product/glp-3-rt/: “GLP-3 RT is a triple-receptor agonist compound targeting GLP-1, GIP, and glucagon receptors.”From “The Ultimate Mile High Compounds Peptide Cheat Sheet” available through www.skool.com/milehighcompoundsofficial/:o “GLP-3 RT (Retatrutide)???? Uses: Weight Loss, Addiction Recovery???? Dosing: Start: 1mg - 2mg weekly. Titrate up to: 12mg weekly.”From the “Retatrutide (GLP- 3 RT) - Peptide Cheat Sheet” available through www.skool.com/milehighcompoundsofficial/:o “2. Benefits & EffectsUnprecedented Weight Loss & Metabolic ControlSignificant Weight Reduction. . .Improved Glycemic Control. . .Enhanced Lipid Profile. . .Liver Fat Reduction. . .Increased Energy Expenditure”GLP-2 TRZOn the webpage https://milehighcompounds.is/product/glp-2-trz/: “GLP-2 TRZ is a research-only compound designed for scientific investigation involving GLP-1 and GIP receptor pathways.”From “The Ultimate Mile High Compounds Peptide Cheat Sheet” available through www.skool.com/milehighcompoundsofficial/:o “GLP-2 TRZ (Tirzepatide)???? Uses: Weight Loss, Addiction Recovery???? Dosing: Start: 2.5mg weekly. Titrate up to: 15mg weekly.”From the “Tirzepatide - Peptide Cheat Sheet” available through www.skool.com/milehighcompoundsofficial/:o “2 Studied Research AreasVisceral Fat & Appetite Regulation. . .Lean Muscle Maintenance Research. . .Liver Health & Lipid Metabolism . . .Cognitive Function & Neuroprotection”GLP-1 SMOn the webpage https://milehighcompounds.is/product/glp-1-sm/: “GLP-1 SM is a research-only compound designed for scientific investigation involving GLP-1 receptor pathways.”From “The Ultimate Mile High Compounds Peptide Cheat Sheet” available through www.skool.com/milehighcompoundsofficial/:o “GLP-1 SM (Semaglutide)???? Uses: Weight Loss???? Dosing: Start: 0.25mg weekly. Titrate up to: 2.5mg weekly.”From the “Semaglutide - Peptide Cheat Sheet” available through www.skool.com/milehighcompoundsofficial/:o “2 Studied Research AreasVisceral Fat & Appetite Regulation . . .Lean Muscle Maintenance Research. . .Liver Health & Metabolism . . .Cognitive Function & Neuroprotection”BAC WaterYour firm offers “BAC Water” for sale alongside peptide products, which are drugs intended for injection and require reconstitution, including the above-mentioned products. The sale of these products together demonstrates that you intend for your “BAC Water” to be used in combination for injection. Therefore, your “BAC Water” is a drug.Your Mile High Compounds products are “new drugs” under section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because they are not generally recognized as safe and effective (GRASE) for use under the above-described conditions prescribed, recommended, or suggested in their labeling. With certain exceptions not applicable here, 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).ConclusionThe violations cited in this letter are not intended to be an all-inclusive statement of violations that may exist in connection with your products. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations.This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address this matter may lead to regulatory or legal action including, without limitation, seizure and injunction.Please notify FDA in writing, within fifteen working days of receipt of this letter, of the specific steps you have taken to correct any violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration. If you cannot complete corrective action within fifteen working days, state the reason for the delay and the time within which you will complete the correction.Your response should be sent to U.S. Food and Drug Administration, CDER/OC/Office of Unapproved Drugs and Labeling Compliance by email to FDAAdvisory@fda.hhs.gov. Please include your firm name and the unique identifier “721600” in the subject line of the email.Sincerely,/S/Tina Smith, M.S.Captain, U.S. Public Health ServiceDirectorOffice of Unapproved Drugs and Labeling ComplianceOffice of ComplianceCenter for Drug Evaluation and ResearchFood and Drug Administration

