Sterility Assurance

FDA Cites Sterile Injectable CGMP Violations at Fresenius Kabi Facility

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FDA issued a warning letter to Fresenius Kabi AG after a January 27 to February 18, 2026 inspection identified significant CGMP violations at its Melrose Park sterile injectable facility. FDA cited inadequate investigations of endotoxin and bioburden signals, media fill failures, complaints, and biological particulate contamination; deficient aseptic process simulations and cleanroom practices; and inadequate visual inspection, facility, and equipment controls. The letter states that investigations overrelied on passing finished-product tests and lacked supported root causes, broad scope, and CAPA effectiveness checks. It also describes recalls of three famotidine injection batches and, following FDA discussions, six batches of other injectable products. FDA requested independent assessments, retrospective reviews, remediation plans, and a response within 15 business days.

FDA Warning Letter: Aseptic Processing and Media-Fill Deficiencies at Empower Pharmacy

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FDA states that its November 3-14, 2025, inspection found Empower Pharmacy’s compounded semaglutide and tirzepatide products did not meet section 503A conditions, making the ineligible products subject to CGMP. Investigators observed that sterile products were prepared under insanitary conditions. Smoke studies did not adequately demonstrate unidirectional airflow under dynamic conditions, and media fills were not conducted under the most challenging conditions. FDA also cited inadequate maintenance systems for equipment controlling aseptic conditions, deficient procedures to prevent microbiological contamination and validate aseptic and sterilization processes, inadequate environmental monitoring, insufficient production and process-control procedures, and failure of the quality control unit to ensure CGMP compliance and product specifications. In reviewing corrective actions, FDA said a revised smoke study remained unfinalized. It also identified unexplained vial-count discrepancies, missing or unclear media-fill records, undefined “N/A” entries, and transcription of original results onto a revised form without a clear audit trail, authorization, or justification.

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.