Delivery Method:VIA ELECTRONIC MAIL READ/DELIVERY RECEIPT REQUESTEDReference #:320-26-117Product:DrugsRecipient:Mr. Santhosh MathaiBusiness Head-PharmaceuticalsReliance Life Sciences Private LimitedDhirubhai Ambani Life Sciences CentreR-282 Ttc Area of MIDC, Thane Belapur Road, RabaleNavi Mumbai 400701 MaharashtraIndia(b)(6)Issuing Office:Center for Drug Evaluation and Research (CDER)United StatesAugust 18, 2026WARNING LETTERReference number: 320-26-117To Mr. Santhosh Mathai:This warning letter advises you of significant violations observed during a U.S. Food and Drug Administration (FDA) inspection of your facility. Promptly address the violations described herein without delay, including ensuring that appropriate resources are allocated to fully address the violations and prevent their recurrence. This is not intended to be an all-inclusive list of the violations that exist at your facility. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations. Failure to adequately address violations may result in regulatory action without further notice.FDA InspectionViolations were observed and documented during an inspection of your drug manufacturing facility, Reliance Life Sciences Private Limited, FDA Establishment Identifier (FEI) 3009510975, at Dhirubhai Ambani Life Sciences Centre, R-282 Ttc Area Of MIDC, Thane Belapur Road, Rabale, Navi Mumbai, Maharashtra, 400701 India, from February 19 to February 27, 2026. This inspection was conducted under FDA’s statutory authority and public health responsibilities to protect the public from unsafe, ineffective, and poor quality drugs.This warning letter summarizes significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals. See Title 21 Code of Federal Regulations (CFR), parts 210 and 211 (21 CFR parts 210 and 211).Because your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your drug products are adulterated within the meaning of section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 351(a)(2)(B).We reviewed your March 20, 2026, response to our Form FDA 483 in detail and acknowledge receipt of your subsequent correspondence.Violations of the Federal Food, Drug, and Cosmetic ActThe following are violations identified during our inspection. As a reminder, this is not an all-inclusive list of violations at your facility.1. Your firm failed to ensure that laboratory records included complete data derived from all tests necessary to ensure compliance with established specifications and standards (21 CFR 211.194(a)).Inaccurate Microbiology Laboratory RecordsYou failed to accurately document microbiology testing results. Specifically, multiple environmental monitoring and (b)(4) samples were documented in logbooks as collected and incubated; however, the corresponding plates could not be located in incubators during the inspection. Colony forming unit (cfus) counts had been recorded as if incubation was actively in progress. In interviews conducted by your management, your analysts confirmed these samples were not collected.In addition, your Laboratory Information Management System (LIMS) did not include a dilution factor to calculate the number of cfus per gram or milliliter of product for microbial limit test results, as required by your own procedures and applicable compendial methods. By releasing drug products based solely on raw plate count averages entered into your LIMS without applying the required dilution factor, you lack scientific evidence that each batch conforms to predetermined specifications prior to distribution. Appropriate testing is an essential part of ensuring that the drug products you manufacture conform to CGMP.Collectively, these deficiencies indicate a significant risk of systematic underreporting of microbial findings, which directly undermines your firm's ability to ensure the safety and quality of drug products distributed to patients.Reliability of data is fundamentally compromised when there is a failure to record data or to maintain complete and accurate records of test results. Furthermore, the lack of reliable data compromises the ability of your quality unit (QU) to exercise its function of ensuring compliance to applicable standards and deprives you of the ability to adequately investigate deviations.Inadequate Electronic Records ControlsYour firm did not have adequate controls to prevent the deletion or overwriting of (b)(4) integrity testing electronic data. Specifically, reports were not saved with unique file names, resulting in data being overwritten after every (b)(4) tests. In addition, (b)(4) integrity testing was not performed for Plant (b)(4). Therefore, your firm has no means of tracking or retrieving records of failed leak tests. The lack of adequate electronic records controls undermines the reliability and integrity of your laboratory data.(b)(4) integrity is critical to preventing product contamination. Routine (b)(4) integrity tests should be performed. The monitoring and maintenance program should identify and eliminate any (b)(4) lacking integrity and minimize the possibility of placing a sterile product at risk.All data must be complete, accurate and retained to enable appropriate assessment and decisions by the QU. The lack of control over the integrity of your data raises questions about the authenticity and reliability of your analytical data and the quality of your drug products.Your response states “the unaccounted samples may have been misplaced”. This explanation is contradictory as it does not address the fact that your own analysts confirmed during management interviews that the microbiological samples were never collected, nor does it address the broader pattern of inaccurate recordkeeping identified during the inspection. Your response indicates your commitment to hiring third parties to conduct a data integrity remediation plan, risk assessment, and product impact assessment. Your response is inadequate. You do not provide sufficient detail including specific timelines and deliverables on your data integrity remediation plan, risk assessment and product assessment. Furthermore, your response does not define the scope of third-party oversight responsibilities or establish accountability measures for the remediation effort.Additionally, you acknowledge deficiencies in your “(b)(4) integrity testing controls” and conducted a retrospective review. Your response is inadequate because although you conclude there is, “no evidence of product contamination attributable to (b)(4) failure”, the thoroughness of this review cannot fully support a definitive risk-based conclusion since you acknowledge that “historical traceability was incomplete”.We acknowledge your firm’s long-term commitment to improving your manufacturing operation, including, but not limited to, hiring additional microbiological laboratory staff and building a larger microbiological laboratory.Your quality system does not adequately ensure the accuracy and integrity of data to support the safety, effectiveness, and quality of the drugs you manufacture. See FDA’s guidance document Data Integrity and Compliance With Drug CGMP: Questions and Answers for guidance on establishing and following CGMP compliant data integrity practices at https://www.fda.gov/media/119267/download.We acknowledge that you are using independent third-party consultants to audit your operation and assist in meeting FDA requirements. In response to this letter, provide:A comprehensive investigation into the extent of the inaccuracies in data records and reporting. Your investigation should include:o A detailed investigation protocol and methodology; a summary of all laboratories, manufacturing operations, and systems to be covered by the assessment; and a justification for any part of your operation that you propose to exclude.o Interviews of current and former employees to identify the nature, scope, and root cause of data inaccuracies. We recommend that these interviews be conducted by a qualified third party.o An assessment of the extent of data integrity deficiencies at your facility. Identify omissions, alterations, deletions, record destruction, non-contemporaneous record completion, and other deficiencies. Describe all parts of your facility’s operations in which you discovered data integrity lapses.o A comprehensive retrospective evaluation of the nature of the testing data integrity deficiencies. We recommend that a qualified third party with specific expertise in the area where potential breaches were identified should evaluate all data integrity lapses.A retrospective review of all microbial limit test results to include the proper dilution factor to calculate the number of cfus per gram or milliliter of product for products currently in the U.S. market and within expiry as of the date of this letter and a report summarizing the findings of the analysis. Your action plan to address any product quality or patient safety risks for your drug products in U.S. distribution, including potential customer notifications and recalls.A current risk assessment of the potential effects of the observed failures on the quality of your drugs. Your assessment should include analyses of the risks to patients caused by the release of drugs affected by a lapse of data integrity and analyses of the risks posed by ongoing operations.A management strategy for your firm that includes the details of your global corrective action and preventive action (CAPA) plan. Your strategy should include:o A detailed corrective action plan that describes how you intend to ensure the reliability and completeness of all the data you generate including analytical data, manufacturing records, and all data submitted to FDA.o A comprehensive description of the root causes of your data integrity lapses including evidence that the scope and depth of the current action plan is commensurate with the findings of the investigation and risk assessment. Indicate whether individuals responsible for data integrity lapses remain able to influence CGMP-related or drug application data at your firm.o Interim measures describing the actions you have taken or will take to protect patients and to ensure the quality of your drugs, such as notifying your customers, recalling product, conducting additional testing, adding lots to your stability programs to assure stability, drug application actions, and enhanced complaint monitoring.o Long-term measures describing any remediation efforts and enhancements to procedures, processes, methods, controls, systems, management oversight, and human resources (e.g., training, staffing improvements) designed to ensure the integrity of your company’s data.o A commitment to have a qualified consultant conduct extensive annual audits, for at least two years, to assist in evaluating CAPA effectiveness after you have executed your data integrity remediation protocol.o An indication of whether you plan to hire a data integrity officer who is fully empowered to receive anonymous complaints from employees reporting data integrity concerns and with the authority to ensure any potential breach is promptly investigated (by independent quality assurance function, along with expertise from outside entities whenever needed).o A status report for any of the above activities already underway or completed.A comprehensive assessment of documentation systems used throughout your manufacturing and laboratory operations to determine where documentation practices are insufficient. Include a detailed CAPA plan that comprehensively remediates your firm’s documentation practices to ensure you retain attributable, legible, complete, original, accurate, contemporaneous (ALCOA) records throughout your operation.A comprehensive independent assessment of your laboratory practices, procedures, methods, equipment, documentation, and analyst competencies. Based on this review, provide a detailed plan to remediate and evaluate the effectiveness of your laboratory system.An action plan and timelines for conducting full microbiological testing of reserve samples to determine the quality of all batches of drug product distributed to the United States that are within expiry as of the date of this letter.A comprehensive, independent assessment of the design and control of your firm’s manufacturing operations, with a detailed and thorough review of all microbiological hazards.A detailed risk assessment addressing the hazards posed by distributing drug products with potentially objectionable contamination. Specify actions you will take in response to the risk assessment, such as customer notifications and product recalls.Complete investigations into all batches with potential objectionable microbial contamination. The investigations should detail your findings regarding the root causes of the contamination.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, the following: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 batch 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.2. Your firm failed to establish and follow appropriate written procedures that are designed to prevent microbiological contamination of drug products purporting to be sterile, and that include validation of all aseptic and sterilization processes (21 CFR 211.113(b)).Poor Aseptic PracticesOur inspection identified aseptic processing design deficiencies that pose significant hazards to drug product sterility. During a mock filling operation and during review of your unidirectional smoke studies, our investigators observed multiple instances of inappropriate aseptic behavior in which operators blocked unidirectional airflow at critical locations without implementing appropriate corrective measures, including discarding potentially compromised vials. Specific examples include:Blocking airflow over the stopper bowl and (b)(4) vials while refilling the stopper bowlPassing forceps over the (b)(4) and removing fallen vials from the (b)(4) and (b)(4) over (b)(4) vialsBlocking airflow during (b)(4) transfer operations, including (b)(4) repositioning of filled vials onto a (b)(4) and mechanical displacement of (b)(4) vials into the (b)(4) via forcepsAny compromise of first-air protection exposes sterile drug products to potential microbiological contamination.Cleaning, Decontamination, and MaintenanceYou failed to adequately clean, decontaminate, and maintain your (b)(4) used for aseptic drug product manufacturing. For example, our investigator observed multiple instances of deterioration and damage inside the (b)(4) used for manufacturing sterile drug products. These instances of deterioration and damage were not adequately addressed through your cleaning, decontamination, and maintenance programs. For example, our investigator observed:Deteriorated (b)(4) used to support the (b)(4) tankExcess sealant adjacent to the HEPA filters in the filling and (b)(4) areasUse of nonsterile wipes soaked in (b)(4) to clean (b)(4)In addition, our investigator observed accumulation of standing water and unknown (b)(4) staining on the wall surface adjacent to the (b)(4) pipelines, located outside the (b)(4) room within the HVAC area.All equipment and associated operational areas should follow a reliable, comprehensive preventive maintenance program. This program should be designed to ensure sustained operational integrity through the systematic implementation of validated cleaning and disinfection protocols, as well as the proactive replacement of components before they deteriorate or degrade. Maintenance and change management procedures should prevent practices that may compromise equipment or introduce contamination risks.Aseptic processes need to be designed to minimize exposure of sterile articles to potential contamination hazards. A suitable monitoring system is critical to maintain appropriate environmental conditions throughout your (b)(4) and cleanrooms. Prompt detection of an emerging problem is essential to preventing contamination of your aseptic production operations.Your response states existing procedures "did not adequately define acceptable hand positioning, intervention speed, first-air protection requirements, rejection criteria for potentially affected exposed units, or required actions following airflow interruption" and acknowledges “equipment design and ergonomic limitations within the (b)(4)”. Additionally, you state you will not resume operations until “successful aseptic process simulation run incorporating all listed interventions under worst-case conditions are completed”. Furthermore, you commit to updating procedures for (b)(4) sanitization and cleaning to include sterile (b)(4) and sterile wipes. Your response also states that remediations were made to equipment, including repairing all sealant joints in the (b)(4), smoothing internal machine surfaces to meet cleanability requirements, and updating maintenance checklists to include criteria for wear, damage, smoothness, cleanability, and material suitability.Your response is inadequate. You do not provide sufficient detail including deliverables on your third-party risk assessment of all aseptic filling lines. Additionally, your response does not sufficiently address the lack of oversight of operator aseptic behavior, equipment cleaning and maintenance, various manual activities, and intervention ergonomics.See FDA’s guidance document Sterile Drug Products Produced by Aseptic Processing - Current Good Manufacturing Practice to help you meet the CGMP requirements when manufacturing sterile drugs using aseptic processing, at https://www.fda.gov/media/71026/download.In your response to this letter, provide the following:Your CAPA plan to implement routine, vigilant operations management oversight of facilities and equipment. This plan should incorporate oversight from a qualified independent consultant and ensure, among other things, prompt detection of equipment/facilities performance issues, effective execution of repairs, adherence to appropriate preventive maintenance schedules, timely technological upgrades to the equipment/facility infrastructure, and improved systems for ongoing management review.A CAPA plan, based on the retrospective assessment of your cleaning and disinfection program, that includes appropriate remediations to your cleaning and disinfection processes and practices, and timelines for completion. Provide a detailed summary of vulnerabilities in your process for lifecycle management of equipment cleaning and disinfection. Describe improvements to your cleaning and disinfection program, including enhancements to cleaning effectiveness; improved ongoing verification of proper cleaning and disinfection execution for all products and equipment; and all other needed remediations.A comprehensive, independent risk assessment by a qualified consultant of all contamination hazards with respect to your aseptic processes, equipment, and facilities, including, but not limited to, the following:o All human interactions within the ISO 5 area (e.g., risk reduction or elimination of manual interventions wherever possible).o Equipment suitability (e.g., reliability, capability, ergonomics, placement) and sufficient cleanroom space.o Personnel Flow and Material Flow (movement throughout all rooms used to conduct and support sterile operations, and all material transfers).o Specific CAPA recommendations that will comprehensively address the design and control hazards identified in the risk assessment.A detailed remediation plan from the independent consultant with timelines to address the findings of the contamination hazards risk assessment. Describe specific tangible improvements to be made to aseptic processing operation design and control at your facility and explain how this CAPA plan will robustly remediate your deficient sterile manufacturing operations. Include comprehensive changes to the design of both your aseptic processing lines and cleanrooms, the specific barrier system to be used (e.g., Restricted Access Barrier, (b)(4)), and associated timelines. Also, describe your plans for qualification and validation of your extensively remediated operations.Ineffective Quality SystemSignificant findings