Sterility Assurance

FDA Warning Letter: Unapproved Injectable Peptide Drugs Marketed by Royal Peptides

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FDA identified violations during a July 2026 review of Royal Peptides LLC’s website. FDA determined that products marketed as Tirzepatide, Semaglutide, Retatrutide, SS-31 (Elamipretide), PT-141, Tesamorelin, and BIMORELIN were drugs based on claims concerning metabolic regulation, weight loss, mitochondrial function, hormone modulation, recovery, and sexual dysfunction. FDA stated that these products were unapproved new drugs because they were not generally recognized as safe and effective for the labeled uses and had no approved applications in effect. Although product labeling included statements such as “for research use only” and “not for human or animal consumption,” FDA cited website evidence indicating intended human drug use. FDA also noted that the firm marketed bacteriostatic water with a peptide guide and calculator that collectively provided means to prepare an injectable drug for human administration. The letter does not describe a manufacturing-site inspection or identify specific CGMP, laboratory, validation, facility, or quality-system deficiencies.

FDA Warning Letter: PReye cited for unsuitable aseptic processing and inadequate quality systems

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FDA states that its March 17–19, 2026, inspection of PReye’s drug manufacturing facility found significant finished-pharmaceutical CGMP violations. The firm manually filled multiple drug products from bulk liquid using a small flow hood on an office desk. FDA observed that the hood was neither certified nor qualified and was located in unclassified office space without HEPA filtration. FDA stated that these conditions lacked appropriate facilities, equipment, and process controls to protect products from microbiological contamination. FDA also found no quality unit function or written procedures defining its responsibilities. Basic procedures were absent, including complaint review, supplier qualification, release testing, change management, cleaning, disinfection, and deviation handling. FDA further reported missing batch numbers for sterile ophthalmic products manufactured since 2024, impairing traceability. The firm committed to cease U.S. manufacturing and distribution of PReye Vitamin SEE; it later voluntarily recalled the product because sterility testing had not been performed.

FDA Warning Letter: Fresenius cited for leaking dialysis solution bags and inadequate visual inspection controls

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FDA inspected Fresenius USA Manufacturing’s Ogden, Utah drug facility from March 2-6, 2026, and cited significant CGMP violations involving complaint investigations, CAPA, process controls, and visual inspection of sterile injectable products. For Delflex Peritoneal Dialysis Solution, an August 2025 investigation covered 35 complaints involving approximately 156 leaking bags from multiple batches and attributed holes to printing. FDA stated that the firm assigned the lowest severity despite its matrix identifying peritonitis as a potential harm at the highest severity, did not recall then, and inadequately investigated risk and implemented CAPA. After inspection, reexamination found perforations without substantial fluid in the overwrap; the firm reassessed risk and recalled affected lots on April 6, 2026 for lack of assurance of sterility. FDA found the response still lacked sufficient CAPA to improve leak detection. FDA also found personnel qualification for visual particulate inspection inadequate because the kit was not adequately representative and records lacked sufficient detail, and said the response did not demonstrate reliable detection at an appropriate level.