Delivery Method:Via EmailProduct:DrugsRecipient:Dynamic Health Group dba SARMS AMERICA2232 Dell Range Blvd, Suite 245Cheyenne,WY82009United Statessupport@sarmsamerica.codynamicgrouphealth@gmail.comdynamichealthgroupp@gmail.comIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesWARNING LETTERDecember 12, 2025RE: 719257Dynamic Health Group dba SARMS AMERICA:This letter is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website at the Internet address https://sarmsamerica.co/ in November 2025. The FDA has observed that you offer products marketed on your firm’s website as selective androgen receptor modulators (SARMs) including, but not limited to, “Ostarine MK-2866,” “MK-677 Ibutamoren,” “Cardarine GW501516,” and “LGD-4033 Ligandrol” (hereinafter products marketed as SARMs) 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).FDA has safety concerns about products that contain SARMs. Life-threatening reactions, including liver toxicity, have occurred in people taking products containing SARMs. SARMs also have the potential to increase the risk of heart attack and stroke.1Despite statements on your product labeling marketing your products, “[F]or research use only,” and “[F]or research purposes only,” evidence obtained from your product labeling, including your website establishes that your products are intended to be drugs for human use. Based on a review of your website, your products marketed as SARMs are drugs under section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1), because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease, and/or intended to affect the structure or any function of the body. Examples from your product labeling, including on your website, that provide evidence of the intended use (as defined in 21 CFR 201.128) of these products as drugs include, but may not be limited to, the following:Ostarine MK-2866On the webpage https://sarmsamerica.co/products/ostarine-mk-2866/:“MK-2866 has demonstrated a variety of potential benefits in research1. Increased strength2. Enhanced protein synthesis3. Accelerated muscle growth4. Boosted energy levels5. Improved bone health6. Better heart health7. Weight loss and reduction in body fat8. Enhanced recovery of connective tissue.”“Studies involving Ostarine1. A 2011 study showed that MK2866 significantly boosted lean body mass, muscle mass, and overall physical functionality in elderly males and postmenopausal females.”MK-677 IbutamorenOn the webpage https://sarmsamerica.co/products/ibutamoren-mk-677/:“MK677, also recognized as Ibutamoren, Oratrope, or Nutrobal . . . functions as a ghrelin agonist. It acts on the pituitary gland to stimulate the secretion of human growth hormone, making it a human growth hormone secretagogue.”“Administered orally, MK677 Ibutamoren mimics the action of the hunger hormone ghrelin, thereby increasing growth hormone (GH) levels in the body. It is notably effective in elevating insulin-like growth factor 1 (IGF-1) levels.”“MK 677 Benefits in Clinical Research1. MK-677 has demonstrated various effects in vivo, including: Increased GH levels Enhanced muscle mass and lean body mass Reduction in body fat Increased bone density Accelerated muscle growth Improved immune function Enhanced REM sleep Increased appetite Reversal of growth hormone deficiency Alleviation of pathology associated with beta-amyloid”“MK 677 and Body Composition1. Research has shown that MK677 increases bone turnover, bone mineral density, muscle mass, and osteoblast activity in older adults, thereby improving overall body composition.2. A randomized controlled trial conducted with health older adults revealed that daily administration of 25 mg of MK-677 improved body composition, bone mineral density, and cholesterol levels over several months, concurrently enhancing appetite.”Cardarine GW501516On the webpage https://sarmsamerica.co/products/cardarine-gw501516/:“Also known as Cardarine GW 501516 or Endurobol, this compound is a PPARδ receptor agonist. These receptors regulate various biological processes within the body. Research indicates that GW-501516 binds to these receptors, activating AMP-activated protein kinase (AMPK). According to studies, AMPK plays a crucial role in energy regulation and helps the body survive metabolic stress. By activating AMPK, GW-501516 can significantly boost fat loss and increase overall energy output.”“About Cardarine SARM . . .It has shown potential in aiding fat burning and possibly preventing obesity in users.o Increases fatty acid oxidation and promotes fat losso Lower LDL cholesterol (“bad cholesterol”)o Higher HDL cholesterol (“good cholesterol”)o Increases enduranceo Reduces inflammationo Decreases insulin resistance and improves glucose tolerance”“Maintaining Heart Health with Cardarineo In a twelve-week study, participants were administered varying dosages of GW-501516 (Cardarine), including 2.5mg, 5.0mg, and 10mg. . . . Fasting insulin, glucose, lipids, and free fatty acid levels were of the levels taken for said baseline. By the end of this twelve-week study, those involved had experienced a significant change in both cholesterol levels, meaning HDL and LDL. It was therefore concluded that GW 501516 has potential as a cardiovascular protection compound.”LGD-4033 LigandrolOn the webpage https://sarmsamerica.co/products/lgd4033-ligandrol/:“The popular SARM, LGD-4033, is known by various names in the scientific community, including Ligandrol, VK5211, and Anabolicum. Researchers have found that Ligandrol is effective in creating lean muscle mass and treating bone conditions such as osteoporosis.”“LGD 4033, also known as Ligandrol, is a selective androgen receptor modulator (SARM) that can provide the benefits of anabolic steroids without the associated negative side effects. It promotes an increase in lean muscle mass, enhances libido, and improves stamina. . . . Taken orally, this tissue-selective SARM can positively impact muscle weakness caused by osteoporosis, cancer, and aging.”“Potential Research Findings1. Lean Muscle Development: LGD-4033 has been studied for its ability to promote increases in lean muscle mass by activating androgen receptors in skeletal muscle.2. Strength Enhancement: Research suggests LGD-4033 may improve strength and power, supporting muscle performance under experimental conditions.3. Endurance Support: Some studies indicate its potential to enhance stamina and physical endurance, aiding in prolonged physical activity during research trials.4. Fat Mass Reduction: Findings suggest LGD-4033 may assist in reducing fat mass while preserving lean tissue, making it a focus of studies related to metabolic health.”Your products marketed as SARMs 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 “719257” 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_____________________1See https://www.fda.gov/consumers/consumer-updates/fda-warns-use-selective-androgen-receptor-modulators-sarms-among-teens-young-adults.