Delivery Method:Via Email Product:DrugsRecipient:Jonathan Snider, OwnerJonathan Speck, OwnerPekCura Labs3210 Bayou BlvdPensacola,FL32503United Statescontact@pekcuralabs.comIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesWARNING LETTERMarch 31, 2026RE: 721709Jonathan Snider and Jonathan Speck:This letter is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website at https://pekcuralabs.com/ in January 2026. The FDA has observed that your website offers “GLP-1-S” (all variations), “GLP-2-T” (all variations), “GLP-3-R” (all variations), and “Bacteriostatic Water” (all variations) (hereinafter PekCura Labs products) for sale in the United States. Based on our review, these products are unapproved new drugs under section 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 355(a). As explained further below, introducing or delivering these products for introduction into interstate commerce violates sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a).These products are especially concerning from a public health perspective because injectable drug products can pose risks of serious harm to users. Injectable products are delivered directly into the body, sometimes directly into the bloodstream, and therefore, bypass some of the body’s key defenses against toxins and microorganisms that can lead to serious and life-threatening conditions.Despite statements on your product labeling marketing your products for “Research, [sic] Development [sic] use only” and “are Not [sic] for Human [sic] consumption of any kind,” evidence obtained from your website establishes that your products are intended to be drugs for human use. Your products are drugs as defined by section 201(g)(1) of the FD&C Act 21, U.S.C. 321(g)(1) because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or intended to affect the structure or function of the body.Examples from your product labeling, including on your website, that provide evidence of the intended use (as defined in 21 CFR 201.128) of these products as drugs include, but may not be limited to, the following:GLP-1-S (all variations)On the webpages https://pekcuralabs.com/shop/pcl-glp-1-s-5mg/, https://pekcuralabs.com/shop/pcl-glp-1-s/, https://pekcuralabs.com/shop/gmp-pcl-glp-1-s/, and https://pekcuralabs.com/shop/gmp-pcl-glp-1-s-5mg/:“What is GLP-1-S? . . . In multiple studies utilizing once-weekly subcutaneous administration at a 2.4 mg dose, GLP-1-S consistently induced substantial reductions in body weight under experimental conditions. . . . GLP-1-S has also been associated with changes in cardiovascular endpoints in long duration studies. . . . GLP-1-S 2.4 mg administered weekly was associated with a reduced incidence of composite cardiovascular outcomes, including death from cardiovascular causes, nonfatalmyocardial infarction, and nonfatal stroke (Lincoff et al., 2023). An earlier trial using 0.5 mg and 1.0 mg doses similarly reported a statistically significant reduction in the rate of first occurrence of cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke in subjects with type 2 diabetes treated with GLP-1-S relative to placebo (Marso et al., 2016).”GLP-2-T (all variations)On the webpages https://pekcuralabs.com/shop/pcl-glp-2-t-10mg/, https://pekcuralabs.com/shop/pcl-glp-2-t-15mg/, https://pekcuralabs.com/shop/pcl-glp-2-t-30mg/, https://pekcuralabs.com/shop/pcl-glp-2-t-60mg/, https://pekcuralabs.com/shop/gmp-pclglp-2-t-15mg/, and https://pekcuralabs.com/shop/gmp-pcl-glp-2-t/:“What is GLP-2-T? . . . Across randomized controlled trials, GLP-2-T induced dose-dependent reductions in HbA1c and body weight, outperforming GLP-1 receptor agonists and basal insulin comparators (Karagiannis et al. 2022). Reductions in fat mass, as confirmed via body composition studies, indicate preferential loss of adiposity over lean mass (Sokary & Bawadi 2025).”GLP-3-R (all variations)On the webpages https://pekcuralabs.com/shop/pcl-glp-3-r-10mg/ and https://pekcuralabs.com/shop/gmp-pcl-glp-3-r-30mg/:“What is GLP-3-R? . . . In controlled studies, GLP-3-R led to significant, dose-dependent reductions in body weight (up to -24.2%), BMI, and waist circumference over 48 weeks, alongside improvements in metabolic