in this letter demonstrate that your firm does not operate an effective quality system in accord with CGMP. In addition to the lack of effective management oversight of your production and laboratory operations, we found your quality unit is not enabled to exercise proper authority and/or has insufficiently implemented its responsibilities. Executive management should immediately and comprehensively assess your company’s global manufacturing operations to ensure that your systems, processes, and products conform to FDA requirements.Drug Recall and Drug Production SuspendedOn June 18, 2026, FDA held a teleconference with you recommending you consider removing any batches of sterile drugs currently in distribution from the U.S. market. On June 19, 2026, you agreed to recall all sterile drug products.We acknowledge your commitment to suspend production of all drugs at this facility for the U.S. market.You are responsible for resolving all deficiencies and systemic flaws to ensure your firm is capable of ongoing CGMP compliance prior to resumption of any manufacturing operations. In addition, based upon the nature of the violations we identified at your firm, you should engage a consultant qualified as set forth in 21 CFR 211.34 to assist your firm in meeting CGMP requirements. The qualified consultant should also perform a comprehensive six-system audit of your entire operation for CGMP compliance and evaluate the completion and efficacy of all CAPA, before you pursue resolution of your firm’s compliance status with FDA.In your notification to the Agency, provide a summary of your remediations to demonstrate that you have appropriately completed all CAPA.ConclusionYou are responsible for investigating and determining the root causes of any violations and implementing corrective and preventative measures to ensure future and sustained compliance so that these violations and any others do not occur.FDA placed all drugs and drug products offered for import into the United States from your firm on Import Alert 66-40 on July 9, 2026.FDA may withhold approval of new applications or supplements listing your firm as a drug manufacturer until any violations are completely addressed and we confirm your compliance with CGMP. We may re-inspect to verify that you have completed corrective actions to any violations.Failure to address any violations may also result in the FDA continuing to refuse admission of articles manufactured at Reliance Life Sciences Private Limited, Navi Mumbai, India into the United States under section 801(a)(3) of the FD&C Act, 21 U.S.C. 381(a)(3). Articles under this authority that appear to be adulterated may be detained or refused admission, in that the methods and controls used in their manufacture do not appear to conform to CGMP within the meaning of section 501(a)(2)(B) of the FD&C Act, 21 U.S.C. 351(a)(2)(B).Send your written response to CDER-OC-OMQ-Communications@fda.hhs.gov within fifteen (15) business days of receipt of this letter1. Identify your written response with FEI 3009510975 and ATTN: Claire Minden in the letter or in the subject line of the email.If you have information that you believe demonstrates that your products are not in violation of the FD&C Act and FDA regulations, include that information for our consideration.If you are considering an action that is likely to lead to a disruption in the supply of drugs produced at your facility, FDA requests that you contact CDER’s Drug Shortages Staff immediately, at drugshortages@fda.hhs.gov, so that FDA can work with you on the most effective way to bring your operations into compliance with the law. Contacting the Drug Shortages Staff also allows you to meet any obligations you may have to report discontinuances or interruptions in your drug manufacture under 21 U.S.C. 356C(b). This also allows FDA to consider, as soon as possible, what actions, if any, may be needed to avoid shortages and protect the health of patients who depend on your products.FDA posts warning letters on www.FDA.gov.Sincerely,/S/Francis GodwinDirectorOffice of Manufacturing QualityOffice of ComplianceCenter for Drug Evaluation and ResearchU.S. Food and Drug Administrationcc: Dr. Sandhya Narasimhanusagent1@masuuglobal.com___________________________1 Under program enhancements for the Generic Drug User Fee Amendments (GDUFA) reauthorization for fiscal years (FYs) 2023-2027, also known as the GDUFA III Commitment Letter, your facility may be eligible for a Post-Warning Letter Meeting to obtain preliminary feedback from FDA on the adequacy and completeness of your corrective action plans.

Delivery Method:Via Email Return Receipt RequestedReference #:320-26-119Product:DrugsRecipient:Ms. Helen GizaChief Executive OfficerFresenius Medical Care AG & Co. KGaAElse-Kröner-Straße 161352 Bad Homburg v.d. HöheGermany(b)(4)Issuing Office:Center for Drug Evaluation and Research (CDER)United StatesWarning Letter 320-26-119August 25, 2026Dear Ms. Giza:The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, Fresenius USA Manufacturing, Inc. dba Fresenius Medical Care North America Ogden Plant, FEI 1713747, at 475 W. 13th St., Ogden, Utah, from March 2 to 6, 2026.This warning letter summarizes significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals. See Title 21 Code of Federal Regulations (CFR), parts 210 and 211 (21 CFR parts 210 and 211).Because your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your drug products are adulterated within the meaning of section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 351(a)(2)(B).We reviewed your March 27, 2026, response to our Form FDA 483 in detail and acknowledge receipt of your subsequent correspondence.During our inspection, our investigator observed specific violations including, but not limited to, the following.1. Your firm failed to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, whether or not the batch has already been distributed (21 CFR 211.192).You failed to adequately investigate customer complaints for the large volume parenteral (LVP) bag drug products you manufacture. Your investigations were not thorough and did not appropriately evaluate the risk to product quality. You also failed to identify and implement adequate and timely corrective actions and preventive actions (CAPAs).Specifically, in August 2025 you initiated an investigation due to a complaint trend for leaking bags of Delflex Peritoneal Dialysis Solution. This investigation noted that you eventually received 35 complaints covering approximately 156 bags from multiple batches. Your investigation attributed the bag leaks “to holes caused by printing.”Despite your Risk Management Matrix indicating peritonitis as a potential harm and recommending the highest severity level, you instead assigned the lowest severity level with the potential harm being “damage of property.” Although you ultimately conducted a recall in April 2026 after our inspection, you chose not to conduct a recall following the results of your August 2025 investigation.Your justifications for these decisions included: the lack of attributable peritonitis cases, product labeling instructed users to inspect bags for leaks, the leaks should be readily detected before treatment, and leaking fluid should collect in the overwrap.Notably, following our inspection, you state that you reexamined part of one batch and “found presence of perforations in the primary container without substantial fluid present in the overwrap,” demonstrating your error in assuming that users can consistently detect leaks. Moreover, users should not be relied upon to detect leaking bags. In addition, once you knew of the trend of leaking bags in marketed product, there should have been a commensurate increase in urgency to contain the issue.Your decision not to recall these batches at that time exposed peritoneal dialysis (PD) patients to potentially non-sterile drug products. The use of non-sterile PD solution elevates the risk of developing peritonitis, the clinical consequences of which may include serious and potentially life-threatening complications. In addition, a significant component in this drug, dextrose, could serve as a nutritional source for contaminating microorganisms and promote their growth.In your response, you acknowledge that the risk assessment should have been based on peritonitis risk, and you should not have assumed that users would detect any leaking unit. Your firm reassessed the risk for this incident and decided to recall the impacted lots. You also revised your procedure to assure that known and potential harms are evaluated during risk assessments.Your response is inadequate. It does not include a sufficient CAPA, including improving detection of leaking units during manufacturing to prevent their release and distribution. This is especially concerning considering the numerous complaints, Field Alert Reports, and recalled batches in the last three years for leaking LVP bags manufactured at your facility. Notably, two Field Alert Reports you previously submitted involved leaking LVP bags with microbial contamination.In response to this letter, provide:A comprehensive, independent assessment of the root causes of leaking bags including, but not limited to:o A failure mode analysis for the potential causes of leaking bags that addresses the deficiencies in the printing technology used by your firm, as well as any other potential causes associated with handling of bags by equipment and personnelo An independent review of your printing controls and their capabilities, including potential for contributing to leaking bagso An analysis of alternative printing technologies that can minimize or eliminate the printing step as a cause of leaking bagso CAPA to address the identified root causes of leaking bags, such as the replacement of the current printing technologyA comprehensive assessment and remediation plan to ensure your quality unit (QU) is given the authority and resources to effectively function. The assessment should also include, but not be limited to:o A determination of whether procedures used by your firm are robust and appropriateo Provisions for QU oversight throughout your operations to evaluate adherence to appropriate practiceso A complete and final review of each batch and its related information before the QU disposition decisiono Oversight and approval of investigations and discharging of all other QU duties to ensure identity, strength, quality, and purity of all productsA comprehensive assessment of your overall system for investigating deviations, discrepancies, complaints, out-of-specification results, and failures. Provide a detailed action plan to remediate this system. Your action plan should include, but not be limited to, significant improvements in investigation competencies, scope determination, root cause evaluation, CAPA effectiveness, quality unit oversight, and written procedures. Address how your firm will ensure all phases of investigations are appropriately conducted.An independent review of in-process criteria for major and critical defects, including but not limited to leakers. Perform a retrospective evaluation, including:o A list of the number and types of all defectso Detailed long-term summaries (i.e., at least 5 years) of batch performance that address the period of recurring leaking incidentso All instances of batches with atypically high defects rates, with potential root cause of these deviationsProvide a comprehensive process capability assessment of your manufacturing process, with special emphasis on the capability of critical operational steps including but not limited to the detection of leaking bags, and any related CAPA to be initiated in response to the capability assessment. Also, include an assessment of operator handling practices and machine stresses that could lead to loss of bag integrity.Provide a remediated program that provides for ongoing statistical assessment of processing line performance to vigilantly monitor state of control. Specifically, include your program for statistical process control of each batch of drug products manufactured by your firm to monitor intra-batch and inter-batch variation and promptly detect a drift in process control.Provide the protocol for and subsequent report from an independent review of the qualification report(s), validation report(s), and maintenance program for the equipment that forms, fills, and seals your drug product bags. Also include an independent review of the methods used to detect leaking bags throughout processing, the frequency of monitoring, and the validation report for each method.A detailed summary of your validation program for ensuring a state of control throughout the product lifecycle, along with associated procedures. Describe your program for process performance qualification, and ongoing vigilant monitoring of both intra-batch and inter-batch variation to ensure a continuing state of control. Also, describe your equipment and facility qualification program.2. Your firm failed to establish adequate written procedures for production and process control designed to assure that the drug products you manufacture have the identity, strength, quality, and purity they purport or are represented to possess (21 CFR 211.100(a)).Your visual inspection program was inadequate to ensure that sterile injectable drug products were essentially free of visible particulates. Specifically, you failed to appropriately qualify personnel who performed visual inspections of injectable products. Your visual inspection qualification kit did not include adequately representative visible particulates (e.g., size), and your qualification records lacked sufficient detail to determine the qualifications of staff who perform visual inspection of (b)(4) bags.Your response states that your visual inspection qualification kit contained representative particulates. You add that you are developing a new kit that will continue to contain such particles, and that you will periodically review production and post market data to verify the kit remains representative.Your response is inadequate. It does not address the failure of your visual inspection qualification program to demonstrate that visual inspection personnel can detect visible particles at a level that meets the appropriate standard. The example particles in your kit may not be representative of smaller particles in your drug products.Visual detection of particulates is a probabilistic process that depends on, among other things, ensuring that visible particulates can be reproducibly detected by trained personnel with appropriate visual acuity. Your qualification kit should contain particles of a size and composition that adequately challenge inspectors across the range of particulate sizes that may be present in your drug product and should be qualified to demonstrate that inspectors can reliably detect visible particulates relevant to your specific product and container/closure system. These qualification kits should typically contain particles in the range of 100-150 microns to adequately challenge inspector detection capabilities.In response to this letter, provide:A remediation plan that better assures ongoing management oversight throughout the manufacturing lifecycle of all drug products. Provide a more data-driven and scientifically sound program that identifies sources of process variability, and assures that manufacturing operations meet appropriate parameters and quality standards. This includes, but is not limited to, evaluating suitability of equipment for its intended use, ensuring quality of input materials, determining the capability and reliability of each manufacturing process step and its controls, and vigilant ongoing monitoring of process performance and product quality.A comprehensive, independent assessment and remediation plan for your visual inspection program to ensure compliance with CGMP. The remediation plan should include but not be limited to:o Improved visual inspection methods, as appropriateo Improved qualification protocols and associated records for all staff performing visual inspectiono Incorporation of U.S. Pharmacopeia (USP) Visible Particulates in Injections standards into your procedureso Use of an appropriate range of visible particulate types and sizes, including particles of also approximately 100-150 microns, as part of staff qualification studieso All other provisions necessary to ensure appropriate qualification of visual particulate inspectorsDrug RecallOn April 6, 2026, you issued voluntary recalls of DELFLEX Dextrose Peritoneal Dialysis Solution due to Lack of Assurance of Sterility. The company announcements were posted to the FDA website:https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=219904https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=219905CGMP ConsultantBased upon the nature of the violations we identified at your firm, you should engage a consultant qualified as set forth in 21 CFR 211.34 to evaluate your operations and to assist your firm in meeting CGMP requirements. The qualified consultant should also perform a comprehensive six-system audit1 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.ConclusionThe violations cited in this letter are not intended to be an all-inclusive list of violations that exist at your facility. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations.If you are considering an action that is likely to lead to a disruption in the supply of drugs produced at your facility, FDA requests that you contact CDER’s Drug Shortages Staff immediately, at drugshortages@fda.hhs.gov, so that FDA can work with you on the most effective way to bring your operations into compliance with the law. Contacting the DrugShortages Staff also allows you to meet any obligations you may have to report discontinuances or interruptions in your drug manufacture under 21 U.S.C. 356C(b). This also allows FDA to consider, as soon as possible, what actions, if any, may be needed to avoid shortages and protect the health of patients who depend on your products.Correct any violations promptly. Failure to promptly and adequately address this matter may result in regulatory or legal action without further notice including, without limitation, seizure and injunction. Unresolved violations may also prevent other Federal agencies from awarding contracts.Failure to address violations may also cause FDA to withhold issuance of Export Certificates. FDA may withhold approval of new applications or supplements listing your firm as a drug manufacturer until any violations are completely addressed and we confirm your compliance with CGMP. We may re-inspect to verify that you have completed corrective actions to address any violations.This letter notifies you of our findings and provides you an opportunity to address the above deficiencies. After you receive this letter, respond to this office in writing within 15 working days1. Specify what you have done to address any violations and to prevent their recurrence. In response to this letter, you may provide additional information for our consideration as we continue to assess your activities and practices. If you cannot complete corrective actions within 15 working days, state your reasons for delay and your schedule for completion.Send your electronic reply to CDER-OC-OMQ-Communications@fda.hhs.gov. Identify your response with FEI 1713747 and ATTN: Russell Riley.Sincerely,/S/Francis GodwinDirectorOffice of Manufacturing QualityOffice of ComplianceCenter for Drug Evaluation and ResearchCC: Mr. Brett A. BartonGeneral ManagerVice President of Manufacturing Operations Ogden PlantFresenius USA Manufacturing, Inc. dba Fresenius Medical Care North America Ogden PlantEmail: (b)(4)________________________1 Under program enhancements for the Generic Drug User Fee Amendments (GDUFA) reauthorization for fiscal years (FYs) 2023-2027, also known as the GDUFA III Commitment Letter, your facility may be eligible for a Post-Warning Letter Meeting to obtain preliminary feedback from FDA on the adequacy and completeness of your corrective action plans.

