# FDA 483 - University of Missouri - Columbia Research Reactor Center - August 15, 2019

Source: https://www.globalkeysolutions.net/records/483/university-of-missouri-columbia-research-reactor-center/9284e324-f469-4b2c-98d9-c986f5985906

> FDA 483 for University of Missouri - Columbia Research Reactor Center on August 15, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: University of Missouri - Columbia Research Reactor Center
- Inspection Date: 2019-08-15
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - West II
- Summary: An FDA inspection of Missouri University Reactor Research (MURR) in Columbia, MO, identified a significant deficiency in their record-keeping practices. The firm failed to maintain records for annual product reviews, specifically for Lutetium (LU-177) and another drug product, with the last reviews conducted in 2016. This indicates a lapse in evaluating drug product quality standards and determining the need for changes in manufacturing or control procedures.

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Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-west-ii/8851d151-0390-4d17-be66-fd86d12aa6b8