483
University of Missouri - Columbia Research Reactor CenterUniversity of Missouri - Columbia Research Reactor Center – FDA 483, Aug 15, 2019
Record Details
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.
- Inspection date
- August 15, 2019
- Product type
- drugs
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ID · 9284e324-f469-4b2c-98d9-c986f5985906
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