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

Source: https://www.keypedia.com/records/483/dr-pablo-forte-soto-md-msc-dphil/4ea030fa-ede9-45bd-bdcd-be3961806740

> FDA 483 for Dr. Pablo Forte Soto MD, MSc, DPhil on May 02, 2025. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Dr. Pablo Forte Soto MD, MSc, DPhil
- Inspection Date: 2025-05-02
- Product Type: other
- Office Name: Office of Inspections and Investigations
- Summary: 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.

## Related Officers

- [Bioresearch Monitoring Foreign Inspection Cadre Member](https://www.keypedia.com/people/richard-w-berning/4637e321-8803-4fcf-911f-bbc810c3487d)

Company: https://www.keypedia.com/companies/dr-pablo-forte-soto-md-msc-dphil/98b1c126-0a8e-4bd9-a951-c135dd756ff7

Office: https://www.keypedia.com/offices/office-of-inspections-and-investigations/7dd0b904-a3df-46bc-a7b2-70ddb6f809c8