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

An unannounced FDA inspection of Xenova Sciences, LLC, an Active Pharmaceutical Ingredient (API) manufacturer in Gretna, NE, was conducted from September 8-12, 2025. This inspection, performed under CPGM 7356.002F for API Process Inspections, assessed compliance with Current Good Manufacturing Practices (CGMP) in drug manufacturing. The inspection resulted in three significant observations, documented in an FDA 483 form. Firstly, the company failed to ensure scientifically sound sampling plans and test procedures for intermediates and API, specifically noting inadequate microbial control validation and a lack of microbial testing in the stability program. Secondly, the quality unit did not consistently ensure CGMP compliance, evidenced by undocumented batch record reviews for destroyed lots, incomplete cleaning validations for critical equipment prior to commercial operations, and insufficient documentation of annual CGMP refresher training for employees. Lastly, production batch records lacked consistent review for completeness and signatures, and critical process parameters were not clearly identified within these records. Xenova Sciences' management acknowledged the findings and committed to submitting a written response to the FDA 483 within 15 business days.