US FDA Deviation, CAPA, and investigation findings

FDA Review Violations 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 Act The following are violations identified during our review. As a reminder, this is not an all-inclusive list of violations that may exist in connection with your products or operations. Unapproved New Drug Violations Based 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” Semaglutide On, 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-31 On 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-141 On 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” Tesamorelin On, 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 water Your 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).

FDA Review Violations 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 Act The following are violations identified during our review. As a reminder, this is not an all-inclusive list of violations that may exist in connection with your products or operations. Unapproved New Drug Violations Based 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 Peptide On 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 Peptide On 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 Peptide On 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” Survodutide On 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.” Mazdutide On 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 Blend On 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).

Failure to design a documented, ongoing stability testing program to monitor the stability characteristics of APIs and to use the results to confirm the appropriate storage conditions and the retest or expiry dates. Based on the records and information you provided, your firm failed to perform routine stability testing to demonstrate that the quality attributes of your APIs remain acceptable throughout the labeled expiry period. For example, your firm did not provide stability test data for (b)(4) manufactured at your facility. Without an appropriate stability program, you lack adequate scientific evidence to support that your APIs meet established specifications and retain their quality attributes through their labeled expiry period. In response to this letter, provide: A retrospective risk assessment showing how you will ensure that your marketed APIs meet stability specifications throughout their shelf life. A comprehensive, independent assessment and CAPA plan to ensure the adequacy of your stability program. Your remediated program should include but should not be limited to: o Stability indicating methods o Stability studies for each API in its marketed container/closure system before distribution is permitted o An ongoing program in which representative lots of each product are added to the program each year to determine if their shelf-life claim remains valid o A detailed definition of the specific attributes to be tested at each station (time point) o All procedures that describe these and other elements of your remediated stability program Drug Listing Violations Section 510(j) of the FD&C Act and 21 CFR Part 207 set forth the requirements for the listing of drugs. Section 510(j) of the FD&C Act and 21 CFR 207.41 require registrants to list each drug they manufacture for commercial distribution. You did not provide drug listing information for demecarium bromide and chlorambucil under your own labeler code, yet you manufactured and shipped these drugs into the United States. Although these drugs are listed in FDA’s drug listing database, they are listed under a different company’s labeler code, not your own. As the manufacturer distributing these drugs into U.S. commerce, you are required to list them under your own labeler code in accordance with 21 CFR 207.41. Failure to list drugs in accordance with 510(j) of the FD&C Act, 21 U.S.C. 360(j), is prohibited under section 301(p) of the FD&C Act, 21 U.S.C. 331(p). Furthermore, under section 502(o) a drug is misbranded if it is not included in a list required by section 510(j). Under section 301(a), the introduction or delivery for introduction into interstate commerce of any drug that is misbranded is prohibited. Complete, accurate, and up-to-date establishment registration and drug listing information is essential to promote and protect patient safety. FDA relies on establishment registration and drug listing information for several key programs, including drug establishment inspections, supply chain security, and post-market surveillance. Establishment registration and drug listing information is also widely used outside FDA for purposes such as electronic prescribing and electronic health records, insurance reimbursement, and patient education. It is your responsibility to ensure that all drugs manufactured at your establishment comply with all establishment registration and drug listing requirements under section 510 of the FD&C Act, 21 U.S.C. 360, 21 CFR Part 207, and all other applicable FDA regulations. Registration and listing information and instructions on how to properly register an establishment or submit drug listings can be found at Electronic Drug Registration and Listing Instructions.

