US FDA Laboratory and QC controls findings

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 methods Stability studies for each drug product in its marketed container-closure system before distribution is permitted 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 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 All procedures that describe these and other elements of your remediated stability program 4. 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 equipment Qualify contract laboratories prior to use for CGMP testing Validate manufacturing operations prior to commercial distribution Calibrate and maintain equipment as appropriate for its intended use in API production operations Test materials for conformance with in-house or compendial specifications prior to use in manufacturing APIs Perform product reviews at least annually In 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 appropriate Provisions for QU oversight throughout your operations to evaluate adherence to appropriate practices A complete and final review of each batch and its related information before the QU disposition decision Oversight and approval of investigations and discharging of all other QU duties to ensure identity, strength, quality, and purity of all products Drug Recall On 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 Guidance FDA 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 Assessment Contamination 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.…

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.

FDA Review Violations 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 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-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).

Your firm failed to establish laboratory controls that include scientifically sound and appropriate specifications, standards, sampling plans, and test procedures designed to assure that components, drug product containers, closures, in-process materials, labeling, and drug products conform to appropriate standards of identity, strength, quality, and purity (21 CFR (211.160(b)). Your firm did not adequately perform system suitability testing for laboratory equipment before testing your (b)(4) and other critical samples. For example, your firm routinely performed total organic carbon (TOC) and conductivity measurements without prior system suitability of the analyzer. In your response, you acknowledge inadequate procedural requirements and insufficient analyst and supervisor training for performing day-of-use system suitability. You commit to revising procedures and to holistically investigate other test methods. Your response is inadequate. You did not provide details of your review of historical system suitability results that concluded there were no adverse trends for drug products on the market within expiry. Additionally, you did not address the lack of system suitability performance for the other examples cited on the Form FDA 483 and did not expand the review to other laboratory systems beyond the TOC and conductivity systems or retrospectively review results generated with the other systems for accuracy. 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. Your retrospective review of system suitability results from laboratory equipment used to generate data in support of drug product manufacturing and release for distribution, including risk assessments and remediation plans.

Failure to validate and verify the suitability of analytical methods. Based on the records and information you provided, your firm failed to perform test method validation (or verification if compendial testing is used) for each test method used for drugs distributed to the United States. Test methods must be validated to show that they are suitable for their intended use or verified to show, at a minimum, equivalence with United States Pharmacopeia (USP) compendial methods. Method validation and verification are necessary to support reliable determinations of identity, strength, quality, purity, and potency of drugs. Without evaluating the validity of methods, you lack the basic assurance that the data provided to customers were an accurate reflection of pharmaceutical product quality and safety. 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 list of chemical and microbial test methods and specifications used to analyze each lot of your APIs before making decisions about the disposition of a lot, and the associated written procedures.

Your firm failed to use validated and stability-indicating test procedures.