Delivery Method:Via Electronic Mail - Delivery and Read Receipt RequestedProduct:DrugsRecipient:Aaron M. SchneiderChief Pharmacy Officer & OwnerRevive Rx LLC dba Revive Rx Pharmacy3831 Golf Drive, Suite AHouston,TX77018-5218United StatesIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesWARNING LETTERWL # 709509September 22, 2025Dear Mr. Schneider:From January 27, 2025, to February 7, 2025, a U.S. Food and Drug Administration (FDA) investigator inspected your facility, Revive Rx LLC dba Revive Rx Pharmacy, located at 3831 Golf Drive, Suite A, Houston, TX 77018. During the inspection, the investigator noted serious deficiencies in your practices for producing drug products, which put patients at risk.FDA issued a Form FDA 483 to your firm on February 7, 2025. We reviewed your March 3, 2025, and March 4, 2025, responses to our Form FDA 483 in detail and acknowledge receipt of your subsequent correspondence. Based on this inspection, it appears that you produced drug products that violate the Federal Food, Drug, and Cosmetic Act (FDCA).A. Compounded Drug Products Under the FDCASection 503A of the FDCA describes the conditions under which human drug products compounded by a licensed pharmacist in a State licensed pharmacy or a Federal facility, or a licensed physician, qualify for exemptions from three sections of the FDCA: compliance with current good manufacturing practice (CGMP) (section 501(a)(2)(B)); labeling with adequate directions for use (section 502(f)(1)); and FDA approval prior to marketing (section 505) [21 U.S.C. §§ 351(a)(2)(B), 352(f)(1) and 355(a)].B. Violations of the FDCAAdulterated Drug ProductsThe FDA investigator noted that drug products intended or expected to be sterile were prepared, packed, or held under insanitary conditions, whereby they may have become contaminated with filth or rendered injurious to health, causing your drug products to be adulterated under section 501(a)(2)(A) of the FDCA. For example, the investigator observed that:1. Your firm exposed drug products intended to be sterile to worse than ISO(b)(4)quality air.2. Your firm did not perform adequate product evaluation and take appropriate corrective action after microbial contamination was recovered within the ISO(b)(4)aseptic processing area.3. Your media fills were not performed under the most challenging or stressful conditions. Therefore, there is a lack of assurance that your firm can aseptically produce drug products within your facility.4. Your firm failed to perform adequate smoke studies under dynamic conditions to demonstrate unidirectional airflow within the ISO(b)(4)area. Therefore, your products intended to be sterile are produced in an environment that may not provide adequate protection against the risk of contamination.5. Your firm failed to sterilize(b)(4)by routine sterilization cycles and protect from contamination by sterilizing(b)(4)on(b)(4)air lines/vents.6. Your firm failed to perform adequate routine environmental monitoring in the ISO(b)(4)area. Specifically,(b)(4)units are not monitored using meaningful environmental monitoring data to include surface, viable active air, or non-viable air samples inside the(b)(4)units.Under section 301(a) of the FDCA [21 U.S.C. § 331(a)], the introduction or delivery for introduction into interstate commerce of any drug that is adulterated is a prohibited act. Further, it is a prohibited act under section 301(k) of the FDCA [21 U.S.C. § 331(k)] to do any act with respect to a drug, if such act is done while the drug is held for sale after shipment in interstate commerce and results in the drug being adulterated.C. Corrective ActionsWe have reviewed your firm’s responses to the Form FDA 483.Regarding your responses related to the insanitary conditions, the following corrective actions appear deficient:1. Related to the transfer of(b)(4)vials through an ISO(b)(4)area, your response is focused on potential long term corrective actions such as upgrading the(b)(4)to change the entire area to ISO(b)(4), purchasing(b)(4)biosafety modules, or evaluating new(b)(4)to reduce or eliminate exposure to the ISO(b)(4)environment. However, your response did not address how you would ensure that other(b)(4)products are not exposed to worse than ISO(b)(4)quality air in the interim. In addition, you did not provide a copy of investigation 030325-02 as referenced in your response.2. Your response did not address microbial recoveries in the ISO(b)(4)areas of(b)(4)CFUs or less, including non-spore forming bacteria. Per your response, it appears that your firm’s action limit is greater than(b)(4)CFUs for all classified areas, including ISO(b)(4)areas. Please note that any microbial contamination in the ISO(b)(4)area is considered an insanitary condition. Any microbial contamination within the ISO(b)(4)area is a serious concern and upon recovery, your firm should immediately assess the impact on drug products produced. This assessment should include a thorough evaluation of how contamination could have entered this critical area, and over what period of time the contamination could have existed, as well as drug products that remain on the market that could be affected.3. You state that your firm “will commit to assessing and improving the current media fill program to include loading and unloading trays of media filled vials in the(b)(4).” However, your response did not address how you would ensure that(b)(4)products have appropriate media fills in the interim to ensure the processes are aseptic. Furthermore, your response did not state that you would cease or pause(b)(4)products you produce until adequate corrections are made.4. You acknowledged in your response that your firm does currently utilize a sterilization process for the(b)(4). Generally speaking,(b)(4)and(b)(4)are considered adequate methods for(b)(4)sterilization. We note it is difficult to demonstrate sterilization of a(b)(4)by chemical treatment, that is(b)(4), such as sporicidal agents on(b)(4)surfaces. You further stated that “We have opened an investigation 030325-06 for observation. A risk assessment of the current process and potential product quality impact will be conducted as part of the investigation. This will be accompanied by feedback from the vendor on sterilization procedures, and the potential addition of(b)(4)on the(b)(4)valves.” However, you did not provide a copy of investigation 030325‐06 as referenced in your response, nor did you provide documentation of improvements or corrections to EM monitoring inside the(b)(4). In addition, your response did not address interim corrections including but not limited to cessation of(b)(4)products until corrections are made. Furthermore, it appears based on the manufacturer’s equipment manual that your(b)(4)are not designed for sterilization cycles.Regarding your responses related to the insanitary conditions, some of your corrective actions appear adequate; however, we cannot fully evaluate the adequacy of the following corrective actions described in your response because you did not include sufficient information or supporting documentation:1. With regard to your TriMix Gel product you state that “Even though the product [Trimix Gel] has been discontinued, an investigation 030325-01 has been opened that includes a review of customer complaints, adverse events, and environmental monitoring for the Trimix Gel product…” However, you did not provide a copy of investigation 030325-01 as referenced in your response.2. You state that your firm’s new “smoke studies will include simulations that capture worst‐case, dynamic conditions on the video, along with interventions common to the processes employed in the facility during aseptic compounding in the ISO(b)(4)BSC hoods.” However, you have not provided any new smoke studies or protocols for new smoke studies. With respect to previously deficient smoke studies, you further state that your firm “opened investigation 030325‐04 for the observation and if there are any potential product quality concerns.” However, you did not provide a copy of investigation 030325‐04 as referenced in your response.Please be aware that section 501(a)(2)(A) of the FDCA concerning insanitary conditions applies regardless of whether drug products you compound meet the conditions of section 503A, including the condition on receipt of a prescription for an identified individual patient prior to compounding and distributing drug products.D. ConclusionThe violations cited in this letter are not intended to be an all-inclusive statement of violations at your facility. