# FDA 483 - Marcia R. Cruz-Correa, M.D., PhD - June 26, 2025

Source: https://www.keypedia.com/records/483/marcia-r-cruz-correa-md-phd/05147901-9614-429c-bb42-122929adf16e

> FDA 483 for Marcia R. Cruz-Correa, M.D., PhD on June 26, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Marcia R. Cruz-Correa, M.D., PhD
- Inspection Date: 2025-06-26
- Product Type: drugs
- Office Name: San Juan District Office
- Summary: The FDA inspected Pan American Center for Oncology Trials DBA PanOncology Trials, LLC in Rio Piedras, PR, from June 16-26, 2025. The inspection revealed a significant issue where the firm failed to report non-serious adverse events to the sponsor as required by study protocols. Specifically, adverse events documented in source records for multiple subjects across two different clinical trials were not transcribed into the electronic data capture system.

## Related Officers

- [investigator](https://www.keypedia.com/people/jose-a-torres/0c491014-1dd0-4024-99b2-203b830b9c2b)
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Company: https://www.keypedia.com/companies/marcia-r-cruz-correa-md-phd/7bf43950-c1ef-4886-8c50-95e75e370880

Office: https://www.keypedia.com/offices/san-juan-district-office/27661cbf-5ba6-4c1b-9b39-4d6df63ca0e8