483
Covance by LabcorpCovance by Labcorp – FDA 483, May 20, 2021
Record Details
An FDA inspection of Covance by Labcorp in Durham, NC, a Contract Research Organization, revealed a failure to ensure proper monitoring of a clinical study. Approximately 100 protocol deviations, some deemed "important," were not identified in a timely manner. These issues impacted subject safety, regulatory compliance, and data integrity.
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ID · 7a6bfe64-9576-4295-abd3-9eee9a8b41af
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