Dr. Pablo Forte Soto MD, MSc, DPhilMay 2, 2025

FDA 483 - Dr. Pablo Forte Soto MD, MSc, DPhil - May 02, 2025

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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.

Company: Dr. Pablo Forte Soto MD, MSc, DPhil
Inspection Date: May 2, 2025
Product Type: Other
Office: Office of Inspections and Investigations
Person: Richard W. Berning (Bioresearch Monitoring Foreign Inspection Cadre Member)

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ID · 4ea030fa-ede9-45bd-bdcd-be3961806740