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations.You should take prompt action to address any violations. Failure to adequately address any violations may result in legal action without further notice, including, without limitation, seizure and injunction.Within fifteen (15) working days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to address any violations. Please include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. This letter notifies you of our concerns and provides you an opportunity to address them. If you believe your products are not in violation of the FDCA, include your reasoning and any supporting information for our consideration. If you cannot completely address this matter within fifteen (15) working days, state the reason for the delay and the time within which you will do so.Your response and any questions regarding the contents of this letter should be sent to compoundinginspections@fda.hhs.gov. In your response, refer to the Warning Letter Number above (# 709509) and include a subject line that clearly identifies the submission as a Response to Warning Letter.Sincerely,/S/F. Gail Bormel, JD, RPhDirectorOffice of Compounding Quality and ComplianceOffice of ComplianceCenter for Drug Evaluation and Researchcc: Mr. Lawerence T. BonkChief Quality Officer

Delivery Method:Via EmailProduct:DrugsRecipient:TITAN SARMS LLC191 University Blvd.Denver,CO80206United Statescontact@titansarms.comjedbigelow@hopkinsroden.comIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesWARNING LETTERDecember 12, 2025TITAN SARMS LLCJedediah Bigelow, Legal Counsel30 N. Gould St., Suite RSheridan, WY 82801RE: 719645TITAN SARMS LLC:This letter is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website at https://www.titansarms.com/ in November 2025. The FDA has observed that you offer products marketed on your firm’s website as selective androgen receptor modulators (SARMs) including, but not limited to, “LGD-4033” (also referred to on your website as Ligandrol), “RAD-140” (also referred to on your website as Testolone), “S-4” (also referred to on your website as Andarine), and “YK-11” (also referred to on your website as Myostatin Inhibitor) (hereinafter products marketed as SARMs) 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).FDA has safety concerns about products that contain SARMs. Life-threatening reactions, including liver toxicity, have occurred in people taking products containing SARMs. SARMs also have the potential to increase the risk of heart attack and stroke.1Despite statements on your product labeling marketing your products as “Research-grade compound[s]” and “RESEARCH-ONLY PURPOSE,” evidence obtained from your product labeling, including your website, establishes that your products are intended to be drugs for human use. Based on a review of your website, your products marketed as SARMs are drugs under section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1), because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease, and/or intended to affect the structure or any function of the body. Examples from your product labeling, including on your website, that provide evidence of the intended use (as defined in 21 CFR 201.128) of these products as drugs include, but may not be limited to, the following:LGD-4033 LigandrolOn the webpage https://www.titansarms.com/product/ligandrol-capsules:“SARMS STATSo CARDIAC ENDURANCEo PROTEIN SYNTHESISo MUSCULAR BULKo MUSCULAR RECOVERYo FAT OXIDATIONo MAXIMAL MASSo MUSCULAR ENDURANCE”“Ligandrol is a Selective Androgen Receptor Modulator (SARM) — known for its potent anabolic activity in muscle and bone tissue.In research settings, it has been shown to:o Increase lean body mass even at low doses.o Enhance muscle strength and endurance capacity.o Aid recovery from musculoskeletal injury.”“MUSCLE HYPERTROPHY:o Clinical studies have shown Ligandrol to significantly increase lean muscle mass in healthy adults within just weeks of administration.”“STRENGTH GAINS:o Participants in research trials have demonstrated measurable improvements in lifting strength and muscular endurance.”“RECOVERY SUPPORT:o By promoting anabolic signaling, Ligandrol can aid in tissue repair following injury or intense training.”RAD-140 TestoloneOn the webpage https://www.titansarms.com/product/rad140-capsules:“RAD-140 (Testolone) is a Selective Androgen Receptor Modulator (SARM) — studied for its high anabolic-to-androgenic ratio and potential neuroprotective benefits.In research settings, it has been shown to:o Stimulate significant muscle growth.o Enhance strength and power output.o Exhibit neuroprotective effects in research models.”“Lean Muscle Retentiono RAD-140 (Testolone) has been observed to induce robust gains in lean muscle mass, even at low research dosages.”“PERFORMANCE ENHANCEMENT:o Its anabolic effects contribute to improvements in maximal strength and explosive power.”S-4 AndarineOn the webpage https://www.titansarms.com/product/s4-capsules:“S-4 (Andarine) is a Selective Androgen Receptor Modulator (SARM) — originally developed for muscle wasting and osteoporosis.In research settings, it has been shown to:o Increase muscle mass while reducing fat.o Support bone density improvements.o Enhance muscular definition and vascularity.”“BODY COMPOSITION:o S-4 is often studied for its ability to reduce fat mass while preserving or increasing lean muscle.”“BONE HEALTH:o Research shows positive effects on bone strength and mineral density.”“AESTHETIC BENEFITS:o May enhance muscle hardness and vascularity in trained subjects.”YK-11 Myostatin inhibitorOn the webpage https://www.titansarms.com/product/yk11-capsules:“YK-11 is a Selective Androgen Receptor Modulator (SARM) — unique for also acting as a myostatin inhibitor, potentially unlocking greater muscle growth.In research settings, it has been shown to:o Increase muscle cell differentiation and size.o Reduce myostatin activity in muscle tissue.o Support rapid strength development.”“MYOSTATIN INHIBITION:o YK-11’s ability to down regulate myostatin expression may allow for greater muscle hypertrophy than SARMs without this effect.”“ACCELERATED STRENGTH:o Research models indicate faster increases in muscular strength compared to baseline.”“CELLULAR GROWTH:o By promoting follistatin expression, YK-11 supports muscle cell development and repair.”In addition, your website includes images of athletic men and women exercising or lifting weights.Your products marketed as SARMs 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 “719645” 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_____________________1See https://www.fda.gov/consumers/consumer-updates/fda-warns-use-selective-androgen-receptor-modulators-sarms-among-teens-young-adults.

