483
Valencia Technologies CorporationFDA 483 - Valencia Technologies Corporation - November 17, 2021
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An FDA inspection of Valencia Technologies, a sponsor of investigational studies, identified one observation related to inadequate clinical monitoring. The firm failed to ensure proper monitoring for an investigational study, specifically by not conducting initial on-site monitoring visits according to its own Clinical Monitoring Plan for several study sites. This indicates a deviation from established procedures for overseeing clinical trials.
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ID · 99f50a60-d120-4f48-bd6d-586193978bf9