483
Covance by LabcorpFDA 483 - Covance by Labcorp - May 20, 2021
Discuss this record with AI
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.
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.
- Office
- Atlanta District Office
- Person
Open in Dashboard
ID · 7a6bfe64-9576-4295-abd3-9eee9a8b41af