　根据《广东省食品药品监督管理局关于〈药品经营许可证〉注销的管理规定》（粤食药监法〔2013〕26号），2025年12月17日，湛江市赤坎区市场监督管理局已依法注销湛江市益民大药房连锁有限公司赤坎京基三期店等2家企业《药品经营许可证》。现予以公布　　附：赤坎区注销情况表。湛江市赤坎区市场监督管理局2025年12月17日序号许可证号许可证有效期限企业名称注销时间注销原因1粤DB7590002182029/7/30湛江市赤坎区药安堂大药房有限公司2025/12/16企业申请2粤CB759A1142027/2/28湛江市益民大药房连锁有限公司赤坎京基三期店2025/12/5企业申请

Delivery Method:Via EmailProduct:DrugsRecipient:Pinnacle Professional Research dba Pinnacle Peptides1001 N Elm Street, Suite 31Greensboro,NC27401United Statesservice@pinnaclepeptides.comIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesWARNING LETTERDecember 12, 2025RE: 719337Pinnacle Professional Research dba Pinnacle Peptides:This letter is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website at the Internet address https://www.pinnaclepeptides.com in November 2025. The FDA has observed that you offer products marketed on your firm’s website as selective androgen receptor modulators (SARMs) including, but not limited to, “SARM’s S4 ANDARINE,” “LGD-4033,” and “MK-2866” (hereinafter products marketed as SARMs) 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).FDA has safety concerns about products that contain SARMs. Life-threatening reactions, including liver toxicity, have occurred in people taking products containing SARMs. SARMs also have the potential to increase the risk of heart attack and stroke.1Despite statements on your product labeling marketing your products, “FOR RESEARCH ONLY” and “NOT FOR HUMAN USE,” evidence obtained from your product labeling, including your website establishes that your products are intended to be drugs for human use. Based on a review of your website, your products marketed as SARMs are drugs under section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1), because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease, and/or intended to affect the structure or any function of the body. Examples from your product labeling, including on your website, that provide evidence of the intended use (as defined in 21 CFR 201.128) of these products as drugs include, but may not be limited to, the following:SARM's S4 ANDARINEOn the webpage https://www.pinnaclepeptides.com/buy-s4-sarms.html:“Andarine . . . is a non-steroidal selective androgen receptor modulator (SARM) . . . anabolic activity is similar to that of testosterone’s . . . for musculoskeletal disorders and benign prostatic hyperplasia [and] found to improve fertility and sexual health in men and women.”“Cancer . . . Andarine might have the ability to inhibit tumor growth. The androgen receptor has been shown to be associated with the development of pancreatic cancer. Hence, SARMs might prove effective in treating pancreatic cancer.”“[A]ndarine shows anticarcinogenic effects on lung cancer by inhibiting cell growth and proliferation and promoting apoptosis.”“Literature supports the evidence that S4 can boost muscle mass and increase strength.”“Andarine positively impacts bone mineral density and might offer a promising treatment for osteoporosis.”LGD-4033On the webpage https://www.pinnaclepeptides.com/buy-lgd-4033.html:“LGD-4033 . . . belongs to the class selective androgen receptor modulator (SARM). . . . [I]t exerts anabolic effects on muscles and bones without causing side effects associated with steroids.”“Osteoporosis . . . Ligandrol binds to the androgen receptors in bone cells and stimulates the activity of osteoblasts. Osteoblasts are the bone cells mainly responsible for the formation of bone and mineral deposition.”“Hormonal decline with age is associated with the loss of muscle health and function. . . . [L]igandrol can counteract these changes and boost muscle strength and mass.”“As ligandrol has been shown to improve bone mineral density, it might also speed up the healing of fractured bones.”MK-2866On the webpage https://www.pinnaclepeptides.com/buy-mk2866.html:“MK-2866 . . . belongs to the class selective androgen receptor modulator (SARM). . . . [I]t increases muscle mass and growth, improves insulin sensitivity and prevents bone loss. It has also been shown to treat breast cancer.”“[MK-2866] binds with androgen receptors in specific tissues such as muscles. This triggers the cascade of intracellular signaling, resulting in protein synthesis within muscle cells that promotes muscle growth and repair.”“One study investigated the effect of ostarine on cachexia in cancer patients. . . . [R]esults indicated a significant increase in lean body mass in patients who took ostarine as compared to the control group.”“Insulin Sensitivity . . . antidiabetic effect”Your products marketed as SARMs 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 “719337” 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__________________1See https://www.fda.gov/consumers/consumer-updates/fda-warns-use-selective-androgen-receptor-modulators-sarms-among-teens-young-adults.

Delivery Method:Via EmailProduct:DrugsRecipient:Andrew PierceAtomix LLC1309 Coffeen Avenue, Suite 1200Sheridan,WY82801United Statescontact@atomixresearch.com(b)(6)Issuing Office:Center for Drug Evaluation and Research (CDER)United StatesWARNING LETTERDecember 12, 2025RE: 719111Andrew Pierce:This letter is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website at https://atomixresearch.com/ in November 2025. The FDA has observed that you offer products marketed on your firm’s website as selective androgen receptor modulators (SARMs) including, but not limited to, “MK-2866” (also referred to on your website as Ostarine or Enobosarm) and “RAD-140” (also referred to on your website as Testolone) (hereinafter products marketed as SARMs) 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). We have also reviewed your Instagram and Facebook accounts at https://www.instagram.com/atomix.research/ and https://www.facebook.com/profile.php?id=61565345070286, which direct consumers to your website https://atomixresearch.com/, to purchase your SARMs products. 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).FDA has safety concerns about products that contain SARMs. Life-threatening reactions, including liver toxicity, have occurred in people taking products containing SARMs. SARMs also have the potential to increase the risk of heart attack and stroke.1Despite statements on your product labeling marketing your products for, “RESEARCH USE ONLY” and “not for human consumption,” evidence obtained from your product labeling, including your website, establishes that your products are intended to be drugs for human use. Based on a review of your website, your products marketed as SARMs are drugs under section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1), because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease, and/or intended to affect the structure or any function of the body. Examples from your product labeling, including on your websites, 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:MK-2866 Ostarine or EnobosarmOn the webpage https://atomixresearch.com/product/mk-2866-ostarine-25-mg-ml-50-ml/:“MK-2866, also known as Ostarine or Enobosarm, is a nonsteroidal selective androgen receptor modulator (SARM). It has been widely studied for its anabolic effects on muscle and bone while minimizing androgenic activity in other tissues.”“MK-2866 enhances lean muscle mass, improves strength, and supports skeletal integrity[.]”On a March 4, 2025, post on your Instagram account at https://www.instagram.com/p/DGyxya0h2cx/:“Ostarine (MK-2866) offers potential benefits in muscle growth and bone health, making it a candidate for treating conditions like muscle wasting and osteoporosis.”On March 4, 2025, Facebook post at https://www.facebook.com/photo/?fbid=122144674874511502&set=a.122112623036511502:“Muscle Growth and DifferentiationOstarine, also known as MK-2866, is a selective androgen receptor modulator (SARM) that has been shown to stimulate muscle tissue proliferation and differentiation. It enhances muscle cell proliferation and protein synthesis, which can be beneficial for conditions like sarcopenia and cachexia.”RAD-140 TestoloneOn the webpage https://atomixresearch.com/product/rad-140-10-mg-ml-50-ml/:“RAD-140, also known as Testolone, is a nonsteroidal selective androgen receptor modulator (SARM) designed to mimic the anabolic effects of testosterone while minimizing androgenic activity in non-muscular tissues.”“RAD-140 promotes lean muscle growth, enhances strength, and supports bone density, without significant prostate or liver toxicity being observed in traditional anabolic agents. It has also shown potential neuroprotective effects in models of neurodegeneration[.]”Your products marketed as SARMs 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 “719111” 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_________________1See https://www.fda.gov/consumers/consumer-updates/fda-warns-use-selective-androgen-receptor-modulators-sarms-among-teens-young-adults.

