483
Dr. Pablo Forte Soto MD, MSc, DPhilDr. Pablo Forte Soto MD, MSc, DPhil – FDA 483, May 2, 2025
Record Details
An FDA inspection of Dr. Pablo Forte Soto MD, MSc, DPhil, FFPM, a clinical investigator in Harrow, United Kingdom, identified a significant issue regarding the maintenance of study documentation. The firm failed to maintain adequate case histories, specifically by destroying critical paper code break envelopes after study closure. This destruction prevented the FDA investigator from verifying the proper conduct of the study.
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