Delivery Method:VIA ELECTRONIC MAIL READ/DELIVERY RECEIPT REQUESTEDProduct:DrugsRecipient:Jeffrey DengFounderPeak Performance Peptides3935 E Rough Rider Rd Unit 1016Phoenix, AZ 85050United Statescontact@pppepz.com(b)(6), (b)(7)(C)Issuing Office:Center for Drug Evaluation and Research (CDER)United StatesAugust 24, 2026WARNING LETTERReference Number: 735127To Jeffrey Deng:This warning letter advises you of significant violations observed during a U.S. Food and Drug Administration (FDA) review of your website. Promptly address the violations described herein without delay, including ensuring that appropriate resources are allocated to fully address the violations and prevent their recurrence. This is not intended to be an all-inclusive list of the violations that may exist in connection with your products or operations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations. Failure to adequately address violations may result in regulatory or legal action without further notice including, without limitation, seizure and injunction.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.FDA ReviewViolations were identified and documented during a review of your website pppepz.com in July 2026. Based on our review, “Bac water,” “GLP-3R” (retatrutide), “Semaglutide,” “SS-31,” “PT-141,” and “Tesamorelin”1 are unapproved new drugs under section 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 355(a). As explained further below, introducing or delivering these products for introduction into interstate commerce violates sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a).This review was conducted as part of FDA’s public health responsibility to protect the public from unsafe, ineffective, and poor-quality drugs.Violations of the Federal Food, Drug, and Cosmetic ActThe following are violations identified during our review. As a reminder, this is not an all-inclusive list of violations that may exist in connection with your products or operations.Unapproved New Drug ViolationsBased on a review of your website, “Bac water,” “GLP-3R” (retatrutide), “Semaglutide,” “SS-31,” “PT-141,” and “Tesamorelin” 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.2 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-3R (retatrutide)On, e.g., the webpage https://pppepz.com/product/retatrutide-5mg/:3“GLP-3R is a synthetic peptide under investigation for its potential effects on metabolic regulation, body weight management, and glycemic control. It acts as a multi-receptor agonist targeting GIP, GLP-1, and glucagon receptors in research settings.”“GLP-3R has been explored for its influence on appetite suppression, energy expenditure, and fat distribution. It is commonly considered in preclinical models studying obesity, metabolic health, and endocrine signaling.”“Studied for effects on glycemic control and insulin sensitivity”“Investigated for influence on appetite regulation and satiety pathways”“Explored for potential impact on body weight and fat distribution”“Considered in preclinical models of cardiometabolic and metabolic research”SemaglutideOn, e.g., the webpage https://pppepz.com/product/semaglutide-5mg/:4“Semaglutide is a synthetic glucagon-like peptide-1 (GLP-1) receptor agonist studied for its potential effects on glucose regulation, appetite control, and metabolic health.”“Semaglutide has been investigated for its influence on insulin secretion, satiety pathways, and body weight management. It is commonly considered in preclinical models exploring endocrine signaling, diabetes, and obesity-related research.”“Studied for effects on insulin secretion and glycemic control”“Investigated for influence on appetite regulation and satiety pathways”“Explored for potential impact on body weight and metabolic health”“Considered in preclinical models of endocrine and cardiometabolic research”SS-31On the webpage https://pppepz.com/product/ss-31-10mg/:“SS-31 (Elamipretide) is a mitochondria-targeted peptide studied for its potential to reduce oxidative stress, improve mitochondrial function, and support cellular energy production.”“SS-31 has been investigated for its effects on mitochondrial health, neuroprotection, and cardiovascular function. It is commonly considered in preclinical models exploring metabolic disorders, age-related diseases, and tissue protection.”“Studied for mitochondrial protection and enhancement of energy metabolism”“Investigated for effects on oxidative stress and cellular health”“Explored for potential neuroprotective and cardiovascular benefits”“Considered in preclinical models of aging, metabolic, and degenerative diseases”PT-141On the webpage https://pppepz.com/product/pt-141-10mg/:“PT-141 is a synthetic peptide studied for its potential effects on sexual arousal and neuroendocrine regulation. It acts on melanocortin receptors, influencing central nervous system pathways related to libido and reproductive signaling.”“PT-141 has been investigated for its effects on sexual behavior, central nervous system modulation, and endocrine signaling. It is commonly considered in preclinical models exploring sexual health, reproductive research, and neuroendocrine pathways.”“Studied for effects on sexual arousal and libido”“Investigated for modulation of melanocortin receptors and CNS pathways”“Explored for influence on reproductive endocrine signaling”“Considered in preclinical models of sexual health and neuroendocrine research”TesamorelinOn, e.g., the webpage https://pppepz.com/product/tesamorelin-5mg/:5“Tesamorelin is a synthetic growth hormone–releasing hormone (GHRH) analog studied for its role in stimulating endogenous growth hormone secretion and regulating metabolic pathways.”“Tesamorelin has been investigated for its effects on body composition, lipid metabolism, and tissue repair. It is commonly used in preclinical research exploring endocrine regulation, fat distribution, and regenerative pathways.”“Studied for stimulation of endogenous growth hormone release”“Investigated for influence on metabolism and lipid regulation”“Explored for potential effects on body composition and tissue repair”“Considered in preclinical models of endocrine and metabolic research”Bac waterYour firm offers “Bac water” for sale to be used to reconstitute the peptide products sold on your website, which are drugs intended for injection, 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.“Bac water,” “GLP-3R” (retatrutide), “Semaglutide,” “SS-31,” “PT-141,” and “Tesamorelin” are “new drugs” under section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because they are not generally recognized as safe and effective (GRASE) for use under the conditions prescribed, recommended, or suggested in their labeling. With certain exceptions not applicable here, a new drug may not be introduced or delivered for introduction into interstate commerce without an approved application from FDA in effect, as described in section 505(a) of the FD&C Act, 21 U.S.C. 355(a). No approved applications pursuant to section 505 of the FD&C Act, 21 U.S.C. 355, are in effect for these products. Accordingly, these products are unapproved new drugs. The introduction or delivery for introduction into interstate commerce of these unapproved new drug products violates sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a).ConclusionAs previously stated, you are responsible for investigating and determining the root causes of any violations and implementing corrective and preventative measures to ensure future and sustained compliance so that these violations and any others do not occur.Send your written response to FDAAdvisory@fda.hhs.gov within fifteen (15) business days of receipt of this letter. Include the specific steps you have taken to correct any violations, an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. Identify your response with reference number “735127” in the subject line of the email.If you have information that you believe demonstrates that your products are not in violation of the FD&C Act and FDA regulations, include that information for our consideration.Please note FDA posts warning letters on www.fda.gov.Sincerely,/S/Tina Smith, M.S.Captain, U.S. Public Health ServiceDirectorOffice of Unapproved Drugs and Labeling ComplianceOffice of ComplianceCenter for Drug Evaluation and ResearchU.S. Food and Drug Administration____________________1 Many of these are offered in different strengths.2 Despite statements on your product labeling marketing your products for “research use only” and “not for human consumption,” evidence obtained from your website establishes that your products are intended to be drugs for human use. In addition to the cited drug claims, you market bacteriostatic water as a solvent for reconstituting your products, thus, providing the means to prepare an injectable drug for human administration.3 Also found on your webpages https://pppepz.com/product/retatrutide-10mg/; https://pppepz.com/product/retatrutide-20mg/; and https://pppepz.com/product/retatrutide-30mg/.4 Also found on your webpages https://pppepz.com/product/semaglutide-10mg/ and https://pppepz.com/product/semaglutide-20mg/.5 Also found on your webpage https://pppepz.com/product/tesamorelin-10mg/.