Delivery Method:VIA EMAIL WITH READ RECEIPTReference #:320-26-24Product:DrugsRecipient:Mr. Kyle HamzaVice PresidentDarmerica, LLC4380 Oakes Road, Suite 800Davie,FL33314United StatesKhamza@darmerica.comkyle@darmerica.comIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesWarning Letter320-26-24December 8, 2025Dear Mr. Hamza:The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, Darmerica, LLC, FEI 3012389174, at 4380 Oakes Road, Suite 800, Davie, from March 3 through 19, 2025.This warning letter summarizes significant violations, including deviations from Current Good Manufacturing Practice (CGMP) for active pharmaceutical ingredients (APIs).Because your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your APIs are adulterated within the meaning of section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 351(a)(2)(B). Your introduction or delivery for introduction into interstate commerce of adulterated drugs is a violation of section 301(a) of the FD&C Act, 21 U.S.C. 331(a).In addition, Darmerica has distributed drugs that are misbranded within the meaning of section 502(a) of the FD&C Act, 21 U.S.C. 352(a), due to false or misleading labeling, and section 502(f)(1) of the FD&C Act, 21 U.S.C. 352(f)(1), due to labeling without adequate directions for use. Darmerica also distributed drugs that are misbranded within the meaning of section 502(o) because they were not properly listed in accordance with section 510(j) of the FD&C Act, 21 U.S.C. 360(j), and 21 CFR Part 207. Your receipt in interstate commerce of misbranded drugs, and your introduction or delivery for introduction into interstate commerce of misbranded drugs, violate sections 301(c) and 301(a) of the FD&C Act, 21 U.S.C. 331(c) and 331(a), respectively.In addition, failure to provide listing information for a drug in accordance with 510(j) of the FD&C Act is prohibited under section 301(p) of the FD&C Act, 21 U.S.C. 331(p).These violations are described in more detail below.We reviewed your April 7, 2025, response to our Form FDA 483 in detail and acknowledge receipt of your subsequent correspondence.During our inspection, our investigators observed specific deviations including, but not limited to, the following.A. Adulterated DrugsFailure of your quality unit to exercise its responsibility to ensure that APIs manufactured at your facility are in compliance with CGMP.FDA investigators observed that your firm lacked adequate quality unit (QU) oversight for the receipt of materials, repackaging, relabeling, and related controls for your APIs, which causes the drugs you distribute to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act. The introduction of such drugs into interstate commerce is a prohibited act under section 301(a) of the FD&C Act, 21 U.S.C. 331(a). Examples of failures of your QU are listed below.1. Failure to Ensure that Your System for Evaluating Suppliers was AdequateFDA’s inspection revealed that your firm received API from(b)(4), FEI(b)(4). Darmerica also served as the firm’s U.S. agent starting in(b)(4). Darmerica remained listed as the U.S. agent for(b)(4)until(b)(4)de-registered its establishment in FDA’s registration system on(b)(4). The first documented shipment from(b)(4)to Darmerica was in(b)(4), and the last shipment to Darmerica was in(b)(4),(b)(4)prior to the FDA inspection at(b)(4). You initially approved(b)(4)as a supplier in(b)(4)and requalified the firm in(b)(4). As an example of a failure of your QU, as part of this qualification process,(b)(4)completed a vendor survey that asked whether it had had any regulatory inspections. In(b)(4),(b)(4)answered in the affirmative, stating that an inspection by FDA resulted in a “satisfactory” outcome even though the U.S. FDA had not inspected the firm. However, the vendor survey completed by(b)(4)in(b)(4)stated that it had not had any regulatory inspections. There is no indication that your firm investigated this discrepancy prior to requalifying(b)(4).Additionally, your quality agreements with(b)(4)included the provision of ongoing stability data generated per a stability protocol and annual stability data for appropriate packaging configuration. However, during an FDA inspection of(b)(4)in(b)(4), FDA investigators observed that there were no stability chambers nor stability and reserve samples available. In addition, the facility did not provide any stability data for at least one lot of each API manufactured in(b)(4)to our investigator. This encompasses the timeframe in which you received drugs from(b)(4)under the terms of the quality agreements that, consistent with your procedures, required adequate stability data as part of supplier qualification. If(b)(4)was unable to and/or did not provide stability data to your firm as required under your(b)(4)quality agreement, qualifying the firm as a supplier again in(b)(4)would indicate another failure of your system for evaluating suppliers.Your response to the Form FDA 483 is inadequate. You indicate that your firm’s failure to verify(b)(4)responses to a vendor survey “is not a failure for Darmerica to qualify all other manufacturers” as per your SOP. However, your firm qualified a supplier that gave inconsistent responses about its inspectional history and was not equipped to provide stability data for its products as required by your quality agreement. Your firm then imported and distributed drugs from that supplier despite its apparent failure to comply with the terms of your quality agreement. As noted below, based on our inspection of records at your facility and a review of FDA import data, FDA is also aware of non-compliance among other firms that have previously supplied APIs to your firm.2. Failure to Adequately Investigate Quality-Related Complaints and RecallsOur inspection also revealed that your firm did not adequately investigate customer complaints. Specifically, your QU failed to extend product quality complaint investigations to other lots of APIs potentially associated with the root cause, failure, or deviation. For example, you were made aware by(b)(4)on May 9, 2023, and(b)(4)on July 10, 2023, that(b)(4)lot(b)(4)manufactured by(b)(4), FEI(b)(4), contained black chunks that did not appear consistent with previous lots of the drug. You distributed API from this lot(b)(4)times to(b)(4)different customers. After receiving the complaint, your firm returned the remaining amount of lot(b)(4)in Darmerica’s inventory to the API manufacturer but did not contact your additional(b)(4)customers or investigate further whether they had also received complaints about any potential contamination.In your response, you state that the Darmerica’s investigation found that the particles were part of the(b)(4)shedding during the manufacturing process and that the supplier classified them as “technically unavoidable particles” that did not affect product quality. You conveyed to the two customers that complained about the product that your supplier suggested that the particles be removed manually. Notably, however, your QU decided to return your remaining impacted inventory of lot(b)(4)to the manufacturer without further investigation.Your response is inadequate. Though your firm conveyed the supplier’s confirmation of the issue to the two customers who initially submitted complaints, you failed to contact your other customers to determine whether they had experienced a similar problem. Your response states that “[a]ll other customers who bought the same product did not have any issue with the product,” but this cannot be confirmed if your firm did not contact those customers to