markers such as HbA1c, fasting glucose, and blood pressure. These effects are attributed to its multi-receptor mechanism enhancing energy expenditure, insulin secretion, and lipid metabolism (Abouelmagd et al., 2025).”Cag (1mg) Tirz (10mg) BlendOn the webpage https://pekcuralabs.com/shop/pcl-ct-blend/:“What is C/T Blend? . . . The pairing of Cagrilintide’s amylinergic modulation with GLP-2-T’s incretin-based pathways presents a complementary approach to the investigation of integrated energy balance and metabolic regulation.”Bacteriostatic Water (all variations)Your firm offers “Bacteriostatic Water” for sale alongside peptide products, which are drugs intended for injection and require reconstitution, including the above-mentioned products. The sale of these products together demonstrates that you intend for your “Bacteriostatic Water” to be used in combination for injection. Therefore, your “Bacteriostatic Water” is a drug.Your PekCura Labs products are “new drugs” under section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because they are not generally recognized as safe and effective (GRASE) for use under the above-described conditions prescribed, recommended, or suggested in their labeling. With certain exceptions not applicable here, 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).ConclusionThe violations cited in this letter are not intended to be an all-inclusive statement of violations that may exist in connection with your products. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations.This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address this matter may lead to regulatory or legal action including, without limitation, seizure and injunction.Please notify FDA in writing, within fifteen working days of receipt of this letter, of the specific steps you have taken to correct any violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration. If you cannot complete corrective action within fifteen working days, state the reason for the delay and the time within which you will complete the correction.Your response should be sent to U.S. Food and Drug Administration, CDER/OC/Office of Unapproved Drugs and Labeling Compliance by email to FDAAdvisory@fda.hhs.gov. Please include your firm name and the unique identifier “721709” in the subject line of the email.Sincerely,/S/Tina Smith, M.S.Captain, U.S. Public Health ServiceDirectorOffice of Unapproved Drugs and Labeling ComplianceOffice of ComplianceCenter for Drug Evaluation and ResearchFood and Drug Administration

序号企业名称经营地址/仓库地址企业类型检查时间检查人员检查结果1安徽乐利医药科技有限公司安徽省合肥市经济技术开发区锦绣大道与习友路交口往南500米新高地科创中心质检A栋901室/安徽省合肥市经开区清潭路716号航嘉（合肥）科技园厂房F-401（2、3号门之间）药品批发企业2026-03-04凌定聪,许漪待整改后评定2安徽申济医药有限公司安徽省合肥市长丰县吴山镇合淮路吴山段360号2幢办公楼202室上下层/安徽省合肥市长丰县吴山镇合淮路吴山段360号3幢厂房第三层药品批发企业2026-03-04李玲,夏新生待整改后评定3安徽沃尔康健康产业有限公司合肥市经济技术开发区合肥医药健康产业园15号楼/合肥市经济开发区医药健康产业园A区9号仓储楼合肥医药健康产业园B区一期B-10#仓库一层药品批发企业2026-03-05李玲,夏新生待整改后评定4安徽创信医药有限公司安徽省合肥市高新区城西桥社区服务中心柏堰湾路2600号综合仓库1二楼东侧/安徽省合肥市高新区柏堰湾路2600号综合仓库楼三楼、四楼药品批发企业2026-03-06凌定聪,许漪待整改后评定5安徽瑞泓医药有限公司合肥市繁华大道与吉林路交口东南角联东U谷17号楼四层/合肥市繁华大道与吉林路交口东南角联东U谷17号楼一层、二层、三层西侧药品批发企业2026-03-11李玲,刘业飞待整改后评定6安徽健康源医药有限公司合肥市包河经济开发区乌鲁木齐路38号标准化厂房二号仓库201/合肥市包河经济开发区繁华大道与吉林路交口东南角联东U谷一期35#一至二层、40-01#三至四楼、40-02#一至四楼 安徽省阜阳市太和县沙河东路168号K栋（委托安徽华源医药集团股份有限公司储存）药品批发企业2026-03-13李玲,刘业飞待整改后评定7安徽海王国安医药有限公司安徽省合肥市经济技术开发区宿松路3888号合肥医药健康产业园综合办公楼201室/合肥市经济技术开发区合肥医药健康产业园11幢1、2、3层；12幢1、2、3层药品批发企业2026-03-18李玲,潘柳待整改后评定8合肥曼迪新药业有限责任公司合肥市包河大道曼迪新大厦/合肥市包河大道曼迪新大厦院内一号仓库、二号仓库药品批发企业2026-03-19李玲,潘柳待整改后评定9安徽国立医药集团有限公司安徽省合肥市包河区包河经济开发区上海路7号园区内综合办公楼二楼 203、205、206、207、208、209、210、211、212 及五楼503、506、508/合肥市包河工业园区（上海路七号）园区内仓库生产楼三层东南角B区、C区 安徽省阜阳市太和县沙河东路168号K栋（委托安徽华源医药集团股份有限公司储存）药品批发企业2026-03-20李玲,潘柳待整改后评定10安徽华源恒信医药有限公司安徽省合肥市经济技术开发区芙蓉路368号安徽九州通医药有限公司院内三期分拣中心四楼402、403、404、410、412、415、416、417、418、419/安徽省合肥市经济技术开发区芙蓉路368号安徽九州通医药有限公司院内二期分拣中心二楼药品批发企业2026-03-24凌定聪,许漪待整改后评定11合肥市国祯医药销售有限公司安徽省合肥市长丰县双凤工业区凤霞路西062号1#综合楼四层/安徽省合肥市长丰县双凤工业区凤霞路西062号1#综合楼一层、二层药品批发企业2026-03-25李玲,韩春艳待整改后评定12安徽广祥药业有限公司安徽省长丰县岗集镇JAC大道西侧4幢（四层）/安徽省长丰县岗集镇JAC大道西侧1幢（一层西）药品批发企业2026-03-26李玲,韩春艳待整改后评定13安徽卓悦健康产业有限公司安徽省合肥市庐江县高新区移湖西路15号A6幢202房西侧/安徽省合肥市庐江县高新区移湖西路15号A6幢102房、202房东侧药品批发企业2026-03-27李玲,欧元元待整改后评定