Delivery Method:VIA UNITED PARCEL SERVICEReference #:320-26-120Product:DrugsRecipient:Mr. Michael DastoorChief Executive Officer and DirectorJabil Inc.10800 Roosevelt Blvd. N.St. Petersburg, FL 33716United States(b)(4)Issuing Office:Center for Drug Evaluation and Research (CDER)United StatesAugust 27, 2026WARNING LETTERReference number: 320-26-120To Mr. Michael Dastoor:This warning letter advises you of significant violations observed during a U.S. Food and Drug Administration (FDA) inspection of your products and facilities. Promptly address the violations described herein without delay, including ensuring that appropriate resources are allocated to fully address the violations and prevent their recurrence. This is not intended to be an all-inclusive list of the violations that exist at your facility. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations. Failure to adequately address violations may result in regulatory action without further notice including, without limitation, seizure and injunction.FDA InspectionViolations were observed and documented during an inspection of your drug manufacturing facility, Pharmaceutics International, Inc. (a Jabil Company), FDA Establishment Identifier (FEI) 3006503102, at 103 Beaver Court, Cockeysville, MD, from February 23 to March 6, 2026. This inspection was conducted under FDA’s statutory authority and public health responsibilities to protect the public from unsafe, ineffective, and poor quality drugs.This warning letter summarizes significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals. See Title 21 Code of Federal Regulations (CFR), parts 210 and 211 (21 CFR parts 210 and 211).Because your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your drug products are adulterated within the meaning of section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 351(a)(2)(B).We reviewed your March 27, 2026, response to our Form FDA 483 in detail and acknowledge receipt of your subsequent correspondence.Violations of the Federal Food, Drug, and Cosmetic ActThe following are violations identified during our inspection and review. As a reminder, this is not an all-inclusive list of violations at your facility.1. Your firm failed to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, whether or not the batch has already been distributed (21 CFR 211.192).Your firm operates as a contract manufacturer of sterile injectables for (b)(4). You failed to adequately investigate a sterility test failure as well as recurring mold recoveries in the ISO 5 (Grade A) filling area.Sterility FailureYou did not adequately investigate a failed sterility test result for your aseptically filled (b)(4) mg/(b)(4)ml. Your firm identified Ustilago spermophora, a fungi, in (b)(4) medium. Your investigation’s root cause finding of “undetermined” was inadequate. Although your firm rejected this batch, your investigation did not thoroughly examine all possible root causes including but not limited to potential routes of fungi migration through your classified areas (e.g., personnel/material flow hazards, HVAC hazards, inadequate disinfection). Additionally, your investigation lacked adequate corrective action and preventive action (CAPA) responses.In your response, we acknowledge your intentions to strengthen investigation requirements, perform a retrospective review of investigations, and review the facility’s contamination control strategy. However, your response does not specifically address the sterility failure investigation.Environmental Monitoring (EM) Action Level ExcursionsYour firm’s investigations into multiple instances of fungi contamination on and below the (b)(4) of aseptic processing lines have been inadequate. For example:On March 20, 2024, Chaetomium globosum was recovered below the (b)(4) of the (b)(4) vial machine in suite (b)(4) after filling a batch of (b)(4) mg/(b)(4)ml. Your investigation was inadequate as it did not adequately evaluate potential root causes, including whether the mold was introduced during filling operations. You released the product without sufficient investigation.On May 16, 2025, fungi was recovered in two locations within the (b)(4) filling line in suite (b)(4). The passive air sample recovered Didymella glomerata during the filling of (b)(4) injection. You attributed the mold recovery to a power failure that occurred during filling. Notably, surface monitoring below the (b)(4) also recovered Mycosphaerella africana after the power was restored. The investigation lacked sufficient CAPA.On June 4, 2025, Chaetomium cruentum/globosum was recovered from the (b)(4) of the (b)(4) vial machine in suite (b)(4) after filling a batch of (b)(4) mg/(b)(4)ml. Your firm rejected the batch but failed to adequately investigate likely root causes. You stated within the investigation, “historically there has never been a mold hit isolated on the grade A space on the (b)(4) filling Line,” however the same mold, Chaetomium globosum, had been recovered, on March 20, 2024, on the same line. The investigation lacked CAPA.Overall, trends of fungal recoveries within your suites (b)(4), and supporting cleanrooms, have significantly increased since 2023. Your firm has closed investigations without implementing robust CAPA. Your firm also has not adequately evaluated the ongoing trend of adverse findings of fungi within your aseptic production area, directly within product, and on product contact surfaces over time.In your response you commit to revise your procedures to perform routine trend analysis and strengthen your investigations. Your response is inadequate because you indicate that product impact conclusions in investigations were appropriate based on a lack of sterility failures, adverse environmental monitoring trends, and complaints, but fail to sufficiently address contamination sources. Your firm has not demonstrated that you have remediated your investigational capabilities to ensure scientifically rigorous investigations to effectively identify root causes so that appropriate CAPA can be implemented.To ensure proper root cause analysis and appropriate CAPA implementation, investigations must be thorough, well-documented, scientifically sound, and timely. Procedural updates and training alone do not address the systemic failures that allowed deficient investigations to persist undetected by quality unit (QU) oversight.In response to this letter, provide:A comprehensive, independent assessment of your overall system for investigating deviations, discrepancies, complaints, out-of-specification results, and failures. Provide a detailed action plan to remediate this system. Your action plan should include, but not be limited to, significant improvements in investigation competencies, scope determination, root cause evaluation, CAPA effectiveness, QU oversight, and written procedures. Address how your firm will ensure all phases of investigations are appropriately conducted.An independent assessment and remediation plan for your CAPA program. Provide a report that evaluates whether the program includes effective root cause analysis, ensures CAPA effectiveness, analyzes investigation trends, improves the CAPA program wherever needed, ensures final QU decision authority, and is fully supported by executive management.A comprehensive, independent risk assessment of all contamination hazards with respect to your aseptic processes, equipment, and facilities, including but not limited to, the following:o All human interactions within the ISO 5 area (e.g., risk reduction or elimination of manual interventions wherever possible)o Equipment suitability (e.g., reliability, capability, ergonomics, placement) and sufficient cleanroom spaceo Air quality in the ISO 5 area and surrounding room including, but not limited to, air volume and flowo Facility layouto Personnel Flow and Material Flow (movement throughout all rooms used to conduct and support sterile operations, and all material transfers)o Specific CAPA recommendations that will comprehensively address the design and control hazards identified in the risk assessmentA detailed remediation plan with timelines to address the findings of the contamination hazards risk assessment. Describe specific tangible improvements to be made to aseptic processing operation design and control at your facility and explain how this CAPA plan will robustly remediate your deficient sterile manufacturing operations. Include comprehensive changes to the design of both your aseptic processing lines and cleanrooms. Also, describe your plans for qualification and validation of your extensively remediated operations.An independent, comprehensive review of your EM program to ensure vigilant, timely detection and response to potential product contamination hazards in your manufacturing environment. This assessment should include, but not be limited to:o establishing appropriate limits,o sampling methods,o sampling locations and frequencies,o trend analysis,o appropriate investigation of deviations and adverse trends,o and a comprehensive CAPA plan based on the findings of the assessment.2. Your firm failed to establish adequate written responsibilities and procedures applicable to the quality control unit (21 CFR 211.22(d)).Your QU did not provide adequate oversight for the manufacture of your drug products. For example, your QU failed to ensure:Documentation of all interventions during filling of sterile drug products. Our investigators observed multiple batch records in which operators failed to document most aseptic interventions. For example, the batch record for (b)(4) injection (b)(4) mg/(b)(4)ml, on February 6, 2026, documented that 12 interventions had occurred during filling. However, records indicated approximately 200 interventions were conducted. Notably, critical interventions, including but not limited to removing vials from the filling zone and removing fallen vials from (b)(4), were not documented. (21 CFR 211.188)Performance of adequate disinfectant efficacy studies. You failed to adequately evaluate your environmental isolates for inclusion in your disinfectant efficacy studies. Studies failed to adequately represent the full spectrum of microbes in your facility. (21 CFR 211.42(c)(10)(v))Reproducible manufacturing processes in the production of sterile (b)(4) drug products. You did not perform a process validation study after implementing a new production step nor provide stability data within your response. (21 CFR 211.100(a)).In your response, you state you will ensure the QU has a role in verifying intervention documentation in batch records and establish a procedure to periodically evaluate disinfectant efficacy. Your response is inadequate because you fail to provide sufficient details on how interventions in your aseptic process simulations will be captured, simulated, and verified. You also do not describe the QU's oversight of the disinfection practices or identify the environmental isolates to be challenged in the disinfection efficacy studies.Complete and accurate batch production and control records are necessary to ensure that manufacturing processes are consistently followed and are reproducible. Additionally, incomplete manufacturing records fundamentally compromise your ability to reliably conduct batch record review, to adequately investigate deviations and batch failures, and to ensure a continued state of control.Your firm’s quality systems are inadequate. You may refer to FDA’s guidance document Quality Systems Approach to Pharmaceutical CGMP Regulations for help implementing quality systems and risk management approaches to meet the requirements of CGMP regulations 21 CFR, parts 210 and 211 at https://www.fda.gov/media/71023/download.In response to this letter, provide: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 appropriateo Provisions for QU oversight throughout your operations to evaluate adherence to appropriate practiceso A complete and final review of each batch and its related information before the QU disposition decisiono Oversight and approval of investigations and discharging of all other QU duties to ensure identity, strength, quality, and purity of all productsA CAPA plan, based on the retrospective assessment of your disinfection program, that includes appropriate remediations to your disinfection processes and practices, and timelines for completion. Include the following as part of the assessment and CAPA plan:o a detailed summary of vulnerabilities in your process for lifecycle management of equipment disinfectiono a list of improvements, with an explanation how each will enhance disinfection effectivenesso improved ongoing verification of proper disinfection execution for all products and equipmento and, any other needed remediations.A detailed summary of your validation program for ensuring a state of control throughout the product lifecycle, along with associated procedures. Describe your program for process performance qualification, and ongoing vigilant monitoring of both intra-batch and inter-batch variation to ensure a continuing state of control. Also, describe your equipment and facility qualification program.A timeline for performing appropriate process performance qualification for each of your marketed drug products. Also provide a risk assessment and any follow up actions to be taken for the distributed drug products produced prior to performing any process validation studies.A comprehensive review of your complaints received for (b)(4) injection, including a retrospective review of all complaints for the last three years from the initial date of the inspection, with an assessment that includes but is not limited to evaluating and comparing the (b)(4) complaints received before and after the (b)(4) step.Appropriate improvements to your cleaning validation program, with special emphasis on incorporating conditions identified as worst-case in your drug manufacturing operation. This should include but not be limited to identification and evaluation of all worst-case:o drugs with higher toxicitieso drugs with higher drug potencieso drugs of lower solubility in their cleaning solventso drugs with characteristics that make their manufacturing equipment difficult to cleano swabbing locations for areas that are most difficult to cleano maximum hold times before cleaningA description of the steps that must be taken in your change management system before introduction of new manufacturing equipment or a new product.A summary of updated SOPs that ensure an appropriate program is in place for verification and validation of cleaning procedures for products, processes, and equipment.3. Your firm failed to establish and follow appropriate written procedures that are designed to prevent microbiological contamination of drug products purporting to be sterile, and that include validation of all aseptic and sterilization processes. Your firm also failed to maintain buildings used in the manufacture, processing, packing, or holding of drug products in a good state of repair (21 CFR 211.113(b) and 21 CFR 211.58).Airflow Visualization (AFV) Smoke Study DeficienciesOur inspection noted deficient smoke studies. Our investigators determined you did not perform AFV smoke studies after modifying your (b)(4) Restricted Access Barrier Systems ((b)(4)RABS) unit by removing the (b)(4) and remounting the nonviable particulate probe in suite (b)(4) of the (b)(4) filling line. Your validation department determined smoke studies were not necessary after the modification, despite your engineers proposing smoke studies be conducted.As another example, two interventions, including product spillage cleaning at the filling station and (b)(4) adjustment lacked adequate smoke to visualize unidirectional airflow. It is not clear whether airflow is adequate to protect the aseptic processing line.In your response, you state you will re-execute AFV studies, develop a standardized AFV protocol template, and revise the change control procedure. Your response is inadequate because you do not explain how you will ensure satisfactory conduct of smoke studies in the future.Thorough smoke studies are essential to evaluate the effects of such interventions on unidirectional airflow and suitability of design modifications. We also note that your Grade A suites (b)(4) are described as (b)(4)RABS. Although your firm characterizes these processing lines as (b)(4)RABS, their design and operation involve an excessive number of interventions and do not meet the minimum standards of a restricted access barrier system.The Grade A area is critical because sterile products are exposed during aseptic production and therefore are vulnerable to contamination if operations are not well designed and diligently controlled. Your aseptic processes should be designed, and operations executed, to prevent contamination hazards to your sterile product. Flaws in the design of cleanrooms and aseptic processing lines, or improper execution of operations, can promote influx of contamination into the critical processing area in which sterile drugs are exposed.Inadequate Environmental MonitoringWe observed inadequate EM technique and insufficient EM locations. Our investigators observed the surface swabbing of the (b)(4) did not include the (b)(4). Additionally, the analyst did not swab the maximum accessible area of the (b)(4) of each (b)(4).In your response, you state the procedures will be updated and a retrospective EM review will be performed. You also performed a historical review of your EM data since 2024 which you indicate has no adverse trends. Your response is inadequate because the quality of the data was compromised by insufficient technique and locations.Environmental monitoring is only as meaningful as the quality of its sampling technique and locations. The purpose of environmental monitoring in an aseptic processing facility is to apply a risk-based approach to reliably detect routes of contamination.Facility Maintenance DeficienciesYour firm did not properly maintain classified areas used in the manufacture of drug products. Our inspection noted peeling paint on the walls and plastic debris on the