investigate the matter. Further, your supplier’s response is indicative of a fundamental lack of understanding of CGMP, as the proposal for customers to manually remove the(b)(4)particles does not satisfy the requirement for drugs to meet the quality and purity characteristics they purport to possess.FDA is concerned that Darmerica accepted this supplier’s response as compliant with CGMP. There is no indication that your firm followed up on this supplier’s response any further or considered whether it was appropriate to continue purchasing API from a firm that displayed such a fundamental lack of understanding of CGMP. Notably, you distributed to clients a different lot of(b)(4), lot(b)(4), manufactured by the same supplier, that you received prior to the second complaint on July 10, 2023 and before the manufacturer could have corrected the issues with the equipment used in the manufacture of(b)(4)API.In addition, your recall procedure lacked clarity on how to handle supplier recalls. For example, your firm quarantined all(b)(4)products immediately after receiving a notice on(b)(4), of the firm’s voluntary recall of drugs from the U.S. market after FDA documented violations at this facility. All remaining(b)(4)material in stock at your firm was returned to(b)(4). However, there is no documented evidence that you informed your downstream customers of(b)(4)voluntary recall of drugs from the U.S. market or of the firm’s violative inspection. Your quality manager said clients were contacted via telephone, but there is no documented evidence that you contacted the numerous customers that received drugs manufactured by(b)(4). None of the APIs distributed to customers were returned to Darmerica. We acknowledge that your response included an updated recall procedure that requires future client contact to be documented.3. Failure to Ensure Adequate Pre-Release Testing of APIsYour firm lacked adequate QU oversight for the relabeling and repackaging of your API. Specifically, your firm failed to perform adequate testing and approve the results for your APIs prior to their release and distribution. For example, your firm released APIs for distribution prior to your QU completing its review. According to your records, your firm received and distributed a(b)(4)API,(b)(4), lot(b)(4)on(b)(4). Though a sample was sent to your third-party testing laboratory for analysis, the(b)(4)distribution of the(b)(4)API occurred prior to your firm’s own QU release of the(b)(4)API on(b)(4)and before the certificate of analysis (COA) was reviewed and authorized by your third-party lab on(b)(4).In your response, you state that due to patients’ need of the medication, the lot was released and distributed before the third-party lab tests were completed. This response is inadequate because without adequate testing, you cannot demonstrate that incoming materials conform to appropriate specifications prior to use in the manufacture of your drugs. As a manufacturer, you have a responsibility to sample, test, and examine incoming materials before release for use in production to assure adequate quality. This violation is of heightened importance given FDA’s documented compliance concerns related to API manufacturers in your supply chain.In response to this letter, provide:A detailed list containing API name, manufacturer name, manufacturer lot number, date of entry, import entry number, port of entry, order number, quantity, grade, usage, date of receipt, and information regarding the first date distributed, such as customer name and address, for all drugs received by your firm within three years from the date of this letter. If an import entry number is not available, that should be noted and provide the shipping records that you have (e.g. invoice, bill of lading, waybill, etc.).The following information, based on a comprehensive review of your material system:o Whether you have notified your customers that they received adulterated drugs from your firm. If you have not notified any customer who received adulterated drugs from Darmerica, notify them, and provide a copy of that notification in your response. The notification should include lot identification, recommended actions, and customer acknowledgement.o Evaluating all manufacturers of materials to determine if they are reliable and appropriately qualified.o An assessment of all materials to determine whether they are consistently of acceptable quality.Supplier qualification procedures implemented for new API manufacturers and supply chain verification measures taken by your firm, including the selection, qualification, and disqualification provisions.A detailed list of the manufacturers that have been evaluated for approval and/or qualification within the past three years from the date of this letter. This list should include, but not be limited to manufacturer name, address, FDA Establishment Identifier (FEI), point of contact and email address, current status (e.g., acceptable, unacceptable, disqualified, or hold), date approved, and whether a quality agreement is in place with the manufacturer. Any manufacturers that had their status changed from acceptable to unacceptable or disqualified should note the date this occurred and reason why.Based on a thorough review, provide a summary of your systemic corrective action and preventive action (CAPA) to remediate the vendor qualification program and prevent use of unsuitable material suppliers.A full reconciliation of any drugs from(b)(4), as well as for all firms or drugs currently on FDA import alerts, to determine if you have any remaining drugs from those firms in your possession. Up to date information regarding import alerts can be found at the following FDA website: https://www.accessdata.fda.gov/cms_ia/ialist.html.A list of investigations initiated within the past three years for deviations, discrepancies, complaints, out-of-specification (OOS) results, and failures.A comprehensive assessment of your overall complaint system, including a comprehensive list of all complaints where you returned drugs to the manufacturer, as well as information on whether you contacted your customers to investigate each complaint and the date of that contact, if applicable. If you have not contacted your customers to investigate each complaint, contact them, and provide a copy of that contact in your response.Provide a detailed action plan to remediate your complaint system. Your action plan should include, but not be limited to,o Significant improvements in investigation competencies, scope determination, root cause evaluation, CAPA effectiveness, QU oversight, and written procedures.o Address how your firm will ensure all phases of investigations are appropriately conducted.A comprehensive assessment and remediation plan to ensure your QU is given the authority and resources to effectively function. The assessment should also include, but not be limited to:o A determination of whether procedures used by your firm are robust and appropriate.o Provisions for QU oversight throughout your operations to evaluate adherence to appropriate practices.o A complete and final review of each lot and its related information before the QU disposition decision.o Oversight and approval of investigations and discharging of all other QU duties to ensure identity, strength, quality, and purity of all products.CGMP Consultant RecommendedBased upon the nature of the deviations identified at your firm, we strongly recommend engaging a consultant qualified to evaluate your operations to assist your firm in meeting CGMP requirements. We also