Your firm failed to establish and follow an adequate written testing program designed to assess the stability characteristics of drug products (21 CFR 211.166(a)). Your firm has not established stability indicating methods for the OTC (b)(4) drug products you distribute to the U.S. market. For example, the validation protocol for the assay of Naphazoline HCl (NPZ) in the (b)(4) formulation detailed a stress study; however, the report stated that the stress study would be performed later and reported separately. Assay for NPZ is a test conducted for stability studies of the (b)(4) formulation. Without forced degradations studies to establish specificity, the accuracy of the test assay results cannot be assured throughout the shelf-life of the product during stability. In your response, you acknowledge that initial forced degradation studies for the current OTC (b)(4) formulations could not be located, and you commit to repeating these studies and creating an action plan based on the results. In addition, you commit to conducting a three-year retrospective review for the active pharmaceutical ingredient (API) testing during stability for each product code and to conducting a review of prior annual product reviews to evaluate any stability trends observed for the API and preservative systems for each product code. Proper document control and data management is foundational to CGMP to ensure the availability and integrity of data. Data should be attributable, legible, contemporaneously recorded, original or a true copy, and accurate (ALCOA) to ensure complete and accurate records. Your response is inadequate. Your review of retrospective data using methods that have not been validated as stability indicating provides insufficient confidence in your marketed drug products. Upon development of your stability indicating methods, you should add additional batches to your stability program, including retains of older batches (e.g., (b)(4) ). You did not assess the impact of inadequate stability testing and the potential for degradation products in OTC (b)(4) drug products within expiry distributed to the U.S. market. 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 independent assessment and CAPA plan to ensure the adequacy of your stability program. Your remediated program should include, but not be limited to: o Stability indicating methods. o Stability studies for each drug product in its marketed container-closure system before distribution is permitted. o An ongoing program in which representative batches of each product are added each year to the program to determine whether the shelf-life claim remains valid o Detailed 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-life. o All procedures that describe these and other elements of your remediated stability program. A commitment to notify FDA within 3 days of any stability failures.

Your firm’s quality control unit failed to exercise its responsibility to ensure drug products manufactured are in compliance with CGMP, and meet established specifications for identity, strength, quality, and purity (21 CFR 211.22). Your firm failed to establish an adequate QU with the responsibilities and authority to oversee the manufacturing of drug products. For example, the QU failed to ensure: Establishment of appropriate written procedures for production and process controls, including appropriate qualification of the (b)(4) system (21 CFR 211.100(a)). Establishment of an appropriate written testing program designed to assess the stability characteristics of drug products and to use results of stability testing to determine appropriate storage conditions and expiration dates (21 CFR 211.166(a)). Establishment of adequate written procedures defining QU responsibilities and controls (21 CFR 211.22(d)). An adequate number of qualified personnel to perform and supervise the manufacturing, processing, packing, or holding of each drug product (21 CFR 211.25(c)). Your firm’s quality systems are inadequate. For help implementing quality systems and risk management approaches to meet the requirements of CGMP regulations 21 CFR, parts 210 and 211, see FDA’s guidance documents Quality Systems Approach to Pharmaceutical CGMP Regulations at https://www.fda.gov/media/71023/download, Q9(R1) Quality Risk Management at https://www.fda.gov/media/167721/download, and ICH Q10 Pharmaceutical Quality System at https://www.fda.gov/media/71553/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 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. CGMP Consultant Recommended 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 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. Drug Listing Violations Section 510(j) of the FD&C Act and 21 CFR Part 207 set forth the requirements for the listing of drugs. In addition to listing a drug that you manufacture under your own labeler code, under 21 CFR 207.41(c)(1), you are required to list each drug you manufacture for commercial distribution under the trade name or label of a PLD using an NDC that includes such PLD’s labeler code. Evidence from the most recent inspection of your site and a search of eDRLS confirms that you are manufacturing KleenLine Alcohol-Free Sanitizing Wipes for a PLD, Brady Industries, Inc., but you did not list this drug under the PLD’s trade name and labeler code as required. Therefore, you failed to fulfill your drug listing obligations in accordance with section 510 of the FD&C Act. Failure to provide listing information for a drug in accordance with 510(j) of the FD&C Act is prohibited under section 301(p) of the FD&C Act. Under section 502(o), a drug is misbranded if it is not included in a list required by section 510(j). Under section 301(a), the introduction or delivery for introduction, or the causing thereof, into interstate commerce of any drug that is misbranded is prohibited. Complete, accurate, and up-to-date establishment registration and drug listing information is essential to promote and protect patient safety. FDA relies on establishment registration and drug listing information for several key programs, including drug establishment inspections, supply chain security, and post-market surveillance. Establishment registration and drug listing information is also widely used outside FDA for purposes such as electronic prescribing and electronic health records, insurance reimbursement, and patient education. We note that the labeling provided in your drug listing for Hand Sanitizing Alcohol-Free Wipes, NDC 84111-000, bears the trade name of what appears to be another PLD. Please update your labeling accordingly. It is your responsibility to ensure that all drugs manufactured at your establishment comply with all establishment registration and drug listing requirements under section 510 of the FD&C Act, 21 U.S.C. 360, 21 CFR Part 207, and all other applicable FDA regulations. Registration and listing information and instructions on how to properly register an establishment or submit drug listings can be found at Electronic Drug Registration and Listing Instructions .

Deviation from the procedural requirements of a decree of injunction.