floors within your Grade C hallway and product transfer room (b)(4) in Suite (b)(4).In your response, you commit to implement post-cleaning visual inspection, require cleaning verification in the cleaning logs, and repair the facility. Your response is inadequate because your product impact evaluation states “…types of debris observed (e.g., paint, plastic) are non-viable particulates...” However, you do not explain the basis for the assertion that paint debris could not harbor microorganisms. In addition, your response does not adequately evaluate the cause of the paint bubbling and peeling from the walls and whether this has contributed to mold identified throughout all your classified areas.Deteriorating surfaces such as peeling paint are potential sources of particulate and microbial contamination. It is critical that the building is maintained to prevent exposure of sterile articles to potential contamination hazards in the manufacturing operation.In response to this letter, provide:Your systematic plan to assure adherence to appropriate aseptic practices, cleanroom behavior, and written procedures, including but not limited to an independent assessment of the following with accompanying CAPA:o suitability of actual practices based on extensive retrospective review and prospective observation of aseptic processing operationso deficiencies in production management oversight, and identification of specific improvements to ensure effective and routine supervisory oversight for all batcheso frequency and depth of quality unit oversight (e.g., audit, ad hoc, daily interactions) of aseptic processing and its support operationso adequacy of written procedureso evaluate how poor aseptic technique and cleanroom behavior may have affected the quality and sterility of your drugsA thorough, independent evaluation of airflow unidirectionality in your aseptic process. Ensure smoke studies are conducted under dynamic conditions, with thorough and complete evaluations of aseptic processing line airflow unidirectionality, including the impact of dynamic interactions and aseptic interventions. These thorough smoke studies should be performed after you remediate your aseptic operation and be conducted using proper practices (e.g., neutrally buoyant media) to appropriately visualize airflow.Your CAPA plan to implement routine, vigilant operations management oversight of facilities and equipment. This plan should incorporate oversight from a qualified independent consultant and ensure, among other things, prompt detection of equipment/facilities performance issues, effective execution of repairs, adherence to appropriate preventive maintenance schedules, timely technological upgrades to the equipment/facility infrastructure, and improved systems for ongoing management review.Additional Guidance on Aseptic ProcessingSee FDA’s guidance document Sterile Drug Products Produced by Aseptic Processing—Current Good Manufacturing Practice to help you meet the CGMP requirements when manufacturing sterile drugs using aseptic processing at https://www.fda.gov/media/71026/download.Quality SystemsSignificant findings in this letter demonstrate that your firm does not operate an effective quality system in accord with CGMP. In addition to the lack of effective management oversight of your laboratory and production operations, we found your quality unit is not enabled to exercise proper authority and/or has insufficiently implemented its responsibilities. Executive management should immediately and comprehensively assess your company’s global manufacturing operations to ensure that your systems, processes, and products conform to FDA requirements.CGMP Consultant RecommendedBased upon the nature of the violations we identified at your firm, you should engage a consultant qualified as set forth in 21 CFR 211.34 to evaluate your operations and to assist your firm in meeting CGMP requirements if your firm intends to resume manufacturing drugs for the U.S. market. The qualified consultant should also perform a comprehensive six-system audit of your entire operation for CGMP compliance and evaluate the completion and efficacy of your CAPA before you pursue resolution of your firm’s compliance status with FDA.Your use of a consultant does not relieve your firm’s obligation to comply with CGMP. Your firm’s executive management remains responsible for resolving all deficiencies and systemic flaws to ensure ongoing CGMP compliance.Request for a Meeting with FDAAfter receiving this letter, we recommend that you reach out to arrange for a teleconference to discuss your corrective and preventive actions in detail. Direct your request to Kathryn Hall at CDER-OC-OMQ-Communications@fda.hhs.gov.ConclusionYou are responsible for investigating and determining the root causes of any violations and implementing corrective and preventative measures to ensure future and sustained compliance so that these violations and any others do not occur.Unresolved violations may prevent other Federal agencies from awarding contracts. Failure to address violations may also cause FDA to withhold issuance of Export Certificates. FDA may withhold approval of new applications or supplements listing your firm as a drug manufacturer until any violations are completely addressed and we confirm your compliance with CGMP. We may re-inspect to verify that you have completed corrective actions to address any violations.If you are considering an action that is likely to lead to a disruption in the supply of drugs produced at your facility, FDA requests that you contact CDER’s Drug Shortages Staff immediately, at drugshortages@fda.hhs.gov, so that FDA can work with you on the most effective way to bring your operations into compliance with the law. Contacting the Drug Shortages Staff also allows you to meet any obligations you may have to report discontinuances or interruptions in your drug manufacture under 21 U.S.C. 356C(b). This also allows FDA to consider, as soon as possible, what actions, if any, may be needed to avoid shortages and protect the health of patients who depend on your products.Send your written response to CDER-OC-OMQ-Communications@fda.hhs.gov within fifteen (15) business days of receipt of this letter1. Identify your written response with FEI 3006503102 and ATTN: Compliance Officer Barbara Wilimczyk-Macri in the letter or/in the subject line of the email.If you have information that you believe demonstrates that your products are not in violation of the FD&C Act and FDA regulations, include that information for our consideration.FDA posts warning letters on www.FDA.gov.Sincerely,/S/Francis GodwinDirectorOffice of Manufacturing QualityOffice of ComplianceCenter for Drug Evaluation and ResearchU.S. Food and Drug Administrationcc: Mr. Devan Patel, Site Manager(b)(4)___________________________1 Under program enhancements for the Generic Drug User Fee Amendments (GDUFA) reauthorization for fiscal years (FYs) 2023-2027, also known as the GDUFA III Commitment Letter, your facility may be eligible for a Post-Warning Letter Meeting to obtain preliminary feedback from FDA on the adequacy and completeness of your corrective action plans.

Delivery Method:VIA ELECTRONIC MAIL READ/DELIVERY RECEIPT REQUESTEDReference #:320-26-116Product:DrugsRecipient:Dr. Santosh R. Patel and Mr. Rajendra C. PatelManaging DirectorsShoolin Pharma Chem LLP412 Deam Rise, Nr. Hetarth Park Plot, Science City RoadSola, Ahmedabad 380059 GujaratIndia(b)(4)Issuing Office:Center for Drug Evaluation and Research (CDER)United StatesAugust 18, 2026WARNING LETTERReference number: 320-26-116To Dr. Santosh R. Patel and Mr. Rajendra C. Patel:This warning letter advises you of significant violations observed during a U.S. Food and Drug Administration (FDA) inspection of your facility. Promptly address the violations described herein without delay, including ensuring that appropriate resources are allocated to fully address the violations and prevent their recurrence. This is not intended to be an all-inclusive list of the violations that exist at your facility. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations. Failure to adequately address violations may result in regulatory action without further notice.FDA InspectionViolations were observed and documented during an inspection of your drug manufacturing facility, Shoolin Pharma Chem LLP, FEI 3038200383, at Block/Survey No. 408, B/h. Ratnamani Tubes, Nr. Maruti Inox, Indrad, Dist. Mehsana, Gujarat, India, from April 13 to 17, 2026. This inspection was conducted under FDA’s statutory authority and public health responsibilities to protect the public from unsafe, ineffective, and poor quality drugs.Your drug products are adulterated under section 501(a)(2)(A) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 351(a)(2)(A), in that they have been prepared, packed, or held under insanitary conditions, whereby they may have become contaminated with filth or rendered injurious to health.This warning letter also summarizes significant violations 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).We reviewed your May 2, 2026, response to our Form FDA 483 in detail.Violations of the Federal Food, Drug, and Cosmetic ActThe following are violations identified during our inspection and review. As a reminder, this is not an all-inclusive list of violations at your facility.Insanitary ConditionsYour firm manufactures APIs for domestic and foreign markets, including erectile disfunction (sildenafil citrate and tadalafil), anticonvulsant and (b)(4) agents, using nondedicated production equipment. Your APIs were imported into the United States and utilized by compounding pharmacies to produce medications for US citizens. Your drug products are adulterated under section 501(a)(2)(A) of the FD&C Act because they were prepared, packed, and held under insanitary conditions.1 Your production operations, including (b)(4) loading, and (b)(4), are conducted in a facility that lacks adequate sanitary conditions. Specifically, our investigator observed evidence of layered unidentified residues, improperly gowned employees in the production area, and corroded equipment surfaces near open processing lines and API packaging. Further, our investigator observed the following:(b)(4) lines (top of photo) showing evidence of leakage; (b)(4) residues on the production area walls, floors, and manufacturing equipment; and product transfer lines stored in a manner that risks contamination with filth and other chemical residuesAn employee was observed wearing open-toed sandals in the production area directly in front of open equipment, with (b)(4) chemical residues and corrosion documented on the product transfer line and the exterior and interior of the (b)(4) during open production operationsThe production area ((b)(4) room) was found to have (b)(4) residue and stains covering the walls, floor, and equipment, in areas where in-process material is handled and storedThe equipment within this production area ((b)(4)) was observed to have (b)(4) layers of residue covering its inner walls, floor, and (b)(4) used to (b)(4) multiple APIsIn response to this letter, provide:A comprehensive plan to remediate the facility, given the pervasive nature of the insanitary conditionsDetailed procedures that demonstrate your firm can maintain buildings and equipment in a clean and sanitary statePhotographic evidence of the completed remediation showing the entire facility is now in an acceptable state of repair and maintenance.CGMP Violations1. Failure to clean, store, and sanitize equipment and utensils to prevent contamination or carry-over of a material that would alter the quality of the API beyond the official or other established specifications.Your firm manufactures sildenafil citrate and tadalafil APIs for the U.S. market. Our investigators observed layers of unidentified residue and apparent rust on and around product contact surfaces of various nondedicated manufacturing equipment used in the production of your APIs.You lack adequate procedures for the cleaning and maintenance of your manufacturing equipment. Additionally, your employees stated that written cleaning and equipment maintenance procedures have not been established, and cleaning verification using swab or rinse sample testing has not been performed.In your response, you acknowledge the absence of formal cleaning and maintenance procedures. You commit to developing standard operating procedures (SOPs), validating a cleaning process, establishing a preventive maintenance program for all equipment, and repairing or replacing all affected equipment.Your response is inadequate because it fails to comprehensively address cleaning and maintenance deficiencies or to outline a system for preventing recurrence. For example, you have not provided evidence of a risk assessment for worst-case product residues to be evaluated as part of a cleaning study; you have not evaluated hold times to determine if microbial bioburden is adequately controlled between cleaning operations; and you have not provided a detailed cleaning process for review.In response to this letter, provide:A comprehensive, independent retrospective assessment of your cleaning effectiveness to evaluate the scope of cross-contamination hazards. Include the identity of residues, other manufacturing equipment that may have been improperly cleaned, and an assessment whether cross-contaminated products may have been released for distribution. The assessment should identify any inadequacies of cleaning procedures and practices and should encompass each piece of manufacturing equipment used to manufacture more than one product.A corrective action and preventive action (CAPA) plan, based on the retrospective assessment of your cleaning program, that includes appropriate remediations to your cleaning processes and practices, and timelines for completion. Include the following as part of the assessment and CAPA plan:o A detailed summary of vulnerabilities in your process for lifecycle management of equipment cleaningo A list of improvements, with an explanation how each will enhance cleaning effectivenesso Improved ongoing verification of proper cleaning execution for all products and equipmento Any other needed remediations.Appropriate improvements to your cleaning validation program, with special emphasis on incorporating conditions identified as worst case in your drug manufacturing operation. This should include but not be limited to identification and evaluation of all worst-case:o Drugs with higher toxicitieso Drugs with higher drug potencieso Drugs of lower solubility in their cleaning solventso Drugs with characteristics that make their manufacturing equipment difficult to cleano Swabbing locations for areas that are most difficult to cleano Maximum hold times before cleaningA description of the steps that must be taken in your change management system before introduction of new manufacturing equipment or a new product.A summary of updated SOPs that ensure an appropriate program is in place for verification and validation of cleaning procedures for products, processes, and equipment.2. Failure to have laboratory control records that include complete data derived from all laboratory tests conducted to ensure your API complies with established specifications and standards.Your firm conducts testing of raw materials, intermediates, and APIs, either in-house or through a contract laboratory; however, your firm failed to ensure that laboratory testing records were complete. For example, when our investigator requested supporting documentation, including equipment printouts, laboratory notebooks, worksheets, and analytical data, your firm was unable to provide any evidence that the testing reported on your certificates of analyses had actually been performed.Additionally, in instances when a contract laboratory performed the testing, your firm reported the results on certificates of analyses printed on company letterhead, without identifying the entity that performed the original analysis.In your response, you acknowledge your failure to maintain adequate records, and you commit to establishing controlled documentation systems and audit-trail review procedures. You also commit to investigating the missing raw data, reconstructing data where available to support previously released batches, and training employees in good documentation practices.Your response is inadequate because it fails to provide evidence of implemented corrective actions. Moreover, you do not consider a retrospective review and risk assessment to evaluate the potential impact of the inadequate documentation on the validity of your reported results.In response to this letter, provide:A comprehensive, independent assessment of your laboratory practices, procedures, methods, equipment, documentation, and analyst competencies. Based on this review, provide a detailed plan to remediate and evaluate the effectiveness of your laboratory system.A comprehensive assessment of documentation systems used throughout your manufacturing and laboratory operations to determine where documentation practices are insufficient. Include a detailed CAPA plan that comprehensively remediates your firm’s documentation practices to ensure that you retain attributable, legible, complete, original, accurate, contemporaneous records throughout your operation.A management strategy for your firm that includes the details of your global CAPA plan to implement attributable, legible, complete, original, accurate, contemporaneous records throughout your operation. The detailed corrective action plan should describe how you intend to ensure the reliability and completeness of all data, including microbiological and analytical data, manufacturing records, and all data submitted to FDA.3. Failure to design a documented, ongoing stability testing program to monitor the stability characteristics of API and to use the results to confirm appropriate storage conditions and retest or expiry dates.Your firm’s stability program is inadequate. For example, you were unable to provide the laboratory control records used to support your labeled (b)(4) expiry dates for tadalafil and sildenafil citrate APIs, respectively. Additionally, your sample storage chambers were observed to be powered off, and out-of-specification for temperature and/or humidity when powered on. Further, you were unable to locate stability samples of tadalafil, which were scheduled for future time-point testing.In your response, you acknowledge the deficiencies of your stability program and propose corrective actions that include revising SOPs, investigating missing samples and affected time points, and performing an impact assessment for ongoing studies.Your response is inadequate because it does not address why the chambers were powered off, and it does not provide sufficient detail or evidence of corrective actions to bring your operations into compliance with CGMP.Without an adequate stability program, you cannot ensure that your APIs meet established specifications and all predetermined quality criteria throughout the APIs’ assigned shelf-life.In response to this letter, provide a comprehensive, independent assessment and CAPA plan to ensure the adequacy of your stability program. Your remediated program should include but not be limited to:Stability-indicating methodsStability studies for each drug product in its marketed container-closure system before distribution is permittedAn ongoing program in which representative batches of each product are added each year to the program to determine whether the shelf-life claim remains validDetailed definition of the specific attributes to be tested at each station (timepoint), as part of a program that encompasses each quality attribute that may change over the product shelf-lifeAll procedures that describe these and other elements of your remediated stability program4. Failure of your quality unit to exercise its responsibility to ensure the API manufactured at your facility are in compliance with CGMP.Your quality unit (QU) failed to exercise its basic responsibilities for oversight of API production and testing operations. For example, your QU failed to:Evaluate the risk of process-related impurities on non-dedicated manufacturing equipment (i.e., microbial contamination, API cross-contamination, (b)(4) impurities)Establish written procedures for the cleaning and maintenance of facilities and equipmentQualify contract laboratories prior to use for CGMP testingValidate manufacturing operations prior to commercial distributionCalibrate and maintain equipment as appropriate for its intended use in API production operationsTest materials for conformance with in-house or compendial specifications prior to use in manufacturing APIsPerform product reviews at least annuallyIn your response, you acknowledge inadequate QU oversight and the absence of a validation lifecycle approach to manufacturing. You commit to establishing an independent QU with the authority to address the deficiencies found during FDA’s inspection.Your response is inadequate because you did not provide a detailed remediation plan or procedures to address the identified deficiencies, nor did you provide any evidence of implemented corrections. Additionally, you have not evaluated the impact of these deficiencies on previously released batches or committed to withhold further distribution until appropriate CAPAs have been implemented and verified.Significant findings in this letter demonstrate that your firm does not operate an effective quality system in accordance with CGMP. In addition to the lack of effective management oversight of your production operations, we found your QU is not enabled to exercise proper authority and/or has insufficiently implemented its responsibilities. Executive management should immediately and comprehensively assess your company’s global manufacturing operations to ensure that your systems, processes, and products conform to FDA requirements.In response to this letter, provide 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:A determination of whether procedures used by your firm are robust and appropriateProvisions for QU oversight throughout your operations to evaluate adherence to appropriate practicesA complete and final review of each batch and its related information before the QU disposition decisionOversight and approval of investigations and discharging of all other QU duties to ensure identity, strength, quality, and purity of all productsDrug RecallOn July 27, 2026, FDA held a teleconference with you, recommending that you recall all your APIs currently in distribution within the U.S. market. On August 4, 2026, you initiated a voluntary recall of all your APIs currently distributed within the U.S. market. The recall was posted to the FDA’s Enforcement Report website at https://www.accessdata.fda.gov/scripts/ires/?Event=99547.Additional API CGMP GuidanceFDA considers the expectations outlined in ICH Q7 when determining whether API are manufactured in conformance with CGMP. See FDA’s guidance document Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients for guidance regarding CGMP for the manufacture of API at https://www.fda.gov/media/71518/download.Cross Contamination AssessmentContamination is generally nonuniformly distributed. Data obtained from retrospectively testing a small proportion of a batch (e.g., retain samples) is limited in its ability to retrospectively assess the extent of contamination in other portions of a batch. The lowest or highest results obtained from testing a small sample size is unlikely to reveal the true range of minimum and maximum contamination level that exists in a batch exposed to the contamination hazards identified at your firm. Consequently, substantial residual uncertainty remains regarding the actual range of variability of contamination levels in batches produced by your firm.Because of the limitations of retrospective testing in gaining a representative understanding of the entire lot, testing retain samples alone is insufficient to determine the scope of the contamination issues and mitigate the associated risks. Further evaluation and scientific rationale is needed in your firm’s risk assessment to reflect the nature of cross-contamination events and determine the degree of cross-contamination risk that may be posed to portions of marketed batches.Data Integrity RemediationYour quality system does not adequately ensure the integrity of data to support the safety, effectiveness, and quality of the APIs you manufacture. See FDA’s guidance document Data Integrity and Compliance With Drug CGMP: Questions and Answers for guidance on establishing and following CGMP compliant data integrity practices at https://www.fda.gov/media/119267/download.CGMP ConsultantBased upon the nature of the violations we identified at your firm, you should engage a consultant qualified to evaluate your operations and to assist your firm in meeting CGMP requirements. The qualified consultant should also perform a comprehensive six-system audit of your entire operation for CGMP compliance and evaluate the completion and efficacy of your CAPA before you pursue resolution of your firm’s compliance status with FDA.Your use of a consultant does not relieve your firm’s obligation to comply with CGMP. Your firm’s executive management remains responsible for resolving all deficiencies and systemic flaws to ensure ongoing CGMP compliance.ConclusionYou are responsible for investigating and determining the root causes of any violations and implementing corrective and preventative measures to ensure future and sustained compliance so that these violations and any others do not occur.FDA placed all drugs and drug products offered for import into the United States from your firm on Import Alert 66-40 on August 11, 2026.FDA may withhold approval of new applications or supplements listing your firm as a manufacturer until any violations are completely addressed and we confirm your compliance with CGMP. We may re-inspect to verify that you have completed corrective actions to any violations.Failure to address any violations may also result in the FDA continuing to refuse admission of articles manufactured at Shoolin Pharma Chem LLP, Block/Survey No. 408, B/h. Ratnamani Tubes, Nr. Maruti Inox, Indrad, Dist. Mehsana, Gujarat, India, into the United States under section 801(a)(3) of the FD&C Act, 21 U.S.C. 381(a)(3). Articles under this authority that appear to be adulterated may be detained or refused admission, in that the methods and controls used in their manufacture do not appear to conform to CGMP within the meaning of section 501(a)(2)(B) of the FD&C Act, 21 U.S.C. 351(a)(2)(B).Send your written response to CDER-OC-OMQ-Communications@fda.hhs.gov within fifteen (15) business days of receipt of this letter. Identify your written response with FEI 3038200383 and ATTN: Christopher Leach in the subject line of the email.If you have information that you believe demonstrates that your products are not in violation of the FD&C Act and FDA regulations, include that information for our consideration.FDA posts warning letters to www.FDA.gov.Sincerely,/S/Francis GodwinDirectorOffice of Manufacturing QualityOffice of ComplianceCenter for Drug Evaluation and ResearchU.S. Food and Drug AdministrationCc: Benjamin L. England, Registered U.S. AgentFDA Imports(b)(4)__________________________1 CDER is including photographs of your facility in this warning letter to document the gross insanitary conditions violations.

Delivery Method:VIA ELECTRONIC MAIL READ/DELIVERY RECEIPT REQUESTEDProduct:DrugsRecipient:Felicia RomeroCEOTXP Innovations LLC dba Tex Peptides539 West Commerce StreetDallas, TX 75208-1953United Statessupport@texpeptide.comtexpeptides@gmail.comIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesAugust 24, 2026WARNING LETTERReference Number: 735067To Felicia Romero:This warning letter advises you of significant violations observed during a U.S. Food and Drug Administration (FDA) review of your website. Promptly address the violations described herein without delay, including ensuring that appropriate resources are allocated to fully address the violations and prevent their recurrence. This is not intended to be an all-inclusive list of the violations that may exist in connection with your products or operations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations. Failure to adequately address violations may result in regulatory or legal action without further notice including, without limitation, seizure and injunction.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.FDA ReviewViolations were identified and documented during a review of your website texpeptide.com in July 2026. Based on our review, “Semaglutide (GLP-1 SEM),” “Tirzepatide (GLP-2 TRZ),” “Retatrutide (GLP-3 RT),” “SS-31 (Elamipretide),” “Tesamorelin,” “PT-141 (Bremelanotide),” and “Bacteriostatic Water 0.9% Benzyl Alcohol (10 ml)” are unapproved new drugs under section 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 355(a). As explained further below, introducing or delivering these products for introduction into interstate commerce violates sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a).This review was conducted as part of FDA’s public health responsibility to protect the public from unsafe, ineffective, and poor-quality drugs.Violations of the Federal Food, Drug, and Cosmetic ActThe following are violations identified during our review. As a reminder, this is not an all-inclusive list of violations that may exist in connection with your products or operations.Unapproved New Drug ViolationsBased on a review of your website,“Semaglutide (GLP-1 SEM),” “Tirzepatide (GLP-2 TRZ),” “Retatrutide (GLP-3 RT),” “SS-31 (Elamipretide),” “Tesamorelin,” “PT-141 (Bremelanotide),” and “Bacteriostatic Water 0.9% Benzyl Alcohol (10 ml)” 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.1 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 SEM (Semaglutide)On the webpage https://texpeptide.com/product/glp-1-sem/:“By binding to GLP-1 receptors, it enhances insulin secretion, suppresses glucagon release, and slows gastric emptying, ultimately helping to regulate blood glucose levels. This makes GLP-1 SEM a key area of interest in the management of type 2 diabetes, obesity, and metabolic disorders.”“In addition to its glucose-lowering effects, GLP-1 SEM has been shown to support weight loss by reducing appetite and promoting a feeling of fullness, making it a valuable therapeutic candidate in obesity management. Research also suggests potential benefits for cardiovascular health, liver function, and neuroprotection, expanding its relevance beyond diabetes care.”GLP-2 TRZ (Tirzepatide)On the webpage https://texpeptide.com/product/glp-2-trz/:“GLP-2 TRZ enhances insulin secretion, reduces glucagon levels, and promotes appetite regulation, offering a powerful approach to improving blood sugar control and weight management.”“Beyond its primary effects on glucose metabolism and weight loss, GLP-2 TRZ is being investigated for its potential in cardiovascular health, lipid regulation, and reducing systemic inflammation. Its role in insulin sensitivity, appetite suppression, and long-term metabolic improvements makes it a promising therapeutic option in endocrinology and obesity research.”GLP-3 RT (Retatrutide)On the webpage https://texpeptide.com/product/glp-3-rt/:“GLP-3 RT offers a unique and comprehensive approach to regulating glucose metabolism, energy balance, and weight management.”“Early research suggests that GLP-3 RT may provide superior outcomes compared to GLP-1 or dual agonists alone, including greater weight reduction, improved insulin sensitivity, enhanced lipid metabolism, and better long-term metabolic stability. Additionally, studies are investigating its potential in cardiovascular protection, liver health (NAFLD/NASH), and neuroendocrine regulation.”SS-31 (Elamipretide)On the webpage https://texpeptide.com/product/ss-31/:“SS-31 helps stabilize mitochondrial membranes, reduce oxidative stress, and improve electron transport chain efficiency, ultimately enhancing cellular energy production (ATP).”“This peptide has been widely studied for its antioxidant and cytoprotective properties, making it a promising therapeutic candidate for conditions linked to mitochondrial dysfunction.”TesamorelinOn the webpage https://texpeptide.com/product/tesamorelin/:“Tesamorelin is a synthetic peptide analog of Growth Hormone-Releasing Hormone (GHRH), a naturally occurring hormone that stimulates the pituitary gland to release growth hormone (GH). By mimicking the natural activity of GHRH, Tesamorelin effectively increases the production and secretion of growth hormone, which in turn elevates levels of insulin-like growth factor-1 (IGF-1) in the body.”PT-141 (Bremelanotide)On the webpage https://texpeptide.com/product/pt-141/:“PT-141, also known as bremelanotide . . . is specifically researched for its ability to increase arousal and desire. PT-141 targets the central nervous system directly to improve libido and pleasure. It’s an effective and powerful enhancer for both mood and your senses.”Bacteriostatic Water 0.9% Benzyl Alcohol (10 ml)Your firm offers “Bacteriostatic Water 0.9% Benzyl Alcohol (10 ml)” for sale to be used to reconstitute the peptide products sold on your website, which are drugs intended for injection, including the six above-mentioned products. The sale of these products together demonstrates that you intend your “Bacteriostatic Water 0.9% Benzyl Alcohol (10 ml)” to be used in combination for injection. Therefore, your “Bacteriostatic Water 0.9% Benzyl Alcohol (10 ml)” is a drug.Semaglutide (GLP-1 SEM),” “Tirzepatide (GLP-2 TRZ),” “Retatrutide (GLP-3 RT),” “SS-31 (Elamipretide),” “Tesamorelin,” “PT-141 (Bremelanotide),” and “Bacteriostatic Water 0.9% Benzyl Alcohol (10 ml)” are “new drugs” under section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because they are not generally recognized as safe and effective (GRASE) for use under the conditions prescribed, recommended, or suggested in their labeling. With certain exceptions not applicable here, a new drug may not be introduced or delivered for introduction into interstate commerce without an approved application from FDA in effect, as described in section 505(a) of the FD&C Act, 21 U.S.C. 355(a). No approved applications pursuant to section 505 of the FD&C Act, 21 U.S.C. 355, are in effect for these products. Accordingly, these products are unapproved new drugs. The introduction or delivery for introduction into interstate commerce of these unapproved new drug products violates sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a).ConclusionAs previously stated, you are responsible for investigating and determining the root causes of any violations and implementing corrective and preventative measures to ensure future and sustained compliance so that these violations and any others do not occur.Send your written response to FDAAdvisory@fda.hhs.gov within fifteen (15) business days of receipt of this letter. Include the specific steps you have taken to correct any violations, an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. Identify your response with reference number “735067” in the subject line of the email.If you have information that you believe demonstrates that your products are not in violation of the FD&C Act and FDA regulations, include that information for our consideration.Please note FDA posts warning letters on www.fda.gov.Sincerely,/S/Tina Smith, M.S.Captain, U.S. Public Health ServiceDirectorOffice of Unapproved Drugs and Labeling ComplianceOffice of ComplianceCenter for Drug Evaluation and ResearchU.S. Food and Drug Administration___________________1 Despite statements on your product labeling marketing your products “research use only”, “for research and laboratory use only”, and “not for human or veterinary use,” evidence obtained from your website establishes that your products are intended to be drugs for human use. In addition to the cited drug claims, you market bacteriostatic water as a solvent for reconstituting your products, thus, providing the means to prepare an injectable drug for human administration.