recommend that the qualified consultant perform a comprehensive audit of 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.Your use of a consultant does not relieve your firm’s obligations to comply with CGMP. Your firm’s executive management remains responsible for resolving all deficiencies and systemic flaws to ensure ongoing CGMP compliance.B. Misbranded DrugsAs discussed below, your firm received and distributed misbranded drugs in interstate commerce, which are prohibited acts under sections 301(c) and 301(a), respectively.1. Distribution of drugs lacking adequate directions for useYou received retatrutide from your supplier,(b)(4), FEI(b)(4). Retatrutide is a GLP-1 API that is not identified as an active ingredient in any drug approved by FDA. You distributed this API to pharmacies seeking to compound human drugs under section 503A of the FD&C Act even though retatrutide is not eligible for use in compounding under section 503A.Additional APIs that you distribute or distributed to compounders seeking to operate under section 503A of the FD&C Act that are ineligible for use in human drug compounding under sections 503A include: dapoxetine hydrochloride, 2-methoxyestradiol (2ME2), tesofensine, FGL acetate aka [GLP-1]-FGL peptide acetate, thymogen, buserelin acetate, elamipretide (SS-31) acetate, larazotide acetate, and cagrilintide acetate.The labeling of these drugs fails to bear adequate directions for use, causing them to be misbranded under section 502(f)(1) of the FD&C Act. Such APIs are not exempt from section 502(f)(1) of the FD&C Act, 21 U.S.C. 352(f)(1), under FDA regulations (see 21 C.F.R. Part 201), and, as noted, they are intended for use in a compounded drug that would be ineligible for the exemptions provided by section 503A of the FD&C Act, 21 U.S.C. 353a. The introduction or delivery for introduction into interstate commerce of these drugs violates section 301(a) of the FD&C Act, 21 U.S.C. 331(a).We have reviewed your May 1, 2025, email submitted in response to our April 2, 2025, teleconference, in which you discuss your distribution of the APIs retatrutide base and cagrilintide acetate. We acknowledge your statement, “Darmerica has ceased importing/distributing Retatrutide and delisted the NDC registration from FDA’s CDER website. As discussed during the April 02, 2025, meeting with FDA, Darmerica stopped the importation and distribution of Cagrilintide and is in the process of delisting the NDC registration from the FDA’s CDER website.” Your corrective actions related to retatrutide base and cagrilintide acetate appear adequate.2. Receipt of drugs whose labeling is false or misleadingUnder section 502(a) of the FD&C Act, a drug is misbranded if its labeling is false or misleading in any particular. Your firm received multiple shipments of API that you knew to be mislabeled. Since March 2022, GLP-1 APIs were shipped to your firm as “custom peptide,” omitting the drug name. Because of this material omission, the labeling of the drug is false or misleading, causing the drug to be misbranded under section 502(a). We note that you acknowledged that this occurred, indicating it was to prevent theft of high demand products and to address the country’s export requirements for specific peptides.3. Receipt of drugs from establishments not duly registered with FDA and failure to provide listing information to FDASection 510 of the FD&C Act, 21 U.S.C. 360, and 21 CFR Part 207 set forth the requirements for establishment registration and drug listing. Under section 502(o), a drug is misbranded if, among other things, it was manufactured in an establishment not duly registered under section 510, or if it was not included in a list required by section 510(j). Under section 301(a), it is a prohibited act to introduce or deliver for introduction into interstate commerce any drug that is misbranded, and under section 301(c), it is a prohibited act to receive in interstate commerce a drug that is misbranded. In addition, failure to provide listing information for a drug in accordance with 510(j) of the FD&C Act is prohibited under section 301(p) of the FD&C Act, 21 U.S.C. 331(p).You received and distributed drugs from facilities that were not duly registered with FDA. For example, you provided an incorrect address for(b)(4), during the March 2025 inspection; that same address was listed in the firm’s establishment registration. An internet search of this firm’s address indicated that it was a residential building and not an API manufacturing facility. After placing the facility on import alert, FDA physically visited the address and confirmed that it is an empty apartment in a residential building. According to the firm’s registered point of contact, the firm had gone out of business the year before; the point of contact did not know who manufactured or distributed GLP-1 APIs that you received and distributed to your customers for use in GLP-1 drug products administered to patients in the United States. This supplier was not duly registered with FDA under section 510 of the FD&C Act, causing its drugs to be misbranded within the meaning of section 502(o).In addition, you distributed drugs for which you did not provide listing information under section 510(j). Specifically, under section 510(j)(1)(C) of the FD&C Act, 21 U.S.C 360(j)(1)(C), and 21 CFR 207.49(a)(4), a registrant must include in drug listings the name and quantity of each API in their listed drugs. In at least 23 of your drug listings, the proprietary name, non-proprietary name, and/or product labeling do not match the active ingredient provided in the Structured Product Labeling (SPL). For example, in your listing for the drug “Hexarelin Acetate” (NDC 71052-621), you list the active ingredient as peptide B27PD in the SPL. Similarly, in the listing for the drug API “Elamipretide (SS-31) Acetate” (NDC 71052-907), you list the active ingredient as peptide B27PD in the SPL. Therefore, “Hexarelin Acetate” and “Elamipretide Acetate” are not listed in accordance with section 510(j)(1)(C) of the FD&C Act, 21 U.S.C 360(j)(1)(C), and 21 CFR 207.49(a)(4), rendering them misbranded under section 502(o) of the FD&C Act, 21 U.S.C 352(o). The introduction of misbranded drugs into interstate commerce is prohibited under section 301(a) of the FD&C Act, 21 U.S.C. 331(a). Failure to provide listing information for a drug in accordance with 510(j) of the FD&C Act is prohibited under section 301(p) of the FD&C Act, 21 U.S.C. 331(p).It is your responsibility to ensure that all products manufactured at your establishment and those that you repackage/relabel comply with all establishment registration and drug listing requirements under section 510 of the FD&C Act, 21 U.S.C. 360, 21 CFR Part 207, and all other applicable FDA regulations. Registration and listing information and instructions on how to properly register an establishment or submit drug listings can be found in the FDA Electronic Drug Registration and Listing Instructions at https://www.fda.gov/drugs/electronic-drug-registration-and-listing-system-edrls/electronic-drug-registration-and-listing-instructions.Other ConcernsDrug Suppliers in Your Supply Chain with a History of Non-ComplianceWe note that a review of records collected from an inspection at your facility and a review of FDA import data demonstrated that FDA has, in the past, put more than(b)(4)of the manufacturers who supply your APIs on import alert because the drugs they manufacture appear to be adulterated under section 501 of the FD&C Act. Drugs from multiple API manufacturers used by Darmerica were listed