# FDA 483 - University of Missouri - Columbia Research Reactor Center - October 23, 2025

Source: https://www.keypedia.com/records/483/university-of-missouri-columbia-research-reactor-center/0a24a002-85ad-4fab-87e5-d5daa2c9b481

> FDA 483 for University of Missouri - Columbia Research Reactor Center on October 23, 2025. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: University of Missouri - Columbia Research Reactor Center
- Inspection Date: 2025-10-23
- Product Type: drugs
- Office Name: Kansas City District Office
- Summary: The Food and Drug Administration (FDA) issued a Form 483 to the University of Missouri - Columbia Research Reactor Center following an inspection conducted from October 15-23, 2025. The inspection of this sterile and non-sterile API manufacturer identified two significant observations related to quality control and deviation management, indicating potential non-compliance with Good Manufacturing Practices.

Firstly, the facility's quality control unit lacked written procedures for, and did not consistently follow, the review of audit trails in computer systems used for product testing, specifically for purity analysis of Active Pharmaceutical Ingredients. The firm's Data Integrity Standard Operating Procedure also failed to mandate such audit trail reviews.

Secondly, the Quality Unit did not adequately investigate and resolve critical deviations, particularly environmental monitoring (EM) excursions in ISO-classified production areas. Investigations into high-risk EM events, involving fungal and bacterial contaminants, were found to be insufficient, lacking comprehensive product impact assessments, thorough root cause analyses, and robust corrective and preventive actions. Despite multiple high-risk excursions, the firm reportedly never rejected a product batch due to these environmental contamination events.

To address these observations, the University of Missouri - Columbia Research Reactor Center is expected to implement prompt corrective actions. This includes revising and adhering to written procedures for audit trail review and significantly enhancing its deviation investigation processes to ensure comprehensive root cause analysis, product impact assessment, and effective resolution of environmental monitoring excursions, aligning with regulatory expectations for API manufacturing.

## Related Documents

- [483 - 2019-08-15](https://www.keypedia.com/records/483/university-of-missouri-columbia-research-reactor-center/9284e324-f469-4b2c-98d9-c986f5985906)

## Related Officers

- [Wayne D. Mcgrath](https://www.keypedia.com/people/wayne-d-mcgrath/42db5ab0-2e0b-4909-951c-e7621cd04f6e)
- [Consumer Safety Officer](https://www.keypedia.com/people/eric-d-bowles/bb6c783b-0933-4231-b79e-c591cbc50104)

Company: https://www.keypedia.com/companies/university-of-missouri-columbia-research-reactor-center/8b52f6ac-83c0-4557-834e-e421d6114e0b

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