FDA 483 - Xenova Sciences, LLC - September 12, 2025

An FDA inspection of Xenova Sciences, LLC's API manufacturing facility in Gretna, NE, revealed significant deficiencies in quality control and CGMP compliance. Observations included failures in scientifically establishing sampling plans and test procedures for microbial control, and inadequate microbial testing in stability programs. The quality unit also failed to ensure CGMP compliance, with issues in batch record review, incomplete cleaning validation, and insufficient employee training documentation.