# FDA 483 - Rogerio Lobo - Unknown Date

Source: https://www.keypedia.com/records/483/rogerio-lobo/d9cf25ab-c433-45d7-b046-0a90f9c819aa

> FDA 483 for Rogerio Lobo on Unknown Date. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Rogerio Lobo
- Product Type: drugs
- Office Name: New York District Office
- Summary: An FDA inspection of Rogerio A. Lobo, M.D. at Columbia University Medical Center in New York revealed significant deficiencies in sponsor oversight of an investigational new drug (IND) study. The firm failed to submit annual reports, adequately monitor clinical investigators, ensure investigator qualifications, and maintain control over the investigational drug. These failures led to issues with adverse event reporting and overall study compliance.

## Related Officers

- [investigator](https://www.keypedia.com/people/thomas-p-hansen/2b3af3e0-445c-460b-be6f-6db03999ff7e)

Company: https://www.keypedia.com/companies/rogerio-lobo/5b228f74-af60-4bea-b969-fddd5ae4963f

Office: https://www.keypedia.com/offices/new-york-district-office/9fa3d265-16ca-438d-8a6e-b47f60dc260d