483
Claudia R. Padilla, M.D.FDA 483 - Claudia R. Padilla, M.D. - November 12, 2021
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Record Details
An FDA inspection of Claudia R. Padilla, M.D. in Dallas, TX, revealed significant deviations from the investigational plan during a clinical study. The firm failed to document the review of electrocardiograms for multiple subjects as required by the protocol. Additionally, laboratory specimens were improperly stored on-site and shipped late, rendering them beyond stability for analysis.
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ID · 1957be82-1b92-4480-bee6-a4fdf43c102b