Delivery Method:VIA ELECTRONIC MAIL READ/DELIVERY RECEIPT REQUESTEDProduct:DrugsRecipient:Rocco Abate and Michael FraunfelterManagersRoyal Peptides LLC2310 SE 2nd St. Ste 7Boynton Beach, FL 33435United Statesadmin@royal-peptides.cominfo@royal-peptides.comIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesAugust 24, 2026WARNING LETTERReference Number: 734884To Rocco Abate and Michael Fraunfelter:This warning letter advises you of significant violations observed during a U.S. Food and Drug Administration (FDA) review of your website. Promptly address the violations described herein without delay, including ensuring that appropriate resources are allocated to fully address the violations and prevent their recurrence. This is not intended to be an all-inclusive list of the violations that may exist in connection with your products or operations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations. Failure to adequately address violations may result in regulatory or legal action without further notice including, without limitation, seizure and injunction.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.FDA ReviewViolations were identified and documented during a review of your website royal-peptides.com in July 2026. Based on our review, “Tirzepatide,” “Semaglutide,” “Retatrutide,” “SS-31 (Elamipretide),” “PT-141,” “Tesamorelin,” and “BIMORELIN” are unapproved new drugs under section 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 355(a). As explained further below, introducing or delivering these products for introduction into interstate commerce violates sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a).This review was conducted as part of FDA’s public health responsibility to protect the public from unsafe, ineffective, and poor-quality drugs.Violations of the Federal Food, Drug, and Cosmetic ActThe following are violations identified during our review. As a reminder, this is not an all-inclusive list of violations that may exist in connection with your products or operations.Unapproved New Drug ViolationsBased on a review of your website, “Tirzepatide,” “Semaglutide,” “Retatrutide,” “SS-31 (Elamipretide),” “PT-141,” “Tesamorelin,” and “BIMORELIN” 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.1 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:Tirzepatide, Retatrutide, and SemaglutideOn the webpage https://royal-peptides.com/shop/tirzepatide-vials/:“Tirzepatide has become a major focus of metabolic, endocrinology, obesity, and peptide science due to its unique activity at both the GLP-1 (Glucagon-Like Peptide-1) and GIP (Glucose-Dependent Insulinotropic Polypeptide) receptors.”“Tirzepatide is a synthetic peptide engineered to activate both the GIP receptor and GLP-1 receptor, making it the first widely researched dual incretin agonist. Unlike traditional GLP-1 receptor agonists that target only one metabolic pathway, Tirzepatide simultaneously stimulates two naturally occurring incretin systems involved in glucose regulation and metabolic signaling.”On the webpage http://royal-peptides.com/tirzepatide-vs-retatrutide-weight-loss-peptides/:“Benefits of Tirzepatide: Enhances insulin sensitivity and glucose control[,] Reduces appetite and cravings[,] Promotes sustainable weight loss[, and] Once-weekly injection for convenienceClinical Results for Weight LossIn studies, Tirzepatide has led to up to 22.5% body weight reduction in participants over 72 weeks—comparable to or even better than Semaglutide (Wegovy, Ozempic).”“Benefits of Retatrutide: Boosts metabolism by activating glucagon receptors[,] Enhances glucose control and insulin function[,] Leads to faster and more substantial weight loss than Tirzepatide[, and] Once-weekly dosingClinical Results for Weight LossEarly trials suggest that Retatrutide may result in up to 24.2% body weight reduction in just 48 weeks, making it one of the most effective weight loss peptides currently being studied.”On the webpage https://royal-peptides.com/retatrutide-vs-tirzepatide/:“One of the main reasons Retatrutide is searched so heavily is its connection to body composition research. Tirzepatide already became a major comparison point in metabolic studies because of its dual GIP and GLP-1 receptor activity. Retatrutide builds on that research conversation by adding glucagon receptor activity.Retatrutide Research InterestRetatrutide is studied for how triple agonist activity may influence metabolic research models. The addition of glucagon receptor activity is especially important because glucagon is involved in energy balance and hepatic glucose output. This makes Retatrutide interesting in models where researchers are examining energy expenditure, body composition, and metabolic regulation.”On the webpage https://royal-peptides.com/shop/tirzepatide-retatrutide-10mg-mix-kit-55-pack/:“Unlock dual research potential with Royal Peptides’ Mix 10-Pack Kit, combining 5 vials of Tirzepatide 10mg and 5 vials of Retatrutide 10mg—two powerhouse GLP-1/GIP receptor agonists studied for their roles in metabolic and weight management research.”On the webpage https://royal-peptides.com/shop/retatrutide-vial/:“Researchers studying incretin biology have long investigated the effects of GLP-1 and GIP receptor activity. Retatrutide expands on this concept by incorporating glucagon receptor activity into the molecule’s design. This additional receptor interaction has created widespread interest among scientists studying metabolic regulation and energy balance.”On the webpage https://royal-peptides.com/shop/semaglutide/:“Semaglutide Single Vials is categorized under metabolic signaling research. It may be examined in research involving metabolic signaling, receptor selectivity and related biochemical pathways.”SS-31 (Elamipretide)On the webpage https://royal-peptides.com/shop/31pv/:“SS-31 (Elamipretide) is a breakthrough mitochondria-targeted tetrapeptide researched for its potential in reducing oxidative stress, enhancing cellular energy production, and supporting mitochondrial function.”“Advanced Research Use: Mitochondrial repair, anti-aging, neuroprotection”Tesamorelin and BIMORELINOn the webpage https://royal-peptides.com/shop/tesamorelin-10mg/:“Tesamorelin is categorized under growth-signaling research. It may be examined in research involving peptide signaling, endocrine pathways and growth-hormone-related mechanisms.”On the webpage https://royal-peptides.com/shop/tesamorelin-ipamorelin-blend/:“BIMORELIN is a cutting-edge dual peptide blend combining Tesamorelin (10mg) and Ipamorelin (3mg) for advanced research into hormone modulation, body composition, and cellular recovery.”“Tesamorelin and Ipamorelin are synthetic peptides frequently utilized in scientific research involving cellular communication, metabolic regulation, recovery pathways, tissue maintenance, and physiological performance studies. When combined, researchers can investigate potential complementary effects across multiple biological systems and signaling networks.”PT-141On the webpage https://royal-peptides.com/shop/pt-141-10mg-vial/:“PT-141, also called Bremelanotide (generic clinical name), is a heavily modified synthetic derivative of alpha-melanocyte-stimulating hormone. It has been tested in clinical trials as a treatment for hypoactive sexual desire disorder and acute hemorrhage.”“Double-blind, placebo-controlled evaluation of the safety, pharmacokinetic properties and pharmacodynamic effects of intranasal PT-141, a melanocortin receptor agonist, in healthy males and patients with mild-to-moderate erectile dysfunction”“PT-141: a melanocortin agonist for the treatment of sexual dysfunction”“Tirzepatide,” “Semaglutide,” “Retatrutide,” “SS-31 (Elamipretide),” “PT-141,” “Tesamorelin,” and “BIMORELIN” are “new drugs” under section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because they are not generally recognized as safe and effective (GRASE) for use under the conditions prescribed, recommended, or suggested in their labeling. With certain exceptions not applicable here, a new drug may not be introduced or delivered for introduction into interstate commerce without an approved application from FDA in effect, as described in section 505(a) of the FD&C Act, 21 U.S.C. 355(a). No approved applications pursuant to section 505 of the FD&C Act, 21 U.S.C. 355, are in effect for these products. Accordingly, these products are unapproved new drugs. The introduction or delivery for introduction into interstate commerce of these unapproved new drug products violates sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a).ConclusionAs previously stated, you are responsible for investigating and determining the root causes of any violations and implementing corrective and preventative measures to ensure future and sustained compliance so that these violations and any others do not occur.Send your written response to FDAAdvisory@fda.hhs.gov within fifteen (15) business days of receipt of this letter. Include the specific steps you have taken to correct any violations, an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. Identify your response with reference number “734884” in the subject line of the email.If you have information that you believe demonstrates that your products are not in violation of the FD&C Act and FDA regulations, include that information for our consideration.Please note FDA posts warning letters on www.fda.gov.Sincerely,/S/Tina Smith, M.S.Captain, U.S. Public Health ServiceDirectorOffice of Unapproved Drugs and Labeling ComplianceOffice of ComplianceCenter for Drug Evaluation and ResearchU.S. Food and Drug Administration________________________1 Despite statements on your product labeling marketing your products “for research use only” and “not for human or animal consumption,” evidence obtained from your website establishes that your products are intended to be drugs for human use. In addition to the cited drug claims, you market bacteriostatic water alongside a “peptide guide” and “peptide calculator,” resources that collectively provide the means to prepare an injectable drug for human administration.

