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

Source: https://www.globalkeysolutions.net/records/483/xenova-sciences-llc/d080cd32-7a08-4961-bf1f-4c82572af6fb

> FDA 483 for Xenova Sciences, LLC on September 12, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Xenova Sciences, LLC
- Inspection Date: 2025-09-12
- Product Type: drugs
- Office Name: Kansas City District Office
- Summary: 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.

## Related Officers

- [Consumer Safety Officer , Investigator](https://www.globalkeysolutions.net/people/lisa-r-hilliard/611735cf-5c20-424c-801a-03888d8d1b0a)

Company: https://www.globalkeysolutions.net/companies/xenova-sciences-llc/57e22573-aa81-4f29-82a3-7623c0363f22

Office: https://www.globalkeysolutions.net/offices/kansas-city-district-office/cd397ab1-df4e-46f1-ab1c-0f6db9abcf79