US FDA Findings

Fairlue to appropriately and regularly clean and disinfect or sterilize equipment located in the ISO 5 area.

Beta-lactam drugs were produced without providing adequate containment, segregation, and/or cleaning of work surfaces, utensils, and/or personnel to prevent cross-contamination.

Microbial contamination was present in the.

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 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).