on import alerts, including Import Alert 66-40 (IA 66-40) for the manufacturer’s apparent failure to conform with CGMP within the meaning of section 501(a)(2)(B) and Import Alert 66-79 (IA 66-79) for refusing to permit access to or copying of any record as required by section 704(a). To understand whether Darmerica has received any or introduced additional adulterated drugs in interstate commerce, we are requesting information regarding timing of receipt and distribution of drugs from the more than(b)(4)facilities listed below.Darmerica suppliers with drugs listed on IA 66-40 for suppliers’ failure to comply with CGMP:(b)(4)For manufacturers whose drugs are placed on IA 66-40 for failure to conform to CGMP within the meaning of section 501(a)(2)(B), FDA has evidence that the drugs listed in the import alerts appear to be adulterated. You are responsible for ensuring that the drugs you receive and distribute are manufactured in compliance with all relevant CGMP requirements for drugs. Up to date information regarding the import alerts can be found at the following FDA website: https://www.accessdata.fda.gov/cms_ia/ialist.html.Darmerica suppliers with drugs from manufacturers listed on IA 66-79 for refusing to permit access to or copying of any record as required by section 704(a).All drugs from the following facilities appear to be adulterated in that they have been manufactured, processed, packed, or held in a facility and the owner, operator, or agent of such facility delays, denies, or limits an inspection, or refuses to permit entry or inspection. These firms were approved by your firm prior to the March inspection:(b)(4)The following firms approved by your firm failed to respond to the agency’s records request during or after your 2025 inspection:After the FDA inspection, you stated that you improved your supplier qualification program. Yet the following firms that have supplied drugs to Darmerica have been found to be violative since the FDA inspection:(b)(4)In your response, provide the following information:Whether you distributed the drugs from a facility listed above during the time period after the supplier was found to have engaged in the violative activity identified and before any resolution (e.g., removal from an IA).For lots of API received and distributed by Darmerica during the relevant timeframe, indicate whether you have notified your customers that they received adulterated drugs from your firm. If you have not notified any customer who received adulterated drug API from Darmerica, notify them. Include lot identification and recommended actions in your notifications. In your response to this warning letter, provide a copy of that notification and customer acknowledgement.Destruction of Incoming LabelsOur investigators observed your firm destroying original labels during API receipt. FDA is concerned that this practice may obscure supply chain information that may be necessary during CGMP investigations, complaints, or other matters.Use of Pre-shipment SamplesDuring our inspection, it was observed that your firm was inappropriately relying on results of quality testing of pre-shipment samples that were shipped directly from the API manufacturer to your third-party laboratory for analysis. For example, your third-party testing laboratory received a sample of a(b)(4)API,(b)(4), manufacturer’s lot(b)(4)from an API manufacturer for testing on February 27, 2025. However, this same API was not received at your facility until March 3, 2025, four days later. Samples used for the sake of identity testing and evaluation of other quality attributes are to be taken at your facility from containers after receipt from the API manufacturer to ensure they are representative of the API in question and account for the conditions of transport to your facility.For more information about sampling and testing of representative samples to ensure suitability prior to use in repackaging or distribution to customers see FDA’s current guidance document,Questions and Answers on Current Good Manufacturing Practice Requirements | Control of Components and Drug Product Containers and Closuresat https://www.fda.gov/drugs/guidances-drugs/questions-and-answers-current-good-manufacturing-practice-requirements-control-components-and-drug.Importation of Unlisted DrugsUnder section 510(j)(1) of the FD&C Act and 21 CFR 207.41(a), a registrant must list each drug that it manufactures, repacks, relabels, or salvages for commercial distribution. As of July 28, 2025,(b)(4)FDA registered manufacturers that identify Darmerica as an importer do not list any drugs with FDA. In numerous instances, Darmerica has attempted to import drugs that are not listed with FDA into the United States. You are responsible for ensuring that the drugs you import are properly listed with FDA.Complete, accurate, and up-to-date establishment registration and drug listing information is essential to promote and protect patient safety. FDA relies on establishment registration and drug listing information for several key programs, including drug establishment inspections, supply chain security, and post-market surveillance. Drug registration and listing information is also widely used outside FDA for purposes such as electronic prescribing and electronic health records, insurance reimbursement, and patient education.ConclusionThe deviations cited in this letter are not intended to be an all-inclusive list of deviations that exist at your facility. You are responsible for investigating and determining the causes of any deviations and for preventing their recurrence or the occurrence of other deviations.This letter notifies you of our findings and provides you an opportunity to address them. After you receive this letter, respond to this office in writing within 15 working days. Specify what you have done to address any deviations and to prevent their recurrence. 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 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 3012389174 and ATTN: Marva Taylor.Sincerely,/S/Jill P. Furman, JDDirectorOffice of ComplianceCenter for Drug Evaluation and Research

全省各级药品监督管理部门深入贯彻落实党中央、国务院关于加强药品安全的一系列决策部署，持续加强药品全链条、全生命周期监督管理，严厉打击违法犯罪行为，依法查处了一批违法违规案件，切实保障人民群众身体健康和用药安全。现将2起违法违规案件典型案例公布如下。一、咸阳市渭城区某中医诊所使用劣药案2025年3月，咸阳市市场监管局执法人员根据投诉线索对咸阳市渭城区某中医诊所进行现场检查，发现该诊所销售超过有效期的药品和中药饮片，该行为违反了《药品管理法》第九十八条第一款、第三款第五项之规定，依据《药品管理法》第一百一十七条第一款、第一百一十九条之规定，给予该诊所没收涉案药品和违法所得、罚款的行政处罚。二、咸阳某大药房连锁有限公司网络销售国家实行特殊管理的药品案2025年5月，咸阳市市场监管局执法人员根据移送的案件线索对咸阳市某大药房连锁有限公司进行现场检查。发现该公司网络销售国家实行特殊管理的药品。该行为违反了《药品网络销售监督管理办法》第八条第二款及《药品网络销售禁止清单（第一版）》第二条第一款第一项、第二条第二款之规定，依据《药品网络销售监督管理办法》第三十三条之规定，责令改正，给予该公司罚款的行政处罚。

　　北京市药品不良反应监测中心严格按照药品生产领域监督检查工作部署，高效完成2025年度药物警戒质量管理规范符合性检查任务，深入排查潜在风险，指导企业完善药物警戒体系，按计划完成49家企业检查，并积极配合有关部门开展相应风险管理措施。　　围绕检查工作的科学性、规范性和协同性，重点推进六方面举措：　　一是科学制定年度检查计划。根据国家药品监督管理局部署的工作重点，结合风险评估情况提出建议检查名单，包含11家委托生产企业、5家疫苗企业、3家新获批创新药企业、10家集采企业，以及2家上年度检查中缺陷较多且整改情况不佳的企业。　　二是持续优化质量管理体系。修订《药物警戒质量管理规范符合性检查工作程序》，提升制度适用性与信息化适配水平。　　三是加强检查员队伍建设。已设立专职GVP检查员队伍，现有省级药物警戒专家级检查员1名、高级检查员3名。通过积极参与层级评定、组织专题培训和入企实训，持续壮大队伍规模、提升专业能力。　　四是精细做好检查准备。检查前组织资料预审和集体研判，聚焦潜在风险，明确检查重点，提升检查针对性和效率。　　五是协同企业属地直属分局联动推进。37家企业检查中引入分局检查员参与，有效促进分局监管力量对企业情况的深入了解。　　六是探索开展非现场检查。选取3家企业试点远程检查，制定《非现场检查资料清单与操作规程》。　　下一步，北京市药品不良反应监测中心将逐步扩大非现场检查比例，力争2026年底前实现首轮符合性检查全覆盖，并总结形成可复制、可推广的检查模式和工作机制，为构建科学高效的药物警戒监管体系提供实践支撑。

　　按照《广东省市场监督管理局关于印发促进经济高质量发展专项资金项目管理工作规程（试行）的通知》（粤市监财〔2023〕457号)和《广东省市场监督管理局食品安全监管专项资金管理细则》（粤市监协调〔2025〕31号）要求，我局抽选专家组成项目验收专家组，对目前已完成的2个项目进行了验收评审。现将项目验收结果公布如下：序号项目名称项目承担单位验收结果12025年特殊食品科普宣传项目广东省食品安全学会通过验收2广东省食品生产经营主体“互联网+AI监管”购买服务项目中国电信股份有限公司广东分公司通过验收　　特此公告。广东省市场监督管理局2025年12月23日