Delivery Method:VIA ELECTRONIC MAIL READ/DELIVERY RECEIPT REQUESTEDProduct:DrugsRecipient:Joseph and Ratsamy DeRosaManagersNuScience Peptides LLC20311 Chartwell Center Dr., Suite 212Cornelius, NC 28031United Statesinfo@nusciencepeptides.comIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesAugust 24, 2026WARNING LETTERReference Number: 733652To Joseph and Ratsamy DeRosa:This warning letter advises you of significant violations observed during a U.S. Food and Drug Administration (FDA) review of your website. Promptly address the violations described herein without delay, including ensuring that appropriate resources are allocated to fully address the violations and prevent their recurrence. This is not intended to be an all-inclusive list of the violations that may exist in connection with your products or operations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations. Failure to adequately address violations may result in regulatory or legal action without further notice including, without limitation, seizure and injunction.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.FDA ReviewViolations were identified and documented during a review of your website nusciencepeptides.com in July 2026. Based on our review, “GLP-2 Tirz Peptide,” “GLP-1 Sema Research Peptide,” “GLP-3 RT (Retatrutide) Research Peptide,” “Survodutide,” “Mazdutide,” “PT-141 Peptide (Bremelanotide),” “Tesamorelin Research Peptide,” “Tesamorelin Ipamorelin Blend,” and “Bacteriostatic water for Peptides (BAC Water)” are unapproved new drugs under section 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 355(a). As explained further below, introducing or delivering these products for introduction into interstate commerce violates sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a).This review was conducted as part of FDA’s public health responsibility to protect the public from unsafe, ineffective, and poor-quality drugs.Violations of the Federal Food, Drug, and Cosmetic ActThe following are violations identified during our review. As a reminder, this is not an all-inclusive list of violations that may exist in connection with your products or operations.Unapproved New Drug ViolationsBased on a review of your website, “GLP-2 Tirz Peptide,” “GLP-1 Sema Research Peptide,” “GLP-3 RT (Retatrutide) Research Peptide,” “Survodutide,” “Mazdutide,” “PT-141 Peptide (Bremelanotide),” “Tesamorelin Research Peptide,” “Tesamorelin Ipamorelin Blend,” and “Bacteriostatic water for Peptides (BAC Water)” 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.1 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 Tirz PeptideOn the webpage https://nusciencepeptides.com/product/glp-2-tz-2/:“GLP-2 Tirz, a research peptide of significant interest, is known for its dual agonist activity on glucagon-like peptide-2 (GLP-2) and glucose-dependent insulinotropic polypeptide (GIP) receptors. This peptide has been extensively studied in rodent models, particularly rats, to explore its metabolic effects and potential therapeutic applications in various conditions. Researchers use these models to gain valuable insights into the complex mechanisms of metabolic regulation and the integrated actions of incretin hormones.”GLP-1 Sema Research PeptideOn the webpage https://pubchem.ncbi.nlm.nih.gov/compound/56843331#datasheet=LCSS (hyperlinked from https://nusciencepeptides.com/product/glp-1-sm/):“**Mechanism of cardiovascular benefit and weight loss** In hypercholesterolemia, semaglutide is believed to reduce the progression of atherosclerosis via decreased gut permeability and decreased inflammation. Weight loss is believed to occur via the reduction of appetite and food cravings after semaglutide administration.”GLP-3 RT (Retatrutide) Research PeptideOn the webpage https://nusciencepeptides.com/product/glp-3-rt/:“GLP-3 RT (Retatrutide) is a novel investigational peptide being explored for its potential research applications in metabolic disorders, particularly obesity and type 2 diabetes. Also known as LY3437943, it functions as a triple receptor agonist — a glp3 peptide that targets the GLP-1, GIP, and glucagon receptor pathways simultaneously”SurvodutideOn the webpage https://nusciencepeptides.com/product/survodutide/:“Survodutide (BI 456906) is a dual agonist targeting both the glucagon receptor (GCGR) and the glucagon-like peptide-1 receptor (GLP-1R), developed for laboratory research into obesity and type 2 diabetes metabolic pathways. Preclinical studies in rodent models have demonstrated its efficacy in promoting weight loss and improving glycemic control.”“In conclusion, survodutide’s dual GCGR/GLP-1R agonism offers a multifaceted approach to treating metabolic disorders. Its efficacy in preclinical models supports further investigation and development as a subject of investigation for obesity and metabolic disorder research.”MazdutideOn the webpage https://nusciencepeptides.com/product/mazdutide/:“Mazdutide (IBI362), a dual agonist targeting both GLP-1 and glucagon receptors, has shown promising results in clinical trials for weight management and metabolic disorders. This mazdutide peptide has been extensively studied in humans, but preclinical research, particularly in rat models, remains limited.”“Furthermore, mazdutide has been associated with reductions in liver fat content and improvements in insulin sensitivity in clinical trials, highlighting its potential for treating non-alcoholic fatty liver disease and type 2 diabetes.”PT-141 Peptide (Bremelanotide)On the webpage https://nusciencepeptides.com/product/pt-141-bremelanotide/:“PT-141, also known as bremelanotide, is a synthetic PT-141 peptide classified as a non-selective agonist of melanocortin receptors, with primary activity at MC3R and MC4R. This research peptide has been widely examined in preclinical models to better understand melanocortin-mediated signaling pathways involved in sexual behavior and neuroendocrine regulation.”“Additional studies examining melanocortin receptor agonists support the role of PT-141 in modulating sexual behaviors across sexes through central nervous system pathways. The involvement of the melanocortin system highlights the relevance of PT-141 peptide in experimental research exploring neural control of sexual function.”Tesamorelin Research Peptide and Tesamorelin Ipamorelin BlendOn the webpage https://nusciencepeptides.com/product/tesamorelin/:“Beyond metabolic effects, tesamorelin has demonstrated the ability to reduce muscle fat and increase muscle area in clinical studies . . . [s]uch findings are particularly relevant for exploring interventions in muscle-wasting conditions.”“Furthermore, research indicates that tesamorelin may enhance cognitive function, including improvements in executive function and verbal memory.”On the webpage https://nusciencepeptides.com/product/tesamorelin-ipamorelin/:“Tesamorelin, a growth hormone-releasing hormone (GHRH) analog, has been shown to significantly reduce visceral adipose tissue and improve liver health by decreasing liver fat and preventing fibrosis progression.”“[R]esearch has indicated that ipamorelin can counteract glucocorticoid-induced reductions in bone formation, suggesting its potential in mitigating bone density loss associated with glucocorticoid therapy.”Bacteriostatic water for Peptides (BAC Water)Your firm offers “Bacteriostatic water for Peptides (BAC Water)” for sale to be used to reconstitute the peptide products sold on your website, which are drugs intended for injection, including the above-mentioned products. The sale of these products together demonstrates that you intend for your “Bacteriostatic water for Peptides (BAC Water)” to be used in combination for injection. Therefore, your “Bacteriostatic water for Peptides (BAC Water)” is a drug.“GLP-2 Tirz Peptide,” “GLP-1 Sema Research Peptide,” “GLP-3 RT (Retatrutide) Research Peptide,” “Survodutide,” “Mazdutide,” “PT-141 Peptide (Bremelanotide),” “Tesamorelin Research Peptide,” “Tesamorelin Ipamorelin Blend,” and “Bacteriostatic water for Peptides (BAC Water)” are “new drugs” under section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because they are not generally recognized as safe and effective (GRASE) for use under the conditions prescribed, recommended, or suggested in their labeling. With certain exceptions not applicable here, a new drug may not be introduced or delivered for introduction into interstate commerce without an approved application from FDA in effect, as described in section 505(a) of the FD&C Act, 21 U.S.C. 355(a). No approved applications pursuant to section 505 of the FD&C Act, 21 U.S.C. 355, are in effect for these products. Accordingly, these products are unapproved new drugs. The introduction or delivery for introduction into interstate commerce of these unapproved new drug products violates sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a).ConclusionAs previously stated, you are responsible for investigating and determining the root causes of any violations and implementing corrective and preventative measures to ensure future and sustained compliance so that these violations and any others do not occur.Send your written response to FDAAdvisory@fda.hhs.gov within fifteen (15) business days of receipt of this letter. Include the specific steps you have taken to correct any violations, an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. Identify your response with reference number “733652” in the subject line of the email.If you have information that you believe demonstrates that your products are not in violation of the FD&C Act and FDA regulations, include that information for our consideration.Please note FDA posts warning letters on www.fda.gov.Sincerely,/S/Tina Smith, M.S.Captain, U.S. Public Health ServiceDirectorOffice of Unapproved Drugs and Labeling ComplianceOffice of ComplianceCenter for Drug Evaluation and ResearchU.S. Food and Drug Administration__________________________1 Despite statements on your product labeling marketing your products “for laboratory, research, and analytical use” and “not intended for human or veterinary use,” evidence obtained from your website establishes that your products are intended to be drugs for human use. In addition to the cited drug claims, you market bacteriostatic water alongside a “peptide calculator,” a resource that provides the means to prepare an injectable drug for human administration.

Delivery Method:VIA ELECTRONIC MAIL READ/DELIVERY RECEIPT REQUESTEDProduct:DrugsRecipient:Zachary David HoffPeptide Partners LLC8350 Bee Ridge, #379Sarasota, FL 34241-9607United Statessupport@peptide.partners(b)(6), (b)(7)(C)Issuing Office:Center for Drug Evaluation and Research (CDER)United StatesAugust 24, 2026Pirsek Technologies6776 Timberland LaneSarasota, FL 34241-9760WARNING LETTERReference Number: 735063To Zachary David Hoff:This warning letter advises you of significant violations observed during a U.S. Food and Drug Administration (FDA) review of your website. Promptly address the violations described herein without delay, including ensuring that appropriate resources are allocated to fully address the violations and prevent their recurrence. This is not intended to be an all-inclusive list of the violations that may exist in connection with your products or operations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations. Failure to adequately address violations may result in regulatory or legal action without further notice including, without limitation, seizure and injunction.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.FDA ReviewViolations were identified and documented during a review of your website https://peptide.partners/ in July 2026. Based on our review,“GLP-1 S (Semaglutide),” “GLP-2 T (Tirzepatide),” “GLP-3 Reta (Retatrutide),” “SS-31 (Elamipretide),” “Tesa Peptide (Tesamorelin),” “PT-141 (Bremelanotide),” and “Reconstitution Solution (BAC)” are unapproved new drugs under section 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 355(a). As explained further below, introducing or delivering these products for introduction into interstate commerce violates sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a).This review was conducted as part of FDA’s public health responsibility to protect the public from unsafe, ineffective, and poor-quality drugs.Violations of the Federal Food, Drug, and Cosmetic ActThe following are violations identified during our review. As a reminder, this is not an all-inclusive list of violations that may exist in connection with your products or operations.Unapproved New Drug ViolationsBased on a review of your website, “GLP-1 S (Semaglutide),” “GLP-2 T (Tirzepatide),” “GLP-3 Reta (Retatrutide),” “SS-31 (Elamipretide),” “Tesa Peptide (Tesamorelin),” “PT-141 (Bremelanotide),” and “Reconstitution Solution (BAC)” 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.1 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 (Semaglutide)On the webpage https://peptide.partners/product/glp-1-semaglutide/:“This laboratory study . . . suggests that semaglutide could have potential benefits for bone health by promoting the generation of new bone tissue.”“[T]his lab experiment . . . [suggests] that semaglutide might help improve metabolism by making muscle cells better at producing energy, even if it doesn’t directly fix the insulin resistance problem.”“[T]his laboratory study . . . suggests that semaglutide could have a protective effect on brain cells, which might be relevant for neurodegenerative diseases like Alzheimer’s.”GLP-2 T (Tirzepatide)On the webpage https://peptide.partners/product/glp-2-tirzepatide/:“This research explains how tirzepatide . . . mainly activates the GIP receptor strongly but only partly activates the GLP-1 receptor . . . [which] may help explain why tirzepatide is effective in lowering blood sugar and reducing weight.”“This study shows that tirzepatide . . . help[s] improve blood sugar and lipid levels without increasing fat mass, offering a better understanding of how tirzepatide works to improve metabolic health in diabetes and obesity.”“This study shows that tirzepatide . . . has direct protective effects on the kidneys, which could be beneficial for patients with diabetic kidney disease.”GLP-3 Reta (Retatrutide)On the webpage https://peptide.partners/product/glp-3-retatrutide-12mg-vials/:“Retatrutide . . . can activate three different hormone receptors in the body that control appetite and metabolism . . . allow[ing] it to effectively ‘talk’ to all three at once, leading to its powerful effects on weight loss and blood sugar control.”“Retatrutide, a new drug for diabetes and obesity, helps lower bad fats in the blood . . . part of Retatrutide’s effectiveness in improving cholesterol levels comes from its direct action on the liver.”“Scientists have discovered how the weight-loss drug Retatrutide can also help treat a type of breast cancer that is more common in obese patients . . . made the cancer cells more sensitive to chemotherapy . . . uncover[ing] a new way that obesity affects cancer and suggests that drugs like Retatrutide could be used to improve cancer treatment in obese patients.”SS-31 (Elamipretide)On the webpage https://peptide.partners/product/ss-31/:“This lab study looked at how the peptide SS-31 could protect eye cells from damage . . . when the cells were treated with SS-31 beforehand, they were better able to survive and had less damage . . . suggest[ing] that SS-31 could be a potential treatment to protect the retina.”“SS-31 helps the cells to clean out waste and damaged parts . . . suggesting it could be a promising agent for treating liver inflammation.”Tesa Peptide (Tesamorelin)On the webpage https://peptide.partners/product/tesamorelin/:“[R]esearchers investigated how Tesamorelin affects the liver in people with HIV-associated fatty liver disease . . . and found that the drug changed the activity of genes involved in inflammation, tissue repair, and cell division . . . provid[ing] important insights into the molecular mechanisms by which Tesamorelin improves liver health in this patient population.”PT-141 (Bremelanotide)On the webpage https://peptide.partners/product/pt-141/:“PT-141 works by binding to and activating specific protein receptors on cell surfaces called melanocortin receptors . . . important for understanding how the drug might work in the body to affect sexual function and other processes controlled by these receptors.”“This study discovered that bremelanotide can kill brain cancer cells (glioblastoma) grown in laboratory culture dishes without harming normal cells.”Reconstitution Solution (BAC)Your firm offers “Reconstitution Solution (BAC)” for sale to be used to reconstitute the peptide products sold on your website, which are drugs intended for injection, including the six above-mentioned products. The sale of these products together demonstrates that you intend for your “Reconstitution Solution (BAC)” to be used in combination for injection. Therefore, your “Reconstitution Solution (BAC)” is a drug.“GLP-1 S (Semaglutide),” “GLP-2 T (Tirzepatide),” “GLP-3 Reta (Retatrutide),” ”SS-31 (Elamipretide),” “Tesa Peptide (Tesamorelin),” “PT-141 (Bremelanotide),” and “Reconstitution Solution (BAC)” are “new drugs” under section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because they are not generally recognized as safe and effective (GRASE) for use under the conditions prescribed, recommended, or suggested in their labeling. With certain exceptions not applicable here, a new drug may not be introduced or delivered for introduction into interstate commerce without an approved application from FDA in effect, as described in section 505(a) of the FD&C Act, 21 U.S.C. 355(a). No approved applications pursuant to section 505 of the FD&C Act, 21 U.S.C. 355, are in effect for these products. Accordingly, these products are unapproved new drugs. The introduction or delivery for introduction into interstate commerce of these unapproved new drug products violates sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a).ConclusionAs previously stated, you are responsible for investigating and determining the root causes of any violations and implementing corrective and preventative measures to ensure future and sustained compliance so that these violations and any others do not occur.Send your written response to FDAAdvisory@fda.hhs.gov within fifteen (15) business days of receipt of this letter. Include the specific steps you have taken to correct any violations, an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. Identify your response with reference number “735063” in the subject line of the email.If you have information that you believe demonstrates that your products are not in violation of the FD&C Act and FDA regulations, include that information for our consideration.Please note FDA posts warning letters on www.fda.gov.Sincerely,/S/Tina Smith, M.S.Captain, U.S. Public Health ServiceDirectorOffice of Unapproved Drugs and Labeling ComplianceOffice of ComplianceCenter for Drug Evaluation and ResearchU.S. Food and Drug Administration_______________________1 Despite statements on your product labeling marketing your products “for research use only” and “not for human or veterinary use,” evidence obtained from your website establishes that your products are intended to be drugs for human use. In addition to the cited drug claims, you market bacteriostatic water as a solvent for reconstituting your products, thus, providing the means to prepare an injectable drug for human administration.

根据《药品管理法》《药品生产监督管理办法》《药品生产质量管理规范（2010年修订）》等法律法规规章的规定，我省复寿堂药业河南省有限公司等29家药品上市许可持有人、药品生产企业接受了药品GMP符合性检查，现将检查结果予以通告。附件：药品GMP符合性检查结果情况表2026年8月28日